Pharmacy and healthcare organizations see problems with ‘Test to Treat’ program – New Hampshire Bulletin
Citing the need to quickly provide urgent antiviral drugs to people who test positive for COVID-19, the Biden administration recently announced that it would allow anyone with symptoms to be tested and receive the drug in a single trip in a pharmacy – without seeing their medical provider for a prescription.
Much of New Hampshire, however, will not have access to the new “Test to Treat” initiative because the only eligible pharmacies here are six Minute CVS Clinics, according to the Department of Health and Human Services. None are north of Concord.
Those who can’t get to a Minute Clinic can still get a prescription from their health care provider, as was the case, and fill it at a pharmacy.
At least for now.
As federal officials finalize program details, pharmacy and health organizations are asking them to rethink key elements to expand access and engage primary care providers. Proponents say success would not only allow more people to access this new initiative, but would also transform the way medicine is practiced.
The Test to Treat program includes two oral antivirals, which hit the market in December, that have been shown to reduce hospitalizations and deaths in people with mild to moderate symptoms of COVID-19. Pfizer’s paxlovid (for adults and children 12 and older who weigh at least 88 pounds) can reduce these results by 88%, and Merck’s molnupiravir (for adults 18 and older) by 30%.
But to work, they must be taken within five days of symptoms. Test to Treat’s one-stop option aims to reduce delays.
Health care leaders say they support the concept, but not the element that bypasses primary care providers who know best the health risks to their patients. Both medications come with considerable considerations for prescribing and follow-up care.
Paxlovid may reduce HIV-1 drug resistance, pose increased risks for people with kidney and liver disease, and has special considerations for people who have taken cancer and blood-thinning medications, among others. Molnupiravir is not recommended for pregnant women, and women and men of childbearing potential are advised to use reliable contraception during and after treatment.
“You really don’t get a real diagnosis through this, and coming up with a cookie-cutter treatment plan that doesn’t consider symptom diagnosis…can be risky,” said Jim Potter, executive vice president. of New Hampshire. Medical Society. “Pharmacists aren’t trained to do this kind of medical diagnosis and physiological assessment. They just aren’t.
He added: “We don’t want to throw cold water on it. We just want to make sure everything is done right, and that includes making sure your primary care provider is involved.
Pharmacist organizations said they did not object to working with primary care providers, but rejected arguments that they were not sufficiently trained. They want the program extended to all pharmacies. Otherwise, they say, equitable access is impossible.
“That leaves out independent pharmacies and non-clinical pharmacies — pharmacies that are available across the country in all kinds of neighborhoods,” said Dr. Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health- System Pharmacists. The group last week asked the Biden administration to lift program limits on pharmacies with clinics. “And there’s no better healthcare professional more qualified to navigate drug interactions that are of concern.”
Limiting the program to certain pharmacies took his association by surprise.
In September, the federal Department of Health and Human Services changed federal rules to add pharmacists to the list of medical professionals authorized to prescribe COVID-19 “therapeutics,” including oral medications. In make the announcementthe agency said it foresees “a need to increase the number of available providers capable of ordering and administering COVID-19 therapies to address rising COVID-19 cases, expand the patient access to these essential therapies and to keep as many patients out of hospital as possible.
Test to Treat, however, is a Food and Drug Administration project, not Health and Human Services, and it did not include pharmacists.
“We met with the FDA,” Ganio said. “We discussed with them the possibility of speaking with a patient about their medical history. I felt we had addressed their concerns.
Ganio noted that urgent care sites are treating people for a wide variety of non-COVID-19 illnesses that require immediate attention without first consulting the person’s primary care provider. And for many people, these emergency services are their only provider of medical care. “There is no difference,” he said.
New Hampshire Independent Pharmacy Association lobbyist Rick Newman has spoken with a few state lawmakers about changing a current bill to include all pharmacists in the program. That seems unlikely at this point in the session, he said, especially since the details of Test to Treat seem to be developing almost daily.
Its members believe they are as qualified as Minute Clinic providers to prescribe antivirals.
“We don’t talk about Mr. Gower in ‘It’s a Wonderful Life,'” Newman said. “We are talking about health professionals. He said 10 to 15 years ago there were similar arguments against allowing pharmacists to administer vaccines.
Newman and Ganio said pharmacists are open to including primary care providers, at a minimum by informing them after prescribing and dispensing the drug.
“There is no part of this process that has to go it alone,” Ganio said. “It can always be an interprofessional program or process. And in many cases, it may be necessary. Some of the drug interactions can be quite serious. Some can be managed easily.
There is an additional hurdle: The Centers for Medicaid and Medicare Services does not require pharmacists to be reimbursed for time spent testing for COVID-19, ordering and prescribing antivirals, and seeing a patient. (Additionally, the state Department of Insurance recommends that people who use the Test to Treat program choose a pharmacy covered by their plan and contact their carrier about potential co-pays.)
Removing barriers to access and reimbursement could revolutionize chronic disease management, Ganio said, because pharmacies are more easily accessible than health care offices for many. The role played by pharmacies in COVID-19 testing and vaccinations are prime examples.
Bruce Berke, lobbyist for the Coalition of New Hampshire Chain Drug Stores, is also monitoring the development of Test to Treat. Its members, of which CVS is not a part, see the same opportunity.
“Efforts in these areas will benefit the consumer and our communities,” he said. “The more health care providers, of which pharmacists are certainly one, know and treat patients in the most effective and efficient way, the better it is for everyone.