Major pharmacy groups argue that a new Biden administration initiative to facilitate access to Covid-19 antivirals will have a limited impact and fail to mitigate certain health inequalities.
The Test to Treat program was announced in the State of the Union address by Joe Biden. In-house clinics, one-stop testing and access to antivirals will be provided by the administration.
In the face of fierce Republican opposition to new Covid-19 spending, the administration aims to provide for free and will roll it out in Veterans Affairs clinics, community health centers and long-term care facilities.
There are some 250 Walgreens stores, and Kroger Little Clinics. Nurse practitioners and physician assistants are authorized by the FDA to prescribe the two currently available Covid antivirals, Pfizer and Paxlovid.
The impact of Test to Treat will be compromised by the fact that in-house clinics are relatively limited in number and largely in urban areas, according to 14 organizations representing pharmacy and pharmacists.
Because of this limitation, rural and underserved communities are less likely to benefit from your test to treat approach.
According to the CDC, 90 percent of Americans live within five miles of a pharmacy.
The FDA is blocking us from using the most accessible healthcare provider out there to make sure that these patients can get these drugs easily.
Test to Treat is not doing a lot, according to Ganio.
On a per-capita basis, the need for Covid-19 antivirals is likely to be greater in rural areas. A recent CDC study found that through January, 58.5% of people aged five and older in rural counties had received at least one coronaviruses vaccine shot, compared with 75.4% in urban counties.
Unvaccinated people with certain medical conditions can be authorized for Paxlovid and molnupiravir. In its clinical trial, Paxlovid was effective at preventing hospitalization and death. The drug proved to be just 30% effective. The FDA only allows its use when other treatments are unavailable or not advised for an individual.
Test to Treat will be affected by theSufficient supply of Paxlovid. The federal government has delivered a woefully inadequate 700,000 Paxlovid courses to the states since December.
In March and April, the administration claims it will distribute 1m courses. Pfizer plans to deliver a cumulative 10m courses by the end of June, according to a representative. The 20m courses will be delivered by the end of September.
The US Department of Health and Human Services amended a federal public health emergency law in September of 2021.
When Paxlovid and molnupiravir were authorized by the FDA, it explicitly restricted the use of pharmacists to prescribe them.
The authors of the letter to Biden submitted data to the FDA at the end of January in hopes of getting the authority to prescribe.
These groups have been lobbying the federal government to make sure Medicare Part B reimburses pharmacists for such prescriptions.
Paxlovid may interact harmfully with other drugs. The FDA advises against giving the treatment to people with severe impairment. There are concerns about molnupiravir's potential toxicities. It is not recommended for pregnant women.
The FDA's decision to forbid pharmacists from writing prescriptions for Paxlovid and molnupiravir was based on several factors, including the drugs' side-effect.
As new data and information becomes available, the FDA could revise the policy.
The American Medical Association said that thepharmacy based clinic component of the Test to Treat plan flaunts patient safety and risks significant negative health outcomes. Providers may endanger patients for whom they lack a comprehensive medical history if they prescribe Covid antivirals at such clinics.
In a letter to Biden, the pharmacy groups said they have the expertise to prescribe these medications.
In an email to the Guardian, Al Carter, executive director of the National Association of Boards of Pharmacy, stated that pharmacists have more complete access to the patients since most patients have more than one prescriber.
Pharmacy students spend their entire education focused on medications and their effects on the body, whereas physicians only take a few classes on pharmacology.
There are a lot of studies that show that increasing services in community pharmacies improves care, according to a clinical pharmacist at the University of California, San Francisco. In a lot of neighborhoods and rural areas, people don't have access to primary care and pharmacy is the most accessible public health provider.