Pharmacy interns and techs who meet HHS requirements can administer childhood, COVID-19 vaccines
The U.S. Department of Health and Human Services (HHS) has released guidance that expands the immunization authorities of state-licensed pharmacy interns and “qualified” pharmacy technicians during the public health emergency. Interns and techs who meet conditions set forth by HHS will not only be allowed to administer ACIP-recommended childhood vaccines (ages 3 to 18) and FDA-authorized or licensed COVID-19 vaccines and tests (ages 3 and older)—including serology tests—but they will also be granted liability coverage for these duties during the public health emergency.
According to the new guidance, to be deemed a “qualified person” under federal law—that is, authorized and granted liability coverage to administer FDA-authorized or FDA-licensed COVID-19 vaccines to patients ages 3 or older or ACIP-recommended childhood vaccinations to patients ages 3 through 18—qualified pharmacy technicians and state-authorized pharmacy interns must satisfy and practice under the following requirements:
- The pharmacy intern must be authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs, but this authorization need not take the form of a license from, or registration with, the state board of pharmacy.
- To be a “qualified pharmacy technician,” pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a CPhT certification from either the Pharmacy Technician Certification Board or National Healthcareer Association.
- The vaccination must be ordered by the supervising qualified pharmacist.
- The supervising qualified pharmacist must be readily and immediately available to the immunizing qualified pharmacy technicians.
- The vaccine must be FDA-authorized or FDA-licensed.
- In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendations.
- In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
- The qualified pharmacy technician or state-authorized pharmacy intern must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.
- The qualified pharmacy technician or state-authorized pharmacy intern must have a current certificate in basic CPR.
- The qualified pharmacy technician must complete a minimum of 2 hours of ACPE-approved, immunization-related continuing pharmacy education during the relevant state licensing period.
- The supervising qualified pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which they administer vaccines, including informing the patient’s primary care provider when available and submitting the required immunization information to the state or local immunization information system—for example, a vaccine registry.
- The supervising qualified pharmacist is responsible for complying with requirements related to reporting adverse events.
- The supervising qualified pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy technician or state-authorized pharmacy intern.
- The qualified pharmacy technician and state-authorized pharmacy intern must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.
- The supervising qualified pharmacist must comply with any applicable requirements or conditions of use as set forth in CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccines.
The guidance applies to all states, even those where state and local laws prohibit or effectively prohibit pharmacists, pharmacy interns, and pharmacy technicians to administer tests and vaccines. States and local laws that permit health care providers beyond pharmacists, state-licensed pharmacy interns, and qualified pharmacy technicians are not preempted—HHS guidances do not affect such laws.