Public Meeting Binder

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Board Meeting

August 14, 2019

NOTE: Pursuant to the Open Meetings Law at La. R.S. 42:16, the Board may, upon 2/3 affirmative vote of those members present and voting, enter into executive session for the limited purposes of (1) discussion of the character, professional competence, or physical or mental health of a licensee, (2) investigative proceedings regarding allegations of misconduct, (3) strategy sessions or negotiations with respect to litigation, (4) discussions regarding personnel matters, or other purposes itemized at La. R.S. 42:17. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; [email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; [email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq. Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Table of Contents

1 – A. Table of Contents 002 1 – B. Meeting Notice & Arrangements 004 1 – C. Acronyms 005 1 – D. Agenda 010 2. Invocation & Pledge of Allegiance 3. Quorum Call 4. Call for Additional Agenda Items & Adoption of Agenda 5. Consideration of Minutes from Previous Meetings ~ May 29, 2019 013 6. Report on Action Items 042 7. Confirmation of Acts 8. Opportunity for Public Comment * Statement of Purpose & Mission of Board 9. Special Orders of the Day 10. Committee Reports A. Finance – Mr. McKay 055 • Consideration of Final Report for Fiscal Year 2018-2019 056 • Consideration of Budget Amendment No. 1 for Fiscal Year 2019-2020 072 B. Application Review – Mr. Soileau 078 C. Reciprocity – Mr. Cassidy 079 • List of Pharmacists Licensed by Reciprocity 080 D. Violations – Mr. Indovina 081 • Consideration of Proposed Voluntary Consent Agreements 082 • Consideration of Proposed Revision of PPM.I.C.7.c ~ Violations Committee – CE Audits/Cases 118 E. Impairment – Ms. Hall 123 • Consideration of Committee Recommendations re Applications F. Reinstatement – Mr. Moore 124 • Consideration of Committee Recommendations re Applications G. Tripartite – Mr. Resweber 125 H. Regulation Revision – Mr. McKay 126 • Consideration of Comments & Testimony from June 26 Public Hearing 127 • Consideration of Regulatory Proposal 2019-E ~ Cannabis MDI (Draft #1) 211 • Consideration of USP-800 Subcommittee Recommendations 212 I. Executive Committee – Mr. Aron 224 • Review of Final Legislative Brief 225 • Consideration of Request to Interpret LAC 46:LIII2451.N ~ Sale of CBD Oil Products in Marijuana Pharmacies 236 • Consideration of Request to Interpret LAC 46:LIII.2457.D.4.b ~ Reporting of Marijuana Product Dispensing Transactions 237 • Consideration of Request to Interpret La. R.S. 37:1213 + LAC 46:LIII.511 + 703.A.4 + 903.A.3.f + 905.B.5 ~ Reporting Changes of Pharmacy Employment 238 • Consideration of Proposed Revision of LPM.I.Q.2 ~ Transitional Duty Employment Audit Form 241 • Consideration of Proposed Revision of PPM.I.A.26 ~ Sale of CBD Oil (Guidance Document) 242 • Consideration of Proposed Revision of PPM.I.B.6 ~ Board Liaisons to Other Entities 246

Board Meeting August 14, 2019 Page 2 of 2

10. Committee Reports (cont.) I. Executive Committee (cont.) • Consideration of Requests for Approval of Pharmacy Technician Training Programs:  Penn Foster College [Scottsdale, AZ] 248  Medical Education & Training Campus [Joint Base San Antonio, TX] 249 11. Staff Reports J. Assistant Executive Director – Mr. Fontenot 251 • Quarterly Report from Prescription Monitoring Program (PMP) 252 • Consideration of Requests for Waivers from PMP Reporting Rule 262 K. General Counsel – Mr. Finalet 279 • Consideration of Proposed Voluntary Consent Agreements 280 L. Executive Director – Mr. Broussard 288 • Narrative Report 289 • Internal Reports  Credentials Div. – Census Report 296  Credentials Div. – License Activity Report 299  Credentials Div. – Pending Application Report 300  Credentials Div. – Exceptions Report 301  Compliance Div. – Census Report 303  Compliance Div. – Complaint Investigation Policy Monitor 304  Compliance Div. – Annual Statistical Summary 305 • External Reports  Annual Report 311 • Examination Reports  Pharmacists – MPJE 325  Pharmacists – NAPLEX 330  Technicians – ExCPT 335  Technicians – PTCE 337 • Hurricane Barry Assessment 343 • Attorney General Civil Law Training – Registration & Schedule 344 • Enhancing Well-being and Resilience Among the Pharmacist Workforce ~ A National Consensus Conference 346 12. Request for Approval of Pilot Project – Automated Medication System in Correctional Facilities – Mr. Robert Sonnier (Institutional Pharmacies of Louisiana – Scott, LA) 352 13. New Agenda Items Added During Meeting 368 14. Announcements 370 15. Recess Acronyms

AACP American Association of Colleges of Pharmacy AAPS American Association of Pharmaceutical Scientists AAPT American Association of Pharmacy Technicians ACA American College of Apothecaries ACCME Accreditation Council for Continuing Medical Education ACCP American College of Clinical Pharmacy ACE Advisory Committee on Examinations (NABP) ACHC Accreditation Commission for Health Care ACPE Accreditation Council for Pharmacy Education ADA American Dental Association ADC automated dispensing cabinet ADS automated dispensing system AFDO Association of Food & Drug Officials AFPE American Foundation for Pharmaceutical Education AIHP American Institute of the History of Pharmacy AMA American Medical Association AMCP Academy of Managed Care Pharmacy AMS automated medication system APEC Australian Pharmacy Examining Council APhA American Pharmacists Association APPE advanced pharmacy practice experience ASAE American Society of Association Executives ASAP American Society for Automation in Pharmacy ASCP American Society of Consultant Pharmacists ASHP American Society of Health-System Pharmacists ASPEN American Society of Parenteral & Enteral Nutrition ASPL American Society for Pharmacy Law ATT authorization to test AVMA American Veterinary Medical Association AWARxE NABP consumer protection program BNDD Bureau of Narcotics and Dangerous Drugs BPS Board of Pharmacy Specialties CAC Citizen Advocacy Center CCAPP Canadian Council for Accreditation of Pharmacy Programs CCGP Commission for Certification in Geriatric Pharmacy CDC U.S. Centers for Disease Control and Prevention CDER U.S. Center for Drug Evaluation and Research (FDA) CDTM collaborative drug therapy management CDS controlled dangerous substances CE continuing education CFR Code of Federal Regulations CHPA Consumer Healthcare Products Association CLEAR Council on Licensure, Enforcement and Regulation CMI consumer medication Information CMS U.S. Centers for Medicare and Medicaid Services CPD continuing professional development CPhA Canadian Pharmacists Association CPPA Center for Pharmacy Practice Accreditation CPSC U.S. Consumer Product Safety Commission

Revised 2018-0101 DEA U.S. Drug Enforcement Administration DEQ La. Department of Environmental Quality DME durable medical equipment DMEPOS durable medical equipment, prosthetics, orthotics, and supplies DNV Det Norske Veritas (Norwegian accreditation organization) DOA La. Div. of Administration DOA – FPC La. Div. of Administration – Facility Planning & Control DOA – ORM La. Div. of Administration – Office of Risk Management DOA – OSR La. Div. of Administration – Office of State Register DOA – OSRAP La. Div. of Administration – Office of Statewide Reporting & Accounting Policy DOE La. Dept. of Education DPSC La. Dept. of Public Safety & Corrections DSCS La. Dept. of State Civil Service DSM disease state management EDK emergency drug kit ELTP Electronic Licensure Transfer Program (NABP) EPA U.S. Environmental Protection Agency EPCS Electronic Prescribing of Controlled Substances (DEA) ETS Educational Testing Service EU European Union ExCPT Examination for the Certification of Pharmacy Technicians FARB Federation of Associations of Regulatory Boards FBI Federal Bureau of Investigation FD&C Federal Food, Drug & Cosmetic Act FDA U.S. Food & Drug Administration FEIS Fiscal & Economic Impact Statement FIP Federation Internationale Pharmaceutique FMI Food Marketing Institute FPGEC Foreign Pharmacy Graduate Examination Committee (NABP) FPGEE Foreign Pharmacy Graduate Equivalency Examination (NABP) FSBPT Federation of State Boards of Physical Therapy FSMB Federation of State Medical Boards FRC Foreign Pharmacy Graduate Equivalency Examination Review Committee (NABP) FTC U.S. Federal Trade Commission GOHSEP Governor’s Office of Homeland Security & Emergency Preparedness GPhA Generic Pharmaceutical Association GPO U.S. Government Publishing Office gTLD generic top level domain (Internet addresses) HCFA Health Care Financing Administration HDMA Healthcare Distribution Management Association HIPAA Health Insurance Portability and Accountability Act (of 1996) HIPDB Healthcare Integrity and Protection Data Bank HMO health maintenance organization IACP International Academy of Compounding Pharmacists ICANN Internet Corporation for Assigned Numbers and Names ICPT Institute for the Certification of Pharmacy Technicians IDOI Internet Drug Outlet Identification (NABP) INEOA International Narcotic Enforcement Officers Association IOM Institute of Medicine IPPE introductory pharmacy practice experience IRS U.S. Internal Revenue Service

Revised 2018-0101 ISMP Institute for Safe Medication Practices JCPP Joint Commission of Pharmacy Practitioners JLCB Joint Legislative Committee on the Budget LAC Louisiana Administrative Code LAMP Louisiana Academy of Medical Psychologists LANP Louisiana Association of Nurse Practitioners LAPA Louisiana Academy of Physician Assistants LASERS La. State Employees Retirement System LASIE Louisiana Association of Self-Insured Employers LBDDD La. Board of Drug & Device Distributors LBP La. Board of Pharmacy LDA Louisiana Dental Association LDAF La. Dept. of Agriculture & Forestry LDH La. Dept. of Health LDI La. Dept. of Insurance LDR La. Dept. of Revenue LFO Legislative Fiscal Office LHA Louisiana Hospital Association LIPA Louisiana Independent Pharmacies Association LLA La. Legislative Auditor LPA Louisiana Pharmacists Association LPC Louisiana Pharmacy Congress LPTA Louisiana Physical Therapy Association LPTB Louisiana Physical Therapy Board LSA Louisiana Sheriffs’ Association LSBD La. State Board of Dentistry LSBME La. State Board of Medical Examiners LSBN La. State Board of Nursing LSBOE La. State Board of Optometry Examiners LSBPNE La. State Board of Practical Nurse Examiners LSBVM La. State Board of Veterinary Medicine LSHP Louisiana Society of Health-System Pharmacists LSMS Louisiana State Medical Society LSNA Louisiana State Nurses Association LTC long term care LTCF long term care facility LVMA Louisiana Veterinary Medical Association MPJE Multistate Pharmacy Jurisprudence Examination (NABP) MRC MPJE Review Committee (NABP) NABP National Association of Boards of Pharmacy NABP-F National Association of Boards of Pharmacy Foundation NABPLAW National Association of Boards of Pharmacy – Law Database NACDS National Association of Chain Drug Stores NADDI National Association of Drug Diversion Investigators NAMSDL National Alliance for Model State Drug Laws NAPLEX North American Pharmacist Licensure Examination (NABP) NAPRA National Association of Pharmacy Regulatory Authorities (Canada) NASCSA National Association of State Controlled Substance Authorities NASPA National Alliance of State Pharmacy Associations NASPER National All Schedules Prescription Electronic Reporting Act NCC MERP National Coordinating Council for Medication Error Reporting and Prevention

Revised 2018-0101 NCPA National Community Pharmacists Association NCPDP National Council for Prescription Drug Programs NCPIE National Council on Patient Information and Education NCPO National Conference of Pharmaceutical Organizations NCSBN National Council of State Boards of Nursing NCVHS National Committee on Vital and Health Statistics NDC National Drug Code NDMA Nonprescription Drug Manufacturing Association NIPCO National Institute for Pharmacist Care Outcomes NISPC National Institute for Standards in Pharmacist Credentialing NOCA National Organization for Competency Assurance NPA National Pharmacy Association NPC National Pharmaceutical Council NPDB National Practitioner Data Bank NPTA National Pharmacy Technician Association NRC NAPLEX Review Committee (NABP) Federal Nuclear Regulatory Commission OAL Optometry Association of Louisiana OBRA Omnibus Budget Reconciliation Act OIG Office of Inspector General ONDCP Office of National Drug Control Policy ONDD Office of Narcotics and Dangerous Drugs OPEB other post employment benefits OSHA Occupational Safety and Health Administration PBM pharmacy benefit management PCAB Pharmacy Compounding Accreditation Board PCCA Professional Compounding Centers of America PCMA Pharmaceutical Care Management Association PCOA Pharmacy Curriculum Outcomes Assessment (NABP) PDMA Prescription Drug Marketing Act PEBC Pharmacy Examining Board of Canada PhRMA Pharmaceutical Research and Manufacturers of America PMP Prescription Monitoring Program PMP-i Prescription Monitoring Program Interconnect (NABP) PTAC Pharmacy Technician Accreditation Commission PTCB Pharmacy Technician Certification Board PTCE Pharmacy Technician Certification Examination PTEC Pharmacy Technician Educators Council PTTP pharmacy technician training program RFID/EPC Radio Frequency Identification / Electronic Product Code RS Louisiana Revised Statutes SAMSHA U.S. Substance Abuse & Mental Health Services Administration SEGBP State Employees Group Benefit Program TJC The Joint Commission TOEFL Test of English as a Foreign Language TOEFL iBT Test of English as a Foreign Language Internet-based Test TSE Test of Spoken English URAC Utilization Review Accreditation Commission USP United States Pharmacopeia / United States Pharmacopeial Convention USP DI U.S. Pharmacopeia Dispensing Information USP-NF U.S. Pharmacopeia – National Formulary

Revised 2018-0101 VAWD Verified-Accredited Wholesale Distributors (NABP) Vet-VIPPS Veterinary-Verified Internet Pharmacy Practice Sites (NABP) VIPPS Verified Internet Pharmacy Practice Sites (NABP) VPP Verified Pharmacy Practice (NABP) WHO World Health Organization WHPA World Health Professions Alliance

Revised 2018-0101 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

NOTICE IS HEREBY GIVEN that a meeting of the Board has been ordered and called for 9:00 a.m. on Wednesday, August 14, 2019 at the Board office, for the purpose to wit: A G E N D A NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official. Revised 08-08-2019

1. Call to Order 2. Invocation & Pledge of Allegiance 3. Quorum Call 4. Call for Additional Agenda Items & Adoption of Agenda 5. Consideration of Minutes from Previous Meetings – May 29, 2019 6. Report on Action Items 7. Confirmation of Acts 8. Opportunity for Public Comment 9. Special Orders of the Day 10. Committee Reports A. Finance – Mr. Pitre • Consideration of Final Report for Fiscal Year 2018-2019 • Consideration of Proposed Budget Amendment for Fiscal Year 2019-2020 B. Application Review – Mr. Soileau C. Reciprocity – Mr. Cassidy D. Violations – Mr. Indovina • Consideration of Proposed Voluntary Consent Agreements (1) Case No. 18-0215 ~ PHY.002662 – MPI, Inc. d/b/a Michel’s Pharmacy of Bayou Vista f/k/a Medicine Shoppe of Bayou Vista [Morgan City, LA] (2) + Case No. 18-0216 ~ PST.011999 – Steve Patrick Michel (3) + Case No. 18-0217 ~ CPT.009534 – Tawanna Lynn Thomas (4) Case No. 19-0101 ~ PHY.007127 – Fred’s Stores of Tennessee, Inc. d/b/a Fred’s Pharmacy No. 3079 [Sterlington, LA] (5) + Case No. 19-0133 ~ CPT.005937 – Jenni Lee Anderson (6) Case No. 19-0089 ~ PHY.007430 – Partners Pharmacy of Texas, LLC d/b/a Advanced Pharmacy [Stafford, TX] (7) Case No. 19-0064 ~ PST.017980 – Christopher Brooks Klingman (8) Case No. 19-0104 ~ PHY.003625 – Pharmaceutical Specialties, LLC d/b/a Pharmaceutical Specialties [Baton Rouge, LA] (9) Case No. 19-0054 ~ PHY.007770 – Belleview Pharmacy, LLC d/b/a Belleview Pharmacy [Plaquemine, LA] (10) + Case No. 19-0056 ~ PST.018760 – Darvis Keon Harvey

Board Meeting August 14, 2019 Page 2 of 3

10. Committee Reports (cont.) D. Violations (cont.) • Consideration of Proposed Revision of PPM.I.C.7.c ~ Violations Committee – CE Audits/Cases E. Impairment – Ms. Hall • Consideration of Committee Recommendations re Applications F. Reinstatement – Mr. Moore • Consideration of Committee Recommendations re Applications G. Tripartite – Mr. Resweber H. Regulation Revision – Mr. McKay • Consideration of Comments & Testimony from June 26 Public Hearing • Consideration of Renewal of Pilot Project – Automated Medication System in Unlicensed Medical Clinic Setting (Highgate Apothecary – Covington, LA) • Consideration of Regulatory Proposal 2019-E ~ Cannabis MDI (Draft #1) • Consideration of USP-800 Subcommittee Recommendations I. Executive – Mr. Aron • Review of Final Legislative Brief • Consideration of Request to Interpret LAC 46:LIII.2451.N ~ Sale of CBD Oil Products in Marijuana Pharmacies • Consideration of Request to Interpret LAC 46:LIII.2457.D.4.b ~ Reporting of Marijuana Product Dispensing Transactions • Consideration of Request to Interpret La. R.S. 37:1213 + LAC 46:LIII.511 + 703.A.4 + 903.A.3.f + 905.B.5 ~ Reporting Changes in Pharmacy Employment • Consideration of Proposed Revision of LPM.I.Q.2 ~ Transitional Duty Employment Audit Form • Consideration of Proposed Revision of PPM.I.A.26 ~ Sale of CBD Oil (Guidance Document) • Consideration of Proposed Revision of PPM.I.B.6 ~ Board Liaisons to Other Entities • Consideration of Approval of Pharmacy Technician Training Programs  Penn Foster College (Scottsdale, AZ)  Medical Education & Training Campus (Joint Base San Antonio, TX) 11. Staff Reports J. Assistant Executive Director – Mr. Fontenot • Quarterly Report of Prescription Monitoring Program (PMP) • Consideration of Requests for Waivers from PMP Reporting Requirement K. General Counsel – Mr. Finalet • Consideration of Proposed Voluntary Consent Agreements & Surrenders (1) Case No. 19-0167 ~ CPT.013944 – Jasman Carrington Wilton

Board Meeting August 14, 2019 Page 3 of 3

11. Staff Reports (cont.) K. General Counsel (cont.) (2) Case No. 19-0174 ~ PST.016442 – Marco Bisa Hawkins Moran (3) Case No. 19-0202 ~ PHY.004331 – Contract Pharmacy Services, Inc. d/b/a Contract Pharmacy Services [Warrington, PA] (4) Case No. 19-0228 ~ PST.020652 – Kelly Leigh Goodson L. Executive Director – Mr. Broussard • Consideration of Annual Report for Fiscal Year 2018-2019 12. Request for Approval of Pilot Project – Automated Medication Systems in Correctional Facilities – Mr. Robert Sonnier (Institutional Pharmacies of Louisiana – Scott, LA) 13. New Agenda Items Added During Meeting 14. Announcements 15. Recess

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Consideration of Minutes from Previous Meetings

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Minutes

Regular Meeting Wednesday, May 29, 2019 at 1:00 p.m. & Administrative Hearing Thursday, May 30, 2019 at 8:30 a.m.

Location: Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700

- 1 –

Table of Contents

Agenda Item No. Description Page No.

Wednesday, May 29, 2019

1. Call to Order 04 2. Invocation & Pledge of Allegiance 04 3. Quorum Call 04 4. Call for Additional Agenda Items & Adoption of Agenda 05 5. Consideration of Minutes from Previous Meeting 05 6. Report on Action Items 05 7. Confirmation of Acts 05 8. Opportunity for Public Comment 06 * Statement of Purpose 06 9. Special Orders of the Day 06 A. Presentation of Pharmacist Gold Certificates 06 B. Presentation of Distinguished Service Award 06 10. Committee Reports A. Finance 07 B. Application Review 07 C. Reciprocity 07 D. Violations 08 E. Impairment 10 F. Reinstatement 12 G. Tripartite 12 H. Regulation Revision 13 I. Executive 16 11. Staff Reports J. Assistant Executive Director 20 K. General Counsel 21 L. Executive Director 22 12. Technology Presentation re Real-Time Benefit Check Ms. Kim Diehl-Boyd, CoverMyMeds 07 13. New Agenda Items Added During Meeting A. Regulatory Project 2019-1A ~ Marijuana Pharmacies 23 14. Announcements 23 15. Recess 24

- 2 –

Agenda Item No. Description Page No.

Thursday, May 30, 2019

A. Call to Order 24 B. Invocation & Pledge of Allegiance 24 C. Quorum Call 24 D. Call for Additional Agenda Items & Adoption of Agenda 24 E. Opportunity for Public Comment 24 * Appearances 24 F. Formal Hearings 25 G. Report of Violations Committee 27 H. Report of General Counsel 28 I. Adjourn 28

- 3 –

A regular meeting of the Louisiana Board of Pharmacy was held on Wednesday, May 29, 2019 at the office of the Louisiana Board of Pharmacy, located at 3388 Brentwood Drive in Baton Rouge, Louisiana 70809-1700. The meeting was held pursuant to public notice, each member received notice, and public notice was properly posted.

1. Call to Order Mr. Carl Aron, President, called the meeting to order at 1:00 p.m.

2. Invocation & Pledge Mr. Aron called upon Mr. Rhonny Valentine for the invocation. Ms. Diane Milano then led the group in the Pledge of Allegiance.

3. Quorum Call Mr. Aron called upon the Secretary, Mr. Richard M. Indovina, Jr., to call the roll to establish a quorum.

Members Present: Mr. Carl W. Aron Mr. Allen W. Cassidy, Jr. Ms. Jacqueline L. Hall Mr. Richard M. Indovina, Jr. Mr. Kevin LaGrange Mr. Robert C. LeBas Mr. Richard Mannino Mr. Marty R. McKay Ms. Diane G. Milano Mr. Ronald E. Moore Mr. Don L. Resweber Mr. Douglas E. Robichaux Mr. Richard A. Soileau Dr. Raymond J. Strong Mr. Rhonny K. Valentine

Member Absent: Dr. J. Robert Cloud Mr. Blake P. Pitre

Staff Present: Mr. Malcolm J. Broussard, Executive Director Mr. Carlos M. Finalet, III, General Counsel Mr. M. Joseph Fontenot, Assistant Executive Director Mr. Benjamin S. Whaley, Chief Compliance Officer Ms. Alicia P. Harris, Pharmacist Compliance Officer Ms. Becky C. Parker, Pharmacist Compliance Officer Mr. Huey J. Savoie, Pharmacist Compliance Officer

- 4 –

Guests: Mr. Alfred Gaudet – Gold Certificate Recipient Ms. Kathleen Gaudet – Gold Certificate Recipient Mr. William Stroud, III – Gold Certificate Recipient Ms. Barbara LeBeouf – Gold Certificate Recipient Mr. Roland Thibodeaux – Gold Certificate Recipient Mr. Bevan Callicott – Cardinal Health Mr. Ben J. Sims – Brookshire Grocery Co. Dr. Alexandre Raymond – Ochsner Medical Center Ms. Kim Diehl-Boyd – CoverMyMeds Dr. Gena Territo-Tynes – Ochsner Medical Center Ms. Patricea Angelle – International Academy of Compounding Pharmacists

Mr. Indovina certified Dr. Cloud and Mr. Pitre were absent; however, the remaining 15 members were present, constituting a quorum for the conduct of official business.

4. Call for Additional Agenda Items & Adoption of Agenda Mr. Aron asked if there were any additional agenda items to be added. Mr. Indovina noted the public hearing for Regulatory Project 2019-1A ~ Marijuana Pharmacies was held earlier that day, that no comments were received, and that it would be appropriate to determine whether to continue the promulgation process that day instead of waiting until the next Board meeting in November. He moved to amend the agenda to add the regulatory project. There were no member questions or public comment. The motion was adopted following a unanimous roll call vote in the affirmative. Mr. Aron added the regulatory project to the agenda, noting the Item Number as 13-A. With no further requests to amend the agenda, and without objection, the members adopted the posted agenda dated May 13, 2019, as amended. Mr. Aron requested authority to re-order the agenda as may become necessary, and there were no objections to that request.

5. Consideration of Minutes Mr. Aron reminded the members they had received the draft minutes from the Regular Board Meeting held on February 19, 2019 in Monroe, Louisiana. With no objections, he waived the reading of the draft minutes. With no requests for amendment or any objection to their approval, Mr. Aron declared the minutes were approved as presented. Mr. Indovina reminded the members to sign the Minute Book.

6. Report on Action Items Mr. Aron called on Mr. Broussard for the report. Mr. Broussard directed the members to a copy of the report in their meeting binder. There were no questions from the members or guests.

7. Confirmation of Acts Pursuant to Mr. Aron’s declaration that the officers, committees, and executive director had attended to the business of the Board since their last meeting in accordance with policies and procedures previously approved by the Board, Mr. Moore moved, Resolved, that the actions taken and decisions made by the Board officers, Board committees, and Executive Director in the general conduct

- 5 –

and transactions of Board business since February 19, 2019 are approved, adopted, and ratified by the entire Board. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

8. Opportunity for Public Comment Mr. Aron reminded the members and guests the Open Meetings Law requires all public bodies to provide an opportunity for public comment at all meetings and for each agenda item upon which a vote is to be taken. He solicited general comments on non- agenda items from the guests present, and none were offered.

* Statement of Purpose Mr. Aron reminded the members of the purpose and mission of the Board of Pharmacy by reciting the relevant portion of the Louisiana Pharmacy Practice Act. He urged the members to keep their legislative mandate in mind as they considered all the matters before them.

9. Special Orders of the Day A. Presentation of Pharmacist Gold Certificates Mr. Aron reminded the members and guests of the Board’s award of a Pharmacist Gold Certificate to a pharmacist completing 50 years of Louisiana pharmacist licensure. He informed the audience the Board issued new licenses to 173 pharmacists in 1969, and of that number the licenses of 50 pharmacists were still in active status. He noted five of those pharmacists were present and had requested to receive their certificates during the Board meeting. Mr. Aron then presented Gold Certificates to the following pharmacists, noting during each presentation a synopsis of the recipient’s professional service: PST.009300 – William Fletcher Stroud, III PST.009422 – Alfred Louis Gaudet PST.009438 – Barbara Ann LeBeouf PST.009544 – Roland James Thibodeaux PST.009633 – Kathleen Vocke Gaudet The members and guests congratulated each of the recipients with standing ovations.

B. Presentation of Distinguished Service Award Mr. Aron noted one of the members was nearing the completion of a six year term of service on the Board. He reminded the members and guests that Governor Bobby Jindal had appointed Ms. Diane Milano to the Board on July 1, 2013 and that her term would expire on June 30, 2019. During his presentation of the Distinguished Service Award to Ms. Milano, he noted her service on various Board committees and faithful participation in Board meetings and administrative hearings. Ms. Milano expressed her appreciation for the award and indicated her hope for continued service through another appointment. The members and guests congratulated her with a generous round of applause.

- 6 –

At this point, Mr. Aron re-ordered the agenda to accommodate a presenter with flight arrangements later that afternoon.

12. Technology Presentation re Real-Time Benefit Check – Ms. Kim Diehl-Boyd, CoverMyMeds. Mr. Aron invited Ms. Diehl-Boyd to the witness table to introduce herself and make her presentation to the members. She directed the members to a copy of her presentation in their electronic meeting binder. She then gave a brief introduction to the company before describing a technology service which allows a prescriber to ascertain a patient’s third party insurance coverage of a medication intended to be prescribed. The service allows the prescriber and the patient to know the approximate price of the medication for the patient at the pharmacy of the patient’s choice prior to the patient leaving the prescriber’s office. The members asked several questions about different aspects of the service. Ms. Diehl-Boyd promised to follow-up after the meeting with information about a question relative to cash prices at pharmacies. Mr. Aron expressed his appreciation for her presentation.

At this point, Mr. Aron recognized Ms. Alicia Harris, a pharmacist compliance officer who recently affiliated with the Board and was not present at the previous Board meeting. He introduced her to the members, confirmed her territory, and welcomed her to the Board’s staff.

Mr. Aron then returned to the sequence of the posted agenda.

10. Committee Reports A. Finance Committee In the absence of Mr. Blake Pitre, Chair of the Finance Committee, Mr. Aron called upon the ranking member, Mr. Marty McKay, for the committee report. Mr. McKay directed the members to the Interim Report for Fiscal Year 2018-2019 in their meeting binder. Mr. McKay summarized the report for the members; there were no questions. He reminded the members no action was necessary for that report. Finally, Mr. McKay closed his report with appreciation to the other committee members for their ongoing efforts.

B. Application Review Committee Mr. Aron called upon Mr. Soileau for the committee report. Mr. Soileau reported the committee had not met since the previous Board meeting. Finally, Mr. Soileau closed his report with appreciation to the other committee members for their ongoing efforts.

C. Reciprocity Committee Mr. Aron called upon Mr. Cassidy for the committee report. He reported the staff had evaluated 86 applications for pharmacist licensure by reciprocity since the last Board meeting and that none of them contained information that warranted a committee level review. In conformance with policies and procedures previously approved by the Board, the staff approved the

- 7 –

applications and issued the credentials. Finally, he closed his report with appreciation to the other committee members for their ongoing efforts.

D. Violations Committee Mr. Aron called upon Mr. Indovina for the committee report. Mr. Indovina reported the committee held preliminary hearings on March 20-21, 2019 to consider their posted agenda which included 22 cases: eight pharmacists, six pharmacy technicians, one pharmacy technician candidate, and seven pharmacy permits. Two respondents failed to appear; the committee voted to refer both of them for formal administrative hearings which were held the following day. After interviews and deliberations at the preliminary hearings, the committee continued one case for further investigation; voted to take no action against another respondent; voted to allow one respondent to enter into a private no-practice agreement while that case is continued; and also voted to issue non-disciplinary Letters of Noncompliance to two respondents. The committee then voted to offer proposed voluntary consent agreements to the remaining 15 respondents. Of that number, 12 accepted their proposed consent agreements; the other three were scheduled for a future administrative hearing. He then reported the receipt of a signed consent agreement from a respondent who case had been previously continued. Mr. Indovina then presented the following proposed consent agreements to the members for their consideration.

Ja’Faira Romeshia Lajoy Holland (CPT.013935): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further, assessed a fine of $250 plus administrative costs.

Destiny Araine Woolfolk (CPT.010453): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board suspended the certificate for one year and stayed the execution of the suspension, then placed the certificate on probation for one year effective May 29, 2019 subject to certain terms enumerated within the consent agreement, and further, assessed administrative costs.

Racheal Jordan Flores (PST.021687): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Warning, and further, assessed administrative and investigative costs.

Walgreen La. Co., Inc. d/b/a Walgreen Pharmacy No. 110-02995 [Baton Rouge, LA] (PHY.002868): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public

- 8 – comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $10,000 plus administrative and investigative costs.

Prescription Dispensing Laboratories, Inc. d/b/a Prescription Dispensing Laboratories [Cedar Park, TX] (PHY.007538): Mr. Indovina moved to approve the proposed voluntary consent agreement. Mr. Finalet responded to a question from one member; there were no public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further, assessed a fine of $5,000 plus administrative costs.

Noah’s Pharmacy, LLC d/b/a Noah’s Pharmacy [Brusly, LA] (PHY.006145 ~ Case No. 18-0364): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board terminated the previously imposed probationary period, suspended the permit for five years and stayed the execution of the suspension, then placed the permit on probation for five years effective May 29, 2019 subject to certain terms enumerated within the consent agreement, and further, assessed administrative and investigative costs.

Gaylyn Elizabeth Bellaire (PST.014692): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board restricted the license by prohibiting the acceptance of an appointment as the pharmacist-in-charge of any pharmacy until after May 29, 2020, and further, assessed a fine of $500 plus administrative costs.

Kimberly Juanita Murphy (PST.016122): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board terminated the previously imposed probationary period, suspended the license for five years and stayed the execution of the suspension, then placed the license on probation for five years effective May 29, 2019 subject to certain terms enumerated within the consent agreement, and further, assessed a fine of $7,500 plus administrative costs.

Noah’s Pharmacy, LLC d/b/a Noah’s Pharmacy [Brusly, LA] (PHY.006145 ~ Case No. 19-0024): Mr. Indovina moved to approve the proposed voluntary consent agreement. He replied to questions from six members; there were no public comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $5,000 plus administrative and investigative costs.

- 9 –

Lato Drug Company, Inc. d/b/a Post Haste Pharmacy [Hollywood, FL] (PHY.006650): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $15,000 plus administrative and investigative costs.

Winn Dixie Stores, Inc. d/b/a Pathstone Health Services [Jacksonville, FL] (PHY.007203): Mr. Indovina moved to approve the proposed voluntary consent agreement. He replied to questions from three members; there were no public comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $12,500 plus administrative and investigative costs.

Leslie Dominique Threatts (CPT.014040): Mr. Indovina moved to accept the voluntary surrender of the credential. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender of the credential, resulting in the active suspension of the certificate for an indefinite period of time effective March 21, 2019.

Thomas Joseph Walker (PST.015721): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further assessed a fine of $1,000 plus administrative and investigative costs.

Mr. Indovina then presented the Complaint Investigation Monitor Report, which demonstrated the opening of 384 new cases and the closure of 349 cases during the current fiscal year. The average number days for staff to complete their case investigation was 51 days. Of the 349 case closures, 15 of them [4.3%] exceeded the policy goal of 180 days for completion of case investigations. Mr. Indovina reported the committee was scheduled to meet on June 11- 12 to consider the 24 cases on that docket, which includes 10 pharmacists, seven pharmacy technicians, one pharmacy technician candidate, five pharmacy permits and one DME permit. Finally, he concluded his report with appreciation to the other committee members for their ongoing efforts and to the compliance officers for the quality of their case investigations.

E. Impairment Committee Mr. Aron called upon Ms. Hall for the committee report. Ms. Hall reported the committee met the previous day to consider four referrals from the staff – two applications for reinstatement of credentials, one appearance for informal conference, and one appearance for guidance. The committee also performed their annual review of the roster of approved addictionists. Following their interviews of the applicants and subsequent deliberations, the

- 10 – committee developed recommendations for the applicants. Ms. Hall then presented the following files to the members for their consideration.

Michael Wayne Lindsey (PST.015624) Ms. Hall moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the applicant’s request for reinstatement of the previously suspended license contingent upon the completion of certain requirements identified within the consent agreement, to suspend the newly- reinstated license for 15 years and stay the execution of the suspension, and then place the license on probation for 15 years effective on the date of reinstatement subject to certain terms enumerated within the consent agreement.

Steve Khai Vu (PST.015586) Ms. Hall moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the applicant’s request for reinstatement of the previously suspended license contingent upon the satisfaction of certain requirements identified within the consent agreement, to suspend the newly- reinstated license for five years and stay the execution of the suspension, then place the license on probation for five years effective on the date of reinstatement subject to certain terms enumerated within the consent agreement.

Todd Michael Durham (PST.016962) Ms. Hall moved to accept the voluntary surrender of the credential. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender of the credential, resulting in the active suspension of the license for an indefinite period of time effective May 28, 2019.

David Evans Collins (PST.014181) Ms. Hall moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the request for reinstatement of the previously suspended license, converted the duration of the suspensive period from an indefinite term to a term of 15 years and stayed the execution of the suspension, then placed the license on probation for 15 years effective May 29, 2019 subject to certain terms enumerated within the consent agreement.

Ms. Hall reported the committee had performed its annual review of the roster of approved addictionists, offered no proposed revisions, and voted to recommend the Board’s continuing approval of the current roster. On behalf of the committee, Ms. Hall then moved, Resolved, to continue the approval of the current Roster of

- 11 –

Approved Addictionists. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Finally, Ms. Hall closed her report with appreciation to her fellow committee members for their work the previous day.

F. Reinstatement Committee Mr. Aron called upon Mr. Moore for the committee report. Mr. Moore reported the committee had met the previous day to consider three referrals from the staff. Following their interviews of the applicants and subsequent deliberations, the committee developed recommendations for the applicants. Mr. Moore then presented the following files to the members for their consideration.

Bocage Pharmacy Centre, Inc. d/b/a Bocage Pharmacy Centre (CDS.039257-PHY): Mr. Moore moved to reinstate the previously suspended CDS license without restriction. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the applicant’s request for reinstatement of the previously suspended license and then restored the CDS license to active and unrestricted status.

Virginia Kay Alexander (CPT.006750): Mr. Moore moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the request for reinstatement of the lapsed certificate contingent upon the satisfaction of certain requirements identified within the consent agreement.

Alicia Williams Lafayette (CPT.006921): Mr. Moore moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the applicant’s request for reinstatement of the lapsed certificate contingent upon the satisfaction of certain requirements identified within the consent agreement.

Mr. Moore closed his report with appreciation to the other committee members for their work the previous day.

G. Tripartite Committee Mr. Aron called upon Mr. Resweber for the committee report. Mr. Resweber reported the committee had not met since the previous Board meeting.

At this point, Mr. Aron declared a recess. It was noted the members recessed at 2:40 p.m. and then reconvened at 3:05 p.m. Mr. Aron resumed the sequence of the posted agenda.

- 12 –

H. Regulation Revision Committee Mr. Aron called upon Mr. McKay for the committee report. Mr. McKay reported the committee met on April 24, 2019 to consider the items on their posted agenda. During that meeting, the committee voted to recommend the approval of four regulatory proposals. He then presented the following proposals to the Board for their consideration.

Regulatory Proposal 2018-B ~ Drug Disposal by Pharmacies (Draft #5) Mr. McKay informed the members of the committee’s deliberations on whether and how a pharmacy could facilitate the disposal of previously dispensed prescription drugs no longer needed or wanted by consumers.  The committee considered whether a pharmacy should accept drug returns from consumers for destruction. They received stakeholder input concerning the potential for diversion within a pharmacy, both for theft as well as return to return to active dispensing stock. They determined it appropriate to allow a pharmacy to accept returns and imposed a quarantine and security requirement in the proposed rule.  The committee considered whether a pharmacy should be required to accept drug returns for prescriptions it dispensed and permitted to accept drugs dispensed by other pharmacies. The committee declined to require pharmacies to accept any drug returns, but determined it appropriate to require pharmacies to inform consumers of their disposal options.  With respect to pharmacies electing to accept drugs for disposal, the committee reviewed existing federal standards for the disposal of certain types of drugs and inserted a requirement to comply with those federal standards. Mr. McKay noted the regulatory proposal inserts the proposed changes into three different chapters – Chapter 15 for hospital pharmacies, Chapter 25 for all pharmacies, and Chapter 27 for controlled substances. On behalf of the committee, Mr. McKay then moved, Resolved, to approve Regulatory Proposal 2018-B ~ Drug Disposal by Pharmacies (Draft #5), and further, to authorize the Executive Director to promulgate the proposed rule upon the instruction of the President, and further, to authorize the President to approve acceptable amendments as may become necessary during the promulgation process. Mr. McKay replied to questions from three members; there were no public comments. The motion was adopted after a unanimous vote in the affirmative.

Regulatory Proposal 2018-N ~ Pharmacy Compounding (Draft #5) Following the publication of the final FDA Guidance Document relative to the compounding of copies of commercially available products, the committee was asked to review the Board’s rules for pharmacy compounding. The committee recommends amending Subsection F of

- 13 –

Section 2535 which is the Board’s rule on pharmacy compounding. The proposal removes the reference to the ASHP website as a source of drugs in shortage, leaving the official FDA website for that information. The proposal also amends the allowance to compound copies of commercially available products with only minor changes to the active ingredient profile using the same language in the FDA Guidance Document. On behalf of the committee, Mr. McKay then moved, Resolved, to approve Regulatory Proposal 2018-N ~ Pharmacy Compounding (Draft #5), and further, to authorize the Executive Director to promulgate the proposed rule upon the instruction of the President, and further, to authorize the President to approve acceptable amendments as may become necessary during the promulgation process. There were no member questions; there was one public comment. The motion was adopted after a unanimous vote in the affirmative.

Regulatory Proposal 2019-A ~ Pharmacy Records (Draft #3) Mr. McKay informed the members the proposal originated as a request from long term care pharmacies to implement the provisions of Act 602 of the 2018 Legislature recognizing the use of chart orders. Since chart orders are analogous to prescriptions, the committee’s deliberations revealed the necessity to amend several different chapters and sections of the rules. Draft #2 was the result of those deliberations. While preparing that draft for the Board’s consideration, staff noted several portions of that draft affected the chapter of rules for automated medication systems, which is the subject of another regulatory proposal still under consideration by the committee. Draft #3 is the result of the removal of the portion of Draft #2 relative to automated medication system. That portion of Draft #2 was transferred to a different regulatory proposal relative to automated medication systems still under review by the committee. Mr. McKay also noted that while the proposal contains suggested revisions to pharmacy record rules to include chart orders, it also includes a large number of technical amendments necessary to conform the Board’s rules to the style required by the state register. On behalf of the committee, Mr. McKay then moved, Resolved, to approve Regulatory Proposal 2019-A ~ Pharmacy Records (Draft #3), and further, to authorize the Executive Director to promulgate the proposed rule upon the instruction of the President, and further, to authorize the President to approve acceptable amendments as may become necessary during the promulgation process. There were comments from two members and no public comments. The motion was adopted after a unanimous vote in the affirmative.

Regulatory Proposal 2019-D ~ Pharmacist Access to PMP (Draft #1) Mr. McKay reminded the members of the legislative mandate to automatically register all prescribers to grant them access to the state prescription monitoring program database. The committee reviewed the

- 14 – current law and rule to determine whether such automatic registration could also be offered to pharmacists. Staff determined no statutory amendment was necessary and that such capacity could be accomplished with a change in the rule. The proposal amends registration procedures in the PMP rules. On behalf of the committee, Mr. McKay then moved, Resolved, to approve Regulatory Proposal 2019-D ~ Pharmacist Access to PMP (Draft #1), and further, to authorize the Executive Director to promulgate the proposed rule upon the instruction of the President, and further, to authorize the President to approve acceptable amendments as may become necessary during the promulgation process. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

Mr. McKay reported on other topics assigned to the committee.  With respect to the committee agenda item relative to automated medication systems, the committee requested additional revisions and an updated draft for the next committee meeting.  With respect to the committee agenda item relative to the planned new USP <800> Hazardous Drugs ~ Handling in Healthcare Settings, the USP-800 Subcommittee held their first meeting on April 23. They planned their approach to developing a recommendation for the Regulation Revision Committee and are actively working to develop a document for consideration during their next meeting on June 12. During the April 24 meeting of the full committee, the members determined it appropriate to suggest a delay in the Board’s enforcement of the new USP <800>. On behalf of the committee, Mr. McKay then moved, Resolved, that the Board delay the enforcement of the provisions of USP <800> Hazardous Drugs ~ Handling in Healthcare Settings until January 1, 2021. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.  With respect to the committee agenda item relative to petitions for the return of inactive pharmacist licenses to active status, the committee reviewed the current rule in Section 505 and determined an interpretation of that rule via a policy document would be sufficient to achieve the desired outcome. The committee communicated that recommendation to the Executive Committee, which had prepared a proposed policy document for the Board’s consideration later during that meeting. The Regulation Revision Committee returned their assignment to the Board with no further action.  With respect to the committee agenda item relative to compounding in nuclear pharmacies, the committee is aware of the September 2018 final guidance document from the FDA on that topic as well as the anticipated new USP <825> Radiopharmaceuticals chapter. The committee is anticipating the appointment of a USP-825 Subcommittee and requested nominations of interested and qualified pharmacists by the members.

- 15 –

 With respect to the committee agenda item relative to pharmacy technician training programs, the committee members reviewed the current rule and then voted to return the item to the Board with no recommendation. There was substantial discussion but no further guidance or direction to the committee.

Finally, Mr. McKay closed his report by identifying the public members of the USP-800 Subcommittee:  Ms. Patricea Angelle, from Prescription Compounds in Baton Rouge;  Ms. Susan Caudle, from Line Avenue Pharmacy in Shreveport;  Ms. Angelle Huff, from The Wellness Corner in Prairieville;  Dr. Gary LeBlanc, from Heart Hospital in Lafayette; and  Dr. Heather Maturin, from Ochsner Medical Center in Baton Rouge. Mr. McKay expressed his appreciation to those pharmacists as well as the committee members for their ongoing efforts.

I. Executive Committee Mr. Aron reported the committee had met the previous day to consider the items on their posted agenda. He indicated Mr. McKay was prepared to offer motions on behalf of the committee.

Proposed Revision of PPM.I.C.5.a ~ Reinstatement Committee – Case Management Mr. Aron reported the Regulation Revision Committee had suggested an interpretation of Section 505 of the Board’s rule relative to the process for returning a pharmacist license on inactive status to active status in lieu of a revision of the rule. The committee reviewed the existing policy of the Reinstatement Committee and determined a revision of that policy describing a process for such petitions would be appropriate. On behalf of the committee, Mr. McKay moved, Resolved, to approve the proposed revision of PPM.I.C.5.a ~ Reinstatement Committee – Case Management for the Board’s Policy & Procedure Manual. Mr. Aron replied to questions from two members; there were no public comments. The motion was adopted after a unanimous vote in the affirmative.

Proposed Revision of Pharmacy Inspection Blueprints Mr. Aron reminded the members of their adoption of the national blueprints for pharmacy inspections in August 2017. He reminded them there were four modules: basic pharmacy services, compounding of nonsterile preparations, compounding of sterile preparations, and nuclear pharmacy services. He informed the members there had been some minor updates to the first three of those blueprints and that it was necessary to update those blueprints in the Board’s Policy & Procedure Manual. On behalf of the committee, Mr. McKay moved, Resolved, to approve the proposed revision of PPM.IV.B.2.d ~

- 16 –

Inspection of Basic Pharmacy Services for the Board’s Policy & Procedure Manual. Mr. Aron replied to questions from multiple members; there was one public comment. The motion was adopted after a unanimous vote in the affirmative. Mr. McKay then moved, Resolved, to approve the proposed revision of PPM.IV.B.2.e ~ Inspection of Nonsterile Compounding Services for the Board’s Policy & Procedure Manual. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Mr. McKay then moved, Resolved, to approve the proposed revision of PPM.IV.B.2.f ~ Inspection of Sterile Compounding Services for the Board’s Policy & Procedure Manual. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

Proposed New Policy PPM.III.B.03 ~ Application for New Pharmacy Intern Registration Proposed New Policy PPM.III.B.03.a ~ Maintenance of Pharmacy Intern Registration Mr. Aron reported the recent inquiry from a college of pharmacy as to the impact of a pharmacy intern taking a leave of absence on his eligibility to retain his pharmacy intern registration. Although the Board has consistently allowed an intern to be out of school for up to one semester and retain the registration, the Board does not have a formal policy. He requested staff develop policies reflecting current practice, and the committee voted to recommend their approval. On behalf of the committee, Mr. McKay moved, Resolved, to approve PPM.III.B.03 ~ Application for New Pharmacy Intern Registration and PPM.III.B.03.a ~ Maintenance of Pharmacy Intern Registration for the Board’s Policy & Procedure Manual. Mr. Aron replied to a question from one member; there were no public comments. The motion was adopted after a unanimous vote in the affirmative.

Continuing Approval of Updated Policy & Procedure Manual Mr. Aron reminded the members of the changes they had made to the manual since their last annual review in May 2018. The committee recommended the continuing approval of the updated manual. On behalf of the committee, Mr. McKay moved, Resolved, to continue the approval of the Board’s updated Policy & Procedure Manual. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

Proposed New Policy LPM.I.R ~ Confined Spaces Mr. Aron reported the Division of Administration’s Office of Risk Management - 17 – suggested the implementation of a new policy relative to confined spaces. The committee voted to recommend its approval. On behalf of the committee, Mr. McKay moved, Resolved, to approve the proposed new policy LPM.I.R ~ Confined Spaces for the Board’s Loss Prevention Manual. Mr. Aron replied to questions from two members; there were no public comments. The motion was adopted after a unanimous vote in the affirmative.

Continuing Approval of Updated Loss Prevention Manual Mr. Aron reported the only change to the manual since the last annual review in May 2018 was the policy just approved. The committee recommended the continuing approval of the updated manual. On behalf of the committee, Mr. McKay moved, Resolved, to continue the approval of the Board’s updated Loss Prevention Manual. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

Annual Review of Roster of Approved Colleges of Pharmacy Mr. Aron reminded the members the only changes to the roster since their last annual review in May 2018 was the addition of one new school in August 2018 and the removal of probationary status for two schools at the same time. The committee recommended the continuing approval of the updated roster. On behalf of the committee, Mr. McKay moved, Resolved, to continue the approval of the Board’s Roster of Approved Colleges of Pharmacy. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

Annual Review of Roster of Approved Pharmacy Technician Training Programs Mr. Aron reminded the members the only change to the roster since their last annual review in May 2018 was the addition of one new program in November 2018 and the removal of three programs in February 2019. Since that meeting, the Board had received a request for approval from two programs. The committee recommended the approval of both new programs as well as the continuing approval of the updated roster. On behalf of the committee, Mr. McKay moved, Resolved, to approve the request from Health Mart Systems for recognition as an approved pharmacy technician training program. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Mr. McKay then moved, Resolved, to approve the request from American National University for recognition as an approved pharmacy technician training program. There were no member questions or public comments. The motion was

- 18 – adopted after a unanimous vote in the affirmative. Mr. McKay then moved, Resolved, to continue the approval of the Board’s updated Roster of Approved Pharmacy Technician Training Programs. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

Annual Legislative Financial Audit Mr. Aron reminded the members of the upcoming annual financial audit and of the necessity to approve the management representation letter. The committee reviewed the proposed letter and recommended its approval. On behalf of the committee, Mr. McKay moved, Resolved, to approve the Management Representation Letter for the 2019 Financial Audit. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

Interim Procurement for Louisiana Medical Marijuana Tracking System (LMMTS) Mr. Aron reminded the members of the tracking system established for the medical marijuana products. The system contracted for by the state agriculture department did not include a method to uniquely identify marijuana products. Marijuana pharmacies require a unique number for such products to facilitate the reporting of the dispensing transactions to the state prescription monitoring program. Mr. Aron directed staff to work with the vendor for LMMTS to establish a method to assign product identification numbers to the marijuana products to be sold by the producers to the pharmacies. The vendor offered a module of their system which had not been requested by the state agriculture department. So as to not interrupt the progress of the implementation of the statewide program, Mr. Aron authorized the interim procurement of the product identification module which will integrate with the remainder of the tracking system. However, in order to continue the purchase of the module in the next fiscal year, Board approval was necessary. The committee reviewed the procurement and recommended the approval of the purchase for the following fiscal year. On behalf of the committee, Mr. McKay moved, Resolved, to approve the proposed agreement with Metrc for the product identification module in the Louisiana Medical Marijuana Tracking System, at the stipulated rate, in an amount not to exceed $20,000 for Fiscal Year 2019-2020. Several members questioned how the module would integrate with the pharmacy information systems and facilitate the reporting of dispensing transactions to the state prescription monitoring program. Some of the members questioned the necessity of the program. Some of the members understood the necessity of the interim procurement and questioned whether it would be necessary every year. Some of the members questioned whether the state agriculture department should include that module in the annual renewal of their contract for the tracking system going forward. There were

- 19 –

no public comments. The motion was adopted after a unanimous vote in the affirmative.

Finally, Mr. Aron closed his report with appreciation for the other committee members and their work the previous day.

At this point, Mr. Aron declared a brief recess. It was noted the members recessed at 5:20 p.m. and then reconvened at 5:30 p.m. Mr. Aron resumed the sequence of the posted agenda.

11. Staff Reports J. Report of Assistant Executive Director Mr. Aron called upon Mr. Fontenot for the report. He directed the members to the quarterly report of the prescription monitoring program, detailing the prescription transaction counts as well as queries from prescribers, dispensers, and law enforcement agencies. He answered questions from several members. Mr. Fontenot then directed the members to the requests from 28 pharmacies seeking a waiver from the duty to report zero prescription transaction reports to the prescription monitoring program. Mr. McKay then moved, Resolved, to authorize the issuance of full PMP reporting waivers to: > PHY.007227-NR – A-1 Pharmacy Services (MS); > PHY.007532-NR – Allivet (FL); > PHY.007298-NR – Benzer Pharmacy (FL); > PHY.007727-NR – Bio Tek reMEDys (DE); > PHY.005543-NR – Clinical Solutions (TN); > PHY.007828-NR – Concentrix CVG Corporation (AZ); > PHY.006342-NR – Coram CVS/Specialty Infusion Services (MN); > PHY.006242-NR – Exactus Pharmacy Solutions (FL); > PHY.000381-HOS – Franklin Foundation Hospital Pharmacy (LA) > PHY.006340-HOS – Franklin Medical Center Pharmacy (LA); > PHY.007826-NR – GoLiveWell Pharmacy (MO); > PHY.007723-NR – Haltom Pharmacy (TX); > PHY.006754-NR – Hometech Advanced Therapies (PA); > PHY.000501-HOS – Iberia Medical Center Pharmacy (LA); > PHY.007286-SAT – Iberia Medical Center North (LA); > PHY.000471-HOS – Hood Memorial Hospital Pharmacy (LA); > PHY.007885-NR – Kroger Specialty Infusion Therapy (TX); > PHY.007881-NR – Lemonaid Pharmacy (MO); > PHY.007842-NR – MediStar Healthcare Connections (AZ); > PHY.007896-NR – Milton Medical & Drug Co. (FL); > PHY.007872-NRN – NuTech (TX); > PHY.007879-HOS – Ochsner LSU Health Shreveport (LA); > PHY.007877-HOS – Our Lady of Lourdes Women’s & Children’s Hospital Pharmacy (LA);

- 20 –

> PHY.007888-HOS – Our Lady of the Lake Ascension Hospital Pharmacy (LA); > PHY.007860-NR – Pinnacle Medical Solutions (MS); > PHY.007870-NR – Skip’s Pharmacy (FL); > PHY.007857-NR – Soleo Health (IL); and > PHY.007807-NR – Unlimited Pharmacy (TX) once they have executed the standard consent agreement for that purpose. Mr. Fontenot replied to questions from two members. There were no public comments. The motion was adopted after a unanimous vote in the affirmative. He then reported on the progress of the program’s collaboration with the Dept. of Health to integrate the PMP into all the electronic health record systems and pharmacy information systems in the state. He noted the grant funding supporting that initiative required completion of the integration by June 30, 2019. Finally, Mr. Fontenot indicated completion of his report.

K. Report of General Counsel Mr. Aron called upon Mr. Finalet for the report. Mr. Finalet reported the May 20, 2019 decision of the 19th Judicial District Court in Rx Greenhouse, LLC, et al vs The Louisiana Board of Pharmacy. The judge affirmed the Board’s decision in its award of the marijuana pharmacy permit for Region 1. Mr. Finalet then presented the following proposed voluntary consent agreements to the members for their consideration.

Randolph Adam Baez (PST.018669): Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further, assessed a fine of $1,000 plus administrative costs.

Pharmcore, Inc. d/b/a Hallandale Pharmacy [Fort Lauderdale, FL] (PHY.00.7866): Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $10,000 plus administrative costs.

Robert Brent Clevenger (PST.021999): Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board suspended the license for four years plus nine months plus twenty days and stayed the execution of the suspension, then placed the license on probation for four years plus nine months plus twenty days effective May 29, 2019 and terminating March 21, 2024 subject to certain terms enumerated within the consent agreement, and further, assessed administrative costs. The Board took note the probationary period

- 21 –

was scheduled to proceed concurrently with the probationary period imposed by the Alabama Board of Pharmacy on his Alabama pharmacist license.

Nguyet Anh Thi Nguyen (CPT.006154): Mr. McKay moved to accept the voluntary surrender of the credential. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender of the credential, resulting in the active suspension of the certificate for an indefinite period of time effective April 22, 2019.

Pharmaceutical Specialties, Inc. d/b/a Hoye’s Pharmacy [Tampa, FL] (PHY.007496): Mr. Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $5,000 plus administrative costs.

Whitney Nicole Cantrelle (PST.021219): Mr. McKay moved to accept the voluntary surrender of the credential. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender of the credential, resulting in the active suspension of the license for an indefinite period of time effective April 29, 2019.

Tanya Centrell Ann Ventress (CPT.004921): Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further, assessed a fine of $250 plus administrative costs.

Brandee Cecilia Lam (PST.021000): Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further, assessed a fine of $1,000 plus administrative costs.

Finally, Mr. Finalet indicated the completion of his report.

L. Report of Executive Director Mr. Aron called upon Mr. Broussard for the report. Mr. Broussard directed the members to his report in the meeting binder. He reviewed the following topics: • Meeting Activity • Reports  Internal Reports Credentials Division Census Report Licensure Activity Report - 22 –

Application Activity Report Exceptions Report Compliance Division Census Report Complaint Investigation Policy Monitor  External Reports Administrative and Legislative Agency Reports • Examinations MPJE NAPLEX ExCPT PTCB • Operations Credentials Division Compliance Division Administrative Division • State Activities La. Legislature La. State Board of Medical Examiners • Regional & National Activities National Association of Boards of Pharmacy (NABP) NABP-AACP District 6 MALTAGON • International Activities International Pharmaceutical Federation (FIP) dotPharmacy Verified Websites Program

Finally, Mr. Broussard indicated the completion of his report.

13. New Agenda Items Added During Meeting A. Regulatory Project 2019-1A ~ Marijuana Pharmacies Mr. Aron reminded the members of the public hearing earlier that day to receive comments and testimony on the proposed rule. The Board received no comments or testimony either prior to or during the public hearing. He questioned whether they wished to entertain any amendments to the proposed rules. With no requests for any further amendments. Mr. McKay then moved, Resolved, to make no revisions to the original proposed rule and to direct staff to submit the required reports and continue the promulgation process. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

14. Announcements Mr. Aron directed the members to the announcements in their meeting binder. He announced the next meeting of the board would be held on August 14 at the Board office in Baton Rouge. - 23 –

15. Recess Having completed the tasks itemized on the posted agenda, with no further business pending before the Board and without objection, Mr. Aron recessed the meeting at 5:45 p.m.

* * *

An Administrative Hearing was convened on Thursday, May 30, 2019 in the Boardroom of the Board’s office, located at 3388 Brentwood Drive in Baton Rouge, Louisiana. The hearing was held pursuant to public notice, each member received notice, each respondent received notice (unless specifically stated otherwise in the official transcript), and public notice was properly posted.

A. Call to Order Mr. Aron called the hearing to order at 8:35 a.m.

B. Invocation & Pledge Mr. Aron called upon Mr. Valentine for the invocation. Dr. Strong then led the group in the Pledge of Allegiance.

C. Quorum Call Mr. Aron called upon Secretary Indovina and he called the roll. After doing so, he certified Dr. Cloud, Mr. Mannino, Mr. Moore, and Mr. Pitre were absent; however, the remaining 13 members were present, constituting a quorum for the conduct of official business.

D. Call for Additional Agenda Items & Adoption of Agenda Mr. Aron asked if there were any additional agenda items, and none were requested. With no objection, the Board adopted the posted agenda dated May 20, 2019.

E. Opportunity for Public Comment Mr. Aron reminded the members and guests the Open Meetings Law requires all public bodies to provide an opportunity for public comment at all meetings and prior to the vote on each agenda item. He solicited general comments on non-agenda items from the guests present, and none were offered.

Appearances Mr. Aron indicated he would serve as the Hearing Officer. Mr. Carlos Finalet served as the Prosecuting Attorney. Ms. Susan Erkle served as the Official Recorder, and Mr. Malcolm Broussard served as the Hearing Clerk. Mr. Aron informed the members the cases on the agenda originated with the Violations Committee, and that the members of that committee in attendance at their December 5, 2018 and March 19, 2019 meetings would be recused from the hearings. In particular, Dr. Cloud, Ms. Hall, Mr. Indovina, Mr. Robichaux, and Mr. Valentine were recused. He reminded the other members they should recuse themselves should the need arise.

- 24 –

Without objection, Mr. Aron waived the reading of the posted agenda and instead direction the insertion thereof into these minutes. The posted agenda is re- created here.

A G E N D A NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official. Revised 05-20-2019

A. Call to Order

B. Invocation & Pledge of Allegiance

C. Quorum Call

D. Call for Additional Agenda Items & Adoption of Agenda

E. Opportunity for Public Comment

* Appearances

F. Formal Hearings

1. Case No. 18-0348 ~ CPT.010443 – Tiffani Lauren Burnaman

2. Case No. 18-0396 ~ CPT.011436 – Christie Elaine Parker

3. Case No. 18-0480 ~ PTC.024692 – Jonnesha D’Shae London

G. Report of Violations Committee – Consideration of Proposed Voluntary Consent Agreements

H. Report of General Counsel – Consideration of Proposed Voluntary Consent Agreements & Voluntary Surrenders/Revocations

I. Adjourn

F. Formal Hearings Mr. Finalet informed the hearing panel the second case listed on the agenda would be continued until a future date due to the delayed arrival of a witness affidavit. With Mr. Aron’s approval, he then began the hearings by calling the first case listed.

Tiffani Lauren Burnaman (CPT.010443) Mr. Finalet appeared for the Board. The respondent, Tiffani Lauren Burnaman, did not appear and was not represented by counsel. Mr. Aron ruled the hearing would proceed as noticed in the form of a default proceeding. Mr. Finalet offered an opening statement, presented no witnesses and six exhibits, and then proffered proposed Findings of Fact, Conclusions of Law, and Board Order. Mr. Finalet tendered the matter to the hearing panel for its consideration. Mr. Soileau moved to enter into executive session for the purpose of deliberating the disciplinary matter and discussing the respondent’s professional competency and fitness for practice. There were no member questions or public comments. The motion was adopted after a unanimous roll call vote in the affirmative.

It was noted the hearing panel entered into executive session at 8:45 a.m. and then - 25 – reconvened at 8:55 a.m. Mr. Aron returned the hearing panel to open session; he reported no decision was made during the executive session and questioned the members as to their disposition of the case.

Mr. Cassidy then moved, Resolved, that the hearing panel, having heard the testimony and considered the evidence, accept the Findings of Fact as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Mr. Cassidy then moved, Resolved, that the hearing panel accept the Conclusions of Law as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Mr. Cassidy then moved, Resolved, that the hearing panel enter the following order at this time: It is ordered, adjudged, and decreed that Louisiana Pharmacy Technician Certificate No. 10443 held by Tiffani Lauren Burnaman shall be, and is hereby, suspended for an indefinite period of time effective on the entry of this order; and further, the respondent shall pay the following assessments: (1) A fine of $500; (2) The administrative hearing fee of $250; and (3) The investigative and hearing costs, including the costs of the prosecuting attorney and the official recorder; and It is further ordered, the acceptance of any future application for the reinstatement of the certificate or any application for any other credential issued by the Board shall be conditioned upon the satisfaction of the following terms: (1) Respondent shall have paid all assessments levied herein; and (2) Respondent shall have no pending legal or disciplinary matters against her in any jurisdiction. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

Jonnesha D’Shae London (PTC.024692) Mr. Finalet appeared for the Board. The respondent, Jonnesha D’Shae London, did not appear and she was not represented by counsel. Mr. Aron ruled the hearing would proceed as noticed in the form of a default proceeding. Mr. Finalet offered an opening statement, presented one witness and six exhibits, and then proffered proposed Findings of Fact, Conclusions of Law, and Board Order. Mr. Finalet tendered the matter to the hearing panel for its consideration. Mr. Cassidy moved to enter into executive session for the purpose of deliberating the disciplinary matter and discussing the respondent’s professional competency and fitness for practice. There were no member questions or public comments. The motion was adopted

- 26 –

after a unanimous roll call vote in the affirmative.

It was noted the hearing panel entered into executive session at 9:10 a.m. and then reconvened at 9:15 a.m. Mr. Aron returned the hearing panel to open session; he reported no decision was made during the executive session and questioned the members as to their disposition of the case.

Dr. Strong then moved, Resolved, that the hearing panel, having heard the testimony and considered the evidence, accept the Findings of Fact as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Dr. Strong then moved, Resolved, that the hearing panel accept the Conclusions of Law as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Dr. Strong then moved, Resolved, that the hearing panel enter the following order at this time: It is ordered, adjudged, and decreed that Louisiana Pharmacy Technician Candidate Registration No. 24692 held by Jonnesha D’Shae London shall be, and is hereby, suspended for an indefinite period of time effective on the entry of this order; and further, the respondent shall pay the following assessments: (4) A fine of $500; (5) The administrative hearing fee of $250; and (6) The investigative and hearing costs, including the costs of the prosecuting attorney and the official recorder; and It is further ordered, the acceptance of any future application for the reinstatement of the certificate or any application for any other credential issued by the Board shall be conditioned upon the satisfaction of the following terms: (3) Respondent shall have paid all assessments levied herein; and (4) Respondent shall have no pending legal or disciplinary matters against her in any jurisdiction. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

Mr. Finalet indicated completion of the cases scheduled for that day. Mr. Aron expressed his appreciation to Ms. Erkle for her recording services that day.

G. Report of Violations Committee Mr. Aron noted the committee presented its proposed consent agreement the previous day and there were no additions to that list.

- 27 –

H. Report of General Counsel Mr. Aron noted Mr. Finalet presented his proposed consent agreements the previous day and there were no addition to that list.

I. Adjourn Having completed the tasks itemized on the posted agenda, with no further business pending before the Board, and without objection, Mr. Aron adjourned the hearing at 9:20 a.m.

Respectfully submitted,

______Richard M. Indovina, Jr. Secretary

- 28 –

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Report on Action Items

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

August 14, 2019

Agenda Item 6: Report on Action Items

During the reports from the Violations, Impairment and Reinstatement Committees and General Counsel, as well as during the Administrative Hearing, you took disciplinary action against a number of credentials. We entered those decisions in the eLicense system which enables their public access in the credential verification module of the Board’s website. We filed the required reports on those actions to the NABP Disciplinary Clearinghouse and the National Practitioner Data Bank. We also published your actions in the quarterly newsletter, with the exception of those cases exempted from such publication by your policies.

During the report from the Regulation Revision Committee, you approved four regulatory proposals, delayed the enforcement of a new Chapter <800> Hazardous Substances – Handling in Healthcare Settings published by USP, and authorized continued progress on a regulatory project. In particular:  With respect to Regulatory Proposal 2018-B ~ Drug Disposal by Pharmacies (Draft #5), we have submitted our required notice to the Occupational Licensing Review Commission (OLRC). We are waiting on their reply as to whether they will require a formal review of the proposed rule or issue a waiver to allow us to proceed without such review.  With respect to Regulatory Proposal 2018-N ~ Pharmacy Compounding (Draft #5), we have submitted our required notice to the OLRC. We are waiting on their reply as to whether they will require a formal review of the proposed rule or issue a waiver to allow us to proceed without such review.  With respect to Regulatory Proposal 2019-A ~ Pharmacy Records (Draft #3), we have submitted our required notice to the OLRC. We are waiting on their reply as to whether they will require a formal review of the proposed rule or issue a waiver to allow us to proceed without such review.  With respect to Regulatory Proposal 2019-D ~ Pharmacist Access to PMP (Draft #1), we have not yet submitted the required notice to the OLRC. The Regulation Revision Committee is considering another PMP-related proposal to implement a new law from the 2019 Legislature. The committee has recommended the filing of several PMP- relative proposals in one single package. The committee anticipates submitting the new PMP proposal, which will incorporate this proposal, to you during your next meeting in November.  With respect to your decision to delay the enforcement of the new USP Chapter <800>, we published an article in your July 2019 edition of the newsletter informing the licensees of your decision.  With respect to Regulatory Project 2019-1A ~ Marijuana Pharmacies, you evaluated the absence of comments at the public hearing and authorized continued progress on that project. We submitted the required notice to the OLRC and requested a waiver from further review. We are waiting for their reply.

During the report from the Executive Committee, you took action on a number of different types of documents.  You approved two new policies and revisions of four existing policies in your Policy & Procedure Manual. You also continued your approval of the manual for the next fiscal year. You also approved one new policy in your Loss Prevention Manual and extended your approval of the manual for the next fiscal year. We have posted the updated manuals and advised staff.  You approved two pharmacy technician training programs. We informed the programs of your requirements, posted the revised roster on our website and alerted the licensing staff.

Finally, copies of the Regulatory Project Promulgation Record as well as the Legislative Action Plan Implementation Report are attached to this report.

Respectfully submitted, Malcolm J Broussard Executive Director Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2019-18 Cannabis MDI

2019-17 Pharmacy Records Waiting for reply from OLRC

2019-16 Pharmacy Compounding Waiting for reply form OLRC

2019-15 Drug Disposal by Pharmacies Waiting for reply from OLRC

454-2019 Comments on Entirety of Rules 5/20/2019 6/26/2019

2019-14 Rulemaking Procedures 4/22/2019 OLRC issued waiver from Commission review

2019-13 CDS License for 3PL Providers 4/22/2019 OLRC issued waiver from Commission review

2019-12 Partial Fill of C-II Prescriptions 4/22/2019 OLRC issued waiver from Commission review

2019-11 Continuing Education Records Pending OLRC hearing

2019-10 License Transfer for Pharmacy Technicians Pending OLRC hearing

2019-9 Delays of Licensure Examinations Pending OLRC hearing

2019-8 Dispensing of Prescription Refills 4/12/2019 OLRC issued waiver from Commission review

2019-7 Veterinary Hospital Pharmacy 4/12/2019 OLRC issued waiver from Commission review

Last update: 08-14-2019 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2019-6 Prescription Monitoring Program 4/12/2019 OLRC issued waiver from Commission review

2019-5 Correctional Center Pharmacies 4/12/2019 OLRC issued waiver from Commission review

2019-4 Telepharmacy Dispensing Sites Pending OLRC hearing

2019-3 Investigational Drugs 4/12/2019 OLRC issued waiver from Commission review

2019-2 Pharmacy Immunizations 4/12/2019 OLRC issued waiver from Commission review

2019-1B Licensing of Marijuana Pharmacies Pending OLRC hearing

2019-1A Marijuana Pharmacies 4/20/2019 5/29/2019 Waiting for reply from OLRC 3/20/2019 OLRC issued waiver from Commission review

2018-3 Drugs of Concern - Naloxone 9/20/2018 10/26/2018 12/3/2018 [none] 1/20/2019 2019 2/26/2019

2018-2 La. Uniform Prior Authorization 8/20/2018 9/28/2018 10/25/2018 [none] 12/20/2018 2019 2/26/2019 Delayed effective date: 1/1/2019

2018-1 Pharmacy Benefit Managers 5/20/2018 6/25/2018 9/11/2018 10/8/2018 Sen. H&W Cmte rejected proposed rule.

2017-2 Equivalent Drug Product Interchange 4/20/2017 5/30/2017 9/27/2017 [none] 11/20/2017 11/20/2017 2/6/2018

2017-1 Internship Requirements 4/20/2017 5/30/2017 9/27/2017 [none] 11/20/2017 1/1/2018 2/6/2018 Delayed effective date: 1/1/2018

Last update: 08-14-2019 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2016-6 Marijuana Pharmacy 1/20/2017 3/2/2017 Comments prompted substantive revision, requiring a second public hearing 6/26/2017 7/5/2017 [none] 8/20/2017 2017 2/6/2018

2016-5 Reinstatement of CDS License 11/17/20/16 Emergency Rule #1 issued; it expired 3/17/2017. 3/15/2017 Emergency Rule #2 issued; it was cancelled upon publication of the Final Rule.

1/20/2017 3/1/2017 3/27/2017 [none] 5/20/2017 2017 2/6/2018

2016-4 Standing Orders for Distribution of Naloxone 8/10/2016 Emergency Rule #1 issued; it expired 12/8/2016. 12/7/2016 Emergency Rule #2 issued; it expired 4/6/2017. 4/5/2017 Emergency Rule #3 issued; it was cancelled upon publication of the Final Rule.

1/20/2017 3/1/2017 3/27/2017 [none] 5/20/2017 2017 2/6/2018

2016-3 Medication Synchronization 4/20/2016 5/25/2016 8/1/2016 [none] 9/20/2016 2016 2/1/2017

2016-2 Pharmacist-in-Charge of Nonresident Pharma 4/20/2016 5/25/2016 11/14/2016 [none] 1/20/2017 2017 2/6/2018

2016-1 CDS Prescriptions 4/20/2016 5/25/2016 6/3/2016 [none] 7/20/2016 2016 2/1/2017

2015-9 Accreditation of Technician Training Program 11/30/2015 Emergency Rule #1 issued; it expired 3/28/2016. 3/24/2016 Emergency Rule #2 issued; it expired 7/22/2016. 7/21/2016 Emergency Rule #3 issued; it expired 11/18/2016. 11/17/2016 Revised Emergency Rule issued; it expired 3/17/2017 3/15/2017 Emergency Rule #5 issued; it expired 7/13/2017 7/10/2017 Emergency Rule #6 issued; it will expire 11/7/2017 11/6/2017 Emergency Rule #7 issued; it was cancelled upon publication of the Final Rule.

1/20/2017 3/1/2017 Comments prompted substantive revision, requiring a second public hearing 6/26/2017 11/6/2017 [none] 12/20/2017 1/1/2018 2/6/2018 Delayed effective date: 1/1/2018

2015-8 Remote Access to Medical Orders 7/20/2015 8/26/2015 9/8/2015 [none] 10/20/2015 2016 2/22/2016

Last update: 08-14-2019 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2015-7 Remote Processor Pharmacy Permit 7/20/2015 8/26/2015 9/8/2015 [none] 10/20/2015 2016 2/22/2016

2015-6 Telepharmacy Services Permit 7/20/2015 8/26/2015 9/8/2015 [none] 10/20/2015 2016 2/22/2016

2015-5 Electronic Signature on Fax Prescription 6/1/2015 Emergency Rule; will expire on 09/30/2015 9/21/2015 Emergency Rule re-issued; will expire on publication of Final Rule.

7/20/2015 8/26/2015 9/8/2015 [none] 10/20/2015 2016 2/22/2016

2015-4 Compounding for Office Use for Veterinarians 6/1/2015 Emergency Rule; will expire on 09/28/2015 9/21/2015 Emergency Rule re-issued; will expire on 01/19/2016 1/15/2016 Emergency Rule re-issued; will expire on 05/14/2016 2/24/2016 Emergency Rule re-issued; will expire on publication of Final Rule 7/20/2015 8/26/2015 Comments prompted substantive revision, requiring a second public hearing 4/19/2016 5/10/2016 [none] 6/20/2016 2016 2/1/2017

2015-3 Electronic Product Verification 4/20/2015 6/25/2015 6/29/2015 [none] 8/20/2015 2016 2/22/2016

2015-2 Expiration Date of Schedule II Prescriptions 12/20/2014 1/28/2015 3/3/2015 [none] 4/20/2015 2016 2/22/2016

2015-1 Dispenser Reporting to PMP 12/20/2014 1/28/2015 3/3/2015 [none] 4/20/2015 2016 2/22/2016

2014-6 Special Event Pharmacy Permit 9/20/2014 10/30/2014 11/18/2014 [none] 1/20/2015 3/15/2015 2/22/2016

2014-5 Prescriptions 6/20/2014 7/28/2014 Comments prompted substantive revision, requiring a second public hearing 10/30/2014 11/18/2014 [none] 1/20/2015 3/15/2015 2/22/2016

2014-4 Pharmacy Compounding 8/8/2014 Emergency Rule - valid for 120 days 12/5/2014 Emergency Rule re-issued; expired on publication of Final Rule on 1/20/2015.

9/20/2014 10/30/2014 11/18/2014 [none] 1/20/2015 3/15/2015 2/22/2016

2014-3 Pharmacy Records 3/20/2014 4/29/2014 Comments prompted substantive revision, requiring a second public hearing 9/30/2014 10/3/2014 [none] 11/20/2014 3/15/2015 3/13/2015

Last update: 08-14-2019 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2014-2 Veterinarian Exclusion from PMP 3/20/2014 4/29/2014 5/8/2014 [none] 6/20/2014 3/15/2015 3/13/2015

2014-1 PMP Delegates 3/20/2014 4/29/2014 5/8/2014 [none] 6/20/2014 3/15/2015 3/13/2015

2013-06 Penal Pharmacy Permit Revision 7/20/2013 8/27/2013 10/3/2013 [none] 11/20/2013 1/15/2014 2/7/2014

2013-05 Collaborative Drug Therapy Management 7/20/2013 8/27/2013 11/8/2013 [none] 12/20/2013 1/15/2014 2/7/2014

2013-04 Preferential Licensing for Military Personnel 7/20/2013 8/27/2013 9/23/2013 [none] 11/20/2013 1/15/2014 2/7/2014

2013-03 Technician Training Programs [Chap. 9] 4/20/2013 5/30/2013 6/4/2013 [none] 7/20/2013 1/15/2014 2/7/2014

2013-02 Hospital Off-Site Satellite Pharmacies [Chap. 1/20/2013 2/27/2013 3/15/2013 [none] 5/20/2013 1/15/2014 2/7/2014

2013-01 Compounding for Prescriber Use ~ ER-1 12/13/2012 Emergency Rule - valid for 120 days 1/18/2013 Sen H&W Cmte rejected Emergency Rule

Compounding for Prescriber Use ~ ER-2 1/31/2013 Replacement Emergency Rule - valid for 120 days 5/29/2013 Replacement Emergency Rule re-issued - valid for 120 days 9/27/2013 Replacement Emergency Rule re-issued - valid for 120 days 2/6/2014 Replacement Emergency Rule re-issued - valid for 120 days 4/4/2014 Replacement Emergency Rule re-issued - expired 8/4/2014; see Project 2014-4 abovce for new ER

Compounding for Prescriber Use [Chap 25] 1/20/2013 2/27/2013 Comments prompted substantive revision, requiring a second public hearing 5/30/2013 Comments prompted substantive revision; additional hearing required 1/20/2014 Time has expired for the 2013 Notice of Intent - New Project & Notice of Intent required.

2012-11 DME Permit [Chapter 24] 11/20/2012 12/27/2012 1/5/2013 [none] 3/20/2013 4/15/2013 2/7/2014

2012-10 PMP [Chapter 29] 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-09 CDS in EDK [§1713, 2743] 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-08 CDS Lic. For Non-Resident Distributor [§2705 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

Last update: 08-14-2019 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2012-07 Security of Rx Dept [§1103] 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-06 Interstate Remote Processing [§1139, 1143] 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-05 Institutional Pharmacy [§1705, 1727] 7/20/2012 8/27/2012 1/2/2013 [none] 2/20/2013 4/15/2013 3/8/2013

2012-04 Chapter 24 - DME Permits ~ Emergency Rule 5/2/2012 Emergency Rule - valid for 120 days 2/7/2014 8/31/2012 Emergency Rule re-issued - valid for 120 days 2/7/2014 12/28/2012 Emergency Rule re-issued - valid for 120 days 2/7/2014

2012-03 Remote Processing [§1143, 1525] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2012-02 Hospital Pharmacy [§1501, 1512, 1513] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2012-01 E-Communications [§505, 905, 1203] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2011-07 Penal Pharmacy [Chapter 18] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2011-02 Cognitive Services [§525] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2011-01 PIC Requirements [§1105] 1/20/2012 2/28/2012 3/19/2012 [none] 5/20/2012 4/15/2013 3/8/2013

2009-04 Digital Imaging of Prescriptions [§1123] 12/20/2009 1/27/2010 2/26/2010 [none] 4/20/2010 1/31/2011 4/5/2011

2009-03 Prescription Transfers [§2523] 12/20/2009 1/27/2010 2/26/2010 [none] 4/20/2010 1/31/2011 4/5/2011

2009-02 Pharmacy Interns [§709] 12/20/2009 1/27/2010 2/26/2010 [none] 4/20/2010 1/31/2011 4/5/2011

2009-01 Drugs of Concern [§2901] 12/20/2009 1/27/2010 2/26/2010 [none] 4/20/2010 1/31/2011 4/5/2011

2008-03 CDS [Chapter 27] 6/20/2008 7/30/2008 8/21/2008 [none] 10/20/2008 1/31/2011 3/16/2009

2008-02 Pharmacies [§1107.B + §1727] 4/20/2008 5/28/2008 6/2/2008 [none] 7/20/2008 1/31/2011 3/16/2009

Last update: 08-14-2019 Louisiana Board of Pharmacy Regulatory Projects - Promulgation Record

Project 1st Report Public 2nd Report Oversight Final Rule Law Book 3rd Report No. Project Name Notice of Intent Hearing Hearing Record Hearing Published Published Completion

2008-01 Pharmacy Interns [ §521.G + §705.C] 4/20/2008 5/28/2008 6/2/2008 [none] 7/20/2008 1/31/2011 3/16/2009

2007-01 Prescription Monitoring Program [Chapter 29] 4/20/2007 5/30/2007 6/5/2007 [none] 7/20/2007 1/31/2011 2/13/2008

2006-03 Pharmacy Practice 11/20/2006 12/27/2006 Comments prompted substantive revision, requiring a second public hearing 3/30/2007 4/20/2007 5/3/2007 [none] 6/20/2007 1/31/2011 2/13/2008

2006-02 Proposal No. 2006-11 - Certified Preceptors 9/20/2006 10/30/2006 11/1/2006 [none] 12/20/2006 1/31/2011 3/30/2007

2006-01 Proposal No. 2006-11 - Certified Preceptors 9/1/2006 Emergency Rule - valid for 120 days [none] N/A N/A 3/30/2007

2005-03 §705 - Practical Experience for Interns 12/20/2005 1/25/2006 1/30/2006 [none] 4/20/2006 9/1/2006 3/30/2007

2005-02 §705 - Practical Experience for Interns 12/20/2005 Emergency Rule - valid for 120 days [none] N/A N/A 3/30/2007

2005-01 §907 - Scope of Practice for Technicians 6/20/2005 7/27/2005 8/25/2005 Refiled report due to disruption caused by Hurricanes Katrina & Rita 1/30/2006 2/14/2006 6/20/2006 9/1/2006 3/30/2007

2004-01 Chapter 8 →Chapter 9: Pharmacy Technician 8/20/2004 9/27/2004 10/5/2004 [none] 11/20/2004 1/1/2005 3/18/2005

2003-01 Complete Revision of Board Rules 7/20/2003 8/26/2003 8/28/2003 [none] 10/20/2003 1/1/2004 2/27/2004

2001-01 §1109 - Prescription Forms 9/20/2001 10/25/2001 11/5/2001 [none] 11/20/2001 1/1/2002 N/A

2000-04 Chapter 7 - Pharmacy Interns 6/20/2000 7/27/2000 8/28/2000 [none] 10/20/2000 12/1/2000 N/A

2000-03 Chapter 8 - Pharmacy Technicians 4/20/2000 5/30/2000 7/5/2000 Comments prompted substantive revisions, requiring a 2nd hearing 7/20/2000 8/24/2000 8/28/2000 [none] 10/20/2000 12/1/2000 N/A

2000-02 §3517 - Drug Donations / Charitable Pharmac 4/20/2000 5/30/2000 6/20/2000 [none] 8/20/2000 10/1/2000 N/A

2000-01 §3517 - Drug Donations / Charitable Pharmac 3/20/2000 Emergency Rule - valid for 120 days [none] N/A N/A N/A

1999-01 Chapter 12 - Automated Medication Systems 9/20/1999 11/29/1999 3/13/2000 [none] 6/20/2000 6/1/2000 N/A

Last update: 08-14-2019 Louisiana Board of Pharmacy Action Plans to Implement Legislation Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Operations Completion HB 138 2019-354 Revised definitions; new drugs in Schedule I 40:961 and 964 8/1/2019 8/1/2019 HB 243 2019-423 Reporting of opioid-related overdoses 40:978.2.1 8/1/2019 8/1/2019 HB 284 2019-426 Prescriber overrides of 7-day supply 40:978(G)(2) 8/1/2019 8/1/2019 HB 358 2019-284 Cannabis metered-dose inhalers 40:1046(A)(1) 8/1/2019 Reg. Proposal 2019-E in Cmte HB 375 2019-219 CBC for CDS license applicants 40:973.1 8/1/2019 Assigned to Cmte HB 423 2019-227 Repeal of student loan disqualifications 37:2951 repealed 8/1/2019 8/1/2019 HB 433 2019-161 Pharmacist may decline to fill prescription 37:1219(D through F) 8/1/2019 Assigned to Cmte HB 452 2019-231 Scheduling of mitragynine 40:964 and 40:989.3 8/1/2019 8/1/2019 HB 491 2019-164 Hemp-derived CBD oil products 40:961.1 8/1/2019 Pending HB 507 2019-331 7% tax on gross sales of marijuana products 40:1046(H)(8)(a) 8/1/2019 8/1/2019 HB 614 2019-256 Public notice for public records 44:33.1(B) 8/1/2019 SB 41 2019-124 Licensure and regulation of PBMs 37:1252 et seq; 40:2861 et seq 8/1/2019 Reg. Proposal 2019-G in Cmte SB 53 2019-080 Access to PMP by federal jurisdictions 40:1007(G) 8/1/2019 Reg. Proposal 2019-F in Cmte SB 99 2019-052 Board member qualifications 37:1174(A)(4) 8/1/2019 Assigned to Cmte SB 119 2019-351 Palliative Care Advisory Council 40:2018.6 Pending SB 241 2019-204 Revision of APA re small business impact 49:953 et seq Review Louisiana Board of Pharmacy Action Plans to Implement Legislation Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Operations Completion HB 45 2018-186 CDS license for 3rd party logistics providers 40:961(42); 972(B)(7); 973(A)(1) 8/1/2018 Reg Project 2019-13 in process HB 150 2018-063 Military spouse renewal fee waiver 37:1208.1 8/1/2018 No rule required PST-MS #12-MS 11/1/2018 HB 151 2018-064 Definition of 'approved school of pharmacy' 37:1164(2) 8/1/2018 No rule required 11/1/2018 HB 153 2018-119 New substances to Schedules I and II 40:964 8/1/2018 8/1/2018 HB 165 2018-677 Penalties for CS violations 40:966; 967 8/1/2018 8/1/2018 HB 186 2018-199 Penalties for CS violations 40:979 8/1/2018 8/1/2018 HB 188 2018-200 Acceptance of gifts by public servants 42:1115.2 anticipated HB 189 2018-454 Rulemaking procedures 49:953(C) 8/1/2018 Reg Project 2019-14 in process HB 224 2018-203 Penalties for legend drug violations 40:1060(13); (15) 8/1/2018 8/1/2018 HB 326 2018-206 Technical corrections to practice acts 37:1164; 1182; 1226.1; 1226.2 8/1/2018 8/1/2018 HB 372 2018-623 Occupational licensing review commission 37:41-47 1/31/2019 1/31/2019 HB 579 2018-708 New indications for therapeutic marijuana 40:1046 8/1/2018 8/1/2018 HB 627 2018-496 New indications for therapeutic marijuana 40:1046 8/1/2018 8/1/2018 HB 748 2018-693 Occupational licensing review by Gov office 49:903 3/14/2019 HB 823 2018-715 Delay termination date of marijuana program 40:1046(J) 8/1/2018 8/1/2018 HCR 70 Review of military licensing procedures anticipated SB 27 2018-644 Nominations to Medicaid P&T Cmte 46:153.3(D) 8/15/2018 8/15/2018 SB 28 2018-219 Exemptions for veterinarians 37:1251(D); 40:978(F)(3); 978.3(E) 8/1/2018 8/1/2018 SB 29 2018-423 Uniform prior authorization form 22:1006.1; 1651(J); 46:460.33 1/20/2018 §1129 & 1130 1/1/2019 SB 40 2018-515 Consumer members to licensing boards 37:1172(A); 1174(B) 8/1/2018 8/1/2018 SB 75 2018-405 Prescriber licensing boards re PMP access 40:978(F)(2) 8/1/2018 8/1/2018 SB 90 2018-028 Voluntary nonopioid directive form 40:1156.1 8/1/2018 LDH 11/1/2018 SB 109 2018-232 Epidemiologist access to PMP 40:1007(E)(8) 8/1/2018 Reg Project 2019-6 in process SB 110 2018-146 PMP definition of 'drugs of concern' 40:1003(10) 8/1/2018 §2901 1/20/2019 SB 131 2018-031 Pharmacist licensure by reciprocity 37:1202; 1203 8/1/2018 No rule required 11/1/2018 SB 134 2018-032 Partial fills for all Schedule II drugs 40:978(A) 8/1/2018 Reg Project 2019-12 in process SB 241 2018-317 Pharmacist communication with patients 22:1657; 37:1219 8/1/2018 No rule required 11/1/2018 SB 260 2018-655 Complaints re board actions or procedures 37:23.1; 23.2 11/1/2018 11/1/2018 SB 391 2018-669 Internet filters in state agency offices 8/1/2018 8/1/2018 SB 477 2018-602 Chart orders for institutional patients 37:1164(59); 1226.4 8/1/2018 Reg Project 2019-17 in process SCR 83 Military licensing info on website 10/1/2018

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Special Orders of the Day

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Finance Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 E-mail: [email protected]

Finance Committee

Final Report for Fiscal Year 2018-2019

August 14, 2019

Blake P. Pitre Chair

Louisiana Board of Pharmacy Finance Committee

Final Report for Fiscal Year 2018-2019

Table of Contents

Statement of Net Position 03

Statement of Equity 05

Statement of Cash Flow 06

Statement of Revenue, Expenses, & Budget Performance 07

Statement of Fund Balance Changes 09

Budget Variance Report 10

Summary of Board Actions 12

Iberia Bank – General Reserve Fund Statement 13

Iberia Bank – OPEB Reserve Fund Statement 13

Iberia Bank – Pension Reserve Fund Statement 14

Cumulative Fund Balance Report 15

Louisiana Board of Pharmacy FY 2018-2019 Statement of Net Position

FY 17-18 FY 18-19 Q4 06/30/2018 Q4 06/30/2019 ASSETS & DEFERRED OUTFLOWS Assets > Current Assets * Cash General Operations HancockWhitney Bank 245,279.77 228,043.77 Iberia Bank 932,997.64 1,684,545.02 Investment Accounts - Iberia Bank 107,440.90 268,913.41 * Total Cash & Cash Equivalents 1,285,718.31 2,181,502.20

* Accounts Receivable 17,170.00 24,295.00

* Accrued Interest Receivable 11,355.30 11,671.80

* Prepaid Expenses 8,154.42 53,834.10

* Grant Receivable 0.00 210,667.00 Total Current Assets 1,322,398.03 2,481,970.10

> Noncurrent Assets * Investment Accounts Iberia Bank - General Reserve Fund 1,190,485.88 1,216,051.35 Iberia Bank - OPEB Reserve Fund 1,157,538.40 1,084,491.59 Iberia Bank - Pension Reserve Fund 1,693,121.81 1,739,912.89 4,041,146.09 4,040,455.83 * Fixed Assets Land: Lot 5-A, Towne Center Business Park 709,079.90 709,079.90 Land: Lot 1-A-2, Leonard Place Subdivision 295,860.00 295,860.00 Office Building - 3388 Brentwood Drive 1,065,861.29 1,354,876.72 Construction in Progress 181,353.19 0.00 Office Equipment 227,265.21 230,345.19 Furniture 173,594.14 177,074.08 Software: Licensure & Website 408,560.00 408,560.00 Accumulated Depreciation (940,172.13) (995,793.19) 2,121,401.60 2,180,002.70

Total Noncurrent Assets 6,162,547.69 6,220,458.53

Total Assets 7,484,945.72 8,702,428.63

Deferred Outflows of Resources OPEB Reserve Fund 42,799.00 71,452.00 Pension Reserve Fund 1,227,635.00 972,930.00 Total Deferred Outflows of Resources 1,270,434.00 1,044,382.00

TOTAL ASSETS & DEFERRED OUTFLOWS 8,755,379.72 9,746,810.63 Louisiana Board of Pharmacy FY 2018-2019 Statement of Net Position

FY 17-18 FY 18-19 Q4 06/30/2018 Q4 06/30/2019 LIABILITIES, DEFERRED INFLOWS, & EQUITY Liabilities > Current Liabilites Grant payable 0.00 1,035,749.00 Accrued salaries and benefits 41,335.18 45,716.43 Unemployment taxes payable 52.92 184.03 State taxes withheld 4,212.00 4,820.00 State retirement withheld 0.00 0.00 Deferred compensation withheld 0.00 0.00 Garnishment payable 0.00 0.00 Accounts payable 8,960.31 4,582.35 Compensated absences (ST) 65,024.75 44,648.86 PES fee payable 100.00 200.00 Contract & retainage payable 111,502.03 0.00 Total Current Liabilities 231,187.19 1,135,900.67

> Long Term Liabilities Compensated absences (LT) 62,582.46 90,377.73 Other Post Employment Benefits (OPEB) Payable 1,934,454.00 1,928,937.00 Net Pension Liability 5,455,797.00 5,297,583.00 Total Long Term Liabilities 7,452,833.46 7,316,897.73

Total Liabilities 7,684,020.65 8,452,798.40

Deferred Inflows of Resources OPEB Reserve Fund 106,345.00 154,202.00 Pension Reserve Fund 144,892.00 80,208.00 Total Deferred Inflows of Resources 251,237.00 234,410.00

Equity 820,122.07 1,059,602.23

TOTAL LIABILITIES, DEFERRED INFLOWS, & EQUITY 8,755,379.72 9,746,810.63 Louisiana Board of Pharmacy Fiscal Year 2018-2019 Statement of Equity

FY 17-18 FY 18-19 Q4 06/30/2018 Q4 06/30/2019

Balance of Equity at Beginning of Year 1,493,402.25 820,122.07

Restatement due to implementation of GASB Statement 75 ~ Accounting & Financial Reporting for OPEB (751,686.00) 741,716.25

Net Income 78,405.82 239,480.16

Balance of Equity at End of Year 820,122.07 1,059,602.23

Components of Equity: Fund Balance at End of Prior Year (1,596,501.35) (1,600,918.63)

Fund Balance - designated 216,816.00 241,038.00

Invested in Fixed Assets 2,121,401.60 2,180,002.70 741,716.25 820,122.07 Louisiana Board of Pharmacy FY 2018-2019 Statement of Cash Flow

Cash flows from operating activities Cash received from licensees 5,130,322.89 Cash payments to suppliers for goods and services (1,524,942.67) Cash payments to employees for services (2,653,003.37) Net cash provided by operating activities 952,376.85

Cash flows from captial and related financing activities Purchase of capital assets (218,772.16) Net cash used by capital and related financing activities (218,772.16)

Cash flows from investing activities Proceeds from redemption of investment 99,000.00 Interest income 63,179.20 Net cash provided (used) by investing activities 162,179.20

Net increase in cash and cash equivalents 895,783.89

Cash and cash equivalents, beginning of period 1,285,718.31

Cash and cash equivalents, end of period 2,181,502.20

Reconciliation of operating income to net cash provided by operating activities

Cash flows from operating activities Operating income 77,674.72

Adjustments to reconcile operating income to net cash provided by operating activities Depreciation 55,621.06 Changes in current assets and liabilities Increase in accounts receivable (7,125.00) Increase in grant receivable (210,667.00) Increase in prepaid expenses (45,679.68) Decrease in deferred outflows related to pensions 254,705.00 Increase in deferred outflows related to OPEB (28,653.00) Decrease in accounts payable and PES fee payable (11,229.99) Increase in grant payable 1,035,749.00 Increase in salaies and benefits payable 4,381.25 Increase in payroll tax liability 739.11 Increase in compensated absences 7,419.38 Decrease in net pension liability (158,214.00) Decrease in OPEB payable (5,517.00) Decrease in deferred inflows related to pensions (64,684.00) Increase in deferred inflows related to OPEB 47,857.00 Total adjustments 874,702.13

Net cash provided by operating activities 952,376.85 Louisiana Board of Pharmacy FY 2018-2019 Statement of Revenue, Expenses, and Budget Performance Revenue FY 17-18 FY 18-19 FY 18-19 Q4 06/30/2018 Q4 06/30/2019 Budget (A#2) Notes

Licensing Fees PST License Application Fee 179,100.00 170,400.00 180,000.00 1 PST License Reciprocity Application Fee 45,750.00 48,750.00 46,000.00 2 PST License Renewal Fee 849,150.00 872,200.00 850,000.00 3 PNT Registration Application Fee 2,780.00 3,520.00 3,000.00 4 PTC Registration Application Fee 35,075.00 27,125.00 35,000.00 5 CPT Certificate Application Fee 53,500.00 55,400.00 55,000.00 6 CPT Certificate Renewal Fee 339,100.00 340,500.00 340,000.00 7 PHY Permit Application & Renewal Fee 282,005.00 280,925.00 285,000.00 8 AMS Registration Application & Renewal Fee 22,800.00 21,750.00 23,000.00 9 DME Permit Application & Renewal Fee 86,750.00 85,350.00 87,000.00 10 EDK Permit Application & Renewal Fee 12,825.00 11,725.00 13,000.00 11 CDS License Application & Renewal Fee 508,855.00 531,170.00 510,000.00 12 Credential Reinstatement Fee 28,990.00 25,340.00 30,000.00 13 Delinquent Renewal Fee for PST & CPT 13,775.00 14,500.00 13,000.00 14 Delinquent Renewal Fee for PHY & CDS 12,117.50 11,647.50 12,000.00 15

Sales of Goods & Services Product Charge for Duplicate Credentials 4,175.00 4,350.00 4,000.00 16 Product Charge for PST Original Certificate 6,845.00 5,475.00 7,000.00 17 Product Charge for PST Silver Certificate 500.00 500.00 500.00 18 Product Charge for Law Book & Supplement 510.00 375.00 500.00 19 Product Charge for Official List of Licensees 21,000.00 25,650.00 21,000.00 20 Product Charge for Document Copies 862.00 272.00 900.00 21 Service Charge for Document Certification 5,100.00 4,240.00 5,000.00 22 Service Charge for Inspection Services 0.00 6,000.00 3,000.00 23 Service Charge for PNT Practical Experience 530.00 350.00 200.00 24 Disposal of Assets 0.00 0.00 0.00

Administrative Fees Recovery of Bank Charges for NSF Fees 375.00 200.00 500.00 25 Handling & Mailing Fees 339.00 377.00 500.00 26

Enforcement Activities Administrative Hearing Fee 31,750.00 22,750.00 32,000.00 27 Fines 263,750.00 268,250.00 300,000.00 28 Cost Recoveries 17,088.97 25,653.33 17,000.00 29

Prescription Monitoring Program (PMP) PMP Assessments 555,830.00 591,220.00 560,000.00 30

Grants Private Grants 0.00 81,200.00 81,000.00 31 Government Grants 0.00 1,810,667.00 1,833,900.00 32

Miscellaneous 1,117.13 283.06 1,000.00 33

TOTAL REVENUE 3,382,344.60 5,348,114.89 5,350,000.00 34 Louisiana Board of Pharmacy FY 2018-2019 Statement of Revenue, Expenses, and Budget Performance Expenses FY 17-18 FY 18-19 FY 18-19 Q4 06/30/2018 Q4 06/30/2019 Budget (A#2) Notes Operations Equipment Rentals 15,668.28 14,974.91 16,000.00 35 Equipment Maintenance 2,307.12 2,201.88 3,000.00 36 Telephone 16,668.44 18,034.76 17,000.00 37 Printing 25,772.54 18,099.33 28,000.00 38 Postage 58,078.09 60,055.00 58,000.00 39 Dues & Subscriptions 11,670.64 10,671.61 12,000.00 40 Financial Service Charges 60,319.77 52,713.75 61,000.00 41 Office Meeting Expenses 14,465.48 5,067.38 15,000.00 42 Office Supply Expenses 21,530.38 21,956.05 22,000.00 43 Utilities 10,885.75 10,422.52 11,000.00 44 Civil Service Assessments (DSCS) 6,663.00 7,966.00 8,000.00 45 Office Insurance (ORM) 11,546.00 16,980.00 17,000.00 46 Depreciation of Fixed Assets 52,453.82 55,621.06 55,000.00 47 Acquisitions 3,049.36 5,676.36 20,000.00 48 Miscellaneous Expenses 0.00 0.00 0.00 Personal Services Salaries for Employees 1,517,733.96 1,669,429.89 1,745,000.00 49 Wages for Temporary Labor 19,370.31 12,420.31 20,000.00 50 Payroll Taxes (FICA & FUTA) 26,139.00 28,503.45 35,000.00 51 Health Insurance Premiums (SEGBP) 165,539.60 170,746.80 192,000.00 52 Pension Plan Premiums (LASERS) 741,611.92 655,213.95 698,000.00 53 Other Post-Employment Benefits (OPEB) 36,806.00 13,687.00 40,000.00 54 Board Member Per Diem 31,425.00 29,850.00 32,000.00 55 Professional Services Accounting & Expense Reimbursement 28,255.00 28,129.50 30,000.00 56 Legal & Expense Reimbursement 29,096.39 47,564.60 60,000.00 57 Information Systems 115,230.50 119,075.00 130,000.00 58 Prescription Monitoring Program 93,700.00 137,915.04 162,000.00 59 PMP Statewide Integration Project 0.00 1,810,667.00 1,833,900.00 60 Drug Price Transparency Website 0.00 81,200.00 81,000.00 61 Property Management 22,520.67 22,091.28 150,000.00 62 Staff Expenses Executive Director 3,634.28 4,822.99 5,000.00 63 General Counsel 9,616.70 9,868.05 10,000.00 64 Assistant Executive Director 2,843.74 4,853.17 5,000.00 65 Compliance Officer - Travel 3,734.72 6,995.39 6,000.00 66 Compliance Officer - Rental Cars 11,141.71 8,991.96 13,000.00 67 Compliance Officer - Fuel for Rental Cars 3,891.75 3,328.07 4,000.00 68 Compliance Officer - Conference Travel Expenses 8,158.21 2,710.29 12,000.00 69 House Staff Travel & Education 0.00 25.00 100.00 70 Mileage 23,111.18 28,049.76 24,000.00 71 Board Expenses Board Meetings 20,156.24 17,492.94 20,000.00 72 Committee Meetings 10,590.77 9,520.15 11,000.00 73 Conference Travel Expenses 14,865.86 19,782.78 20,000.00 74 President's Expenses 2,271.36 7,233.21 8,000.00 75 Mileage - Members & President 17,610.97 19,831.98 18,000.00 76 TOTAL EXPENSES 3,270,134.51 5,270,440.17 5,708,000.00 77 Louisiana Board of Pharmacy FY 2018-2019 Summary of Income and Fund Balance Changes

Summary

FY 17-18 FY 18-19 FY 18-19 Q4 06/30/2018 Q4 06/30/2019 Budget (A#2) Notes

Income Statement

Total Revenue 3,382,344.60 5,348,114.89 5,350,000.00 78

Total Expenses 3,270,134.51 5,270,440.17 5,708,000.00 79

Net Ordinary Income 112,210.09 77,674.72 (358,000.00) 80

Other Income & Expenses

Investments (33,804.27) 161,805.44 0.00 81

Net Income 78,405.82 239,480.16 (358,000.00) 82

FY 17-18 FY 18-19 FY 18-19 Q4 06/30/2018 Q4 06/30/2019 Budget (A#2) Fund Balance

Beginning Fund Balance 1,493,402.25 820,122.07 820,122.07

Total Income 3,348,540.33 5,509,920.33 5,350,000.00

Total Expenses 3,270,134.51 5,270,440.17 5,708,000.00

GASB-75 Restatement (751,686.00) 0.00 0.00

Ending Fund Balance 820,122.07 1,059,602.23 462,122.07

Reservations of Fund Balance 1,750,000.00 1,750,000.00 1,750,000.00

Unreserved Fund Balance (929,877.93) (690,397.77) (1,287,877.93)

Notes on Reservation of Fund Balance Unfunded Pension Liability 1,000,000.00 1,000,000.00 1,000,000.00 Unfunded OPEB Liability 500,000.00 500,000.00 600,000.00 Compensated Absences 150,000.00 200,000.00 150,000.00 Building Renovation & Repair 100,000.00 50,000.00 0.00 Total 1,750,000.00 1,750,000.00 1,750,000.00 Louisiana Board of Pharmacy FY 2018-2019 Budget Variance Notes

Notes Account Name % Variance Comment

Revenue

1 PST License Application Fee (5.33) Overestimated by 32 applicants 2 PST Reciprocity Application Fee 5.98 Underestimated by 18 applicants 3 PST License Renewal Fee 2.61 Underestimated by 222 applicants 4 PNT Registration Fee 17.33 Underestimated by 52 applicants 5 PTC Registration Fee (22.50) Overestimated by 315 applicants 6 CPT Certificate Application Fee 0.73 Underestimated by 2 applicants 7 CPT Certificate Renewal Fee 0.15 Underestimated by 10 applicants 8 PHY Application & Renewal Fees 0.32 Underestimated activity 9 AMS Application & Renewal Fees (0.54) Overestimated by 8 applicants 10 DME Application & Renewal Fees (1.90) Overestimated growth and renewals 11 EDK Application & Renewal Fees (9.81) Overestimated by 51 permits 12 CDS Application & Renewal Fees 4.15 Underestimated growth and renewals 13 Credential Reinstatement Fee (15.53) Overestimated by 23 applicants 14 Delinquent Renewal (people) 11.54 Underestimated number of delinquent renewals 15 Delinquent Renewal (places) (2.94) Overestimated number of delinquent renewals 16 Duplicate credentials 8.75 Underestimated demand 17 PST Original Certificate (21.79) Overestimated demand by 20 requests 18 PST Silver Certificate 0.00 Lucky guess 19 Law Books & Supplements (25.00) Overestimated demand 20 Official Lists of Licensees 222.14 Underestimated demand by 31 requests 21 Document Copies (69.78) Overestimated demand 22 Document Certification (15.20) Overestimated demand 23 Inspection Services 100.00 Timing issue; payment for 2 years in same fiscal year 24 PNT Experience Certifications 75.00 Underestimated demand by 15 requests 25 NSF Fee Recoveries (60.00) Overestimated incidence of NSF checks 26 Handling & Mailing Fees (24.60) Overestimated demand 27 Administrative Hearing Fees (28.91) Overestimated caseload by 37 cases 28 Fines (10.58) Overestimated assessments 29 Cost Recoveries 50.90 Underestimated cost recoveries 30 PMP Assessments 5.58 Underestimated growth and renewals of CDS licenses 31 Private Grants 0.25 Close estimate 32 Government Grants (1.27) Timing issue for LDH; balance rec'd July 2019 33 Miscellaneous (71.69) Overestimated minor revenue 34 Total Revenue (0.04) Overestimated total revenue Louisiana Board of Pharmacy FY 2018-2019 Budget Variance Notes

Notes Account Name % Variance Comment Expenses

35 Equipment Rentals (6.41) Reduction in use of color printing 36 Equipment Maintenance (26.60) Overestimated need 37 Telephone 6.09 Underetimated utilization 38 Printing (35.36) Deferred some year-end projects 39 Postage 3.54 Underestimated demand 40 Dues & Subscriptions (11.07) Re-evaluated need for certain subscriptions 41 Financial Service Charges (13.58) Overestimated use of online renewals 42 Office Meeting Expenses (66.22) Overestimated use of meeting security 43 Office Supply Expenses (0.19) Close estimate 44 Utilities (5.25) Overestimated use 45 Civil Service Assessments (DSCS) (0.43) Premium set by state 46 Office Insurance (ORM) (0.12) Premium set by state 47 Depreciation of Fixed Assets 1.13 Underestimated amount of depreciation 48 Acquisitions (71.62) Deliberate deferrals 49 Salaries for Employees (4.33) Personnel turnover contributed to lower salary expense 50 Wages for Temporary Labor (37.90) Overestimated need for student labor 51 Payroll Taxes (FICA & FUTA) (18.56) Overestimate related to turnover and less students 52 Health Insurance (SEGBP) (11.07) Premiums at 10.28% of salary expense 53 Pension Plan (LASERS) (6.13) Premium set by state; includes inflows + outflows 54 OPEB (65.78) Premium set by state 55 Board Member Per Diem (6.72) Overestimated meeting activity 56 Accounting Services (6.24) Overestimated cost of services 57 Legal Services (20.73) Overestimated cost of services 58 Information Systems (8.40) Overestimated need for special support services 59 Prescription Monitoring Program (14.87) New features on phased implementation 60 PMP Statewide Integration Project (1.27) Timing issue with LDH; balance paid in July 61 Drug Price Transparency Website 0.25 Budget was not precise. 62 Property Management (85.28) Renovation-related expenses recorded on balance sheet 63 Staff - Executive Director (3.54) Overestimated cost of meeting travel 64 Staff - General Counsel (1.32) Overestimated cost of meeting travel 65 Staff - Asst. Exec. Director (2.94) Overestimated cost of meeting travel 66 C.O. - Travel 16.59 Underestimated cost of field travel 67 C.O. - Rental Cars (30.83) Overestimated need 68 C.O. - Fuel for Rental Cars (16.80) Overestimated cost 69 C.O. - Conference Travel (77.41) Limited to USP 795/797/800 training 70 House Staff - Travel & Education (75.00) Limited to CBC-related travel 71 Mileage - entire staff 16.87 Underestimated mileage for staff 72 Board - Meeting Expenses (12.54) Overestimated meeting travel needs 73 Board - Committee Expenses (13.45) Overestimated committee meeting activity 74 Board - Conference Travel (1.09) Overestimated conference meeting activity 75 Board - President's Expenses (9.58) Overestimated meeting travel 76 Mileage - Board & President 10.18 Underestimated mileage for members 77 Total Expenses (7.67) Overestimated total expenses

Summary

78 Total Revenue 58.2% increase over FY 18, but only 3.95% over w/o federal grant 79 Total Expenses 61.2% increase over FY 18; but only 5.79% over w/o federal grant 80 Net Ordinary Income 30.78% decrease from FY 18 81 Investments Significant difference from FY 18; 39% from proceeds; rest is FMV 82 Net Income 205% increase over FY 18 Louisiana Board of Pharmacy FY 2018-2019 Summary of Board Actions

Date Action

11/14/2017 Original Budget - Finance Committee Approval

11/15/2017 Original Budget - Board Approval

8/14/2018 Budget Amendment #1 - Finance Committee Approval

8/15/2018 Budget Amendment #1 - Board Approval

11/13/2018 Budget Amendment #2 - Finance Committee Approval

11/14/2018 Budget Amendment #2 - Board Approval

Acceptance of Final Report Investment Account ~ Portfolio Snapshots

Reserve Account

OPEB Account

Pension Account

Louisiana Board of Pharmacy

Cumulative Fund Balance Reports

FY 98-99 FY 99-00 FY 00-01 FY 01-02 FY 02-03 FY 03-04 FY 04-05 FY 05-06 FY 06-07 FY 07-08 Actual Actual Actual Actual Actual Actual Actual Actual Actual Actual

Beginning Fund Balance 910,394 1,127,239 1,267,076 1,351,191 1,521,807 1,588,141 1,478,412 1,587,349 1,677,669 2,077,236

Total Income 984,414 1,030,423 1,168,798 1,200,575 1,223,872 1,274,804 1,524,411 1,627,306 2,228,918 2,657,168

Total Expenses 767,569 890,586 1,084,683 1,029,959 1,170,252 1,384,533 1,415,474 1,536,986 1,829,351 2,184,076

Ending Fund Balance 1,127,239 1,267,076 1,351,191 1,521,807 1,588,141 1,478,412 1,587,349 1,677,669 2,077,236 2,550,328

Reservations of Fund Balance 48,884 102,368 476,000 524,000 1,210,000 1,245,000 1,300,000 1,300,000 1,400,000 2,050,000

Unreserved Fund Balance 1,078,355 1,164,708 763,515 997,807 378,141 233,412 287,349 377,669 677,236 500,328

FY 08-09 FY 09-10 FY 10-11 FY 11-12 FY 12-13 FY 13-14 FY 14-15 FY 15-16 FY 16-17 FY 17-18 Actual Actual Actual Actual Actual Actual Actual Actual Actual Actual

Beginning Fund Balance 2,550,328 2,607,575 2,715,185 2,810,463 2,936,874 3,225,350 (620,086) 363,796 1,293,857.73 1,493,402.25

Total Income 2,570,282 2,706,829 2,808,468 2,775,418 2,849,249 3,059,394 3,615,033 3,512,690 3,191,751.77 3,348,540.33

Total Expenses 2,513,035 2,599,219 2,713,190 2,649,007 2,560,773 2,764,020 2,631,151 2,582,629 2,992,207.25 3,270,134.51

GASB Restatements (4,140,810) (751,686.00) (GASB-68) (GASB-75) Ending Fund Balance 2,607,575 2,715,185 2,810,463 2,936,874 3,225,350 (620,086) 363,796 1,293,857 1,493,402.25 820,122.07

Reservations of Fund Balance 1,900,000 1,650,000 1,650,000 500,000 750,000 2,162,000 1,272,000 772,000 1,750,000.00 1,750,000.00

Unreserved Fund Balance 707,575 1,065,185 1,160,463 2,436,874 2,475,350 (2,782,086) (908,204) 521,857 (256,597.75) (929,877.93) Louisiana Board of Pharmacy

Cumulative Fund Balance Reports

FY 18-19 FY 19-20 FY 20-21 FY 21-22 FY 22-23 FY 23-24 FY 24-25 FY 25-26 FY 26-27 FY 27-28 Actual Actual Actual Actual Actual Actual Actual Actual Actual Actual

Beginning Fund Balance 820,122.07 1,059,602.23

Total Income 5,509,920.33

Total Expenses 5,270,440.17

GASB Restatements

Ending Fund Balance 1,059,602.23

Reservations of Fund Balance 1,750,000.00

Unreserved Fund Balance (690,397.77)

FY 28-29 FY 29-30 FY 30-31 FY 31-32 FY 32-33 FY 33-34 FY 34-35 FY 35-36 FY 36-37 FY 37-38 Actual Actual Actual Actual Actual Actual Actual Actual Actual Actual

Beginning Fund Balance

Total Income

Total Expenses

GASB Restatements

Ending Fund Balance

Reservations of Fund Balance

Unreserved Fund Balance Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Finance Committee

Proposed Budget Amendment No. 1 Fiscal Year 2019-2020

August 14, 2019

Blake P. Pitre Chair

Louisiana Board of Pharmacy FY 2019-2020 Budget Amendment #1

Revenue FY 18-19 FY 19-20 FY 19-20 Actual Original BA-1 Notes Licensing Fees PST License Application Fee 170,400.00 180,000.00 170,000.00 1 PST License Reciprocity Application Fee 48,750.00 46,000.00 49,000.00 2 PST License Renewal Fee 872,200.00 850,000.00 872,000.00 3 PNT Registration Application Fee 3,520.00 3,000.00 3,500.00 4 PTC Registration Application Fee 27,125.00 35,000.00 28,000.00 5 CPT Certificate Application Fee 55,400.00 55,000.00 55,000.00 CPT Certificate Renewal Fee 340,500.00 340,000.00 340,000.00 PHY Permit Application & Renewal Fee 280,925.00 285,000.00 281,000.00 6 AMS Registration Application & Renewal Fee 21,750.00 23,000.00 23,000.00 DME Permit Application & Renewal Fee 85,350.00 87,000.00 87,000.00 EDK Permit Application & Renewal Fee 11,725.00 13,000.00 13,000.00 CDS License Application & Renewal Fee 531,170.00 510,000.00 532,000.00 7 Credential Reinstatement Fee 25,340.00 30,000.00 26,000.00 8 Delinquent Renewal Fee (people) 14,500.00 14,000.00 14,000.00 Delinquent Renewal Fee (places) 11,647.50 12,000.00 12,000.00

Sales of Goods & Services Product Charge for Duplicate Credentials 4,350.00 4,000.00 4,500.00 9 Product Charge for PST Original Certificate 5,475.00 7,000.00 6,000.00 10 Product Charge for PST Silver Certificate 500.00 500.00 500.00 Product Charge for Law Book & Supplement 375.00 500.00 500.00 Product Charge for Official List of Licensees 25,650.00 21,000.00 26,000.00 11 Product Charge for Document Copies 272.00 500.00 500.00 Service Charge for Document Certification 4,240.00 5,000.00 5,000.00 Service Charge for Inspection Services 6,000.00 3,000.00 3,000.00 Service Charge for PNT Practical Experience 350.00 500.00 500.00 Disposal of Assets 0.00 0.00 0.00

Administrative Fees Administrative Fee for NSF Items 200.00 500.00 500.00 Administrative Fee for Handling & Mailing 377.00 500.00 500.00

Enforcement Activities Enforcement: Administrative Hearing Fee 22,750.00 32,000.00 23,000.00 12 Enforcement: Fines 268,250.00 300,000.00 265,000.00 13 Enforcement: Cost Recoveries 25,653.33 18,000.00 25,000.00 14

Prescription Monitoring Program (PMP) Assessments 591,220.00 560,000.00 591,000.00 15

Grants Private Grants 81,200.00 41,000.00 42,000.00 16 Government Grants 1,810,667.00 0.00 0.00

Miscellaneous 283.06 1,000.00 1,000.00

TOTAL REVENUE 5,348,114.89 3,478,000.00 3,500,000.00 17 Louisiana Board of Pharmacy FY 2019-2020 Budget Amendment #1

Expenses FY 18-19 FY 19-20 FY 19-20 Actual Original BA-1 Notes Operations Equipment Rentals 14,974.91 16,000.00 15,000.00 18 Equipment Maintenance 2,201.88 2,500.00 2,200.00 19 Telephone 18,034.76 16,500.00 29,000.00 20 Printing 18,099.33 16,000.00 17,000.00 21 Postage 60,055.00 58,000.00 60,000.00 22 Dues & Subscriptions 10,671.61 12,000.00 12,000.00 Financial Service Charges 52,713.75 60,000.00 53,000.00 23 Office Meeting Expenses 5,067.38 14,500.00 5,000.00 24 Office Supply Expenses 21,956.05 21,500.00 22,000.00 25 Utilities 10,422.52 11,000.00 11,000.00 Civil Service Assessment (DSCS) 7,966.00 8,000.00 8,400.00 26 Office Insurance (ORM) 16,980.00 17,000.00 22,000.00 27 Depreciation of Fixed Assets 55,621.06 52,500.00 55,000.00 28 Acquisitions 5,676.36 20,000.00 100,000.00 29 Miscellaneous 0.00 0.00 0.00 Personal Services Salaries for employees 1,669,429.89 1,789,000.00 1,789,000.00 Wages for temporary labor 12,420.31 20,000.00 20,000.00 Payroll Taxes (FICA + FUTA) 28,503.45 36,000.00 36,000.00 Health Insurance Premiums (SEGBP) 170,746.80 197,000.00 197,000.00 Pension Plan Premiums (LASERS) 655,213.95 716,000.00 727,000.00 30 Other Post Employment Benefits (OPEB) 13,687.00 37,000.00 15,000.00 31 Board Member Per Diem 29,850.00 32,000.00 30,000.00 32 Professional Services Accounting & Expense Reimbursement 28,129.50 30,000.00 30,000.00 Legal & Expense Reimbursement 47,564.60 50,000.00 50,000.00 Information Systems 119,075.00 135,000.00 154,000.00 33 Prescription Monitoring Program 137,915.04 208,000.00 208,000.00 Drug Price Transparency Website 81,200.00 42,000.00 42,000.00 Statewide Integration PMP Gateway 1,810,667.00 0.00 0.00 Property Management 22,091.28 30,000.00 30,000.00 Staff Expenses Executive Director 4,822.99 5,000.00 5,000.00 Assistant Executive Director 4,853.17 5,000.00 5,000.00 General Counsel 9,868.05 10,000.00 10,000.00 Compliance Officer - Travel 6,995.39 6,000.00 7,000.00 34 Compliance Officer - Rental Cars 8,991.96 13,000.00 9,000.00 35 Compliance Officer - Fuel for Rental Cars 3,328.07 4,000.00 4,000.00 Compliance Officer - Conference Travel 2,710.29 14,000.00 14,000.00 House Staff Education & Travel 25.00 500.00 400.00 36 Mileage - entire staff 28,049.76 24,000.00 30,000.00 37 Board Expenses Board Meeting Expenses 17,492.94 20,000.00 18,000.00 38 Committee Expenses 9,520.15 11,000.00 10,000.00 39 Conference Travel Expenses 19,782.78 20,000.00 20,000.00 President's Expenses 7,233.21 8,000.00 8,000.00 Mileage - Members & President 19,831.98 18,000.00 20,000.00 40 TOTAL EXPENSES 5,270,440.17 3,806,000.00 3,900,000.00 41 Louisiana Board of Pharmacy FY 2019-2020 Budget Amendment #1

Summary of Fund Balance FY 18-19 FY 19-20 FY 19-20 Q4 06/30/2019 Original BA-1 Notes

Total Revenue 5,348,114.89 3,478,000.00 3,500,000.00 42

Total Expenses 5,270,440.17 3,806,000.00 3,900,000.00 43

Net Ordinary Income 77,674.72 (328,000.00) (400,000.00) 44

Other Income & Expenses

Investments 161,805.44 0.00 0.00

Net Income 239,480.16 (328,000.00) (400,000.00)

FY 18-19 FY 19-20 FY 19-20 Q4 06/30/2019 Original BA-1

Beginning Fund Balance 820,122.07 469,074.10 1,059,602.23

Total Income 5,509,920.33 3,478,000.00 3,500,000.00

Total Expenses 5,270,440.17 3,806,000.00 3,900,000.00

State-Imposed Adjustments 0.00 0.00 0.00

Ending Fund Balance 1,059,602.23 141,074.10 659,602.23

Reservations of Fund Balance 1,750,000.00 1,750,000.00 1,750,000.00

Unreserved Fund Balance (690,397.77) (1,608,925.90) (1,090,397.77)

Unfunded Pension Liability 1,000,000.00 1,000,000.00 1,000,000.00 Unfunded OPEB Liability 500,000.00 600,000.00 600,000.00 Compensated Absences 200,000.00 150,000.00 150,000.00 Building Renovation & Repair 50,000.00 0.00 0.00 Total 1,750,000.00 1,750,000.00 1,750,000.00 Louisiana Board of Pharmacy FY 2019-2020 Budget Amendment #1

Notes Revenue 1 Using historical data, estimate 567 applicants @ $300 each 2 Using historical data, estimate 327 reciprocity applicants @ $159 each 3 Using historical data, estimate 8,720 pharmacist renewals @ $100 each 4 Using historical data, estimate 350 intern applicants @ $10 each 5 Using historical data, estimate 1,120 candidate applicants @ $25 each 6 Using historical data for pharmacy permits and renewals 7 Using historical data for CDS licenses and renewals 8 Using historical data for credential reinstatement fees 9 Using historical data for sales of duplicate credentials 10 Using historical data for sales of pharmacist certificates, 80 @ $75 each 11 Using historical data for sales of official lists, 173 @ $150 each 12 Using historical data, estimate 92 cases with administrative hearing fees of $250 each 13 Using historical data, estimate for fines approximates 7.5% of total anticipated revenue 14 Using historical data for recovery of investigative costs. 15 Using historical data for PMP assessments, 23,640 @ $25 each 16 After initial implementation cost, annual grant should approximate $42,000 17 Revised estimate for total revenue reflects 0.6% increase from original budget

Expenses 18 Using historical data for equipment rental charges. 19 Using historical data for equipment maintenance and repairs 20 Using historical data for telephone charges + $14,000 for replacement system 21 Using historical data for office printing expenses 22 Using historical data for postage expenses 23 Using historical data for financial service charges due to online credit card fees 24 Using historical data for office meeting expenses include meeting security charges 25 Using historical data for office supply expenses 26 State increased the premium for State Civil Service participation fees 27 State increased the premium for office insurance 28 Using historical data for depreciation of fixed assets 29 Includes $100,00 for computer replacements due to withdrawal of support for Windows 7 30 State increased the premium for LASERS; now at 40.7% of salaries 31 Using historical data for OPEB estimate 32 Using historical data for board member per diem payments 33 Includes increase in eLicense maintenance + Metrc product ID module agreement 34 Using historical data for compliance officer field travel expenses 35 Using historical data for rental car expenses for compliance officers 36 Lower estimate for house staff travel expenses 37 Using historical data for increased staff mileage expenses 38 Using historical data for board meeting expenses 39 Using historical data for board committee meeting expenses 40 Using historical data for board member mileage expenses 41 Revised estimate for total expenses reflects 2.5% increase from original budget

Summary 42 Revised estimate reflects 1.1% decrease from FY 19 adjusted by omission of grant 43 Revised estimate reflects 12.7% increase from FY adjusted by omission of grant 44 Revised estimate reflects 22% increase from original projected deficit Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Application Review Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Reciprocity Committee

New Pharmacist Credentials Issued by Reciprocity Issued Since 05/13/2019

Applicant Interviewer Result 1 Tawanna Nicole Matthews (MS) Waived PST.022960 issued 05/16/19 2 Jennifer Michelle-Skinner Chesser (MI) Waived PST.022962 issued 05/16/19 3 James Matthew Curtis (AR) Waived PST.022963 issued 05/16/19 4 Lawrence DeMaio (FL) Waived PST.022964 issued 05/16/19 5 Ryan Kelso Taylor (NJ) Waived PST.022965 issued 05/16/19 6 Andrew Thienvan Fitzgerald (TX) Waived PST.022968 issued 05/16/19 7 Mikki Leigh Kline (TX) Waived PST.022969 issued 05/16/19 8 Kyle Lynddell Coleman (KS) Waived PST.022970 issued 05/16/19 9 Raya Alice Marie Elizabeth Manship (AZ) Waived PST.022971 issued 05/16/19 10 Megan McKenzie Malley (MS) Waived PST.022972 issued 05/16/19 11 Joseph Chi Trung Phan (GA) Waived PST.022973 issued 05/16/19 12 Ahmad Zaiter (FL) Waived PST.022974 issued 05/16/19 13 Clay Douglas Pehrson (AZ) Waived PST.022975 issued 05/16/19 14 Rafael Angel Diaz (FL) Waived PST.022976 issued 05/16/19 15 Alisa Brown Chamblee (VA) Waived PST.022978 issued 05/16/19 16 Anna Marie Baldwin (MS) Waived PST.022979 issued 05/16/19 17 Timothy Kyle Riordan (TX) Waived PST.022980 issued 05/16/19 18 Alisha Nicole Chamberlain (IN) Waived PST.022982 issued 05/22/19 19 Roy Michael Napoli (TX) Waived PST.022983 issued 05/31/19 20 Holly Elaine Vandermey (TX) Waived PST.022984 issued 05/31/19 21 Paul Anthony Koerner (KS) Waived PST.022985 issued 05/31/19 22 Angela Sue Northrop (OH) Waived PST.022986 issued 05/31/19 23 Kayla Ann Petty (IN) Waived PST.022987 issued 05/31/19 24 William A Bartkowiak (IL) Waived PST.022988 issued 05/31/19 25 Douglas Allen Gebhard (PA) Waived PST.022989 issued 05/31/19 26 Michael David Green (IO) Waived PST.022992 issued 05/31/19 27 Jeffrey Wayne Brooks Jr. (FL) Waived PST.022994 issued 06/10/19 28 Lindsey Mae Fovel (NY) Waived PST.022995 issued 06/10/19 29 Kayla Shea Douglas (MS) Waived PST.022996 issued 06/17/19 30 Diana Sue Tow (TX) Waived PST.022997 issued 06/18/19 31 Emily Ann Jensen (IO) Waived PST.022998 issued 06/18/19 32 Michelle Nguyen (WA) Waived PST.022999 issued 06/19/19 33 Chawn Harris Simon (MS) Waived PST.023000 issued 06/20/19 34 Christy Kyounghye Min (VA) Waived PST.023001-M issued 06/20/19 35 Roy Christopher Putrino (NY) Waived PST.023002 issued 06/20/19 36 Raj Naran Patel (IL) Waived PST.023003 issued 06/20/19 37 Dominique Danele Smith (NC) Waived PST.023004 issued 06/20/19 38 Manid Lee Pokorney (MO) Waived PST.023005 issued 06/20/19 39 Elizabeth Ann Murphy (NY) Waived PST.023007 issued 06/20/19 40 Taylor Bret Allen (AZ) Waived PST.023008 issued 06/20/19 41 Jordan Rae Burt (FL) Waived PST.023009 issued 06/20/19 42 Holly Christine Winn (CA) Waived PST.023010-M issued 06/25/19 43 Gregory Joseph France (OH) Waived PST.023011 issued 06/26/19 44 Marc Adrian Breneman (MO) Waived PST.023013 issued 06/26/19 45 Julie Rebecca Mandel (PA) Waived PST.023016 issued 06/26/19 46 Rashmi Shingari (NC) Waived PST.023018 issued 06/26/19 47 Rodel Christian Garcia Raymundo (FL) Waived PST.023019 issued 06/26/19 48 Tyler Edward Dinkelaker (MO) Waived PST.023020 issued 06/26/19 49 Katrina Anne Lancaster (MO) Waived PST.023022 issued 06/26/19 50 Dhrumilkumar D. Patel (MS) Waived PST.023026 issued 06/26/19 51 Brandon Lee Salke (MO) Waived PST.023027 issued 06/28/19 52 Hiba Zuhiar Cheetany (IL) Waived PST.023028 issued 06/28/19 53 Graham Benjamin Brown (TX) Waived PST.023031 issued 06/28/19 54 Jordan Bowers Cuccia (AL) Waived PST.023036 issued 07/03/19 55 Michael George Castellon (FL) Waived PST.023044 issued 07/03/19 56 Russell Frederick Whitford (TX) Waived PST.023048 issued 07/11/19 57 Timothy James Davis (PA) Waived PST.023049 issued 07/11/19 58 Jill Renee Meyer (AL) Waived PST.023060 issued 07/22/19 59 Zachary Tyler Tackett (NC) Waived PST.023078 issued 07/23/19 60 Desire Ebot Eyong (TX) Waived PST.023079 issued 07/23/19 61 James Patrick Demarest (CO) Waived PST.023080 issued 07/23/19 62 Jeffrey Scott Lang (NV) Waived PST.023085 issued 07/23/19 63 Leanna Elizabeth Barker (AL) Waived PST.023086 issued 07/23/19 64 Sarah Allison Jackson (ID) Waived PST.023087 issued 07/23/19 65 Parth Kamalnayan Parikh (VA) Waived PST.023088 issued 07/23/19 66 Theresa Ann Jacques (FL) Waived PST.023092 issued 07/24/19 67 Kristina Babakhanova (NY) Waived PST.023095 issued 07/30/19 68 Nathan Allen Hunnell (PA) Waived PST.023097 issued 07/30/19 69 Cory Alan Swymer (GA) Waived PST.023100 issued 07/31/19 70 Alexandra Blake Ferrante (KY) Waived PST.023108 issued 07/31/19 71 Rachel Ann Wiechert (MO) Waived PST.023109 issued 07/31/19 72 Alaina Ann Dekerlegand (FL) Waived PST.023111 issued 07/31/19 Total: 72 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Violations Committee

1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Violations Committee – CE Audits/Cases Policy No. I.C.7.c 4 5 Approved: 02-15-2006 Revised: 08-15-2018 6 7 8 1. The statutory authority for continuing education (CE) is RS 37:1210. 9 10 2. The regulatory authority for CE is LAC 46:LIII.507 and 909. 11 12 3. The Board staff will measure compliance with CE requirements by auditing 13 CE records maintained at CPE Monitor. 14 15 4. In an effort to provide guidance to staff as they address situations where they 16 discover noncompliance with relevant CE regulations, the following courses of 17 action shall be followed: 18 19 A. The following charges shall be considered and entered as appropriate: 20 1. R.S. 37:1241(A)(1) – Has practiced or assisted in the practice of 21 pharmacy, or knowingly permitted or has permitted anyone in his employ 22 or under his supervision to practice or assist in the practice of pharmacy, 23 in violation of the provisions of this Chapter and any rules and regulations 24 promulgated thereto in accordance with the Administrative Procedure Act. 25 [This charge shall be applicable to all cases] 26 2. R.S. 37:1241(A)(2) – Attempted to or obtained a license, registration, 27 certificate, permit or any other designation deemed necessary to engage 28 in the practice of pharmacy by fraud or misrepresentation. 29 [This charge shall be applicable when the licensee certified their 30 compliance with CE rules on their renewal application and the subsequent 31 audit revealed they did not comply with CE rules; it shall also be 32 applicable when the licensee falsifies CE transcripts or other documents.] 33 3. R.S. 37:1241(A)(7) – Has failed to report to the board any adverse action 34 taken by another licensing jurisdiction, government agency, law 35 enforcement agency, or court for conduct that would constitute grounds for 36 action as defined in this Section. 37 [This charge shall be applicable when a licensee credentialed in another 38 jurisdiction is disciplined for violation of CE rules in that jurisdiction and 39 then fails to disclose that disciplinary action on their subsequent 40 application for the renewal of their Louisiana license.] 41 4. R.S. 37:1241(A)(22) – Has failed to furnish to the board, its investigators, 42 or representatives any information legally requested by the board. 43 [ThisDRAFT charge shall be applicable when a licensee fails to respond 44 appropriately to a board representative in connection with a CE audit.] 45 5. LAC 46:LIII.507.C – A minimum of 1.5 ACPE or board-approved CPE 46 units, or 15 hours, shall be required each year as a prerequisite for 47 pharmacist license renewal. Of this number, no less than 0.3 ACPE or 48 board-approved CPE units, or three hours, shall be acquired through live 49 presentations, as designated by ACPE or the board. Alternatively, should 50 a pharmacist choose to not acquire at least 0.3 ACPE or board-approved 51 CPE units, or three hours, through live presentations, then he shall 52 acquire an additional 0.5 ACPE or board-approved CPE units, or five 53 hours, through any other acceptable method, over and above the 54 minimum requirement, for a total of two ACPE or board-approved CPE 55 units, or 20 hours. 56 [This charge shall be applicable when a pharmacist fails to comply with 57 the CE requirements.] 58 6. LAC 46:LIII.909.A – A minimum of one technician-specific ACPE or 59 board-approved CPE unit, or 10 credit hours, shall be required each year 60 as a prerequisite for annual renewal of a pharmacy technician certificate. 61 Such CPE units shall be credited in the 12-month period prior to the 62 expiration date of the certificate. 63 [This charge shall be applicable when a technician fails to comply with the 64 CE requirements.] 65 66 B. Staff shall prepare a proposed voluntary consent agreement for consideration 67 by the licensee. 68 1. The proposed voluntary consent agreement shall identify the appropriate 69 charges based upon the facts of the case. 70 2. The proposed voluntary consent agreement shall propose the following 71 sanctions: 72 a. For the violation of R.S. 37:1241(A)(2), a Letter of Reprimand, which 73 shall be published in the Board’s newsletter. 74 b. For the violation of R.S. 37:1241(A)(7), a Letter of Reprimand, which 75 shall be published in the Board’s newsletter. 76 c. For the violation of R.S. 37:1241(A)(22), a Letter of Warning. 77 d. For the violation of LAC 46:LIII.507.C, a Letter of Reprimand, which 78 shall be published in the Board’s newsletter. 79 e. For the violation of LAC 46:LIII.909.A, a Letter of Reprimand, which 80 shall be published in the Board’s newsletter. 81 f. Where there are multiple citations, a single sanction shall apply, and 82 the more severe option identified above shall apply. 83 3. The proposed voluntary consent agreement shall propose the following 84 assessments: 85 a. A single administrative hearing fee of $250 shall be assessed on all 86 proposed voluntary consent agreements. 87 b. Staff shall calculate and enter an amount sufficient to recover the cost 88 of staff investigation. 89 c. For the violation of R.S. 37:1241(A)(2), a fine in the range of $250 – 90 $1,000 for pharmacists and $100 - $250 for technicians. 91 d. For the violation of R.S. 37:1241(A)(7), a fine in the range of $250 – 92 $1,000DRAFT for pharmacists and $100 - $250 for technicians. 93 e. For the violation of R.S. 37:1241(A)(22), a fine in the range of $250 – 94 $750 for pharmacists and $100 - $250 for technicians. 95 f. For the violation of LAC 46:LIII.507.C, a fine based on the number of 96 credit hours in deficit: 97 i. $250 for 0 – 5 hours; and 98 ii. $50 for each credit hour more than 5. 99 g. For the violation of LAC 46:LIII.909.A, a fine based on the number of 100 credit hours in deficit: 101 i. $50 for 0 – 5 hours; and 102 ii. $25 for each credit hour more than 5. 103 4. When the CE audit identifies a deficiency in the number of CPE units or 104 credit hours, the proposed voluntary consent agreement shall instruct the 105 licensee to remedy the deficiency by: 106 a. acquiring that number of CPE units or credit hours prior to the 107 expiration date of the current renewal; and 108 b. transmitting a copy of the CPE Monitor transcript to the board office as 109 evidence of compliance with that instruction 110 Staff shall instruct the licensee the CE acquired for the remediation shall 111 not be applicable for the CE requirement for the next renewal. 112 5. When the licensee has been the subject of previous disciplinary action by 113 the board for violation of the CE rules, staff shall not propose a voluntary 114 consent agreement, and shall refer the case to the Violations Committee. 115 116 C. Staff shall transmit the proposed voluntary consent agreement to the licensee 117 for his consideration, and shall identify a deadline for the licensee to respond 118 to the proposal. 119 1. In the event the licensee elects to accept the proposed voluntary consent 120 agreement, staff shall present the proposal to the board for its 121 consideration and approval. 122 2. In the event the licensee elects to not accept the proposed voluntary 123 consent agreement, staff shall schedule the case for a preliminary hearing 124 by the Violations Committee. 125 126 B. For an initial violation of the above provisions, staff shall issue the 127 Respondent a Letter of Noncompliance. 128 1. The Letter of Noncompliance shall identify the appropriate allegations 129 based upon the facts of the case. However, the Letter of Noncompliance 130 shall not be considered disciplinary action by the Board. 131 2. When the CE audit identifies a deficiency in the number of CPE units or 132 credit hours, the proposed Letter of Noncompliance shall instruct the 133 licensee to remedy the deficiency by: 134 a. Acquiring that number of CPE units or credit hours; and 135 b. Transmitting a copy of the CPE Monitor transcript to the Board office 136 as evidence of compliance with that instruction; and further, 137 c. Staff shall instruct the licensee the CE acquired for the remediation 138 shall not be applicable for the CE requirement for the next renewal. 139 140 C. For a second violation of the above provisions, staff shall prepare a proposed 141 voluntaryDRAFT consent agreement for consideration by the licensee. 142 1. The proposed voluntary consent agreement shall identify the appropriate 143 charges based upon the facts of the case. 144 2. The proposed voluntary consent agreement shall propose a Letter of 145 Reprimand, which shall be published in the Board’s newsletter. The Letter 146 of Reprimand shall be considered a disciplinary action. 147 3. The proposed voluntary consent agreement shall propose the following 148 assessments: 149 a. A fine of $500 for pharmacists and $100 for technicians. 150 b. A single administrative hearing fee of $250 shall be assessed on all 151 proposed voluntary consent agreements. 152 c. Staff shall calculate and assess an amount sufficient to recover the 153 cost of staff investigation and preparation. 154 4. When the CE audit identifies a deficiency in the number of CPE units or 155 credit hours, the proposed voluntary consent agreement shall instruct the 156 licensee to remedy the deficiency by: 157 a. Acquiring that number of CPE units or credit hours prior to the 158 expiration date of the current renewal; and 159 b. Transmitting a copy of the CPE Monitor transcript to the Board office 160 as evidence of compliance with that instruction; and further, 161 c. Staff shall instruct the licensee the CE acquired for the remediation 162 shall not be applicable for the CE requirement for the next renewal. 163 5. Staff shall transmit the proposed voluntary consent agreement to the 164 licensee for his consideration, and shall identify a deadline for the licensee 165 to respond to the proposal. 166 a. In the event the licensee elects to accept the proposed voluntary 167 consent agreement, staff shall present the proposal to the Board for its 168 consideration and approval. 169 b. In the event the licensee elects to not accept the proposed voluntary 170 consent agreement, staff shall schedule the case for an informal 171 conference before the Violations Committee. 172 173 D. When the licensee has been the subject of previous disciplinary action by the 174 Board for violation of the CE rules, staff shall not propose a voluntary consent 175 agreement, and shall refer the case to the Violations Committee. 176 177 178 179 180 181 182 183 184 185 186 187 188 189 DRAFT 190 191 192 193 194 195 196 Revision History 197 198 08-14-2019 Re-structured policy to provide for a non-disciplinary Letter of 199 Noncompliance for the first offense, and then the proposed consent 200 agreement for the second offense. Re-structured the disciplinary 201 action within the consent agreement to be a Letter of Reprimand 202 regardless of the nature of the specific violation. Re-structured the 203 fine to be a $500 fine for pharmacists and $100 for technicians. 204 205 08-15-2018 Re-numbered policy. 206 207 05-23-2018 Made the following revisions to the original policy: 208  Amended Paragraph 3 to insert CPE Monitor. 209  Replaced Paragraph 4.

DRAFT Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Impairment Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Reinstatement Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Tripartite Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Regulation Revision Committee

Department of Health Board of Pharmacy

Notice of Public Hearing

In compliance with the Administrative Procedure Act, more specifically R.S. 49:953(C)(2)(a) as adopted by Act 454 of the 2018 Regular Legislative Session, the Louisiana Board of Pharmacy hereby gives notice of a public hearing to receive comments and testimony concerning the entirety of its rules [LAC 46:LIII.Chapters 1 through 33] as to whether any of them may be contrary to law, outdated, unnecessary, overly complex, or burdensome. A public hearing on these rules is scheduled for 9:00 am on Wednesday, June 26, 2019 at the Board office, which is located at 3388 Brentwood Drive in Baton Rouge, Louisiana 70809-1700. To request reasonable accommodations for persons with disabilities, please call the Board office at 225.925.6496. During the hearing, all interested persons will be afforded an opportunity to submit data, views, or arguments, either orally or in writing. The deadline for the receipt of all comments is 12:00 noon that same day. Interested persons may submit written comments, via United States Postal Service or other mail carrier, or in the alternative, by personal delivery to Malcolm J Broussard, Executive Director, at the Board office. While the Board will consider and respond to verbal testimony, only written comments will be included in the Board’s report to the Joint Legislative Oversight Committee on Health and Welfare.

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

NOTICE IS HEREBY GIVEN that a Public Hearing has been ordered and called for 9:00 a.m. on Wednesday, June 26, 2019 at the Board office, for the purpose to wit:

A G E N D A Revised 05-10-2019

1. Call to Order

2. Appearances

3. Solicitation of comments re Board’s rules [LAC 46:LIII.101 through 3301]

4. Opportunity for Public Comment

5. Adjourn

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Summary of Testimony & Public Comments re Regulatory Project 454-2019 ~ Comprehensive Rule Review at June 26, 2019 Public Hearing

1. Testimony from C. Bevan Callicott, on behalf of himself Asked how often Act 454 public hearings would be scheduled. Offered no comments or suggestions regarding rule changes.

2. Testimony from Katie Nguyen, on behalf of herself Requested the Board to consider mandatory lunch breaks for pharmacists practicing in pharmacies. Offered no comments or suggestions regarding other rules.

3. June 26, 2019 letter from Mary Staples, on behalf of National Association of Chain Drug Stores (NACDS) Request the Board to consider amendments to the following sections of rules: • §511, to remove the requirement to notify the Board of employment changes; • §521.B, to eliminate the separate authority to administer document, allowing the prescription for the medication to indicate that authority, for the life of the prescription; • §709.B, to eliminate the ratios for pharmacy interns; • §901, to amend the definition of a training program to allow the Board to approve programs that are not nationally-accredited; • §903.A.2.c.i, to change the proof of enrollment to either nationally-accredited or board- approved, and not to limit programs to being both; • §903.A.3.f, to remove the requirement to notify the Board of employment changes; • §903.B.2, to eliminate the requirement for a training program to notify the Board when students separate from the training program; • §903.D.1, to remove the board approval of technician examinations and specify the requirement for accreditation by NCCA (National Commission for Certifying Agencies); • §903.D.2, to remove the time delays on re-examination; • §905.A.3.a, to amend the eligibility for a technician certificate to allow national accreditation or board approval of training program; • §905.A.3.b, to reduce the experiential requirement from 600 hours to 320 hours (8 weeks), or in the alternative, 440 hours as required by PTCB certification; • §907.A.2, to remove the ratios for pharmacy technicians; • §907.A.3, to re-frame the scope of practice from a list of prohibited tasks to a list of permitted tasks, citing a list of activities associated with medication dispensing and assisting with clinical activities; • §1101.C, to remove the requirement for the signature of the PIC on the permit application form and simply require the name of the PIC on the form; • §1101.C.2, to change the permit renewal cycle from annual to biennial; • §1103, to remove sections for square footage, counter space, and aisle space; • §1103.H.1, to remove the first sentence specifying storage space; • §1103.K, to remove the requirement for a printed law book; Regulatory Project 454-2019 June 26, 2019 Public Hearing Summary of Comments Page 2 of 2

• §1105.A.1.b, to reduce the amount of practice experience to qualify for a PIC privilege, from two years to either six months or one year; • §1105.A.2, to remove the minimum number of hours for a PIC to be present; • §1105.I, to change the 10-day notice for PIC changes to 30 days; • §1109, to clarify that a pharmacist assisting a patient in a clinical capacity does not created a pharmacist absence; • §1111, to insert a similar clarification relative to pharmacist assisting a patient; • §1113, to repeal the prohibition on mechanical drug dispensing devices, or in the alternative, to allow for such devices when approved by the Board; • §1123, to remove the requirement to store hardcopy prescriptions for one year, in favor of allowing imaging systems to retain those records for at least two years; • §1131.A.1, to remove the requirement for a PIC signature, in favor of the signature of an authorize representative; • §1131.A.4, for pharmacy opening procedures, to remove section on DEA registration; • §1201, to amend the definition of ‘final check of work’ to allow for technology solutions in lieu of mandatory human checks; • §1207.A, to designate the PIC or verifying pharmacist as accountable for the accuracy of the AMS, with additional clarification that counting machines are not AMS devices; • §2307.A.1.c, to repeal the two year practice requirement for the PIC; • §2425.A.1, to reduce the mileage from 20 miles to 10 miles relative to telepharmacy dispensing sites; • §2425.A.6, to remove the requirement for a telepharmacy dispensing site to close if a new community pharmacy opens within 20 miles of the dispensing site; • §2425.E.2.c, to remove staffing parameters as well as references to staffing ratios; • §2425.E.3.g, to require counseling on new prescriptions and an offer to counsel on refills; • §2511.C.1, to remove the minimum size of a prescription form; • §2511.C.5, to allow for the electronic capture of facsimile prescriptions; • §2511.C.5.d, to remove the 2016 expiration date; • §2511.D.1, to allow a technician or intern enter a verbal transcription of a prescription into the dispensing information system, with the pharmacist held accountable to such prescriptions; • §2513, to repeal the section on prescription receipt and verification as redundant and unnecessary; • §2519.B.2, to remove C-V prescriptions, in alignment with 21 CFR 1306.22; • §2521, to extend the 72-hour allowance for emergency refills to a 30-day supply, or in the alternative, an exception for unit-of-use containers; • §2525.B.2, to remove the 6-month expiration date for C-V prescriptions; • §2733.C.1.a, to remove the annual CDS inventory as unnecessary; and • §2747.B.5, to allow for partial fills as requested by patients.

4. June 26, 2019 letter from John Rocchio, on behalf of CVS Health Requested the Board to consider amendments to the following sections of rules: • §907, to remove the ratios for pharmacy technicians and technician candidates; • §1109, to clarify a pharmacist is not absent if assisting a patient in a clinical capacity; and • §1111, to insert a similar clarification about a pharmacist absence from the pharmacy.

- END -

the

EXHIBIT

Page

Board

Drug

order,

Administer

the

nursing

serve

recommend

licensees.

lens

the

requirements.

utilization

Chain

employment

pharmacist

and

all

prescriptive

prescription.

best

the

Pharmacy’s

for

applaud

the

issued

Authority

has

medicine

reducing

notification

through

life

burden

Board

current

applies

Association

notification

Additionally,

our

and

the

rules

prescription.

executed

them

pharmacy.

aimed

prescriber

the

require

facility

National

are

keep

apply

the

view

the

medication.

properly

administrative

approach

states

and

approach,

comment

practice

the

should

this such

few

personnel,

critical

care

and

Board comments

the

Medications

this

Louisiana,

Review

very

the

administration

medication

consider

AMENDMENTS

Rule

eliminating

administer

the

opportunity

extensive

rules

standard

supervision,

Administer

unnecessary

section

requests

STORES its

the

(A)

authorize

Our

operating

Board

rules

Procedures requirement

this

Pharmacy

70809-1700

this

the

allowed

NACDS

practice,

administer

recommend

ASSOCIATION

days

DRUG

Change

Orders

Pharmacy

ask

RECOMMENDED

existing

Drive

members

approach.

striking

180

appreciates

Broussard

believe

Ucensure

state.

Board

prescriber

Louisiana

1. comments

our

AND

scope

consideration

care

(B):

the

should

Pharmacists

the

criteria

CHAIN

NATIONAL

of the

Director

Board

infoJpharmac.la.gov

Broussard:

2019

225-925-6649

review

(NACDS)

the

Rouge,

Employment

Prescription

Brentwood

and

Mr.

26,

Malcolm

allow

Louisiana

recommend

behalf

accepting

Fax: Email:

pharmacist

meets

eliminating

and

§521.

Chapter changes

rules §511. We Subsection

patients COMMENTS

Baton (Board) counterparts. technology, Subchapter

RE:

By On standard

By Dear for

Stores

Louisiana

Executive

Mr.

3388

June NACDS Chapter 7. Pharmacy Interns

§709. Scope of Practice– (B) We recommend striking section B, eliminating the intern to pharmacist ratio. Limiting the number of assistants that a pharmacist may leverage in the dispensing process has not demonstrated a positive impact on patient safety. The advanced training and education of pharmacy interns should make this a clear rule that is open for change.

We believe that interns work better and can learn more with other interns, especially in non-drug dispensing or research rotations/internships. We support eliminating the limitation of pharmacy interns that may assist in the prescription filling process. We recommend allowing the precepting pharmacist to determine the appropriate ratio based on their workplace and job duties.

A. Pharmacy interns may perform any duty of a pharmacist provided he is under the supervision of a pharmacist. B. The ratio of pharmacy interns to pharmacists shall be 1:1. However, the ratio of pharmacy interns on rotation with a board-approved college of pharmacy to pharmacists shall be no more than 3:1. C. A pharmacy intern may not: 1. present or identify himself as a pharmacist; 2. sign or initial any document which is required to be signed or initialed by a pharmacist unless a preceptor cosigns the document; 3. independently supervise pharmacy technicians; or 4. administer immunizations unless properly credentialed as required by the board.

Chapter 9. Pharmacy Technicians

§901. Definitions Employer-based training programs prepare technicians for their practice setting. If an employer can show that the core elements of a program are met, they should be allowed the flexibility to provide their own program. Understanding that employee turnover is a reality of any business, we believe there is a potential resolution to the challenges associated with staffing while technicians work towards achieving national certification. Chain pharmacies have a comprehensive training regimen that covers the pertinent competencies required to fulfill the allowed tasks of a Louisiana technician. We believe Louisiana Statute 37:1212 grants the Board the authority to approve company-based training programs as a method of certification, which will be focused on the actual activities being performed at that practice site. We recommend this amendment.

Training Program—a pharmacy technician training program that is currently nationally-accredited and has been approved by the board. The Board may

2 | P a g e

approve an employer-based training program that is not nationally accredited if deemed acceptable by the Board.

§903. Pharmacy Technician Candidates

Subsection (A)(2)(c)(i): We believe that the Board should allow for both board-approved or nationally accredited programs. If a program is nationally accredited, there is no purpose in also requiring it to be “board-approved”. Instead, we recommend a process to allows for employer-based programs that are not necessarily nationally accredited. Therefore, we suggest changing “and” to “or” to allow for both board-approved or nationally accredited programs. If the Board wishes to mandate national accreditation, then we recommend striking “and board approved”. We also suggest similar changes throughout the chapter to ensure consistency of all rules pertaining to certification programs and requirement.

Subsection (A)(3)(f): We recommend striking the change of employment requirement. We believe this requirement to be administratively burdensome and is overly unnecessary to notify the Board of a change in employment. Under current regulations the candidate is already required to notify the Board regarding mailing address changes. Removal of this requirement would not only lessen the administrative burden on the Board and the candidate, it would also align with current requirements in most states.

Subsection (B)(2): We recommend striking this section regarding notification of failure by the technician from a training program. The burden of notifying the Board when a trainee is no longer enrolled in a training program should not be the responsibility of the training program. If a technician candidate attempts to become employed elsewhere, the new place of employment has a responsibility to ensure proper credentialing of the candidate prior to hire and engagement in all technician activities. Additionally, it should be the responsibility of the candidate, not the training program, is to notify the Board of a change in program. This is an unnecessary administrative responsibility that has no significant impact on patient safety.

Subsection (D)(1): The Board should amend “board-approved” and instead indicate that any exams conducted by organizations accredited by NCCA (National Commission for Certifying Agencies) are acceptable as these are currently the exams conducted by PTCB or NHA only. This is a general standard across the nation. In addition, it does not require the board to specify exam names in the rule nor create a potential bias towards one exam or another.

Subsection (D)(2): We recommend striking time frames for retesting. Currently, both the Pharmacy Technician Certification Board (PTCB) and the National Healthcareer Association (NHA) have minimum time-periods in which a candidate must wait prior to re-taking the exam to ensure the integrity of the exam. Additionally, we believe that a one year waiting period is a lengthy time frame in which it is likely to diminish the candidate’s chances of passing this exam as well as decrease interest in gaining certification.

3 | P a g e

§905. Pharmacy Technician Certificate

Subsection (A)(3)(a): We recommend striking “and board-approved” or amending it to “or board-approved” for the same reasons provided in section 903.

Subsection (A)(3)(b): We recommend reducing the 600-hour requirement to 320 hours, or 8 weeks full time, which we think is enough to appropriately train pharmacy technicians. If the Board is not willing to decrease the required hours to 320, at minimum, we suggest revising the existing language to align with the current PTCB training requirements of 440 hours for entry level pharmacy technicians.

§907. Technician Scope of Practice

Subsection (A)(2): We recommend that the Board eliminate pharmacy technician ratios. Our experience in states with similar ratio requirements to the current Louisiana rule, staffing issues arise due to the limited number of certified technicians available to meet the high end of the ratio allowance. There is no evidence that limiting the number of technicians promotes the safety of pharmacy practice. Conversely, states that place a cap on the number of technician candidates leave pharmacists with the decision to either staff their location without adequate support or violate ratio regulations.

Pharmacists are professionals who can manage their pharmacies. Dictating a technician ratio is an antiquated policy in the present pharmacy practice environment. Arbitrary ratios prevent pharmacies from maximizing use of pharmacy technicians to provide a broader set of patient care services to the public. Many Boards of Pharmacy, recognizing this to be true, have over the years relaxed or removed restrictive ratios to allow for optimal use of pharmacy technicians. Notably, the National Association of Boards of Pharmacy (NABP) has long supported the complete elimination of the pharmacist to technician ratio.

Given the growing demand for pharmacist-provided patient care services in community pharmacies, there is a corresponding need to deploy pharmacy technicians for administrative and non-judgmental duties. Furthermore, elimination of technician to pharmacist ratios will enable pharmacists to focus more on counseling patients, performing MTM, providing disease management programs, engaging in other important patient care services, and collaborating with other health care professionals, thus integrating more fully in a patient’s care. These services also help patients better adhere to their medication regimens and ultimately serve to improve patients’ health and wellness and reduce our nation’s health care costs. Therefore, we strongly urge the Board to eliminate technician ratios to maximize the utilization of technicians by pharmacists.

Subsection (B): The current rules do not delineate specific tasks pharmacy technicians may perform. Instead, it outlines limitations for the duties performed by pharmacy technicians

4 | P a g e and allow pharmacists to determine what duties may be performed by technicians within those limitations. NACDS strongly supports pharmacists practicing at the top of their profession to allow for optimal patient care and improved health outcomes. When considering an enhanced role for pharmacy technicians in collaborative health settings, several duties can be reasonably delegated from these two categories: (1) medication dispensing support; and (2) technical support for clinical services provided by pharmacists and other health professionals. As such, where appropriate, we recommend that the Board strongly considers adopting changes that would allow pharmacy technician to perform duties in the following areas:

Medication Dispensing: Some pharmacist duties related to medication dispensing can be delegated to pharmacy technicians, thus allowing pharmacists to devote more time to patient care. The following tasks are related to medication dispensing and can be performed by a technician:

• Accepting a verbal prescription: Allows the technician to accept a verbal prescription by phone. Currently, 16 states permit this activity for certified technicians.1

• Transferring a prescription: Allows the technician to transfer a patient’s prescription to another pharmacy. Currently, 13 states permit this activity for certified technicians.2

• Consulting with a prescriber for clarifications: When information on a prescription is incomplete, a pharmacy technician can contact the prescriber and appropriately obtain the needed information. However, if the inquiry regarding the missing information requires the professional judgment of a pharmacist, then the pharmacist would contact the prescriber. Currently, six states permit this activity for certified technicians.3

• Final product verification: A new optimizing care practice model is emerging that allows technicians to verify the accuracy of another technician’s work and eliminate the final verification of a prescription by a pharmacist. Currently, this task is allowed in the community setting in Arizona, Idaho, and North Dakota. Iowa is currently soliciting comments on a proposed rule regarding technician product verification.

o Arizona: Qualified technicians may perform a final technology assisted verification of a product and subsequently type and affix a label for the

1 Currently allowed in ID, IL, IA, LA, MA, MI, MO, NH, NC, ND, OH, PR, RI, SC, TN, and WI. National Association of Boards of Pharmacy; Survey of Pharmacy Law; 2018; pp. 50. 2 Currently allowed in AZ, ID, LA, MA, MI, MO, NC, ND, PR, RI, SC, TN, and WY. Id. at 51. 3 Currently allowed in DE, IL, ID, IA, MI and SD. 5 | P a g e

prescription medication. A pharmacist, or graduate or pharmacy intern must verify the accuracy of the label.4

o Idaho: A certified technician may perform final verification on prescription drug orders that have previously undergone prospective drug review by a pharmacist.5

o Iowa: Proposed rule would allow certified technicians provide drug product verification.6

o North Dakota: Allows the preparation of a prescription or order for dispensing or administration to be performed by one registered pharmacy technician and verified by another registered pharmacy technician working in the same licensed pharmacy, under specific conditions.7

• Checking the Prescription Monitoring Program (PMP): Technicians should be allowed to initiate a check of the PMP, but not be allowed to make decisions on whether a medication should be dispensed based on the findings in the PMP report. Technicians are currently allowed to check the PMP in Maine and Idaho.8

Assisting with Clinical Services: The following are potential tasks that may be delegated to a technician with proper training to augment the role of pharmacists in providing direct patient care services. It is important to note that these tasks would not allow technicians to perform clinical services, but to perform steps that are part of a clinical service that do not require professional judgment. Except for Idaho, which now allows technicians to administer vaccines, these tasks are not expressly allowed in any state. However, it has been suggested that pharmacy technicians can be trained to perform the following:

• Perform basic physical assessment: Performing basic assessments such as taking a patient’s temperature or blood pressure can be considered non-judgmental tasks

4 Arizona Admin. Code R4-23-1104(A) and (B), https://apps.azsos.gov/public_services/Title_04/4-23.pdf. 5 Rules of the Idaho State Board of Pharmacy, 27.01.01.410 6 Technician Product Verification Programs, Proposed Rule, Nov 2018, https://pharmacy.iowa.gov/sites/default/files/documents/2018/11/draft_tpv_ch_40_pre-notice.pdf. 7 North Dakota Administrative Code, Section 61-02-07.1-12. Conditions require that: there are policies and procedures outlining pharmacy technician scope of practice, including training for the specific activity and appropriate recordkeeping; the pharmacy has a continuous quality improvement system in place to periodically verify the accuracy of the final product; any error must trigger pharmacist review of the process; the pharmacy has a system in place to review all quality related events and errors recorded and takes corrective action based on the information to reduce quality related events and eliminate errors reaching the patient; and the pharmacist-in-charge and permit holder are jointly responsible for the final product dispensed or released for administration from the pharmacy. 8 Idaho Statute, Title 37, Article III, Section 2726 (12). In Idaho, House Bill 374 was recently signed into law allowing technicians to check the PMP as a delegate of the supervising pharmacist as of July 1, 2016. The law provides practitioners with a new tool to streamline access to the PMP and allows for the designation of up to four delegates to access the PMP on their behalf. The bill amends the existing definition of “delegate” to include a registered pharmacy technician. A delegate may access information to the extent the information relates specifically to a current patient to whom the practitioner is prescribing or considering prescribing any controlled substance. Presently, regulations have not been proposed to implement this change in the law. 6 | P a g e

and may be tasks that pharmacists can delegate to pharmacy technicians. Allowing pharmacy technicians to perform such assessments may leverage scarce healthcare resources to improve efficiency in pharmacies that offer point-of-care testing. For example, if a pharmacy technician can check a patient’s temperature and administer a screening for influenza, then the pharmacist may assess the results and initiate treatment if appropriate.9

• Conduct medication reconciliation: Properly trained technicians can compile an initial medication list based on an interview with the patient. Assessing that information and making clinical recommendations would be performed by the pharmacist using his or her professional judgment.

• Administer vaccines: Prescribers routinely delegate vaccine administration to healthcare paraprofessionals. Similarly, there is an opportunity to allow pharmacists to delegate this task to a properly trained and certified pharmacy technician. In Idaho, technicians who are appropriately trained and certified may administer vaccines.10

• Administer CLIA-waived laboratory tests: CLIA-waived tests are “simple and have a low risk for erroneous results”11 with most having diagnostic capabilities. Under federal law, CLIA waived tests can be performed by laypersons. Consequently, performing a CLIA-waived test is a task that may be delegated to a properly trained technician. The decision to order, interpret, and act on the results of the test, however, requires professional judgment and would remain the duty of the pharmacist.

Chapter 11. Pharmacies

§1101. Pharmacy Subsection (C)(1): We recommend not requiring the signature of the PIC on the initial application as it is an unnecessary administrative burden for the pharmacy. Instead of the PICs signature, we recommend that the Board accept the name of a PIC on the application.

Subsection (C)(2): We recommend changing from annual to biennial renewals for pharmacy permits.

§1103. Prescription Department Requirements:

9 Pharmacy Today; The Promise of Point of Care Testing; Volume 22, Issue 2, pp 34-37; February 2016. In Nebraska, a Hy-Vee pharmacist is authorized through a collaborative practice agreement with a local primary care physician to dispense amoxicillin, azithromycin, or oseltamivir to treat influenza. 10 Rules of the Idaho State Board of Pharmacy, 27.01.01.330.02(b)(3) 11 Clinical Laboratory Improvement Amendments, Center for Disease Control, https://wwwn.cdc.gov/clia/resources/waivedtests/, last visited November 22, 2016. 7 | P a g e

Pharmacy practice has changed over the years and many requirements in this section are outdated. Some pharmacies today do not even stock medications, but rather only provide pharmacy services. Many of the requirements in this section are overly prescriptive, outdated, and unnecessary. We recommend eliminating these three subsections:

C. Square Footage. A prescription department that is new or remodeled on or after January 1, 2004 shall be not less than three hundred (300) total square feet, and shall be inaccessible to the public. D. Prescription Counter. A prescription counter on which to compound or dispense medications shall have a working surface of not less than a minimum of twenty- four (24) total square feet. The minimum unobstructed free working surface shall be kept clear at all times for the compounding or dispensing of prescriptions. E. Prescription Aisle Space. The aisle space behind the prescription counter shall be not less than thirty (30) inches in width.

Subsection H)(1): We recommend striking the first sentence and leaving only: “Drugs that require special storage shall be properly stored.”

H. Drug Inventory. 1. Storage. The pharmacy shall provide sufficient space on-site for proper storage of labels, prescription containers, and an adequate prescription inventory in order to compound and dispense prescription orders. Drugs that require special storage shall be properly stored.

Subsection (K): References - The requirement to keep hardcopies of the Louisiana Board of Pharmacy Laws and Regulations is outdated and should be eliminated. Electronic copies of the laws and regulations are available and can be updated automatically, whereas paper copies must be manually considering laws/rules constantly change. Therefore, we recommend revising this section to allow electronic copies of Louisiana laws and regulations.

§1105. Pharmacist-in-Charge Subsection (A)(1)(b): Under current rule, a licensed pharmacist is not be able to serve as PIC until they have obtained a minimum of two years of experience practicing pharmacy in Louisiana or another state. We believe that this requirement is problematic for community pharmacies. While we recognize the important role of the PIC in the operation of pharmacies and appreciate the Board’s intent for developing standards that serve to protect public health, safety, and welfare in the pharmacy setting, this requirement unfairly disadvantages skilled pharmacists and pharmacies who have to wait until the arbitrary timeline requirements are met. Additionally, it potentially exacerbates staffing issues in areas where pharmacies already have challenges recruiting pharmacists.

8 | P a g e

We believe that the designation of a PIC should be made on a case-by-case basis and should be based on the level of knowledge and training that a pharmacist has without regard to the number of years in practice. Pharmacists who are appointed to this position are those who are motivated and dedicated to protecting patient safety while upholding the statutes and rules under which they practice. Careful consideration is made prior to appointing a PIC and we believe each institution should have the right to determine if a pharmacist can perform as their PIC. We recommend the Board amend this provision in the proposed rule to require six months to one year of experience.

Subsection (A)(2): We recommend eliminating the minimum hours requirement. The Board rules have made clear that the PIC is accountable for the pharmacy following all laws and regulations, therefore a minimum hours requirement is unnecessary and overly prescriptive.

Subsection (I): The current rules require the notification in writing to the Board within 10 days of any discharge or termination of the licensed pharmacist or change of the status of the PIC. Additionally, the current rules require the permit holder to designate a new pharmacist-in-charge within 10 days of the departure of the prior pharmacist-in-charge. We disagree with the current language and recommend for notification of only the PIC. Staffing changes occur on a regular basis as pharmacists acquire new employment within the industry. We believe that this level of notification provides no additional patient protection and instead creates an additional administrative burden on the PIC as well as the Board staff.

In addition to making changes to only require notification of changes for the PIC, we also ask the Board to increase the report time from 10 days to 30 days to prevent unintended notification consequences. Currently most states allow the pharmacy license holder 30 days to find an adequate replacement for the PIC. We believe that given the level of responsibility of the PIC, the 10-day requirement is unrealistic and unreasonable. We recommend the Board allow more time for this process to be adequately completed.

§1109. Pharmacist Temporary Absence, and §1111. Pharmacist Absence We suggest amending the current rule to enable a pharmacist to assist a patient in a clinical capacity from outside of the pharmacy department without being considered absent. It is important to not obstruct safe pharmaceutical care practice in the evolving world of pharmacy services.

§1113. Mechanical Drug Dispensing Devices We recommend striking this rule. This rule prohibiting the dispensing of medications directly to patients by mechanical devices or machines may create confusion and/or potentially limit opportunities for increased access. Furthermore, we believe that this technology has been prohibited without evidence of public safety concern, as well as an

9 | P a g e inhibition of patient access to pharmaceutical care. If the Board will not consider elimination of the rule, instead we recommend that the Board considers incorporating an approval process to enable the expansion of patient access to pharmacy care.

A. Dispensing of prescription drugs directly to a patient or caregiver by mechanical devices or machine is prohibited, unless the device is approved by the Board. This prohibition shall not apply to automated medication systems as defined and provided for in Chapter 12 of these regulations.

§1123. Records We ask the Board to strike the requirement to retain a prescription hard copy for a year. Digital images of prescriptions for legend drugs have enabled pharmacies to utilize their software system to receive faxed prescriptions, without utilizing paper, and to scan written and oral transcribed prescriptions into the system for secure record keeping. The requirement to retain the hard copy for a year creates the unnecessary use of paper and limits the storage space within a pharmacy. We recommend the Board consider adopting these amendments:

K. Filing and Retention of Prescription Forms 1. Written prescription forms not stored in accordance to paragraph J (including transcriptions of verbal prescriptions received in the pharmacy, prescriptions received by facsimile in the pharmacy, as well as written prescription forms presented to the pharmacy) shall be assembled and stored in prescription number sequence. Prescriptions for controlled dangerous substances listed in Schedule II shall be filed separately from all other prescriptions. Where multiple medications are ordered on a single prescription form and includes one or more controlled dangerous substances listed in Schedule II, then such forms shall be filed with other Schedule II prescriptions. These original hard copy prescription forms shall be retained in the prescription department for a minimum of two years following the most recent transaction.

2. For those pharmacies utilizing an electronic imaging system as described in Paragraph J of this Section, written prescription forms may be assembled and stored in prescription number sequence, or in the alternative, a date scanned sequence. Further, these original hard copy prescriptions shall be retained in the prescription department for a minimum of one year following the most recent transaction.

3. Prescription forms stored in an electronic imaging system shall be retained within the system in a readily retrievable manner for a minimum of two years from the last transaction. received as an electronic image or electronic facsimile directly within the pharmacy information system shall be retained within the information system for a minimum of two years following the most recent transaction. Further, the pharmacy

10 | P a g e

may produce a hard copy of the prescription form but shall not be required to do so merely for recordkeeping purposes.

§1131. Pharmacy Opening Procedures Subsection (A)(1): We recommend the Board amend this section to allow for the signature of appropriate authorized representative of the pharmacy versus the signature of the PIC on the initial pharmacy permit application and Louisiana Controlled Dangerous Substance License application. As stated previously, staffing changes occur on a regular basis as pharmacists acquire new employment within the industry. When a new PIC is designated, the signature and documents are outdated. Allowing the appropriate authorized representative of the pharmacy to sign the initial permit application removes any inaccuracies with frequent employment changes of the PIC, and allows for more accuracy in the application and records processes.

Subsection (A)(4): This requirement is unnecessary in rules as it appears to be advisement to the applicant vs. a mandatory requirement.

Chapter 12. Automated Medication Systems

§1201. Definitions, and §1207. Pharmacist Review Technology has enabled the utilization of automated product checks that ensure the correct product on the label is dispensed. This has enabled Boards of Pharmacy to safely enable barcode scanning validation actuated by a technician or automated system to meet the requirements of a final pharmacist check. The dispensing pharmacist would be designated as the responsible pharmacist, with the duty of ensuring the accuracy of the technological verification system utilized. In line with these comments, we recommend the following amendments:

§1201. Definitions Final Checks of Work – the requirement that only a pharmacist supervises and releases the completed product prepared by a pharmacy technician, unless otherwise noted in this Section

§1207. Pharmacist Review A. The Pharmacist-in-Charge or verifying pharmacist shall be responsible for the accuracy of medication produced by the Ssystem shall be used in settings that ensure medication orders are reviewed by a pharmacist prior to administration and The system must be maintained in accordance with established policies and procedures and good pharmacy practice. A policy and procedure protocol shall be adopted to retrospectively review medications which cannot be reviewed prior to administration, as provided in LAC 46:LIII.1209.2.

11 | P a g e

We also recommend that clarifying language be added to indicate that indicates “counting machines” to not be included as automated dispensing systems.

Chapter 23. Nonresident Pharmacy

§2307. Pharmacist-in-Charge Similar to Section 1105 which requires a pharmacist to practice for two years prior to becoming a PIC, creating a determining factor of pharmacy management by time of practice is not a holistic view of who can take the responsibility of a PIC. Time of practice is not a holistic view of who can take the responsibility of a PIC. This requirement forces the selection of an individual based on years of practice rather than their individual capabilities to manage a pharmacy. With respect to mandating this of nonresident PICs, the state is, in some instances, prohibiting the domicile PIC of the nonresident pharmacy from being responsible for the actions of his or her pharmacy. In exchange, the rules seek to assign responsibility to another individual simply on the merits of that individual’s tenure being in excess of two years. Consistent with the suggestion made above for Section 1105, we recommend that the Board delete this provision in the rules.

A. The opportunity to accept an appointment as the pharmacist-in-charge (PIC) of a pharmacy is a professional privilege. The following requirements are attached to a PIC privilege: 1. The acquisition of the PIC privilege shall require: a. Possession of an active Louisiana pharmacist license; b. Possession of an active license in the state in which the pharmacy is located, and further, said license shall not have any restrictions which prohibit the position of pharmacist-in-charge; c. Active practice as a pharmacist for a minimum of two years under the jurisdiction of any board of pharmacy in the United States; and cd. …

Chapter 24. Limited Service Providers

§2425. Telepharmacy Dispensing Site Subsection (A)(1): We recommend reducing the mileage requirement to 10 miles. For those patients that lack transportation or have other mobility issues, even a few miles may create an access barrier. As currently written, 20 miles does not resolve the access concerns that these rules are intended to fix.

Subsection (A)(6): We recommend striking this section of the rule that requires the closing of a dispensing site if a new community pharmacy opens within 20 miles of the existing telepharmacy dispensing site. This section creates an unnecessary barrier for telepharmacies to open. Telepharmacy continues to grow nationally and will have a significant impact on rural areas. Where primary care physicians may be scarce, 91.7% of

12 | P a g e the country’s population lives within 5 miles of a pharmacy. We applaud Louisiana for having a telepharmacy platform in the state, however we request that the relevant rule be reevaluated to ensure that telepharmacy allows for flexibility to accommodate the inevitable changes in technology.

To reevaluate the rule comprehensively, we suggest looking at actions taken by the Indiana Board of Pharmacy (which has established a subcommittee to develop telepharmacy rules that meet the needs for patient population in Indiana) and the Illinois State Board of Pharmacy (which has developed industry leading rules that are currently used in Illinois).

Subsection (E)(2)(c): We recommend eliminating this section of the rule. The economics/business aspects of the pharmacy should dictate the number of personnel required to staff a telepharmacy location. In addition, as stated above, we recommend striking any ratio references in this rule.

Subsection (E)(3)(g): We recommend counseling requirements only on new prescriptions and an offer to counsel requirement on all refills. The vast majority of patients do not require nor want counseling on refills.

Chapter 25. Prescriptions, Drugs, and Devices

§2511. Prescriptions Subsection (C): We recommend the following changes to align with current electronic technology for transmitting prescriptions as well as to remove provisions that are administratively burdensome and unduly unnecessary.

• Striking the size requirements of a written prescription. • Expanding the rule to allow for electronic capture of facsimile prescriptions. With increased technology, facsimile prescriptions may now be received and stored electronically without a requirement to be in paper format. • Striking the expiration date of 12/31/2016 of this section of this rule, thereby allowing for prescriptions received by the pharmacy that bears the electronic signature of a prescriber to be construed as a validly formatted prescription for non- controlled prescriptions.

Subsection (D): We recommend adding language that would allow a pharmacy intern or technician to initial the form or add an identifier in the electronic record keeping system. Additionally, we suggest adding language that states that the verifying pharmacists would assume the responsibility for the accuracy of the order received by the technician or the pharmacy intern.

1. Upon the receipt of an oral prescription from an authorized prescriber, the pharmacist or pharmacy intern or pharmacy technician shall reduce the order to a

13 | P a g e

written form prior to dispensing the medication. As an alternative to recording such prescriptions on paper forms, a pharmacist they may enter the prescription information directly into the pharmacy’s dispensing information system. In the event a pharmacy intern or pharmacy technician transcribes such a prescription, the intern or technician must initial the form, or add an identifier in the electronic record keeping system. The verifying pharmacists assumes responsibility for the accuracy of the order received by a technician or pharmacy intern. supervising pharmacist shall initial or countersign the prescription form prior to processing the prescription.

§2513. Prescription Receipt and Verification Written, oral and electronic transmission of prescriptions as well as the verification of a prescription are all basic standards of practice and otherwise identified and throughout various Board laws and rules. We recommend the Board delete this section as it is redundant and unnecessary.

§2519. Prescription Refills; Medication Synchronization and Refill Consolidation Subsection (B)(2): We recommend that the Board amend this section to align with the §1306.22 of the Federal Code. Currently, under Federal Regulation, the DEA only specifies that C-III and C-IV prescriptions to be refilled up to 5 times. We recommend amending (B)(2) to strike C-V’s from this section of the rule to align with these requirements.

§2521. Emergency Refills Continuity of chronic care is essential for patients. Pharmacists should be enabled to assist a patient with demonstrated chronic therapy by providing an ample supply of medications when the prescriber cannot be reached for renewal. The current provision of 72-hours is on the low end of allowable quantities and may not bridge the gap being experienced by the patient. In the pharmacist’s clinical judgment, a patient should be enabled to receive a month supply of their chronic medication. This should follow a reasonable attempt by the pharmacist to reach the prescriber. It is also important to note that medications such as inhalers and oral contraceptives cannot be broken down into a 72-hour supply. Regardless of the Board’s desire to extend the day supply allowed for an emergency refill, a carve out for unit dosed packaging that cannot be separated into a 72-hour increment should be enabled. We recommend the Board adopt this amendment:

A. Using sound professional judgment, a pharmacist may provide a refill adequate of medication for a seventy-two (72) hour regimen when an emergency for medication has been adequately demonstrated and the prescribing practitioner is not available. This refill should not exceed a 30-day supply, or the previously prescribed quantity, whichever is less.

§2525. Prescription Expiration

14 | P a g e

Subsection (B)(2): We recommend that the Board amend this section to align with the §1306.22 of the Federal Code. Currently, under Federal Regulation, the DEA only specifies that C-III and C-IV prescriptions to expire 6 months from the date written. Therefore, we recommend amending (B)(2) to strike C-V’s from this section of the rule to align with these Federal Code requirements.

DEA: §1306.22 Refilling of prescriptions. No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times

DEA FAQ’s: Question: Can controlled substance prescriptions be refilled? Answer: Prescriptions for schedule II-controlled substances cannot be refilled. A new prescription must be issued. Prescriptions for schedules III and IV controlled substances may be refilled up to five times in six months. Prescriptions for schedule V controlled substances may be refilled as authorized by the practitioner.

Chapter 27. Controlled Dangerous Substances

§2733. Inventory Requirements Subsection (C)(1)(a): This subsection is unnecessary since annual inventory is required and shall include all stocks of controlled substances medications.

§2747. Dispensing Requirements Subsection (B)(5): We recommend that the Board review the current rules and amend as necessary to align with Section 702 (21 U.S.C 829(f)) of the Comprehensive Addiction and Recovery Act (CARA) to allow partial fills at the request of the prescriber or patient.

Conclusion

We thank the Board for the opportunity to provide input and proposing changes to your rules. We look forward to working with you to ensure that patients in Louisiana continue to receive optimal healthcare at their community pharmacy. If you have any questions or need additional information, please contact me at [email protected] or 817-442-1155.

Sincerely,

Mary Staples Regional Director, State Government Affairs

15 | P a g e

of a of of to Rules their of health, to the been to pulled provide family in LEIT reasons achieving in determine enabling the entry number technician to highest be its technicians in technicians patient provided to maximum of Model never impact Boards the to new and towards able assist 02895 order related new of a future and has would assist RI to be technician technician proficient a certified shift and current the interest Odve hire Act of be will enables Health negative hiring there pharmacists, only for the technicians the to a and pharmacists CVS and is committed that non-work in available CVS need ratio, One Woonsocket, pharmacist Association assist are establish reducing number for seek a services for to to Pharmacy counseling, the success requires routinely the to result We the allowing pharmacy candidate to services of promoting time, care to pharmacy are in that a of State of personnel National without sought Affairs at means the forced review, health. provided limiting the likely record is employment patient response Model This success volume never pharmacy technician number a support that mission better of more or track training pharmacies ends of addition, The the As to two. Regulatory utilization far In pharmacy personnel, or technicians is of existing safety path supporting indicate Board’s from Louisiana.”2 century of expanded drug the an number one a to prescription of candidate the and limit eliminated technician practice. duties. their maximum, historicjurisdictions and Increasing Ratio the support only Director over specialty on abolished. state the with career, number / have develop Sr. States. over of care. in restrictions the produced was with with the pharmacy enabled to arbitrary certified as prescription that technician overwhelming pharmacy of a a clInc in aligns advances. that an patients medications as due ratio non-clinical of an ratio Decreasing been Technician one United states patient takes change and all states note it a to help the When not minute such the are capacity currently make citizens these / to supervision 21 process or to increase safety care, reveals has is time assigning my the once the clinical an and the dispensing available. with there Practice; must certification, Pharmacy in to across removed by of actions the on in 70809 of of As Drive ratio of patient experience caremarK featuring now important a you ‘vorkforce. education ,‘ assist mission LA evidence appropriate landscape is focus to supports to located ratio. During process welfare clinical promotes Scope It (NABP) Director pursuit Board purpose. ratio, their Broussard, Broussard pharmacy technicians 2019 create clinical higher a learning and technological Rouge, to from pharmacists of assistants Brentwood Health Health’s Mr. as pharmacy

writing Health 26, §907. national maintain stated increased l999. staff bolster am Pharmacy critical certified dispensing away verification in and pharmacist candidates to to Additionally, three move candidate. mandated I CVS such Dear RE: The removing our order safety, CVS an assist Louisiana Malcolm pharmacies 3388 Baton safew. Executive June

iJ ecw

patient care and safety than the utilization of a sufficient number of technician candidates. CVS Health recommends striking pharmacy technician ratio limitations under section 907 in its entirety. Louisiana ADC 46 LIII: 907 Scope of Practice A. Pharmacy technician candidates and pharmacy technicians may assist the pharmacist by performing those duties and functions assigned by the pharmacist while under his direct and immediate supervision. 1. The ratio of candidates to pharmacists on duty shall not exceed one to one at any given time. 2. The ratio of technicians to pharmacists on duty shall not exceed two to one at any given time. However, the ratio of technicians to pharmacists on duty may be increased to three to one if no technician candidates are on duty at the same time.

RE: Louisiana ADC 46 LIII: 1109 Pharmacist Temporary Absence and §1111. Pharmacist Absence CVS Health believes clarification is required within section 1109, detailing that a pharmacist outside of the prescription department providing individualized patient care will not be considered an absence of a pharmacist. We suggest amending the current rule to enable a pharmacist to assist a patient in a clinical capacity from outside of the pharmacy department without being considered absent. The following amendments will assist pharmacists in understanding this allowance: Louisiana ADC 46 LIII: 1109 Pharmacist Temporary Absence A. A pharmacist shall be considered to be temporarily absent from the prescription department when not within the confines of the prescription department but remains on-site, unless assisting a patient in a clinical capacity. … Louisiana ADC 46 LIII: 1111. Pharmacist Absence A. A pharmacist is considered absent from the prescription department when he is not in the prescription department and is off-site.

CVS Health is grateful for the opportunity to comment provided through Act 454 of the Louisiana Legislature. We strive to enable pharmacists to have adequate technician support in the prescription filling process, and we strongly support the individualized patient care that is enabled through the allowance for a pharmacist to engage a patient from outside of the pharmacy department, without impacting the functionality and availability of the pharmacy team in producing prescriptions to the point of pharmacist verification. If you have any questions or need additional information, please contact me directly at 617-599-9091.

Sincerely,

John N. Rocchio PharmD. RPh. Sr. Director, Pharmacy Regulatory Affair

References: 1. Berenbrok et al. Pharmacy Technician Role Expansion. An Evidence-Based Position Paper. 2018. Available from: https://pages.pharmacy.pitt.edu/epittpharmacy/2018/08/07/pittpharmacy-team-reports- on-expanded-role-of-pharmacy-technicians/ (Accessed April 8, 2019). 2. Louisiana Board of Pharmacy, About Us, 2019. Available from: http://www.pharmacy.la.gov/index.cfm?md=pagebuilder&tmp=home&pid=44 (Accessed June 26, 2019). 3. National Association of Boards of Pharmacy. The Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act). 2019. Available from: https://nabp.pharmacy/publications-reports/resource-documents/model-pharmacy-act-rules/ (Accessed April 8, 2019). 4. National Association of Boards of Pharmacy. Report of the Task Force on Manpower Shortage. 1999. Available from: https://nabp.pharmacy/wp- content/uploads/2016/07/TF_Pharmacy_Manpower_Report_1999.pdf (Accessed April 8, 2019).

Louisiana Board of Pharmacy

Public Hearing Attendance Record June 26, 2019

Regulatory Project 454-2019 Comprehensive Rule Review In The Matter Of: STATE OF LOUISIANA PARISH OF EAST BATON ROUGE LOUISIANA BOARD OF PHARMACY

Public Hearing June 26, 2019

Associated Reporters, Inc. 2431 South Acadian Thruway Suite 550 Baton Rouge, La. 70808

Original File PHARM BD 06292019X.TXT Min-U-Script® with Word Index 1

1 STATE OF LOUISIANA

2 PARISH OF EAST BATON ROUGE

3 LOUISIANA BOARD OF PHARMACY

7 A Public Hearing was held by the

8 Louisiana Board of Pharmacy, on Wednesday,

9 June 26, 2019, at their office located at

10 3388 Brentwood, Baton Rouge, Louisiana 70809

11 beginning at 9:00 a.m.

15 BEFORE:

16 Susan Erkel

17 Certified Court Reporter

18 In and For the State of

19 Louisiana

25 2

1 A P P E A R A N C E S

3 MALCOLM BROUSSARD, EXECUTIVE DIRECTOR

5 * * * * * * * *

25 3

1 I N D E X

3 CAPTION...... 1

4 APPEARANCE ...... 2

5 INDEX...... 3

6 PROCEEDINGS...... 4

7 REPORTER'S CERTIFICATE ...... 50

8 REPORTER'S PAGE...... 52

25 4

1 P R O C E E D I N G S

2 MR. BROUSSARD:

3 Good morning. Today is Wednesday,

4 June 26, 2019. The time is 9:00 a.m. We

5 are assembled in the Boardroom at the

6 Louisiana Board of Pharmacy located at

7 3388 Brentwood Drive in Baton Rouge,

8 Louisiana. My name is Malcolm Broussard,

9 and I serve the Board of Pharmacy as its

10 Executive Director. In his absence,

11 Board President Carl Aron has requested

12 that I moderate this hearing. I now call

13 this public hearing to order. As a

14 courtesy to everyone else in the room,

15 please take this time to silence all

16 pagers, cell phones, and other electronic

17 communications devices. Further, should

18 you find it necessary to take or make a

19 telephone call, please step outside the

20 meeting room to do so.

21 For your safety, the emergency exit

22 path from this room is through the door

23 into the lobby and then through the front

24 door through which entered the building.

25 For your comfort, restrooms are located 5

1 in the lobby -- ladies on the opposite

2 side of the lobby, just past the

3 receptionist's window, and gentlemen,

4 just outside the door to this room. In

5 addition, we have a water cooler in this

6 room. Please help yourself.

7 For your peace of mind, please ensure

8 you did not park in one of the three

9 spaces between this building and the back

10 of the building in front of this one, or

11 in front of the building in front of this

12 one. Those parking spaces do not belong

13 to the Board, and tow trucks are regular

14 visitors to that area. Additional

15 parking is available in the rear of the

16 Perlis clothing store on Jefferson

17 Highway, and there is a stairway

18 connecting that parking lot to the

19 Board's parking area in front of our

20 building.

21 This hearing is held in accordance

22 with the Administrative Procedure Act and

23 the Open Meetings Law. As required by

24 these laws, this hearing is convened

25 pursuant to public notice, and notice has 6

1 been properly posted. The purpose of

2 today's hearing is to receive public

3 comments and testimony on the entirety of

4 the Board's rules, from Section 101

5 through 3301.

6 The Board published its Potpourri

7 Notice in the May 2019 edition of the

8 Louisiana Register. Further, the Board

9 distributed an electronic Notice of

10 Rulemaking Activity on May 20, 2019 to

11 its electronic List of Interested

12 Parties, as well as all pharmacies,

13 pharmacists, pharmacy interns, pharmacy

14 technicians, pharmacy technician

15 candidates, pharmacy technician training

16 programs, and all prescribers with

17 controlled substance licenses. As

18 indicated in the Notice, the Board has

19 convened this public hearing to receive

20 public comments and testimony on the

21 entirety of its rules as to whether any

22 of them may be contrary to law, outdated,

23 unnecessary, overly complex, or

24 burdensome.

25 The Board will consider the comments 7

1 and testimony offered today to determine

2 whether any revisions to the current

3 rules are necessary. We will reply to

4 your comments as soon as possible

5 thereafter. Prior to making any comments

6 today we ask that you sign the guest

7 register for this event.

8 Copies of today's agenda and the

9 notice are available at the registration

10 desk. In addition, we have a copy of the

11 relevant portion of the Table of Contents

12 from the Louisiana Pharmacy Law Book

13 identifying all of the sections in all of

14 the chapters of the Board's rules. Those

15 rules are also available in the Public

16 Library section of the Board's website at

17 www.pharmacy.la.gov, as well as the

18 website of the Louisiana Register.

19 While we may answer questions to

20 clarify language and interpretation, is

21 it not our intent to debate any issues

22 today. Again, the purpose of this

23 hearing is to receive your comments and

24 testimony for the Board's consideration.

25 As indicated in the notice, the deadline 8

1 for all comments and testimony on these

2 rules is 12:00 noon today.

3 We are now prepared to receive your

4 comments and testimony. As you begin

5 your comments, we ask that you identify

6 yourself and any organization you may

7 represent.

8 MR. CALLICOTT:

9 How often do you anticipate these

10 hearings occurring?

11 MR. BROUSSARD:

12 The question was how often we

13 anticipate these hearings? The law that

14 requires this hearing was adopted last

15 year and is Act 454 of the 2018

16 legislature. So you'll hear me refer to

17 this as an Act 454 Hearing. The law

18 requires that every agency with

19 rulemaking authority in Louisiana conduct

20 this kind of hearing prior to January 1,

21 2020 and every six years thereafter. So

22 I guess the next one will be six years

23 from now. Does that answer your

24 question?

25 MR. CALLICOTT: 9

1 Yes. It's just new.

2 MR. BROUSSARD:

3 It is. Mr. Callicott, I guess in

4 further response to your question, the

5 Board could always convene such a hearing

6 before the six year requirement. But the

7 law requires at least once every six

8 years. It might consider the results of

9 this hearing in making a determination

10 whether it should offer such a hearing

11 sooner than the six year requirement.

12 On the other hand, I wouldn't place

13 to much of a significance on the first

14 one because it is the first of its kind.

15 MR. CALLICOTT:

16 I was just always perceived that they

17 were open to feedback and the dialogue.

18 MR. BROUSSARD:

19 It is the Board's rules allow for

20 anyone to make a request for a rule

21 making at any time. So that's always the

22 option, but I think the legislature

23 envisioned that some agencies might not

24 be such -- so open so they required every

25 agency to adopt this pattern of once 10

1 prior to January 1, 2020 and at least

2 every six years thereafter.

3 MR. CALLICOTT:

4 Thank you.

5 MR. BROUSSARD:

6 You're welcome. Seeing no one

7 rushing to the table, I'm going to place

8 the hearing in recess at 9:10 a.m. and if

9 anyone who wishes to make a comment,

10 please speak to either the Reporter or

11 myself and we'll put us back on the

12 record and enter the comment into the

13 record.

14 We are in recess at 9:11.

15 (THE MEETING WAS RECESSED.)

16 MR. BROUSSARD:

17 We will open the record again at

18 10:05.

19 MS. NGUYEN:

20 Hi. My name is Katrina Nguyen. And

21 what other information do you need? Just

22 my name?

23 MR. BROUSSARD:

24 Are you appearing for an organization

25 or just on your own? 11

1 MS. NGUYEN:

2 I appear on my own but I work at

3 Xavier.

4 MR. BROUSSARD:

5 The College of Pharmacy?

6 MS. NGUYEN:

7 Yes, the College of Pharmacy.

8 MR. BROUSSARD:

9 Okay.

10 MS. NGUYEN:

11 But I don't represent the College of

12 Pharmacy. I represent myself today.

13 MR. BROUSSARD:

14 Okay. Good.

15 MS. NGUYEN:

16 And I guess we are open to any rule I

17 would like to see possibly a requirement

18 to give pharmacist like a lunch break

19 because I felt like even though it's

20 salary, but a lot of time it does add to

21 the stress and everything when

22 pharmacists have to work without a

23 required lunch break. They just usually

24 take lunch when it calms down. But you

25 come and work at a store that's busy on a 12

1 day that, you know, with drive-through,

2 and on a day where you constantly

3 running, running, running, sometime it

4 takes a long time for people to start to

5 have their lunch like to 2:00, 3:00 p.m.

6 And like I felt, you know, even

7 minimum-wage worker get a lunch break and

8 so I felt like pharmacists with a higher

9 level of knowledge and the kind of work

10 we do, at least a lunch break should be

11 there. I know other states like

12 California require pharmacists to take a

13 lunch break, a 30 minute lunch break. So

14 I think if we can at least consider that

15 I know it's not there right now in the

16 book, but if that's possible it would

17 make it easier if you have to work on a

18 hunger or empty stomach, you know,

19 sometime you are easy to get upset,

20 you're not thinking straight.

21 I feel like, and especially for

22 people who have conditions, you know,

23 like if they're a diabetic patient and

24 their still working and if they're

25 hypoglycemic because they didn't get a 13

1 lunch break and weren't to eat and we're

2 not supposed to have food next to our

3 workstation, all right, so I felt like a

4 lunch would be a nice thing to have for

5 pharmacist.

6 MR. BROUSSARD:

7 Okay. Did you have any suggestions

8 about the length of the break?

9 MS. NGUYEN:

10 The length, it's up to -- I guess

11 it's open for suggestions, and if

12 possible, I understand it's a business.

13 They still have to run their business.

14 It's hard to close down for a long time.

15 Maximum, I would say an hour. Minimum,

16 half an hour. At least, you know, time

17 to warm it up or they need to go buy

18 something nearby quickly, they'll have

19 time to walk, run quickly, buy them and

20 then eat quickly and go.

21 And I feel like, you know, if you

22 have trusted technicians and trusted

23 intern who work there they can be, you

24 know, out, you know, like go to the back

25 and eat, you know, wherever and stuff, 14

1 you know, without interruption and then

2 -- or within the premise.

3 And then you know, still have a

4 pharmacy open and do everything else that

5 technician in pharma, you know, an intern

6 can do, you know, like selling

7 prescriptions that was already verified

8 and it's already been bagged up, things

9 like that. Still can run. So business

10 is not really losing half an hour of

11 their time, you know. A technician can

12 still always, you know, take in

13 prescriptions and type it in and get it

14 ready for the pharmacist to come back and

15 work on it. So I think that's, you know,

16 I think half an hour minimum should be,

17 you know, I feel like would be good.

18 MR. BROUSSARD:

19 Okay.

20 MS. NGUYEN:

21 I wouldn't think more than one hour

22 because that would be too long. I don't

23 know if employer like retail pharmacy

24 would be okay with that.

25 MR. BROUSSARD: 15

1 Okay.

2 MS. NGUYEN:

3 I also hold a license in California

4 so when I practiced in California, we're

5 a little different because we're, you

6 know, we have unions. And so union

7 required these companies to give us half

8 an hour lunch break.

9 MR. BROUSSARD:

10 Okay.

11 MS. NGUYEN:

12 So I think if we start at half an

13 hour it wouldn't be, you know, too much

14 to ask since already it is present in

15 other states.

16 MR. BROUSSARD:

17 Okay. If I could ask a question

18 about the California -- is it a union

19 rule or a Board rule for the 30 minutes?

20 MS. NGUYEN:

21 That's a good question. I don't

22 remember. It's been a while.

23 MR. BROUSSARD:

24 Okay. And is it only --

25 MS. NGUYEN: 16

1 I want to say more of a union thing

2 because I have to take a lunch break

3 within five hours of my clock-in time.

4 If I take longer than five hours, five

5 hours one minute then the company has to

6 pay me overtime and pay me the lunch

7 premium.

8 MR. BROUSSARD:

9 And that sort of leads to my next

10 question. Does the 30 minute rule apply

11 only to full-time employees? Does it

12 apply to part-time maybe who doesn't work

13 an eight hour or six hour?

14 MS. NGUYEN:

15 I always worked four hour shifts so I

16 never worked half hour, like half day

17 shift. But I would think it makes sense

18 you only extend that to a full-time

19 worker who's there eight hours and needs

20 to eat. But if it's like you work less

21 than four hours, working there for us --

22 union is different than salary. So in

23 union, full-time is ten hours not eight

24 hours then we earn overtime is after ten

25 hours. So if you work at least five 17

1 hours then you should get half an hour

2 lunch break. If you work less than that

3 you shouldn't be getting that. You

4 already have your break, five, ten,

5 fifteen minutes in between then.

6 MR. BROUSSARD:

7 Okay. So for instance, something

8 that Board could consider if an employee,

9 if a pharmacist works four hours or more

10 in single time, they're entitled to a

11 break of "x" minutes duration?

12 MS. NGUYEN:

13 Yeah. I think that would make sense.

14 I feel like with the recent changes most

15 of the company open for 12 hour shift,

16 but now they have changed that. I know

17 CVS do like overlapping shifts and stuff

18 so I think four hours that, you know, a

19 half an hour break with every four hours

20 make sense. But that's just a number we

21 are talking about. The Board still needs

22 to discuss about this.

23 MR. BROUSSARD:

24 And that's the Board's -- it's

25 actually this topic is already on the 18

1 agenda for the Board's Regulation

2 Revision Committee. There's a -- I

3 believe the agenda item is called the

4 Pharmacy Staffing and Patient Safety.

5 The Board has received some letters for

6 pharmacists with the same issues that

7 you've mentioned so the committees

8 looking at it and the difficulty is

9 trying to find something that's

10 reasonable that could apply to every

11 practice state.

12 Most pharmacist think about chain

13 drugstores because that's the most

14 common. But, of course, there are other

15 practice settings.

16 MS. NGUYEN:

17 I used to be an intern at Children's

18 Hospital and I feel like the staff

19 hospital pharmacist they do have their

20 entitled break. It's scheduled into

21 their work time and they can say I'm

22 going to take a lunch break and when they

23 take a lunch break, I believe, I do want

24 to say the wrong number. I want to say

25 they have an hour because, you know, they 19

1 go down and the line is long and by the

2 time you get your food it's time to go

3 back to work so I think again, an hour

4 lunch break and then return.

5 Like someone leave at 11:00. Someone

6 leave at 12:00. Someone leave at 1:00.

7 Someone leave at 2:00. But they take

8 turns and they do have lunch break built

9 in. At least at the hospital that I work

10 at as an intern I observed that. And

11 even myself, all day I get that much

12 break. I want to say an hour.

13 I have no clear memory, I don't know,

14 but most community pharmacy where it's an

15 independent pharmacy, they're usually

16 pretty good about giving you lunch break,

17 I find that retail company are the one

18 that tends to put that aside more and a

19 lot of time for pharmacists, we know it

20 ourselves, we, you know, I'll just say it

21 out loud, you know.

22 A lot of time they're overworked

23 because they're always working with a

24 larger volume of scripts with less people

25 to help and most company only hire 20

1 another pharmacist if you increase your

2 volume to like every 200 prescription for

3 example. So if somebody who is working

4 398 prescription, they still only get one

5 helper. But they're working, if you

6 round it up, it'll be at like 400 volume,

7 but they only get one worker because they

8 didn't make the next 200 mark.

9 So they're actually working overtime

10 but just the thought that somebody who

11 had two helpers, you see, because of

12 that, they felt obligated to skip lunch,

13 skip break, only take bathroom break when

14 they have to take the break and then work

15 around the clock because they have to

16 deliver otherwise, you know, the customer

17 comes, complains and we want our

18 customers and our patients to have trust

19 in us to know that, you know, we have

20 their health at heart and we can't do

21 that if we're constantly worrying about

22 taking things out and forget the human

23 factor.

24 We're worried about the, you know,

25 process, getting it out, getting it out. 21

1 You know a lot a company flag you if you

2 didn't get it out in time and all of

3 that. So working under constant pressure

4 like that sometime when you, you know,

5 it's just like myself and I had to study

6 for an exam or you take a test, sometimes

7 you got tunnel vision. So pharmacist

8 working. They also work in that sense.

9 They also like worry about let me crank

10 it out and not get the customer upset and

11 get a complaint.

12 And, you know, meet the demand of the

13 employer like you got to pick up the

14 phone by how many. We got to finish the

15 prescription by how many minutes. And I

16 know the board don't have any, you know,

17 control over that. That's the company's

18 policy. But I just felt like if we can

19 make it easier for them, at least give

20 them a lunch break, they can at least

21 take a rest.

22 I feel like sometimes 30 minute rest

23 is really good to recharge and go back in

24 because otherwise pharmacist that want to

25 do more for their patients, counsel 22

1 patients which I know we're required to

2 do, but you know, I'll tell you the truth

3 that when I see some pharmacist who

4 doesn't counsel at all because they just

5 so busy just trying to crank it out.

6 And they don't want -- they're more

7 concerned about patient getting upset.

8 And also, we understand in patient treat

9 pharmacy like, I go and grab something

10 and that's it, you know. They don't give

11 the pharmacist the fair amount of time to

12 really put the things out correctly, to

13 make it and to work to process everything

14 correctly, especially drive-through.

15 They're thinking like McDonald's, you

16 know, and we can't blame the consumer,

17 out patients patience when the industry

18 kind of allowed them to, kind of mislead

19 them to think that that's the way it

20 should be.

21 And it's all because of business.

22 It's because of volume. It's all because

23 of the money. And I understand you have

24 to, you know, make revenue to sustain the

25 business. So I feel like and I 23

1 understand that there's a lot that the

2 Board cannot do that because it is a

3 company. They have the right to do that

4 and how to run their own business.

5 But I feel like if we can possibly at

6 least help them lighten the load a little

7 bit by giving them a 30 minute break.

8 They can sit down away from all the

9 volume because a lot of time what I find

10 is even the pharmacist, when it slow down

11 and they take a lunch and they heat their

12 food up to take a lunch, sometime if they

13 have a walk in, they get to stop what

14 they're doing, come back and finish it

15 before they come and finish their food.

16 So it's not really sitting down eating,

17 you know.

18 And so if they can just be away and

19 then be away from the pharmacy, move

20 back, if they want to be at the pharmacy

21 that's their choice but at least we give

22 them a break that they deserve. And, you

23 know, I feel like especially patients

24 with conditions, you know, I mean we're

25 pharmacist. We're still human and we 24

1 have people who aging, who have diabetes

2 and if they have to work, you know, and

3 having a hypoglycemic episodes like

4 headache, it is really hard to make sound

5 decisions and it 's really hard to make

6 things, work things fast.

7 If you have GERD, acid reflux, you

8 dealing with all the time acid coming up,

9 it just, you know, I think it's fair to

10 at least have half an hour for every, you

11 know, if could be four hour, it could be

12 five hours, whichever the number,

13 whichever the Board consider to be a

14 full-time split in half.

15 MR. BROUSSARD:

16 I mean I think the Board conundrum is

17 recognizing that a business has the right

18 to establish its own policies and

19 procedures. However, the business has a

20 permit from the Board to operate a

21 pharmacy in a manner that's to protect

22 the public health and safety. And what

23 you've indicated is that there are times

24 when some of the business policies and

25 procedures may place a pharmacist in such 25

1 a position that public safety might be

2 compromised.

3 MS. NGUYEN:

4 Yes, I feel so. Other company don't

5 say that you don't have a break. They do

6 say you can a break. It's just it's not

7 required within how many timeframe and so

8 pharmacist sometime work, you know, long

9 hours and skip lunch and sometimes after

10 you are hungry then you're not hungry

11 anymore. So when it slow down they can't

12 really eat. They don't have appetite to

13 eat anymore. But I felt like if the head

14 pharmacist health is not be safe, if they

15 have conditions then it will interfere

16 with the work that they will do and then

17 it will affect the patient safety.

18 MR. BROUSSARD:

19 So how would you counter the argument

20 that sometimes comes up in these kinds of

21 conversations -- how would you counter

22 the argument that the Board should not

23 regulate to that level of detail that if

24 the pharmacist doesn't like the working

25 conditions, they should just go find a 26

1 job someplace else?

2 MS. NGUYEN:

3 So I would counter by saying that

4 there's precedent like the Board of

5 Pharmacy -- I mean in California a

6 company works that way so it's possible.

7 And they have the same company over there

8 like over here. So they can consult

9 within their company to see if that hurt

10 their business at all. I don't think it

11 hurt their business at all. In fact,

12 it's actually helped because when

13 pharmacist can work better they can

14 relate with people better and that's how

15 you keep your volume. That's how you

16 keep your patient.

17 You just mentioned it, Mr. Broussard,

18 about the fact that the Board can

19 initiate policy if it concerns public

20 safety. So the Board do have a little, I

21 guess, you know, a little legality way to

22 at least be involved instead of being

23 completely hands off. So when it comes

24 to safety, like my example of diabetic

25 pharmacist. They have the right to take 27

1 care themselves too. And, you know, if

2 they have to eat, you have the pharmacist

3 who are pregnant and who needs to

4 breast-feed and who needs to go pump and

5 they cannot do that when they don't have

6 a break.

7 All of that factor in, breast-feeding

8 mothers, you know, can do that. And as

9 far as why not work at another company?

10 Well, every company functions that way.

11 If I like community and every company,

12 almost every company functions that way,

13 you talk about major retail chains, you

14 know, then it's just not fair for the

15 pharmacist. I also feel that they also

16 make the company looks more humane if

17 they allow pharmacist to have a break.

18 At least they show that they care about

19 the employee and their employee is not

20 just a number that can be replaced.

21 I also feel that it's easy to say

22 that, you know, you don't like it, go

23 somewhere else. But that's just like a

24 way of taking off your responsibility

25 that you're supposed to have. Isn't it 28

1 part of labor law that you supposed to at

2 least provide a working environment for

3 your employee, whether it's, you know,

4 ventilation, air, safety. So shouldn't

5 that be part of the safety about the

6 health. Health is a safety. It's a

7 major safety.

8 What if we have a pharmacist who's

9 hypoglycemic and then hits something.

10 Now that bills going to go up with what

11 do you call that -- worker compensation.

12 And we're not just talking about that.

13 We're talking about the safety of the

14 pharmacist. And if the technician gets

15 breaks but the pharmacist doesn't, you

16 know. It just doesn't make sense.

17 I felt like we work -- we are working

18 at a higher degree level, profession

19 level profession. At a minimum we should

20 get a lunch break just like everyone else

21 and you know you can also say other,

22 every other business provide a lunch

23 break for their worker. I don't see why

24 it's impossible for company to do that

25 for pharmacists. Their manager, front- 29

1 end, get a lunch break. Their cashier

2 get lunch break. Everybody in the

3 company get a lunch break except the

4 pharmacist. You know, it's required.

5 They go punch out and take break.

6 Pharmacist care enough about the patient

7 and the employer to skip lunch break to

8 perform well and they deserve at least

9 recognition that they deserve a break.

10 I feel like it's a basic minimum

11 working condition. You can't expect

12 someone to go hungry for hours and work

13 well and perform well. You know, the

14 basic needs of humans is you know, food,

15 clothing and shelter. So I feel that how

16 I would counter the company. Everybody

17 needs lunch breaks. It's not something

18 new. I know this. It's not a novel idea

19 that nobody ever worked with before.

20 Within their own company, like I say,

21 everyone get lunch break, you know the

22 cashier, the stock person, the front-end

23 manager, you know, everyone get a lunch

24 break, even technician do and just

25 pharmacist is not. I mean they get it, 30

1 the lunch break, but it's never make it

2 to the point where pharmacist are forced

3 to do it. If you don't force them to

4 take it, they feel that they have to -- I

5 mean they want to keep their job so they

6 have to skip it to do it.

7 MR. BROUSSARD:

8 Okay.

9 MS. NGUYEN:

10 And don't think you asking for long

11 hours. Just half an hour, no more than

12 an hour, you know. I think we only get

13 half an hour in California because the

14 Board in California I believe say that

15 the pharmacy can be opened without a

16 pharmacist present for no more than 30

17 minutes. So if the business is located

18 in a shopping center, you know, the

19 pharmacist can go to the next door store,

20 and it's still considered within the

21 premise of entire business structure, not

22 within the retail company itself.

23 And so in California, you can walk

24 next door to a restaurant next door and

25 get food there and then come back within 31

1 30 minutes then the pharmacy is okay to

2 open. If the pharmacist leave more than

3 30 minutes, then the Board require the

4 pharmacy to close down and then put a

5 return time. And usually that's why we

6 don't do that. We only do 30 minutes.

7 MR. BROUSSARD:

8 And that is actually a fairly common

9 rule among the states. Louisiana has the

10 same. It's called a temporary absence

11 and it's 30 minutes. The pharmacy may be

12 open for up to 30 minutes without a

13 pharmacist present.

14 MS. NGUYEN:

15 So I guess it makes sense to make it

16 a 30 minute time frame then. And then

17 they don't have to close the place down

18 and then the business would be more

19 willing to agree with it if they didn't

20 have to close the business down. Because

21 for business, if I'm a customer and I

22 come in during the time the pharmacist

23 take a break then -- and they come twice

24 like that, I will probably figure what

25 kind of business are they running here. 32

1 I won't come back. So I think 30 minute

2 would be a time we should give them that

3 way they can still stay open. In fact,

4 we supposed to put a sign saying the

5 pharmacist will take their break from

6 this time to this time, an announcement

7 like, by the counter and the drop off and

8 pick up counter there's a sign saying

9 that. Our pharmacist will take a lunch

10 from this time to that time frame, but we

11 will still be open for regular

12 transactions, you know, like pick up

13 transaction.

14 So we have a sign to put it back then

15 everyone would understand that and it

16 won't interfere with their business. I

17 hope that will get passed and it will be

18 good for everyone.

19 MR. BROUSSARD:

20 It's a relatively new item on their

21 agenda, only the last two to three months

22 I think. They have had some

23 conversations. But they're struggling

24 with trying to find the right balance.

25 MS. NGUYEN: 33

1 I see.

2 MR. BROUSSARD:

3 So you can find the agenda for the

4 Regulation Revision Committee on the

5 Board's website. Their next meeting I

6 believe is July 24th. It's a long agenda

7 so I don't know if they'll se spend time

8 on that particular topic. But the

9 committee has been assigned that topic by

10 the Board for them to develop a proposal

11 and come to the Board with that for them

12 to consider that.

13 MS. NGUYEN:

14 I see. So I don't know if I can come

15 in July here because, you know, I drive

16 from New Orleans and my son has to be out

17 there waiting, you know. I am the only

18 caretaker and it's summer and he's

19 outgrown the age to go to daycare so I

20 had to drag him with me. But I will keep

21 on looking forward to news from the Board

22 or an e-mail from the Board so I can keep

23 up-to-date with that.

24 MR. BROUSSARD:

25 And when the Board does develop a 34

1 proposal, it would go through the

2 ordinary rulemaking process where we

3 publish a notice of intent and we have a

4 public hearing like this to receive

5 comments and testimony. So even if

6 you're not able to be here personally, we

7 can accept written comments and testimony

8 so you always have that opportunity as

9 well.

10 MS. NGUYEN:

11 Right. That's good to know. My only

12 -- I don't know if this is possible and

13 because I communicate a lot with the

14 student pharmacists, and if it's the way

15 the Board -- the way the law book is

16 organized, a lot of time I hear comments

17 from students pharmacists and maybe they

18 don't know any better. I'm not an expert

19 either. I don't have a JD so I'm not an

20 expert either but they feel that the --

21 you know they always ask me how come if

22 -- and we talk about marijuana

23 regulations and law and procedure rules.

24 How come it's like some of them it's

25 in this section, some of it in the 35

1 chapter, some of it's in that chapter.

2 And they find like how do I look at all

3 the chapter. I mean they're supposed to

4 look at everything when they study

5 anyway. But like when they want to come

6 back and read about it, let's say they

7 get licensing already and then the

8 marijuana law passed and so they wanted

9 to go back and look at it, you now, it's

10 just the way we organize it, it seems

11 like it's a little bit here, a little bit

12 there in different chapter.

13 So I don't know if it's possible if

14 we organize everything in one chapter

15 which I figure probably not. And I

16 explain it to them that the Board

17 organizes that way because certain part

18 of the marijuana law is talking about

19 licensing and then it goes through

20 licensing section, the registration

21 licensing section. And the other part is

22 dispensing. It goes through the

23 pharmacist responsibility who's

24 dispensing.

25 So, you know, I feel like since I'm 36

1 here I should bring it up since that's

2 the comments I get a lot from the

3 student. They find it confusing to

4 navigate the law book, you know, so. And

5 I don't know how they time there, they'll

6 look at it before they give me that

7 comment. They may not only -- they may

8 just look at once, skim it through and

9 just say that.

10 MR. BROUSSARD:

11 And I appreciate the comments about

12 the law book because I'm the editor of

13 it. I put it together at the Board's

14 direction. And it's organized basically

15 into laws which are passed by the

16 legislature are presented first. And

17 then the rules that are adopted by the

18 Board come after the laws.

19 MS. NGUYEN:

20 Okay.

21 MR. BROUSSARD:

22 With respect to marijuana, there is a

23 law from the legislature about marijuana.

24 That's in one section. And there's a

25 chapter -- a subchapter of rules about 37

1 marijuana pharmacies. So relative to

2 marijuana, medical marijuana, there are

3 two places in the book where it appears.

4 MS. NGUYEN:

5 Thank you for that. Now that I

6 understand how it's organized and knowing

7 better, I can just make a comment better

8 for them. And what I explained earlier

9 doesn't, you know.

10 MR. BROUSSARD:

11 I guess a recommendation I would

12 offer is spend just a few moments looking

13 at that Table of Contents in the front of

14 the book and you can see how -- how it's

15 laid out and organized. But the other

16 thing is, it is in Adobe PDF document,

17 electronically searchable so keying a

18 couple of search terms, marijuana, for

19 instance, will give you the places where

20 that appears and marijuana will also

21 appear in the Criminal Section in

22 Schedule I because that's where it's

23 listed. But then you'll see the big

24 section of law that the legislature

25 passed that authorizes that to be 38

1 recommended and dispensed in the section

2 of rules that has all of the details

3 about how all that is done.

4 But the basic structure is the laws

5 are presented and then the rules are

6 presented.

7 MS. NGUYEN:

8 Now that I understand how it's

9 organized better, I can explain that to

10 them better. I'm aware of the sections

11 they are at. I just didn't see it

12 organized in that sense. Like I say, I'm

13 not a JD and so for me --

14 MR. BROUSSARD:

15 I'm not an attorney either. And I

16 don't know if anyone else would want to

17 reorganize it. They're certainly free to

18 do so.

19 MS. NGUYEN:

20 I like the way you have it. It makes

21 sense the way we have it now. It makes

22 sense. I just brought the comment up

23 because students keep asking me about

24 that.

25 MR. BROUSSARD: 39

1 It's good to hear that.

2 MS. NGUYEN:

3 And I don't have a good explanation.

4 Now that I know the way it is organized I

5 have a better explanation for them and I

6 didn't remember or think of like the

7 search functions on Adobe.

8 MR. BROUSSARD:

9 Right.

10 MS. NGUYEN:

11 If I remember that I would have been

12 able to just comment on that.

13 MR. BROUSSARD:

14 We don't attempt to do a manual index

15 because know we know it's electronically

16 searchable with the Adobe product but the

17 Table of Contents is there as well and I

18 think just a few minutes reviewing that,

19 seeing how it's laid out, laws and then

20 rules, and that way if you have a

21 specific question you probably have a

22 pretty good idea of where to begin your

23 search. Or if you don't, you can always

24 use electronic search terms.

25 MS. NGUYEN: 40

1 Yeah. So now I know I will be able

2 to give feedback on that comment from the

3 students now.

4 MR. BROUSSARD:

5 But we're always open as well if they

6 have an idea for reorganization, that's

7 something that they believe would be more

8 functional, we're certainly open to

9 hearing that.

10 MS. NGUYEN:

11 I think their thought processes are

12 that really -- they felt like they don't

13 really have to know which one is

14 legislature and which one is rulemaking,

15 rule. They just know what they need to

16 know to get their license. And when they

17 think that way, you know, it just changes

18 the way how it's organized. But I think,

19 you know, what we have makes more sense.

20 After all, this is a law making entity so

21 it's to be organized that way.

22 MR. BROUSSARD:

23 And the other reality is that we have

24 all kinds of clients, not just our

25 licensees. We have people in the 41

1 industry who are attorneys, some are not

2 attorneys. There are all kinds of

3 clients for the Board's law book. We

4 certainly would hope that our licensees

5 would be able to use the book to find

6 what they need in a reasonable amount of

7 time. But there were other clients

8 beside licensees that we have to be aware

9 of and take care as well.

10 MS. NGUYEN:

11 And I mean the search button should

12 serve the purpose to search in a

13 reasonable time. It's just I didn't

14 think of that. I wasn't thinking, quick

15 thinking enough to think of that function

16 when they ask me those questions. And

17 because I have more than one person who

18 asked me that, that's why I thought,

19 okay, make sure I bring this up.

20 This had nothing to do I guess the

21 other rules and the law book, you know.

22 Just some feedback.

23 MR. BROUSSARD:

24 It's relevant because it's all of the

25 laws rule and they are contained in the 42

1 law book so that's reasonable. I

2 appreciate the comment.

3 MS. NGUYEN:

4 Thank you for being open.

5 MR. BROUSSARD:

6 Your welcome.

7 MS. NGUYEN:

8 I think that's all I have as far as,

9 you know, the rule book. I think I want

10 to close, as least, you know, option for

11 pharmacist. I think the only other thing

12 is -- I mean I know it's like -- it's an

13 issue over and over again. But I don't

14 know where the Board stands on even the

15 law enforcement stands when it come to

16 marijuana regulation since, you know,

17 the federal government still considers it

18 to be Schedule I although they've been

19 open up a little bit more where this can

20 kind of -- dosage form according to the

21 plant.

22 MR. BROUSSARD:

23 And that's part of the law and it's

24 part of the rule so is it just a question

25 or a suggestion? 43

1 MS. NGUYEN:

2 You know what, I think just disregard

3 that one.

4 MR. BROUSSARD:

5 Okay.

6 MS. NGUYEN:

7 Yeah. Disregard it.

8 MR. BROUSSARD:

9 And you're right. Federally it is

10 still a Schedule I substance. Louisiana

11 has adopted a law as have other states

12 that authorizes the use of the marijuana

13 for medical purposes. In fact, in the

14 Board's rule for marijuana pharmacies,

15 the very section, we call it a preamble

16 and a warning, first section, the

17 legislature directed the Board to adopt

18 these rules.

19 The second section marijuana is still

20 a Schedule I substance and if you have a

21 federal registration you are at risk of

22 violating your federal registration

23 because nothing the state does can

24 override a federal law.

25 And the third section is knowing 44

1 this, if you want to move forward this,

2 if you want to move forward in this line

3 of work, consult your legal counsel.

4 MS. NGUYEN:

5 Oh, okay. So what about the

6 consumer, if the consumer get the

7 recommendation from the provider and went

8 to the dispensary and get some and

9 somehow they have a car accident or they

10 have a ticket and then the police officer

11 find, you know, find trace or smell it

12 and then I wonder how that would go if

13 it's within Louisiana are they still

14 going to be processed, prosecuted

15 according to the law?

16 MR. BROUSSARD:

17 No. And that's actually in the --

18 there's a section about that in the

19 controlled substance law and there's

20 immunity from prosecution for patients

21 who have legitimately acquired medical

22 marijuana products. They will not be

23 able to smell it because the law

24 prohibits the use of marijuana in its raw

25 form. It must be a pharmaceutical grade 45

1 product so it will not smell like

2 marijuana. We would certainly caution

3 consumers to keep it in the labeled

4 container that comes from the marijuana

5 pharmacy so that it's obvious that it was

6 dispensed properly. But the law does

7 provide immunity from prosecution to

8 patients who have legitimately acquired

9 product.

10 Now that only applies to Louisiana.

11 It wouldn't apply in any other state.

12 And you raise and interesting question

13 actually not so much in terms of a car

14 accident, but perhaps an employment

15 situation for employees who are using the

16 product if they are a subject to drug

17 testing.

18 MS. NGUYEN:

19 That's true.

20 MR. BROUSSARD:

21 Employment law is federal in origin.

22 Workers' Compensation is federal in

23 origin. Some case law from Colorado

24 suggests that while the consumer in

25 Colorado was protected under state law, 46

1 they did not escape the reach of the

2 federal law. So if it was an employment

3 situation, if the question arose in a

4 court of law, the court was obligated to

5 side with federal because federal law

6 still prohibits the use of marijuana.

7 And I think Louisiana will experience

8 those same kinds of situations where we

9 have an intersection of state and federal

10 law that are not consistent. State law

11 covers but federal laws still prohibits.

12 So there's -- there will be situations

13 coming in the future as patients begin to

14 use the marijuana products and find

15 themselves in situations where federal

16 law still prevails.

17 MS. NGUYEN:

18 So pretty much use it and dispense it

19 at your own risk and consult with an

20 attorney.

21 MR. BROUSSARD:

22 That's the guidance we put in our --

23 the very first section of our marijuana

24 rules is yes, the legislature told us to

25 do these rules but you know, as long as 47

1 marijuana is still Schedule 1, there's

2 this junction here so if you have any

3 exposure to federal authority, either in

4 the form of a DEA registration, your

5 employer accepts federal funds in the

6 school, for instance, of if your employer

7 has federal exposure in terms of

8 employment law, Workers' Compensation,

9 other areas as well, just because the

10 state passes a law doesn't mean it

11 overrides federal law.

12 MS. NGUYEN:

13 I understand. The federal law is

14 stricter so comply with them.

15 MR. BROUSSARD:

16 Yes. Yes.

17 MS. NGUYEN:

18 Thank you for clearing that up.

19 MR. BROUSSARD:

20 You're welcome.

21 MS. NGUYEN:

22 And I have no more comments.

23 MR. BROUSSARD:

24 Okay.

25 MS. NGUYEN: 48

1 Thank you.

2 MR. BROUSSARD:

3 Thank you for coming today.

4 MS. NGUYEN:

5 It was a good experience. It was

6 good to see you.

7 MR. BROUSSARD:

8 Good to see you again.

9 MS. NGUYEN:

10 It was such a great review for the

11 student. I hope they will do well.

12 MR. BROUSSARD:

13 I hope so too.

14 MS. NGUYEN:

15 Yes, yes. And hopefully you come

16 back to us and do it more, every year for

17 us.

18 MR. BROUSSARD:

19 If they ask, I will try.

20 MS. NGUYEN:

21 It would be great.

22 MR. BROUSSARD:

23 Good. Take care. Bye-bye.

24 There are no other commentators in

25 the room. It is 10:35. We are back in 49

1 recess.

2 (THE MEETING WAS RECESSED.)

3 MR. BROUSSARD:

4 We are back in session and on the

5 record. The time is now 12:00 noon.

6 There's no commentator in the room. No

7 one has alerted us as to their pending

8 arrival. This public hearing is now

9 adjourned.

11 (THE HEARING ADJOURNED AT 12:00 P.M.)

25 50

1 C E R T I F I C A T E

2 This certification is valid only for a

3 transcript accompanied by my original signature

4 and official seal on this page.

5 I, SUSAN ERKEL, Certified Court Reporter, in

6 and for the State of Louisiana, as the officer

7 before whom this hearing was taken, do hereby

8 certify that the foregoing 49 pages

9 were reported by me in the voice-writing method,

10 and was prepared and transcribed by me or under

11 my personal direction and supervision, and is a

12 true and correct transcript to the best of my

13 ability and understanding;

14 That the transcript has been prepared in

15 compliance with transcript format guidelines

16 required by statute or by rules of the board, and

17 that I am informed about the complete

18 arrangement, financial or otherwise, with the

19 person or entity making arrangements for

20 deposition services;

21 That I have acted in compliance with the

22 prohibition on contractual relationships, as

23 defined by Louisiana Code of Civil Procedure

24 Article 1434 and in rules and advisory opinions

25 of the board; 51

1 That I have no actual knowledge of any

2 prohibited employment or contractual

3 relationship, direct or indirect, between a court

4 reporting firm and any party litigant in this

5 matter nor is there any such relationship between

6 myself and a party litigant in this matter; and

7 That I am not related to counsel or to the

8 parties herein, nor am I otherwise interested in

9 the outcome of this matter.

12 ______

13 SUSAN ERKEL

14 CERTIFIED COURT REPORTER

15 LICENSE NO. 24005

25 52

1 R E P O R T E R ' S P A G E

3 I, SUSAN ERKEL, Certified Court Reporter

4 in and for the State of Louisiana, before

5 whom this statement was taken, do hereby

6 state on the Record:

7 That due to the interaction in the

8 spontaneous discourse of this proceeding,

9 dashes (--) have been used to indicate

10 pauses, changes in thought, and/or talkovers;

11 That same is the proper method for a

12 Court Reporter's transcription of

13 proceedings, and that the dashes (--) do not

14 indicate that words or phrases have been left

15 out of this transcript;

16 That any words and/or names which could

17 not be verified through reference material

18 have been denoted with the phrase "(spelled

19 phonetically)."

22 ______

23 SUSAN ERKEL

24 CERTIFIED COURT REPORTER

25 LICENSE NO. 24005

STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing LOUISIANA BOARD OF PHARMACY June 26, 2019

air (1) attorney (2) 4:5 13:17,19 A 28:4 38:15;46:20 Board's (12) Bye-bye (1) alerted (1) attorneys (2) 5:19;6:4;7:14,16, 48:23 able (5) 49:7 41:1,2 24;9:19;17:24;18:1; 34:6;39:12;40:1; allow (2) authority (2) 33:5;36:13;41:3; C 41:5;44:23 9:19;27:17 8:19;47:3 43:14 absence (2) allowed (1) authorizes (2) Book (12) California (8) 4:10;31:10 22:18 37:25;43:12 7:12;12:16;34:15; 12:12;15:3,4,18; accept (1) almost (1) available (3) 36:4,12;37:3,14;41:3, 26:5;30:13,14,23 34:7 27:12 5:15;7:9,15 5,21;42:1,9 call (4) accepts (1) although (1) aware (2) break (44) 4:12,19;28:11; 47:5 42:18 38:10;41:8 11:18,23;12:7,10, 43:15 accident (2) always (10) away (3) 13,13;13:1,8;15:8; called (2) 44:9;45:14 9:5,16,21;14:12; 23:8,18,19 16:2;17:2,4,11,19; 18:3;31:10 accordance (1) 16:15;19:23;34:8,21; 18:20,22,23;19:4,8, CALLICOTT (5) 5:21 39:23;40:5 B 12,16;20:13,13,14; 8:8,25;9:3,15;10:3 according (2) among (1) 21:20;23:7,22;25:5,6; calms (1) 42:20;44:15 31:9 back (16) 27:6,17;28:20,23; 11:24 acid (2) amount (2) 5:9;10:11;13:24; 29:1,2,3,5,7,9,21,24; can (33) 24:7,8 22:11;41:6 14:14;19:3;21:23; 30:1;31:23;32:5 12:14;13:23;14:6,9, acquired (2) announcement (1) 23:14,20;30:25;32:1, breaks (2) 11;18:21;21:18,20; 44:21;45:8 32:6 14;35:6,9;48:16,25; 28:15;29:17 23:5,8,18;25:6;26:8, Act (3) anticipate (2) 49:4 breast-feed (1) 13,13,18;27:8,20; 5:22;8:15,17 8:9,13 bagged (1) 27:4 28:21;30:15,19,23; Activity (1) anymore (2) 14:8 breast-feeding (1) 32:3;33:3,14,22;34:7; 6:10 25:11,13 balance (1) 27:7 37:7,14;38:9;39:23; actually (6) appear (2) 32:24 Brentwood (1) 42:19;43:23 17:25;20:9;26:12; 11:2;37:21 basic (3) 4:7 candidates (1) 31:8;44:17;45:13 appearing (1) 29:10,14;38:4 bring (2) 6:15 add (1) 10:24 basically (1) 36:1;41:19 car (2) 11:20 appears (2) 36:14 brought (1) 44:9;45:13 addition (2) 37:3,20 bathroom (1) 38:22 care (5) 5:5;7:10 appetite (1) 20:13 BROUSSARD (54) 27:1,18;29:6;41:9; Additional (1) 25:12 Baton (1) 4:2,8;8:11;9:2,18; 48:23 5:14 applies (1) 4:7 10:5,16,23;11:4,8,13; caretaker (1) adjourned (2) 45:10 begin (3) 13:6;14:18,25;15:9, 33:18 49:9,11 apply (4) 8:4;39:22;46:13 16,23;16:8;17:6,23; Carl (1) Administrative (1) 16:10,12;18:10; belong (1) 24:15;25:18;26:17; 4:11 5:22 45:11 5:12 30:7;31:7;32:19;33:2, case (1) Adobe (3) appreciate (2) beside (1) 24;36:10,21;37:10; 45:23 37:16;39:7,16 36:11;42:2 41:8 38:14,25;39:8,13; cashier (2) adopt (2) area (2) better (8) 40:4,22;41:23;42:5, 29:1,22 9:25;43:17 5:14,19 26:13,14;34:18; 22;43:4,8;44:16; caution (1) adopted (3) areas (1) 37:7,7;38:9,10;39:5 45:20;46:21;47:15, 45:2 8:14;36:17;43:11 47:9 big (1) 19,23;48:2,7,12,18, cell (1) affect (1) argument (2) 37:23 22;49:3 4:16 25:17 25:19,22 bills (1) building (5) center (1) Again (5) Aron (1) 28:10 4:24;5:9,10,11,20 30:18 7:22;10:17;19:3; 4:11 bit (4) built (1) certain (1) 42:13;48:8 arose (1) 23:7;35:11,11; 19:8 35:17 age (1) 46:3 42:19 burdensome (1) certainly (4) 33:19 around (1) blame (1) 6:24 38:17;40:8;41:4; agencies (1) 20:15 22:16 business (19) 45:2 9:23 arrival (1) Board (34) 13:12,13;14:9; chain (1) agency (2) 49:8 4:6,9,11;5:13;6:6,8, 22:21,25;23:4;24:17, 18:12 8:18;9:25 aside (1) 18,25;9:5;15:19;17:8, 19,24;26:10,11; chains (1) agenda (6) 19:18 21;18:5;21:16;23:2; 28:22;30:17,21; 27:13 7:8;18:1,3;32:21; assembled (1) 24:13,16,20;25:22; 31:18,20,21,25;32:16 changed (1) 33:3,6 4:5 26:4,18,20;30:14; busy (2) 17:16 aging (1) assigned (1) 31:3;33:10,11,21,22, 11:25;22:5 changes (2) 24:1 33:9 25;34:15;35:16; button (1) 17:14;40:17 agree (1) attempt (1) 36:18;42:14;43:17 41:11 chapter (6) 31:19 39:14 Boardroom (1) buy (2) 35:1,1,3,12,14;

Min-U-Script® Associated Reporters, Inc. (1) able - chapter 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing LOUISIANA BOARD OF PHARMACY June 26, 2019

36:25 20;30:22 controlled (2) 28:18 31:4,17,20 chapters (1) company's (1) 6:17;44:19 deliver (1) drag (1) 7:14 21:17 conundrum (1) 20:16 33:20 Children's (1) compensation (3) 24:16 demand (1) Drive (2) 18:17 28:11;45:22;47:8 convene (1) 21:12 4:7;33:15 choice (1) complains (1) 9:5 deserve (3) drive-through (2) 23:21 20:17 convened (2) 23:22;29:8,9 12:1;22:14 clarify (1) complaint (1) 5:24;6:19 desk (1) drop (1) 7:20 21:11 conversations (2) 7:10 32:7 clear (1) completely (1) 25:21;32:23 detail (1) drug (1) 19:13 26:23 cooler (1) 25:23 45:16 clearing (1) complex (1) 5:5 details (1) drugstores (1) 47:18 6:23 Copies (1) 38:2 18:13 clients (3) comply (1) 7:8 determination (1) duration (1) 40:24;41:3,7 47:14 copy (1) 9:9 17:11 clock (1) compromised (1) 7:10 determine (1) during (1) 20:15 25:2 correctly (2) 7:1 31:22 clock-in (1) concerned (1) 22:12,14 develop (2) 16:3 22:7 counsel (3) 33:10,25 E close (5) concerns (1) 21:25;22:4;44:3 devices (1) 13:14;31:4,17,20; 26:19 counter (6) 4:17 earlier (1) 42:10 condition (1) 25:19,21;26:3; diabetes (1) 37:8 clothing (2) 29:11 29:16;32:7,8 24:1 earn (1) 5:16;29:15 conditions (4) couple (1) diabetic (2) 16:24 College (3) 12:22;23:24;25:15, 37:18 12:23;26:24 easier (2) 11:5,7,11 25 course (1) dialogue (1) 12:17;21:19 Colorado (2) conduct (1) 18:14 9:17 easy (2) 45:23,25 8:19 court (2) different (3) 12:19;27:21 comfort (1) confusing (1) 46:4,4 15:5;16:22;35:12 eat (7) 4:25 36:3 courtesy (1) difficulty (1) 13:1,20,25;16:20; coming (3) connecting (1) 4:14 18:8 25:12,13;27:2 24:8;46:13;48:3 5:18 covers (1) directed (1) eating (1) comment (8) consider (6) 46:11 43:17 23:16 10:9,12;36:7;37:7; 6:25;9:8;12:14; crank (2) direction (1) edition (1) 38:22;39:12;40:2; 17:8;24:13;33:12 21:9;22:5 36:14 6:7 42:2 consideration (1) Criminal (1) Director (1) editor (1) commentator (1) 7:24 37:21 4:10 36:12 49:6 considered (1) current (1) discuss (1) eight (3) commentators (1) 30:20 7:2 17:22 16:13,19,23 48:24 considers (1) customer (3) dispensary (1) either (5) comments (15) 42:17 20:16;21:10;31:21 44:8 10:10;34:19,20; 6:3,20,25;7:4,5,23; consistent (1) customers (1) dispense (1) 38:15;47:3 8:1,4,5;34:5,7,16; 46:10 20:18 46:18 electronic (4) 36:2,11;47:22 constant (1) CVS (1) dispensed (2) 4:16;6:9,11;39:24 Committee (3) 21:3 17:17 38:1;45:6 electronically (2) 18:2;33:4,9 constantly (2) dispensing (2) 37:17;39:15 committees (1) 12:2;20:21 D 35:22,24 else (6) 18:7 consult (3) disregard (2) 4:14;14:4;26:1; common (2) 26:8;44:3;46:19 day (4) 43:2,7 27:23;28:20;38:16 18:14;31:8 consumer (4) 12:1,2;16:16;19:11 distributed (1) e-mail (1) communicate (1) 22:16;44:6,6;45:24 daycare (1) 6:9 33:22 34:13 consumers (1) 33:19 document (1) emergency (1) communications (1) 45:3 DEA (1) 37:16 4:21 4:17 contained (1) 47:4 done (1) employee (4) community (2) 41:25 deadline (1) 38:3 17:8;27:19,19;28:3 19:14;27:11 container (1) 7:25 door (6) employees (2) companies (1) 45:4 dealing (1) 4:22,24;5:4;30:19, 16:11;45:15 15:7 Contents (3) 24:8 24,24 employer (5) company (20) 7:11;37:13;39:17 debate (1) dosage (1) 14:23;21:13;29:7; 16:5;17:15;19:17, contrary (1) 7:21 42:20 47:5,6 25;21:1;23:3;25:4; 6:22 decisions (1) down (10) employment (4) 26:6,7,9;27:9,10,11, control (1) 24:5 11:24;13:14;19:1; 45:14,21;46:2;47:8 12,16;28:24;29:3,16, 21:17 degree (1) 23:8,10,16;25:11; empty (1)

Min-U-Script® Associated Reporters, Inc. (2) chapters - empty 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing LOUISIANA BOARD OF PHARMACY June 26, 2019

12:18 37:8 13:2;19:2;23:12,15; 44:25 hits (1) end (1) explanation (2) 29:14;30:25 great (2) 28:9 29:1 39:3,5 force (1) 48:10,21 hold (1) enforcement (1) exposure (2) 30:3 guess (8) 15:3 42:15 47:3,7 forced (1) 8:22;9:3;11:16; hope (4) enough (2) extend (1) 30:2 13:10;26:21;31:15; 32:17;41:4;48:11, 29:6;41:15 16:18 forget (1) 37:11;41:20 13 ensure (1) 20:22 guest (1) hopefully (1) 5:7 F form (3) 7:6 48:15 enter (1) 42:20;44:25;47:4 guidance (1) Hospital (3) 10:12 fact (4) forward (3) 46:22 18:18,19;19:9 entered (1) 26:11,18;32:3; 33:21;44:1,2 hour (22) 4:24 43:13 four (6) H 13:15,16;14:10,16, entire (1) factor (2) 16:15,21;17:9,18, 21;15:8,13;16:13,13, 30:21 20:23;27:7 19;24:11 half (13) 15,16;17:1,15,19; entirety (2) fair (3) frame (2) 13:16;14:10,16; 18:25;19:3,12;24:10, 6:3,21 22:11;24:9;27:14 31:16;32:10 15:7,12;16:16,16; 11;30:11,12,13 entitled (2) fairly (1) free (1) 17:1,19;24:10,14; hours (16) 17:10;18:20 31:8 38:17 30:11,13 16:3,4,5,19,21,23, entity (1) far (2) front (6) hand (1) 24,25;17:1,9,18,19; 40:20 27:9;42:8 4:23;5:10,11,11,19; 9:12 24:12;25:9;29:12; environment (1) fast (1) 37:13 hands (1) 30:11 28:2 24:6 front- (1) 26:23 human (2) envisioned (1) federal (17) 28:25 hard (3) 20:22;23:25 9:23 42:17;43:21,22,24; front-end (1) 13:14;24:4,5 humane (1) episodes (1) 45:21,22;46:2,5,5,9, 29:22 head (1) 27:16 24:3 11,15;47:3,5,7,11,13 full-time (4) 25:13 humans (1) escape (1) Federally (1) 16:11,18,23;24:14 headache (1) 29:14 46:1 43:9 function (1) 24:4 hunger (1) especially (3) feedback (3) 41:15 health (5) 12:18 12:21;22:14;23:23 9:17;40:2;41:22 functional (1) 20:20;24:22;25:14; hungry (3) establish (1) feel (17) 40:8 28:6,6 25:10,10;29:12 24:18 12:21;13:21;14:17; functions (3) hear (3) hurt (2) even (7) 17:14;18:18;21:22; 27:10,12;39:7 8:16;34:16;39:1 26:9,11 11:19;12:6;19:11; 22:25;23:5,23;25:4; funds (1) hearing (18) hypoglycemic (3) 23:10;29:24;34:5; 27:15,21;29:10,15; 47:5 4:12,13;5:21,24; 12:25;24:3;28:9 42:14 30:4;34:20;35:25 Further (3) 6:2,19;7:23;8:14,17, event (1) felt (9) 4:17;6:8;9:4 20;9:5,9,10;10:8; I 7:7 11:19;12:6,8;13:3; future (1) 34:4;40:9;49:8,11 Everybody (2) 20:12;21:18;25:13; 46:13 hearings (2) idea (3) 29:2,16 28:17;40:12 8:10,13 29:18;39:22;40:6 everyone (6) few (2) G heart (1) identify (1) 4:14;28:20;29:21, 37:12;39:18 20:20 8:5 23;32:15,18 fifteen (1) gentlemen (1) heat (1) identifying (1) exam (1) 17:5 5:3 23:11 7:13 21:6 figure (2) GERD (1) held (1) immunity (2) example (2) 31:24;35:15 24:7 5:21 44:20;45:7 20:3;26:24 find (13) gets (1) help (3) impossible (1) except (1) 4:18;18:9;19:17; 28:14 5:6;19:25;23:6 28:24 29:3 23:9;25:25;32:24; giving (2) helped (1) increase (1) Executive (1) 33:3;35:2;36:3;41:5; 19:16;23:7 26:12 20:1 4:10 44:11,11;46:14 goes (2) helper (1) independent (1) exit (1) finish (3) 35:19,22 20:5 19:15 4:21 21:14;23:14,15 Good (15) helpers (1) index (1) expect (1) first (5) 4:3;11:14;14:17; 20:11 39:14 29:11 9:13,14;36:16; 15:21;19:16;21:23; Hi (1) indicated (3) experience (2) 43:16;46:23 32:18;34:11;39:1,3, 10:20 6:18;7:25;24:23 46:7;48:5 five (6) 22;48:5,6,8,23 higher (2) industry (2) expert (2) 16:3,4,4,25;17:4; government (1) 12:8;28:18 22:17;41:1 34:18,20 24:12 42:17 Highway (1) information (1) explain (2) flag (1) grab (1) 5:17 10:21 35:16;38:9 21:1 22:9 hire (1) initiate (1) explained (1) food (6) grade (1) 19:25 26:19

Min-U-Script® Associated Reporters, Inc. (3) end - initiate 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing LOUISIANA BOARD OF PHARMACY June 26, 2019 instance (3) 22:18,18;31:25;42:20 18:5 minute (7) 17:7;37:19;47:6 kinds (4) level (4) M 12:13;16:5,10; instead (1) 25:20;40:24;41:2; 12:9;25:23;28:18, 21:22;23:7;31:16; 26:22 46:8 19 major (2) 32:1 intent (2) knowing (2) Library (1) 27:13;28:7 minutes (11) 7:21;34:3 37:6;43:25 7:16 makes (5) 15:19;17:5,11; Interested (1) knowledge (1) license (2) 16:17;31:15;38:20, 21:15;30:17;31:1,3,6, 6:11 12:9 15:3;40:16 21;40:19 11,12;39:18 interesting (1) licensees (3) making (4) mislead (1) 45:12 L 40:25;41:4,8 7:5;9:9,21;40:20 22:18 interfere (2) licenses (1) Malcolm (1) moderate (1) 25:15;32:16 labeled (1) 6:17 4:8 4:12 intern (4) 45:3 licensing (4) manager (2) moments (1) 13:23;14:5;18:17; labor (1) 35:7,19,20,21 28:25;29:23 37:12 19:10 28:1 lighten (1) manner (1) money (1) interns (1) ladies (1) 23:6 24:21 22:23 6:13 5:1 line (2) manual (1) months (1) interpretation (1) laid (2) 19:1;44:2 39:14 32:21 7:20 37:15;39:19 List (1) many (3) more (17) interruption (1) language (1) 6:11 21:14,15;25:7 14:21;16:1;17:9; 14:1 7:20 listed (1) marijuana (22) 19:18;21:25;22:6; intersection (1) larger (1) 37:23 34:22;35:8,18; 27:16;30:11,16;31:2, 46:9 19:24 little (7) 36:22,23;37:1,2,2,18, 18;40:7,19;41:17; into (4) last (2) 15:5;23:6;26:20,21; 20;42:16;43:12,14, 42:19;47:22;48:16 4:23;10:12;18:20; 8:14;32:21 35:11,11;42:19 19;44:22,24;45:2,4; morning (1) 36:15 Law (40) load (1) 46:6,14,23;47:1 4:3 involved (1) 5:23;6:22;7:12; 23:6 mark (1) most (5) 26:22 8:13,17;9:7;28:1; lobby (3) 20:8 17:14;18:12,13; issue (1) 34:15,23;35:8,18; 4:23;5:1,2 Maximum (1) 19:14,25 42:13 36:4,12,23;37:24; located (3) 13:15 mothers (1) issues (2) 40:20;41:3,21;42:1, 4:6,25;30:17 May (9) 27:8 7:21;18:6 15,23;43:11,24;44:15, long (8) 6:7,10,22;7:19;8:6; move (3) item (2) 19,23;45:6,21,23,25; 12:4;13:14;14:22; 24:25;31:11;36:7,7 23:19;44:1,2 18:3;32:20 46:2,4,5,10,10,16; 19:1;25:8;30:10;33:6; maybe (2) much (5) 47:8,10,11,13 46:25 16:12;34:17 9:13;15:13;19:11; J laws (7) longer (1) McDonald's (1) 45:13;46:18 5:24;36:15,18;38:4; 16:4 22:15 must (1) January (2) 39:19;41:25;46:11 look (5) mean (9) 44:25 8:20;10:1 leads (1) 35:2,4,9;36:6,8 23:24;24:16;26:5; myself (4) JD (2) 16:9 looking (3) 29:25;30:5;35:3; 10:11;11:12;19:11; 34:19;38:13 least (17) 18:8;33:21;37:12 41:11;42:12;47:10 21:5 Jefferson (1) 9:7;10:1;12:10,14; looks (1) medical (3) 5:16 13:16;16:25;19:9; 27:16 37:2;43:13;44:21 N job (2) 21:19,20;23:6,21; losing (1) meet (1) 26:1;30:5 24:10;26:22;27:18; 14:10 21:12 name (3) July (2) 28:2;29:8;42:10 lot (10) meeting (4) 4:8;10:20,22 33:6,15 leave (5) 5:18;11:20;19:19, 4:20;10:15;33:5; navigate (1) junction (1) 19:5,6,6,7;31:2 22;21:1;23:1,9;34:13, 49:2 36:4 47:2 legal (1) 16;36:2 Meetings (1) nearby (1) June (1) 44:3 loud (1) 5:23 13:18 4:4 legality (1) 19:21 memory (1) necessary (2) 26:21 Louisiana (11) 19:13 4:18;7:3 K legislature (8) 4:6,8;6:8;7:12,18; mentioned (2) need (4) 8:16;9:22;36:16,23; 8:19;31:9;43:10; 18:7;26:17 10:21;13:17;40:15; Katrina (1) 37:24;40:14;43:17; 44:13;45:10;46:7 might (3) 41:6 10:20 46:24 lunch (35) 9:8,23;25:1 needs (6) keep (7) legitimately (2) 11:18,23,24;12:5,7, mind (1) 16:19;17:21;27:3,4; 26:15,16;30:5; 44:21;45:8 10,13,13;13:1,4;15:8; 5:7 29:14,17 33:20,22;38:23;45:3 length (2) 16:2,6;17:2;18:22,23; Minimum (4) new (4) keying (1) 13:8,10 19:4,8,16;20:12; 13:15;14:16;28:19; 9:1;29:18;32:20; 37:17 less (3) 21:20;23:11,12;25:9; 29:10 33:16 kind (7) 16:20;17:2;19:24 28:20,22;29:1,2,3,7, minimum-wage (1) news (1) 8:20;9:14;12:9; letters (1) 17,21,23;30:1;32:9 12:7 33:21

Min-U-Script® Associated Reporters, Inc. (4) instance - news 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing LOUISIANA BOARD OF PHARMACY June 26, 2019 next (8) 30:12;31:6;32:21; 16:6,24;20:9 permit (1) 7:4;12:16;13:12; 8:22;13:2;16:9; 33:17;34:11;36:7; overworked (1) 24:20 26:6;34:12;35:13 20:8;30:19,24,24; 42:11;45:10 19:22 person (2) possibly (2) 33:5 Open (16) own (6) 29:22;41:17 11:17;23:5 NGUYEN (46) 5:23;9:17,24;10:17; 10:25;11:2;23:4; personally (1) posted (1) 10:19,20;11:1,6,10, 11:16;13:11;14:4; 24:18;29:20;46:19 34:6 6:1 15;13:9;14:20;15:2, 17:15;31:2,12;32:3, pharma (1) Potpourri (1) 11,20,25;16:14; 11;40:5,8;42:4,19 P 14:5 6:6 17:12;18:16;25:3; opened (1) pharmaceutical (1) practice (2) 26:2;30:9;31:14; 30:15 pagers (1) 44:25 18:11,15 32:25;33:13;34:10; operate (1) 4:16 pharmacies (3) practiced (1) 36:19;37:4;38:7,19; 24:20 park (1) 6:12;37:1;43:14 15:4 39:2,10,25;40:10; opportunity (1) 5:8 pharmacist (38) preamble (1) 41:10;42:3,7;43:1,6; 34:8 parking (4) 11:18;13:5;14:14; 43:15 44:4;45:18;46:17; opposite (1) 5:12,15,18,19 17:9;18:12,19;20:1; precedent (1) 47:12,17,21,25;48:4, 5:1 part (6) 21:7,24;22:3,11; 26:4 9,14,20 option (2) 28:1,5;35:17,21; 23:10,25;24:25;25:8, pregnant (1) nice (1) 9:22;42:10 42:23,24 14,24;26:13,25;27:2, 27:3 13:4 order (1) particular (1) 15,17;28:8,14,15; premise (2) nobody (1) 4:13 33:8 29:4,6,25;30:2,16,19; 14:2;30:21 29:19 ordinary (1) Parties (1) 31:2,13,22;32:5,9; premium (1) noon (2) 34:2 6:12 35:23;42:11 16:7 8:2;49:5 organization (2) part-time (1) pharmacists (9) prepared (1) notice (8) 8:6;10:24 16:12 6:13;11:22;12:8,12; 8:3 5:25,25;6:7,9,18; organize (2) passed (4) 18:6;19:19;28:25; prescribers (1) 7:9,25;34:3 35:10,14 32:17;35:8;36:15; 34:14,17 6:16 novel (1) organized (9) 37:25 Pharmacy (25) prescription (3) 29:18 34:16;36:14;37:6, passes (1) 4:6,9;6:13,13,14, 20:2,4;21:15 number (4) 15;38:9,12;39:4; 47:10 15;7:12;11:5,7,12; prescriptions (2) 17:20;18:24;24:12; 40:18,21 past (1) 14:4,23;18:4;19:14, 14:7,13 27:20 organizes (1) 5:2 15;22:9;23:19,20; present (3) 35:17 path (1) 24:21;26:5;30:15; 15:14;30:16;31:13 O origin (2) 4:22 31:1,4,11;45:5 presented (3) 45:21,23 patience (1) phone (1) 36:16;38:5,6 obligated (2) Orleans (1) 22:17 21:14 President (1) 20:12;46:4 33:16 patient (7) phones (1) 4:11 observed (1) otherwise (2) 12:23;18:4;22:7,8; 4:16 pressure (1) 19:10 20:16;21:24 25:17;26:16;29:6 pick (3) 21:3 obvious (1) ourselves (1) patients (8) 21:13;32:8,12 pretty (3) 45:5 19:20 20:18;21:25;22:1, place (4) 19:16;39:22;46:18 occurring (1) out (14) 17;23:23;44:20;45:8; 9:12;10:7;24:25; prevails (1) 8:10 13:24;19:21;20:22, 46:13 31:17 46:16 off (3) 25,25;21:2,10;22:5, pattern (1) places (2) Prior (3) 26:23;27:24;32:7 12,17;29:5;33:16; 9:25 37:3,19 7:5;8:20;10:1 offer (2) 37:15;39:19 pay (2) plant (1) probably (3) 9:10;37:12 outdated (1) 16:6,6 42:21 31:24;35:15;39:21 offered (1) 6:22 PDF (1) please (5) Procedure (2) 7:1 outgrown (1) 37:16 4:15,19;5:6,7;10:10 5:22;34:23 officer (1) 33:19 peace (1) pm (2) procedures (2) 44:10 outside (2) 5:7 12:5;49:11 24:19,25 often (2) 4:19;5:4 pending (1) point (1) process (3) 8:9,12 over (5) 49:7 30:2 20:25;22:13;34:2 once (3) 21:17;26:7,8;42:13, people (6) police (1) processed (1) 9:7,25;36:8 13 12:4,22;19:24;24:1; 44:10 44:14 one (18) overlapping (1) 26:14;40:25 policies (2) processes (1) 5:8,10,12;8:22; 17:17 perceived (1) 24:18,24 40:11 9:14;10:6;14:21;16:5; overly (1) 9:16 policy (2) product (4) 19:17;20:4,7;35:14; 6:23 perform (2) 21:18;26:19 39:16;45:1,9,16 36:24;40:13,14; override (1) 29:8,13 portion (1) products (2) 41:17;43:3;49:7 43:24 perhaps (1) 7:11 44:22;46:14 only (15) overrides (1) 45:14 position (1) profession (2) 15:24;16:11,18; 47:11 Perlis (1) 25:1 28:18,19 19:25;20:4,7,13; overtime (3) 5:16 possible (6) programs (1)

Min-U-Script® Associated Reporters, Inc. (5) next - programs 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing LOUISIANA BOARD OF PHARMACY June 26, 2019

6:16 really (9) 38:17 20:6 35:10 prohibits (3) 14:10;21:23;22:12; replaced (1) rule (11) selling (1) 44:24;46:6,11 23:16;24:4,5;25:12; 27:20 9:20;11:16;15:19, 14:6 properly (2) 40:12,13 reply (1) 19;16:10;31:9;40:15; sense (10) 6:1;45:6 rear (1) 7:3 41:25;42:9,24;43:14 16:17;17:13,20; proposal (2) 5:15 Reporter (1) Rulemaking (4) 21:8;28:16;31:15; 33:10;34:1 reasonable (4) 10:10 6:10;8:19;34:2; 38:12,21,22;40:19 prosecuted (1) 18:10;41:6,13;42:1 represent (3) 40:14 serve (2) 44:14 receive (5) 8:7;11:11,12 rules (17) 4:9;41:12 prosecution (2) 6:2,19;7:23;8:3; request (1) 6:4,21;7:3,14,15; session (1) 44:20;45:7 34:4 9:20 8:2;9:19;34:23;36:17, 49:4 protect (1) received (1) requested (1) 25;38:2,5;39:20; settings (1) 24:21 18:5 4:11 41:21;43:18;46:24,25 18:15 protected (1) recent (1) require (2) run (4) shelter (1) 45:25 17:14 12:12;31:3 13:13,19;14:9;23:4 29:15 provide (3) receptionist's (1) required (7) running (4) shift (2) 28:2,22;45:7 5:3 5:23;9:24;11:23; 12:3,3,3;31:25 16:17;17:15 provider (1) recess (3) 15:7;22:1;25:7;29:4 rushing (1) shifts (2) 44:7 10:8,14;49:1 requirement (3) 10:7 16:15;17:17 public (11) RECESSED (2) 9:6,11;11:17 shopping (1) 4:13;5:25;6:2,19, 10:15;49:2 requires (3) S 30:18 20;7:15;24:22;25:1; recharge (1) 8:14,18;9:7 show (1) 26:19;34:4;49:8 21:23 respect (1) safe (1) 27:18 publish (1) recognition (1) 36:22 25:14 side (2) 34:3 29:9 response (1) safety (12) 5:2;46:5 published (1) recognizing (1) 9:4 4:21;18:4;24:22; sign (4) 6:6 24:17 responsibility (2) 25:1,17;26:20,24; 7:6;32:4,8,14 pump (1) recommendation (2) 27:24;35:23 28:4,5,6,7,13 significance (1) 27:4 37:11;44:7 rest (2) salary (2) 9:13 punch (1) recommended (1) 21:21,22 11:20;16:22 silence (1) 29:5 38:1 restaurant (1) same (4) 4:15 purpose (3) record (4) 30:24 18:6;26:7;31:10; single (1) 6:1;7:22;41:12 10:12,13,17;49:5 restrooms (1) 46:8 17:10 purposes (1) refer (1) 4:25 saying (3) sit (1) 43:13 8:16 results (1) 26:3;32:4,8 23:8 pursuant (1) reflux (1) 9:8 Schedule (5) sitting (1) 5:25 24:7 retail (4) 37:22;42:18;43:10, 23:16 put (8) Register (3) 14:23;19:17;27:13; 20;47:1 situation (2) 10:11;19:18;22:12; 6:8;7:7,18 30:22 scheduled (1) 45:15;46:3 31:4;32:4,14;36:13; registration (5) return (2) 18:20 situations (3) 46:22 7:9;35:20;43:21,22; 19:4;31:5 school (1) 46:8,12,15 47:4 revenue (1) 47:6 six (7) Q regular (2) 22:24 scripts (1) 8:21,22;9:6,7,11; 5:13;32:11 review (1) 19:24 10:2;16:13 quick (1) regulate (1) 48:10 se (1) skim (1) 41:14 25:23 reviewing (1) 33:7 36:8 quickly (3) Regulation (3) 39:18 search (6) skip (5) 13:18,19,20 18:1;33:4;42:16 Revision (2) 37:18;39:7,23,24; 20:12,13;25:9;29:7; regulations (1) 18:2;33:4 41:11,12 30:6 R 34:23 revisions (1) searchable (2) slow (2) relate (1) 7:2 37:17;39:16 23:10;25:11 raise (1) 26:14 right (9) second (1) smell (3) 45:12 relative (1) 12:15;13:3;23:3; 43:19 44:11,23;45:1 raw (1) 37:1 24:17;26:25;32:24; Section (15) somebody (2) 44:24 relatively (1) 34:11;39:9;43:9 6:4;7:16;34:25; 20:3,10 reach (1) 32:20 risk (2) 35:20,21;36:24; somehow (1) 46:1 relevant (2) 43:21;46:19 37:21,24;38:1;43:15, 44:9 read (1) 7:11;41:24 room (7) 16,19,25;44:18;46:23 someone (5) 35:6 remember (3) 4:14,20,22;5:4,6; sections (2) 19:5,5,6,7;29:12 ready (1) 15:22;39:6,11 48:25;49:6 7:13;38:10 someplace (1) 14:14 reorganization (1) Rouge (1) Seeing (2) 26:1 reality (1) 40:6 4:7 10:6;39:19 sometime (5) 40:23 reorganize (1) round (1) seems (1) 12:3,19;21:4;23:12;

Min-U-Script® Associated Reporters, Inc. (6) prohibits - sometime 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing LOUISIANA BOARD OF PHARMACY June 26, 2019

25:8 stricter (1) test (1) tunnel (1) warm (1) sometimes (4) 47:14 21:6 21:7 13:17 21:6,22;25:9,20 structure (2) testimony (8) turns (1) warning (1) somewhere (1) 30:21;38:4 6:3,20;7:1,24;8:1,4; 19:8 43:16 27:23 struggling (1) 34:5,7 twice (1) water (1) son (1) 32:23 testing (1) 31:23 5:5 33:16 student (3) 45:17 two (3) way (18) soon (1) 34:14;36:3;48:11 thereafter (3) 20:11;32:21;37:3 22:19;26:6,21; 7:4 students (3) 7:5;8:21;10:2 type (1) 27:10,12,24;32:3; sooner (1) 34:17;38:23;40:3 thinking (4) 14:13 34:14,15;35:10,17; 9:11 study (2) 12:20;22:15;41:14, 38:20,21;39:4,20; sort (1) 21:5;35:4 15 U 40:17,18,21 16:9 stuff (2) third (1) website (3) sound (1) 13:25;17:17 43:25 under (2) 7:16,18;33:5 24:4 subchapter (1) though (1) 21:3;45:25 Wednesday (1) spaces (2) 36:25 11:19 union (5) 4:3 5:9,12 subject (1) thought (3) 15:6,18;16:1,22,23 welcome (3) speak (1) 45:16 20:10;40:11;41:18 unions (1) 10:6;42:6;47:20 10:10 substance (4) three (2) 15:6 weren't (1) specific (1) 6:17;43:10,20; 5:8;32:21 unnecessary (1) 13:1 39:21 44:19 ticket (1) 6:23 wherever (1) spend (2) suggestion (1) 44:10 up (17) 13:25 33:7;37:12 42:25 timeframe (1) 13:10,17;14:8;20:6; whichever (2) split (1) suggestions (2) 25:7 21:13;23:12;24:8; 24:12,13 24:14 13:7,11 times (1) 25:20;28:10;31:12; who's (3) staff (1) suggests (1) 24:23 32:8,12;36:1;38:22; 16:19;28:8;35:23 18:18 45:24 Today (7) 41:19;42:19;47:18 willing (1) Staffing (1) summer (1) 4:3;7:1,6,22;8:2; upset (3) 31:19 18:4 33:18 11:12;48:3 12:19;21:10;22:7 window (1) stairway (1) supposed (5) today's (2) up-to-date (1) 5:3 5:17 13:2;27:25;28:1; 6:2;7:8 33:23 wishes (1) stands (2) 32:4;35:3 together (1) use (7) 10:9 42:14,15 sure (1) 36:13 39:24;41:5;43:12; within (9) start (2) 41:19 told (1) 44:24;46:6,14,18 14:2;16:3;25:7; 12:4;15:12 sustain (1) 46:24 used (1) 26:9;29:20;30:20,22, state (7) 22:24 topic (3) 18:17 25;44:13 18:11;43:23;45:11, 17:25;33:8,9 using (1) without (4) 25;46:9,10;47:10 T tow (1) 45:15 11:22;14:1;30:15; states (4) 5:13 usually (3) 31:12 12:11;15:15;31:9; Table (4) trace (1) 11:23;19:15;31:5 wonder (1) 43:11 7:11;10:7;37:13; 44:11 44:12 stay (1) 39:17 training (1) V work (26) 32:3 talk (2) 6:15 11:2,22,25;12:9,17; step (1) 27:13;34:22 transaction (1) ventilation (1) 13:23;14:15;16:12, 4:19 talking (4) 32:13 28:4 20,25;17:2;18:21; still (19) 17:21;28:12,13; transactions (1) verified (1) 19:3,9;20:14;21:8; 12:24;13:13;14:3,9, 35:18 32:12 14:7 22:13;24:2,6;25:8,16; 12;17:21;20:4;23:25; technician (6) treat (1) violating (1) 26:13;27:9;28:17; 30:20;32:3,11;42:17; 6:14,15;14:5,11; 22:8 43:22 29:12;44:3 43:10,19;44:13;46:6, 28:14;29:24 trucks (1) vision (1) worked (3) 11,16;47:1 technicians (2) 5:13 21:7 16:15,16;29:19 stock (1) 6:14;13:22 true (1) visitors (1) worker (5) 29:22 telephone (1) 45:19 5:14 12:7;16:19;20:7; stomach (1) 4:19 trust (1) volume (6) 28:11,23 12:18 temporary (1) 20:18 19:24;20:2,6;22:22; Workers' (2) stop (1) 31:10 trusted (2) 23:9;26:15 45:22;47:8 23:13 ten (3) 13:22,22 working (12) store (3) 16:23,24;17:4 truth (1) W 12:24;16:21;19:23; 5:16;11:25;30:19 tends (1) 22:2 20:3,5,9;21:3,8; straight (1) 19:18 try (1) waiting (1) 25:24;28:2,17;29:11 12:20 terms (4) 48:19 33:17 works (2) stress (1) 37:18;39:24;45:13; trying (3) walk (3) 17:9;26:6 11:21 47:7 18:9;22:5;32:24 13:19;23:13;30:23 workstation (1)

Min-U-Script® Associated Reporters, Inc. (7) sometimes - workstation 225 216 2036 STATE OF LOUISIANA PARISH OF EAST BATON ROUGE Public Hearing LOUISIANA BOARD OF PHARMACY June 26, 2019

13:3 worried (1) 3 20:24 worry (1) 3:00 (1) 21:9 12:5 worrying (1) 30 (13) 20:21 12:13;15:19;16:10; written (1) 21:22;23:7;30:16; 34:7 31:1,3,6,11,12,16; wrong (1) 32:1 18:24 3301 (1) wwwpharmacylagov (1) 6:5 7:17 3388 (1) 4:7 X 398 (1) 20:4 Xavier (1) 11:3 4

Y 400 (1) 20:6 year (4) 454 (2) 8:15;9:6,11;48:16 8:15,17 years (4) 8:21,22;9:8;10:2 9

1 9:00 (1) 4:4 1 (3) 9:10 (1) 8:20;10:1;47:1 10:8 1:00 (1) 9:11 (1) 19:6 10:14 10:05 (1) 10:18 10:35 (1) 48:25 101 (1) 6:4 11:00 (1) 19:5 12 (1) 17:15 12:00 (4) 8:2;19:6;49:5,11 2

2:00 (2) 12:5;19:7 20 (1) 6:10 200 (2) 20:2,8 2018 (1) 8:15 2019 (3) 4:4;6:7,10 2020 (2) 8:21;10:1 24th (1) 33:6 26 (1) 4:4

Min-U-Script® Associated Reporters, Inc. (8) worried - 9:11 225 216 2036 Regulatory Proposal 2019-E ~ Cannabis Metered Dose Inhalers Draft #1

1 Louisiana Administrative Code 2 3 Title 46 – Professional and Occupational Standards 4 5 Part LIII: Pharmacists 6 7 Chapter 24. Limited Service Providers 8 9 Subchapter E. Marijuana Pharmacy 10 11 §2443. Marijuana Products 12 A. – B.8. … 13 C. Product Dosage Forms. 14 1. The producer shall limit their production of pharmaceutical grade marijuana products to the 15 following dosage forms: 16 a. Oils, extracts, tinctures, or sprays; 17 b. Solid oral dosage forms, e.g., capsules or pills; 18 c. Liquid oral dosage forms, e.g., solutions or suspensions; 19 d. Gelatin-based chewables; 20 e. Topical applications, oils or lotions; 21 f. Transdermal patches; or 22 g. Suppositories; or 23 h. Metered-dose inhalers. 24 C.2. – E.4.f. … 25 26 AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1046. 27 HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 43:1540 (August 2017), 28 amended by LR 29 DRAFT

1 Louisiana Board of Pharmacy 2 3388 Brentwood Drive 3 Baton Rouge, Louisiana 70809-1700 4 Telephone 225.925.6496 ~ E-mail: [email protected] 5 6 7 Blueprint for Inspection of Pharmacies 8 9 Module I – Basic Pharmacy Services 10 11 Version 1.3 12 13 … 14 15 Facility and Security 16 17 37.05 Does the pharmacy have a hazardous waste handling and 18 collection system? For example, empty bottles that contained 19 chemotherapy medications or warfarin, or hazardous drug 20 compounding waste? If yes, indicate how often the bin is 21 emptied/collected and the vendor used? 22 23 … 24 25 46.00 Does the pharmacy utilize any automated apparatuses for prescription 26 processing/counting (such as robotics, Baker cells, etc.)? List number 27 and types. 28 Subcommittee 29 46.01 If yes, do they have and follow policies and procedures addressing 30 cross-contamination and identification of drug products? 31 32 46.02 There are policy and procedures that address transportation of 33 hazardous drugs (e.g. transport via pneumatic tube). 34 35 … 36 37 Product Receipt and Inventory 38 39 … USP-800 40 Recommendations 41 57.00 Is the most recent complete controlled substance inventory available for 42 review? 43 44 57.01 Does the pharmacy maintain other required inventories (such as 45 change in PIC, theft/loss, etc.)? 46 47 57.02 Does the pharmacy handle hazardous drugs based on “NIOSH List 48 of Antineoplastic and Other Hazardous Drugs in Healthcare 49 Settings”? If yes, does facility maintain a current list of hazardous 50 drugs handled by facility which is updated and reviewed at least 51 every 12 months? The facility also has policy and procedures for 52 hazardous drugs that may enter the market after the most recent 53 version of the NIOSH List. 54 55 57.03 Does the pharmacy have a designated person responsible for 56 overseeing hazardous drug handling at the facility? 57 58 57.04 There is signage that is prominently displayed which identifies the 59 hazardous drug handling areas. Access to areas where hazardous 60 drugs are handled is restricted to authorized personnel and located 61 away from break rooms and refreshment areas for personnel, 62 patients, or visitors. 63 64 57.05 The facility has policy and procedures that address receipt, 65 handling, and storage of hazardous drugs. 66 67 57.06 Hazardous drugs are stored in a manner that prevents spillage or 68 breakage. 69 70 … 71 72 Module II – Compounding Nonsterile Preparations 73 74 Version 1.2 75 76 General Operations Information 77 78 … Subcommittee 79 80 13.00 Does the pharmacy perform compounding with hazardous drugs? If so, 81 indicate percentage of total compounding activity designated as such. 82 83 13.01 Is the pharmacy aware of the more stringent requirements of the 84 proposed USP Chapter <800>? 85 86 13.01.01 Based on “NIOSH List of Antineoplastic and Other 87 Hazardous Drugs in Healthcare Settings”, does the 88 pharmacy compound with Group 1 drugs? 89 USP-800Recommendations 90 1301.02 Based on “NIOSH List of Antineoplastic and Other 91 Hazardous Drugs in Healthcare Settings”, does the 92 pharmacy compound with Group 2 and Group 3 93 drugs? If yes, are there risk assessments for these 94 drugs that include alternative containment strategies 95 and/or work practices? 96 97 98 14.00 Are Safety Data Sheets (SDS) [formerly known as Material Safety Data 99 Sheets (MSDS)] available to personnel for drugs and chemicals used in 100 the pharmacy (including those for compounding, if applicable)? Verify that 101 personnel can access them and are familiar with the format. 102 103 … 104 Component Selection and Use 105 106 21.00 All bulk drug substances (APIs) used are: 107 (1) Compliant with the standards of an applicable USP or NF monograph, 108 if one exists; or 109 (2) A component of an FDA-approved human drug product; or 110 (3) On the list of bulk drug substances for use in compounding developed 111 by the FDA and issued through regulation. [Note: must comply with (1) 112 or (2) above until the FDA list is issued] 113 114 … 115 116 21.10 Bulk component containers are labeled with appropriate OSHA 117 hazard communication labels and hazardous substances (including 118 hormones) are segregated. 119 120 … 121 122 Environment 123 124 33.00 The nonsterile compounding area is a controlled environment and 125 separate from the general pharmacy. 126 127 33.01 Facility has designatedSubcommittee hazardous drug compounding area(s). 128 129 33.02 Are both nonsterile and sterile hazardous drugs being compounded 130 in the same room? 131 132 33.03 Is particle-generating activity being performed when sterile 133 compounding is in process? 134 135 33.04 Is a C-PEC being used for nonsterile compounding also being used 136 for sterile compounding? 137 138 33.05USP-800 Is Recommendationsthe C-PEC properly deactivated, decontaminated, cleaned, and 139 disinfected prior to resuming sterile compounding? 140 141 33.06 An eyewash station is readily available. 142 143 33.07 All water sources and drains are located at least one meter away 144 from the C-PEC. 145 146 … 147 148 36.00 Procedures are implemented to prevent cross-contamination, especially 149 when compounding with drugs such as hazardous drugs and known 150 allergens like penicillin that require special precautions. 151 152 37.00 The compounding area is well-lit. 153 154 37.01 For NIOSH List Group 1, surfaces of ceilings, walls, floors, fixtures, 155 shelving, counters, and cabinets in the nonsterile compounding 156 area must be smooth, impervious, free from cracks and crevices 157 and non-shedding. 158 159 37.02 For NISOH List Group 2 and Group 3, configuration of the space 160 utilized for compounding these hazardous drugs is dedicated or 161 properly deactivated, decontaminated, and cleaned if non- 162 hazardous drug compounding is done in this containment 163 ventilated enclosure (CVE) at any other time. 164 165 38.00 The pharmacy performs hazardous nonsterile compounding in a 166 ventilated cabinet such as a BSC, CAI, or CACI or CVE (containment 167 ventilated enclosure); however, CAI may not be used for hazardous drugs 168 that may volatilize. {USP Chapter <800> will change hazardous drug 169 compounding requirements.} The C-PECs used for manipulation of 170 nonsterile hazardous drugs must either be externally vented (preferred) or 171 have redundant HEPA filters in series. Does the C-PEC operate 172 continuously? 173 174 38.01 Ventilated cabinets (BSC, CAI, CACI, CVE) used for hazardous 175 compounding are certified or tested periodically. 176 Subcommittee 177 38.02 If the hoods or isolators are not located in a closed, controlled room 178 environment, there is documentation from the manufacturer and 179 site testing to verify proper functioning of equipment under dynamic 180 conditions for the safety of personnel. 181 182 38.03 For NIOSH List Group 1, the C-PEC is located in a Containment 183 Secondary Engineering Control (C-SEC) which is externally vented 184 with at least 12 air changes per hour (ACPH) and negative 185 pressure between 0.01 and 0.03” water column relative to adjacent 186 areas. 187 USP-800Recommendations 188 39.00 Appropriate protective attire (gowns, gloves, masks, etc.) is available. 189 190 39.01 If hazardous drugs are used, appropriate protective attire is 191 available (gowns, gloves, hair and shoe covers, eye and face 192 protection, etc.). 193 194 40.00 There is a sink in the compounding area with hot and cold potable water, 195 soap or detergent, and air-driers or single-use towels. 196 197 … 198 199 48.00 Hazardous drugs are appropriately identified and marked, received, 200 handled and stored by appropriately trained personnel (OSHA regulations 201 and NIOSH Alerts). 202 203 48.01 Pharmacy has a designated hazardous drug receiving area that is 204 neutral/normal or negative pressure relative to surrounding areas. 205 206 48.02 NIOSH List Group 1 antineoplastic hazardous drugs requiring 207 manipulation other than counting or repackaging of final dosage 208 forms are segregated and stored in an externally ventilated, 209 negative pressure room (at least 0.01” water column) to adjacent 210 areas with at least 12 ACPH. 211 212 48.03 Refrigerated antineoplastic hazardous drugs are stored in a 213 dedicated refrigerator in a negative pressure area with at least 12 214 air changes per hour. 215 216 48.04 The NIOSH List Group 2 and Group 3 hazardous drugs, including 217 non-antineoplastic, reproductive risk only, and final dosage forms 218 of antineoplastic hazardous drugs may be stored with other 219 inventory if permitted by entity policy. 220 221 49.00 Trash is disposed of in a safe, sanitary, and timely manner. 222 223 49.01 Hazardous waste is disposed of in a safe, sanitary, and timely 224 manner. 225 Subcommittee 226 Training 227 228 50.00 All personnel of reproductive capability who handle or compound 229 hazardous drugs or chemicals have confirmed in writing that they 230 understand the risks of handling hazardous drugs, including teratogenicity, 231 carcinogenicity, and reproductive issues? 232 233 51.00 There is documentation that all personnel that perform compounding are 234 appropriately trained including policies and procedures, documentation, 235 hazardous drug handling, and compounding technique and are not 236 USP-800allowed toRecommendations compound or supervise compounding until training is 237 successfully completed. 238 239 … 240 241 54.00 There is documentation available showing employees performing 242 nonsterile compounding are evaluated at least annually. 243 244 54.01 If performing hazardous nonsterile compounding, there is 245 documentation available showing employees are evaluated at least 246 annually. 247 248 … 249 250 Compounding Equipment 251 252 … 253 254 60.00 The pharmacy uses separate equipment and utensils to compound 255 allergenic, cytotoxic, or hazardous products, or has detailed procedures 256 for meticulous cleaning of equipment and utensils immediately after use to 257 prevent cross contamination or exposure. 258 259 60.01 Do policy and procedures exist for deactivation, decontamination, 260 and cleaning activities for handling hazardous drugs? 261 262 … 263 264 Compounding Procedures 265 266 … 267 268 68.00 Personnel don appropriate protective garb when performing 269 compounding. 270 271 68.01 If hazardous compounding, personnel don appropriate protective 272 garb when compounding. 273 274 68.02 PPE is properly Subcommitteedisposed of upon completion of hazardous 275 compounding activities. 276 277 … 278 279 73.00 Personnel are appropriately garbed for protection when cleaning. 280 281 … 282 283 Finished Preparation Release Checks and Tests 284 USP-800 285 … Recommendations 286 287 80.00 Labels on immediate patient-specific containers include identifiers for the 288 persons preparing the compound and performing the final verification, 289 BUD, and an indication that this is a compounded preparation, special 290 requirements for storage, and appropriate packaging and labeling of 291 hazardous materials. 292 293 … 294 295 80.04 If hazardous, labeling contains storage and handling information. 296 297 … 298 299 Patient Counseling and Communication 300 301 85.00 Patient/caregiver training programs or materials contain information and 302 precautions regarding the handling and disposal of products such as 303 fentanyl, hormones, and chemotherapy medications. 304 305 … 306 307 Module III – Compounding Sterile Preparations 308 309 Version 1.2 310 311 … 312 313 General Operations Information 314 315 … 316 317 012.00 Does the pharmacy perform compounding with hazardous drugs? If so, 318 indicate the percentage of sterile compounding activity designated as 319 such. 320 321 012.01 Does the pharmacy have a plan to comply with USP Chapter 322 <800> by the implementation date? Is the pharmacy aware of the 323 more stringent requirementsSubcommittee of the USP Chapter <800>? 324 325 012.01.01 Based on “NIOSH List of Antineoplastic and Other 326 Hazardous Drugs in Healthcare Settings”, does the 327 pharmacy compound with Group 1 drugs? 328 329 012.01.02 Based on “NIOSH List of Antineoplastic and Other 330 Hazardous Drugs in Healthcare Settings”, does the 331 pharmacy compound with Group 2 and Group 3 332 drugs? If yes, are there risk assessments for these 333 drugs that include alternative containment strategies 334 USP-800Recommendationsand/or work practices? 335 336 012.02 Are hazardous drugs segregated and stored in a room that is 337 negative pressure (at least 0.01” water column) to adjacent areas 338 and with at least 12 ACPH (air changes per hour)? Are hazardous 339 drugs in NIOSH List Group 1, antineoplastic hazardous drugs 340 requiring manipulation other than counting or repackaging of final 341 dosage forms segregated and stored in a room that is negative 342 pressure between 0.01 and 0.03” water column relative to adjacent 343 areas, which is externally vented with at least 12 ACPH? 344 345 012.03 Is hazardous drug waste quarantined in a designated area and 346 disposed of in compliance with local, state, and federal 347 regulations? 348 349 013.00 Are Safety Data Sheets (SDS) [formerly known as Material Safety Data 350 Sheets (MSDS)] available to personnel for drugs and chemicals used in 351 the pharmacy (including those for compounding, if applicable)? Verify that 352 personnel can access them and are familiar with the format. 353 354 … 355 356 Component Selection and Use 357 358 022.00 All bulk drug substances (APIs) used are: 359 (1) Compliant with the standards of an applicable USP or NF monograph, 360 if one exists; or 361 (2) A component of an FDA-approved human drug product; or 362 (3) On the list of bulk drug substances for use in compounding developed 363 by the FDA and issued through regulation. [Note: must comply with (1) 364 or (2) above until the FDA list is issued] 365 366 … 367 368 022.10 Bulk component containers are labeled with appropriate OSHA 369 hazard communication labels and hazardous substances (including 370 hormones) are segregated. 371 372 … Subcommittee 373 374 Environment 375 376 027.00 If the facility performs both sterile and nonsterile compounding, the areas 377 are separated and distinct. 378 379 … 380 381 027.01 Are both nonsterile and sterile hazardous drugs being compounded 382 in the same room? 383 USP-800Recommendations 384 027.02 Are the C-PECs being used for nonsterile compounding sufficiently 385 effective that the room can continuously maintain ISO 7 386 classification throughout the compounding activity? 387 388 027.03 Are the C-PECs placed at least one meter apart? 389 390 027.04 Is particle-generating activity being performed when sterile 391 compounding is in process? 392 393 027.05 Is a C-PEC being used for nonsterile compounding also being used 394 for sterile compounding? 395 396 027.06 Is the C-PEC properly deactivated, decontaminated, cleaned, and 397 disinfected prior to resuming sterile compounding? 398 399 037.00 A working sink, located on the clean side of the line of demarcation, is 400 available that enables pharmacy personnel to wash hands and enter the 401 sterile compounding area without contaminating his/her hands and is 402 away from/not adjacent to any PECs. 403 404 037.01 An eyewash station is readily available. 405 406 … 407 408 040.00 All air ducts controlling air flow into the sterile compounding clean/buffer 409 room and anteroom are equipped with HEPA filters that maintains the 410 clean/buffer room in an ISO Class 7 environment and the anteroom with 411 an ISO Class 7 (when adjacent to hazardous drugs cleanroom) or ISO 412 Class 8 environment. 413 414 040.01 For NIOSH List Group 1, the pharmacy performs hazardous sterile 415 compounding in a ventilated cabinet such as a BSC, CAI, or CACI. 416 The C-PECs used for manipulation of these sterile hazardous 417 drugs must be externally vented and provide ISO Class 5 or better 418 air quality (e.g., Class II or III BSC, CACI, Class II BSC types A2, 419 B1, or B2). Note: CAI may not be used for hazardous drugs that 420 may volatilize. 421 Subcommittee 422 040.02 Ventilated cabinets (BSC, CAI, CACI) used for hazardous 423 compounding are certified or tested periodically. 424 425 040.03 Are non-hazardous drug preparation being made in the same C- 426 PEC as hazardous preparations? If yes, is the non-hazardous 427 preparation being placed into a protective outer wrapper during 428 removal from the C-PEC and labeled to require PPE handling 429 precautions? 430 431 040.04 Are refrigerated antineoplastic hazardous drugs stored in a 432 USP-800dedicatedRecommendations refrigerator in a negative pressure area with at least 12 433 ACPH? 434 435 … 436 437 045.00 Completely enclosed anteroom and clean/buffer room (with a door) are 438 equipped with monitors or gauges to measure differential pressure. 439 440 … 441 442 045.03 Hazardous compounding room and drug storage area is at least 443 0.01” water column negative pressure to ISO Class 7 anteroom. 444 445 … 446 447 053.00 For BSC or LAFW that is NOT located in an ISO Class 7 clean/buffer 448 room, the BSC or LAFW has been certified to maintain ISO Class 5 during 449 compounding activities. 450 451 … 452 453 053.05 The sink is separated from the immediate area of the ISO Class 5 454 BSC or LAFW (not adjacent). 455 456 054.00 For CAI/CACI that is NOT located in an ISO Class 7 clean/buffer room, 457 the CAI/CACI has been certified to maintain ISO Class 5 under dynamic 458 conditions including transferring of ingredients, components, and devices, 459 and during preparation of compounded sterile preparations. 460 461 … 462 463 054.04 For NIOSH List Group 1 hazardous compounding in a CACI that is 464 NOT located in a clean/buffer room, the CACI is located in a 465 physically separated area that maintains a negative pressure of 466 0.01” water column pressure to adjacent areas and a minimum of 467 12 air changes per hour (ACPH). 468 469 … 470 Subcommittee 471 Training 472 473 070.00 There is documentation that compounding personnel are appropriately 474 trained including policies and procedures, documentation, hazardous drug 475 handling, cleaning/disinfection/spills, garbing/gowning/hand hygiene, and 476 aseptic technique. Compounding personnel includes persons performing, 477 supervising, and verifying compounding activities. List number of 478 personnel training files viewed. 479 480 … 481 USP-800Recommendations 482 071.00 All personnel of reproductive capacity who handle or compound 483 hazardous drugs or chemicals have confirmed in writing that they 484 understand the risks of handling hazardous drugs. Teratogenicity, 485 carcinogenicity, reproductive issues. 486 487 072.00 There is documentation, such as an observational checklist, that all 488 personnel (including housekeeping or other outside personnel) that 489 perform cleaning activities in the compounding areas including hazardous 490 compounding areas are appropriately trained in garbing, cleaning, and 491 disinfection. 492 493 … 494 495 075.00 There is documentation that all compounding personnel (including those 496 supervising or performing verifications) have passed an initial written 497 exam, and subsequent annual written exams for the appropriate 498 compounding risk levels and NIOSH hazardous drugs, when applicable. 499 Indicate frequency if testing more than annually. 500 501 076.00 There is documentation that all compounding personnel have passed an 502 initial and subsequent annual competency assessments of aseptic 503 compounding skills using observational audit tools including handling 504 NIOSH hazardous drugs, when applicable. Compounding skills 505 evaluations shall include use of equipment. Indicate frequency, if testing 506 more than annually. 507 508 … 509 510 Garbing 511 512 … 513 514 089.00 Garbing includes head and facial hair covers and masks. There is a 515 mirror available to check that all hair is covered. 516 517 089.01 PPE is properly disposed of upon completion of hazardous 518 compounding activities. 519 Subcommittee 520 … 521 522 Environmental Monitoring 523 524 .. 525 526 099.00 The HEPA filtered air changes per hour (ACPH) were measured for the 527 compounding rooms. 528 529 … USP-800 530 Recommendations 531 099.03 ISO Class 7 hazardous sterile compounding room is certified as 532 having a minimum of 30 ACPH. Typically all of the air will be from 533 outside. 534 535 … 536 537 100.00 Air pattern analysis using smoke testing was performed under dynamic 538 conditions (people working in the PECs and rooms). The smoke flow is 539 described in the report for the various tests as turbulent, sluggish, smooth, 540 etc. 541 542 … 543 544 100.02 Air pattern analysis was conducted to confirm positive pressure 545 (and negative pressure into hazardous compounding rooms for 546 NIOSH List Group 1) at all points around all openings, doorways, 547 and pass-throughs. 548 549 … 550 551 101.00 Differential air pressure between rooms was measured. 552 553 … 554 555 101.02 For NIOSH List Group 1, the differential pressure measured was at 556 least 0.01” water column negative from the hazardous clean/buffer 557 room to the anteroom with the doors closed. 558 559 … 560 561 Patient Counseling and Communication 562 563 143.00 Do patient/caregiver training programs or materials contain information 564 and precautions regarding the handling and disposal of hazardous 565 products such as chemotherapy medications? 566 567 … 568 Subcommittee 569

USP-800Recommendations

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Executive Committee

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Final Legislative Brief

2019-0814

Regular Session of the 2019 Louisiana Legislature Convened 2019-0408 @ 1200 – Adjourned 2019-0606 @ 1800

Last Items Reviewed

HB 620 HR 320 HCR 122 HSR 3 HCSR 3 SB 243 SR 279 SCR 145 SSR 1 SCSR 0 Acts 448

Total Items Filed = 1,736 Items on Watch List = 70 Watched Items Successful = 39 Successful Items with Action Plans = 16

House of Representatives

Bills

HB 69 Zeringue Health & Welfare Provides relative to the membership of the Louisiana State Board of Dentistry. 06-11-2019 Signed as Act 324; effective 06-11-2019.

This bill amends the dental practice act to temporarily expand the size of the dental board, to facilitate the appointment of an oral and maxillofacial surgeon to the board. We monitored this item to observe the legislative reconstruction of a licensing board.

HB 119 Bishop Insurance Provides relative to the denial of a prescription based upon step therapy or fail first protocols or non- formulary status. 06-11-2019 Signed as Act 206; effective 01-01-2020.

This bill amends the insurance law to require any insurer which denies a prescription claim based on step therapy, fail first protocols, or non-formulary status to provide the prescriber with a list of acceptable alternative disease-specific drug therapies. We monitored this item for any potential amendments to pharmacy law; there were none.

HB 138 Connick Administration of Criminal Justice Provides relative to certain substances in the Uniform Controlled Substance Law. 06-17-2019 Signed as Act 354; effective 08-01-2019.

The Board approved this Legislative Proposal 2019-A; it amends the Controlled Substance Law to harmonize the state definition of marijuana and list of controlled substances with the federal definition and list.

Action Plan:  Update Controlled Substances Law in Louisiana Pharmacy Law Book.

Items in blue print sponsored by Board. Page 1 of 9 HB 169 Hoffmann Health & Welfare Authorizes a data system for the collection of information on health effects and outcomes associated with medical marijuana. 06-11-2019 Signed as Act 207; effective 08-01-2019.

This bill amends the medical practice act to authorize the medical board to develop and operate a database containing health effects and outcomes associated with use of medical marijuana. Only reports filed by patients using medical marijuana, physicians recommending medical marijuana, and physicians treating patients using medical marijuana will be accepted. We monitored this item for any potential amendments to include pharmacies or pharmacists as data reporters; there were none.

HB 196 Falconer Commerce Exempts the La. Professional Engineering & Land Surveying Board and the State Board of Architectural Examiners from time limitations for disciplinary proceedings by professional and occupational boards and commissions. 06-11-2019 Signed as Act 281; effective 08-01-2019.

This bill amends the professional licensing law to exempt these two boards from the requirement to notify the licensee of a complaint filed against them no later than six months after receipt of the complaint. We monitored this item for any amendment to the list of licensing boards not subject to this requirement; there were none.

HB 243 Miller Health & Welfare Provides relative to opioid data reporting. 06-20-2019 Signed as Act 423; effective 06-20-2019.

This bill amends the state sanitary code to require reporting by emergency departments of certain information concerning opioid-related overdoses (admissions and discharges). The law also amends the vital records law to require coroners to report drug overdose deaths. The law also amends the naloxone section in the controlled substance law to require first responders to report opioid-related overdoses to the Dept. of Health and whether naloxone was administered; the law also amended the public records law to exempt these first responder reports. We monitored this item for any potential amendment to include pharmacies or pharmacists; there were none.

Action Plan:  Update the naloxone section in the Controlled Substance Law in Louisiana Pharmacy Law Book.

HB 244 Pierre Judiciary Provides relative to vapor products and alternative nicotine products. 06-20-2019 Signed as Act 424; effective 06-20-2019.

This bill amends the alcohol and tobacco control law to include vapor products and alternative nicotine products which requires dealers of such products to obtain a permit from the Alcohol & Tobacco Control (ATC) office and be regulated by that office. The bill added E-liquids, which may or may not contain nicotine and which cannot contain CBD or cannabis, to the list of regulated items. We monitored this item for any potential amendments to the therapeutic marijuana law; there were none.

HB 250 Davis Health & Welfare Requires residential treatment facilities to provide access to medication-assisted treatment for patients with opioid use disorder. 06-20-2019 Signed as Act 425; effective 01-01-2020.

This bill amends the licensing law for residential treatment facilities to require them to offer, no later than January 1, 2021, onsite access to at least one FDA-approved opioid agonist treatment and at least one FDA-approved partial opioid antagonist treatment. The bill specifies that onsite access shall not require the facility to maintain drug stocks but can allow for delivery to the patient at the facility. We monitored this item for any potential amendment affecting pharmacies or pharmacists; there were none.

Items in blue print sponsored by Board. Page 2 of 9 HB 284 Abraham Health & Welfare Provides relative to prescribing and dispensing of opioid drugs. 06-20-2019 Signed as Act 426; effective 08-01-2019

This bill amends the prescription section of the Controlled Substance Law to require a prescriber electing to override the 7-day limit on prescriptions of opioids to specify on the prescription form that more than a 7-day supply is medically necessary. We monitored this item for any potential amendments affecting pharmacies or pharmacists. There were none.

Action Plan:  Update prescription section of Controlled Substances Law in Louisiana Pharmacy Law Book.  Notify licensees via the Legislative Bulletin.

HB 358 James Health & Welfare Provides relative to marijuana for therapeutic use. 06-11-2019 Signed as Act 284; effective 08-01-2019.

This bill amended the Therapeutic Marijuana Law to remove the requirement that the recommending physician be domiciled in Louisiana (but still must be licensed by the state medical board); and further, authorized the Board of Pharmacy, by rule, to add metered dose inhalers as an allowable dosage form.

Action Plan:  Update Therapeutic Marijuana Law in Louisiana Pharmacy Law Book.  Revise marijuana rule to add metered-dose inhaler to the list of allowable dosage forms.

HB 375 Turner Health & Welfare Provides relative to criminal history record checks for certain licenses issued by the Louisiana Board of Pharmacy. 06-11-2019 Signed as Act 219; effective 08-01-2019.

The Board approved this Legislative Proposal 2019-B; it amends the licensing section of the Controlled Substance Law to authorize the Board to require criminal history record checks for applicants for a CDS license.

Action Plan:  Update Controlled Substance Law in Louisiana Pharmacy Law Book.  Revise Chapter 27 – Controlled Dangerous Substances to add CBC requirement for CDS license.  Update application form and/or instructions to alert applicants of CBC requirement.

HB 378 James Appropriations Provides relative to the creation of digitized credentials. 06-11-2019 Signed as Act 220; effective 06-11-2019.

This bill amends the public finance law to authorize the Commissioner of Administration to promulgate rules to authorize the use of digitized credentials in electronic wallets. We monitored this item for potential use with credentials issued by the Board.

HB 404 Schexnayder House & Governmental Affairs Abolishes certain boards, commissions, authorities, like entities, and related funds. 06-22-2019 Signed as Act 434; effective 06-30-2019.

This bill abolishes four inactive boards and commissions and increases the membership of one board. We monitored this item to ensure neither the Board of Pharmacy nor the PMP Advisory Council were amended into the bill. They were not.

Items in blue print sponsored by Board. Page 3 of 9 HB 423 Emerson Commerce Provides for the revocation of occupational and professional licenses for failure to pay student loans. 06-11-2019 Signed as Act 227; effective 08-01-2019

This bill amends the professional licensing law to repeal the section of law requiring licensing boards to deny applications for or renewals of licenses for applicants in default of student loans.

Action Plan:  Revise application instruction documents to remove reference to this repealed law.

HB 433 LeBas Health & Welfare Authorizes a pharmacist to decline to dispense a covered prescription drug if the coverage provider reimburses the pharmacy in an amount less than the drug’s acquisition cost. 06-06-2019 Signed as Act 161; effective 06-06-2019.

This bill amends the insurance law and the pharmacy practice act to authorize a pharmacist or pharmacy to decline to dispense a covered drug if the reimbursement is less than the drug’s acquisition cost.

Action Plan:  Update the pharmacy law in the Louisiana Pharmacy Law Book.  Notify licensees via the Legislative Bulletin.

HB 452 Turner Administration of Criminal Justice Provides relative to Schedule I controlled dangerous substances. 06-11-2019 Signed as Act 231; see Act for future effective date.

This bill amends the controlled substance law to provide for the anticipatory automatic scheduling of mitragynine (Kratom) – at the same time and in the same schedule when the federal government makes that determination. When so scheduled, the existing prohibition on distribution to minors will be automatically repealed.

Action Plan:  Update controlled substance law in Louisiana Pharmacy Law Book.

HB 491 Schexnayder Agriculture, Forestry, Aquaculture, & Rural Development Provides for the regulation of industrial hemp. 06-06-2019 Signed as Act 164; effective 06-06-2019 and 01-01-2020.

This bill amends the agriculture law to establish a state-sanctioned industrial hemp program regulated by the Dept. of Agriculture. The bill also amends the controlled substance law to exempt industrial hemp from the definitions of Cannabis and Marijuana. The bill establishes a regulatory structure for the retail sale of hemp-derived CBD products, with such products requiring registration by the Dept. of Health, and the sellers requiring registration by the Alcohol & Tobacco Control unit of the Dept. of Revenue.

Action Plan:  Update controlled substance law in Louisiana Pharmacy Law Book.  Schedule reconsideration of PPM.I.A.26 ~ Sale of CBD Oil (Guidance Document).

HB 507 Abramson Ways & Means Levies a 7% tax on the gross sales of therapeutic marijuana and dedicates the avails into the New Opportunities Waiver Fund. 06-11-2019 Signed as Act 331; effective 07-01-2019.

This bill amends the therapeutic marijuana law to revise the disposition of the 7% tax on the gross sales of marijuana products by the product producer. Instead of the Dept. of Agriculture retaining those proceeds

Items in blue print sponsored by Board. Page 4 of 9 for its own use, the Dept. of Revenue shall receive those proceeds for distribution to the Community and Family Support System Fund (used for support of citizens with developmental disabilities). The bill also prohibits any sales and use taxes on the retail sales of marijuana products to patients. We monitored this amend for any potential amendments to other sections of the medical marijuana law.

Action Plan:  Update therapeutic marijuana law in Louisiana Pharmacy Law Book.

HB 538 LeBas Health & Welfare Provides relative to pharmacy record audits. 06-06-2019 Signed as Act 167; effective 08-01-2019.

This bill amends the insurance law relative to insurance audits of pharmacy records. Different aspects of audits are addressed including a new provision relative to audits involving clinical judgment. The previous law required a licensed pharmacist perform or consult on the audit; the new law requires that pharmacist to be licensed in Louisiana. We monitored this item for potential amendments to pharmacy law; there were none.

HB 560 Abramson Ways & Means Authorizes the imposition of tax on hemp and CBD. 06-11-2019 Signed as Act 247; see Act for effective date.

This bill amends the tax law to impose a 3% excise tax on the retail sale of hemp-derived CBD products, in addition to any sales and use taxes on the retail sales of such products. Requires the Dept. of Revenue to collect the tax and deposit the proceeds in the Early Childhood Education Fund. The bill conditioned the effective date of this act upon the effective date of the act originating as HB 138 (Board’s CDS update bill), which is 08-01-2019. The taxes are due beginning 01-01-2020. We monitored this item due to its connection with a Board-sponsored bill.

HB 614 Miguez House & Governmental Affairs Exempts certain information from the Public Records Law. 06-11-2019 Signed as Act 256; effective 08-01-2019.

This bill amends the public records law to exempt the social security number, driver’s license number, financial institution account number, credit or debit card number, or armed forces identification number of a person that is submitted to a public agency, except for such data recorded in mortgage or conveyance records, court records, or marriage records. The bill also exempts personal healthcare data reported to the state by a healthcare provider when required to do so without the patient’s consent. The bill requires a records custodian to inform the public their communications with the agency may become public record.

Action Plan:  Update custodian of records notice on website.  Update written and electronic communications platforms to provide public notice.

Resolutions

HR 254 Jordan Requests the Dept. of Insurance to study and make recommendations regarding the regulation of pharmacy services administrative organizations. 06-05-2019 Passed; Sent to the Secretary of State.

Requests the insurance commissioner to submit his report and recommendations to the legislative committees on insurance no later than 02-01-2020. We monitored this item for potential inclusion of the Board; we were not included.

HR 257 Hoffmann Requests the Dept. of Health to study the benefits and costs of eliminating prior authorization requests for

Items in blue print sponsored by Board. Page 5 of 9 medication-assisted treatment for opioid use disorder. 06-05-2019 Passed; Sent to the Secretary of State.

Requests the Dept. of Health to make the changes necessary to eliminate prior authorization requirements in the Medicaid program for all formulations of buprenorphine/naloxone and naltrexone. We monitored this item for potential inclusion of the Board; we are not included.

Senate

Bills

SB 29 Cortez Commerce, Consumer Protection, & International Affairs Provides relative to professional and occupational licensing boards and commissions. 06-11-2019 Signed as Act 179; effective 08-01-2019.

This bill amends the professional licensing law to prohibit a professional licensing board from (1) including nondisparagement provisions in their consent agreements or (2) initiate disciplinary proceedings against a licensee for providing testimony or records to a legislative body. We monitored this item for any potential amendment specifically relative to pharmacy; there were none.

SB 36 Mills Health & Welfare Provides relative to emergency departments. 06-11-2019 Signed as Act 438; effective 08-01-2019.

This bill amends the hospital licensing law to prohibit freestanding emergency departments and requires all emergency departments to be part of a licensed hospital. The bill exempts any facilities with a construction permit issued prior to 04-01-2019. We monitored this item for its potential impact on a new class of a CDS license. Since hospital licenses already include multiple locations under a single license number, this will not require any change in license type configuration.

SB 41 Mills Health & Welfare Provides relative to regulation of pharmacy benefit managers. 06-06-2019 Signed as Act 124; effective 08-01-2019 and 07-01-2020.

This bill amends the insurance law and pharmacy law and creates a new section of law relative to the licensure and regulation of pharmacy benefit managers. The new law requires those PBMs operating in the state to obtain a registration from the Dept. of Insurance and allows those PBMs to obtain a permit from the Board of Pharmacy. The bill requires the insurance commissioner and the board to promulgate rules. The new PBM law establishes a monitoring advisory council which will assist the insurance commissioner and the board with investigations and compliance audits. The bill requires the insurance commissioner and board to discipline credentials it issues. The bill authorizes the attorney general to prosecute unfair trade practices. The bill requires the board to submit monthly reports to the attorney general containing a cumulative list of complaints submitted to the board.

Action Plan:  Update pharmacy law and insert new PBM law in Louisiana Pharmacy Law Book.  Notify licensees via Legislative Bulletin.  Update PPM.I.B.6 ~ Board Liaisons to Other Entities.  Identify board representative to PBM Monitoring Advisory Council.  Establish communication links with Dept. of Insurance and Dept. of Justice.  Collaborate with Dept. of Insurance for council administration.  Develop MOU or CEA to share council expenses with Dept. of Insurance.  Task the Regulation Revision Committee to develop regulatory proposal for Board approval and subsequent promulgation.  Develop application form based on rule requirements.  Configure new license type in eLicense based on rule requirements.

Items in blue print sponsored by Board. Page 6 of 9 SB 53 Johns Health & Welfare Provides relative to prescription monitoring information. 06-04-2019 Signed as Act 80; effective 08-01-2019.

The Board approved this Legislative Proposal 2019-C; it amends the PMP law to allow the sharing of PMP information with federal jurisdictions.

Action Plan:  Update PMP law in Louisiana Pharmacy Law Book.  Task the Regulation Revision Committee to develop a regulatory proposal for Board approval and subsequent promulgation.  Implement file-sharing permissions in PMP administrative dashboard.

SB 57 Walsworth Senate & Governmental Affairs Provides for certain records management services. 06-01-2019 Signed as Act 46; effective 08-01-2019.

This bill amends the public records law, and more particularly the law for the state archives division within the Dept. of State. The new law removed the preference for microfilming for record preservation by state agencies and establishes that agency as the central document conversion office for the state. We monitored this item in preparation for our own record conversion project.

SB 66 Riser Senate & Governmental Affairs Provides relative to open meetings of public bodies. 06-11-2019 Signed as Act 340; effective 08-01-2019.

This bill amends the open meetings law and more specifically the enforcement thereof. The bill increased the amount of the fine for any member of a public body who participates in a meeting held in violation of that law, from $100 to $500. We monitored this item due to its potential impact on board operations.

SB 99 Boudreaux Health & Welfare Provides relative to board member qualifications. 06-01-2019 Signed as Act 52; effective 08-01-2019.

This bill amends the pharmacy practice act, more specifically the qualifications for board members, to lower the amount of time required for licensed practice in Louisiana, from 5 years to 2 years. We monitored this item for any potential amendments; there were none.

Action Plan:  Update the pharmacy law in the Louisiana Pharmacy Law Book.

SB 119 Colomb Health & Welfare Creates the Palliative Care Interdisciplinary Council. 06-11-2019 Signed as Act 351; effective 08-01-2019.

This bill created the Palliative Care Interdisciplinary Advisory Council within the Dept. of Health, for the purpose of assessing the availability of patient-centered and family-focused palliative care in the state and making recommendations to the secretary and the legislature. One of the 17 members shall be a pharmacist appointed by the Board of Pharmacy, who shall have at least two years of experience in providing individual or interdisciplinary palliative care to pediatric, youth, or adult populations in inpatient, outpatient, or community settings. Unless reauthorized by the legislature, the council shall cease to exist on 03-31-2022. We monitored this item for any potential amendment relative to pharmacy; there were none.

Action Plan:  Update PPM.I.B.6 ~ Board Liaisons to Other Entities.  Identify board liaison to Dept. of Health.

Items in blue print sponsored by Board. Page 7 of 9 SB 166 Lafleur Health & Welfare Provides relative to physician assistants. 06-11-2019 Signed as Act 276; effective 08-01-2019.

This bill amended the medical practice act to change the eligibility requirement for a physician assistant to apply for prescriptive authority, from an active and unrestricted license to a current license. We monitored this item for any potential amendments relative to the scope of their prescriptive authority; there were none.

SB 169 Barrow Health & Welfare Provides relative to the state immunization registry. 06-11-2019 Signed as Act 192; effective 06-11-2019.

This bill amends the public health law relative to the state immunization registry. The bill changes the reference to children in favor of clients, which allows the receipt of information about adults. We monitored this item for any potential amendment relative to pharmacies or pharmacists; there were none.

SB 239 Mills Health & Welfare Provides relative to the Medicaid prescription drug benefit plan. 06-11-2019 Signed as Act 263; effective 08-01-2019.

This bill amends the Medicaid law to require the Dept. of Health to establish a single preferred drug list which shall include all drug classes subject to a prior authorization requirement. The bill creates a new section of law which allows the department to remove the Medicaid pharmacy services from managed care and administer the program directly, and further, if the department uses a managed care firm to administer the benefit, then the firm shall be paid a transaction fee only, with no other gains to be retained by the firm. We monitored this item for any potential amendment to pharmacy law or board operations; there were none.

SB 240 Boudreaux Health & Welfare Provides relative to the provision of medication-assisted treatment (MAT). 06-20-2019 Signed as Act 414; effective 08-01-2019.

This bill amends the medical practice relative to physician assistants and the nursing practice act relative to advanced practice registered nurses, to authorize both types of practitioners to provide medication- assisted treatment (MAT) for opioid dependence in accordance with federal government rules for that activity from the Substance Abuse and Mental Health Services Administration (SAMHSA). We monitored this item for any potential amendment relative to prescriptive authority privileges or other pharmacy- related amendments; there were none.

SB 241 Riser Commerce, Consumer Protection, & International Affairs Provides for the Small Business Protection Act. 06-11-2019 Signed as Act 204; effective 02-01-2020.

This bill amends the administrative procedure act to enact the Small Business Protection Act as a successor to the Regulatory Flexibility Act. The bill establishes an office within the Secretary of State’s Commercial Division to administer this new law. The bill revises the adoption of rules by agencies by including that new office in the list of entities to receive all notices and reports. The bill requires the addition of a small business impact statement to the list of other impact statements as part of the proposed notice of intent package.

Action Plan:  Update rulemaking procedures and templates.

Resolutions

SR 255 Barrow To request the La. Dept. of Health, La. State Board of Medical Examiners, and La. Board of Pharmacy to

Items in blue print sponsored by Board. Page 8 of 9 study and make recommendations relative to certain provisions of Louisiana law on medical marijuana. 06-06-2019 Passed; Sent to the Secretary of State.

Requests the identified agencies to consider whether pediatric consultations should be required for all pediatric patients receiving recommendations for medical marijuana, not just for autism as presently required. Requests the agencies to consider whether facilities housing physicians recommending medical marijuana should be licensed as such by the Dept. of Health, similar to pain management clinics. Report and recommendations due to the Senate no later than 02-01-2020.

Concurrent Resolutions

SCR 31 Barrow Health & Welfare Designates a lead agency over the Interagency Heroin and Opioid Coordination Plan. 06-04-2019 Passed; Sent to the Secretary of State.

Act 88 of the 2017 Legislature established the Advisory Council on Heroin and Opioid Prevention and Education (AC-HOPE), housed within the Drug Policy Board in the Office of the Governor. That law requires the AC-HOPE to develop and Interagency Heroin and Opioid Coordination Plan; although the law requires the Dept. of Health to staff the council, the law did not identify a lead agency. During the council’s survey of agencies and organizations with opioid-relative initiatives, some organizations were slow to respond with data. The absence of a lead agency with authority to demand data production was identified as a challenge. This resolution seeks to resolve that issue by designating the Dept. of Health as the lead agency for the state plan to address the opioid crisis.

SCR 78 Boudreaux Health & Welfare Requests the Louisiana State Board of Nursing and the Louisiana State Board of Medical Examiners to report on the number of advanced practice registered nurses and the number of physician assistants that provide medication-assisted treatment (MAT) in Louisiana. 06-04-2019 Passed; Sent to the Secretary of State.

Requests both boards to submit reports beginning 02-01-2020 and annually thereafter.

Items in blue print sponsored by Board. Page 9 of 9 Louisiana Board of Pharmacy Action Plans to Implement Legislation Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Operations Completion HB 138 2019-354 Revised definitions; new drugs in Schedule I 40:961 and 964 8/1/2019 8/1/2019 HB 243 2019-423 Reporting of opioid-related overdoses 40:978.2.1 8/1/2019 8/1/2019 HB 284 2019-426 Prescriber overrides of 7-day supply 40:978(G)(2) 8/1/2019 8/1/2019 HB 358 2019-284 Cannabis metered-dose inhalers 40:1046(A)(1) 8/1/2019 Reg. Proposal 2019-E in Cmte HB 375 2019-219 CBC for CDS license applicants 40:973.1 8/1/2019 Assigned to Cmte HB 423 2019-227 Repeal of student loan disqualifications 37:2951 repealed 8/1/2019 8/1/2019 HB 433 2019-161 Pharmacist may decline to fill prescription 37:1219(D through F) 8/1/2019 Assigned to Cmte HB 452 2019-231 Scheduling of mitragynine 40:964 and 40:989.3 8/1/2019 8/1/2019 HB 491 2019-164 Hemp-derived CBD oil products 40:961.1 8/1/2019 Pending HB 507 2019-331 7% tax on gross sales of marijuana products 40:1046(H)(8)(a) 8/1/2019 8/1/2019 HB 614 2019-256 Public notice for public records 44:33.1(B) 8/1/2019 SB 41 2019-124 Licensure and regulation of PBMs 37:1252 et seq; 40:2861 et seq 8/1/2019 Reg. Proposal 2019-G in Cmte SB 53 2019-080 Access to PMP by federal jurisdictions 40:1007(G) 8/1/2019 Reg. Proposal 2019-F in Cmte SB 99 2019-052 Board member qualifications 37:1174(A)(4) 8/1/2019 Assigned to Cmte SB 119 2019-351 Palliative Care Advisory Council 40:2018.6 Pending SB 241 2019-204 Revision of APA re small business impact 49:953 et seq Review Louisiana Board of Pharmacy Action Plans to Implement Legislation Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Operations Completion HB 45 2018-186 CDS license for 3rd party logistics providers 40:961(42); 972(B)(7); 973(A)(1) 8/1/2018 Reg Project 2019-13 in process HB 150 2018-063 Military spouse renewal fee waiver 37:1208.1 8/1/2018 No rule required PST-MS #12-MS 11/1/2018 HB 151 2018-064 Definition of 'approved school of pharmacy' 37:1164(2) 8/1/2018 No rule required 11/1/2018 HB 153 2018-119 New substances to Schedules I and II 40:964 8/1/2018 8/1/2018 HB 165 2018-677 Penalties for CS violations 40:966; 967 8/1/2018 8/1/2018 HB 186 2018-199 Penalties for CS violations 40:979 8/1/2018 8/1/2018 HB 188 2018-200 Acceptance of gifts by public servants 42:1115.2 anticipated HB 189 2018-454 Rulemaking procedures 49:953(C) 8/1/2018 Reg Project 2019-14 in process HB 224 2018-203 Penalties for legend drug violations 40:1060(13); (15) 8/1/2018 8/1/2018 HB 326 2018-206 Technical corrections to practice acts 37:1164; 1182; 1226.1; 1226.2 8/1/2018 8/1/2018 HB 372 2018-623 Occupational licensing review commission 37:41-47 1/31/2019 1/31/2019 HB 579 2018-708 New indications for therapeutic marijuana 40:1046 8/1/2018 8/1/2018 HB 627 2018-496 New indications for therapeutic marijuana 40:1046 8/1/2018 8/1/2018 HB 748 2018-693 Occupational licensing review by Gov office 49:903 3/14/2019 HB 823 2018-715 Delay termination date of marijuana program 40:1046(J) 8/1/2018 8/1/2018 HCR 70 Review of military licensing procedures anticipated SB 27 2018-644 Nominations to Medicaid P&T Cmte 46:153.3(D) 8/15/2018 8/15/2018 SB 28 2018-219 Exemptions for veterinarians 37:1251(D); 40:978(F)(3); 978.3(E) 8/1/2018 8/1/2018 SB 29 2018-423 Uniform prior authorization form 22:1006.1; 1651(J); 46:460.33 1/20/2018 §1129 & 1130 1/1/2019 SB 40 2018-515 Consumer members to licensing boards 37:1172(A); 1174(B) 8/1/2018 8/1/2018 SB 75 2018-405 Prescriber licensing boards re PMP access 40:978(F)(2) 8/1/2018 8/1/2018 SB 90 2018-028 Voluntary nonopioid directive form 40:1156.1 8/1/2018 LDH 11/1/2018 SB 109 2018-232 Epidemiologist access to PMP 40:1007(E)(8) 8/1/2018 Reg Project 2019-6 in process SB 110 2018-146 PMP definition of 'drugs of concern' 40:1003(10) 8/1/2018 §2901 1/20/2019 SB 131 2018-031 Pharmacist licensure by reciprocity 37:1202; 1203 8/1/2018 No rule required 11/1/2018 SB 134 2018-032 Partial fills for all Schedule II drugs 40:978(A) 8/1/2018 Reg Project 2019-12 in process SB 241 2018-317 Pharmacist communication with patients 22:1657; 37:1219 8/1/2018 No rule required 11/1/2018 SB 260 2018-655 Complaints re board actions or procedures 37:23.1; 23.2 11/1/2018 11/1/2018 SB 391 2018-669 Internet filters in state agency offices 8/1/2018 8/1/2018 SB 477 2018-602 Chart orders for institutional patients 37:1164(59); 1226.4 8/1/2018 Reg Project 2019-17 in process SCR 83 Military licensing info on website 10/1/2018

From: Kevin LaGrange Sent: Monday, June 10, 2019 1:08 PM To: [email protected]; [email protected]; [email protected] Cc: Eric Vidrine ; [email protected] Subject: CBD Sales

Malcolm,

I am starting to see news articles stating the sale of CBD is now legal in Louisiana https://www.theadvocate.com/baton_rouge/news/business/article_628604b4-893a-11e9-9136- 3359dc3bd924.html and retailers will need to register with Alcohol and Tabaco Control (ATC). With the current marijuana rules and regulations written by the Board of Pharmacy, 2551.N “No marijuana pharmacy shall sell anything other than marijuana products; however, the pharmacy may elect to sell over-the-counter (OTC) medications, durable medical equipment (DME), and other retail products from the same premises but outside the prescription department”, will the Board allow Therapeutic Marijuana Pharmacies like The Apothecary Shoppe to sell CBD products within our facility since they specifically won’t be produced by LSU or Southern? If we can, will we be required to register with ATC or will there be some other method/process since we currently had the ability to do so if the products were produced by LSU or Southern?

La the 70804; about Rouge.

in of

Baton

as all .c&VJkeis.ln.i’oi

Rouge. and

aconiplaim of

Dr..

their a that

Baton

the

has

LMMTS

serve report

product

system

The

reporting

obligations

Board

using

marijuana

report

will

not the 44486; Breniwood

115.342.9845;

dispensing

LMMTS.

state,

which

inventory

information

for of

dispensing

information

in acknowledging

Box

access

dispensary

production The opponunitelofile 3388

70804,-

shall

one of

which the

their

the the

LA producer.

transactions

level

rules

registration

program

shall product

systems.

system, they

subsequent

required pharmacies’

Phannacr; perpetual Rouge,

but

dispensing their

the

number

purpose

are

the

pharmacy.

patient

consider product

applicants

transactions Board’s

Baton inventory

Board

“seed-to-sale”

extends

the and

and

no the

oJ’Reprcsentatives;

monitoring not

LMMTS.

report

pharmacies

The

the information

94)83:

for

satisfy

information

dispensaries.

stakeholders

maintain producer House inventory-related Box Louisiana

licensees

does

shall

the

pharmacy’s can all

La.

marijuana

jarmacp models, its

U) there

pharmacies

PMP.

identification

and

a to

70809-1700

info(dpharmacv.l&gov

producers

Drive

impacts

the

LMMTS

multiple

marijuana

product

enter Board

disposed prescription

Affairs;

(LMMTS) in Senate;

notice

since

dispensing

the

reportable

inventory-related

system from

following: LMMTS

La.

scope

the the

and

product

that

E-mail:

and all

gives the

from

state

establish

marijuana

own a

—

pharmacies Louisiana

distribution

from

Louisiana

dispensary.

The

obviously

Brentwood

to System

Affairs;

46:LIIl.2457.D.4.b

number

access from

Board

the

Further, such

Governmental data

the

enter

tracking

Woarb their

the the &

LMMTS whether

system,

purchased

3388

LAC

transaction

include

rule

the have

Rouge,

by ut-c, MEMORANDUM one

the

IIB

(NDC)

and dispensed, of

to product

House

from

its

required

Louisiana,

purchases

will

Tracking Louisiana’s

Governmet,tal

dispensary

a products.

manage

225.925.6496 LMMTS.

Legislat

in &

purchases

Baton

of are

Product

held,

PMP

Code to

access

back

products

with and

complaints

information collected

Senate

LMMTS transactions

Providers

their

pharmacies

transactions

Parties product

Pharmacy LMMTS

Louisiana whether

shall to

such

Drug

2019

of Broussard

(2)Committee

Marijuana

interpreted of

the Iouitana

Practice

marijuana

products pharmacies

Requirements

states

Telephone Interpretation

of sales

va’ inventory-related

MarU’uana 13,

from

capture

those acquired,

suhtnit

Louisiana

number dispensing

Service

has marijuana

pharmacies arisen

via.

transactions receipt

may

transactions dispensing Maruuana

t’3,iCommittecon

receipt

the

such

National

Medical pharmacy

Interested Board

Malcolm June

20)8-655

dispensing

medical has

You

multiple to

require Board

Act marijuana phurn,ac

Limited

marijuana to

transactions

the in The

system.

products sales

Standards medical

Inventory

such While

with

all information

for infi%i 24. keftlatrv

Recordkeeping

reports

designed

Marijuana

The

of registration

4. used

procedures.

46:Llll.2457.D.4.b] dispensing

question

Louisiana

pharmacy’s medical

or §2457.

h&ea

acknowledge

report proxy Subchapter

compliance

transactions

their

product to Chapter receipt

marUuana requires

system. for

[LAC a

transaction

to pharmacies the

Re: been acknowledging dispensing

Date:

system patient

From: consumer

The

system distribution

To: The In actions 225.925.6396; 70809,- Boards 225.342.2403; NOTICE: From: Crystal Carter To: Joe Fontenot; Malcolm J. Broussard Subject: Request for Rule Clarification Date: Thursday, June 06, 2019 5:13:59 PM

Good afternoon! I had a question from a member that I wanted to get further clarification about before responding.

In the January newsletter, there was a reminder about reporting changes in mailing address and pharmacy employment. The question was asked about the section on the Form 090 relative to “Additional Site of Employment.” If a chain pharmacist is working at multiple locations, are they are required to report each location as an additional site? And if so, does that apply to a situation where they are only working one shift for a special circumstance?

I have not had this kind of question before, so I just wanted to reach out directly for that clarification.

I appreciate your time.

Crystal

Crystal Carter, MPA | Client Strategist Louisiana Pharmacists Association [email protected] | [email protected] (225) 346-6883 | (225) 344-1132 (fax) 620 Florida St., Suite 210 | Baton Rouge, LA 70801 www.louisianapharmacists.com

Upcoming Events July 18-20, 2019 – Annual Convention & Trade Show – L’Auberge Casino Lake Charles December 8, 2019 – CE Caravan – Northshore

LPA Mission: As members of LPA, we have the power to improve lives and improve the healthcare landscape.

______This email has been scanned by the Symantec Email Security.cloud service. For more information please visit http://www.symanteccloud.com ______

Louisiana Revised Statutes of 1950

Title 37 – Professions and Occupations

Chapter 14 – Pharmacy Practice Act

§1213. Notification of change of business place or employment A pharmacist, pharmacy technician, pharmacy intern, or pharmacy technician candidate shall notify the board, in writing, of any change of employment within a time frame determined by the board by rule. (Amended by Act 357 of 2012 Legislature, effective August 1, 2012)

* * *

Louisiana Administrative Code

Title 46 – Professional and Occupational Standards

Part LIII – Pharmacists

§511. Employment Change A. A licensed pharmacist shall notify the board within ten days, with documentation, attesting to any change in employment. This documented notice shall include the pharmacist’s full name and license number, the name and address of old and new employment, and the permit numbers of those pharmacies involved.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2084 (October 2003), effective January 1, 2004.

* * *

§703. Registration A. – A.3. … 4. A pharmacy intern shall notify the board in writing within 10 days of a change in location(s) of employment. This notice shall include the pharmacy intern’s name and registration number, the name and address of old and new employment, and the permit numbers of those pharmacies involved. A.5. – A.5.b. …

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1211. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 26:2285 (October 2000), amended LR 29:2086 (October 2003), effective January 1, 2004, amended by the Department of Health, Board of Pharmacy, LR 43:2163 (November 2017), effective January 1, 2018.

* * *

§903. Pharmacy Technician Candidates A. – A.3.e. … f. A pharmacy technician candidate shall notify the board, in writing, no later than 10 days following a change in location(s) of employment. The written notice shall include the candidate’s name, registration number, and name, address, and permit numbers for old and new employers. B. – D.2.b. …

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1212. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 30:2485 (November 2004), effective January 1, 2005, amended LR 39:1777 (July 2013), amended by the Department of Health, Board of Pharmacy, LR 43:2496 (December 2017), effective January 1, 2018, repromulgated LR 44:49 (January 2018).

* * *

§905. Pharmacy Technician Certificate A. – B.4. … 5. A pharmacy technician shall notify the board, in writing, no later than 10 days following a change in location(s) of employment. The written notice shall include the technician’s name, certificate number, and name, address, and permit numbers for old and new employers. 6. …

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1212. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 30:2486 (November 2004), effective January 1, 2005, amended LR 38:1235 (May 2012), LR 39:1777 (July 2013), amended by the Department of Health, Board of Pharmacy, LR 43:2497 (December 2017), effective January 1, 2018.

TRANSITIONAL DUTY EMPLOYMENT AUDIT FORM – DA WC4000

The purpose of this form is to record an agency’s Transitional Duty activity for the current month only.

Month of Report______Location code______

Agency______Contact Person______

The agency has developed and implemented a Transitional Duty Employment plan: ______Yes ______No

Transitional Duty Employment is monitored at the department level: ______Yes ______No

REPORT THE FOLLOWING ACTIVITY:

1. Number of lost time workers’ compensation claims during the past month: ______. * 2. Number of employees returned to work on transitional duty: ______. 3. Number of employees returned to work full duty: ______. 4. Number of employees on workers’ compensation at month’s end: ______. 5. Number of employees who are separated from the agency and still receiving workers’ compensation: _____. 6. The RTW committee has met and reviewed all W/C claims eligible for Transitional Duty Employment: ____ yes ____ no.

*NOTE: Lost time refers to whole days an employee has missed from work due to a work-related accident for which indemnity benefits would be paid.

Please keep completed forms on file at the location or department level that is responsible for Transitional Duty Employment.

THIS FORM IS FOR INTERNAL USE ONLY.

FORM DA WC4000 REVISED 07.2019

1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Sale of CBD Oil (Guidance Statement) Policy No. I.A.26 4 5 Approved: 11-14-2018 Revised: 02-19-2019 6 7 8 Preamble 9 • During their November 14, 2018 meeting, the Board approved the original Guidance Document re 10 Cannabidiol (CBD) Oil for the benefit of its licensees, particularly those holding state controlled 11 substance (CDS) licenses and federal registrations from the U.S. Drug Enforcement 12 Administration (DEA). On December 20, 2018, the Agriculture Improvement Act of 2018, more 13 commonly known as the 2018 Farm Bill, became effective. The 2018 Farm Bill created federal 14 recognition for hemp as an agricultural commodity and authorized its use in compliance with the 15 provisions of that law. That law also amended the federal controlled substances law to exempt 16 the tetrahydrocannabinol (THC) found in hemp from the listing of THC in Schedule I of the federal 17 list of controlled substances. 18 • During their February 19, 2019 meeting, the Board took note of the recent federal legislation. 19 They also took note that the Louisiana Legislature has not yet adopted state law to recognize 20 hemp, nor has the state legislature created an exemption for the THC found in hemp from the 21 THC which appears in Schedule I of the state list of controlled substances. Further, there is no 22 differentiation in the source of CBD. In the interim, state law is more stringent than federal law. 23 The Board members voted to revise their original guidance document by removing the references 24 to the federal law but left intact the references to the state law. Finally, their ultimate guidance 25 remains the same: the sale of CBD oil by its licensees would constitute a violation of the state 26 controlled substance law and place them at risk for criminal and/or administrative sanctions. The 27 text of the revised guidance document follows. 28 • During their August 14, 2019 meeting, the Board took note of Act 164 of the 2019 Legislature, 29 which established a statewide industrial hemp program. The definition of hemp mirrors the 30 federal definition of hemp in that it excludes up to 0.3% THC found in hemp from the provisions of 31 the controlled substance law. The act also established a regulatory structure for the retail sale of 32 hemp-derived cannabidiol CBD products. 33 34 35 1. The Board continues to receive questions about cannabidiol (CBD) oil, derived 36 from hemp or derived from marijuana. Act 261 of the 2015 Legislature, which 37 established the state medical marijuana program, made no exception for 38 possession or sale of CBD oil. Louisiana’s controlled substance law includes 39 CBD oil in the definition of marijuana. 40 41 2. All marijuana products shall comply with the rules adopted for the state medical 42 marijuana program; they must have a known source as well as known quantities 43 of active ingredients. Further, they may only be dispensed by marijuana 44 pharmacies licensed by the Board of Pharmacy. 45 46 3. Since marijuana is listed in Schedule I of the state’s list of controlled substances, 47 no one, includingDRAFT board licensees, may possess or sell CBD oil. Violations of the 48 Louisiana Revised Statutes or Louisiana Administrative Code can subject a 49 person to criminal or administrative action. 50 51 For its licensees intending to participate in the retail sale of hemp-derived cannabidiol 52 products, the Board encourages compliance with all applicable federal and state laws 53 and rules. 54 Frequently Asked Questions re CBD Oil 55 56 1. Is CBD (cannabidiol) oil legal under Louisiana law? 57 No. The Louisiana Controlled Dangerous Substances Law defines 58 marijuana as: 59 “all parts of plants of the genus Cannabis, whether growing or not; 60 the seeds thereof; the resin extracted from any part of such plant; 61 and every compound, manufacture, salt, derivative, mixture, or 62 preparation of such plant, its seeds or resin, but shall not include 63 the mature stalks of such plant, fiber produced from such stalks, oil, 64 or cake made from the seeds of such plant, any other compound, 65 manufacture, salt, derivative, mixture, or preparation of such 66 mature stalks (except the resin extracted therefrom), fiber, oil, or 67 cake, or the sterilized seed of such plant which is incapable of 68 germination, or cannabidiol when contained in a drug product 69 approved by the United States Food and Drug Administration.” 70 CBD is a compound of marijuana and therefore is considered marijuana 71 under Louisiana law. Marijuana is listed in Schedule I of the state 72 controlled substance list. There is no lawful possession of a substance 73 listed in Schedule I, except for the marijuana products authorized in the 74 state medical marijuana program. [La. R.S. 40:961(26)] 75 76 2. Is CBD extracted from hemp legal under Louisiana law? 77 No. Louisiana law does not make a distinction between CBD extracted 78 from hemp and CBD extracted from marijuana. CBD is a compound of 79 marijuana and therefore is considered marijuana under Louisiana law. 80 81 3. Does the State of Louisiana have a hemp program? 82 At this time, the State of Louisiana does not have a hemp program. 83 84 4. Can I or my business sell CBD oil products? 85 No. CBD oil, whether derived from hemp or marijuana, is listed in 86 Schedule I of the state’s list of controlled substances. There is no lawful 87 possession of a substance listed in Schedule I, except for the marijuana 88 products authorized in the state medical marijuana program. 89 90 5. What are the consequences for selling CBD oil? 91 Violations of the Louisiana Revised Statutes or Louisiana Administrative 92 Code can subject a person to criminal or administrative action. 93 94 6. How does the Board of Pharmacy intend to enforce this guidance statement? 95 The Board’s efforts at this time are educational. In the event licensees 96 continueDRAFT to sell CBD oil despite having accurate guidance information, the 97 Board may reassess its compliance methodology. 98 99 7. How is a DEA licensee allowed to dispense Marinol and Epidiolex? 100 Marinol and Epidiolex have been approved by the federal Food & Drug 101 Administration (FDA) as prescription drug products, and further, have 102 been scheduled by the DEA in other controlled substance schedules used 103 for prescription drug products [Schedule II for the Marinol product in 104 aqueous formulation, Schedule III for the Marinol product in oil 105 formulation, and Schedule V for the Epidiolex product]. 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 DRAFT 146 147 148 149 150 151 152 Revision History 153 154 08-14-2019 Updated preamble, removed three numbered items relative to state 155 law, added single sentence encouraging compliance with 156 applicable laws and rules, and removed FAQ section. 157 158 02-19-2019 Removed references to federal law, consistent with provisions of 159 newly-enacted federal Agriculture Improvement Act of 2018. 160

DRAFT 1 Louisiana Board of Pharmacy Policies & Procedures 2 3 Title: Board Liaisons to Other Entities Policy No. I.B.6 4 5 Approved: 08-15-2018 Revised: 6 7 8 1. The membership of the Drug Policy Board, an agency within the Office of the 9 Governor, is identified at La. R.S. 49:219.2. Within that listing is “a member of 10 the Board of Pharmacy.” That law specifies the member from the Board of 11 Pharmacy serves at the pleasure of the appointing governor and at the expense 12 of the Board of Pharmacy. The President of the Board of Pharmacy shall 13 nominate a member of the Board of Pharmacy to serve as a member of the Drug 14 Policy Board. 15 16 2. The membership of the Prescription Monitoring Program Advisory Council is 17 identified at La. R.S. 40:1005(A). Within that listing is “the President of the 18 Board of Pharmacy or his designee.” That law specifies the member from the 19 Board of Pharmacy serves at the pleasure of the Board and at the expense of 20 the Board of Pharmacy. In the event the President is unable to attend a council 21 meeting, he shall appoint a designee. 22 23 3. The membership of the Medicaid Pharmaceutical and Therapeutics Committee 24 is identified at La. R.S. 46:153.3(D)(2)(a). Within that listing is “two practicing 25 pharmacists nominated by the Louisiana Board of Pharmacy.#2 One pharmacist 26 shall be an independent pharmacist and one pharmacist shall be a pharmacist 27 representing a chain pharmacy.” The law requires the Board of Pharmacy to 28 nominate two pharmacists to the Office of the Governor, and shall certify by 29 affidavit that the practice of each nominee involves either the care of or the 30 supervision of the care of Medicaid recipients. The law requires the 31 gubernatorial appointments be confirmed by the Louisiana Senate. The law 32 further stipulates that a member who misses two consecutive meetings may be 33 replaced. The replacement process requires the Dept. of Health to notify the 34 Board upon the second recorded absence, and if the Board does not nominate a 35 replacement within 30 days, the department may do so. The President of the 36 Board of Pharmacy shall nominate two pharmacists no later than August 1, 37 2018. 38 39 4. The membership of the Collaborative Drug Therapy Management Advisory 40 Committee, constituted as provided in LAC 46:XLV.7417, shall assist the Board 41 of Medical Examiners and the Board of Pharmacy on matters relative to 42 collaborative drug therapy management. The President of the Board shall appoint a pharmacistDraft to serve on the committee, and said pharmacist shall serve 43 44 at the pleasure of the Board of Pharmacy and without compensation. 45 46 5. The membership of the Pharmacy Benefit Manager Monitoring Advisory Council 47 is specified at La. R.S. 40:2869 and includes the president of the Board of 48 Pharmacy, who may appoint a designee. The president or his appointee serves 49 at the pleasure of the Board of Pharmacy, and is eligible for per diem and travel 50 expense reimbursements in accordance with Board travel policies 51 52 6. The membership of the Palliative Care Interdisciplinary Advisory Council is 53 identified at La. R.S. 40:2018.6(C). The 17-member council includes one 54 member appointed by the Board of Pharmacy, who shall be a pharmacist with at 55 least two years experience providing individual or interdisciplinary palliative care 56 to pediatric, youth, or adult populations in inpatient, outpatient, or community 57 settings. Members serve at the pleasure of the appointing authority and without 58 compensation. Members missing three consecutive meetings shall be replaced 59 by the appointing authority. The council shall meet at least quarterly. Unless 60 extended by the legislature, the council shall expire on March 31, 2022. 61 62 63 64 65 66 67 68 69 70 71 72 73 74 #2 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 Draft 93 94 95 96 97 98 99 Revision History 100 101 08-14-2019 Added Items 4, 5 and 6. 102 103

Draft 7/17/2019 Online Directory

Technician Program Information

Penn Foster College

https://www.pennfoster.edu/programs-and-degrees/medical-and-health-careers/pharmacy-technician-professional-career- diploma

14300 N. Northsight Blvd, Suite 125 Code: AZ-11 Scottsdale AZ 85260

Accreditation Status: Candidate Category: Technical Training Sub-Category:

Program Director Reporting Administrator Karen Davis CPhT, BHS. Lisa Rutsky (912) 547-1454 (570) 961-4133

Email: [email protected] Email: [email protected]

Program Contact

RELATED ASHP SITES PARTNER WITH ASHP CONTACT CONNECT WITH ASHP

AJHP Online Corporate Support Policy Email ASHP    AHFS Drug Information Business Opportunities 4500 East-West Highway, Suite 900 Bethesda, MD 20814 ASHP eLearning Advertising   1-866-279-0681 My eBooks Library ASHP Foundation

ASHP Advantage SafeMedication.com

ASHP Connect

RELATED ASHP SITES  PARTNER WITH ASHP  CONTACT Email ASHP 4500 East-West Highway, Suite 900 Bethesda, MD 20814 1-866-279-0681 CONNECT WITH ASHP     

https://accreditation.ashp.org/directory/#/program/technician/programInfo/AZ-11 1/1 7/17/2019 Online Directory

Technician Program Information

Medical Education and Training Campus

3018 William Hardee Road, Bldg 895 Code: TX-33

Joint Base San Antonio TX 78234

Accreditation Status: Accredited Category: Technical Training Sub-Category:

Program Director Reporting Administrator Justin Lusk Christine Edwards LTC, USA, RDN (210) 808-2200 (210) 808-1365 Email: [email protected] Email: [email protected]

Program Contact

Certicate Faculty or Sta

Didactic course work: 344/430 Pharmacists: 4

Laboratory course work: 134/196 Technicians: 29

Experiential Training: 120/240 Lab/clerical support: 2

Lecture class size: 20 students/Instructor

Laboratory class size: 6 students/Instructor

Spaces per entering class: 80

Enrollment Experimental Training Sites

Interview required: No Community pharmacy: 2

Flexible scheduling allowed: No Hospital: 2

Class Scheduling: Full-Time Home health care: 2

Managed care: 2

Technician Training Demographics

Special Program Features: This is a military /federal only program designed to prepare students for service in military/federal pharmacies in the U.S. and overseas. The program has an advanced phase focused on preparing students for independent duty in operational settings within the military. 40-computer-based-training modules were developed in partnership with the Dept. of Veteran's Aairs, and are utilized as blended learning throughout

the curriculum. Training facilities were completed in 2010, incorporating state of the art classrooms and laboratories. The faculty is comprsed of pharmacists and technicians respresenting all military services. https://accreditation.ashp.org/directory/#/program/technician/programInfo/TX-33 1/2 7/17/2019 Online Directory

Acceptance Requirements: Basic military training and various other requirements based on service aliation.

General Location Training Sites: Wilford Hall Medical

Center, Lackland Air Force Base, TXBrooke Army Medical Center, Ft Sam Houston, TX

Special Requirements : Special Requirements of Training

Site: Students must have successfully completed all Didactic and Laboratory training.

Academic Degree: Certicate of Completion

RELATED ASHP SITES PARTNER WITH ASHP CONTACT CONNECT WITH ASHP

ASHP Advantage SafeMedication.com

ASHP Connect

RELATED ASHP SITES  PARTNER WITH ASHP  CONTACT Email ASHP 4500 East-West Highway, Suite 900 Bethesda, MD 20814 1-866-279-0681 CONNECT WITH ASHP     

https://accreditation.ashp.org/directory/#/program/technician/programInfo/TX-33 2/2 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Report of Assistant Executive Director

PRESCRIPTION MONITORING PROGRAM (PMP)

BOARD MEETING – AUGUST 14, 2019

1 NUMBER OF ELIGIBLE PRESCRIPTION TRANSACTIONS REPORTED TO THE PMP

Total Reported: 134,277,579 (01/01/2008 through 06/30/2019)

14,000,000

12,000,000

10,000,000

8,000,000

6,000,000

4,000,000

2,000,000

0 2,010 2,011 2,012 2,013 2,014 2,015 2,016 2,017 2,018 2,019 RXs 12,124,061 12,584,423 12,989,950 13,032,083 13,020,364 12,350,630 12,288,867 11,967,723 11,307,326 5,437,382

2 Opioid Prescriptions* Dispensed to Louisiana Residents (*Prescription counts based on the following AHFS Drug Classes: Opiate Agonist and Antitussives without DM products. Opiate Partial Agonist not included)

5,400,000 5,222,241 5,161,521 5,200,000

5,000,000 4,887,502

4,800,000

4,600,000

4,356,741 4,400,000

Number Number of Prescriptions 4,200,000

4,000,000

3,800,000 2015 2016 2017 2018 Year 3 Hydrocodone/APAP Prescriptions Number of Louisiana Patients

840,000 818,815 809,635 820,000

800,000 768,670 780,000

760,000

740,000

720,000 692,700 700,000 Number Number of Patients 680,000

660,000

640,000

620,000 2015 2016 2017 2018 Year 4 Hydrocodone/APAP Prescriptions Number of Prescriptions to Louisiana Patients

2,500,000 2,354,587 2,293,196 2,135,085 1,904,777 2,000,000

1,500,000

1,000,000 Number Number of Prescriptions 500,000

0 2015 2016 2017 2018 Year 5 Hydrocodone/APAP Prescriptions Number of Doses to Louisiana Patients

160,000,000 141,759,576 135,260,928 140,000,000 122,159,828 120,000,000 104,952,537 100,000,000

80,000,000

60,000,000 Number Number of doses

40,000,000

20,000,000

0 2015 2016 2017 2018 Year 6 Stimulant Prescriptions* Dispensed to Louisiana Residents (*Prescription counts based on the following AHFS Drug Classes: Amphetamines, Amphetamine Derivatives, and Respiratory & CNS Stimulants)

2,200,000 2,175,389 2,133,921 2,150,000

2,100,000 2,069,725

2,050,000

2,000,000 1,968,049

1,950,000 Number Number of Prescriptions

1,900,000

1,850,000 2015 2016 2017 2018 Year

7 PMP User Stats for 2019Q2 (04/01/2019 - 06/30/2019)

Number of Providers Number of Providers Number of PMP Requests Number of PMP Requests Eligible with PMP Active by Providers by Providers for PMP Access Access Privileges through AWARxE™ through GATEWAY™ PMP Role Title - Healthcare Provider (as of 06/30/2019) (as of 06/30/2019) During 2019Q2 During 2019Q2 Physician (MD, DO) 13,149 8,767 401,705 2,023,067 Nurse Practitioner (APRN) 3,435 2,675 94,087 317,520 Dentist (DDS) 2,224 1,531 6,249 657 Physician Assistant (PA) 928 688 30,021 34,675 Optometrist (OD) 360 154 7 0 Podiatrist (DPM) 163 111 520 0 Medical Psychologist (MP) 91 83 5,469 0 Medical Intern/Resident 1,047 1,029 2,790 0 Prescriber's Delegate NA 2,368 204,522 NA Pharmacist (PST) 9,255 4,246 522,828 364,003 Pharmacist's Delegate NA 926 41,913 NA Totals 30,652 22,578 1,310,111 2,739,922 PMP User Stats for 2019Q1 (01/01/2019 - 03/31/2019) Number of Providers Number of Providers Number of PMP Requests Number of PMP Requests Eligible with PMP Active by Providers by Providers for PMP Access Access Privileges through AWARxE™ through GATEWAY™ PMP Role Title - Healthcare Provider (as of 03/31/2019) (as of 03/31/2019) During 2019Q1 During 2019Q1 Physician (MD, DO) 13,047 8,748 373,300 1,483,241 Nurse Practitioner (APRN) 3,322 2,575 88,031 60,903 Dentist (DDS) 2,226 1,525 5,479 22 Physician Assistant (PA) 895 668 27,013 7,354 Optometrist (OD) 359 155 15 0 Podiatrist (DPM) 163 112 348 0 Medical Psychologist (MP) 91 81 4,708 0 Medical Intern/Resident 1,157 1,017 2,763 288 Prescriber's Delegate NA 2,239 199,711 NA Pharmacist (PST) 8,894 4,189 504,328 349,849 Pharmacist's Delegate NA 854 38,361 NA 8 Totals 30,154 22,163 1,244,057 1,901,657 Provider Requests for Louisiana PMP Data Through Gateway – All States

9 LAW ENFORCEMENT REQUESTS

Total Number of Law Enforcement Requests Processed: 10,715 01/01/2009 through 6/30/2019

1,600 1,398 1,400 1,230 1,224 Requests 1,200 1,150 Processed 1,011 1,000 889 845 843 823 800 680 622 600 400 200 0 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 10 Requests for Full Exemption from PMP Reporting August 14, 2019

In accordance with LA.R.S:40.4.X-A.1006.C. The board may issue an exemption from the reporting requirement to a dispenser whose practice activities are inconsistent with the intent of the program. The board may rescind any previously issued exemption without the need for an informal or formal hearing.

Permit Permit Name Scope of Practice DEA City State Type

7533 NR AMOP Pharmacy Specialty Pharmacy Yes Warren MI

ARx Patient Solutions Overland 7923 NR Mail Order Pharmacy No KS Pharmacy Park Shavano 7928 NR BriovaRx Specialty Non Dispensing Pharmacy No TX Park Coastline Pharmacy, 7906 NR Mail Order Yes Jupiter FL LLC

5704 NR DaVita Rx Medication Therapy No Irving TX Management

7909 NR Dermrx Pharmacy Dermatology Yes Dallas TX

Factor One Source 7910 NR Specialty Pharmacy Yes Cumberland MD Pharmacy LLC Lake Worth 7873 NR Community Pharmacy Yes Lake Worth FL Pharmacy LHC Group 7460 IR Pharmaceutical Sterile Compounding Only No Lafayette LA Services II Home 7468 NR Nufactor Infusion/Specialty/Mail Yes Kernersville NC Order Home Infusion/Specialty 7934 NR PharmaScript, Inc. Yes Chicago IL Pharmacy Premier Specialty Hoffman 7925 NR Specialty Pharmacy Yes IL Infusion LLC Estates Quaker Community 7751 NR Specialty Pharmacy Yes Easton PA Pharmacy, LLC Solara Medical 7901 NR Specialty Pharmacy Yes Chula Vista CA Supplies, LLC Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Report of General Counsel

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Report of Executive Director

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

August 14, 2019

Agenda Item 11-L: Report of Executive Director

1. Meeting Activity 2. Reports 3. Examinations 4. Operations 5. State Activities 6. Regional & National Activities 7. International Activities

1. Meeting Activity In addition to Board and committee meetings, I have also participated in or attended the following meetings since the last Board meeting. June 3 Metrc Implementation Status Conference [via conference call] June 6 dotPharmacy Applicant Appeal Conference [via conference call] June 10 Pharmacy Site Visit June 11 Metrc Implementation Status Conference [via conference call] June 14 Louisiana Medical Marijuana Project Team June 18 Metrc Training Session June 21 Licensing Board Executive Officers July 17 dotPharmacy Executive Board [via webinar] August 6 La. Pharmacy Congress

2. Reports A. Internal Reports (posted in the Library) 1. Credentials Division a. Census Report b. Licensure Activity Report c. Pending Applications Report d. Exceptions Report 2. Compliance Division a. Census Report – Practitioner Recovery Program & Disciplinary Status b. Complaint Investigation Policy Monitor c. Annual Statistical Summary

B. External Reports Since the last Board meeting, we have filed the following reports on your behalf: 1. La. Office of the Governor – Boards & Commissions a. Annual Report 2. La. Office of the Governor – Drug Policy Board / HOPE Advisory Council a. Naloxone Dispensing Report 3. La. Div. of Administration – Office of the Commissioner a. Annual Report for Sexual Harassment Complaints [Act 2018-270] 4. La. Div. of Administration – Boards & Commissions a. Annual LaTrac Report of Board Activity [Act 2009-12] b. Quarterly Report of Member Expense Reimbursements c. Ad hoc reports of personnel salaries, meeting notices, and budgets

Page 1 of 7

5. La. Div. of Administration – Facility Planning & Control a. Semiannual Report of Leased Office Space [Act 2016-66] 6. La. Div. of Administration – Property Assistance Agency a. Annual Inventory of Property & Equipment b. Annual Asset Certification Report c. Monthly Agency Fleet Mileage Report 7. La. Div. of Administration – Office of Group Benefits a. Annual Designations of Master User & Agency Coordinator b. Ad hoc reports of non-discrimination testing 8. La. Div. of Administration – Office of Risk Management a. Annual Agency Driver Authorization Report b. Annual Loss Prevention Compliance Audit c. Semiannual Property Exposure Report d. Quarterly Risk Exposure Report e. Quarterly Property Safety & Maintenance Inspections f. Monthly Loss Claims Report g. Monthly Report re Transitional Return to Work 9. La. Div. of Administration – Office of State Procurement a. Monthly Report on Status of Professional Contracts [Act 2015-87] b. Ad hoc reports on contractor performance review 10. La. Div. of Administration – Office of State Register a. Ad hoc notices for rulemaking projects 11. La. Div. of Administration – Office of Statewide Reporting & Accounting Policy a. Comprehensive Annual Financial Report b. Annual Report of Taxable Compensation c. Quarterly Report of Accounts Receivable [Act 1995-745] 12. La. Dept. of Children & Family Services a. Ad hoc rosters for credential renewals for pharmacists and technicians 13. La. Dept. of Culture, Recreation, & Tourism – State Library of Louisiana a. Annual Publications Report Form b. Semiannual Roster & Agency Inventory of Agency Publications c. Ad hoc document publication reports 14. La. Dept. of Economic Development a. Ad hoc rulemaking notices 15. La. Dept. of Health – Bureau of Health Services Financing a. Monthly Report of Pharmacy Openings & Closures 16. La. Dept. of Health – Office of Public Health a. Semi-annual Report of Active MA Registrations 17. La. Dept. of Insurance a. Annual Report of Investigation Referrals [Act 2009-251] 18. La. Dept. of Justice – Office of the Attorney General a. Quarterly Report of Private Legal Fees Paid [Act 2006-611] b. Ad hoc notices for emergency rules 19. La. Dept. of Revenue a. Quarterly Employer’s Return of State Withholding Tax b. Ad hoc rosters for credential renewals for pharmacists and technicians 20. La. Dept. of State – Division of Archives a. Annual Report of Records Officer Designation 21. La. Dept. of State Civil Service a. Annual Confirmation of Agency EEO Policy b. Annual Report of Performance Evaluations c. Ad hoc Payroll Comparison Report 22. La. Dept. of Treasury – Cash Management Review Board a. Quarterly Report of Agency Bank Accounts [Act 2016-587] 23. La. Board of Regents – ULM College of Pharmacy a. Annual Report of Pharmacy Education Support Fees Collected 24. La. State Employees Retirement System a. Monthly Report of Employer & Employee Contributions 25. La. Workforce Commission a. Quarterly Report of Employer’s Unemployment Tax

Page 2 of 7

26. La. House of Representatives – Office of the Speaker a. Annual Report of Rulemaking Activity b. Ad hoc notices for rulemaking projects 27. La. House of Representatives – Poynter Legislative Research Library a. Annual Filing of Legislative Reports 28. La. House of Representatives – Committee on Commerce a. Annual Report of Licensed Ex-Offenders [Act 2017-262] 29. La. House of Representatives – Committee on House & Governmental Affairs a. Quarterly Report of Board Complaints [Act 2018-655] 30. La. House of Representatives – Committee on Health & Welfare a. Annual LaTrac Report on Board Activity [Act 2009-12] b. Annual Report on Rulemaking Activity c. Annual Notice of Budget Adoption d. Comprehensive Annual Financial Report e. Ad hoc notices for rulemaking projects 31. La. Senate – Office of the President a. Annual Report on Rulemaking Activity b. Ad hoc notices for rulemaking projects 32. La. Senate – Committee on Health & Welfare a. Annual LaTrac Report on Board Activity [Act 2009-12] b. Annual Report on Rulemaking Activity c. Annual Notice of Budget Adoption d. Comprehensive Annual Financial Report e. Ad hoc notices for rulemaking projects 33. La. Senate – Committee on Senate & Governmental Affairs a. Annual Report on Boards & Commissions b. Quarterly Report of Board Complaints [Act 2018-655] 34. La. Legislature – Legislative Auditor a. Comprehensive Annual Financial Statement b. Annual Inventory of Property & Equipment c. Annual Asset Certification Report d. Annual Notice of Budget Adoption 35. La. Legislature – Legislative Fiscal Office a. Annual Notice of Budget Adoption b. Annual LaTrac Report of Board Activity [Act 2009-12] c. Ad hoc impact statements for rulemaking projects 36. La. Legislature – Joint Legislative Committee on the Budget a. Annual Notice of Budget Adoption b. Annual LaTrac Report of Board Activity [Act 2009-12] 37. U.S. Dept. of Commerce – Census Bureau a. Annual Survey of Public Employment & Payroll 38. U.S. Dept. of Health & Human Services – Office of Public Health a. Quarterly Report to ESAR-VHP 39. U.S. Dept. of Labor – Bureau of Labor Statistics a. Monthly Survey of Current Employment Statistics 40. U. S. Dept. of Treasury – Internal Revenue Service a. Annual Filings (Forms 1094, 1095-C, 1096, 1099, W-2, & W-3) b. Quarterly Report of Form 941 – Employer’s Federal Tax Return

3. Examinations A. Pharmacists

1. MPJE – the results for the first trimester of 2019 are available.

2. NAPLEX – the results for the first trimester of 2019 are available.

Page 3 of 7

B. Technicians

1. NHA – the results for the first half of 2019 are available.

2. PTCB – the results for the first half of 2019 are available.

4. Operations A. Credentials Division As of June 30, 2019, we had 69,943 active credentials under management by the Board. That number reflects a 7.8% increase from the beginning of this fiscal year on July 1, 2018. About 65% of the credentials (45,174) reside in the Pharmacy Program with the balance in the CDS Program. We opened the renewal cycle for DME permits on July 1; it will close on August 31. We sent renewal reminder notices to 642 permits. By July 31, 433 had renewed, and of that number, 90.3% did so online.

B. Compliance Division Our 7 pharmacist compliance officers are responsible for inspecting all the pharmacies and other facilities holding controlled substances (CDS). The census reports available for this meeting reflect 1,431 pharmacies within the state, as well as 339 DME permits, and an additional 521 various types of facilities and persons for CDS visits, including hospitals, researchers, animal euthanasia technicians, etc. In addition to their routine site visits, the compliance officers are also responsible for investigating complaints filed with the Board. We began this fiscal year with 180 cases pending from the prior fiscal year. We entered 433 new cases and closed 434, leaving 179 cases still open for this fiscal year. Of the 434 cases closed, 63% were disposed of through staff activities and the balance through committee and Board action.

C. Administrative Division We have a personnel change to report. Ms. Erica Brown, who was a licensing assistant taking care of technician credentials, resigned to take a position with Southern University. We have transferred Ms. Arielle Shelton from the Administrative Division to the Credentials Division to manage the technician credentials. Hurricane Barry arrived in Louisiana on July 15. The state commissioner of administration ordered the closure of all state offices, including the Board, on the previous Friday, July 12. Although there was flooding and power outages, none of those events affected the Board’s office. The compliance officers contacted or visited the pharmacies in their territories to assess the impact of the storm. Most pharmacies suffered temporary power losses, although some pharmacies found it necessary to quarantine some previously refrigerated stock. We are aware of two pharmacies which suffered physical damage from flood waters. Both locations have remediated the damage, but one of them was a sterile compounding pharmacy which has not yet resumed compounding operations. Chief Compliance Officer Ben Whaley prepared an assessment for your review, and it is posted in the Boardroom Library.

5. State Activities A. La. Legislature The Regular Session of the 2019 Legislature adjourned on June 6. A total of 1, 736 items were filed for consideration. The legislature adopted 454 bills; the governor vetoed 8 of them and signed the remaining 448 items into law. All three of the Board’s legislative proposals were successful. We issued Bulletin 19-01 on July 1 to notify our clients of all new legislation affecting pharmacy practice. A copy of the Final Legislative Brief was posted in the Boardroom Library.

Page 4 of 7

B. La. Dept. of Agriculture & Forestry The agency published in the July 2019 edition of the Louisiana Register a list of pesticides authorized for use on cannabis plants by producers of medical marijuana products.

C. La. Dept. of Health – Office of Public Health The agency published an Emergency Rule on July 10 to enable the registration of hemp-derived cannabidiol products as authorized by Act 164 of the 2019 Legislature.

D. La. Dept. of Revenue – Office of Alcohol & Tobacco Control The agency published an Emergency Rule on June 27 to enable the registration of distributors and retailers of hemp-derived cannabidiol products as authorized by Act 164 of the 2019 Legislature.

E. La. Attorney General The agency has resumed its continuation of the Civil Law Training for members and staff of boards and commissions. The topics covered include laws relative to open meetings, public records, and administrative hearing procedures. The sessions are conducted once per month at the Attorney General’s office building near the state capitol. The announcement containing the schedule of events and registration information was posted in the Boardroom Library.

6. Regional & National Activities A. National Association of Boards of Pharmacy (NABP) The annual meeting of this association is one of the three meetings for which certain of your travel expenses are eligible for reimbursement, subject to the limitations itemized in the Board’s travel policy as well as the state’s travel policy in PPM-49. For your planning purposes, the association will hold its 116th Annual Meeting on May 14-16, 2020 in Baltimore, MD. Registration details will be provided when they are available.

B. NABP-AACP District 6 The annual meeting of this association is one of the three meetings for which certain of your travel expenses are eligible for reimbursement, subject to the limitations itemized in the Board’s travel policy as well as the state’s travel policy in PPM-49. For your planning purposes, Districts 6, 7, and 8 will meet together again on October 6-9, 2019 at The Grove Hotel in Boise, ID. Registration details will be provided when they are available.

C. MALTAGON The annual meeting of this association is one of the three meetings for which certain of your travel expenses are eligible for reimbursement, subject to the limitations itemized in the Board’s travel policy as well as the state’s travel policy in PPM-49. The Mississippi Board of Pharmacy is hosting the 2019 conference at the Beau Rivage Resort & Casino in Biloxi, MS on Oct. 27-30. We distributed the information necessary to secure your hotel accommodations and register for the conference. Please take note of the deadline dates in the registration materials. If you have questions or need additional information, please let us know. As a gentle reminder, the Louisiana Board is scheduled to host the conference in 2021.

D. Enhancing Well-being and Resilience Among the Pharmacist Workforce ~ A National Consensus Conference Louisiana Board Member Jackie Hall participated in the conference, which was a collaborative effort of the American Pharmacists Association (APhA), Accreditation Council for Pharmacy Education (ACPE), American Association of Colleges of Pharmacy (AACP), National Association of Boards of Pharmacy (NABP), and the National Association of State Pharmacy Association Executives (NASPA). The objectives of the consensus conference were to:

Page 5 of 7

• Evaluate factors that contribute to well-being and resilience at the individual, organizational, and profession levels. • Develop strategies that could improve pharmacist well-being and resilience and decrease moral distress within individuals, managers, organizations, and the procession. • Identify and prioritize strategies that will drive change and fuel improvements in well-being and resilience. • Develop actionable recommendations that guide organizations and individuals in implementing positive change. The conference was held July 17-19 in Chicago, IL. Complete conference proceedings and outcomes will be formally published in the Fall of 2019. In the interim, we have posted a copy of the 50 consensus recommendations in the Boardroom Library.

7. International Activities A. International Pharmaceutical Federation (FIP) The Emirates Pharmacy Society will host the FIP World Congress on Sep. 22-26 in Abu Dhabi, UAE. The educational offerings include plenary sessions, platform presentations and poster sessions, all within the four primary topics for the congress:  Topic A – New trends in science, practice, and education These topics focus on technology, digitalization, robotics, individualization, virtual classroom, communication, patient-centered care, and ethical challenges.  Topic B – New roles, opportunities, and responsibilities These topics focus on pharmacists’ roles, roles of individuals, new services, collaboration and education.  Topic C – Health now! Responding to the challenges of today, these topics recognizes that challenges can be faced by looking at new research, ethical considerations, new values, access to health, health systems, environmental sustainability, non-communicable diseases, empowerment of patients, and quality assessment.  Topic D – Targeting special interests These topics will target special interests in the different fields of pharmacy and pharmaceutical sciences. FIP has announced the 2020 congress will be held Sep. 13-17 in Seville, Spain. The 2021 congress will be held on Aug. 29 – Sept. 2 in Brisbane, Australia.

B. dotPharmacy Verified Websites Program dotPharmacy is a generic top level domain (gTLD) on the Internet. Although it is owned by NABP, the dotPharmacy domain is governed by a global collaboration including the International Pharmaceutical Federation (FIP) and the National Association of Pharmacy Regulatory Authorities (NAPRA – Canada) and endorsed by multiple global partners, including the World Health Organization (WHO), Interpol, and the Pharmaceutical Group of the European Union (PGEU). dotPharmacy is different from most TLDs in that authority to host a website on dotPharmacy is restricted to applicants whose legitimacy has been verified by NABP or one of its global partners. The vision for dotPharmacy is to create an online pharmacy community where patients can go to safely order prescription drugs, knowing the sites have already been verified as legitimate pharmacies that are licensed by the appropriate pharmacy regulatory authority. In addition to pharmacies, the plan is to create a presence for a number of related organizations, including professional membership organizations, colleges of pharmacy, boards of pharmacy, drug manufacturers, and consumer-oriented drug information organizations. dotPharmacy began accepting applications for website registrations in June 2015. By July 2019, there were 641 registered domains held by pharmacy organizations representing approximately 60% of the physical pharmacy locations in the U.S. Although most of the domains are based in the U.S., 62 domains are based in other countries around the world, including Canada, the Netherlands, Germany, Malta, and the United Kingdom. Discussions and negotiations are underway with pharmacy regulatory

Page 6 of 7

authorities in Australia, Brazil, China, India, New Zealand, Scotland, South Africa, and Turkey. More information, including a list of registered domains, is available at www.safe.pharmacy. The Louisiana Board has two website addresses in the dotPharmacy domain: www.laboard.pharmacy and www.la.pharmacy. The domain name fees for these websites have been waived by NABP. For now, visitors to these sites are automatically re-directed to the Board’s website at www.pharmacy.la.gov.

Respectfully submitted, Malcolm J Broussard Executive Director

Page 7 of 7

Louisiana Board of Pharmacy Pharmacy Program - Census Report

6/30/2018 11/1/2018 2/6/2019 5/13/2019 6/30/2019

PST.VI LA 14 15 18 26 9 NR 20 20 30 2 17 Total 34 35 48 28 26

PST-GVI LA 24 24 30 19 20 NR 8 8 10 4 6 Total 32 32 40 23 26

PST-M LA 0 0 0 6 0 NR 8 8 8 2 8 Total 8 8 8 8 8

PST-MS LA 0 1 3 3 NR 2 2 0 2 Total 2 3 3 5

PST-G LA 194 222 178 159 186 NR 27 36 28 48 31 Total 221 258 206 207 217

PST LA 5,690 5,644 5,584 5,594 5,795 NR 3,090 3,153 3,026 3,136 3,230 Total 8,780 8,797 8,610 8,730 9,025 Active PST 9,009 9,065 8,915 8,948 9,255

PNT LA 910 869 914 897 892 NR 158 147 205 195 200 Total 1,068 1,016 1,119 1,092 1,092

PNT-FPG Total 2 2 1 2 2 PNT 1,070 1,018 1,120 1,094 1,094

CPT LA 6,433 6,801 6,917 7,057 6,452 NR 152 174 175 178 147 Total 6,585 6,975 7,092 7,235 6,599

CPT-M Total 1 2 2 2 1

CPT-MS Total 0 0 0 1 Active CPT 6,586 6,977 7,094 7,237 6,601

PTC LA 1,931 1,794 1,675 1,555 1,544 NR 69 57 58 49 51 PTC 2,000 1,851 1,733 1,604 1,595 Louisiana Board of Pharmacy Pharmacy Program - Census Report

6/30/2018 11/1/2018 2/6/2019 5/13/2019 6/30/2019

PHY CH 10 10 10 9 9 HOS 163 162 162 162 161 HOX 6 7 5 5 5 IN 11 11 11 11 11 INX 11 11 11 11 11 IR 584 586 588 594 597 IRX 6 6 7 8 8 NR 534 560 543 553 561 NRN 8 8 9 10 10 NRP 2 2 1 1 1 NU 13 13 13 13 13 PE 0 0 0 0 0 PEN 0 0 0 0 0 PEX 3 4 4 4 4 RC 630 613 593 595 596 RPP 1 1 1 1 2 SAT 6 6 6 6 6 SPL 0 0 0 0 0 TDS 0 0 0 0 0 TM 1 3 7 8 PHY 1,988 2,001 1,967 1,990 2,003

AMS AMS 498 128 129 136 116 AMS-X 372 359 360 357 345 AMS 870 487 489 493 461

EDK EDK 435 128 445 449 374 EDK-X 11 359 8 8 6 EDK 446 487 453 457 380

DME LA 205 322 332 340 339 NR 437 278 289 300 301 DME 642 600 621 640 640

CDTM 69 75 75 77 78

MAR 3,073 3,121 3,167 3,180 3,161

PMP 15,835 18,166 19,051 19,858 19,686

SWP 45 48 45 43 41

TMD 71 100 96 120 127

TOTAL 41,770 44,063 44,914 45,792 45,174 Louisiana Board of Pharmacy CDS Program - Census Report

6/30/2018 6/30/2019 Classification ACS Animal Control Shelter 0 0 AMS Automated Medication System 35 40 AMX Automated Medication System - Exempt 2 2 APN Advanced Practice Registered Nurse 2,975 3,434 ASC Ambulatory Surgical Center 0 0 CRX Correctional Center 0 0 DDS Dentist 2,174 2,224 DET Drug Detection Canine - Private Agency 0 6 DEX Drug Detection Canine - Law Enforcement 8 0 DIS Distributor 290 285 DPM Podiatrist 158 163 DVM Veterinarian 1,188 1,216 DYS Dialysis Center 0 0 EMC Emergency Center 0 0 EMS Emergency Medical Service 0 0 ETC Animal Euthanasia Tech - Cert 3 3 ETL Animal Euthanasia Tech - Lead 26 25 HOS Hospital 301 297 HOX Hospital - Exempt 5 5 INT Intern or Resident 318 1,047 LAB Analytical Laboratory 8 8 LAX Analytical Laboratory - Exempt 4 4 MD Physician 12,824 13,138 MDT Physician via Telemedicine 2 11 MED Medical Clinic 0 0 MFR Manufacturer 45 47 MP Medical Psychologist 91 91 OD Optometrist 349 360 PA Physician's Assistant 783 928 PHX Pharmacy - Exempt 22 24 PHY Pharmacy 1,313 1,279 REP Sales Representative 0 0 RES Researcher 104 106 RHC Rural Health Clinic 0 0 RNT APRN via Telehealth 5 1 ROF Registered Outsourcing Facility 19 19 SAC Substance Abuse Clinic 6 6 SAX Substance Abuse Clinic - Exempt 0 0 MIS Other 0 0 TOTAL 23,058 24,769

Highlighted credentials subject to inspection

Total Credentials Under Board Management

Pharmacy Program 41,770 45,174 CDS Program 23,058 24,769 TOTAL 64,828 69,943 New Credentials Issued FYE 2019 ~ 4rd Quarter April 1, 2019 - June 30, 2019

Prefix Subcategory CredentialType Total AMS Automated Medication System 11 AMS X Automated Medication System - Exempt 15 Prefix Totals 26 CDS AMS CDS License - Automated Medication System 4 CDS APN CDS License - APRN 146 CDS DDS CDS License - Dentist 55 CDS DIS CDS License - Distributor 3 CDS DPM CDS License - Podiatrist 1 CDS DVM CDS License - Veterinarian 40 CDS ETL CDS License - Animal Euthanasia Technician, Lead (AET-L) 2 CDS HOS CDS License - Hospital 8 CDS INT CDS License - Medical Intern or Resident 16 CDS MD CDS License - Physician 190 CDS MDT CDS License - Physician via Telemedicine 1 CDS PA CDS License - Physician Assistant 32 CDS PHY CDS License - Pharmacy 18 CDS RES CDS License - Researcher 4 CDS ROF CDS License - Registered Outsourcing Facility 1 CDS TM CDS License - Therapeutic Marijuana 3 Prefix Totals 524

CDTM Collaborative Drug Therapy Management (V) 1

CPT Certified Pharmacy Technician 83

DME Durable Medical Equipment (DME) Provider 18

EDK Emergency Drug Kit 9

MA Medication Administration (V) 46

PHY HOS Pharmacy - Hospital Inpatient 3 PHY IR Pharmacy - Community ~ Independent 13 PHY NR Pharmacy - Nonresident 29 PHY RC Pharmacy - Community ~ Chain 5 PHY RPP Pharmacy - Remote Processor 1 PHY TM Pharmacy - Therapeutic Marijuana 3 Prefix Totals 54

PIC Pharmacist-in-Charge (V) 27

PMP CDS PMP - CDS Credential (V) 175 PMP PHY PMP - PHY Dispenser Account (V) 92 PMP PST PMP - Pharmacist (V) 8 Prefix Totals 275

PNT Pharmacy Intern 38 PNT FPG Pharmacy Intern - Foreign Pharmacy Graduate 1 Prefix Totals 39

PST Pharmacist 119 PST MS Pharmacist - Military Spouse 3 Prefix Totals 122

PTC Pharmacy Technician Candidate 253

SWP Special Work Permit 9

TM CPT Therapeutic Marijuana Designation - CPT 7 TM PST Therapeutic Marijuana Designation - PST 11 Prefix Totals 18

Grand Totals 1504 Pending Applications

PHARMACY CREDENTIALS Prefix Subcat. CredentialType 2/12/2018 5/9/2018 8/2/2018 11/2/2018 2/6/2019 5/13/2019 8/1/2019 AMS Automated Medication System 5 7 5 5 8 9 7 CPT Certified Pharmacy Technician 44 64 29 29 33 58 46 DME Durable Medical Equipment 20 22 17 18 20 12 14 EDK Emergency Drug Kit 4 4 4 5 7 2 PHY CH Pharmacy - Charitable 1 1 1 PHY HOS Pharmacy - Hospital Inpatient 4 1 1 5 6 6 9 PHY IN Pharmacy - Institutional 1 1 1 1 PHY IR Pharmacy - Community ~ Independent 32 26 21 20 22 18 21 PHY NR Pharmacy - Nonresident 84 70 74 73 60 67 61 PHY NRN Pharmacy - Nonresident Nuclear 2 2 1 PHY NU Pharmacy - Nuclear PHY PEN Pharmacy - Penal 3 3 3 1 PHY RC Pharmacy - Community ~ Chain 176 2 4 3 2 1 PHY RPP Pharmavy - Remote Processor 2 1 1 PHY SAT Pharmacy - Hospital Off-Site Satellite 1 1 1 1 PHY SPL Pharmacy - Special Event 1 1 PHY TM Pharmacy - Therapeutic Marijuana 34 9 9 8 6 2 95 PIC Pharmacist-in-Charge PNT FPG Pharmacy Intern - Foreign Graduate 1 1 1 1 PNT Pharmacy Intern 44 40 31 173 74 35 57 PST Pharmacist 297 381 480 278 272 348 305 PTC Pharmacy Technician Candidate 338 320 286 289 223 235 245 Subtotal 1087 952 967 913 731 802 865

CDS CREDENTIALS Prefix Subcat. CredentialType 2/12/2018 5/9/2018 8/2/2018 11/2/2018 2/6/2019 5/13/2019 8/1/2019 CDS AMS CDS - Automated Medication System 2 3 4 1 1 1 CDS APN CDS - APRN 12 17 17 14 14 11 10 CDS DDS CDS - Dentist 1 9 4 3 2 1 CDS DET CDS - Drug Detection / Canine 4 1 3 1 CDS DIS CDS - Distributor 6 5 6 17 15 14 13 CDS DPM CDS - Podiatrist 1 CDS DVM CDS - Veterinarian 3 2 5 4 1 CDS ETC CDS - Animal Euthanasia Tech, Certified 1 CDS ETL CDS - Animal Euthanasia Tech, Lead 1 1 3 1 CDS HOS CDS - Hospital 10 8 9 8 12 13 13 CDS INT CDS - Medical Intern or Resident 18 14 7 7 8 CDS MD CDS - Physician 17 33 27 34 24 18 20 CDS MFR CDS - Manufacturer 4 6 4 4 CDS MP CDS - Medical Psychologist CDS OD CDS - Optometrist 1 CDS PA CDS - Physician Assistant 4 5 10 11 8 11 14 CDS PHY CDS - Pharmacy 85 26 22 27 24 21 20 CDS PHX CDS - Pharmacy - Exempt 2 2 1 1 CDS RES CDS - Researcher 9 5 5 2 2 3 5 CDS RNT CDS - APRN via Telehealth 1 CDS ROF CDS - Registered Outsourcing Facility 1 2 2 1 3 2 1 CDS SAC CDS - Substance Abuse Clinic 4 4 1 5 1 1 CDS TM CDS - Therapeutic Marijuana 34 9 8 6 2 1 Subtotal 192 128 155 149 127 110 107

OTHER CREDENTIALS Prefix Subcat. CredentialType 2/12/2018 5/9/2018 8/2/2018 11/2/2018 2/6/2019 5/13/2019 8/1/2019 CDTM Collaborative Drug Therapy Management LB Law Book MA Medication Administration 3 3 3 10 10 10 8 PMP PMP - CDS Credential 207 221 206 143 342 310 310 PMP PMP - MIS Credential PMP PMP - PHY Credential 2 1 PMP PMP - PST Credential 4 225 210 5 345 2 2 SWP Special Work Permit 10 10 10 10 10 10 10 TM CPT Therapeutic Marijuana Designation - CPT 7 4 18 17 26 26 TM OMO Therapeutic Marijuana Designation - OMO 2 6 2 TM PST Therapeutic Marijuana Designation - PST 3 14 4 2 7 10 11 Subtotal 229 486 439 190 732 368 367

TOTAL 1508 1566 1561 1252 1590 1280 1339 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

August 14, 2019

Agenda Item 11-L: Report of Executive Director

Section 2 – A – 1 – d ~ Exceptions Report

1. PIC at Multiple Pharmacies Board Policy I.A.4 permits the Executive Director to approve requests from pharmacists wishing to serve as the Pharmacist-in-Charge (PIC) of more than one pharmacy at the same time. The decision to approve such a request requires the concurrence of the President, as well as notice to the Board at its next meeting. As authorized by the President, the Executive Director has delegated this authority to the General Counsel and the Assistant Executive Director. • On May 20, 2019 Mr. Aron and Mr. Fontenot concurred to grant a request from Charles Edward Maier (PST.015447) for temporary dual PIC privileges at Lakeside Pharmacy (PHY.007013-IR) in Monterey and Island Pharmacy (PHY.007660-IR) in Sicily Island for a limited period of time ending August 31, 2019. • On May 22, 2019 Mr. Aron and Mr. Fontenot concurred to grant a request from Glenn Joseph Green, Jr. (PST.017753) for temporary dual PIC privileges at Priority Health Care Pharmacy (PHY.007348-IR) in Marrero and Priority Health Care Pharmacy - Gretna (Application – Pending) in Gretna for a limited period of time ending 6 months after first issuance of the pharmacy permit for the Gretna location. • On June 6, 2019 Mr. Aron and Mr. Fontenot concurred to grant a request from Eugene Irvine Dreher, IV (PST.014527) for temporary dual PIC privileges at M. C. Clinic Pharmacy (PHY.000689-IR) in Morgan City and HPC Specialty Pharmacy (PHY.00739- IR) also in Morgan City for a limited period of time ending November 25, 2019. • On July 22, 2019, Mr. Aron and Mr. Broussard concurred to grant a request from Jamie J. Stocker (PST.022212) for temporary dual PIC privileges at PAM Specialty Hospital of Covington (PHY.006380) as well as PAM Specialty Hospital of Hammond (PHY.006716), for up to six months.

2. Special Work Permits for military-trained applicants and their spouses LAC Title 46: LIII §904 authorizes the Board to provide preferential licensing procedures for military-trained applicants and their spouses. As authorized by the President, the Executive Director has delegated this authority to the General Counsel and the Assistant Executive Director. • On May 20, 2019, Mr. Finalet granted a request of Daniel Richard Hess. He has been issued SWP.00840 to practice for up to 120 days while his application to become a PTC is in process. The SWP will expire on September 30, 2019.

3, Special Work Permits Board Policy I.A.7 permits the Executive Director to issue Special Work Permits to document the resurrection of expired non-renewable credentials and for other purposes as authorized by the Board. The decision to approve such a request requires the concurrence of the President, as well as notice to the Board at its next meeting. As authorized by the President, the Executive Director has delegated this authority to the General Counsel and the Assistant Executive Director. • On May 28, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Jasmine Shawyne Antoine. She had previously obtained PTC.020009 which expired on November 9, 2014. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience. • On May 28, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Teri-Lynne Page 1 of 2 Pushee. She had previously obtained PTC.024509 which expired on March 30, 2018. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience. • On June 6, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Amber Courville. She had previously obtained PTC.021225 which expired on September 30, 2015. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience. • On June 13, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Lanisha Dillon. She had previously obtained PTC.024512 which expired on April 3, 2018. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience. • On July 1, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Valerie Jaye Hildestad. She had previously obtained PTC.009430 which expired on October 7, 2004. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience. • On July 18, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Alesia Willett Roman. She had previously obtained PTC.023444 which expired on June 8, 2017. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience. • On July 18, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Brittany Rochele Alford. She had previously obtained PTC.025675 which expired on June 27, 2019. She is ExCPT-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience.

Page 2 of 2 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Compliance Division Census Report

August 14, 2019

Practitioner Recovery Program • Probation Completion Report

[none since May 2019 Board meeting]

• Active Probation 42 Pharmacist 1 Pharmacy intern 7 Technician

• Active Suspension 39 Pharmacist 2 Pharmacy intern 17 Technician 4 Technician candidate

Disciplinary Restrictions • Probation Completion Report

06-23-2019 PST.018721 Lee Eric Ori 08-15-2019 PST.013189 Stuart Hall Burgess

• Active Probation 15 Pharmacist 1 Pharmacy intern 2 Technician 1 Technician candidate 4 Pharmacy permit 1 CDS-PHY license

• Active Suspension/ 53 Pharmacist Inactivation 1 Pharmacy intern 80 Technician 20 Technician candidate 1 Special work permit 12 Pharmacy permit 7 CDS-PHY license 97 CDS license for practitioners Louisiana Board of Pharmacy Compliance Division

Complaint Investigation Completion Policy Monitor

FY 17-18 FY 18-19 FY 19-20 FY 20-21 6/30/2018 6/30/2019

Pending at Beginning of Fiscal Year 160 180

New Cases Added 500 433

Cases Closed 480 434

Cases Remaining 180 179

Average No. Days to Close Investigation 52

No. Investigations Closed > 180 Days 19

% Investigations Beyond Policy Limit 4.4%

% Cases Closed by Board Action 27% Louisiana Board of Pharmacy - Compliance Division Statistical Summary for Fiscal Year 2018-2019

Individual Performance Data Investigations Inspections Cases Audits Reports CDS PHY/DME Total Assigned Completed Submitted > Compliance Officers

Aaron, Cary D. 1st Qtr. 20 60 80 7 1 3 2nd Qtr. 3 77 80 19 1 13 3rd Qtr. 12 37 49 18 0 9 4th Qtr. 20 46 66 5 0 24 Total 55 220 275 49 2 49 Completion Rate:

Dennis, Daniel M. 1st Qtr 14 66 80 16 0 10 2nd Qtr 10 60 70 5 0 10 3rd Qtr 8 71 79 10 0 7 4th Qtr 5 59 64 10 0 11 Total 37 256 293 41 0 38 Completion Rate:

Gross, Nicole L. 1st Qtr 12 40 52 4 0 11 2nd Qtr 22 37 59 6 0 6 3rd Qtr 16 43 59 4 0 4 4th Qtr 12 51 63 10 0 4 Total 62 171 233 24 0 25 Completion Rate:

Harris, Alicia P. (hired 2-4-2019) 1st Qtr N/A N/A N/A N/A N/A N/A 2nd Qtr N/A N/A N/A N/A N/A N/A 3rd Qtr 2 26 28 4 0 0 4th Qtr 17 32 49 10 0 5 Total 19 58 77 14 0 5 Completion Rate:

Parker, Becky (hired 2-4-2019) 1st Qtr N/A N/A N/A N/A N/A N/A 2nd Qtr N/A N/A N/A N/A N/A N/A 3rd Qtr 6 21 27 5 0 1 4th Qtr 11 60 71 9 0 8 Total 17 81 98 14 0 9 Completion Rate:

Savoie, Huey J. 1st Qtr 9 52 61 9 1 11 2nd Qtr 6 56 62 3 0 3 3rd Qtr 17 57 74 3 0 1 4th Qtr 8 66 74 9 0 6 Total 40 231 271 24 1 21 Completion Rate: Louisiana Board of Pharmacy - Compliance Division Statistical Summary for Fiscal Year 2018-2019

Investigations Inspections Cases Audits Reports CDS PHY/DME Total Assigned Completed Submitted > Compliance Officers

Trisler, Rayland M. (retired 4-1-2019) 1st Qtr 8 43 51 12 1 9 2nd Qtr 7 24 31 5 0 14 3rd Qtr 0 1 1 0 0 1 4th Qtr N/A N/A N/A N/A N/A N/A Total 15 68 83 17 1 24 Completion Rate:

Whaley, Benjamin S. 1st Qtr 5 22 27 7 0 4 2nd Qtr 4 18 22 3 0 4 3rd Qtr 11 17 28 5 0 4 4th Qtr 4 15 19 8 0 5 Total 24 72 96 23 0 17 Completion Rate:

TOTAL 269 1157 1426 Completion Rate

> Administrative Officers Fontenot, M. Joseph 1st Qtr 0 0 0 1 0 0 2nd Qtr 0 0 0 3 0 2 3rd Qtr 0 0 0 4 0 3 4th Qtr 0 0 0 1 0 3 Total 0 0 0 9 0 8

Finalet, Carlos M. 1st Qtr 0 0 0 62 0 33 2nd Qtr 0 0 0 64 0 63 3rd Qtr 0 0 0 40 0 44 4th Qtr 0 0 0 52 0 39 Total 0 0 0 218 0 179

Broussard, Malcolm J. 1st Qtr 0 0 0 0 0 0 2nd Qtr 0 0 0 0 0 0 3rd Qtr 0 0 0 0 0 0 4th Qtr 0 0 0 0 0 0 Total 0 0 0 0 0 0

Agency Summary 1st Qtr 68 283 351 118 3 81 2nd Qtr 52 272 324 108 1 115 3rd Qtr 72 273 345 93 0 74 4th Qtr 77 329 406 114 0 105 TOTAL 269 1157 1426 433 4 375 Louisiana Board of Pharmacy - Compliance Division Statistical Summary for Fiscal Year 2018-2019

Summary of Investigations and Adjudications

Number of Cases Pending from Prior Fiscal Year(s) 180

Number of Complaints Received during Current Fiscal Year: 433

Number of Complaints Closed during Current Fiscal Year: 434

Number of Complaints Pending at End of Fiscal Year: 179

Disposition of Closed Complaints:

Withdrawn 5

No violations found 88

Administrative/Field corrections 122

Referred to another agency 26

Administrative sanction 19

Termination of previously imposed probationary periods 11

Referred to appropriate Board Committee 163 434 Total

Committee Action on Referrals

12 Case dismissed

146 Voluntary Consent Agreement 2 Denial / Refusal to Issue 17 Reinstatement 6 Modifications of Previous Orders 16 Assessment 3 Letter of Warning 29 Letter of Reprimand 13 Voluntary Surrender 19 Probation 4 Suspension 7 Revocation 30 Other decisions

5 Formal Hearing 1 Denial of Reinstatement 2 Suspension 2 Revocation

163 Total Louisiana Board of Pharmacy - Compliance Division Statistical Summary for Fiscal Year 2018-2019

Analysis of Adjudications by Type of Credential

PST PNT CPT PTC PHY/DME CDS TOTAL

Denial / Refusal to Issue 1 0 1 1 0 0 3

Reinstatement 6 0 8 0 0 3 17

Modification of Previous Orders 6 0 0 0 0 0 6

Assessment 1 0 0 0 15 0 16

Letter of Warning 1 0 0 0 2 0 3

Letter of Reprimand 12 0 12 0 5 0 29

Voluntary Surrender 7 0 3 1 0 2 13

Probation 14 1 2 0 2 0 19

Suspension 4 0 1 1 0 0 6

Revocation 0 0 5 2 2 0 9

Other Decisions 20 0 2 1 7 0 30

TOTAL 72 1 34 6 33 5 151 Louisiana Board of Pharmacy - Compliance Division Statistical Summary - Cumulative Data

FY FY FY FY FY FY FY FY FY FY 02-03 03-04 04-05 05-06 06-07 07-08 08-09 09-10 10-11 11-12 Summary of Complaint Investigations

Complaints Pending from Prior Year(s) 46 96 132 124 98 82 112 140 127 197

Complaints Received During Year 355 315 273 250 239 280 519 356 432 349

Complaints Closed During Year 305 279 281 276 255 250 491 369 362 389

Complaints Pending at Year End 96 132 124 98 82 112 140 127 197 157

Disposition of Closed Complaints

Withdrawn 20 11 7 4 10 3 23 16 26 23

No violations found 36 46 31 36 30 39 49 41 58 51

Field/administrative corrections 25 34 47 70 40 73 65 76 54 83

Referred to another agency 1 1 3 7 11 2 6 7 5 6

Administrative sanction 89 78 73 37 34 38 255 72 42 46

Termination of probationary period

Referred for Board action 134 109 120 122 130 95 93 157 177 180 Total 305 279 281 276 255 250 491 369 362 389

Committee Action on Referrals

Cases Dismissed 43 17 16 25 20 19 38 24 39 20

Voluntary Consent Agreements 79 80 91 90 97 67 47 124 132 150

Assessment only 11 11 7 2 4 38 25 18 10 12

Denial / Refusal to Issue 1 9 1

Letter of Noncompliance 0 0 0 0 0 0 0 0 0 0

Letter of Warning 20 14 12 26 18 7 3 5 6 3

Letter of Reprimand 13 5 19 12 18 13 13 30 35 17

Voluntary Surrender 9 10 23 25 17 6 8 34 23 21

Probation 9 17 10 13 16 20 5 17 21 31

Suspension 6 10 4 1 5 10 5 2 2 10

Revocation 11 13 16 11 19 9 4 17 11 28

Other decisions 15 27

Formal Hearings 12 12 13 7 13 9 8 9 6 10

Assessment only 0 0 0 0 1 3 0 0 0 0

Denial / Refusal to Issue 0 0 0 0 0 0 0 0 0 0

Letter of Warning 0 2 0 0 0 0 0 0 0 0

Letter of Reprimand 0 0 1 0 0 0 0 0 0 0

Probation 0 1 0 2 2 0 0 0 1 0

Suspension 4 2 2 0 3 3 0 3 2 2

Revocation 8 7 10 5 7 4 8 6 3 8

Interlocutory Hearings 0 2 3 0 1 0 0 0 0 0

Summary Suspension 0 0 2 0 1 0 0 0 0 0

Last update: 07-30-2019 Louisiana Board of Pharmacy - Compliance Division Statistical Summary - Cumulative Data

FY FY FY FY FY FY FY FY 12-13 13-14 14-15 15-16 16-17 17-18 18-19 19-20 Totals Summary of Complaint Investigations

Complaints Pending from Prior Year(s) 218 255 252 214 224 160 180 179 2,317

Complaints Received During Year 392 479 404 411 391 500 433 5,445

Complaints Closed During Year 355 482 442 401 468 480 434 5,405

Complaints Pending at Year End 255 252 214 224 147 180 179 2,357

Disposition of Closed Complaints

Withdrawn 25 13 18 18 10 12 5 227

No violations found 32 86 83 48 76 70 88 742

Field/administrative corrections 67 107 113 80 118 63 122 1,052

Referred to another agency 3 11 7 7 16 79 26 93

Administrative sanction 24 15 21 13 4 37 19 841

Termination of probationary period 24 27 15 23 27 14 11 116

Referred for Board action 180 223 185 212 217 205 163 2,334 Total 355 482 442 401 468 480 434 5,405

Committee Action on Referrals

Cases Dismissed 21 41 31 37 26 55 12 417

Voluntary Consent Agreements 157 155 125 163 159 144 146 1,716

Assessment only 9 18 28 18 12 12 16 223

Denial / Refusal to Issue 5 5 2 6 4 17 2 33

Letter of Noncompliance 0 0 0 0 9 6 17 9

Letter of Warning 3 13 5 2 5 3 3 142

Letter of Reprimand 19 7 14 35 29 20 29 279

Voluntary Surrender 21 25 15 13 12 18 13 262

Probation 29 31 16 21 17 28 19 273

Suspension 22 6 2 13 4 4 4 102

Revocation 19 5 14 6 10 4 7 193

Other decisions 30 46 29 49 57 32 36 253

Formal Hearings 2 27 29 12 32 6 5 201

Assessment only 0 0 0 0 0 0 0 4

Denial / Refusal to Issue 0 3 2 0 1 0 1 6

Letter of Warning 0 0 0 0 0 0 0 2

Letter of Reprimand 0 0 0 0 0 0 0 1

Probation 0 0 1 1 1 1 0 9

Suspension 1 20 23 1 1 5 2 67

Revocation 1 4 3 10 10 0 2 94

Interlocutory Hearings 0 0 0 0 0 0 0 6

Summary Suspension 0 0 0 0 0 0 0 3

Last update: 07-30-2019 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Annual Report

Fiscal Year 2018-2019

July 1, 2019

Mission

Created by the Louisiana Legislature in 1888, the mission of the Louisiana Board of Pharmacy remains unchanged over a century later: to regulate the practice of pharmacy in such a manner as to protect the public health, safety, and welfare of the citizens of Louisiana. Toward that goal, the Louisiana Pharmacy Practice Act specifically authorizes the Board to restrict the practice of pharmacy to qualified persons, as well as to control and regulate all persons and sites that sell prescription drugs or devices or provide pharmacy care services to consumers in this state.

Licensure

In order to facilitate the restriction of practice to qualified persons, the Board has established educational, experiential, and examination requirements for pharmacist licensure. As authorized by the legislature, the Board has contracted its high-stakes examination procedures with professional testing services.

A. Examinations for Pharmacists The North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE) are administered by the National Association of Boards of Pharmacy (NABP). These computer adaptive tests are administered in continuous window opportunities at multiple sites throughout the state. A minimum scaled score of 75 is required on each test to qualify for pharmacist licensure; the maximum scaled score is 150 for the NAPLEX and 100 for the MPJE. NABP publishes summary data for the examinations on a trimester basis. The results for all Louisiana-based NAPLEX and MPJE candidates in Calendar Year 2018 are summarized here:

NAPLEX Jan – Apr May – Aug Sept – Dec

No. of Louisiana Candidates 17 215 50 State Mean Scaled Score 72.88 93.10 76.24 Louisiana Pass Rate 35.29% 86.98% 50% No. of National Candidates 1,349 13,152 3,582 National Mean Scaled Score 77.61 96.25 82 National Pass Rate 56.56% 89.57% 69.24%

MPJE Jan – Apr May – Aug Sept – Dec

No. of Louisiana Candidates 111 370 211 State Mean Scaled Score 78 77.47 76.64 Louisiana Pass Rate 82.79% 78.82% 69.19% No. of National Candidates 5,845 18,851 9,201 National Mean Scaled Score 77.49 78.21 76.94 National Pass Rate 76.46% 83.07% 72.86%

B. Examinations for Technicians The Board has approved two pharmacy technician certification examinations – the Pharmacy Technician Certification Examination (PTCE) administered by the Pharmacy Technician Certification Board and the Examination for Certified Pharmacy Technicians (ExCPT) administered by National Healthcareer Association (NHA). Both examinations are computer adaptive tests which are administered in continuous window opportunities at multiple sites throughout the state. The results for all Louisiana-based PTCE and ExCPT candidates for Calendar Year 2018 are summarized here:

PTCE ExCPT Jan. – June July – Dec. Jan. – June July – Dec.

No. of Louisiana Candidates 657 572 57 66 Louisiana Pass Rate 40.9% 44.1% 46.2% 63.6% No. of National Candidates 27,331 21,512 National Pass Rate 57% 58% 64% 70%

C. Census Data At the close of the fiscal year on June 30, 2019, a review of our records yielded the following census information:

2019 2018 2017 • Pharmacy Program 1. Pharmacists > Number of active licenses 9,255 9,009 8,577 > Number of licensees within the state 5,795 5,690 5,588 2. Pharmacy Interns > Number of active registrations 1,094 1,070 1,094 3. Pharmacy technicians > Number of active certificates 6,601 6,586 6,561 4. Pharmacy technician candidates > Number of active registrations 1,595 2,000 2,052 5 Pharmacies > Number of active permits 2,033 1,988 1,983 - Community – Independent 605 590 583 - Community – Chain 596 630 651 - Hospital 172 175 175 - Institutional 22 22 23 - Marijuana 8 0 0 - Nuclear 13 13 14 - Charitable 9 10 11 - Penal 4 3 2 - Remote processor 2 1 0 - Nonresident 572 544 524 6. Equipment Permits > Emergency drug kit (EDK) 380 446 411 > Automated medication systems (AMS) 461 870 439 > Durable medical equipment (DME) 640 642 637 7. Special Activity Credentials > CDTM Registration 78 69 66 > Med. Administration Registration 3,161 3,073 2,820 > Special Work Permits 41 45 48 > Marijuana Pharmacy Designations 127 71 0 > PMP Access Registrations 19,686 15,835 (new)

Subtotal of Credentials in Pharmacy Program 45,174 41,770 24,688

2018 2018 2017 • CDS Program 1. Automated Medication System (AMS) 42 37 28 2. Advanced Practice RN (APRN) 3,435 2,980 2,343 3. Dentist 2,224 2,174 1.929 4. Drug Detection / Canine 6 8 8 5. Distributor 285 290 284 6. Podiatrist 163 158 136 7. Veterinarian 1,216 1,188 1,007 8. Animal Euthanasia Technician 28 29 25 9. Hospital 302 306 283 10. Laboratory 12 12 11 11. Physicians & Interns/Residents 14,196 13,144 11,575 12. Manufacturer 47 45 38 13. Medical Psychologist 91 91 84 14. Optometrist 360 349 297 15. Pharmacies 1,303 1,335 1,359 16. Physician Assistant 928 783 667 17. Registered Outsourcing Facility 19 19 13 18. Researcher 106 104 100 19. Substance Abuse Clinic 6 6 6

Subtotal of Credentials in CDS Program 24,769 23,058 20,193

Total Active Credentials under Management 69,943 64,828 44,881

D. New Credentials During the past fiscal year, the Board issued 5,864 new credentials in the Pharmacy Program and 2,929 new credentials in the CDS Program. Of note within the Pharmacy Program, we issued 523 new pharmacist licenses, 527 new pharmacy technician certificates, and 1,034 new pharmacy technician candidate registrations during the past fiscal year. Of note within the CDS Program, we issued new CDS licenses to 1,720 physicians, interns and residents, as well as 577 advanced practice registered nurses, and 163 dentists.

E. License Transfer (Reciprocity) Persons already licensed as a pharmacist by any other state who wish to obtain a license in Louisiana must successfully complete the MPJE as well as the application and criminal background check. Of the 523 new pharmacist licenses issued this past fiscal year, 295 were issued subsequent to completion of the reciprocity process. Compliance

A. Enforcement In order to control and regulate the practice of pharmacy in Louisiana, the Board employs five pharmacist compliance officers to perform routine inspections and special investigations throughout the year in all places under the Board’s jurisdiction. In addition to pharmacies, the compliance officers also inspect healthcare facilities to monitor compliance with controlled substance requirements. The compliance officers visited 1,426 pharmacies and other facilities during the year to perform routine inspections, site visits for permit changes and other calls for assistance. The compliance and administrative officers began the fiscal year with 180 cases from the previous fiscal year, received 433 new cases, and closed 434 cases, leaving 179 cases for the next fiscal year. Of the 434 cases closed during the fiscal year: 5 of the original complaints were withdrawn, 11 resulted from termination of previously imposed probationary periods, 88 were determined to be without violation, 26 cases were referred to other agencies, 122 resulted in field/administrative corrections, 19 resulted in administrative sanctions, and 163 cases were referred to the Board’s committees. The committees took no action in 12 of their cases, issued approvals for 30 non- disciplinary petitions, and recommended voluntary consent agreements for 121 cases. Of that number, all but five accepted the proposed discipline; those five respondents were referred for formal administrative hearings. The decisions from the formal hearings resulted in one denial of reinstatement, two suspensions, and two revocations. Compliance officers coordinate other investigative activities with a wide range of agencies, including local police departments, parish sheriff departments, other state regulatory and law enforcement agencies, and federal agencies such as the Drug Enforcement Administration, the Food and Drug Administration, and the Consumer Product Safety Commission. Though the compliance officers utilize the educational approach as the fundamental mechanism to achieve compliance, certain circumstances warrant formal board action.

B. Adjudications During the past fiscal year, the Board conducted two administrative hearings and levied formal disciplinary action against several credentials. A summary of that activity is presented here:

Pharmacist Intern Technician Candidate Permit CDS Sanction Denial / Refusal 1 0 1 1 0 0 Reinstatement 6 0 8 0 0 3 Change Previous Orders 6 0 0 0 0 0 Assessment 1 0 0 0 15 0 Letter of Warning 1 0 0 0 2 0 Letter of Reprimand 12 0 12 0 5 0 Voluntary Surrender 7 0 3 1 0 2 Probation 14 1 2 0 2 0 Suspension 4 0 1 1 0 0 Revocation 0 0 5 2 2 0 Other Decisions 20 0 2 1 7 0

C. Practitioner Recovery Program The Board established its program in 1988 to assist practitioners obtain treatment for their impairment, maintain their recovery, and assist their re-entry into professional practice. As of July 1, 2019 there were 42 pharmacists, one pharmacy intern, and seven pharmacy technicians actively engaged in the recovery program. They surrendered their credentials while in treatment; following treatment and upon favorable recommendation by board-certified addiction medicine specialists, they applied for the reinstatement of their credentials. The Board reinstated their credentials on probation, and the licensees practice under various restrictions designed to monitor their re-entry to professional practice. In addition, the credentials for 39 pharmacists, two interns, 17 technicians, and four technician candidates were still on active suspension for impairment reasons.

Board Activity

A. Regulatory The Board’s Regulation Revision Committee is tasked with the continuous review of the Board’s rules and their recommendation for revision as appropriate. The Board initiated and completed two regulatory projects during the fiscal year.  Louisiana Prescription Drug Uniform Prior Authorization Form, amending LAC 46:LIII.1129 and 1130, in collaboration with the La. State Board of Medical Examiners, as directed by Act 423 of the 2018 Legislature; and  Naloxone as Drug of Concern, amending LAC 46:LIII.2901, as directed by Act 146 of the 2018Legislature. As directed by other legislative acts and by the Board’s own initiative, the Board initiated 17 additional regulatory projects; these are pending review by the Occupational Licensing Review Commission for approval to initiate the formal promulgation process.

B. Legislative During the 2019 regular session, the Board sponsored three bills, all of which were successful.  Act 80 amended the prescription monitoring program law to enable the sharing of prescription monitoring information with federal agencies and jurisdictions.  Act 219 amended the licensing section of the controlled dangerous substance law to authorize the Board to require criminal history record checks for certain applicants for the state controlled dangerous substance license.  Act 354 amended the state’s list of controlled dangerous substances to harmonize the state list with recent federal scheduling actions.

C. Prescription Monitoring Program Finally, the Board continued its operation of Louisiana’s Prescription Monitoring Program (PMP). The vendor contract to operate the program is held by Appriss, Inc., based in Louisville, KY. As reported previously, Appriss acquired the previous vendor (Optimum Technology) in 2016 and transitioned the program to its operating platform, Aware Rx. The number of prescribers and dispensers authorized to access the program’s database continues to increase, as has the average number of queries per day. Since the program is required to file an annual report to the legislature, we have appended that report to this one to facilitate its separation.

Board Office

The Board currently employs 22 people on a full-time basis in a variety of professional, technical, and clerical roles; the Board also supports the local Cooperative Office Education (COE) program in Baton Rouge area high schools by hiring high school senior students on a temporary basis. The physical and mailing address of the board office is: Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, LA 70809-1700 Telephone (225) 925-6496

The board’s website address is www.pharmacy.la.gov and general email is received at [email protected].

Conclusion

The board has had an active year on several fronts, and all of these activities have contributed to the overall mission of the board. The officers and members of the board, as well as the entire office staff, are committed to achieving our goal of protecting the public’s health, safety and welfare through appropriate regulation of the practice of pharmacy in this state. We understand that public service is a privilege, and we endeavor to render that service honorably.

Respectfully submitted, Malcolm J Broussard Executive Director

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Prescription Monitoring Program Annual Report

Fiscal Year 2018-2019

July 1, 2019

Introduction

The Louisiana Prescription Monitoring Program (PMP) is an electronic database used to collect and monitor prescription data for all Schedule II, III, IV, and V controlled substances, as well as certain drugs of concern, dispensed by a pharmacy in Louisiana or to a Louisiana resident from a pharmacy located in another state. The PMP also provides a venue for monitoring patient prescription history for practitioners.

Act 676 of the 2006 Louisiana Legislature authorized the development, implementation, operation, and evaluation of an electronic system for the monitoring of controlled substances and other drugs of concern that are dispensed within the state or to state residents by pharmacies located in other states. The goal of the program is to improve the state’s ability to identify and inhibit the diversion of controlled substances and drugs of concern in an efficient and cost-effective manner and in a manner that shall not impede the appropriate utilization of these drugs for legitimate medical purposes.

The PMP was implemented in August 2008. Pharmacies and dispensing prescribers were instructed how and when to transmit their dispensing transactions to the program vendor for assimilation into the PMP database. Prescribers, dispensers, and other persons authorized to access PMP information were instructed how to secure their access privileges. The web portal to the PMP database was opened to queries on January 1, 2009, and the program remains fully operational.

Advisory Council

The enabling legislation created the PMP Advisory Council to assist the Board in the development and operation of the program. The council consists of the following members, each of whom may appoint a designee: 1. The president of the Louisiana State Board of Medical Examiners; 2. The president of the Louisiana State Board of Dentistry; 3. The president of the Louisiana State Board of Nursing; 4. The president of the Louisiana State Board of Optometry Examiners; 5. The president of the Louisiana Academy of Physician Assistants; 6. The president of the Louisiana Board of Pharmacy; 7. The superintendent of the Louisiana State Police; 8. The administrator of the United States Drug Enforcement Administration; 9. The speaker of the Louisiana House of Representatives; 10. The president of the Louisiana Senate; 11. The chairman of the House Committee on Health and Welfare; 12. The chairman of the Senate Committee on Health and Welfare; 13. The secretary of the Department of Health; 14. The president of the Louisiana State Medical Society; 15. The president of the Louisiana Dental Association; 16. The president of the Louisiana Association of Nurse Practitioners; 17. The president of the Optometry Association of Louisiana; 18. The president of the Louisiana Pharmacists Association; 19. The president of the Louisiana Independent Pharmacies Association; 20. The president of the National Association of Chain Drug Stores; 21. The president of the Louisiana Sheriffs’ Association; 22. The president of the Louisiana District Attorneys Association; 23. The president of the Pharmaceutical Research and Manufacturers of America; and 24. The president of the Louisiana Academy of Medical Psychologists.

During Fiscal Year 2018-2019, the council convened all four of their regularly-scheduled quarterly meetings. Representatives from six of the 24 organizations attended 100% of the meetings; ten entities attended 75%; two attended 50%; two attended 25%, and four entities had no representation at any of the meetings. During each of the meetings, program staff presented data concerning the number of prescription transactions reported to the program database as well as the number of queries to the database by prescribers, dispensers, law enforcement, and regulatory agencies. The staff also reported on the addition of new states available through the PMP InterConnect interstate network, as well as the increased utilization by the private sector of the PMP Gateway service, which integrates the PMP access portal into existing practice information systems in a variety of settings, including hospitals, clinics, practitioner offices, and pharmacies. The council reviewed new legislation adopted during the 2018 legislative session, and staff provided updates on the operational implementation of the legislative mandates.

Vendor Contract

With the 2013 contract expiring at the end of 2018, the Board solicited public bids for an expanded list of improvements and technical specifications. The La. Office of State Procurement awarded the new contract in January 2019 to Appriss, which was the sole bidder.

Program Highlights

• August 1, 2018 – established access for an epidemiologist with the La. Dept. of Health for public health surveillance purposes, as authorized by 232 of the 2018 Legislature. • December 21, 2018 – Louisiana Office of State Procurement awarded the PMP vendor contract to Appriss, Inc. with an effective date of January 1, 2019. • April 3, 2019 – through participation with the PMP InterConnect™ sponsored by the National Association of Boards of Pharmacy, achieved connection with the United States Military Health System and 26 states, including Alabama, Alaska, Arizona, Arkansas, Connecticut, Delaware, Florida, Georgia, Idaho, Kansas, Massachusetts, Minnesota, Mississippi, Montana, Nevada, New Mexico, North Carolina, North Dakota, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, and West Virginia. • May 6, 2019 – first distribution of Prescriber Report Cards. The Prescriber Report Card is intended to give prescribers insight into their opioid prescribing patterns. Reports are provided quarterly to all registered PMP prescriber users with an active account and a defined role and specialty who have written at least one opioid prescription during the prior six-month period.

Louisiana PMP Statewide Integration Project

On January 1, 2019, the Board partnered with the Louisiana Dept. of Health’s Office of Public Health, Bureau of Community Preparedness (LDH-OPH-BCP) and Appriss Health to provide a statewide PMP integration option to all healthcare providers in Louisiana utilizing a service called PMP Gateway®. Gateway offers healthcare providers an option to integrate PMP data within the provider’s electronic health record (EHR) or pharmacy information system to provide a streamlined clinical workflow for providers. The integration eliminates the need for providers to log in separately to the PMP web portal; instead, the EHR automatically initiates a patient query and returns the patient’s PMP information directly within the provider’s EHR or pharmacy information system.

Included as part of the integration, users now have access to an advanced analytics and patient support tool called NarxCare®. In addition to the existing Louisiana PMP functionality, NarxCare aggregates and analyzes prescription information from pharmacies and presents visual interactive information, as well as advanced analytic insights, machine learning risk scores and more to help prescribers and pharmacists provide better patient safety and outcomes for every patient. NarxCare also provides tools and resources that support patients’ needs and assists a healthcare provider to connect their patient to treatment when appropriate. This statewide initiative is funded by a Centers for Disease Control and Prevention (CDC) grant awarded to LDH-OPH-BCP and covers the costs of the licensing fees associated with the integration and NarxCare service.

As of June 30, 2019, the Louisiana PMP was interoperable with 80 licensees (EHR and pharmacy information systems) across the state. There were an additional 179 licensee applicants (EHRs and pharmacy information systems) which had applied for integration and were in process to complete the necessary requirements to obtain access. It is important to note that several licensees have numerous facilities across the state. Ochsner Health System, for example, is one licensee with multiple facilities across the state from New Orleans to Shreveport. Other such licensees include Franciscan Missionaries of Our Lady Health System, Lafayette General Health System, Wal-Mart Pharmacies, and Kroger Pharmacies.

Program Metrics

The data on the following pages provide summary data for the operational aspects of the program for Calendar Year 2018. The first graphic presents information about the use of the information by the authorized users as identified in the governing legislation. Data for the different categories of prescribers are presented, including the number of prescribers authorized to obtain PMP access privileges, the number with active access privileges and the number of queries to the PMP database by those prescribers. Other authorized users include law enforcement and regulatory agencies; information concerning the number of queries originating from those entities is also presented.

The second graphic presents information concerning the numbers of controlled substance prescriptions dispense in the state, including summary data for different types of drugs like opioids and benzodiazepines. Just over 11 million prescriptions were dispensed in the state during Calendar Year 2018, with an average of 2.424 prescriptions per Louisiana resident.

Outlook for Next Fiscal Year

The program is implementing several new features this year, including monitoring for mandatory use compliance as well as the initiation of clinical alerts. • The controlled substance law contains some mandatory use provisions for certain prescribers in certain situations, and there are some exceptions to those requirements. The monitor can alert staff when prescribers appear to deviate from the mandatory use requirements. Staff will relay the information to the prescriber’s licensing authority which can then determine whether an exception applies or compliance was not achieved. • The program will offer prescribers multiple types of clinical alerts. These electronic alerts are delivered directly to a prescriber’s dashboard and his email if desired to alert the prescriber that patient has  Exceeded a set prescriber/dispenser threshold;  Exceeded a daily active MME threshold;  Exceeded a daily active MME threshold for methadone;  Exceeded a days count threshold for opioid prescriptions; or  Been prescribed opioids and benzodiazepines concurrently. Louisiana Board of Pharmacy Prescription Monitoring Program Authorized User Statistics for Calendar Year 2018

Number of Providers Number of Providers Number of PMP Requests Number of PMP Requests Eligible for PMP Access with Active PMP Access Privileges through AWARxE™ through GATEWAY™ (as of 12/31/2018) (as of 12/31/2018) Healthcare Provider Roles Physician (MD, DO) 13,000 8,605 1,393,029 3,543,306 Nurse Practitioner (APRN) 3,226 2,473 300,383 109,849 Dentist (DDS) 2,225 1,509 21,658 0 Physician Assistant (PA) 880 624 65,442 10,435 Optometrist (OD) 360 148 35 0 Podiatrist (DPM) 161 109 879 0 Medical Psychologist (MP) 89 83 19,786 0 Medical Intern/Resident 1,076 937 3,354 0 Prescriber's Delegate NA 2,127 793,101 NA Pharmacist (PST) 9,069 4,156 1,289,904 720,124 Pharmacist's Delegate NA 812 140,533 NA Totals 30,086 21,583 4,028,104 4,383,714

Law Enforcement, Prosecutorial Officicals, & Specialty Courts DEA (patient requests) 521 Specialty Courts 102 FBI 335 Homeland Security 3 Local Law Enforcement 366 HHS - OIG 12 State Attorney General 1 State Police 40 Total 1380

Regulatory Agencies LA State Board of Medical Examiners 1,149 LA State Board of Dentistry 38 LA State Board of Nursing 918 LA State Board of Pharmacy 1,744 DEA (licensee requests) 808 Total 4,657

Other Roles Medical Examiner / Cororner 262 Louisiana Medicaid 726 Total 988 DISPENSATION DASHBOARD A high level overview of reported dispensation activity. Last Updated @ 7/29/2019 112040 AM Quick Slicers: State Rx per Capita 2.424 2015 2016 2017 2018 2019

EACH (TABLETS, KITS, ETC.. 513,932K d y e t i Prescriptions s Days Supply t GRAMS (SOLIDS) 3,256K n n e a p 81,609K

u MILLILITERS (LIQUIDS) 11,307,069 s 265,983,525 i Q D UNSPECIFIED 118K

YoY Prescriptions (#) YoY Prescriptions (#) by Drug Schedule YoY Prescriptions (#) by Drug Classes

Schedule 2 2018 5,139,558 Opioid 2018 4,786,754 10M Schedule 3 2018 725,533 Benzo 2018 2,498,343 Schedule 4 2018 4,579,843 Anxiolytic, Hypnotics, Se.. 2018 998,486 Schedule 5 2018 539,681 Other 2018 3,023,486 Unscheduled 2018 321,288 5M Unspeciﬁed 2018 1,166

0M 2018

Prescriptions >= 90 MME vs. All Rx by Patient Demographic Environment New vs. Reﬁll Prescriptions Opioids vs. Non Opioids (%)

RURAL 19% GTE 90 2.9% Reﬁll 20.3% Non-Opioid 58% SUPER RURAL 4% LT 90 97.1% New 79.7% Opioid 42% URBAN 77% Conclusion

The program has completed approximately ten years of operation. Based on feedback from authorized users, it appears to represent an efficient and cost-effective use of resources. Data from the program suggests we have made some progress in the reduction of diversion of controlled substances. Our interstate collaborations have yielded high marks for our program design and operation. We look forward to fully developing the potential of our program to identify and inhibit the diversion of controlled substances in Louisiana.

We appreciate the contributions from and collaboration with our partners on the Prescription Monitoring Program Advisory Council. We also acknowledge the contributions from our administrative coordinators, Ms. Danielle Hartzog and Ms. Nerissa Montgomery, and the program manager, Mr. Joseph Fontenot, for their assistance with the development of this report and administrative oversight of the program.

Respectfully submitted, Malcolm J. Broussard Executive Director Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Multistate Pharmacy Jurisprudence Examination (MPJE™)

January 1 – April 30, 2019

State & National Summary Data Frequency Distribution of Scaled Scores

August 14, 2019

MPJE-LA-2019 Trimester 1

Multistate Pharmacy Jurisprudence Examination® (MPJE®) State Summary Report

Louisiana

Test Window: January 1, 2019 - April 30, 2019

Table 1 First-Time Candidates, ACPE-Accredited Programs Only

Total Scaled Standard Candidates Pass Rate % Score Mean Deviation

State 118 86.44% 79.25 3.72 National 4648 81.95% 78.09 4.11

Table 2 All Candidates

Total Scaled Standard Candidates Pass Rate % Score Mean Deviation

State 157 79.62% 78.26 3.97 National 6583 76.77% 77.38 4.11

Table 3 Total Scaled Score Min/Max

Table 3 contains information on the range of Min Max scaled scores achieved by FT ACPE (First-Time, ACPE-Accredited) candidates as well as the FT ACPE 58 96 pool of all candidates. It also shows the All Candidates 58 96 boundaries of the Scaled Score Range. Scale Score Range 0 100

Candidates who did not answer enough questions to receive a score are reflected in pass rate data as a fail but are not included in mean scaled score data.

Page 1 of 3 The following tables and graphs are scaled score frequency distributions for MPJE candidates. Candidates who did not answer enough questions to receive a score are not reflected in the frequency distributions.

Table 4 & Graph 1 State Frequency Distribution of Scaled Scores

Based on Total Tests Administered N = 157

30 Frequency

Scaled Score Interval

Page 2 of 3 Table 5 & Graph 2 National Frequency Distribution of Scaled Scores

Based on Total Tests Administered N = 6580

3500

3000

2500

2000

1500 Frequency

1000

500

Scaled Score Interval

Page 3 of 3 Multistate Pharmacy Jurisprudence Examination (MPJE) for Louisiana Board of Pharmacy

2018 2019 2020 2021 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

First-Time Candidates, ACPE-Accredited Programs Only

No. of State Candidates 76 329 131 118

State Pass Rate 90.53% 78.37% 71.76% 86.44%

State Scaled Score Mean 79.02 77.56 77.19 79.25

No. of National Candidates 4,113 16,502 5,987 4,648

National Pass Rate 82.37% 85.00% 76.03% 81.95%

National Scaled Score Mean 78.26 78.50 77.46 78.09

All Candidates

No. of State Candidates 111 370 211 157

State Pass Rate 82.79% 78.82% 69.19% 79.62%

State Scaled Score Mean 78.00 77.47 76.64 78.26

No. of National Candidates 5,845 18,851 9,201 6,583

National Pass Rate 76.46% 83.07% 72.86% 76.77%

National Scaled Score Mean 77.49 78.21 76.94 77.38 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

North American Pharmacist Licensure Examination (NAPLEX™)

January 1 – April 30, 2019

State & National Summary Data Frequency Distribution of Scaled Scores

August 14, 2019

NAPLEX-LA-2019 Trimester 1

North American Pharmacist Licensure Examination® (NAPLEX®) State Summary Report

Louisiana

Test Window: January 1, 2019 - April 30, 2019

Table 1 First-Time Candidates, ACPE-Accredited Programs Only

Total Scaled Standard Area 1 Scaled Standard Area 2 Scaled Standard Candidates Pass Rate % Score Mean Deviation Score Mean Deviation Score Mean Deviation

State 3 66.67% 71.33 26.65 11.00 1.00 11.33 2.08 National 374 67.11% 82.00 20.14 11.79 1.20 11.87 1.41

Table 2 All Candidates

Total Scaled Standard Area 1 Scaled Standard Area 2 Scaled Standard Candidates Pass Rate % Score Mean Deviation Score Mean Deviation Score Mean Deviation

State 24 70.83% 76.50 15.53 11.42 0.83 11.67 1.17 National 1344 61.24% 77.80 17.60 11.48 1.07 11.70 1.23

Table 3 Total Scaled Score Min/Max

Table 3 contains information on the range of scaled Min Max scores achieved by FT ACPE (First-Time, ACPE- Accredited) candidates as well as the pool of all FT ACPE 17 135 candidates. It also shows the boundaries of the Scaled All Candidates 1 135 Score Range. Scale Score Range 0 150

Page 1 of 3 The following tables and graphs are scaled score frequency distributions for NAPLEX candidates.

Table 4 & Graph 1 State Frequency Distribution of Scaled Scores

Based on Total Tests Administered N = 24

Cumulative Percent of Scaled Score Range Frequency the Upper Limit of the Interval [0,4] 0 0% [0,4] 0 [5,9] 0 0% [5,9] 0 [10,14] 0 0% [10,14] 0 [15,19] 0 0% [15,19] 0 [20,24] 0 0% [20,24] 0 [25,29] 0 0% [25,29] 0 [30,34] 0 0% [30,34] 0 [35,39] 0 0% [35,39] 0 [40,44] 1 4% [40,44] 1 [45,49] 0 4% [45,49] 0 [50,54] 2 13% [50,54] 2 [55,59] 1 17% [55,59] 1 [60,64] 1 21% [60,64] 1 [65,69] 1 25% [65,69] 1 [70,74] 1 29% [70,74] 1 [75,79] 6 54% [75,79] 6 [80,84] 4 71% [80,84] 4 [85,89] 3 83% [85,89] 3 [90,94] 2 92% [90,94] 2 [95,99] 0 92% [95,99] 0 [100,104] 1 96% [100,104]1 [105,109] 1 100% [105,109]1 [110,114] 0 100% [110,114]0 [115,119] 0 100% [115,119]0 [120,124] 0 100% [120,124]0 [125,129] 0 100% [125,129]0 [130,134] 0 100% [130,134]0 [135,139] 0 100% [135,139]0 [140,144] 0 100% [140,144]0 [145,150] 0 100% [145,150]0

3 Frequency

Scaled Score Interval

Page 2 of 3 Table 5 & Graph 2 National Frequency Distribution of Scaled Scores

Based on Total Tests Administered N = 1344

Cumulative Percent of Scaled Score Range Frequency the Upper Limit of the Interval [0,4] 2 0% [0,4] 2 [5,9] 0 0% [5,9] 0 [10,14] 0 0% [10,14] 0 [15,19] 3 0% [15,19] 3 [20,24] 2 1% [20,24] 2 [25,29] 3 1% [25,29] 3 [30,34] 11 2% [30,34] 11 [35,39] 12 2% [35,39] 12 [40,44] 26 4% [40,44] 26 [45,49] 21 6% [45,49] 21 [50,54] 43 9% [50,54] 43 [55,59] 60 14% [55,59] 60 [60,64] 83 20% [60,64] 83 [65,69] 119 29% [65,69]119 [70,74] 136 39% [70,74]136 [75,79] 184 52% [75,79]184 [80,84] 176 66% [80,84]176 [85,89] 141 76% [85,89]141 [90,94] 96 83% [90,94] 96 [95,99] 96 90% [95,99] 96 [100,104] 50 94% [100,104]50 [105,109] 41 97% [105,109]41 [110,114] 20 99% [110,114]20 [115,119] 9 99% [115,119]9 [120,124] 6 100% [120,124]6 [125,129] 2 100% [125,129]2 [130,134] 1 100% [130,134]1 [135,139] 1 100% [135,139]1 [140,144] 0 100% [140,144]0 [145,150] 0 100% [145,150]0

200

180

160

140

120

100

Frequency 80

Scaled Score Interval

Page 3 of 3 North American Pharmacist Licensure Examination (NAPLEX) for Louisiana Board of Pharmacy

2018 2019 2020 2021 Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

First-Time Candidates, ACPE-Accredited Programs Only

No. of State Candidates 1 204 24 3

State Pass Rate 0.00% 89.22% 45.83% 66.67%

State Scaled Score Mean 50.00 94.10 76.04 71.33

No. of National Candidates 290 12,271 2,019 374

National Pass Rate 64.48% 91.64% 72.76% 67.11% 72.20 National Scaled Score Mean 97.54 84.56 82.00

All Candidates

No. of State Candidates 17 215 50 24

State Pass Rate 35.29% 86.98% 50.00% 70.83%

State Scaled Score Mean 72.88 93.10 76.24 76.50

No. of National Candidates 1,349 13,152 3,582 1,344

National Pass Rate 56.56% 89.57% 69.24% 61.24%

National Scaled Score Mean 77.61 96.25 82.00 77.80 Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Examination for the Certification of Pharmacy Technicians (ExCPT™)

April – June 2019

Cumulative Record (since January 2018)

August 14, 2019

National Healthcareer Association ExCPT

Calendar Year 2018 Calendar Year 2019 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr

First-Time Candidate Group No. of LA Candidates 7 32 34 32 48 71

No. of LA Candidates who passed 2 16 20 22 41 127

State Pass Rate 29% 50% 59% 69% 85% 56%

No of National Candidates 1835 3942

No. of National Candidates who passed 1356 2503

National Pass Rate 66% 61% 70% 70% 74% 63%

Multiple Attempts Group No. of LA Candidates 2 6 2 5 1 1

No. of LA Candidates who passed 1 3 2 2 1 1

State Pass Rate 50% 50% 100% 40% 100% 100%

No. of National Caniddates 172 194

No. of National Candidates who passed 94 95

National Pass Rate 62% 47% 40% 55% 55% 49% Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Pharmacy Technician Certification Examination (PTCE™)

January – June 2019

Cumulative Record (since January 2000)

August 14, 2019

Louisiana Board of Pharmacy

Pharmacy Technician Certification Examination (PTCB) Data

2000-2018 2000-2019 National Data 1/1/2018 to 6/30/2018 7/1/2018 to 12/31/2018 Totals Data 1/1/2019 to 6/30/2019 7/1/2019 to 12/31/2019 Totals Data First Attempt No. of Candidates Attempting 22,517 17,277 39,794 21,026 No. of Candidates Passing 13,510 10,539 24,049 12,616 Pass Rate 60% 61% 60.0% 60%

Repeaters No. of Candidates Attempting 4,814 4,235 9,049 4,610 No. of Candidates Passing 2,166 1,948 4,114 2,167 Pass Rate 45% 46% 45.0% 47%

Totals No. Candidates Attempting 27,331 21,512 48,843 895,313 25,636 No. Candidates Passing 15,579 12,477 28,056 625,288 14,783 Pass Rate 57% 58% 57.0% 70% 57%

Louisiana Data First Attempt No. of Candidates Attempting 452 400 852 402 No. of Candidates Passing 199 184 383 193 Pass Rate 44.0% 46.0% 44.9% 48.0%

Repeaters No. of Candidates Attempting 205 172 377 138 No. of Candidates Passing 74 71 145 51 Pass Rate 36.1% 41.3% 38.5% 37.0%

Totals No. Candidates Attempting 657 572 1,229 17,062 540 No. Candidates Passing 269 252 521 10,191 243 Pass Rate 40.9% 44.1% 42.4% 59.7% 45.0% Louisiana Board of Pharmacy

Pharmacy Technician Certification Examination (PTCB) Data

2000-2013 2000-2014 2000-2015 National Data Data 1/1/2014 to 6/30/2014 7/1/2014 to 12/31/2014 Data 1/1/2015 to 06/30/2015 7/1/2015 to 12/31/2015 Data

No. of Candidates Attempting 628,957 26,423 27,085 682,465 22,197 36,167 740,829 No. of Candidates Passing 470,680 15,233 15,125 501,038 13,280 21,643 535,961

Pass Rate 74.8% 57.7% 55.8% 73.4% 59.8% 59.8% 72.3%

Louisiana Data

No. of Candidates Attempting 11,002 630 568 12,200 480 632 13,314 No. of Candidates Passing 7,451 287 265 8,003 255 304 8,562

Pass Rate 67.7% 45.6% 46.7% 65.6% 53.1% 48.1% 64.3%

2000-2016 2000-2017 National Data 1/1/2016 to 12/31/2016 Total Candidates Data 1/1/2017 to 12/31/2017 Total Candidates Data First Attempt No. of Candidates Attempting 43,958 53,330 794,159 43,180 52,311 846,470 No. of Candidates Passing 26814 30,931 566,892 25,908 30,340 597,232 Pass Rate 61% 58% 71% 60% 58% 71%

Repeaters No. of Candidates Attempting 9,372 9,131 No. of Candidates Passing 4,217 4,200 Pass Rate 45% 46%

Louisiana Data First Attempt 840 1,298 14,612 843 1,221 15,833 No. of Candidates Attempting 412 571 9,133 405 537 9,670 No. of Candidates Passing 49% 44% 62.50% 48% 44% 61% Pass Rate

Repeaters No. of Candidates Attempting 458 378 No. of Candidates Passing 156 129 Pass Rate 34% 34% Louisiana Board of Pharmacy

Pharmacy Technician Certification Examination (PTCB) Data

2000-2009 1/1/2010 4/1/2010 7/1/2010 10/1/2010 2000-2010 1/1/2011 4/1/2011 7/1/2011 10/1/2011 National Data Data 3/31/2010 6/30/2010 9/30/2010 12/31/2010 Data 3/31/2011 6/30/2011 9/30/2011 12/31/2011

No. of Candidates Attempting 415,875 11,611 15,033 16,025 12,774 471,318 11,219 14,026 12,356 14,031 No. of Candidates Passing 309,035 8,521 11,216 12,349 9,275 350,396 8,366 10,472 9,565 10,826

Pass Rate 74% 73% 75% 77% 73% 74% 75% 75% 77% 77%

Louisiana Data

No. of Candidates Attempting 9,843 217 421 320 268 11,069 247 437 268 257 No. of Candidates Passing 6,688 121 287 219 166 7,481 161 306 182 168

Pass Rate 68% 56% 68% 68% 62% 68% 65% 70% 68% 65%

2000-2011 1/1/2012 4/1/2012 7/1/2012 10/1/2012 2000-2012 Changed to semi-annual reports National Data Data 3/31/2012 6/30/2012 9/30/2012 12/31/2012 Data 1/1/2013 to 6/30/2013 7/1/2013 to 12/31/2013

No. of Candidates Attempting 522,950 11,851 14,356 14,375 11,180 574,712 25,448 28,797 No. of Candidates Passing 389,625 9,232 11,044 10,982 8,471 429,354 19,581 21,745

Pass Rate 75% 78% 77% 76% 76% 75% 77% 76%

Louisiana Data

No. of Candidates Attempting 12,278 246 368 329 239 13,460 622 537 No. of Candidates Passing 8,298 158 269 226 168 9,119 412 351

Pass Rate 68% 64% 73% 69% 70% 68% 66% 65% Louisiana Board of Pharmacy

Pharmacy Technician Certification Examination (PTCB) Data

2000-2005 2000-2006 2/5/2007 4/24/2007 8/27/2007 11/26/2007 National Data Data 3/11/2006 7/22/2006 9/9/2006 11/18/2006 Data 3/9/2007 5/25/2007 9/28/2007 12/31/2007

No. of Candidates Attempting 225,206 12,383 18,992 3,029 15,285 274,895 8,768 10,730 14,666 10,881 No. of Candidates Passing 177,102 8,559 12,609 2,006 9,145 209,421 6,034 7,487 10,497 7,472

Pass Rate 79% 69% 66% 66% 60% 76% 69% 70% 72% 69%

Louisiana Data

No. of Candidates Attempting 5,713 288 420 59 312 6,792 216 306 266 207 No. of Candidates Passing 4,179 181 239 37 137 4,773 133 196 177 121

Pass Rate 73% 63% 57% 63% 44% 70% 62% 64% 67% 58%

2000-2007 2/4/2008 4/28/2008 8/18/2008 11/10/2008 2000-2008 1/1/2009 4/1/2009 7/1/2009 10/1/2009 National Data Data 3/14/2008 6/20/2008 10/10/2008 12/19/2008 Data 3/31/2009 6/30/2009 9/30/2009 12/31/2009

No. of Candidates Attempting 319,940 7,547 14,291 16,385 11,792 369,955 13,087 8,424 13,735 10,674 No. of Candidates Passing 240,911 5,165 10,155 11,781 7,770 275,782 9,141 6,363 10,067 7,682

Pass Rate 75% 68% 72% 72% 66% 75% 70% 76% 73% 72%

Louisiana Data

No. of Candidates Attempting 7,787 128 392 304 215 8,826 301 260 238 218 No. of Candidates Passing 5,400 72 233 182 118 6,005 184 196 166 137

Pass Rate 69% 56% 59% 60% 55% 68% 61% 75% 70% 63% Louisiana Board of Pharmacy

Pharmacy Technician Certification Examination (PTCB) Data

1995-1999 National Data Data 3/25/2000 7/22/2000 11/18/2000 3/10/2001 7/14/2001 11/10/2001 3/16/2002 7/27/2002 11/16/2002

No. of Candidates Attempting 58,382 8,101 12,317 12,941 8,442 12,057 10,608 8,874 13,399 11,521 No. of Candidates Passing 47,973 6,206 10,006 9,520 6,116 9,799 8,354 7,072 10,681 9,164

Pass Rate 82% 77% 81% 74% 72% 81% 79% 80% 80% 80%

Louisiana Data

No. of Candidates Attempting 514 141 346 327 187 310 324 269 383 308 No. of Candidates Passing 390 92 271 221 125 227 228 184 269 213

Pass Rate 76% 65% 78% 68% 67% 73% 70% 68% 70% 69%

2000-2002 National Data Data 3/29/2003 7/26/2003 11/15/2003 3/20/2004 7/17/2004 11/13/2004 3/19/2005 7/23/2005 11/19/2005

No. of Candidates Attempting 98,260 12,147 14,162 13,401 11,508 15,942 13,795 13,673 18,250 14,068 No. of Candidates Passing 76,918 9,506 11,720 11,006 9,100 12,196 10,818 11,009 14,246 10,583

Pass Rate 78% 78% 83% 82% 79% 77% 78% 81% 78% 75%

Louisiana Data

No. of Candidates Attempting 2,595 385 384 351 285 382 290 337 488 216 No. of Candidates Passing 1,830 294 286 271 211 281 214 274 351 167

Pass Rate 71% 76% 74% 77% 74% 74% 74% 81% 72% 77% Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809 www.pharmacy.la.gov

______Interoffice_Memo______

To: Malcolm Broussard Date: August 08, 2019 Executive Director

From: Benjamin S. Whaley, R.Ph., Chief Compliance Officer

Subject: Hurricane Barry Assessment

The impact of Hurricane Barry on Louisiana pharmacies was limited. In order to determine this, the compliance officers called or visited various pharmacies in each of their respective territories and inquired whether they were impacted or if they knew of other pharmacies that were impacted. The Board also received formal notifications from the corporate offices of multiple chain pharmacies and healthcare organizations.

While most of the affected pharmacies only temporarily lost power, there were a small number of pharmacies in which management determined the outage could have compromised the refrigerated stock. For these pharmacies, the Board office was notified accordingly, and the drugs were quarantined for reverse distribution.

With the exception of two pharmacies, we are not aware of any physical damage caused by the storm. A Walgreens in New Orleans took on a small amount of water, and their management addressed it accordingly. Option Care, a sterile compounding pharmacy in Elmwood, also had water intrusion which entered the cleanroom. Compounding was immediately discontinued, and the services were outsourced to their Texas and Alabama locations. Both out-of-state locations possess valid NR permits. The PIC stated that the cleanroom has been remediated, but they currently have no plans to resume compounding at this location.

Because the impact is very limited, the pharmacies that had issues were able to resolve them quickly. It does not appear there will be any long-term effects from Hurricane Barry.

______Benjamin Whaley, R.Ph. Chief Compliance Officer Louisiana Board of Pharmacy

Enhancing Well-being and Resilience Among the Pharmacist Workforce: A National Consensus Conference

Introduction Nearly a half-century of research has described the issues and concerns associated with job stress, moral distress, work overload, burnout, and level of control within the pharmacy profession. After decades of discussion and engagement in diverse strategies by pharmacy stakeholders combined with rapid changes in the practice models of pharmacy and an ever-changing, evolving health care system, it is clear that the pharmacist workforce is currently at a critical juncture. The well-being and resilience of the pharmacist workforce must be effectively and efficiently addressed by all pharmacy stakeholders. To address this important issue, a collaboration was formed between the American Association of Colleges of Pharmacy (AACP), the Accreditation Council for Pharmacist Education (ACPE), the 18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM American Pharmacists Association (APhA), the National Association of Boards of Pharmacy (NABP), and the National Alliance of State Pharmacy Associations (NASPA) and the Enhancing Well-being and Resilience Among the Pharmacist Workforce: A National Consensus Conference was planned and conducted. The objectives of the consensus conference were to: • Evaluate factors that contribute to well-being and resilience at the individual, organizational, and profession levels. • Develop strategies that could improve pharmacist well-being and resilience and decrease moral distress within individuals, managers, organizations, and the profession. • Identify and prioritize strategies that will drive change and fuel improvements in well-being and resilience. • Develop actionable recommendations that guide organizations and individuals in implementing positive change. Diverse stakeholders within the profession—representing pharmacists and employers from across practice settings, schools and colleges of pharmacy, and professional organizations—came together in Chicago from July 17–19, 2019, and engaged in a thoughtful and intentional process to discuss issues and concerns associated with well-being, moral distress, work overload, and burnout. The goal of the conference was the development and approval of meaningful and actionable recommendations that can be effectively implemented broadly to address this important issue.

18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM Enhancing Well-being and Resilience Among the Pharmacist Workforce: A National Consensus Conference

Consensus Recommendations Recommendations Related to the Improvement of Pharmacist Work Conditions and Patient Safety A total of 50 recommendations were developed and approved by consensus to provide • Employers must prioritize patient safety, immediate, viable, and sustainable solutions to quality of care, and pharmacist well-being create improvements in critical areas related when setting workload expectations and to well-being and resilience for pharmacy ensure the pharmacy workforce is adequately professionals at the societal level, at the staffed, trained, and utilized to complete the organizational level, and the individual level. The expected work volume. intent of these recommendations is broad, with • Employers, payers, accreditors, and opportunities for action by any individual or 18333-22x8_Sign_.indd 2 regulators should assess the relevance, 6/7/2019 9:48:44 AM organization within the pharmacy profession to frequency, and need for required effect change within their spheres of influence. administrative tasks in order to reduce The accepted consensus recommendations burdens that detract from quality patient reflect opportunities to support meaningful and care and compromise pharmacists’ actionable change by addressing improvement of: well-being. • Pharmacist work conditions and patient • Employers should promote professional safety autonomy, seek pharmacy team input, and encourage open communication to • Payment models effectively establish and meet patient care • Relations between pharmacists and and business objectives (e.g., quotas/metrics/ employers goals) and achieve shared success. • Pharmacist and student pharmacist • Employers should provide pharmacists with well-being mandatory, scheduled, uninterrupted meal breaks away from the pharmacy workflow to • Well-being education and training promote pharmacist well-being and improve • Communications patient safety. • Data, information, and research on • Employers and boards of pharmacy pharmacist well-being should adopt a Just Culture approach to management of medication errors that It is anticipated that accepted recommendations focuses on system improvement within a will be broadly implemented across the learning culture. profession to effect meaningful change. It is anticipated that additional insights and action • Employers should implement workflow and plans will be developed by organizations, technology solutions that facilitate effective individuals, and other stakeholders to contribute and efficient provision of patient-centered to improving the well-being and resilience of the care, decrease pharmacist burden, and pharmacist workforce. alleviate moral distress.

18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM Enhancing Well-being and Resilience Among the Pharmacist Workforce: A National Consensus Conference

• Employers should support staffing and • Professional associations should collaborate scheduling models that allow pharmacists with other stakeholders to advocate for flexibility to establish and maintain legislative changes in payment models relationships with their pharmacy team, their focused on fair compensation for pharmacist patients, and their local communities. professional services by medical and pharmacy payers independent of medication • The National Association of Boards of products, devices, or supplies. Pharmacy should work with its membership and stakeholders to craft model language Recommendations Related to the Improvement of related to meal breaks and other working Relations Between Pharmacists and Employers 18333-22x8_Sign_.indd 2 conditions that prioritize the delivery of safe 6/7/2019 9:48:44 AM and effective patient care. • Employers and pharmacist managers should create a culture that facilitates open • State boards of pharmacy should evaluate communication and trust, which empowers legislative and regulatory requirements to the pharmacy workforce to identify and streamline and remove unnecessary burden actively participate in creating solutions to on pharmacists and their ability to safely address burnout. provide patient care. • Pharmacists should establish and • Professional associations should work with communicate mutually agreeable boundaries boards of pharmacy to disseminate informa- with managers, supervisors, patients, and tion about state statutes and rules related to other health professionals without fear of well-being, working conditions, and burnout. retribution. • Employers and pharmacist managers should • Employers and pharmacist managers should advocate for expanded roles for pharmacy conduct root cause analyses to understand technicians and support technician career pharmacist burnout and moral distress advancement to enhance the pharmacist’s within their workforce, create viable solutions ability to provide patient care. to address identified issues, and routinely conduct follow-up assessments. Recommendations Related to the Improvement of Payment Models • Employers should hold forums to hear the concerns of frontline pharmacists, implement • The pharmacy profession should actively solutions, and communicate actions made engage and partner with other health toward addressing the identified issues. professional organizations, patient advocacy groups, regulators, and pharmacy benefit • Pharmacists should actively engage in managers/payers that represent top productive dialogue with employers—without market share to (1) drive transparency and fear of retribution—to improve awareness expose PBM/health plan payment models of issues that negatively affect well-being that create patient safety issues, and (2) and resilience and identify and implement eliminate the erosion in reimbursement that solutions. compromises sustainability of and investment disincentivizes organizations from investing in pharmacist-provided patient care services.

18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM Enhancing Well-being and Resilience Among the Pharmacist Workforce: A National Consensus Conference

• Employers should train and sensitize non- • Employers and pharmacist managers should pharmacist managers and supervisors allow flexibility for pharmacists to engage about the professional requirements and in a variety of professional opportunities expectations of pharmacists as health care and practice responsibilities to reduce providers, including strategies to support a redundancy that leads to burnout. positive and safe work environment. • Employers should reward and incentivize • Employers, pharmacist managers, and employees to engage in well-being activities. practicing pharmacists should work to ensure • Pharmacist managers should engage in job fit by being mutually transparent and ongoing leadership training that includes 18333-22x8_Sign_.indd 2 authentic about requirements, expectations, 6/7/2019 9:48:44 AM communications, team building, staff responsibilities, and anticipated challenges development, advocacy, pharmacist burnout, for specific pharmacy positions. moral distress, and workism and implement these skills to effectively lead their workforce. Recommendations Related to the Improvement of Pharmacist and Student Pharmacist Well-being • Employers and schools and colleges of • Pharmacists should assume their professional pharmacy should establish strategic plan responsibility to proactively identify personal priorities that facilitate the development of a stressors, learn self-care techniques, and culture of well-being and resilience. consistently apply strategies that address • The Accreditation Council for Pharmacy well-being and help prevent burnout. Education should require the inclusion of • Employers and schools and colleges of annual well-being assessments for students, pharmacy should establish trauma and faculty, and staff to facilitate regular dialogue, second victim support programs and destigmatize behavioral health, and guide resources, including access to respite time to organizational initiatives within schools and help pharmacists and student pharmacists colleges of pharmacy. recover and cope with situations (e.g., armed • The Accreditation Council for Pharmacy robberies, suicides, natural disasters, tragic Education should integrate concepts related medication errors, and terroristic threats) to well-being and resilience into accreditation that affect their safety, well-being, and standards and guidance. professional confidence. • The American Society of Health-System • Pharmacist managers should prioritize and Pharmacists should revise residency model well-being and resilience for their accreditation standards to include well-being workforce. of residents and preceptors as a critical • State boards of pharmacy should consider factor. the relationship between pharmacist well- • Professional associations should adopt and being and patient safety when promulgating prioritize the findings from theEnhancing rules and regulations that govern the practice Well-being and Resilience Among the of pharmacy. Pharmacist Workforce: A National Consensus Conference.

18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM Enhancing Well-being and Resilience Among the Pharmacist Workforce: A National Consensus Conference

Recommendations Related to the Improvement of • Professional associations and schools of Well-being Education and Training pharmacy should develop and deliver training that teaches strategies and skill sets to • Employers, pharmacy associations, and effectively manage personal financial issues schools and colleges of pharmacy should that affect well-being. provide education and training on how to effectively manage angry and abusive Recommendations Related to the Improvement of individuals and address situations in which Communications personal safety may be compromised. • Professional associations should support • Employers, pharmacist managers, and 18333-22x8_Sign_.indd 2 the Pharmacists for Healthier Lives outreach 6/7/2019 9:48:44 AM pharmacists should apply a change- campaign to enhance public perceptions management approach to prepare and of the pharmacist’s role in improving health support the pharmacy workforce in outcomes. responding and adapting to changes in pharmacy practice. • Accreditors should utilize standard assessment processes and solicit user • Schools and colleges of pharmacy should feedback to continuously improve the clarity incorporate ongoing education, self- and value of guidance documents. evaluation, and reflection for student pharmacists, faculty, staff, preceptors, and • Professional associations should develop a graduate students on topics of well-being, unified communications approach that is resilience and behavioral health. accessible to all pharmacists and consolidates relevant information to reduce professional • All faculty, staff, student pharmacists, and isolation and communication overload. preceptors should complete formal training that addresses behavioral health awareness • Conference proceedings and (e.g., Mental Health First Aid and Question. recommendations should be widely Persuade. and Refer.). disseminated by pharmacy organizations, including using the subscriber data from CPE • The pharmacy profession should leverage Monitor® to reach all relevant stakeholders. existing programs (e.g., the APhA Institute on Substance Use Disorders and state pharmacy recovery networks) in order to address the consequences of burnout. • Professional associations should develop and deliver training, tools, and resources that teach strategies and skills related to personal well-being and professional resilience, and address behavioral health issues.

18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM Enhancing Well-being and Resilience Among the Pharmacist Workforce: A National Consensus Conference

Recommendations Related to the Improvement Recommendations Related to the Improvement of of Data, Information, and Research on Pharmacist Pharmacist Professional Development Well-being • Employers should partner with professional • Professional associations and schools and associations and schools and colleges of colleges of pharmacy should conduct pharmacy to provide and encourage access research to establish national standards to mentors, role models, career options, related to pharmacy metrics that promote and relatable stories to help pharmacists patient safety and pharmacist well-being. and student pharmacists improve their • Professional associations and state boards competence and confidence throughout their

18333-22x8_Sign_.indd 2 of pharmacy should support dissemination careers. 6/7/2019 9:48:44 AM of profession-wide surveys that assess well- • Employers and schools and colleges of being and patient safety and advocate for pharmacy should provide training and pharmacists to complete them. resources to support pharmacists and • The American Association of Colleges of student pharmacists in all settings and Pharmacy should collect and disseminate roles to enhance business and people- well-being and resilience best practice tools management skills. and approaches being used in schools and • Employers should support networking and colleges of pharmacy. engagement opportunities that promote • Professional associations should advocate for professional collegiality between pharmacists research of pharmacist work environments and other health care team members. to evaluate aspects that lead to burnout and identify best practices, and pursue funding sources to support these efforts.

18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Agenda Item 12

Request for Approval of Pilot Project

Automated Medication System in Correctional Facility

Mr. Robert Sonnier Institutional Pharmacies of Louisiana Scott, LA

wIPIJ INSTITUTIONAl. Yours RM Managing Robert Institutional Enclosed: Thank anything Again, any is representative Please Dear Power includes Pharmacy August 3388 Re: Baton Louisiana Executive MalcolmJ. a S/cl pharmacist technical II Mr. Brentwood Very IARMACIES you Rouge, a feel Point M. A Request 1, sincere a you Correctional Broussard, Board 2019 Director Partner Sonnier, meeting. copy for Truly, free Broussard Pharmacies presentation OF need questions Louisiana obliging Copy from LOUISIANA who of to for thanks of Drive the distribute prior Jr., Pharmacy Approval In of deals Omnicell®, Setting letter response Request RPh my for that 70809 to of slides with request allowing the Louisiana, I may this of sent August regulatory Letter! Pilot William to that information arise. to to your us Project: would you be LLC valuable 141h Copy email, C. included via affairs Maguire, meeting be e-mail of Use to please used Presentation meeting Board for of on concerning please Automated RPh, at Omnicell® the find your members time docket will the feel direction. Slides accompany to enclosed and free our for Medication make at your request will the to this contact August information be discretion. us present request. and for System me 14t[1 the a copy at to meeting. Board A If which (AMS) any there answer company of time. Toll Fax: Phone: Scott, 106 the of in is Abigayle’s Free: 337.2689390 He LA 3372684023 70583 866.9910211 Row ‘V INSTITU11ONAL facility facility. care of specification. country. Request administration. facility. the program of Section type company. administration using Dear VIA 3388 August Executive MalcoImJ. Baton Louisiana automation a board, E-MAIL: pilot giver II of Mr. Brentwood IARfIAC patient-specific Rouge, that The Institutional Re: I setting We 1, of Louisiana am The for to that Broussard, Board 2019 This physically Director the allowing lbS Broussard automated allow are provides Approval writing mbroussardpharmacvJa.gov OF Omnicell® We would Louisiana Louisiana in type (AMS) Request LOUISIANA due of explicitly of a Drive the would medications pharmacy correctional Pharmacy to of on our Pharmacies on-site allow twenty-four in use the profile-driven automation behalf system for AMS a pharmacy 70809 not Department asking Correctional of correctional for Approval in an intend law would of this a to we automated facility for twenty-four of Institutional currently inmates (24) to AMS would Louisiana is this for allow technology of currently utilize of hour, Setting facility where any Pilot type implementation Health like our in does future medication an around Project: a of (24) respectfully to Pharmacies there pharmacy not correctional used automated and system not utilize and hour having rules, Hospitals is the allow in allow Use not many capacity. is to system, clock laws to in manufactured of requests a of only a the medication real-time, setting. order license directly registered Automated Louisiana, hospital and (LDH). nursing use be the to regulations utilized of from consideration Omnicell®, interface, provide We such unit systems care. system nurse to the by Medication are in request dose, automation the This a Health asking for or to bi-directionally, correctional across in Omnicell® in other the is medication allow a for a approval an correctional correctional for Standards unit-dose System a the important licensed this pilot in approval this Toll Phone: Scott, Fax: 106 type from Abigayie’s Free: 337.268.9390 LA 337.268.4023 70583 866.991.0211 Row Malcolm J. Broussard, Executive Director July 31, 2019 Page 2

We look forward to the Board’s review and consideration of this request, and are hoping for approval at the August meeting to allow implementation before the end of the third quarter of 2019.

Description of Proposed Drug Logistics

Institutional Pharmacies of Louisiana will be responsible for the prescription order profiling and review of all medications prior to administration as well as medication inventory stored within the AMS.Alldrug logistics including proper barcoding, delivery and stocking of medications into the system will be the responsibility of the pharmacy. The pharmacy will maintain the physical inventory, establish appropriate par levels and replenish the AMSwhen needed, while maintaining all pharmacy records of medications removed and administered from its inventory.

Description of Work Flow

Each unit-dose medication within the AMSinventory will contain the manufacturer’s NDCbarcode, lot and expiration date. Medications will be ordered from registered wholesalers. In some instances, a few items may be unit-dose packaged and bar coded by Institutional Pharmacies of Louisiana. Allunit-dosed medications will be loaded or re-stocked into the AMS by a pharmacist or licensed pharmacy technician using a barcode scanning process (Safety Stock®).

Nursing or facility staff will send all medication orders to pharmacy via phone, secure fax, HL7,orNCPDPSCRIPTstandards.Upon receipt of the physician medication orders, a pharmacist will review for clinical appropriateness and then input the order into the pharmacy information system. Once the order has been reviewed and Drug Utilization Review completed and keyed into the pharmacy information system, the real time patient profiling technology will allow the order to appear in the specific inmate’s profile on the AMS,allowing the nurse to administer one individual’s intended dose at a time.

All medications within the AMSwill have a set par level which will be determined by the pharmacy. Automated daily reporting will allow pharmacy to monitor all par levels and generate appropriate stock replenishment for the AMS.The AMSwill be replenished as often as necessary to maintain appropriate stock levels. AMSreplenishment or restocking of inventory will be performed using a bar coded safety scanning process.

i06 Abigayles Row • Scott, LA 70583 • Phone; 337.268.4023 • Toll Free; 866.99i.0211 • Fax: 337.237.1634 Malcolm J. Broussard, Executive Director July 31, 2019 Page 3

Description of System Security

The media (hard drive) on Omnicell XTcabinets is encrypted using Microsoft BitLocker Drive encryption. BitLockeris pre-configured by Omnicell before shipping to a customer facility.

Both Microsoft Windows 10 and Microsoft BitLockeruse FIPS140-2 validated cryptographic modules, which maintain a very high level of confidentiality and integrity of the information on XTcabinets. Omnicell encryption renders data unreadable to unauthorized agents using sophisticated technology. Any data in transit is also rendered unreadable via the same strong encryption technology.

Omnicell also incorporates biometric fingerprint scanning technology which allows two fingerprints to be registered for each user and will identify and log all healthcare professionals accessing the AMS.This technology is FIPSCertified (Federal Information Processing Standards Publication 201).

Basis for Approval

Automated Medication Systems, such as Omnicell®,have been utilized for medication administration in various healthcare facilities across the country for more than twenty years. These systems render an effective way to administer medications, in a unit dose form, safely and efficiently and offer an alternative to bulky and costly blister card dispensing commonly seen in correctional settings. Although the blister card method works well for most LongTerm Care (Nursing Home) settings, we feel it may not always be the best alternative for the correctional setting. We have found through most of our interviews and site surveys in these correctional institutions, that inmates receive their medications usually by FedEx®or UPS mail service that sometimes may take up to twenty-four to forty-eight hours to arrive. This means that the “turn-around” time for medication delivery may be one to two days, delaying inmates from starting medications such as antibiotics or antihypertensives. Another common problem we discovered is the amount of waste that accumulates due to short-stay visits or inmate transfers that often occur within these correctional facilities. The problem of unutilized or wasted medications seems to be a priority focus of the Louisiana Parish jails we visited. AMS technology can be utilized to eliminate the over dispensing of oral medications, decrease waste of unused tablets and capsules and therefore, decrease the cost associated with such waste.

With overall pharmacy monitoring and management of the AMSin this type of setting, the pilot project will prove the value, safety and efficiency of utilizing this technology.

106 Ahigayles Row • Scott, LA 70583 • Phone: 337.268.4023 • Toll Free: 866.991.0211 • Fax: 337.2371634 July

answer Approval challenges, Duration authority Conclusion Current in licensure Malcolm monitored promulgated personnel, Page Board, Medication

advance 106

31,

Abigayle’s as

any

2019

Louisiana

of by

to frequently

and

for in

Broussard, plan

request

questions

System

Pilot

approve the

the

AMS

the Row

manner

accessed

allow

Pilot

Louisiana

pharmacy

opportunity

implementation that

(AMS) •

present for

that

Executive

pilot Scott,

that

may

Within

the

this

Department

any LA

to licensed

pilot, will

regulations

technology 70583

correctional

allow

of to

the

required,

serve

Director

the

its

present

Discretion

approved, • in

AMS Louisiana members pharmacists,

and

the Phone:

Health

technology

this

correctional

protect

setting

not

this

update 337.268.4023

request.

remain

may

Board

allow

type

the

(LDH).

pharmacy

due

Louisiana

have them

Scott,

Robert 106 Ph: Managing Respectfully Institutional

Board of

for

setting. •

337-268-4023

setting. We

Pharmacy’s

Abigayle’s

correctional

place

the

regarding

the Toll

are

technicians

the

inmates.

placement

70583 Free:

absence

Pharmacy Partner Sonnier,

until

asking

success,

Pharmacies

with 866.991.0211

Row

this

such

will August

settings,

Appreciation,

that

Jr.,

request.

commit

and

time

proper

RPh.

the 14th •

well

licensed

Automated

controlled,

that Fax:

Board

Louisiana,

meeting

facility

as 337.237.1634

rules

return

any

thank

use

nursing

can

its

LLC

you

the

be July

St. Office:

wiPIiam,maouire1,omniceJI.com Contact William Omnicell,

htb:tlm’w,onmicaII 2003 Malcolm Mobile: Page

Petersburg, rS

31, 106

Candy

5 s

800-845-0053 red

404-422-2718 Abigavle’s

2019

Information

Inc.

J. by

Maguire,

Blvd.

Broussard, Care comlmts

FL Row

33702

North

RPh •

for

Executive Scott,

Implementation

Pharmacy LA 70583

Director •

Consultant Phone:

Partner 337268.4023

Regulatory • Toll

Affairs Free: 866.991.0211 • Fax: 337.237.1633 INSTITUTIONAL PHARMACIES of LOUISIANA SCOTT, LOUISIANA

REQUEST FOR APPROVAL OF PILOT PROJECT: Use of Automated Medication System (AMS) in a Correctional Setting

Louisiana Board of Pharmacy August 14, 2019 Agenda

 Introduction of Automation (Omnicell®)  Restocking and Barcoding  Safety Stock® Technology  Drawer and Bin Configuration (Locking Lids)  Biometric I.D.  Reporting Omnicell XT Series Automated Dispensing Cabinets

Three-Cell One-Cell Two-Cell

Quarter-Height Cell Half-Height Cell Restocking with Barcoding

Bar code technology is the first layer for security and accuracy. This technology directs the pharmacist or pharmacy technician to the correct location during the restock process. The software also directs the nurse to the correct drug while administering medication to patients. SafetyStock® software SafetyStock® software provides an additional layer of safety, using bar code scanning and light-lid technology to ensure that medication items are restocked accurately and that the correct medication is issued from the AMS cabinet.

Both the drawer and the bin light up to help guide technician to the proper drug location

SafetyStock bar code confirmation includes three primary elements: 1. Labeling and scanning confirmation of the correct drug in the correct bin using light lid technology 2. Labeling and scanning for restock confirmation of the correct drug in the correct bin by using light-lid technology 3. Labeling and scanning for bin location confirmation for the correct drug by using light-lid technology Drawer and Bin Configuration

All drawers and bins specified for the AMS in the correctional setting will be “HIGH” security type with individual locking lids. These drawers and bins are made of steel and cannot open unless the correct drug is barcoded and SafetyStock® is used to guide the operator to the correct bin. • IF the user attempts to open another bin, a sensor alarm will sound, and an email immediately notifies both the DON and PIC. Biometric I.D.

• All healthcare professionals accessing the Omnicell drug cabinet (AMS) will use a fingerprint scanner (biometrics) to enter the cabinet. • Allows two fingerprints to be registered for each user. • FIPS Certified – NIST (National Institute of Standards and Technology) FIPS 201 (Federal Information Processing Standards Publication 201) Extensive Reporting

More than 100 standard reports are available through the Omnicell® OmniCenter®server. Reporting Categories • Financial • Operational • Pharmacy Examples of Pharmacy Reports • Safety Stock Reports • Waste Transaction Reports • Transaction by User Report • Transaction by Inmate Report • Restock Reports • Item Expiration Tracking Report Question Time Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Agenda Item 15

New Agenda Items Added During Meeting

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Announcements

Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

August 14, 2019

Agenda Item 14: Announcements

Aug. 15 ULM College of Pharmacy ~ P-1 Orientation Aug. 19 Louisiana Medical Marijuana Project Team Aug. 30 Xavier College of Pharmacy ~ P-1 Orientation

Sept. 2 Labor Day – Board office closed Sept. 4-5 NABP Work Group on Development of Interstate Endorsement Credential – Rosemont, IL Sept. 12-13 MPJE Item Review Conference – Mt. Prospect, IL Sept. 18-19 Violations Committee Informal Conference Sept. 22-26 FIP World Congress – Abu Dhabi, UAE Sept. 26-27 Tri-Regulator Symposium – Frisco, TX

Oct. 1-2 NABP Executive Officer Forum – Mt. Prospect, IL Oct. 3 dotPharmacy Executive Board – Mt. Prospect, IL Oct. 6-9 NABP-AACP Districts 6-7-8 Annual Meeting – Boise, ID Oct. 10 Drug Policy Board Oct. 16 La. Pharmacy Congress Prescription Monitoring Program Advisory Council Oct. 21-22 Practitioner Diversion Awareness Conference – New Orleans, LA Oct. 21-24 National Association of State Controlled Substance Authorities (NASCSA) Annual Meeting – Richmond, VA Oct. 26-29 NCPA Annual Meeting – San Diego, CA Oct. 27-30 MALTAGON Conference – Biloxi, MS

Nov. 11 Veterans Day – Board office closed Nov. 12 Reinstatement, Impairment, Finance, & Executive Committees Nov. 13 Board Meeting Nov. 14 Administrative Hearing

End of Meeting Binder