In early July -- through 11 pages, a pen stroke, and a stamped envelope en route to Murray Hill in New York City -- an FDA lifer changed the landscape of American healthcare.
But the letter, written by the agency's acting chief scientist, Jacqueline O'Shaughnessy, PhD, didn't actually contain any new science. There were no novel virus-busters nor immune-suppressors nor tissue-rejuvenators. Instead, the FDA deemed that what was most truly "appropriate to protect the public health or safety" as it related to the COVID-19 medication nirmatrelvir-ritonavir (Paxlovid) was a systems change.
Pharmacists, the agency determined, should be able to prescribe the drug.
The decision is unusual for the agency, in part because the FDA mostly focuses on whether drugs should be approved -- not on who should be able to disseminate them once they are approved.
It's also peculiar because nirmatrelvir-ritonavir, as the first oral therapy authorized for COVID-19, was supposed to be tide-shifting. Back in December 2021, Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, called it "a major step forward in the fight against this global pandemic." And, she added, the drug's authorization was coming "at a crucial time" -- just as the Omicron variant was beginning to take the world by storm.
A Fumbled Rollout
However, the months since its approval have been met with a crescendo of confusion.
Doctors have expressed frustration about lack of clarity in the FDA's prescribing guidelines about which patients can be said to have "mild-to-moderate coronavirus disease," and which "are at high risk for progression to severe COVID-19." The latter category encompasses tens of millions of Americans -- from those with potentially mild illnesses like asthma or diabetes to those with potentially debilitating disorders like end-stage lung scarring or metastatic cancers.
The drug's so-called "rebound" phenomenon -- during which patients have recurrent symptoms or test positive for COVID-19 in the days and weeks after starting nirmatrelvir-ritonavir -- has also befuddled physicians, stalling the therapy's broader rollout.
Then, there's the fact that the FDA recommended prescriptions only for those who had been diagnosed with COVID-19, and only within 5 days of diagnosis. But as at-home testing rates have soared -- using diagnostics notoriously less accurate than PCR-testing -- confirming an accurate diagnosis is even more challenging. And since the average American has to wait between 4- and 8-times longer than the FDA's recommended window to score a doctor's appointment, many patients may simply fail to get to the clinic soon enough.
The net effect: America's doctors wrote just over one million prescriptions for nirmatrelvir-ritonavir in the months after its approval (through late May). Over the same period, over 30 million Americans had a mild or moderate case of COVID-19 -- many of whom may be considered high-risk for severe illness.
Moreover, the barriers to access disproportionately impact the communities already the most marginalized. In high social vulnerability zip codes -- defined by 15 indicators including household income, race/ethnic composition, English language competency, and housing availability -- nirmatrelvir-ritonavir dispensing rates were half those of other neighborhoods. This is despite the fact that the proportion of pharmacies (48%) in these communities approximates the proportion of U.S. residents who live in them (49%) -- this suggests the gap lies with prescription patterns, not with pharmacy proximity.
In this way, despite the hope and hype, the initial nirmatrelvir-ritonavir rollout perpetuated racial disparities in COVID-19 care observed since the earliest days of the pandemic. To the extent that health systems change may well be the best medicine for all Americans, the FDA's decision to allow pharmacists to prescribe nirmatrelvir-ritonavir is a game changer.
Prescription Barriers Extend Beyond Paxlovid
Barriers to accessing prescriptions aren't a new phenomenon. They didn't start during the COVID-19 pandemic or with nirmatrelvir-ritonavir.
Prescription rates of everything from addiction cessation medications to menopausal hormone therapies to anti-arthritic and opiate painkillers are lower in communities of color. Research indicates these inequities are likely a function of multiple factors including shortages of prescribing clinicians (doctors, but also nurse practitioners and physicians' assistants in some regions), obstacles to seeing a prescribing clinician, and implicit bias held by clinicians, among others. In other words, the same hurdles that hindered nirmatrelvir-ritonavir.
That's where pharmacists could, and should, come in. Yet, according to GoodRx, a company that helps patients obtain and manage their prescriptions, only seven states allow pharmacists to independently prescribe more than a cursory set of medications.
The restrictions exist despite national studies from organizations like the U.S. Public Health Service showing improved patient outcomes when pharmacists are allowed to prescribe medications. And this is despite the fact that many common medications -- like statins for high cholesterol, inhalers for asthma, and anti-fungal creams -- have benign side effect profiles that rarely require surveillance by prescribing clinicians. Millions of patients a year use medications just like these.
Taking Action to Promote Access
Given these benefits -- and the countless patients who might stand to gain from them -- some state policymakers are working vigorously to expand pharmacists' "scope of practice."
Such laws would grant pharmacists more independence and authority to directly prescribe selected therapies like hormonal contraceptives, vaccines, and travel medications. According to the National Alliance of State Pharmacy Associations, as of 2018, over 50 bills introduced by dozens of lawmakers on either side of the aisle were under consideration.
However, these incremental, state-by-state efforts are not enough in a country where many are getting sicker every day simply because they can't get to a doctor. Just as the FDA leveraged its authority to promote health systems change as the best medicine for COVID-19, it should do the same for other routine and safe therapeutics.
"There is nothing wrong with underlining personal agency," the late Paul Farmer, MD, PhD, wrote in Infections and Inequalities, "but there is something unfair about using personal responsibility as a basis for assigning blame while simultaneously denying those who are being blamed the opportunity to exert agency in their lives."
Similarly, alleviating the immense inequities in our country's health will take democratizing healthcare delivery in a way that returns agency to patients. Empowering pharmacists to prescribe medications would be a huge step toward liberating patients from the gridlock of a physician-centered system -- a form of liberation that could save lives today, tomorrow, and years from now.
Eli Cahan, MD, MS, is a pediatrician at UCSF and an investigative journalist
https://www.medpagetoday.com/opinion/second-opinions/100208.
