With children across the country returning to school amid the COVID-19 pandemic and the upcoming flu season approaching, families can now look to licensed pharmacists to administer childhood vaccines. The United States has experienced a drastic decrease in vaccination rates among children as a consequence of the COVID-19 pandemic. In an attempt to address this concerning trend, a recent Department of Health and Human Services (“HHS”) directive now allows pharmacists and pharmacy interns in every state who meet certain requirements to administer FDA-approved vaccinations for children between ages 3 and 18. The declaration effectively supersedes more restrictive state laws addressing pharmacists’ ability to order and administer vaccines.
Background
The Public Readiness and Emergency Preparedness Act (“PREP Act”) authorizes the Secretary of HHS to issue a declaration during public health emergencies to provide liability immunity to certain individuals and entities against any claim of loss caused by the manufacture, distribution, administration or use of medical countermeasures. On March 10, 2020, the Secretary of HHS issued a declaration under the PREP Act to implement medical countermeasures to combat the COVID‑19 pandemic and to provide liability immunity to those health care providers and entities that implement these countermeasures (the “Declaration”).
On August 19, 2020, the Secretary amended the Declaration to address a public health concern that has been indirectly caused by the COVID-19 pandemic: an alarming decrease in the rate of childhood immunizations. Due to the COVID-19 pandemic, many pediatric practices that traditionally provide childhood vaccinations have been closed or are operating under reduced office hours. This has inevitably assisted in decreasing childhood vaccination rates across the nation. The Centers for Disease Control (“CDC”) confirmed that the decline in pediatric vaccinations was due to changes in health care access, social distancing and other COVID-19 mitigation strategies. The CDC also noted that parental concerns about potentially exposing children to COVID-19 during traditional well-child visits might be contributing to the observed decline in vaccination rates. HHS stated that this decline in childhood vaccination rates is a public health threat that increases the risk of outbreaks for vaccine-preventable diseases.
Expanding Pharmacists’ Scope of Practice
In order to address this COVID-19 collateral health concern, HHS amended the Declaration for a third time, making two major alterations. First, the amendment clarified that “Covered Countermeasures” under the Declaration include not only measures used to combat COVID-19 but also other diseases, health conditions or threats that may have been caused by COVID-19, including the decrease in the rate of childhood immunizations. Second, the amendment permits qualified pharmacists and pharmacist interns to provide FDA-approved vaccinations to children between the ages of 3 and 18 as a Covered Countermeasure. HHS believes that pharmacists are well-positioned to expand access to childhood vaccinations. As of 2018, nearly 90% of Americans lived within 5 miles of a community pharmacy and pharmacists already play a significant role in providing annual flu shots in most communities. Therefore, HHS amended the Declaration to permit state-licensed pharmacists in all states, and pharmacy interns acting under their supervision, to administer vaccines to individuals aged 3 to 18, provided the following requirements are met:
- The vaccine must be FDA-authorized or FDA-licensed;
- The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ standard immunization schedule;
- The pharmacist must complete a practical training program of at least 20 hours of Accreditation Council for Pharmacy Education (“ACPE”) approved training that includes hand-on injection technique, clinical evaluations of indications and contraindications of vaccines, and the recognition and treatment of emergency reaction to vaccines;
- The pharmacy intern must complete an ACPE-approved practical training program that includes hand-on injection technique, clinical evaluations of indications and contraindications of vaccines and the recognition and treatment of emergency reaction to vaccines;
- The pharmacist and/or intern must have a current CPR certificate;
- The pharmacist must complete a minimum of 2 hours of ACPE-approved immunization related education;
- The pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which they administer vaccines; and
- The pharmacist must inform the vaccination patient and their accompanying adult caregivers of the importance of well-child visits.
Key Takeaways
The COVID-19 pandemic continues to have unanticipated indirect effects on American public health. HHS, through the PREP Act Declaration, appears to be actively monitoring and attempting to combat these indirect public health effects as they arise, and the expansion of pharmacists’ authority to administer childhood vaccines is one example. The administration of childhood vaccines under the Declaration is a new opportunity for pharmacies and pharmacists to provide expanded services in states where such authority was not previously granted. In providing such services, pharmacy providers should comply with HHS requirements and continue to monitor additional guidance from state pharmacy boards related to the ordering and administration of vaccines. Finally, pharmacy providers should be aware of requirements under their current payer contracts related to reimbursement for vaccines to ensure that they are paid for such services.
If you have any questions or would like additional information about this topic, please contact:
- Julie Lappas at (317) 977-1490 or jlappas@hallrender.com;
- Matt Reed at (317) 429-3609 or mreed@hallrender.com; or
- Your regular Hall Render attorney.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
