Rules of the Road: Pharmacists and Vaccines
/Gov. Ned Lamont issued Executive Order No. 9Q on Dec. 7, 2020 authorizing pharmacies to administer COVID-19 vaccines. The Connecticut General Assembly’s Office of Legislative Research has previously issued a Research Report on the topic of Pharmacists’ Administration of Vaccines, originally published on November 14, 2019.
by James Orlando
State law authorizes licensed pharmacists to administer to adults (age 18 or older) any federally approved vaccine listed on the National Centers for Disease Control and Prevention’s (CDC) Adult Immunization Schedule (CGS § 20-633). The vaccination must be administered according to an order (typically a standing order) of a licensed health care provider and the Department of Consumer Protection’s (DCP) implementing regulations.
The law requires the DCP commissioner, in consultation with the public health commissioner and the Commission of Pharmacy, to adopt regulations:
1. requiring pharmacists who administer vaccines to successfully complete a training program;
2. defining the basic requirements of the training program, including several specified components;
3. identifying qualifying accredited training programs; and
4. establishing a control and reporting system.
PA 05-212 first granted pharmacists the authority to administer flu vaccines. In 2010, the law was expanded to include vaccines for invasive pneumococcal disease and herpes zoster (shingles) (PA 10-82). In 2012, the law was again expanded to include any federally approved vaccine listed on the CDC’s Adult Immunization Schedule (PA 12-207).
Regulations on Pharmacists’ Administration of Vaccines
In 2006, DCP adopted regulations implementing the law on pharmacists’ administration of vaccines. The regulations were last amended in 2012 (Conn. Agencies Reg., § 20-633-1 et seq.).
Training Program
Under the regulations, to be eligible to administer vaccines as authorized by law, a pharmacist must complete an immunization training program that is accredited by the Accreditation Council for Pharmacy Education (Conn. Agencies Regs., §§ 20-633-2 & -3).
The program’s course of study must include current CDC guidelines and recommendations for the vaccination of adult patients. It must also include the following components:
1. mechanisms of action for vaccines, contraindications, drug interactions, and monitoring after vaccine administration;
2. subcutaneous and intramuscular injections;
3. immunization screening questions, informed consent forms, recordkeeping, registries, and reporting mechanisms;
4. vaccine storage;
5. biohazard waste disposal and sterile techniques;
6. establishing protocols;
7. immunization coalitions and other available community resources;
8. mechanisms for reporting adverse events to the Vaccine Adverse Event Reporting System;
9. reimbursement procedures and vaccine coverage by federal, state and local entities;
10. administration techniques;
11. current CPR certification; and
12. annual continuing education in immunizations (Conn. Agencies Reg., § 20-633-4).
Control and Reporting Systems
Under the regulations, in order for a pharmacist to administer vaccines, a licensed health care provider authorized to order or prescribe legend drugs must establish a written protocol with the pharmacist or pharmacy. The protocols must be in writing and must include the following:
1. the name of the provider and pharmacist and the types of vaccines that the pharmacist is authorized to administer;
2. the procedures, decision criteria, or plan the pharmacist must follow when exercising the administration authority, including when to refer the patient to the physician;
3. emergency procedures; and
4. recordkeeping and documentation procedures, including recording the name of the pharmacist who administered the vaccine (Conn. Agencies Reg., § 20-633-5).
James Orlando is Chief Attorney with the Connecticut General Assembly's Office of Legislative Research, which provides “objective research for Connecticut’s legislature.”
CT by the Numbers periodically highlights non-partisan research as a means of furthering awareness and knowledge of public policy issues.
