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

1. (1) A pharmacist may administer viral influenza vaccinations:

   1. (A) To persons twelve (12) years of age or older; and
   2. (B) Pursuant to a written protocol authorized by a physician licensed pursuant to Chapter 334, RSMo, who is actively engaged in the practice of medicine in the state of Missouri.
2. (2) A pharmacist may not delegate the administration of viral influenza vaccinations to another person, except to a pharmacist intern who has met qualifications under subsections (4)(B), (C), and (D) and is working under the direct supervision of a pharmacist qualified to administer viral influenza vaccinations.
3. (3) The authorizing physician is responsible for the oversight of, and accepts responsibility for, the viral influenza vaccinations administered by the pharmacist.

4. (4) Pharmacist Qualifications—A pharmacist who is administering viral influenza vaccinations must:

   1. (A) Hold a current, unrestricted license to practice pharmacy in this state;
   2. (B) Hold a current provider level 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 viral influenza vaccinations 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 per year related to administration of viral influenza vaccinations. 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 viral influenza vaccinations; and
   7. (G) On a yearly basis prior to administering viral influenza vaccinations, 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 (F) of this section.

5. (5) General Requirements.

   1. (A) A pharmacist shall administer viral influenza vaccinations in accordance with treatment guidelines established by the Centers for Disease Control and Prevention

6. (CDC) or in accordance with manufacturer’s guidelines.

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

7. (6) Administration by Written Protocol with a Missouri Licensed Physician.

   1. (A) A pharmacist may enter into a written protocol with a physician for the administration of viral influenza vaccinations to patients twelve (12) years of age or older. 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 viral influenza vaccinations. 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 viral influen-

za vaccination which may be administered;

1. 4. The identity of the patient or groups

of patients to receive the authorized viral influenza vaccination;

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 address of the pharmacy

at which the pharmacist may administer the authorized viral influenza vaccination;

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 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. (7) Record Keeping.

   1. (A) A pharmacist who administers a viral influenza vaccination shall maintain the following records regarding each administration. These records must be separate from the prescription files of a pharmacy and 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 vaccination;

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) All administrations of viral influenza vaccinations must have a prescription as authorized by protocol on file within seventytwo (72) hours after administration at a pharmacy documenting the dispensing of the drug.
2. (C) All records required by this regulation shall be kept by the pharmacist and be available for two (2) years from the date of such record, for inspecting and copying by the authorizing physician, the State Board of Pharmacy or the State Board of Registration for the Healing Arts and/or their authorized representatives.

1. (8) Notification Requirement.

   1. (A) A pharmacist administering viral influenza vaccinations 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 viral influenza

vaccination administered;

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 viral influenza vaccinations shall report the administration to all entities as required by state or federal law. AUTHORITY: section 338.010, RSMo Supp. 2007 and section 338.140, RSMo 2000.* Emergency rule filed Oct. 24, 2007, effective Nov. 3, 2007, expired April 30, 2008. Original rule filed Oct. 24, 2007, effective May 30, 2008.

Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007 and 338.140, RSMo 1939, amended 1981, 1989, 1997.