PURPOSE: This rule establishes the procedures for pharmacists to administer vaccines per written protocol with a physician.

1. (1) A pharmacist may administer vaccines authorized by Chapter 338, RSMo, pursuant to a written protocol authorized by a physician licensed pursuant to Chapter 334, RSMo, who is actively engaged in the practice of medicine.

   1. (A) A pharmacist shall administer vaccines in accordance with treatment guidelines established by the Centers for Disease Con- 20 CSR 2150-5

trol (CDC) and in accordance with manufacturer’s guidelines, provided that a pharmacist shall not administer vaccines to persons under twelve (12) years of age.

1. (B) A pharmacist shall comply with all state and federal laws and regulations pertaining to Vaccine Information Statements and informed consent requirements.

1. (2) A pharmacist may not delegate the administration of vaccines to another person, except to a pharmacist intern who has met the qualifications under subsections (4)(B), (C), and
2. (D) and is working under the direct supervision of a pharmacist qualified to administer vaccines.
3. (3) The authorizing physician is responsible for the oversight of, and accepts responsibility for, the vaccines administered by the pharmacist.

4. (4) Pharmacist Qualifications. A pharmacist who is administering a vaccine authorized by Chapter 338, RSMo, must:

   1. (A) Hold a current, unrestricted license to practice pharmacy in this state;
   2. (B) Hold a current cardiopulmonary resuscitation (CPR) certification issued by the American Heart Association or the American Red Cross or equivalent;
   3. (C) Successfully complete a certificate program in the administration of vaccines accredited by the Accreditation Council for Pharmacy Education (ACPE) or a similar health authority or professional body approved by the State Board of Pharmacy;
   4. (D) Maintain documentation of the above certifications;
   5. (E) Complete a minimum of two (2) hours (0.2 CEU) of continuing education as defined per calendar year related to administration of vaccines. A pharmacist may use the continuing education hours required in this subsection as part of the total continuing education hours required for pharmacist license renewal;
   6. (F) Provide documentation of subsections (A), (B), (C), and (E) of this section to the authorizing physician(s) prior to entering into a protocol or administering vaccines; and
   7. (G) On a yearly basis prior to administering vaccines, establish a new protocol with the authorizing physician and notify the State Board of Pharmacy of their qualifications to do so. This notification shall include the types of drugs being administered and a statement that the pharmacist meets the requirements of subsections (A), (B), (C), (E), and
5. (F) of this section.
6. (5) Administration by Written Protocol with a FINANCIAL INSTITUTIONS AND PROFESSIONAL REGISTRATION

Missouri Licensed Physician.

1. (A) A pharmacist may enter into a written protocol with a physician for the administration of vaccines authorized by Chapter 338, RSMo, provided that a pharmacist shall be prohibited from administering vaccines to patients under twelve (12) years of age. The physician must be no further than fifty (50) miles by road, using the most direct route available, from the pharmacist who is administering the vaccine. The written protocol may be valid for a time period not to exceed one (1) year. The protocol must include the following:

   1. 1. The identity of the participating phar-

macist and physician, including signatures;

1. 2. Time period of the protocol;
2. 3. The identification of the vaccines

which may be administered;

1. 4. The identity of the patient or groups

of patients to receive the authorized vaccine(s);

1. 5. The identity of the authorized routes

and anatomic sites of administration allowed;

1. 6. A provision to create a prescription

for each administration under the authorizing physician’s name;

1. 7. A provision establishing a course of

action the pharmacist shall follow to address emergency situations including, but not limited to, adverse reactions, anaphylactic reactions, and accidental needle sticks;

1. 8. A provision establishing a length of

time the pharmacist shall observe an individual for adverse events following an injection;

1. 9. A provision establishing the disposal

of used and contaminated supplies;

1. 10. The street addresses of the pharma-

cy or other locations at which the pharmacist may administer the authorized vaccine;

1. 11. Record-keeping requirements and

procedures for notification of administration; and

1. 12. A provision that allows for termina-

tion of the protocol at the request of any party to it at any time.

1. (B) The protocol, and any subsequent amendments or alterations, shall be signed and dated by the pharmacist and authorizing physician prior to its implementation, signifying that both are aware of its content and agree to follow the terms of the protocol. The authorizing physician and pharmacist shall each maintain a copy of the protocol from the beginning of implementation to a minimum of eight (8) years after termination of the protocol.

1. (6) Record Keeping.

   1. (A) A pharmacist administering vaccines pursuant to this rule shall maintain a record of each administration which shall include:

      1. 1. The name, address, and date of birth

of the patient;

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

the administration;

1. 3. The name, dose, manufacturer, lot

number, and expiration date of the vaccine;

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

primary health care provider, as identified by the patient;

1. 5. The name or identifiable initials of

the administering pharmacist; and

1. 6. The nature of an adverse reaction and

who was notified, if applicable.

1. (B) If the vaccine was administered on behalf of a pharmacy, the pharmacist shall ensure the records required by subsection (6)(A) of this rule are promptly delivered to the pharmacy.
2. (C) Within seventy-two hours (72) hours after administration of a vaccine, the administering pharmacist shall obtain a prescription from the authorizing physician for the drug dispensed or shall create a prescription, as authorized by protocol documenting the dispensing of the drug. Notwithstanding any other provision of this rule, prescription records shall be maintained as provided by Chapter 338, RSMo, and the rules of the board.

3. (D) The records required by this rule shall be maintained securely and confidentially as follows:

   1. 1. If the vaccine is administered on

behalf of a pharmacy, both the pharmacy and the administering pharmacist shall ensure that all records required by this rule are maintained at the pharmacy separate from the prescription files of the pharmacy. If the vaccine is not being administered 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; and

1. 2. Records shall be maintained for two

1. (2) years from the date of such record and shall be 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 shall be produced within three (3) business days after a request from the State Board of Pharmacy and/or its authorized representative. Failure to maintain or produce records as provided by this rule shall constitute grounds for discipline.

2. (7) Notification Requirement.

   1. (A) A pharmacist administering vaccines authorized by Chapter 338, RSMo, shall notify the authorizing physician within seventy-two (72) hours after administration of the following:

      1. 1. The identity of the patient;
      2. 2. The identity of the vaccine(s) admin-

istered;

1. 3. The route of administration;
2. 4. The anatomic site of the administra-

tion;

1. 5. The dose administered; and
2. 6. The date of administration.
3. (B) The pharmacist shall provide a written report to the patient’s primary health care provider, if different than the authorizing physician, containing the documentation required in subsection (A) of this section within fourteen (14) days of the administration.
4. (C) In the event of any adverse event or reaction experienced by the patient pursuant to a written protocol, the pharmacist shall notify the patient’s primary health care provider and authorizing physician, if different, within twenty-four (24) hours after learning of the adverse event or reaction.
5. (D) A pharmacist administering vaccine(s) shall report the administration to all entities as required by state or federal law.
6. (E) Documentation that notifications required by this rule have been sent must be maintained as provided in section (6) of this rule.

AUTHORITY: section 334.125, RSMo 2000 and sections 338.010 and 338.220, RSMo Supp. 2009.* 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.

*Original authority: 334.125, RSMo 1959, amended 1993, 1995; 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009; and 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997, 1999, 2001, 2004, 2007, 2009.