The U.S. Department of Health and Human Services (HHS) issued a third amendment on Wednesday to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to allow state-licensed pharmacists to administer all childhood vaccines to children and teens between ages three and 18. The move, while described as a way of giving “easier access to lifesaving vaccines for our children, as we seek to ensure immunization rates remain high during the COVID-19 pandemic” by HHS Secretary Alex Azar, leaves medical professionals in the pediatric space concerned and calling it “incredible misguided,” however.
In a statement from the American Academy of Pediatrics (AAP), the organization’s President Sally Goza, MD, FAAP said that the academy opposes the announcement.
“This move is incredibly misguided. In the middle of a pandemic, what families are looking for is reassurance and clinical guidance from the doctors they trust most to care for their children: pediatricians,” Goza said. “Pediatricians’ offices are open and safe. We have all necessary childhood and adolescent vaccines in stock with trained medical professionals who can administer them. We know that the best, safest place for children to get vaccinated is in their medical home.”
— Amer Acad Pediatrics (@AmerAcadPeds) August 19, 2020
Per the HHS amendment, the change would authorize the state-licensed pharmacists (and state licensed/registered pharmacy interns under their supervision) to administer vaccines, provided they meet the following requirements:
- 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.
For the AAP, despite potentially good intentions of the decision, it’s ultimately unnecessary and could potentially lead to children receiving sub-par care compared to the experience of getting their vaccines with their own pediatrician (who knows their medical histories, bodies and are able to more clearly answer questions parents may have.
“Most children and adolescents receive vaccines as part of routine well-child check-ups, when other important health care is provided, including developmental and mental health screenings, counseling about nutrition and injury-prevention, and chronic disease management,” according to the AAP release. “Conversations about immunizations are part of those visits, and can be tailored to respond to parents’ unique questions.”
The Academy also raises some serious concerns about what this means for health inequality around the United States and for the pervasive “vaccine hesitancy” that is exacerbated by fear and misinformation.
Noting that few of these pharmacies participate in the federally-funded Vaccines for Children program — which works to give no cost vaccinations to kids from Medicaid-eligible families, uninsured, underinsured, native or indigenous backgrounds, they argue that expanding pharmacies abilities to give vaccines will not address concerns about vaccination rates among vulnerable communities.
“This unprecedented expansion of pharmacies’ ability to administer vaccines to children is not a solution to the vaccine hesitancy that is driving down rates of childhood immunizations in the U.S.,” Dr. Goza said. “Many parents have questions about their children’s vaccines, and pediatricians are ready to talk with them. It’s what we do, every day, one-on-one with thousands of parents, as part of the long-term trusting relationships that families have with their physicians…Now more than ever, parents trust their children’s pediatrician,” Dr. Goza says. “Rather than create an unnecessary alternative method to deliver immunizations to children, our federal government should invest in the one we have: pediatricians.”
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