Missouri Board Objectives Of Pharmacy Discuss Missouri pharmacy law.
Identify regulatory changes and initiatives related to Missouri law. 2014 Legislative/Rule Update
This CPE is accredited by ACPE for both Pharmacy Technicians and Pharmacists Kim Grinston, J.D.
Executive Director Missouri Board of Pharmacy Jefferson City, Missouri
To obtain our objectives of this presentation:
Attendees will be informed on the following: Ms. Kim Grinston does not have conflicts Updates on 2014 legislative actions of interest to disclose to the attendees of relating to pharmacy practice this meeting or to the CPE Accrediting Body
Update on new and pending Board rules
Other Board changes/updates
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
Assessment Questions Disclaimer
Can a pharmacy fill a Rx written by a Missouri This presentation is provided for informational purposes Assistant Physician after 8/28? only. The statements provided today are not legally binding and do not constitute opinions of the Board.
Will pharmacists be able to automatically This presentation does not constitute a comprehensive administer hep A, hep B, tetanus, diphtheria and review of all governing law or controlled substance pertussis vaccines on 8/28? requirements. To ensure compliance, licensees should thoroughly review Chapter 338, RSMo, 20 CSR 2220 and all applicable state and federal laws. Can a RPh submit their renewal application before completing their CE? This presentation does not constitute a rule statement of general applicability or binding law. In the event of a Naloxone sales to law enforcement agencies conflict or inconsistency, duly promulgated or enacted state should be documented in the pharmacy’s or federal law shall control. The Board expressly reserves the right to revise the contents as deemed appropriate or prescription records? True or false. necessary. Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
1 2014 Legislative Changes SB 808- Assistant Physicians
Adds an “assistant physician” license class. SB 808
Practice restrictions. Will have authority to prescribe. SB 716 Authority would include controlled substances (III, IV & V). SB 754
Asst. physicians different from physician HB 2040 assistants. Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
SB 808- Assistant Physicians SB 808- Immunizations
Board of Healing Arts Statement: Adds hepatitis A & B and diphtheria, tetanus & Senate bills 716 & 754. . .established licensure for pertussis. Assistant Physicians. These bills will become law effective August 28, 2014. However, before the Expanded immunization authority effective 8/28. Board can accept applications, the Board will need to establish rules related to licensure, including submission of applications, renewal, supervision, New Notification of Intent is NOT required. and other matters necessary to protect the public. However, new vaccines must be authorized in The rule promulgation process is lengthy; the protocol. Amendments must be signed by therefore, we do not anticipate the licensure of RPh and authorizing physician. Assistant Physicians to begin until at least the summer or fall of 2015. No additional training required at this time.
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
SB 808- Immunizations SB 808- Immunizations (Notification) (Notification)
PCP notification within 14 days mandatory for all Only required if the PCP’s information is known. vaccines (includes vaccines administered by prescription). RPh should make a good faith attempt to collect Notification must include: PCP information from the patient (i.e.,- asking The identity of the patient; verbally or on the immunization authorization The identity of the vaccine or vaccines administered; form). The route of administration; The anatomic site of the administration; RPh should document the patient’s record when The dose administered; and the patient refuses or is unable to provide PCP The date of administration. information.
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
2 SB 808- Immunizations SB 808- Immunizations (Adverse Events) (Emergency Treatment Protocols)
“ A pharmacist who is administering a vaccine Emergency treatment protocols: shall request a patient to remain in the pharmacy Protocol: 20 CSR 2220-6.050(5)(A) requires that a safe amount of time after administering the protocols include “a course of action the pharmacist shall vaccine to observe any adverse reactions. Such follow to address emergency situations including, but not limited to, adverse reactions, anaphylactic reactions, pharmacist shall have adopted emergency and accidental needle sticks.” treatment protocols;”
Pending final rules, pharmacists should use their Rx Order: 20 CSR 2220-6.040(4) already requires written policies and procedures covering all aspects of professional discretion when determining a “safe drug administration, including, “the appropriate handling amount of time.” of acute adverse events.”
RPh should document patient’s refusal to stay.
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
SB 808- Immunizations SB 808- Hospital Pharmacy
Statute provides RPh must post an immunization Allows joint rulemaking authority with the “certificate.” Department of Health for medication dispensing by the pharmacy and MTS services by a pharmacist. Does not include floor meds/other Board will not be issuing a separate certificate. professionals.
Post NOI confirmation page or NOI list published by the Board. Does not give the Board full regulatory jurisdiction over hospital in-patient pharmacy.
Alternatively, NOI list may be electronically maintained/accessible at the pharmacy. DHSS still has sole jurisdiction over hospital services purely subject to DHSS’ jurisdiction.
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
SB 808 (Class B Hospital Pharmacy) SB 808- Military Licenses
Class B Hospital Outpatient Pharmacies- May Formalizes Board’s current interpretation. include clinics/facilities under common control, management or ownership of a hospital/hospital “So long as the person involved does not system. represent or hold himself or herself out as a pharmacist licensed to practice in this state, a Hospital is defined in section 197.020. Missouri pharmacist license shall not be required for a legally qualified pharmacist serving in the armed forces of the [U.S.] or a legally qualified May dispense by Rx or by medication order. pharmacist employed by the government of the [U.S.] or any bureau, division, or agency thereof May dispense to a “hospital clinic of facility” who is engaged in the practice of pharmacy while onsite administration/dispensing by a health care in the discharge of his or her official duties.” provider. Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
3 SB 808- Military Licenses HB 2040- Naloxone
Can’t hold themselves out as a Missouri Section 190.255 authorizes any licensed drug licensed pharmacist. distributor or pharmacy to sell naloxone to a “qualified first responder agency”. [HB 2040].
Must be part of their official duties. A “qualified first responder agency” is defined as “any state or local law enforcement Would not exempt pharmacists operating agency, fire department or ambulance service independently or outside of their official that provides documented training to its staff activities. related to the administration of naloxone in an apparent narcotic or opiate overdose situation.”
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
HB 2040- Naloxone HB 2040- Naloxone
Sales should be documented by invoice. Drug distributor license not needed, provided the total amount of all medication sold by the pharmacy without a prescription does not exceed Invoices should include: five percent (5%) of the pharmacy’s total The date of sale; annual prescription drug sales. [§ 338.315.2, § Product name; 338.330(2)]. Quantity sold; The identity of the qualified first responder agency; and The transferring pharmacy’s full address. The 5% limit is calculated based on all drugs sold by the pharmacy and not just naloxone sales. Invoices maintained separate from Rx records.
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
Other Regulatory Updates Other Regulatory Updates
Mandatory Reporting- Sec. 383.133 Mandatory Reporting- Sec. 383.133
Any entity that employs a RPh to provide Reporting is required now. Reports “health care services” must report: should be submitted online. Any final disciplinary action against the pharmacist that might have led to disciplinary action by the Board under sec. 338.055, and Reports must be made within 15 days of the final disciplinary action/voluntary Any RPh voluntary resignation against whom any complaints or reports have been made resignation. that might have led to disciplinary action.
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
4 Other Regulatory Updates Other Regulatory Updates
Mandatory Reporting- Sec. 383.133 Sterile compounding rule still under review
Examples: Pharmacist renewals (10/31/14) Practicing without a license CE between 9/1/12 and 10/31/14 Falsifying Rx CE must be complete when you renew Immunizing/administering w/o a protocol Diverting meds/Theft Renewal fee decrease. Compounding for office stock Pharmacists $50 Dispensing w/o a valid Rx Interns $20 Unlicensed practice/Assisting in unlicensed Techs (possibly $20) *Rule still pending practice.
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
MTS Renewals MTS Renewals
Same time as RPh license (10/31) Don’t want to renew: Paper renewal OR 6-hrs MTM CE required. Can be used as Notify the Board in advance. part of 30-overall CE hours. E-Mail: [email protected] Board or ACPE approved. ACPE Universal DO NOT RENEW MTS in subject line. Activity Number “01”- Drug Therapy Include license # & DOB Related. Can’t renew online without prior notification.
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
Next Lunch with the Chief Webinar Assessment Questions
BNDD Update with Michael Boeger Can a pharmacy fill a Rx written by a Missouri August 21, 2014 Assistant Physician after 8/28?
Noon – 1PM Will pharmacists be able to automatically administer hep A, hep B, tetanus, diphtheria and pertussis vaccines on 8/28? Future LWTC webinars:
October 15, 2014 Can a RPh submit their renewal application before completing their CE?
Naloxone sales to law enforcement agencies should be documented in the pharmacy’s prescription records? True or false.
Missouri Board of Pharmacy Missouri Board of Pharmacy Jefferson City, Missouri Jefferson City, Missouri
5 Missouri Board Of Pharmacy
2014 Legislative/Rule Update
Kim Grinston, J.D. Executive Director
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