680-X-2-.46 Training for Immunizing Pharmacists

(1) Purpose: The Alabama State Board of Pharmacy (Board) is charged with the duty and responsibility to maintain standards of professional conduct and to regulate professional practice and is further charged to protect the health, safety and welfare of the citizens of the State of Alabama. In conformity with this purpose, this rule shall provide guidelines for administering vaccinations by Alabama licensed and/or registered pharmacists, interns and externs.

(2) In order to administer immunizations, a pharmacist, intern or extern must be licensed and/or registered by the Alabama Board of Pharmacy and comply with the following requirements:

a. Complete a 20-hour Accreditation Council for Pharmacy Education (ACPE) approved practical training program to include hands-on injection technique training, the recognition and treatment of emergency reactions to vaccines and successful examination to assure sufficient knowledge of vaccines.

b. The training may be obtained as a component of an accredited Doctor of Pharmacy curriculum.

c. The pharmacist, intern, and/or extern must have and maintain a current certificate in basic cardiopulmonary resuscitation.

d. The pharmacist is responsible for his or her activities or those of the intern/extern in complying with requirements related to reporting adverse events to the Vaccine Adverse Event Reporting System (VAERS), including but not limited to:

i. Any adverse event listed in the VAERS table of Reporting Events Following Vaccination within the listed specified time period. ii. Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine.

e. The vaccine must be FDA-authorized or FDA-licensed.

f. In the case of a designated emergency vaccine, the vaccine must be ordered and administered according to the Advisory Committee on Immunization Practices (ACIP) vaccine recommendation(s).

g. A childhood vaccine must be ordered and administered according to ACIP standard immunization schedule.

h. The pharmacist must ensure that storage, use and administration of any sterile product meets the United States Pharmacopeia (USP) requirements, as well as those of the Centers for Disease Control and Alabama Administrative Code 680.

i. The pharmacy must have available an epinephrine kit (epinephrine in 1mg/ml aqueous solution, 1:1000 dilution) or an epinephrine autoinjector.

j . The pharmacist must ensure compliance with blood borne pathogen requirements, including, but not limited to medical waste disposal, and FDA-cleared sharps disposal containers.

(3) The pharmacist, intern, or extern shall submit to the Board documentation of the satisfactory completion of the requirements of (2)(a) or (2)(b) above within 10 days of completion.

(4) Pharmacists, interns, or externs trained to administer immunizations prior to June 30, 2021 shall submit either of the following to the Board before July 31, 2021:

a. Documentation of immunization training, or

b. Affidavit attesting to completion of immunization training.

(5) For each submission of the documentation referenced in paragraph (2)a, (2)b, or (4) above, the Secretary of the Board shall issue to the pharmacist, intern, or extern a certificate for immunization authority which shall be displayed in a conspicuous place.

(6) Any pharmacist, intern, or extern performing immunizations without complying with this rule shall be subject to discipline by the Board.

Author: Donna C. Yeatman R.Ph. Executive Secretary

Statutory Authority:Code of Ala. 1975, §34-23-92.

History: filed, 2021; effective