Monoclonal Antibodies
Rachel Balick
On September 9, 2021, HHS made its 9th amendment to the PREP Act to expand the authority of licensed pharmacists as well as certain pharmacy interns’ and pharmacy technicians’ to deliver COVID-19 therapeutics such as monoclonal antibodies. Pharmacists can order certain COVID-19 therapies under conditions outlined in the 9th amendment. The authorities also apply to any future intramuscular, subcutaneous, or oral COVID-19 therapeutics that receive FDA’s OK.
The amendment also gave pharmacists, pharmacy technicians, and interns across the country the authority to provide patients crucial access to monoclonal antibody COVID-19 treatment and post-exposure prophylaxis.
Pharmacy interns and technicians who are directly supervised by a licensed pharmacist and who meet other criteria can administer the treatments intramuscularly, subcutaneously, or orally.
These federally granted authorities apply even when state laws place restrictions on licensing or dictate narrow scopes of practice that would effectively prohibit a qualified person from prescribing, dispensing, or administering covered COVID-19 therapeutics.
Licensed pharmacists, licensed or registered pharmacy interns, and qualified pharmacy technicians must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education before they can use the new PREP Act authorities. This training program must cover
- Hands-on injection technique.
- Clinical evaluation of indications and contraindications of COVID-19 therapeutics.
- Recognition and treatment of emergency reactions to COVID-19 therapeutics.
- Any additional training required by FDA approval, authorization, or licensing.
APhA’s Pharmacy-based Immunization Delivery Certificate Training Program already meets the amendment’s requirements for education on hands-on injection technique as well as the recognition and treatment of emergency reactions to products such as COVID-19 therapeutics.
Development of training that addresses clinical evaluation of indications and contraindications of COVID-19 therapeutics and the component of the 9th PREP amendment regarding “any additional training required in the FDA approval, authorization, or licensing” is underway at press time.
Pharmacists, pharmacy interns, and pharmacy technicians must also have a current certificate in basic cardiopulmonary resuscitation and comply with recordkeeping requirements.
Quick links
HHS’ Monoclonal Antibody Resources for Clinicians (combatcovid.hhs.gov/hcp/resources-clinicians)
NIH’s COVID-19 Treatment Guidelines for Anti-SARS-CoV-2 Monoclonal Antibodies (apha.us/NIHCOVID19MaB)
APhA’s complete resource for pharmacists is available at
www.pharmacist.com/Practice/COVID-19/Therapeutics