On July 6, the U.S. Meals and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral remedy PaxlovidTM (nirmatrelvir and ritonavir) to permit prescribing by pharmacists for faster and simpler entry for sufferers.
Pfizer’s Paxlovid was first granted an EUA in December 2021, that means that the FDA licensed the product for emergency use, although it has not been accredited for any function by the FDA. Paxlovid is used to deal with sufferers 12 years or older who check optimistic for COVID-19 and who’re at excessive threat that the illness will progress and change into extreme, resulting in hospitalization or dying. The drug has been proven to considerably scale back the danger of hospitalization or dying. Paxlovid should be taken inside 5 days after the onset of signs, so well timed entry is essential.
Pharmacists are usually prohibited from performing sure scientific actions, similar to assessing sufferers or independently prescribing medicines. These limitations have quickly been lifted through the COVID-19 pandemic, because the Public Readiness and Preparedness Act (PREP Act) licensed pharmacists to take actions like administering COVID-19 checks and vaccines, and order and administer sure COVID-19 therapies.
Regardless of the final authorizations within the PREP Act, the preliminary EUA for Paxlovid didn’t permit pharmacists to prescribe Paxlovid. The preliminary authorization restricted prescribers to docs, superior observe registered nurses, and doctor assistants, which made it tough for some sufferers to acquire the drug through the five-day window.
The July 6 up to date authorization permits state-licensed pharmacists to prescribe Paxlovid in sure circumstances. There should be “ample info” accessible to the pharmacist, both via the affected person’s medical data or by talking with one other well being care supplier, to evaluate kidney and liver operate. The pharmacist should additionally be capable to receive an entire listing of medicines, each over-the-counter and prescription, that the affected person is presently taking with a view to consider potential drug interactions. If these situations are met, the pharmacist might select to prescribe Paxlovid to the affected person.
Paxlovid is a crucial piece of the White Home’s COVID-19 response plan going ahead. The federal government bought 20 million programs of Paxlovid, and has labored to arrange test-to-treat websites the place sufferers can obtain a COVID-19 check and get an instantaneous Paxlovid prescription if their check is optimistic. With the brand new authorization, pharmacies can change into extra test-to-treat websites throughout the nation.
Though well timed prescribing of Paxlovid is necessary, among the many elements to thought-about earlier than prescribing Paxlovid beneath the up to date EUA are the next.
- Figuring out Whether or not a Affected person Is at Excessive Danger: The EUA doesn’t instruct suppliers concerning tips on how to decide whether or not a affected person is eligible for Paxlovid. Suppliers are given flexibility to evaluate the advantages and dangers for a possible affected person when deciding whether or not to prescribe the drug. The Facilities for Illness Management and Prevention or Nationwide Institutes of Well being pointers could also be useful sources concerning situations that place sufferers at elevated threat of illness development when evaluating a possible Paxlovid prescription.
- “Ample Info”: The EUA doesn’t outline what constitutes “ample info” to evaluate kidney and liver operate. Sufferers have been suggested to carry copies of their medical data with them to the pharmacy when searching for Paxlovid, however the FDA has not given in depth steerage on tips on how to decide whether or not the data are “ample.”
- Assessing Drug Interactions: There exist comparable considerations with the requirement that pharmacists assess potential drug interactions previous to prescribing Paxlovid. They need to assessment all medicines, together with prescription and over-the-counter medicine, to establish any potential destructive interactions between relevant medicines.
- Correct Recordkeeping: Suppliers administering Paxlovid should keep data concerning the shelling out and administration of the drug. They need to additionally keep all data related to the EUA till notified by Pfizer or the FDA.
- Reporting Necessities: The EUA requires suppliers to report back to the FDA all remedy errors and critical antagonistic occasions thought-about to be probably associated to Paxlovid that happen throughout remedy. Such stories could also be made through the on-line MedWatch type.
- Hold As much as Date with Authorizations: The EUA doesn’t authorize pharmacist prescribing of Paxlovid indefinitely. Pharmacists ought to look ahead to any future declarations ending their authorization to prescribe Paxlovid.
- Assessment the Reality Sheet for Well being Care Suppliers: The FDA has offered a Paxlovid Reality Sheet for Well being Care Suppliers.