A big news Biden administration initiative to facilitate access to Covid-19 antiviral drugs will have a limited impact and fail to alleviate certain health inequalities, large pharmaceutical groups claim because pharmacists are restricted from prescribing the pills.
Announced in Joe Biden’s State of the Union speech, the “Test to Treat” program is intended to address the insane difficulties Americans have had in accessing Covid-19 treatments. The administration will channel new increasing stocks of antiviral pills to larger retail pharmacies that have in-house clinics, providing one-stop testing and access to antiviral agents.
The program, which the administration aims to offer for free (in light of fierce Republican opposition to new Covid-19 spending), is also scheduled to be launched in Veterans Affairs clinics, local health centers and long-term care facilities.
The largest participants include about 250 Walgreens stores, 225 Kroger Little Clinics and 1,200 CVS MinuteClinics. CVS clinics are staffed in particular by nurses and medical assistants, authorized by the Food and Drug Administration (FDA) to prescribe the two currently available Covid antiviral agents, Pfizers Paxlovid and Merck and Ridgeback Biotherapeutics’ molnupiravir.
In a letter to Biden on March 9, calling for the authority of pharmacists to prescribe these pills, 14 organizations representing pharmacies and pharmacists insisted that the effect of Test to Treat would be compromised by the fact that such internal clinics is relatively limited in number and largely in urban areas.
“Unfortunately, rural and underserved communities are less likely to benefit from your test-to-treatment approach because of this limitation,” the letter said.
According to the Centers for Disease Control and Prevention (CDC), 90% of Americans live within five miles of one of approximately 60,000 pharmacies.
“The FDA still prevents us from leveraging the most accessible healthcare provider out there to ensure that these patients can easily obtain these drugs,” said Michael Ganio, a pharmacist in Columbus, Ohio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, who are signatories of the letter to Biden.
“In terms of expanding access,” Ganio said, “Test to Treat doesn’t do much.”
The need for Covid-19 antiviral drugs is likely to be greater in rural areas, at least on a per capita basis. A recent CDC study found that by January, 58.5% of people aged five and older in rural areas had received at least one vaccination shot against coronavirus, compared with 75.4% in urban areas.
Paxlovid and molnupiravir are approved for people at high risk for severe Covid-19, especially unvaccinated people with certain medical conditions. Paxlovid was 88% effective in preventing hospitalization and death in its clinical trial. Molnupiravir has only been shown to be 30% effective. The FDA only allows its use when other treatments are not available or not recommended for an individual.
Adequate supply of Paxlovid will be the key to Test to Treat. Since the end of December, the federal government has delivered woefully inadequate 700,000 Paxlovid courses to states, with the weekly allocation rising from 100,000 in January to 175,000 in March.
The administration has claimed that it will distribute 1 million. courses in March and 2.5 million. in April. A Pfizer representative will only state that the company plans to deliver a cumulative 10m courses by the end of June. The administration has agreed to buy 20 million. lanes expected to be delivered before the end of September.
In September 2021, the U.S. Department of Health and Human Services amended a federal emergency law on public health, the Prep Act, to authorize licensed pharmacists to “order and administer selected Covid-19 therapies” – which at the time meant monoclonal antibodies and vaccines.
But when the FDA approved Paxlovid and molnupiravir in December, it explicitly restricted pharmacists from prescribing them.
The authors of the letter to Biden say they submitted the data to the FDA in late January in hopes of persuading it to give pharmacists a prescribing authority.
These groups have also lobbied the federal government to ensure that Medicare Part B would reimburse pharmacists for such a prescription – a step that would likely make health insurance companies follow suit.
Prescribing Paxlovid safely can be challenging because it can interact harmful with other drugs. In addition, the FDA advises against giving the treatment to people with severe kidney or liver failure. Experts have also expressed concern about the potential toxicity of molnupiravir. It can not be prescribed to minors and is not recommended for pregnant women.
Chanapa Tantibanchachai, an FDA press officer, said the agency’s decision to ban pharmacists from prescribing Paxlovid and molnupiravir “was based on several factors, including the drug’s side effects profiles, the need to assess the potential for drug interactions, the need to assess potential renal function problems. of potential problems) and the need to evaluate patients for pre-existing conditions “associated with severe Covid-19.
Tantibanchachai said the FDA could revise the policy “as new data and information becomes available”.
On March 4, the American Medical Association said that the “pharmacy-based clinic component of the Test to Treat plan demonstrates patient safety and risks significant adverse health outcomes.” The AMA argued that by prescribing Covid antiviral drugs at such clinics, providers could endanger patients for whom they lack a comprehensive medical history.
In their letter to Biden, the pharmacy groups insisted that they have the expertise to prescribe these drugs.
In an email to the Guardian, Al Carter, executive director of the National Association of Boards of Pharmacy, stated: “Pharmacists have more complete access to patients’ medications compared to physicians, especially since most patients have more than one prescribing physician who does not necessarily speak. together.
“Pharmacists spend their entire education focusing on medication and their impact on the body; whereas doctors take the minimum number of classes in pharmacology. “
Katherine Yang, a clinical pharmacist at the University of California, San Francisco, said: “There are a lot of studies that show that when you increase services in local pharmacies, you improve care. In many neighborhoods and rural areas, people may not have access to primary care, and pharmacists are the most accessible public healthcare provider patients can see. “