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Volume XII, Number 230

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FDA Allows Pharmacists to Prescribe the COVID-19 Antiviral Paxlovid

On July 6, the U.S. Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker and easier access for patients.

Pfizer’s Paxlovid was first granted an EUA in December 2021, meaning that the FDA authorized the product for emergency use, even though it has not been approved for any purpose by the FDA. Paxlovid is used to treat patients 12 years or older who test positive for COVID-19 and who are at high risk that the disease will progress and become severe, leading to hospitalization or death. The drug has been shown to significantly reduce the risk of hospitalization or death. Paxlovid must be taken within five days after the onset of symptoms, so timely access is key.

Pharmacists are typically prohibited from performing certain clinical activities, such as assessing patients or independently prescribing medications. These limitations have temporarily been lifted during the COVID-19 pandemic, as the Public Readiness and Preparedness Act (PREP Act) authorized pharmacists to take actions like administering COVID-19 tests and vaccines, and order and administer certain COVID-19 treatments.

Despite the general authorizations in the PREP Act, the initial EUA for Paxlovid did not allow pharmacists to prescribe Paxlovid. The initial authorization limited prescribers to doctors, advanced practice registered nurses, and physician assistants, which made it difficult for some patients to obtain the drug during the five-day window.

The July 6 updated authorization allows state-licensed pharmacists to prescribe Paxlovid in certain circumstances. There must be “sufficient information” available to the pharmacist, either through the patient’s medical records or by speaking with another health care provider, to assess kidney and liver function. The pharmacist must also be able to obtain a complete list of medications, both over-the-counter and prescription, that the patient is currently taking in order to evaluate potential drug interactions. If these conditions are met, the pharmacist may choose to prescribe Paxlovid to the patient.

Paxlovid is an important piece of the White House’s COVID-19 response plan going forward. The government purchased 20 million courses of Paxlovid, and has worked to set up test-to-treat sites where patients can receive a COVID-19 test and get an immediate Paxlovid prescription if their test is positive. With the new authorization, pharmacies can become additional test-to-treat sites across the country.

Although timely prescribing of Paxlovid is important, among the factors to considered before prescribing Paxlovid under the updated EUA are the following.

  • Determining Whether a Patient Is at High Risk: The EUA does not instruct providers regarding how to determine whether a patient is eligible for Paxlovid. Providers are given flexibility to assess the benefits and risks for a potential patient when deciding whether to prescribe the drug. The Centers for Disease Control and Prevention or National Institutes of Health guidelines may be helpful resources regarding conditions that place patients at increased risk of disease progression when evaluating a potential Paxlovid prescription.

  • “Sufficient Information”: The EUA does not define what constitutes “sufficient information” to assess kidney and liver function. Patients have been advised to bring copies of their medical records with them to the pharmacy when seeking Paxlovid, but the FDA has not given extensive guidance on how to determine whether the records are “sufficient.”

  • Assessing Drug Interactions: There exist similar concerns with the requirement that pharmacists assess potential drug interactions prior to prescribing Paxlovid. They must review all medications, including prescription and over-the-counter drugs, to identify any potential negative interactions between applicable medications.

  • Proper Recordkeeping: Providers administering Paxlovid must maintain records regarding the dispensing and administration of the drug. They must also maintain all records associated with the EUA until notified by Pfizer or the FDA.

  • Reporting Requirements: The EUA requires providers to report to the FDA all medication errors and serious adverse events considered to be potentially related to Paxlovid that occur during treatment.  Such reports may be made via the online MedWatch form.

  • Keep Up to Date with Authorizations: The EUA does not authorize pharmacist prescribing of Paxlovid indefinitely. Pharmacists should watch for any future declarations ending their authorization to prescribe Paxlovid.

  • Review the Fact Sheet for Health Care Providers: The FDA has provided a Paxlovid Fact Sheet for Health Care Providers.

© 2022 Foley & Lardner LLPNational Law Review, Volume XII, Number 215
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About this Author

Lea Gulotta James Business Litigation Attorney Foley Lardner Boston
Associate

Lea James is an associate working in the litigation department of Foley & Lardner LLP. Lea is based in the firm's Boston office where she is a member of the Business Litigation & Dispute Resolution Practice.

...
617-226-3163
Kyle Faget, Foley Lardner, Government policy lawyer
Partner

Kyle Faget is a Partner and business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams. Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to joining...

617.502.3292
Nathan A. Beaver, Foley Lardner, FDA Enforcement Lawyer, Regulatory Attorney,
Partner

Nathan A. Beaver is a partner and food and drug lawyer with Foley & Lardner LLP, where his practice focuses on the representation of manufacturers whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics, and foods with special emphasis on the strategic considerations involving the approval...

202.295.4039
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