HHS Responds to ASHP Request, Authorizes Pharmacists to Administer Monkeypox Vaccines and Therapeutics

In response to advocacy from ASHP and other pharmacy organizations, the Department of Health and Human Services (HHS) has authorized pharmacists, and pharmacy interns and pharmacy technicians supervised by a pharmacist, to prescribe, dispense, or administer smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics. The authorization extends to pharmacists and technicians whose licensure has lapsed or expired in the past five years.

HHS used its authority under the Public Readiness and Emergency Preparedness (PREP) Act in order to improve access to vaccines and treatments necessary to address the monkeypox outbreak. As with previous PREP Act declarations, the new authorities come with some limitations, including training and recordkeeping requirements. For a pharmacist, pharmacy intern, or pharmacy technician to prescribe, dispense, or administer these vaccines and therapeutics, the following requirements must be met:

• The vaccine or therapeutic must be authorized, approved, or licensed by the Food and Drug Administration (FDA).
• Vaccination must be ordered and administered according to the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccine recommendation(s).
• The healthcare professionals and students must have documentation of completion of the CDC-provided or -recommended training for the countermeasure and any additional training required in the FDA licensing, approval, authorization. In the absence of training requirements or recommendations from the CDC, other training(s) may be substituted if:
  • It is approved or accredited training from a national or state recognized accrediting body or association, the FDA, or equivalent organization for the administration route of the medical countermeasure.
  • It includes hands-on instruction for the administration route as appropriate for the countermeasure, supervised by someone that administers within their normal scope of practice.
  • It includes clinical evaluations of indications or contraindications of smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures.
  • It includes the recognition and treatment of emergency reactions to smallpox (variola virus), monkeypox virus, or other orthopoxvirus countermeasures.
• The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in the appropriate route of intradermal, subcutaneous, or intramuscular injections, dermal/percutaneous scarification, intranasal or oral administration and for whom the appropriate route of intradermal, subcutaneous, or intramuscular injections, dermal/percutaneous scarification, intranasal or oral administration is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics to be administered.
• The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation.
• The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which they administer vaccines or therapeutics, 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 healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the CDC provider agreement and any other federal requirements that apply to the administration of smallpox (variola virus), monkeypox virus, or other orthopoxvirus vaccines or therapeutics.

“ASHP applauds HHS’ use of the PREP Act to enhance access to vaccines and treatments for monkeypox,” said Tom Kraus, ASHP's vice president of government relations. “For both vaccines and therapeutics, time is of the essence, and pharmacists and their team are best positioned to quickly ramp up patient services.”

Although the PREP Act declaration takes immediate effect, pharmacists and their teams may need some lead time to complete the requisite training and set up recordkeeping and documentation procedures. ASHP will continue to update members as additional information becomes available. In the interim, we encourage you to visit our monkeypox resource page for more information.