New Guidance for Pharmacists to Administer COVID-19 Vaccines When Approved
Pharmacists should ramp up their vaccination capabilities now that the HHS has authorized them to administer COVID-19 vaccines, once approved. Although there are some stipulations, state-licensed pharmacists will be able to provide approved immunizations against novel coronavirus to those 3-years-old and older, according to the guidance. Here are more details.
WASHINGTON, DC – Community pharmacists will be on the frontlines in the battle to get as many Americans immunized as possible, once a COVID-19 vaccine is approved for use.
Recent guidance from the Department of Health and Human Services authorizes state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, COVID-19 vaccinations to persons ages 3 or older, subject to certain requirements.
The guidance, issued, through the Assistant Secretary for Health, falls under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines when they are made available.
"This action builds upon our Administration's progress toward delivering a safe, effective, and widely available vaccine by 2021," said Assistant Secretary for Health Adm. Brett P. Giroir, MD, who said, . “Allowing pharmacists to order and administer COVID-19 vaccines will greatly expand convenient access for the American people."
Pharmacists also are eligible to receive immunity under the PREP Act with respect to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of Food and Drug Administration-authorized or FDA-licensed COVID-19 vaccines, according to HHS.
“A key component of that response will be access to a COVID-19 vaccine across the United States. Pharmacists, in partnership with other healthcare providers, are well-positioned to increase access to vaccinations—particularly in certain areas that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved,” according to the guidance document. “As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy. Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate.”
The HHS notes that pharmacists already play a significant role in annual influenza vaccination, and, In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine. The guidance points out that nearly every state allows pharmacists to order and administer vaccines to both adults and children under certain circumstances.
To qualify as "covered persons" when administering FDA-approved COVID-19 vaccines, the following stipulations must be in place:
- The vaccine must be FDA-authorized or licensed.
- The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices' (ACIP) COVID-19 vaccine recommendation.
- 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.
- The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic CPR.
- 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 reviewing the vaccine registry or other vaccination records prior to administering a vaccine.
- The licensed pharmacist 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 licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the national Centers for Disease Control and Prevention COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).
HHS says its authorization preempts any state and local laws that prohibit or effectively prohibits those who satisfy these requirements from ordering or administering COVID-19 vaccines in those circumstances but does not preempt state and local laws that permit additional individuals to administer COVID-19 vaccines to additional persons.