In an announcement today from the U.S. Department of Health and Human Services (HHS), licensed pharmacists are allowed to provide all vaccines recommended by the CDC's Advisory Committee on Immunization Practices (ACIP) to children aged 3 to 18. This would consequently allow for authorizing a future COVID-19 vaccine and would supersede any state's laws and regulations.
"Today’s action means easier access to lifesaving vaccines for our children, as we seek to ensure immunization rates remain high during the COVID-19 pandemic,” said HHS Secretary Alex Azar. “The Trump Administration has worked to allow pharmacists—alongside all of America’s heroic healthcare workers—to practice at the top of their license, empowering the public with more options to protect their health and well-being.”
From the release, the rules stipulate as follows:
- The vaccine must be approved or licensed by the Food and Drug Administration (FDA).
- The vaccination must be ordered and administered according to the CDC’s Advisory Committee on Immunization Practices (ACIP) immunization schedules.
- The licensed 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 licensed or registered pharmacy intern must complete a practical training program that is 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 have a current certificate in basic cardiopulmonary resuscitation.
- The licensed pharmacist must complete a minimum of 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 with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to 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.
"This is great news from HHS," said Scott J. Knoer, MS, PharmD, FASHP, Executive Vice President and CEO of APhA. "We have long advocated that pharmacists are uniquely positioned to address this public health emergency, and we worked with HHS to develop this strategy to engage all pharmacists. As Admiral Brett Giroir, the assistant secretary for health, said today, pharmacists have always been a trusted voice in the community, and they're accessible. We couldn't agree more!"
The decision comes in a time when routine vaccinations for children are reaching a low point, compounded by the stay-at-home lifestyle during the coronavirus pandemic.
“As a pediatric critical care physician who has treated critically ill children suffering from vaccine preventable diseases, I know first-hand the devastation to the child – and to the family and community – of a death or severe brain damage that could have been avoided by a safe and effective vaccine,” said HHS Assistant Secretary for Health Brett P. Giroir, M.D. "The cornerstone of public health, vaccines, makes these dreaded diseases preventable. As we expand options during the COVID-19 response, we are also reminding parents, grandparents, and caretakers that there is no substitute for a critically important well-child visit with a pediatrician or other licensed primary care provider when available.”