HHS Permits Pharmacists to Order and Administer COVID-19 Vaccines

The Department of Health and Human Services (HHS) has authorized state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns under the supervision of the pharmacist to administer, coronavirus disease 2019 (COVID-19) vaccines to individuals ages 3 or older, according to an announcement.¹

The guidance was issued under the Public Readiness and Emergency Preparedness (PREP) Act and comes after HHS recently authorized all state-licensed pharmacists and pharmacy interns to order and administer childhood vaccinations amid the pandemic. ​

“This is tremendous news,” Scott J Knoer, MS, PharmD, FASHP, executive vice president and CEO of the American Pharmacists Association said in a statement.² “It properly recognizes that pharmacists serve a vital role in the nation’s response to this pandemic. It increases patients’ access to care during this emergency with providers whom they trust, at a time and place that is convenient for them.”

“This is an extremely important decision by the Administration,” NACDS President and CEO Steven C. Anderson said in a statement.³ “When safe and effective COVID-19 vaccinations are available, it will be essential to have pharmacies and pharmacists prepared to be ‘ready, set, go.’”

The authorization includes the following requirements:¹

• The vaccine must be FDA-authorized or FDA-licensed.
• The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendation.
• The pharmacist must complete a practical training program of at least 20 hours that is 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 pharmacy intern must complete a practical training program that is approved by the ACPE.
• The pharmacist and pharmacy intern must have a current certificate in basic CPR.
• The pharmacist must complete a minimum of 2 hours of ACPE-approved, immunization-related continuing pharmacy education during each state licensing period.
• The pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including reviewing the vaccine registry or other vaccination records prior to administering a vaccine.
• The pharmacist must, if the patient is 18 years of age or younger, inform the patient and adult caregiver of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate.
• The pharmacist and pharmacy intern must comply with any applicable requirements as set forth in the CDC COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

Additionally, HHS noted that the authorization preempts any state and local laws that prohibit or effectively prohibit those who satisfy these requirements from ordering or administering COVID-19 vaccines as set forth above. The authorization does not preempt state and local laws to permit additional individuals to administer COVID-19 vaccines to additional individuals.

References

1. Trump Administration Takes Action to Expand Access to COVID-19 Vaccines. News release. HHS; September 9, 2020. Accessed September 9, 2020. https://www.hhs.gov/about/news/2020/09/09/trump-administration-takes-action-to-expand-access-to-covid-19-vaccines.html​
2. APhA Hails HHS Announcement Authorizing Pharmacists to Administer COVID-19 Vaccines. News release. APhA; September 9, 2020. Accessed September 9, 2020. https://www.pharmacist.com/press-release/apha-hails-hhs-announcement-authorizing-pharmacists-administer-covid-19-vaccines.
3. NACDS Welcomes HHS Decision to Empower Pharmacists to Administer Safe and Effective COVID-19 Vaccinations. News release; September 9, 2020. Accessed September 9, 2020. https://www.nacds.org/news/nacds-welcomes-hhs-decision-to-empower-pharmacists-to-administer-safe-and-effective-covid-19-vaccinations/​