Opinion: Pharmacies shouldn’t be the only place to get Paxlovid, the new Covid pill

It’s easy to feel like we’re in a pandemic “Groundhog Day” loop as the U.S. faces yet another Covid-19 surge with overwhelmed hospitals, closed schools, and companies delaying return-to-office plans.

To be sure, the existence of vaccines, boosters, and some important new therapies make this January feel different than the last one. But as another year of pandemic fatigue looms, the country is once again in the position of having to decide how to allocate and distribute scarce health care resources, from ICU beds to Covid-19 drugs.

Important mistakes are still being made.

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In the penultimate week of 2021, the Food and Drug Administration granted emergency use authorization to Paxlovid, a two-drug antiviral developed by Pfizer for treating individuals ages 12 and up who test positive for Covid-19 and are at high risk for progression to the severe form of the disease. When started within five days of symptom onset, Paxlovid seems to be highly effective at reducing hospitalization or death.

That the drug can be taken at home is a major benefit over other therapeutic options, including another pill, molnupiravir, which may be less effective, as well as remdesivir and sotrovimab, both of which must be administered intravenously at hospitals or clinics.

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The problem is that there isn’t nearly enough Paxlovid to treat the staggering number of people who could benefit from it. For example, in Pennsylvania, where we live and work, there were more than 33,000 new cases of Covid-19 diagnosed on January 7, 2022, by far the most since the pandemic started, and more than 60% of American adults are estimated to have at least one chronic condition that puts them at high risk for severe Covid-19. Supply pales in comparison to this demand: Pennsylvania received only 2,080 total treatment courses of Paxlovid in its initial allocation from the federal government. In the first week of distribution, Michigan received 1,600 courses of the drug; Wyoming received only enough for 100 people. Additional shipments are expected to ramp up over the next month, but nationwide shortages look like they’ll last until April.

We’ve been here before, with vaccines and earlier Covid-19 treatments. The difference, however, was that the federal government distributed other scarce therapies to state and territorial health departments, which distributed them to hospitals and clinics, which in turn determined which patients would receive them. Facing shortages, many hospitals developed allocation processes that identified the highest risk patients who were most likely to benefit from these therapies, based on things like vaccine status, immune suppression, and certain conditions that increase risk. They then tried to choose fairly among these individuals using approaches such as weighted lottery systems. These randomly select among eligible patients, with some having better odds based on things like residence in a disadvantaged community, essential worker status, and pregnancy.

Although there may be other fair ways to do this, the important thing about these approaches is that they aimed to minimize giving advantages to the most well-off, well-connected, and well-informed patients.

This is not how things are working for Paxlovid. Because this is an at-home treatment, several states — including Arizona, Georgia, Pennsylvania, and Virginia — have decided to distribute the drug to commercial retail pharmacies rather than hospitals. On one hand, this makes sense because pharmacies may be easier places for patients to access the drug and hospitals have their hands full right now. On the other hand, pharmacies are not in the position to easily verify patient eligibility or select those at highest risk for severe Covid-19.

Because Paxlovid has so far been allocated to just a tiny fraction of pharmacies, they will likely be inundated with hundreds or thousands of prescriptions, many for patients they’ve never served before. This unfamiliarity may place patients at risk because Paxlovid can have life-threatening interactions with other medications patients may be taking but the pharmacy may not know about. Although this is also true of other drugs, a unique challenge with Paxlovid is that its emergency use authorization status means it doesn’t come up in the drug interaction apps that physicians typically use, making another layer of review helpful.

Pharmacies that do try to verify eligibility and medical history will likely require clinicians to send test results and medical records, creating burden on both ends as well as delay. Hospitals and health systems, in contrast, already have access to this information for many patients.

A decentralized, pharmacy-based approach will also result in a “first come, first served” allocation, which will benefit those who are already most fortunate. The New York Times tells the story of a 48-year-old Texan with diabetes who was able to access Paxlovid after securing a prescription via a telemedicine appointment, calling 19 pharmacies, and making multiple trips to get the drug after a problem with his prescription. This story demonstrates precisely the sort of effort that many people, including those at higher risk, would never be able to undertake due to lack of time, resources, or know-how.

The only thing worse than expecting patients to engage in this sort of wild goose chase would be asking overburdened health care providers to do it each time they write a prescription.

The Department of Health and Human Services has distributed approximately 15% of the Paxlovid supply to federally-funded health centers serving disadvantaged communities, but states still need to equitably allocate their shares of the drug to people likely to benefit the most. Distributing Paxlovid only via retail pharmacies while the supply remains low will result in those with the loudest voices, the strongest advocates, and the most time and resources getting access — even though those factors have nothing to do with whose need for the pills is greatest.

Instead, states should allocate a significant supply of Paxlovid to their hospitals and health systems, which can more easily verify patient eligibility, check important drug interactions, and fairly distribute the medication. Yes, this will add to their already heavy load in the midst of the current Omicron surge, but it can also help more effectively reduce hospital admissions by getting the pills to patients most likely to end up there, decreasing the strain.

When the supply increases, pharmacies can play an important and expanded role, especially if they’re able to offer both testing and prescriptions onsite. In the meantime, unless hospitals and health systems are allowed to lead the allocation process, it will be left to doctors to carefully prescribe Paxlovid only for their patients at the very highest risk of severe Covid-19 outcomes — once again problematically leaving public health solutions in the hands of individuals and asking them to make ethically challenging choices on their own.

Holly Fernandez Lynch is a senior fellow at the Leonard Davis Institute for Health Economics and an assistant professor of medical ethics, health policy, and law at the University of Pennsylvania. Keith Hamilton is an infectious diseases physician and associate professor of clinical medicine and infectious diseases at the University of Pennsylvania.

Source: STAT