PURPOSE: This rule establishes the procedures for pharmacists to administer vaccines per written protocol with a physician. (1) A pharmacist may administer vaccines authorized by Chapter 338, RSMo, pursuant to a written protocol with a Missouri licensed physician who is actively engaged in the practice of medicine. Unless otherwise restricted by the governing protocol, vaccines may be administered at any Missouri licensed pharmacy or at any non-pharmacy location identified in the governing protocol.

1. (A) Vaccines must be administered in accordance with treatment guidelines established by the Centers for Disease Control (CDC) and the manufacturer’s guidelines, provided CDC guidelines shall control in the event of a conflict. Vaccines may not be administered to persons under twelve (12) years of age unless otherwise authorized by law.
2. (B) Pharmacists shall ensure compliance with all state and federal laws and regulations pertaining to Vaccine Information Statements and informed consent requirements.
3. (C) Vaccines must be stored in accordance with CDC guidelines/recommendations and within the manufacturer’s labeled requirements, including, when vaccinating outside of a pharmacy.
4. (D) A pharmacist may only delegate vaccine administration to an intern pharmacist who has met the qualifications of subsections (3)(B) and (C) of this rule and is working under the direct supervision of a pharmacist qualified to administer vaccines. Proof of an intern’s compliance with subsections (3)(B) and (C) must be maintained by both the supervising pharmacist and the intern pharmacist for a minimum of two (2) years.
5. (2) The authorizing physician is responsible for the oversight of, and accepts responsibility for, the vaccines administered by the pharmacist.

6. (3) Pharmacist Qualifications. Pharmacists administering vaccines by protocol as authorized by Chapter 338, RSMo, must first file a Notification of Intent (NOI) to administer vaccines with the Missouri Board of Pharmacy. To file a NOI, a pharmacist must—

   1. (A) Hold a current Missouri pharmacist license;
   2. (B) Hold a current healthcare provider level cardiopulmonary resuscitation (CPR) or basic life support (BLS) certification issued by the American Heart Association, the American Red Cross, or an equivalent organization. The qualifying BLS or CPR certification program must have included a live in-person skills assessment; and

   3. (C) Have successfully completed a certificate program in administering vaccines accredited by the Accreditation Council for Pharmacy Education (ACPE), provided by an ACPE or regionally accredited pharmacy or medical school/college or approved by the Board of Pharmacy. The required certificate program must include a live/in-person training component and include instruction in:

      1. 1. Current CDC guidelines and recom-

mendations for vaccines authorized by Chapter 338, RSMo, including recommended immunization schedules;

1. 2. Basic immunology and vaccine pro-

tection;

1. 3. Physiology and techniques for vaccine

administration, including hands-on training in intramuscular, intradermal, subcutaneous and nasal administration routes, and other common routes of vaccine administration;

1. 4. Preand postvaccine screening or

assessment; and

1. 5. Identifying and treating adverse

immunization reactions;

1. (D) Notifications of Intent must be filed on the board’s website or on a form approved by the board.

1. (4) Protocol Requirements.

   1. (A) In addition to filing a NOI, pharmacists administering vaccines under this rule must first enter into a written protocol with a Missouri licensed physician. The written protocol may be valid for a time period not to exceed one (1) year. The protocol must be renewed annually and include the following:

      1. 1. The identity of the participating phar-

macist and physician;

1. 2. Time period of the protocol;
2. 3. Authorized vaccines;
3. 4. The patient or groups of patients

authorized for vaccination;

1. 5. Allowed routes and anatomic sites of

administration;

1. 6. If applicable, authorization to create a

prescription for each administration under the physician’s name;

1. 7. Emergency response procedures,

including, but not limited to, procedures for handling/addressing adverse reactions, anaphylactic reactions, and accidental needle sticks;

1. 8. The length of time the pharmacist

must observe an individual for adverse events following an injection;

1. 9. Procedures for disposing of used and

contaminated supplies;

1. 10. The street addresses of any non-phar-

macy locations at which the pharmacist may administer vaccines;

1. 11. Record-keeping requirements and any

required notification procedures; and

1. 12. A provision allowing termination of

the protocol at any time at the request of any party.

1. (B) The protocol, and any subsequent amendments or alterations, must be reviewed and manually or electronically signed and dated by the pharmacist and authorizing physician prior to its implementation, signifying that both are aware of its contents and agree to follow the terms of the protocol. A copy of the protocol must be maintained by both the pharmacist and the authorizing physician for a minimum of eight (8) years after termination of the protocol.
2. (C) Additional pharmacists or immunization locations may be added to an existing protocol if the amendment is signed and dated by the authorizing physician(s) and, if applicable, any newly added pharmacist(s). Existing pharmacists are not required to resign the protocol unless other protocol terms or provisions are changed.

1. (5) Record Keeping.

   1. (A) The pharmacist shall ensure a record is maintained for each vaccine administered by protocol that includes:

      1. 1. The patient’s name, address, and date

of birth;

1. 2. The date, route, and anatomic site of

the administration;

1. 3. The vaccine’s name, dose, manufac-

turer, lot number, and expiration date;

1. 4. The name and address of the patient’s

primary health care provider, as provided by the patient;

1. 5. The identity of the administering

pharmacist or, if applicable, the identity of the administering intern pharmacist and supervising pharmacist; and

1. 6. The nature of any adverse reaction

and who was notified, if applicable.

1. (B) Within seventy-two (72) hours after a vaccine is administered, a prescription must be obtained from the authorizing physician for the drug dispensed or a prescription must be created in the physician’s name documenting the dispensing as authorized by protocol. Notwithstanding any other provision of this rule, prescription records must be maintained as provided by Chapter 338, RSMo, and the rules of the board.

2. (C) The records required by this rule must be securely and confidentially maintained as follows:

   1. 1. If the vaccine is administered on

behalf of a pharmacy, both the pharmacy and the administering pharmacist shall ensure the records required by subsection (5)(A) are promptly delivered to and maintained at the pharmacy separate from the pharmacy’s prescription files;

1. 2. If the vaccine is not being adminis-

tered on behalf of a pharmacy, all records shall be maintained securely and confidentially by the administering pharmacist at an address that shall be identified in the protocol prior to administering the vaccine;

1. 3. Prescription records must be main-

tained as required by Chapter 338, RSMo, and the rules of the board; and

1. 4. Records required by this rule must be

maintained for two (2) years and made available for inspecting and copying by the State Board of Pharmacy or the State Board of Registration for the Healing Arts and/or their authorized representatives. Records maintained at a pharmacy must be produced during an inspection by the board and/or their authorized representatives. Records not maintained at a pharmacy must be produced within three (3) business days after a request from the State Board of Pharmacy, the Board of Registration for the Healing Arts and/or their authorized representative. Failure to maintain or produce records as provided by this rule shall constitute grounds for discipline.

1. (6) Notification of Immunizations. Pharmacists immunizing by protocol must—

   1. (A) Notify all persons or entities as required by state and federal law;
   2. (B) Notify the protocol physician as required by the governing protocol;
   3. (C) Notify the patient’s primary care provider as required by Chapter 338, RSMo; and
   4. (D) Notify the patient’s primary health care provider and, if different, the protocol physician, within twenty-four (24) hours after learning of any adverse event or reaction experienced by the patient. Adverse events or reactions must also be reported to the Vaccine Adverse Event Reporting System (VAERS) or its successor, within thirty (30) days.
   5. (E) Unless otherwise provided by the governing protocol, notification may be made via a common electronic medication record that is accessible to and shared by both the physician and pharmacist. Proof of notification must be maintained in the pharmacist’s records as provided in subsection (5)(B) of this rule.

2. (7) Notification of Intent Renewal. A Notification of Intent (NOI) to immunize by protocol must be renewed biennially with the immunizing pharmacist’s Missouri pharmacist license. To renew a NOI, pharmacists must—

   1. (A) Have a current healthcare provider cardiopulmonary resuscitation (CPR) or basic life support (BLS) certification that complies with subsection (3)(B) of this rule; and
   2. (B) Have completed a minimum of two (2) hours of continuing education (0.2 CEU) related to administering vaccines or CDC immunization guidelines in a course approved by the Board of Pharmacy or provided by an 20 CSR 2220-6

ACPE accredited continuing education provider within the applicable pharmacist biennial renewal period (November 1 to October 31 of the immediately preceding even numbered years).

1. (C) The required continuing education (CE) shall be governed by 20 CSR 2220-7.080 and may be used to satisfy the pharmacist’s biennial continuing education requirements. The initial training program required by section (3) of this rule may be used to satisfy the CE requirements of this subsection if the training program was completed within the applicable pharmacist biennial renewal cycle.

AUTHORITY: sections 338.140 and 338.220, RSMo 2016, and section 338.010, RSMo Supp. 2017.* Emergency rule filed Oct. 24, 2007, effective Nov. 3, 2007, expired April 30, 2008. Original rule filed Oct. 24, 2007, effective May 30, 2008. Emergency amendment filed Oct. 22, 2009, effective Nov. 1, 2009, expired April 29, 2010. Amended: Filed Oct. 22, 2009, effective June 30, 2010. Amended: Filed Feb. 9, 2018, effective Sept. 30, 2018. ** Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009, 2011, 2014, 2017; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011; and 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997, 1999, 2001, 2004, 2007, 2009, 2011, 2014. **Pursuant to Executive Orders 20-04, 20-10, and 20-12, 20 CSR 2220-6.050, subsections (7)(A) and (7)(B) was suspended from July 13, 2020 through December 30, 2020.