On July 6th, 2022 the FDA revised the Emergency Use Authorization (EUA) for Paxlovid. With this update, licensed pharmacists were granted the ability to prescribe Paxlovid to eligible patients, with certain limitations existing to ensure the safety and correct use of the medication. In today’s blog post, we will discuss this approval and what pharmacies need to know.
What is Paxlovid is approved to treat?
Per the EUA, Paxlovid is approved to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19, including hospitalization or death.
Patients are eligible for Paxlovid by reporting a positive COVID-19 home test result from a rapid antigen diagnostic test, or a positive PCR test to their provider.
Conditions where Paxlovid can be prescribed by a pharmacist:
Per the FDA, Paxlovid may 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.
When should a pharmacist refer the patient to a physician, nurse practitioner, physician assistant, or person authorized under state law to prescribe drugs for an in-person or telehealth appointment?
Per the FDA, pharmacists should not prescribe Paxlovid and refer the patients when:
- 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.
What should pharmacies have patients provide during their consultations?
- Electronic or printed health records at least less than 12 months old, including any laboratory work. This is imperative so the pharmacist can assess the liver and kidney function of the patient. If the patient is unable to supply this, they can provide the pharmacist with their healthcare provider’s information so they can reach out for it.
- A list of all medications they are taking, including OTCs. This is imperative so the pharmacist can check for drug interactions.
Through this new prescribing ability, pharmacists will continue to keep their communities healthy and cared for during these uncertain times.