Jennifer Gershman, Pharm.D., CPh

Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) received 

 for the FDA on Dec. 22, 2021 for the treatment of mild-to-moderate COVID-19 in adults and children 12 years and older weighing at least 40 kilograms (88 pounds) with positive results of direct SARS-CoV-2 testing who are at high risk of progression to severe disease.

Pfizer has begun distributing Paxlovid, but it is available in limited supply. According to HHS, 64,970 courses had been distributed as of Jan. 7, 2022.

Institute for Safe Medication Practices (ISMP)

 has issued important safety concerns regarding Paxlovid and recommendations for physicians and pharmacists when prescribing and dispensing the medication.

, the recommended dose of Paxlovid for patients with normal renal function or mild renal impairment (estimated glomerular filtration rate (eGFR) 

 60 to < 90 ml/min) is 300 milligrams of nirmatrelvir (two, 150 mg tablets) with 100 milligrams ritonavir (one 100 mg tablet). Additionally, all 3 tablets must be taken together orally twice daily for five days. 

Patients with moderate renal impairment (eGFR 

 30 to < 60 ml/min) are supposed to take smaller doses: 150 mg of nirmatrelvir (one tablet) with 100 mg ritonavir (one tablet) taken together twice daily for five days. And patients with severe renal impairment (eGFR < 30 ml/min) are supposed to avoid Paxlovid altogether.

 to remove one of the nirmatrelvir tablets for both the morning and evening doses from each blister card and cover the empty blisters with pre-printed moderate renal impairment dosing instructions on all five cards with manufacturer-supplied stickers prior to dispensing Paxlovid. Pharmacists are also supposed to educate patients with moderate renal impairment that the packaging was altered to reflect the dosing changes. 

 to obtain additional stickers. Pharmacies should ensure that their staff are educated about these essential steps. Additionally, prescribers should ensure that the appropriate dosing is on all Paxlovid prescriptions for patients with moderate renal impairment. 

There are also drug interactions to be aware of with Paxlovid because it is an inhibitor of CYP3A, and it is critical for pharmacists to educate prescribers and patients about these since they can result in decreased Paxlovid efficacy or toxicity of the patient’s other therapies. Paxlovid treatment is contraindicated with the following medications:

Alpha1-adrenoreceptor antagonist: alfuzosin

Antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine

Antipsychotics: lurasidone, pimozide, clozapine

Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine

PDE5 inhibitor: sildenafil (Revatio) for pulmonary arterial hypertension

Sedative/hypnotics: triazolam, oral midazolam

Anticonvulsants: carbamazepine, phenobarbital, phenytoin

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Smaller doses are recommended for people with moderate renal impairment and the treatment should not be taken by people with serious kidney disease. There are also drug interactions to be aware of because Paxlovid is an inhibitor of CYP3A.

Medication Safety Considerations for COVID-19 Treatment Paxlovid

Included in the 408-page proposed rule are provisions that would make substance abuse treatment centers eligible as essential community providers.

The Biden administration recently released the 

Notice of Benefit and Payment Parameters 2023 Proposed Rule

 that is designed to make health insurance coverage more accessible and affordable in 2023. “Today’s rule is part of the Biden-Harris Administration’s ongoing efforts to ensure an equitable health care system as we continue to make coverage more accessible and affordable,” said Health and Human Services Secretary Xavier Becerra in a 

Executive Order on Promoting Competition in the American Economy

, which emphasizes affordable health insurance. This is the Biden administration’s first full notice and generally applies to changes for the 2023 plan year, not 2022.

The goal of the proposed rule is to improve shopping for healthcare coverage, establish rules ensuring the public can access care, and advance health equity for individuals purchasing coverage on the ACA marketplaces.

All insurance companies selling coverage on the federal healthcare.gov exchange and on the state-based exchanges would be required to provide standardized plan options for every product network type, metal type, and plan classification in addition to any service area where the issuer will provide marketplace plans.

CMS also proposes to implement network adequacy rules, which would include important features such as distance to care and appointment wait times. Additionally, the proposed rule will help to provide healthcare for low-income and medically underserved consumers, specifically through essential community providers (ECPs). Insurers would be required to include 35% of available ECPs in their network for each plan’s service area. The proposed rule would also include substance use disorder treatment centers as eligible ECPs, partly in response to the opioid epidemic. In November 2021, the 

 showing an estimated 100,306 death from drug doses in the 12-month period ending in April 2021, an increase of 28.5% from the April 2019-April 2020 time period. The same announcement said that 75,673 of those deaths were from opioids, an increase of 35% from the year before

The proposed rule will also prohibit health insurance companies from discriminating based on sexual orientation and gender identity and will restore protection for covered services that were previously removed in 2020 to reduce healthcare disparities and increase access to care. Health insurance companies must also rely on evidence-based medicine for making clinical decisions as part of the plan design under the proposed rule requirements.

Katie Keith, J.D., M.P.H., who writes “Following the ACA” analyses for the 

’ Forefront blog, has posted three in-depth pieces about the rule. Full text access it free and available 

. Keith is the director of the Health Policy and the Law Initiative at the O’Neill Institute for National and Global Health Law at Georgetown University Law Center.

Jennifer Gershman, Pharm.D., CPh

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Medication Safety Considerations for COVID-19 Treatment Paxlovid

Proposed Rule Could Make Healthcare Coverage More Affordable and Accessible for Consumers