Rules of Department of Commerce and Insurance Division 2220—State Board of Pharmacy Chapter 6—Pharmaceutical Care Standards

Title Page

20 CSR 2220-6.030 Provision of Drug and/or Medical Information (Rescinded November 30, 2019) ...... 3 20 CSR 2220-6.040 Administration by Medical Prescription Order ...... 3 20 CSR 2220-6.050 Administration of Vaccines Per Protocol...... 4 20 CSR 2220-6.055 Non-Dispensing Activities...... 6 20 CSR 2220-6.060 General Provisions...... 7 20 CSR 2220-6.070 Certificate of Medication Therapeutic Plan Authority...... 7 20 CSR 2220-6.080 Medication Therapy Services By Protocol...... 8 20 CSR 2220-6.100 Pharmacy Standards for Dispensing Blood-Clotting Products ...... 10 20 CSR 2220-6.200 Pharmacist Authority to Prescribe Pursuant to Section 338.665 ...... 12

JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 1 Secretary of State Chapter 6—Pharmaceutical Care Standards 20 CSR 2220-6

Title 20—DEPARTMENT OF (3) Pharmacist Qualifications. A pharmacist 1. Drug administration procedures; COMMERCE AND INSURANCE who is administering drugs pursuant to a med- 2. Authorized routes of administration; Division 2220—State Board of Pharmacy ical prescription order must first file a 3. Drug storage; Chapter 6—Pharmaceutical Care Notification of Intent to administer drugs by 4. Pre- and post- administration assess- Standards medical prescription order with the board. To ment and counseling; file a Notification of Intent, a pharmacist 5. Biohazard waste disposal and disposal 20 CSR 2220-6.030 Provision of Drug must— of used/contaminated supplies; and/or Medical Information (A) Hold a current Missouri pharmacist 6. Identifying and handling acute adverse license; events or immunization reactions, including (Rescinded November 30, 2019) (B) Hold a current healthcare provider level anaphylactic reactions; and AUTHORITY: sections 338.095, RSMo Supp. cardiopulmonary resuscitation (CPR) certifi- 7. Recordkeeping and notification pro- cation or Basic Life Support certification cedures and requirements. 1993, 338.010, RSMo Supp. 1990, 338.140, issued by the American Heart Association, the (C) Drugs must be stored within the man- RSMo Supp. 1989 and 338.280, RSMo 1986. American Red Cross, or an equivalent organi- ufacturer’s labeled requirements, including This rule originally filed as 4 CSR 220-6.030. zation. The certificate program must have when administering outside of a pharmacy. Original rule filed March 1, 1994, effective included an in-person skills assessment; Vaccines must be stored in accordance with Sept. 30, 1994. Moved to 20 CSR 2220- (C) Have successfully completed a certifi- CDC guidelines at all times. 6.030, effective Aug. 28, 2006. Rescinded: cate program in medication administration and (D) Patients must be asked to remain in the Filed May 13, 2019, effective Nov. 30, 2019. emergency procedures accredited by the pharmacy a safe amount of time after Accreditation Council for Pharmacy Education administering a vaccine to observe any adverse

(ACPE), provided by an ACPE or regionally reactions, as required by section 338.010, 20 CSR 2220-6.040 Administration by accredited pharmacy or medical school/college RSMo. Medical Prescription Order or approved by the Board of Pharmacy. The required training program must provide (5) Requirements of Medical Prescription PURPOSE: This rule establishes procedures instruction in— Order for Administration. At a minimum, the for pharmacists to administer medication 1. Administration techniques, including medical prescription order from a licensed pursuant to a medical prescription order. hands-on training in routes of administration; prescriber must include: 2. Drug storage and handling; (A) The name of the licensed prescriber (1) A pharmacist who complies with the pro- 3. Informed consent requirements; issuing or authorizing the order; visions of this rule may administer drugs and 4. Pre- and post- administration assess- (B) The name of the patient to receive the devices pursuant to a medical prescription ment and counseling; drug; order, including vaccines. 5. Biohazard waste disposal; and (C) The name of the drug and dose to be 6. Identifying and treating adverse reac- administered; (2) Except as otherwise provided by law, a tions, including anaphylactic reactions and (D) The route of administration; pharmacist may not delegate medication needle sticks; (E) The date of the original order; and administration to another person, except to an (D) If a pharmacist wishes to administer (F) The date or schedule, if any, of each intern pharmacist or qualified pharmacy tech- drugs by a route of administration not included subsequent administration. nician who has met the qualifications under in the original certification program, the phar- subsections (3)(B)–(E) and is working under macist must first be trained in the techniques (6) Record Keeping. the direct supervision of a pharmacist who of that route of administration by a licensed (A) Pharmacists administering or supervis- has met the qualifications to administer drugs health care practitioner who is authorized to ing administration of medication pursuant to pursuant to a medical order. administer medication. Documentation of the this rule shall ensure the following records (A) For purposes of this rule, a “qualified required training and training date(s) must be are manually or electronically maintained pharmacy technician” is defined as a current- maintained at the pharmacy and available to separate from the prescription files of a phar- ly registered Missouri pharmacy technician the board on request; and macy for each administration: who— (E) Proof of compliance with this section 1. The name, address, and date of birth 1. Holds an active pharmacy technician must be maintained for a minimum of two (2) of the patient; certification issued by a certification entity years. 2. The date, route, and anatomic site of accredited by the National Commission for the administration; Certifying Agencies; (4) General Requirements. 3. The medication name and dose. For 2. Has an initial and, if applicable, (A) Medication must be administered in vaccines and biologics, the manufacturer, annual documented assessment of competen- compliance with all applicable state and fed- expiration date, and lot number must also be cy in medication administration; and eral laws, including applicable Vaccine documented and recorded; 3. Has assisted in the practice of phar- Information Statements and informed consent 4. For vaccines, the name and address of macy as a registered/licensed pharmacy tech- requirements. Except as otherwise authorized the patient’s primary health care provider, as nician in the state of Missouri or another by law, vaccines must also be administered in identified by the patient or an indication that U.S. state or territory for a minimum of one accordance with treatment guidelines estab- a primary health care provider was not pro- (1) year. lished by the Centers for Disease Control and vided; (B) Proof of an intern’s or qualified phar- Prevention (CDC) or in accordance with 5. The identity of the administering macy technician’s compliance with subsec- manufacturer’s guidelines. pharmacist, or if applicable, the administer- tions (3)(B)–(E) must be maintained by both (B) Pharmacists must have a current and ing intern pharmacist or qualified pharmacy the supervising pharmacist and the intern accurate written policy and procedure manual technician and his/her supervising pharma- pharmacist/qualified pharmacy technician for covering all aspects of administering drugs by cist; and a minimum of two (2) years. medical prescription order, including: 6. If applicable, the nature of an adverse

JOHN R. ASHCROFT (9/30/21) CODE OF STATE REGULATIONS 3 Secretary of State 20 CSR 2220-6—DEPARTMENT OF COMMERCE AND INSURANCE Division 2220—State Board of Pharmacy

reaction and who was notified. by subsection (6)(B) or electronically retriev- of age unless otherwise authorized by law. (B) All records required by this regulation able at the request of the board or the board’s (B) Pharmacists shall ensure compliance must be kept by the pharmacist for two (2) authorized designee. with all state and federal laws and regulations years from the date of such record. Except as pertaining to Vaccine Information Statements otherwise required by section (3), records (8) Notification of Intent Refiling. To contin- and informed consent requirements. must be kept at the pharmacy where the pre- ue administration, a Notification of Intent to (C) Vaccines must be stored in accordance scription order is maintained. If not adminis- administer drugs by medical prescription with CDC guidelines/recommendations and tered on behalf of a pharmacy, records not order must be refiled with the board bienni- within the manufacturer’s labeled require- maintained at a pharmacy may be securely ally along with the pharmacist’s Missouri ments, including, when vaccinating outside of stored at a location designated by the pharma- pharmacist license. To refile, a pharmacist a pharmacy. cist. Records maintained at a pharmacy must must meet the requirements of subsection (D) A pharmacist may only delegate vac- be produced immediately or within two (2) (3)(B) above. cine administration to an intern pharmacist or hours of a request from the board or the qualified pharmacy technician who has met board’s authorized designee. Records not (9) A qualified pharmacy technician adminis- the qualifications of subsections (3)(B) and maintained at a pharmacy must be produced tering medication pursuant to this rule must (C) of this rule and is working under the within three (3) business days of a board be supervised by a Missouri-licensed phar- request. direct supervision of a pharmacist qualified macist who is authorized to administer medi- to administer vaccines. Proof of an intern’s or cation pursuant to this rule and who is phys- (7) Notification Requirements. Pharmacists qualified pharmacy technician’s compliance ically present on-site when the medication is with subsections (3)(B) and (C) must be administering or supervising administration administered. of medication under this rule, shall ensure— maintained by both the supervising pharma- cist and the intern pharmacist/qualifying (A) For vaccines, a pharmacist shall AUTHORITY: section 338.280, RSMo 2016, pharmacy technician for a minimum of two inform the patient that the administration of and sections 338.010.1 and 338.140, RSMo (2) years. the vaccine will be entered into the Supp. 2020.* Emergency rule filed May 1, (E) For purposes of this rule, a “qualified ShowMeVax system, as administered by the 2008, effective May 11, 2008, expired Feb. pharmacy technician” is defined as a current- Department of Health and Senior Services. 18, 2009. Original rule filed May 1, 2008, The patient shall attest to the inclusion of effective Nov. 30, 2008. Amended: Filed Dec. ly registered Missouri pharmacy technician such information in the system by signing a 15, 2017, effective June 30, 2018. ** who— form provided by the pharmacist. Entry into Emergency amendment filed Nov. 25, 2020, 1. Holds an active pharmacy technician ShowMeVax must occur within fourteen (14) effective Dec. 11, 2020, expired June 8, 2021. certification issued by a certification entity days. If the patient indicates that he or she Amended: Filed Nov. 25, 2020, effective May accredited by the National Commission for does not want such information entered into 30, 2021. Certifying Agencies; the ShowMeVax system, the pharmacist must 2. Has an initial and, if applicable, provide a written report within fourteen (14) *Original authority: 338.010, RSMo 1939, amended 1951, annual documented assessment of competen- days of administration of a vaccine to the 1989, 1990, 2007, 2009, 2011, 2014, 2017, 2018, 2019; cy in vaccine administration; and patient’s primary health care provider, if pro- 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019; and 338.280, RSMo 1951, amended 1971, 1981. 3. Has assisted in the practice of phar- vided by the patient, containing— macy as a registered/licensed pharmacy tech- 1. The identity of the patient; nician in the state of Missouri or another 2. The identity of the vaccine or vac- **Pursuant to Executive Order 21-07, 20 CSR 2220-6.040, section (8) was suspended from July 13, 2020 through August 5, 2021. U.S. state or territory for a minimum of one cines administered; (1) year. 3. The route of administration; 4. The anatomic site of the administra- 20 CSR 2220-6.050 Administration of Vac- (2) The authorizing physician is responsible tion; cines Per Protocol 5. The dose administered; and for the oversight of, and accepts responsibili- ty for, the vaccines administered by the phar- 6. The date of administration; PURPOSE: This rule establishes the proce- (B) The prescriber is notified within twen- dures for pharmacists to administer vaccines macist. ty-four (24) hours after learning of an adverse per written protocol with a physician. event or reaction experienced by a patient fol- (3) Pharmacist Qualifications. Pharmacists lowing administration. Notification is manda- (1) A pharmacist may administer vaccines administering vaccines by protocol as autho- tory and cannot be waived. Vaccine adverse authorized by Chapter 338, RSMo, pursuant rized by Chapter 338, RSMo, must first file a events or reactions must also be reported to to a written protocol with a Missouri licensed Notification of Intent (NOI) to administer vac- the Vaccine Adverse Event Reporting System physician who is actively engaged in the prac- cines with the Missouri Board of Pharmacy. (VAERS) or its successor, within thirty (30) tice of medicine. Unless otherwise restricted To file a NOI, a pharmacist must— days; by the governing protocol, vaccines may be (A) Hold a current Missouri pharmacist (C) Any notifications required by state and administered at any Missouri licensed phar- license; federal law are properly completed and doc- macy or at any non-pharmacy location as (B) Hold a current healthcare provider level umented; and allowed in the governing protocol. cardiopulmonary resuscitation (CPR) or basic (D) Notifications required by this section (A) Vaccines must be administered in accor- may be made electronically or in writing or dance with current treatment guidelines estab- life support (BLS) certification issued by the via a common electronic medication record lished by the Centers for Disease Control American Heart Association, the American that is accessible to and shared by both the (CDC) and the manufacturer’s guidelines, Red Cross, or an equivalent organization. The physician and pharmacist. Documentation of provided CDC guidelines shall control in the qualifying BLS or CPR certification program the required notifications, including the noti- event of a conflict. Vaccines may not be must have included a live in-person skills fication date, must be maintained as required administered to persons under seven (7) years assessment; and

4 CODE OF STATE REGULATIONS (9/30/21) JOHN R. ASHCROFT Secretary of State Chapter 6—Pharmaceutical Care Standards 20 CSR 2220-6

(C) Have successfully completed a certifi- the protocol at any time at the request of any 2. If the vaccine is not being adminis- cate program in administering vaccines accred- party. tered on behalf of a pharmacy, all records ited by the Accreditation Council for Pharmacy (B) The protocol, and any subsequent shall be maintained securely and confidential- Education (ACPE), provided by an ACPE or amendments or alterations, must be reviewed ly by the administering pharmacist at an regionally accredited pharmacy or medical and manually or electronically signed and address that shall be identified in the protocol school/college or approved by the Board of dated by the pharmacist and authorizing physi- prior to administering the vaccine; Pharmacy. The required certificate program cian prior to its implementation, signifying 3. Prescription records must be main- must include a live/in-person training compo- that both are aware of its contents and agree to tained as required by Chapter 338, RSMo, nent and include instruction in: follow the terms of the protocol. A copy of the and the rules of the board; and 1. Current CDC guidelines and recom- protocol must be maintained by both the phar- 4. Records required by this rule must be mendations for vaccines authorized by macist and the authorizing physician for a maintained for two (2) years and made avail- Chapter 338, RSMo, including recommended minimum of eight (8) years after termination able for inspecting and copying by the State immunization schedules; of the protocol. Board of Pharmacy or the State Board of 2. Basic immunology and vaccine pro- (C) Additional pharmacists or immuniza- Registration for the Healing Arts and/or their tection; tion locations may be added to an existing authorized representatives. Records main- 3. Physiology and techniques for vaccine protocol if the amendment is signed and tained at a pharmacy must be produced dur- administration, including hands-on training in dated by the authorizing physician(s) and, if ing an inspection by the board and/or their intramuscular, intradermal, subcutaneous and applicable, any newly added pharmacist(s). authorized representatives. Records not main- nasal administration routes, and other com- Existing pharmacists are not required to re- tained at a pharmacy must be produced with- mon routes of vaccine administration; sign the protocol unless other protocol terms in three (3) business days after a request from 4. Pre- and post- vaccine screening or or provisions are changed. the State Board of Pharmacy, the Board of assessment; and Registration for the Healing Arts and/or their 5. Identifying and treating adverse (5) Record Keeping. authorized representative. Failure to maintain immunization reactions; (A) The pharmacist shall ensure a record is or produce records as provided by this rule (D) Notifications of Intent must be filed on maintained for each vaccine administered by shall constitute grounds for discipline. the board’s website or on a form approved by protocol that includes: the board. 1. The patient’s name, address, and date (6) Notification of Immunizations. Pharmacists of birth; immunizing by protocol must— (4) Protocol Requirements. 2. The date, route, and anatomic site of (A) Notify all persons or entities as (A) In addition to filing a NOI, pharma- the administration; required by state and federal law; cists administering vaccines under this rule 3. The vaccine’s name, dose, manufac- (B) Notify the protocol physician as must first enter into a written protocol with a turer, lot number, and expiration date; required by the governing protocol; Missouri licensed physician. The written pro- 4. The name and address of the patient’s (C) Notify the patient’s primary care tocol may be valid for a time period not to primary health care provider, as provided by provider as required by Chapter 338, RSMo; exceed one (1) year. The protocol must be the patient; and renewed annually and include the following: 5. The identity of the administering (D) Notify the patient’s primary health 1. The identity of the participating phar- pharmacist or, if applicable, the identity of care provider and, if different, the protocol macist and physician; the administering intern pharmacist or quali- physician, within twenty-four (24) hours after 2. Time period of the protocol; fied pharmacy technician and supervising learning of any adverse event or reaction 3. Authorized vaccines; pharmacist; and experienced by the patient. Adverse events or 4. The patient or groups of patients 6. The nature of any adverse reaction reactions must also be reported to the Vaccine authorized for vaccination; and who was notified, if applicable. Adverse Event Reporting System (VAERS) or 5. Allowed routes and anatomic sites of (B) Within seventy-two (72) hours after a its successor, within thirty (30) days. administration; vaccine is administered, a prescription must (E) Unless otherwise provided by the gov- 6. If applicable, authorization to create a be obtained from the authorizing physician erning protocol, notification may be made via prescription for each administration under the for the drug dispensed or a prescription must a common electronic medication record that physician’s name; be created in the physician’s name document- is accessible to and shared by both the physi- 7. Emergency response procedures, ing the dispensing as authorized by protocol. cian and pharmacist. Proof of notification including, but not limited to, procedures for Notwithstanding any other provision of this must be maintained in the pharmacist’s handling/addressing adverse reactions, ana- rule, prescription records must be maintained records as provided in subsection (5)(B) of phylactic reactions, and accidental needle as provided by Chapter 338, RSMo, and the this rule. sticks; rules of the board. 8. The length of time the pharmacist (C) The records required by this rule must (7) Notification of Intent Renewal. A must observe an individual for adverse events be securely and confidentially maintained as Notification of Intent (NOI) to immunize by following an injection; follows: protocol must be renewed biennially with the 9. Procedures for disposing of used and 1. If the vaccine is administered on immunizing pharmacist’s Missouri pharmacist contaminated supplies; behalf of a pharmacy, both the pharmacy and license. To renew a NOI, pharmacists must— 10. Authorization to administer vaccines the administering pharmacist shall ensure the (A) Have a current healthcare provider car- at a non-pharmacy location, if applicable; records required by subsection (5)(A) are diopulmonary resuscitation (CPR) or basic 11. Record-keeping requirements and any promptly delivered to and maintained at the life support (BLS) certification that complies required notification procedures; and pharmacy separate from the pharmacy’s pre- with subsection (3)(B) of this rule; and 12. A provision allowing termination of scription files; (B) Have completed a minimum of two (2)

JOHN R. ASHCROFT (9/30/21) CODE OF STATE REGULATIONS 5 Secretary of State 20 CSR 2220-6—DEPARTMENT OF COMMERCE AND INSURANCE Division 2220—State Board of Pharmacy

hours of continuing education (0.2 CEU) 2220-2.190, when applicable; this rule shall be construed to eliminate or related to administering vaccines or CDC (B) Obtain patient history/information; otherwise exempt any pharmacist, pharmacy immunization guidelines in a course approved (C) Review patient records/medical histo- technician, intern pharmacist, or pharmacy by the Board of Pharmacy or provided by an ries; permit holder from the record-keeping, con- ACPE accredited continuing education (D) Patient assessment/evaluation, as fidentiality, or security requirements other- provider within the applicable pharmacist authorized by Missouri law; wise imposed by Chapter 338, RSMo, or the biennial renewal period (November 1 to (E) Billing and insurance claim submis- rules of the board. Violations of this section October 31 of the immediately preceding even sions/review; shall constitute grounds for discipline. numbered years). (F) Drug utilization review; (C) The required continuing education (CE) (G) Assess health plan and medication eli- (5) This rule shall not be construed to autho- shall be governed by 20 CSR 2220-7.080 and gibility/coverage; rize a pharmacist to conduct the unauthorized practice of medicine or to conduct any activ- may be used to satisfy the pharmacist’s bien- (H) Pharmacy compliance audits/evalua- ity for which a license is required pursuant to nial continuing education requirements. The tions; (I) Administer drugs, vaccines, or biologi- Chapters 330, 331, 332, 334, or 337, RSMo. initial training program required by section (3) cals, as authorized by law and the rules of the of this rule may be used to satisfy the CE board; (6) A pharmacy technician and intern phar- requirements of this subsection if the training (J) Peer review/peer consultations; macist may be used to assist a pharmacist program was completed within the applicable (K) Review, select, and develop formula- with non-dispensing activities outside of a pharmacist biennial renewal cycle. ries or plan/practice guidelines; pharmacy subject to the following: (L) Review compliance with benefit guide- (A) The pharmacy technician/intern phar- (8) A qualified pharmacy technician immu- lines; macist must be under the direct supervision of nizing pursuant to this rule must be super- (M) Manage inventory, including purchas- a Missouri licensed pharmacist as required by vised by a Missouri-licensed pharmacist who ing and ordering; 20 CSR 2220-2.710. The supervising pharma- is authorized to immunize by protocol and (N) Manage/review information systems; cist must ensure pharmacy technician/intern who is physically present on-site when the (O) Patient medication review; pharmacist activities comply with state and vaccine is administered. (P) Consultation with other health care federal law and must provide the personal professionals; assistance, direction, and approval required to AUTHORITY: sections 338.010, 338.140, and (Q) Patient referrals; verify and ensure delegated non-dispensing 338.220, RSMo Supp. 2020.* Emergency rule (R) Prescription order entry/review, pro- activities are safely and properly performed; filed Oct. 24, 2007, effective Nov. 3, 2007, vided that a pharmacist shall only be autho- (B) The pharmacy technician or intern expired April 30, 2008. Original rule filed rized to accept a prescription on the premises pharmacist must have completed employer Oct. 24, 2007, effective May 30, 2008. of a Missouri licensed pharmacy, as required approved training in the activities performed Emergency amendment filed Oct. 22, 2009, by section 338.095.5, RSMo; and and have an initial and, if applicable, annual effective Nov. 1, 2009, expired April 29, (S) Medication therapy management, pur- documented assessment of proficiency. 2010. Amended: Filed Oct. 22, 2009, effec- suant to and as authorized by Chapter 338, Documentation of the completed training and tive June 30, 2010. Amended: Filed Feb. 9, RSMo, and the rules of the board. proficiency assessment must be maintained in 2018, effective Sept. 30, 2018. ** Emergency the pharmacy’s records for a minimum of two amendment filed Jan. 4, 2021, effective Jan. (2) Confidentiality. A pharmacist, pharmacy (2) years and provided to the board or the 19, 2021, expired July 17, 2021. Amended: technician, or intern pharmacist performing board’s designee upon request; Filed Jan. 4, 2021, effective July 30, 2021. non-dispensing activities pursuant to this rule (C) A sufficient mechanism must be in shall comply with all applicable state and fed- place to allow real-time communication Original authority: 338.010, RSMo 1939, amended 1951, eral confidentiality laws and regulations. between a pharmacist and the 1989, 1990, 2007, 2009, 2011, 2014, 2017, 2018, 2019; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, Sufficient storage and security for confiden- technician/intern pharmacist when needed. A 2019; and 338.220, RSMo 1951, amended 1969, 1981, tial documents and electronic data processing pharmacist must be available to respond to 1989, 1997, 1999, 2001, 2004, 2007, 2009, 2011, 2013, hardware must be provided by the pharmacy pharmacy technician/intern pharmacist ques- 2014, 2020. permit holder or the pharmacist. In addition, tions at all times non-dispensing activities are data processing systems must utilize suffi- being performed; and **Pursuant to Executive Order 21-07, 20 CSR 2220-6.050, subsec- tions (7)(A) and (7)(B) was suspended from July 13, 2020 through cient security software to ensure confidential- (D) Adequate security and supervision August 31, 2021. ity and prevent unauthorized access. Any must be maintained at all times to prevent breach in the security or confidentiality of the unauthorized access to, and unauthorized data processing systems or confidential docu- storage/transfer of, confidential patient infor- 20 CSR 2220-6.055 Non-Dispensing Act- ments shall be documented and reported to mation or patient records. ivities the board in writing within seven (7) days of (E) The provisions of this section (6) do not the breach. apply to technicians or intern pharmacists PURPOSE: This rule establishes procedures engaged in delivering filled prescriptions/med- and requirements for the performance of non- (3) Notwithstanding any other provision of ication orders on behalf of the pharmacy as dispensing activities outside of a pharmacy. this rule, a pharmacist shall not meet with authorized by 20 CSR 2220-2.013. patients in the pharmacist’s residence or liv- (1) Pursuant to section 338.220, RSMo, a ing quarters. AUTHORITY: sections 338.010 and 338.140, pharmacist may perform the following non- RSMo Supp. 2019, and sections 338.035 and dispensing activities outside of a licensed (4) A pharmacist, pharmacy technician, or 338.220, RSMo 2016.* Emergency rule filed pharmacy: intern pharmacist performing non-dispensing Oct. 23, 2009, effective Nov. 2, 2009, expired (A) Patient counseling/education, as autho- activities pursuant to this rule shall ensure April 30, 2010. Original rule filed Oct. 22, rized by Missouri law, provided the pharma- compliance with Chapter 338, RSMo, and 2009, effective June 30, 2010. ** Amended: cist shall be obligated to comply with 20 CSR the rules of the board at all times. Nothing in Filed Feb. 7, 2020, effective Aug. 30, 2020.

6 CODE OF STATE REGULATIONS (9/30/21) JOHN R. ASHCROFT Secretary of State Chapter 6—Pharmaceutical Care Standards 20 CSR 2220-6

Emergency amendment filed June 5, 2020, medication or device, and implementing such therapeutic authority shall enter into a written effective June 19, 2020, expired Sept. 1, selection(s). Medication therapy services protocol with a Missouri-licensed physician 2020. shall not include the sole act of dispensing a that complies with the requirements of 20 drug or device pursuant to a valid prescrip- CSR 2220-6.080, prior to performing medi- *Original authority: 338.010, RSMo 1939, amended 1951, tion for the product, generic substitutions cation therapy services. 1989, 1990, 2007, 2009, 2011, 2014, 2017, 2018, 2019; 338.035, RSMo 1990, amended 1993, 1995, 2007; made pursuant to section 338.056, RSMo, or 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, medication therapy management that does not (2) Applicants for certification shall hold an 2019; and 338.220, RSMo 1951, amended 1969, 1981, include the initiation or implementation of a active Missouri pharmacist license. Appli- 1989, 1997, 1999, 2001, 2004, 2007, 2009, 2011, 2013, cations shall be submitted on forms provided 2014. modification of medication therapy, as pro- vided herein; by the Missouri State Board of Pharmacy and shall be accompanied by the certificate of **Pursuant to Executive Order 21-07, 20 CSR 2220-6.055, section (E) Pharmacy resident—A Missouri- (6) was suspended from March 20, 2020 through August 31, 2021. licensed pharmacist enrolled in a residency medication therapeutic plan authority fee and

training program accredited by the American proof the applicant— (A) Holds a doctor of pharmacy (PharmD) 20 CSR 2220-6.060 General Provisions Society of Health-System Pharmacists or a degree earned from a school, accredited by residency training program with a valid appli- the Accreditation Council for Pharmacy PURPOSE: This rule establishes definitions cation for accreditation pending with the Education (ACPE); or for 20 CSR 2220-6.060 to 20 CSR 2220- American Society of Health-System (B) Has successfully completed a post- 6.080 governing medication therapy services Pharmacists; graduate medication therapy certificate by pharmacists. (F) Prescription order for medication ther- course or program accredited or granted by apeutic plan—A lawful order that is issued by the APCE, American Society of Health- (1) Definitions. The following definitions the authorizing physician within the scope of System Pharmacists, American Society of shall apply for purposes of 20 CSR 2220- his/her professional practice for the provision Consultant Pharmacists, or the American 6.060 to 20 CSR 2220-6.080: of medication therapy services by a pharma- Pharmacists Association; or (A) Authorizing physician(s)—The physi- cist for a specific patient, including, patients (C) Holds a current certification from the cian identified in the written protocol as of a health care entity; and Board of Pharmaceutical Specialties, the authorizing the pharmacist to provide medi- (G) Protocol—A medication therapy proto- Commission for Certification in Geriatric cation therapy services; col, as defined herein. Pharmacy, or the National Certification (B) Health care entity—For purposes of Board for Diabetes Educators; or this rule, a health care entity shall be defined (2) The provisions of 20 CSR 2220-6.060 to (D) Has completed a post-graduate medi- as any entity or organization that is licensed 20 CSR 2220-6.080 and 20 CSR 2150-5.026 cation therapy certificate course that, at a or certified by the state or federal government to 20 CSR 2150-5.028 shall only be deemed minimum, included training in the following as a hospital, hospice facility, ambulatory applicable to persons or entities under the areas: surgical center, nursing home, long-term care jurisdiction of the Missouri State Board of 1. Assessing patient specific data and facility, residential care facility, assisted liv- Pharmacy and the Missouri State Board of issues; ing facility, intermediate care facility, skilled Registration for the Healing Arts, as estab- 2. Establishing medication therapeutic nursing facility, or a habilitation center as lished by Chapter 338, RSMo, and Chapter goals or medication related action plans for defined by Chapter 630, RSMo, and that is 334, RSMo. identified medication conditions and medica- required to maintain patient medical records tion related concerns; by state or federal law; AUTHORITY: sections 338.010, 338.140.1., 3. Assessing and addressing adverse (C) Medication therapy protocol—A writ- and 338.380, RSMo Supp. 2011.* Original reactions and adverse drug events; ten agreement between a physician and a rule filed Jan. 13, 2012, effective Aug. 30, 4. Modifying and monitoring medica- pharmacist for the provision of medication 2012. tion regimens; therapy services. A medication therapy proto- 5. Improving patient care and outcomes col shall comply with the provisions of 20 *Original authority: 338.010, RSMo 1939, amended 1951, through medication therapy services; 1989, 1990, 2007, 2009, 2011; 338.140, RSMo 1939, 6. Evaluating treatment progress; CSR 2220-6.080; amended 1981, 1989, 1997, 2011; and 338.380, RSMo (D) Medication therapy services—The 2007. 7. Assessing and monitoring pharma- cokinetic and pharmacodynamic changes in designing, initiating, implementing, or moni- medication regimen reviews; toring of a plan to monitor the medication 20 CSR 2220-6.070 Certificate of Medi- 8. Medication reconciliation; therapy or device usage of a specific patient, cation Therapeutic Plan Authority 9. Drug utilization review; or to enhance medication therapeutic out- 10. Applicable state or federal law; comes of a specific patient, by a pharmacist PURPOSE: This rule establishes procedures 11. Formulating and documenting per- who has authority to initiate or implement a for obtaining a certificate of medication ther- sonal medication records; modification of the patient’s medication ther- apeutic plan authority, as authorized by sec- 12. Documenting clinical outcomes; apy or device usage pursuant to a medication tion 338.010, RSMo. 13. Interpreting, monitoring, ordering, therapy protocol. For purposes of 20 CSR and assessing patient test results; and 2220-6.060 to 20 CSR 2220-6.080, modifi- (1) A pharmacist shall obtain a certificate of 14. Patient education and counseling. cation shall include selecting a new, different, medication therapeutic authority from the or additional medication or device, discontin- Missouri State Board of Pharmacy to provide (3) Certificate Renewal. A certificate of med- uing a current medication or device, or medication therapy services that include initi- ication therapeutic plan authority shall be selecting a new, different, or additional ating or implementing a modification of a renewed biennially with the certificate hold- strength, dose, dosage form, dosage sched- patient’s medication therapy or device usage. er’s Missouri pharmacist license. For pur- ule, or route of administration for a current Pharmacists with a certificate of medication poses of renewal, six (6) of the continuing

JOHN R. ASHCROFT (9/30/21) CODE OF STATE REGULATIONS 7 Secretary of State 20 CSR 2220-6—DEPARTMENT OF COMMERCE AND INSURANCE Division 2220—State Board of Pharmacy

education hours required for renewing the Except as otherwise provided in subsection annual review on the written protocol. certificate holder’s Missouri pharmacist (2)(B) of this rule, the prescription order for (D) The authorizing physician shall review license shall be earned in courses/programs a medication therapeutic plan shall be valid the pharmacist’s medication therapy service related to medication therapy management. for no more than one (1) year and shall activities regularly, but not less than once The continuing education required by this include: every three (3) months. If the pharmacist is rule shall be governed by the rules of the 1. The patient’s name, address, and date providing medication therapy services for, or Missouri State Board of Pharmacy governing of birth; on behalf of, a health care entity, the review pharmacist continuing education. 2. The date the prescription order for a requirements shall be satisfied if the pharma- medication therapeutic plan is issued; cist’s work and services are reviewed every (4) The Missouri State Board of Pharmacy 3. The clinical indication for medication three (3) months by a clinical care committee, may discipline or terminate a pharmacist’s therapy services; pharmacy and therapeutics committee, or a certificate of medication therapeutic plan 4. The length of time for providing med- reviewing body/committee of the health care authority if the Missouri State Board of ication therapy services, if less than one (1) entity that includes a Missouri-licensed Pharmacy determines that the pharmacist has year; and physician. The review required by this sub- violated the terms of a protocol, the require- 5. The authorizing physician’s name and section may be accomplished in person or by ments of Chapter 338, RSMo, or rules of the address; electronic means. board governing medication therapy services (B) A prescription order for a medication (E) The practice location of the authorizing or any other state or federal drug law. therapeutic plan may be transmitted orally, physician shall be no further than fifty (50) electronically, or in writing. If an oral pre- miles by road from the pharmacist identified AUTHORITY: sections 338.010, 338.140.1., scription order for a medication therapeutic in the written protocol. and 338.380, RSMo Supp. 2011.* Original plan is issued, all information required under (F) An authorizing physician shall notify rule filed Jan. 13, 2012, effective Aug. 30, subsection (2)(A) of this rule shall be docu- the Missouri State Board of Registration for 2012. mented by the pharmacist and maintained in the Healing Arts of a written protocol for the patient’s record in accordance with sec- medication therapy services entered with a *Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009, 2011; 338.140, RSMo 1939, tion (7) of this rule; pharmacist at each renewal of the authorizing amended 1981, 1989, 1997, 2011; and 338.380, RSMo (C) The pharmacist shall review relevant physician’s license. 2007. prescription records, patient profiles, patient medical records, or other medical informa- (4) Protocol Requirements.

20 CSR 2220-6.080 Medication Therapy tion to determine the services to be rendered; (A) The medication therapy services per- Services By Protocol and formed by a pharmacist pursuant to the pro- (D) In lieu of compliance with 20 CSR tocol shall be within the authorizing physi- PURPOSE: This rule establishes procedures 2220-2.018, prescription orders for medica- cian’s scope of practice and within the skill, for the provision of medication therapy ser- tion therapy services shall comply with the education, training, and competence of both vices by protocol, as authorized by section provisions of this rule, provided the pharma- the authorizing physician and the pharmacist. 338.010, RSMo. cist shall maintain the prescription order in (B) The written protocol between the the patient record required by section (7) of authorizing physician and pharmacist shall, at (1) Except as otherwise provided herein, a this rule and shall document any change or a minimum, include the following: pharmacist who holds a certificate of medica- alteration made to the prescription ordered 1. The identity and signatures of the tion therapeutic plan authority from the based on contact with the prescriber in the authorizing physician and pharmacist; Missouri State Board of Pharmacy shall be applicable patient record. 2. The effective dates of the protocol; authorized to provide medication therapy ser- 3. A statement of clinical conditions, vices in Missouri if the pharmacist— (3) Authorizing Physician Requirements. diagnoses, diseases, and specific drugs, or (A) Holds a current Missouri pharmacist (A) The authorizing physician shall be drug categories included in the written proto- license that is not under discipline with the actively engaged in the practice of medicine col and the type of medication therapy ser- Missouri State Board of Pharmacy; and in the state of Missouri and shall hold a cur- vices allowed in each case; (B) Has entered into a written protocol rent and unrestricted Missouri physician 4. A statement of the methods, proce- with a Missouri licensed physician that com- license pursuant to Chapter 334, RSMo. dures, decision criteria, and plan the pharma- plies with the requirements of this rule. (B) The authorizing physician shall be cist is to follow when conducting medication responsible for the oversight of the medica- therapy services; (2) General Requirements. A pharmacist may tion therapy services provided by the pharma- 5. Procedures for documenting medica- provide medication therapy services only cist that are authorized by protocol. The tion therapy decisions made by the pharma- with current certification and as authorized authorizing physician shall also consider the cist and a plan for communication, feedback, by the protocol and the authorizing physician. level of skill, education, training, and compe- and reporting to the authorizing physician A pharmacist providing medication therapy tence of the pharmacist and ensure that the concerning specific decisions made; services pursuant to this rule shall comply activities authorized by the protocol are con- 6. A mechanism and procedure that with the following: sistent with the pharmacist’s level of skill, allows the authorizing physician to override, (A) Prior to providing medication therapy education, training, and competence. rescind, modify, or otherwise amend the pro- services, the pharmacist shall receive a pre- (C) The written protocol shall be reviewed tocol. All modifications or amendments to the scription order for a medication therapeutic and signed by the pharmacist and the autho- protocol shall be documented in writing, plan from the authorizing physician for a spe- rizing physician at least annually and revised signed, and dated by all involved parties prior cific patient which authorizes the pharmacist as needed. The authorizing physician and to the implementation of such modification or to perform medication therapy services. pharmacist shall document the date of the amendment. The protocol may be immediately

8 CODE OF STATE REGULATIONS (9/30/21) JOHN R. ASHCROFT Secretary of State Chapter 6—Pharmaceutical Care Standards 20 CSR 2220-6

rescinded by the authorizing physician or the cokinetic and pharmacodynamic changes in Society of Health-System Pharmacists or a pharmacist with or without cause, provided medication regimen reviews; residency training program with a valid appli- the rescission is documented in writing. If 7. Medication reconciliation; cation for accreditation pending with the any conflict arises regarding the professional 8. Drug utilization review; American Society of Health-System judgment of the pharmacist and physician 9. Formulating and documenting per- Pharmacists; and with regard to the subject of the medication sonal medication records; 3. The resident is providing medication therapy services, the physician has ultimate 10. Documenting clinical outcomes; therapy services under the supervision of a authority; 11. Interpreting, monitoring, and Missouri pharmacist certified by the Missouri 7. A statement that the pharmacist shall assessing patient test results; State Board of Pharmacy to perform medica- not delegate the responsibility of medication 12. Initiation of drug therapy, as autho- tion therapy services. therapy services to another person; rized by protocol; and (J) The provisions of subsection (4)(I) shall 8. A description of any authority granted 13. Patient education and counseling. only apply to medication therapy services to the pharmacist to administer any drug or (D) The protocol required by this section provided by a pharmacist as part of his/her medication including the identification of any shall be signed and dated by the authorizing residency training. such drug, medication, or device; physician and the pharmacist. If the protocol 9. A description of drug therapy related includes multiple authorizing physicians or (5) Notification Requirements. A pharmacist patient assessment procedures or testing that participating pharmacists, a separate protocol shall comply with the following notification may be ordered or performed by the pharma- shall not be required for each physician or requirements: cist, including any authority to order or per- pharmacist if all authorizing physicians and (A) Within twenty-four (24) hours after form routine or other laboratory testing; pharmacists have signed and dated a state- learning of an anaphylactic or other adverse 10. Provisions for allowing the pharma- ment agreeing to be governed by the terms of medication reaction, adverse needle stick, or cist to access the patient’s medical records for the written protocol. other adverse event experienced by a patient, purposes of providing medication therapy ser- (E) Any revisions, modifications, or the pharmacist shall notify the patient’s vices; amendments to the protocol must be in writ- authorizing physician or an authorized 11. A provision for providing the autho- ing. The authorizing physician shall promptly designee of the authorizing physician; rizing physician access to patient records for notify the pharmacist of any such revision, (B) The pharmacist shall notify the autho- medication therapy services provided by the modification, or amendment and shall main- rizing physician or an authorized designee of pharmacist for patients of the authorizing tain documentation of the notification, the authorizing physician in the written pro- physician; including the date such notification was tocol of any modification of therapy, within 12. Provisions establishing a course of made. The authorizing physician may dele- twenty-four (24) hours, provided the protocol action the pharmacist is authorized to follow gate the notification requirements of this sub- may include more stringent notification to address emergency situations, including, section to an authorized designee, provided requirements; but not limited to, anaphylactic or other the physician shall be ultimately responsible (C) A pharmacist shall be deemed in com- adverse medication reactions, adverse needle for compliance with the notification require- pliance with the notification requirements of sticks, or other adverse events; ments. this rule if the pharmacist is providing medi- 13. Criteria for timely communication (F) A pharmacist shall not be authorized to cation therapy services for, or on behalf of, a from the authorizing physician to the pharma- adjust, change, or modify any controlled sub- health care entity, as defined by this rule, and cist and from the pharmacist to the authoriz- stance prescribed for a patient, except as documentation of the notifications required by ing physician, not inconsistent with the provi- authorized by state or federal law. this section is recorded in a patient medical sions of this rule; (G) The protocol shall be maintained by record that is required to be maintained by 14. The notification requirements the authorizing physician and the pharma- the health care entity pursuant to state or fed- required by section (5) of this rule; and cist for a minimum of eight (8) years after eral law; and 15. The method for reviewing the phar- termination of the protocol. The protocol (D) Notifications required by this section macist’s medication therapy work or services may be maintained electronically. shall be in writing unless otherwise autho- by the authorizing physician, as required by (H) A protocol shall automatically and rized by the authorizing physician. subsection (3)(D) of this rule. immediately terminate if the pharmacist ceas- (C) The written protocol shall include a es to maintain an active Missouri pharmacist (6) Modifying Drug Therapy. description of medication therapy services the license, the authorizing physician is deceased, (A) A pharmacist may be authorized by pharmacist is authorized to render or provide. or if the authorizing physician fails to main- protocol to modify a patient’s non-controlled Such services may include: tain an active, unrestricted Missouri physi- substance medication therapy, subject to the 1. Assessing patient-specific data and cian license. following: issues; (I) Pharmacy Residents. If specifically 1. If the pharmacist modifies medication 2. Establishing medication therapeutic authorized by the protocol, a pharmacy resi- therapy and a medication or device is to be goals or medication related action plans for dent shall be authorized to perform medica- dispensed, the pharmacist shall create a pre- identified medical conditions and medication tion therapy services under the written proto- scription for the medication or device modi- related concerns; col of a Missouri pharmacist in lieu of an fied under the authorizing physician’s name. 3. Assessing and addressing adverse individual protocol, if— Such prescription may be dispensed by a reactions and adverse drug events; 1. The resident holds a certificate of licensed pharmacy and shall be maintained in 4. Modifying and monitoring medica- medication therapeutic plan authority from the prescription records of the dispensing tion regimens; the Missouri State Board of Pharmacy; pharmacy as provided by the rules of the 5. Evaluating treatment progress; 2. The resident is enrolled in a residency Missouri State Board of Pharmacy; and 6. Assessing and monitoring pharma- training program accredited by the American 2. If the pharmacist modifies medication

JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 9 Secretary of State 20 CSR 2220-6—DEPARTMENT OF COMMERCE AND INSURANCE Division 2220—State Board of Pharmacy

therapy or a device, the pharmacist shall doc- or medication therapy services plan; 2220-6.050 or the administration of medica- ument such modification according to section 9. Any informed consent for procedures, tion by protocol as governed by 20 CSR (7) of this rule. Pharmacists providing medi- medications, or devices; and 2220-6.040. cation therapy services for patients of a health 10. Any consultation with any other care entity shall be deemed in compliance treatment provider for the patient and the (12) The Missouri State Board of Registration with the provisions of this subsection if the results of such consultation. for the Healing Arts and the Missouri State modification is documented in a patient med- (B) Pharmacist Record Retention. Except Board of Pharmacy separately retain the right ical record that the health care entity is as otherwise provided herein, records and duty to discipline their respective required to maintain under state or federal required to be maintained by a pharmacist licensees for violations of any state or federal law. pursuant to this rule shall be maintained statutes, rules, or regulations regardless of (B) The pharmacist shall not modify any securely and confidentially for a minimum of the licensee’s participation in a protocol controlled substance prescription. A pre- seven (7) years after termination of the proto- agreement. scription from the authorizing physician shall col unless more stringent requirements are be required to modify a controlled substance. established for record keeping under state or (13) The provisions of 20 CSR 2220-6.060 to (C) For purposes of 20 CSR 2220-6.060, federal law. All records required to be main- 20 CSR 2220-6.080 and 20 CSR 2150-5.026 20 CSR 2220-6.070, and 20 CSR 2220- tained by the pharmacist by this rule shall be to 20 CSR 2150-5.028 shall only be deemed 6.080, modification of medication therapy maintained by the pharmacist at an address applicable to persons or entities under the shall include selecting a new, different, or that shall be identified in the written proto- jurisdiction of the Missouri State Board of additional medication or device, discontinu- col. Pharmacy and the Missouri State Board of ing a current medication or device, or select- (C) Physician Record Retention. Except as Registration for the Healing Arts, as estab- ing a new, different, or additional strength, otherwise provided herein, records required lished by Chapter 338, RSMo, and Chapter dose, dosage form, dosage schedule, or route to be maintained by the authorizing physician 334, RSMo. of administration for a current medication or pursuant to this rule shall be maintained AUTHORITY: sections 338.010, 338.140.1., device, and implementing such selection(s). securely and confidentially for a minimum of and 338.380, RSMo Supp. 2011.* Original Medication therapy services shall not include seven (7) years after termination of the proto- rule filed Jan. 13, 2012, effective Aug. 30, the sole act of dispensing a drug or device col unless more stringent requirements are 2012. pursuant to a valid prescription for the prod- established for record keeping pursuant to state or federal law. uct or generic substitutions made pursuant to *Original authority: 338.010, RSMo 1939, amended 1951, section 338.056, RSMo. 1989, 1990, 2007, 2009, 2011; 338.140, RSMo 1939, (8) Production of Records. Records main- amended 1981, 1989, 1997, 2011; and 338.380, RSMo (7) Record Keeping. tained at a pharmacy must be produced dur- 2007.

(A) A pharmacist shall document and ing an inspection or investigation by the Missouri State Board of Pharmacy, Missouri maintain an adequate patient record of medi- 20 CSR 2220-6.100 Pharmacy Standards State Board of Registration for the Healing cation therapy services provided to each for Dispensing Blood-Clotting Products patient. The records may be maintained in Arts, or their authorized representatives, as requested by the respective board or the electronic format provided the records are PURPOSE: This rule implements the provi- board’s designee. Records not maintained at a capable of being printed for review by the sions of section 338.400, RSMo, and estab- pharmacy shall be produced within three (3) Missouri State Board of Registration for the lishes pharmacy standards for dispensing business days after a request from the Healing Arts and the Missouri State Board of blood-clotting products. Pharmacy. An adequate and complete patient Missouri State Board of Pharmacy, Missouri State Board of Registration for the Healing record shall include documentation of the fol- (1) Definitions. The following definitions are Arts, and/or its authorized representative. lowing: hereby adopted and applicable to this rule: Failure to maintain or produce records as 1. The identification of the patient, (A) “Bleeding disorder,” a medical condi- provided by this rule shall constitute grounds including, name, birthdate, address, and tele- tion characterized by a deficiency or absence for discipline. phone number; of one (1) or more essential blood-clotting 2. The date(s) of any patient visit or (9) Nothing in this rule shall be construed to components in the human blood, including consultation, including the reason for any permit medical diagnosis of any condition by all forms of hemophilia, acquired hemophil- such visit/consultation; a pharmacist or the independent issuing of a ia, von Willebrand’s disease, and other 3. Any pertinent assessments, observa- prescription by a pharmacist. bleeding disorders that result in uncontrol- tions, or findings; lable bleeding or abnormal blood-clotting. 4. Any diagnostic testing recommended (10) A pharmacist shall not violate or prac- As defined by section 338.400, RSMo, or performed; tice in a manner inconsistent with the provi- “bleeding disorder” does not include a bleed- 5. The name of any medication or sions of this rule or a written protocol. A ing condition secondary to another medical device modified and the strength, dose, pharmacist’s failure to abide by the require- condition or diagnosis, except for acquired dosage schedule, dosage form, and route of ments of this rule or the provisions of a writ- hemophilia; administration of any medication modified or ten protocol shall be subject to disciplinary (B) “Blood-clotting product,” a medicine administered; action pursuant to the provisions of Chapter approved for distribution by the federal Food 6. Referrals to the authorizing physi- 338, RSMo. and Drug Administration (FDA) that is used cian; for the treatment and prevention of symptoms 7. Referrals for emergency care; (11) The requirements of this rule shall not associated with bleeding disorders, including, 8. Any contact with the authorizing apply to the administration of vaccines pur- but not limited to, recombinant and plasma physician concerning the patient’s treatment suant to protocol as governed by 20 CSR derived factor products, von Willebrand factor

10 CODE OF STATE REGULATIONS (6/30/21) JOHN R. ASHCROFT Secretary of State Chapter 6—Pharmaceutical Care Standards 20 CSR 2220-6

products, antifibrinolytics, bypass products cy shall contact the patient for authorization (B) The pharmacy shall identify in for patients with inhibitors, prothrombin to dispense prior to shipping a refill of any advance, or make arrangements with, a sup- complex concentrates, and activated pro- blood-clotting product to the patient. The plier or suppliers capable of providing all thrombin complex concentrates. Except as date of patient authorization shall be docu- brands, assays, and vial sizes of blood-clot- otherwise provided by section 338.400, mented in the pharmacy’s prescription ting products approved by the federal FDA, RSMo, a “blood-clotting product” does not records; including products manufactured from human include medical products approved solely for (E) Barring extenuating circumstances, plasma and those manufactured from recom- the treatment or prevention of side effects of prescriptions for blood clotting factor con- binant technology techniques. A list of all a blood-clotting drug or medication; centrates shall be dispensed within plus or designated or identified suppliers shall be (C) “Established patient,” For purposes of minus ten percent (10%) of prescribed maintained at the pharmacy and made avail- section 338.400, RSMo, and this rule, an assays, or as otherwise authorized or directed able during inspection. This requirement “established patient” shall be defined as a by the prescriber; and shall not be construed to require a pharmacy (F) Recalls or Withdrawals. Prior to dis- bleeding disorder patient that has been dis- to purchase products prior to receiving a pensing any blood clotting factor concentrate, pensed a legend blood-clotting product by the valid prescription order; pharmacy on more than three (3) occassions the pharmacy shall ask the patient or the patient’s designee to designate a preferred (C) A pharmacist shall be available twenty- in a single calendar year; and contact method for receiving notifications in four (24) hours a day, seven (7) days a week, (D) “Pharmacy,” an entity engaged in the the event of a recall or withdrawal of the con- every day of the year, either on-site or on practice of pharmacy as defined in section centrate dispensed or any related ancillary call, to fill prescriptions for blood-clotting 338.100, RSMo, that provides blood-clotting infusion equipment and supplies dispensed by products, within the time frames designated products and ancillary infusion equipment or the pharmacy. The preferred contact method by section 338.400, RSMo, and the provi- supplies to patients with bleeding disorders. shall be documented with the patient infor- sions of this rule; mation required by 20 CSR 2220-2.190(2). (D) Pharmacists engaged in dispensing or (2) General Requirements. All Missouri 1. Notice of concentrate or ancillary filling blood-clotting factor concentrates or licensed pharmacists and pharmacy permit infusion equipment and supplies recalls and who provide patient counseling regarding holders shall comply with the following withdrawals shall be provided to the patient blood-clotting factor concentrates to bleeding requirements when dispensing blood-clotting via the patient’s preferred contact method disorder patients shall have sufficient knowl- factor concentrates: within twenty-four (24) hours of receipt of a edge, experience, and training to perform the (A) Prescriptions for blood-clotting factor recall or withdrawal notification from the duties assigned. To ensure continued compe- concentrates shall be dispensed as written or manufacturer or any state or federal entity tency, pharmacists engaged in counseling authorized by the prescribing physician, in that requires or recommends patient notifica- bleeding disorder patients shall complete four accordance with state and federal law. No tion. The pharmacy shall also notify the pre- changes or substitutions shall be made unless (4) continuing education hours (0.40 CEU) scribing physician within twenty-four (24) related to blood-clotting factor concentrates, approved by the prescriber. If the pharmacy hours of such recall or withdrawal and shall has received prescriber authorization to infusion treatment or therapy, or blood-clot- obtain a prescription for an alternative prod- ting disorders or diseases each biennial change or substitute the blood-clotting factor uct if a new or amended prescription is concentrate originally prescribed, the patient renewal period. The continuing education required to dispense or deemed necessary required by this rule may be used to satisfy or the patient’s designee shall be notified and and appropriate by the prescriber. the pharmacist’s continuing education counseled regarding the change or substitu- 2. If attempts to contact the patient via requirements. Proof of compliance with this tion prior to dispensing via the preferred con- the preferred contact method are unsuccess- section shall be maintained at the pharmacy tact method identified by the patient or ful, the pharmacy shall mail notification to designee pursuant to subsection (2)(E); the patient or the patient’s authorized for a minimum of four (4) calendar years and (B) If requested by the patient or the designee within the required twenty-four (24) shall be made available during inspection or patient’s designee, the pharmacy shall ship hours or the next business day. at the request of the board; and deliver blood-clotting factor concentrates 3. The time, date, and method of notifi- (E) If requested by the patient or the to the patient or the patient’s designee as pre- cation to the patient and prescriber shall be patient’s designee, the pharmacy shall pro- scribed within two (2) business days of documented in the pharmacy’s records and vide for the shipment and delivery of blood- receiving a prescription or refill request for maintained for two (2) years from the date of clotting products to the patient or the established patients and three (3) business recall or withdrawal. patient’s designee as prescribed within two days for new patients in nonemergency situa- (2) business days of receiving a prescription tions. Nonemergency situations shall include, (3) In addition to the provisions of section or refill request for established patients and but may not be limited to, routine prophylaxis (2), pharmacies that dispense blood-clotting three (3) business days for new patients in requests. Appropriate cold chain manage- nonemergency situations; ment and packaging practices must be used to products to established patients, or that offer ensure proper drug temperature, stability, or advertise to provide blood-clotting prod- (F) Established patients shall be provided integrity, and efficacy are maintained during ucts specifically for bleeding disorder access to blood-clotting products within shipment in accordance with manufacturer patients, shall comply with the following twelve (12) hours of notification from a requirements; standards of care: physician of the patient’s emergent need for a (C) Patients must be provided with a des- (A) The pharmacy shall annually notify the blood-clotting product. For purposes of this ignated pharmacy contact telephone number board in writing of the pharmacy’s intent to section, determination of an emergent need for reporting problems with a delivery or provide legend blood-clotting products for shall be within the professional medical judg- product on each dispensing at no cost to the bleeding disorder patients. Notification shall ment of the physician. Emergent need patient; be made on or before January 31 of each cal- requests shall be documented in the pharma- (D) Unless otherwise authorized by the endar year in a manner and form approved by cy’s prescription records; patient or the patient’s designee, the pharma- the board; (G) The pharmacy shall provide or have

JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 11 Secretary of State 20 CSR 2220-6—DEPARTMENT OF COMMERCE AND INSURANCE Division 2220—State Board of Pharmacy

available for purchase containers for the dis- delivering blood-clotting factor concentrates ments for pharmacists prescribing as autho- posal of hazardous waste, including, but not to established patients in the event of an rized by section 338.665, RSMo. limited to, sharp or equivalent biohazard emergency or disaster; waste containers; (E) Notifying patients prior to terminating (1) Definitions. (H) At a minimum, the pharmacy shall business or terminating the dispensing of any (A) A nicotine replacement therapy prod- provide or have available for purchase ancil- blood-clotting factor concentrate or prior to a uct; as defined by section 338.665, RSMo. lary equipment and supplies required to known or an anticipated termination of phar- infuse a blood-clotting therapy product into a macy services for a bleeding disorder patient. (2) Training. Pharmacists prescribing must human vein, including, syringes, needles, Notification shall be provided in writing and, be competent to perform the services provid- sterile gauze, field pads, gloves, alcohol when reasonably possible, shall be provided a ed and shall maintain ongoing/continued swabs, numbing creams, tourniquets, medical minimum of seven (7) days prior to any such competency. tape, and cold compression packs. If supplies termination; are depleted, the pharmacy shall restock the (F) Shipping or providing blood-clotting (3) Pharmacist prescribing and patient care required ancillary equipment and supplies in products to the patient within the time frames activities must be safely and properly per- a reasonable amount of time which shall not required herein; formed. exceed seven (7) calendar days; (G) Receiving, processing, and dispensing (A) Pharmacists shall collect patient or (I) The pharmacy shall have contact infor- prescription or dispensing requests for a medical history to allow the pharmacist to mation available for a nurse or nursing ser- blood-clotting product to bleeding disorder properly assess the patient and safely provide vice or agency with experience in providing patients, including procedures for handling patient care. Prior to prescribing, the phar- infusion related nursing services or nursing and processing physician request indicating a macist shall use a screening procedure based services for bleeding disorder patients if such patient’s emergent need for a blood-clotting on generally accepted clinical guidelines to services are not provided by the pharmacy; product; identify appropriate patients for treatment. (J) If requested by the patient or the (H) Ensuring appropriate cold chain man- The pharmacist shall refer high-risk patients patient’s authorized designee, the pharmacist agement and packaging practices are used to or patients with a contraindication to the shall explain any known insurance copay- ensure proper drug temperature, stability, patient’s primary care provider or an appro- ments, deductibles, coinsurance payments, or integrity, and efficacy are maintained during priate healthcare provider, as deemed neces- lifetime maximum insurance payment limits. shipment in accordance with manufacturer sary or appropriate. For purposes of complying with this section, requirements; and (B) In addition to this rule, pharmacists the pharmacy may rely on information sup- (I) Handling and processing preauthoriza- shall comply with all applicable provisions of plied by the patient’s insurer; and tion notifications and requests and communi- Chapter 338, RSMo, and the rules of the (K) The pharmacy shall register with the cating preauthorization requirements to the Board of Pharmacy governing prescribing and National Patient Notification System, or its patient and applicable prescriber. record-keeping, including, but not limited to, successor, to receive recall notification for all 20 CSR 2220-2.018. Pharmacists may pro- products included in the National Patient (5) This rule shall not be construed to require vide a prescription to the patient or transmit Notification System. The pharmacy shall dispensing without appropriate payment or a prescription for that patient to a pharmacy maintain current and accurate contact infor- payment arrangements. If the pharmacy is for dispensing. mation with the National Patient Notification waiting for authorization, certification, or System. other action from a third-party payer prior to (4) Patient medical records. Prescribing phar- dispensing, the pharmacy shall notify the macists shall maintain an adequate and com- (4) Pharmacies that provide legend blood- patient that the prescription is available for plete patient medical record for each patient clotting products to treat or prevent symp- dispensing and explain any alternative pay- that documents the care provided. Patient toms of established bleeding disorder ment options. Notification shall be provided medical records must be individually retriev- patients, or that offer or advertise to provide as soon as reasonably practicable. At a mini- able. blood-clotting products specifically for bleed- mum, however, notification shall be provided (A) At a minimum, the required patient ing disorder patients, shall develop and fol- to the patient prior to the expiration of the medical record must include: low written policies and procedures to ensure shipping and delivery time frames required 1. The patient’s name, birthdate, compliance with section 338.400, RSMo, by subsection (2)(E), (3)(B), or (3)(F) of this address and telephone number; and the provisions of this rule. The pharmacy rule. 2. The date(s) the patient was seen; shall review the policies and procedures on 3. The patient’s primary care provider, an annual basis and document such review. At AUTHORITY: section 338.280, RSMo 2000, if provided; a minimum, the pharmacy’s written policies and sections 338.140 and 338.400, RSMo 4. Documentation of the patient screen- and procedures must include procedures for: Supp. 2012.* Original rule filed Nov. 13, ing as required by section (3) of this rule; (A) Processing prescriptions for blood- 2012, effective May 30, 2013. 5. Any pertinent medical or medication clotting products by pharmacy staff to ensure information/history; the timely handling and dispensing of blood- *Original authority: 338.140, RSMo 1939, amended 1981, 6. The name and dosage of any medica- 1989, 1997, 2011; 338.280, RSMo 1951, amended 1971, clotting products; 1981; and 338.400, RSMo 2011. tion prescribed; (B) Processing partial fill requests by 7. Any recommended medication treat- patients to reduce or eliminate excessive dis- ment plan(s) or follow-up consultation(s); pensing; 20 CSR 2220-6.200 Pharmacist Authority and (C) Providing and documenting recall noti- to Prescribe Pursuant to Section 338.665 8. Any healthcare provider referrals. fications in accordance with this rule; (B) Patient medical records must be (D) Transferring, dispensing, refilling, or PURPOSE: This rule establishes require- securely and confidentially maintained in

12 CODE OF STATE REGULATIONS (6/30/21) JOHN R. ASHCROFT Secretary of State Chapter 6—Pharmaceutical Care Standards 20 CSR 2220-6

compliance with applicable state and federal law. At a minimum, patient medical records must be maintained for five (5) years from the date created. Records maintained at a pharmacy must be produced immediately or within two (2) hours of a request from the board or the board’s authorized designee. Records not maintained at a pharmacy must be produced within three (3) business days of a board request.

AUTHORITY: sections 338.010, 338.140, and 338.665, RSMo Supp. 2019.* Original rule filed March 9, 2020, effective Oct. 30, 2020.

Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009, 2011, 2014, 2017, 2018, 2019; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019; and 338.665, RSMo 2019.

JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 13 Secretary of State