The Department of Health and Human Services (HHS) expanded its guidance allowing pharmacy staff to order and administer COVID-19 tests, COVID-19 vaccinations, and pediatric immunizations to patients three years of age and older. Previous guidance allowed pharmacy interns to administer these immunizations under the supervision of a qualified licensed pharmacist. The guidance clarifies the requirements for “qualified licensed pharmacy interns” and extends administration authority to “qualified pharmacy technicians” acting under a qualified licensed pharmacist’s supervision. Both interns and technicians will be included in the Public Readiness and Emergency Preparedness (PREP) Act’s liability waiver, and HHS’s action will supersede any state laws that might prevent the guidance from taking effect. This authorization is merely a floor – it would not supersede more permissive state laws allowing pharmacy technicians or pharmacy interns acting under a pharmacist’s supervision to administer pediatric immunizations and COVID-19 tests and immunizations to patients younger than three.
ASHP applauds HHS for offering providers additional flexibility to ensure that patients will have access to testing and vaccinations in pharmacies.
“ASHP is pleased that HHS recognizes the important role pharmacy technicians and pharmacy interns play in the healthcare system,” said Tom Kraus, ASHP vice president of government relations. “Fully engaging all pharmacy personnel in testing and immunization is an important step in the fight against the COVID-19 pandemic and will help prepare us for the next viral health threat.”
Pursuant to the PREP Act, HHS is allowing “qualified pharmacy technicians” and “state-authorized pharmacy interns” across the country to administer pediatric and COVID-19 immunizations as well as COVID-19 tests under a qualified pharmacist’s supervision, provided that a number of requirements are met. A state-authorized 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.” A qualified pharmacy technician, if working in a state with licensure and/or registration requirements, must be licensed and/or registered in accordance with the state requirement. In states without state licensure or registration, the qualified pharmacy technician must have a Certified Pharmacy Technician (CPhT) certification from either the Pharmacy Technician Certification Board or National Healthcareer Association.
The administration authority comes with a number of prerequisites. Specifically, in order to administer FDA-approved/licensed, Advisory Committee on Immunization Practices (ACIP) recommended immunizations, state-authorized pharmacy interns and qualified pharmacy technicians will need to meet the following requirements:
- The vaccination is ordered by the supervising qualified pharmacist;
- The supervising qualified pharmacist is readily and immediately available;
- In the case of a COVID-19 vaccine, the vaccination is ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s);
- In the case of a childhood vaccine, the vaccination is ordered and administered according to ACIP’s standard immunization schedule;
- The state-authorized pharmacy intern or qualified pharmacy technician has completed a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE), including hands-on injection technique and the recognition and treatment of emergency reactions to vaccines;
- The state-authorized pharmacy intern or qualified pharmacy has a current certificate in basic cardiopulmonary resuscitation;
- The state-authorized pharmacy intern or qualified pharmacy has completed two hours of ACPE-approved, immunization-related continuing pharmacy education during the relevant State licensing period(s);
- The supervising qualified 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 and submitting the required immunization information to the state or local immunization information system (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 the CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).
Although the expansion of the pediatric immunization guidance is a step in the right direction, it is important to note two things — first, the new authority is time-limited to the COVID-19 public health emergency (PHE). It is unclear if it can or will be extended past the PHE. Second, it does not appear that new authority will function as a type of modified provider status. Today’s PREP Act declaration specifically reiterates that pharmacist ordering and administration for immunization authority does not impact Medicare and Medicaid screening and enrollment requirements, indicating that the new authority will not function as modified provider status.