HHS guidance authorizes pharmacists, pharmacy interns to administer COVID-19 vaccines

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HHS guidance authorizes pharmacists, pharmacy interns to administer COVID-19 vaccines

By Sandra Levy - 09/09/2020

New action from the Department of Health and Human Services will bring pharmacy to the front line of national COVID-19 vaccination efforts.

The department on Wednesday issued a guidance authorizing state-licensed pharmacists to order and administer COVID-19 vaccinations to patients 3 years old and older, and allowing state-licensed pharmacy interns working under a pharmacist's supervision to administer the vaccine to the same age group, subject to certain requirements.

Pharmacy organizations, including the American Pharmacists Association, the National Association of Chain Drug Stores, the National Community Pharmacists Association, and the American Society of Health-Systems Pharmacists, which have been advocating for pharmacists to administer COVID-19 vaccines when they are approved, hailed the announcement.

“This is tremendous news,” said Scott Knoer, APhA executive vice president and CEO. “It properly recognizes that pharmacists serve a vital role in the nation’s response to this pandemic. It increases patients’ access to care during this emergency with providers whom they trust, at a time and place that is convenient to them.”

NACDS president and CEO Steve Anderson said, “This is an extremely important decision by the Administration. When safe and effective COVID-19 vaccinations are available, it will be essential to have pharmacies and pharmacists prepared to be ‘ready, set, go.’ NACDS has emphasized that America’s pharmacies present patients and the nation with an efficient, effective and essential component of vaccine deployment. There is a community pharmacy within five miles of 90% of Americans. A Centers for Disease Control and Prevention study found that including pharmacies in a pandemic vaccination model can help the nation vaccinate 80% of the population seven weeks faster. The Administration’s action today reflects these facts."

Anderson continued, “In the best interest of public health, it will be essential for this decision to be recognized by all as a clear runway, without further barriers, so pharmacies and pharmacists can prepare completely to administer COVID-19 vaccinations. We are committed to continuing the tremendous work that is underway to prepare fully to help reach all Americans, including those who have suffered from disparities of healthcare. Pharmacists are among the most trusted and accessible healthcare professionals, and that will go a long way in meeting the challenges facing our nation.” 

Doug Hoey, NCPA CEO said,"The country needs pharmacists to be a major player in the administration of coronavirus vaccines. NCPA appreciates steps the Trump administration is taking to make sure that pharmacies can administer these immunizations when they come to market. As with coronavirus testing, ensuring access to vaccines in community pharmacies rather than solely in national chains will be critical if NCPA members are to help Operation Warp Speed meet its goal of administering 300 million doses nationwide. Independent pharmacy is ready and eager to partner in the administration of the vaccines.”

Tom Kraus, ASHP vice president of government relations, said, "Leveraging a highly qualified and empowered clinical pharmacy workforce in all care settings is a vital step in a successful vaccination plan. Pharmacists and pharmacy technicians participate in patient screening and education, vaccine administration, and reporting of adverse events that make significant contributions to vaccine awareness and immunization rates." 

Kraus added, "We commend HHS for taking this step to ensure that patients can turn to our nation’s most accessible healthcare providers to access the COVID-19 vaccine as pharmacists participate in the global effort to protect our communities from worsening and future outbreaks. It’s time for Medicare to follow suit and make sure that Medicare beneficiaries can receive COVID-19 testing and vaccination services from pharmacists."

To qualify as "covered persons" under 42 U.S.C. § 247d-6d((i)(8)(B) when administering COVID-19 vaccines authorized or licensed by the FDA to persons ages 3 or older, state-licensed pharmacists and pharmacy interns licensed or registered by their state board of pharmacy must satisfy the following requirements:

  • The vaccine must be FDA-authorized or FDA-licensed;
  • The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices' 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. 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; and
  • 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 Centers for Disease Control and Prevention COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccines.

The authorization preempts any state and local laws that prohibit or effectively prohibits those who satisfy these requirements from ordering or administering COVID-19 vaccines as set forth above. The authorization does not preempt state and local laws that permit additional individuals to administer COVID-19 vaccines to additional persons.