Lives are on the line.
Emergency authorization of the first at-home and orally administered medications for the treatment of COVID-19 has finally arrived.
Pfizer’s life-saving Paxlovid pill, which was proven in clinical trials to prevent hospitalization for those with active COVID infections by as much as 89%, is an astonishing scientific breakthrough with the potential to save countless lives and curtail the length of this horrible pandemic.
But an unusual clause hidden deep in the details of the FDA authorization means that getting access to it won’t be as easy, cheap, or equitable as it could be.
The FDA does not typically provide guidance to include or exclude which healthcare professionals may prescribe medications; this is usually a role left to the states. Because the FDA introduced the clause in the EUA regarding Paxlovid and Molnupiravir, this creates a significant challenge and hurdle for states to decide for themselves. If you or a loved one needs it, you’ll have to navigate the expensive and inequitable labyrinth that is our broken healthcare system.
According to the FDA authorization, prescriptions for Paxlovid and Molnupiravir can be issued by physicians, nurse practitioners, and physician assistants. That might not seem like a problem at first glance — of course a qualified medical professional should assess before prescribing this pill. However, during the 2009 swine flu pandemic, the oral antiviral drug Tamiflu was granted a EUA without prescriptive authority guidelines.
Imagine this: you begin experiencing mild symptoms and visit your local pharmacy to get a COVID test. You receive the unfortunate news that there is a confirmed positive test. Behind the pharmacy counter is the medication that could save your life.
But your pharmacist can’t give it to you. It would help if you found a way to get a prescription. Depending on where you live and your social-economic status, this could take days or weeks, and with antiviral medication, time is of the essence.
Now, you have to book an appointment at your local urgent care or emergency room — if you can afford one, and if your work and childcare schedules permit you to endure the growing wait times. Finally, you can return to that same pharmacy a second time to pick up your medicine. Only then can a physician, nurse, or PA run that very same COVID test and use their prescriptive authority to allow you access to Paxlovid.
This scenario will be a reality for many. This is why our healthcare system is broken.
At a time when the omicron variant threatens to overwhelm our healthcare system, demanding that potentially COVID-positive patients rely on these same channels for any chance of treatment is a horrible strategy.
And that is to say nothing of the many thousands of Americans for whom access to these points of care has long been inaccessible.
Are we supposed to accept the idea that people who can’t afford access to urgent care clinics, emergency rooms, or primary care physicians are indefinitely denied access to this drug that could save their lives?
There is a better way: a little-known policy called “Test and Treat” enables pharmacists to prescribe patients directly. With this program, a pharmacist can issue a questionnaire, and upon review, eligible patients would be given the medication and educated on how to use it, all in one visit.
While not well-known, Test and Treat has been offered at some pharmacies to treat common conditions such as flu, strep throat, and urinary tract infections. Many studies have shown that when pharmacists can prescribe for common conditions such as birth control and opioid overdoses, the cost of care decreases, and health outcomes improve with greater access to medications.
Ninety-three percent of Americans live within 5 miles of a pharmacy, putting pharmacies in a unique position to provide quick and equitable access to Paxlovid at a lower cost. That’s precisely why pharmacists, who typically go through 4-8 years of medical training, have become invaluable community health resources as we’ve rolled vaccines out across the country.
Prohibiting pharmacies from assessing COVID symptoms and writing same-visit Paxlovid prescriptions to the patients who need them is gravely irresponsible. It will cost people their lives. And even worse, this approach stands to exacerbate further racist and classist disparities in access to COVID care that have already been a grim hallmark of this pandemic.
This is an outrage. This is not how we reduce the impact on our healthcare system using this game-changing medication, and this isn’t how we save the lives of our community members.
Suppose pharmacists are qualified enough to save lives by issuing millions of vaccines in 2021. They’re also skilled enough to give people with active COVID cases antivirals with the proper training.
James Lott, PharmD.
James Lott is the founder and CEO of Scripted, a Chicago-based health technology startup. James is a pharmacist and graduate of the University of Chicago Harris School of Public Policy. In 2020 he was recognized as Crain’s Chicago Business 40 Under 40 and was a recipient of the Clinton Global Initiative Commitment to Action Award.
Are you with us?
Co-sign James' letter and help us spread the word.
Spread the word with #LetUsPrescribe
Copy and paste the following message to share on social media:
Pharmacies can’t prescribe life-saving COVID-19 treatments like Paxlovid.
This will cost lives. #LetUsPrescribe scripted.co/open-letter