The US Department of Health and Human Services (HHS) issued a third amendment to the Declaration under the Public Readiness and Emergency Preparedness Act authorizing all state-licensed pharmacists to order and administer vaccines to patients aged 3 to 18 years during the coronavirus disease 2019 (COVID-19) pandemic, regardless of state laws and regulations to the contrary.
HHS issued the amendment in order to increase access to childhood vaccines and decrease the risk of vaccine-preventable disease outbreaks as children across the US return to daycare and school. The impact of the pandemic on pediatric vaccination was examined in a May 2020 Morbidity and Mortality Weekly Report. Using data from the Centers for Disease Control and Prevention (CDC) Vaccine Tracking System and Vaccine Safety Datalink, researchers were able to assess a decline in routine pediatric vaccine ordering, as well as in administered doses.
State-licensed pharmacists (and pharmacy interns acting under their supervision to administer vaccines, if the pharmacy intern is licensed or registered by his/her state board of pharmacy) are authorized to administer vaccines under the following requirements:
- The vaccine must be approved or licensed by the Food and Drug Administration.
- Vaccination must be ordered and administered according to the CDC’s Advisory Committee on Immunization Practices 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); ACPE training is also required for licensed or registered pharmacy interns. The 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 2 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.
Pharmacists and pharmacy interns may still order or administer vaccines to patients aged 2 or younger to the extent authorized under state law to meet a community need.
Commenting on the HHS action, Scott J. Knoer, MS, PharmD, FASHP, Executive Vice President and CEO of the American Pharmacists Association (APhA), said: “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.”
However, not everyone is on board with the new strategy. In response to the announcement, the American Academy of Pediatrics (AAP) announced that the organization opposed the authorization allowing state-licensed pharmacists to order and administer childhood vaccines.
“This move is incredibly misguided,” said AAP President Sally Goza, MD, FAAP. Pediatricians’ offices are open and safe. “We have all necessary childhood and adolescent vaccines in stock with trained medical professionals who can administer them.” She added that allowing pharmacists to administer vaccines to children was unlikely to help improve rates of childhood immunization. “Many parents have questions about their children’s vaccines, and pediatricians are ready to talk with them,” said Dr Goza.
For more information visit hhs.gov.
- HHS expands access to childhood vaccines during COVID-19 pandemic. https://www.hhs.gov/about/news/2020/08/19/hhs-expands-access-childhood-vaccines-during-covid-19-pandemic.html. Accessed August 19, 2020.
- In major win, HHS authorizes pharmacists to order and administer vaccines to children nationwide during the public health emergency. https://www.prnewswire.com/news-releases/in-major-win-hhs-authorizes-pharmacists-to-order-and-administer-vaccines-to-children-nationwide-during-the-public-health-emergency-301115072.html. Accessed August 19, 2020.
- American Academy of Pediatrics opposes HHS action on childhood vaccines; calls it ‘incredibly misguided’. https://services.aap.org/en/news-room/news-releases/aap/2020/american-academy-of-pediatrics-opposes-hhs-action-on-childhood-vaccines-calls-it-incredibly-misguided/. Accessed August 19, 2020.