Recently, the U.S. Health and Humans Services Department (HHS) issued a declaration entitled “Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19.”
This declaration allows pharmacists and pharmacy interns to administer vaccines to children between the ages of 3 and 18 for the duration of the public health emergency. This is a blanket declaration that applies to every state regardless of local scope of practice law.
The declaration includes requirements related to:
- The vaccine must be FDA-authorized or FDA-licensed.
- The vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
- Pharmacists and pharmacy interns must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE).
- Pharmacists must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.
- Pharmacists must comply with recordkeeping and reporting requirements of the jurisdiction in which they are administering 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)
- Reporting adverse events
- Reviewing the vaccine registry or other vaccination records prior to administering a vaccine.
- Pharmacists will be required to inform their patients and the adult caregivers of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.
The declaration includes a citation to an HHS Advisory Opinion that sets forth the legal framework under the PREP Act that HHS claims allows for the preemption of state laws.
The AMA released a statement in opposition to the declaration and asking that the declaration be rescinded.
Moreover, the AMA is aware that many scope of practice issues that have arisen during the public health emergency, and will continue to advocate for a physician-led care team that includes pharmacists.