The following editorial was written by a non-clinician and does not constitute medical advice.
To improve access to the antiviral Paxlovid, the Food and Drug Administration (FDA) will now allow pharmacists to prescribe the drug; the agency announced this last week, July 6.
Previously, patients seeking the drug, which has been shown to be highly effective in preventing serious illness and death from COVID-19, needed a doctor’s prescription.
This hurdle never really made sense. Paxlovid should not be taken more than five days after the onset of symptoms in order to have a lot of effect.
Forcing people to get a doctor’s appointment before accessing medication makes prompt treatment almost impossible in many cases.
Who knows how many people who contracted COVID and could have benefited from Paxlovid have died because they couldn’t get it in time? Unfortunately, this is standard operating procedure for the FDA – to take its time before giving patients access to effective treatments.
The data regarding the effectiveness of Paxlovid are staggering.
In a study published last month, only 0.1% of COVID patients who received Paxlovid were hospitalized for five to 15 days after treatment. Only 0.7% went to the emergency room.
Easy access to Paxlovid may not matter much to young, healthy people with little fear of the virus. But for at-risk patients, such as the elderly and those with serious chronic conditions, a drug that can virtually eliminate the chance of landing in hospital from COVID-19 is life-changing.
Indeed, Dr. Anthony Fauci, the president’s chief medical adviser, said he believed Paxlovid kept him out of hospital after he tested positive for COVID last month.
At the same time, an antiviral like Paxlovid should offer hope that we don’t need to go back to mandatory masking and social distancing.
There is no justification for the permanent state of emergency that so many in the public health community are calling for if people have easy access to a therapy like Paxlovid. — not to mention effective vaccines.
From the moment Paxlovid’s lifesaving potential became apparent, health officials should have done everything in their power to get the drug to everyone who needed it. But that’s not what happened.
The federal government made the drug free for those at risk last year — and sent millions of Paxlovid pills to pharmacies nationwide. But less than half of those doses ended up in patients.
One reason for this is the FDA’s previous requirement that only physicians could prescribe the drug. For people who live in medically underserved communities, seeing a doctor on short notice may not be an option.
These communities have disproportionately paid the price for the FDA’s tough rules.
Consider a recent study by Centers for Disease Control and Prevention (CDC) researchers that found patients living in ZIP codes deemed “socially vulnerable” were receiving COVID-19 antivirals. — including Paxlovid — less often than those who live in more favored areas.
This is despite the fact that vulnerable postcodes have more places where patients can receive these drugs.
Paxlovid’s slow rollout offers even more evidence to ease government regulations that restrict healthcare provision.
For example, policymakers could remove scope of practice laws that unnecessarily restrict nurse practitioners, physician assistants, and other qualified health professionals from administering treatments and performing procedures without the supervision of physicians. ‘doctor.
Rules prohibiting doctors from practicing outside a specific state — and thus creating a shortage of doctors where there is no need — are another prime candidate for restoration.
The decision to allow pharmacists to prescribe Paxlovid stands out as a rare case where FDA officials admitted that their own rules and requirements put public health at risk. They might consider moving away more often.
Sally C. Pipes is President and CEO and Thomas W. Smith Fellow in Health Policy at the Pacific Research Institute. His latest book is “False Premise, False Promise: The Disastrous Reality of Medicare for All” (Encounter Books 2020). Follow her on Twitter @sallypipes. Read Sally Pipes reports – More here.
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