Ala. Admin. Code r. 680-X-2-.46

Current through Register Vol. 42, No. 8, May 31, 2024

Section 680-X-2-.46 - Immunization Training

(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 pharmacists and/or registered interns, externs, and technicians.

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

(b) The intern and/or extern must be under the direct supervision of an Alabama licensed pharmacist.

(3) Technicians must be registered by the Alabama Board of Pharmacy, in good standing, acting under the direct supervision of an Alabama licensed pharmacist and in order to administer vaccines, shall comply with the following requirements:

(a) The registered pharmacy technician must complete a minimum two (2) hours of 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 registered technician must have a current certificate in basic cardiopulmonary resuscitation;

(c) The vaccine must be ordered by an Alabama licensed pharmacist or pursuant to a valid prescription;

(d) The Alabama licensed pharmacist must be readily and immediately available to the immunizing registered pharmacy technician;

(e) The registered technician shall submit to the Board of Pharmacy documentation of the satisfactory completion of the requirements of (3)(a) within 10 days of completion.

(f) For each submission of the documentation referenced in paragraph e. above, the Secretary of the Board shall issue to the registered technician a certificate for immunization authority, which shall be displayed in a conspicuous place.

(4) The pharmacist, in his or her capacity and as part of their supervision of intern, extern, and/or technician shall report any adverse event required by the Vaccine Adverse Event Reporting System (VAERS), including but not limited to:

(a) Any adverse event listed in the VAERS table of Reporting Events Following Vaccination within the listed specified time period.

(b) Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine.

(5) The pharmacist is further responsible to ensure, the following:

(a) The vaccine must be FDA-authorized or FDA-licensed;

(b) 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);

(c) A childhood vaccine must be ordered and administered according to ACIP's standard immunization schedule;

(d) Storage, use and administration of any sterile product used in the administration of immunizations meets the United States Pharmacopeia (USP) requirements, as well as those of the Centers for Disease Control and any applicable provision of the Alabama Pharmacy Practice Act and/or any rules of the Board now in effect or which may become effective in the future;

(e) The pharmacy must have available an epinephrine kit (epinephrine in lmg/ml aqueous solution) or an epinephrine autoinjector;

(f) Compliance with blood borne pathogen requirements, including, but not limited to medical waste disposal, and FDA-cleared sharps disposal containers;

(g) Compliance with all record keeping and reporting requirements, which are now in effect or may become required in the future.

(6) The licensed pharmacist must complete a minimum of two hours of Board approved, immunization-related continuing pharmacy education each renewal cycle.

(7) The supervising pharmacist shall ensure any pharmacists, interns, externs, and registered technicians prior to providing immunizations completion of the immunization training set out above and is acting in compliance with all requirements of the rule.

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

Ala. Admin. Code r. 680-X-2-.46

Adopted by Alabama Administrative Monthly Volume XXXIX, Issue No. 11, August 31, 2021, eff. 10/15/2021.

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

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