On August 19, 2020, Secretary of the U.S. Department of Health and Human Services (HHS) Alex Azar issued a third amendment to HHS’ Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (Directive). The Directive allows certain state-licensed pharmacists to order and administer “any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule.” Licensed or registered pharmacist interns may also administer, but not order, such vaccines under the supervision of a pharmacist. Notably, the Directive preempts state law and local scope-of-practice legal requirements.
Secretary Azar noted that twenty-two states limit the vaccinations that pharmacists can administer and three prohibit pharmacists from immunizing kids. Citing government reports regarding vaccination rate reductions, Secretary Azar noted that the Directive is aimed at preventing such reductions. The referenced government report from the Centers For Disease Control and Prevention (CDC) reflected declines in routine pediatric vaccine orders and administration during the COVID-19 pandemic. The CDC provided that the reduction may indicate that “U.S. children and their communities face increased risks for outbreaks of vaccine-preventable diseases.”
Like other COVID-19 related government actions that CG attorneys have written about, HHS provided requirements to comply with the Directive.
- The vaccine must be FDA-authorized or FDA-licensed.
- The vaccination must be ordered and administered according to ACIP’s standard immunization schedule.\
- The licensed pharmacist must complete a practical training program of at least 20 hours approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
- The licensed or registered pharmacy intern must complete a practical training program approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
- The licensed pharmacist and licensed or registered pharmacy intern must be CPR certified.
- The licensed pharmacist must complete at least two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.
- The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements regarding reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records before administering a vaccine.
- The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.
Importantly, most requirements in the Directive apply to the “licensed pharmacist,” not necessarily a pharmacy or other pharmacist employer. Pharmacists that intend to administer vaccines under the Directive should coordinate with their employers and ensure all requirements are satisfied, like the record-keeping requirements. Until further guidance is provided, compliance with the requirements of the Directive is the responsibility of the licensed pharmacist. The Directive in its entirety can be found here.
The attorneys at Chilivis Grubman represent clients of all types and sizes, including individual providers, in connection with a wide variety of regulatory and compliance matters, including government investigations, audits, licensing board actions, and litigation. If you need assistance with such a matter, please contact us today.