HHS Authorizes Pharmacists to Prescribe Monkeypox Vaccines and Therapeutics

Strategic Insights -

The Department of Health and Human Services (HHS) has authorized pharmacists and pharmacy interns and technicians supervised by a pharmacist to prescribe, dispense, or administer smallpox, monkeypox virus, or other orthopoxvirus vaccines or therapeutics. This decision comes in response to advocacy from the American Society of Health System Pharmacists (ASHP) and other pharmacy organizations, which aim to improve access to vaccines and treatments necessary to address the monkeypox outbreak. 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 to enable this expansion. Training and recordkeeping requirements are in place to ensure the safe administration of these vaccines and therapeutics.

Key Takeaways:

  • Pharmacists, pharmacy interns, and pharmacy technicians supervised by a pharmacist can prescribe, dispense, or administer smallpox, monkeypox virus, or other orthopoxvirus vaccines or therapeutics under the HHS authorization.
  • The authorization includes pharmacists and technicians whose licensure has lapsed or expired in the past five years.
  • Extensive requirements must be met, including documentation of completion of CDC-provided training, observation period, current certificate in basic cardiopulmonary resuscitation, and compliance with recordkeeping and reporting requirements.
  • Pharmacy teams may need lead time to complete the requisite training and set up recordkeeping and documentation procedures.
  • ASHP will continue to update members on additional information and encourages visiting the monkeypox resource page for more details.

Statistics:

  • The authorization is made possible through the Public Readiness and Emergency Preparedness (PREP) Act.
  • The authorization applies to smallpox, monkeypox virus, or other orthopoxvirus vaccines or therapeutics.
  • The extension of licensure to those who lapsed or expired in the past five years includes pharmacists and technicians.
  • Training and recordkeeping requirements must be met to ensure safe administration.

Sources:

  • American Society of Health System Pharmacists, September 30.