After months of effort by the American Pharmacists Association (APhA) and other stakeholders, FDA has updated the EUA for the COVID-19 oral antiviral, Paxlovid, to permit pharmacists to order and prescribe Paxlovid under certain conditions.
The federal government had already authorized pharmacists to order and dispense oral therapeutics under the PREP Act. However, the ability for all pharmacists to prescribe was not included under the conditions in the original EUA for Paxlovid. FDA’s label change removes this barrier to permit Paxlovid to “also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions:
- Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and hepatic function; and
- Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction.
The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
- Sufficient information is not available to assess renal and hepatic function.
- Sufficient information is not available to assess for a potential drug interaction.
- Modification of other medications is needed due to a potential drug interaction.
- Paxlovid is not an appropriate therapeutic option based on the authorized Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.”
FDA’s change comes following a new analysis by CDC, which confirmed APhA’s earlier findings of inequitable dispensing of COVID-19 oral antivirals. Increasing access to authorized prescribers, including pharmacists, will increase availability and provide more opportunities for socially vulnerable and medically underserved communities to access these lifesaving medications.
“APhA thanks FDA for recognizing the expertise of pharmacists as critical providers of care for important COVID-19 treatments”, “Opening the door for pharmacists as prescribers will open the door to equitable access at pharmacies in communities across the country.”
“Removing barriers to pharmacist prescribing of oral antivirals has the potential to be a game-changer for addressing health equity and providing timely access to these life-saving treatments in pockets of the country where pharmacists may be the only health care provider for miles—just as it has been for the administration of COVID-19 vaccines. Pharmacists are educated, trained, and able to assess patients in accordance with clinical guidelines for appropriate use of these more convenient COVID-19 treatment options. We look forward to working with our colleagues to improve access to this lifesaving medication. Our members are ready to get to work!,”
Ilisa BG Bernstein, PharmD, JD, FAPhA, APhA interim executive vice president and CEO
Bernstein concluded, “While we appreciate the opportunity to serve our patients in this capacity, this effort will only be successful and sustainable if CMS and other payers take immediate action to provide adequate and appropriate payment for pharmacist consultations and services.”