COVID-19 initiative preparing to launch

Plan promises `one-stop shop' for infected people

Imagine walking into a pharmacy for a COVID-19 test — and leaving with a free treatment.

That's the vision behind President Joe Biden's ambitious “Test to Treat” initiative, announced at Tuesday's State of the Union address, which aims to provide an easy and efficient way to reduce illness.

But successful execution of this “one-stop shop” plan — which federal officials say will be rolled out later this month at CVS, Walgreens and other retail and long-term care facility pharmacies — will be challenging, according to experts. In fact, it's far from clear that a fully functioning program can possibly be ready to go on the ambitious time frame being suggested.

“We need a much better supply of anti-COVID pills, accurate tests, and solid coordination with pharmacists to pull this off,” tweeted Scripps Research Executive Vice President Eric Topol.

Studies show that Pfizer's antiviral pill, called Paxlovid, reduces the risk of hospitalization or death by 89% if provided within five days of symptoms. It is also assumed to reduce the risk of viral transmission.

“Early `same day' treatment after a positive test for any infectious disease, particularly respiratory viral ones like COVID and flu, has long been a North Star goal in medicine,” said critical care pulmonologist Dr. Vin Gupta of the Institute for Health Metrics and Evaluation at the University of Washington.

By removing the need for a doctor's visit and a search of pharmacies for available supplies, the new approach could transform a process that is currently slow and burdensome, he said. It's part of the White House's 96-page coronavirus strategy unveiled on Wednesday.

“Narrowing that window from diagnosis to treatment, especially for someone who is high risk, is really critical,” he said. “Brick and mortar health care systems, up until now, really struggle with that. It's been too difficult for patients to navigate.”

CVS and Walgreens do not yet have a start date or estimated number of locations for the program's launch. But they endorsed the effort.

“With our MinuteClinic retail clinics and CVS Pharmacy footprint, we are uniquely positioned to help support the government's Test to Treat initiative and look forward to helping to provide expanded access as additional inventory becomes available,” said Matt Blanchette of CVS Pharmacy.

What would it take for the program to work?

• Adequate supplies of medication: At present, there aren't enough pills for everyone. This means that a pharmacist must decide, based on someone's medical history, who meets the criteria for treatment. But pharmacists don't have access to private medical records. And the patient may not know whether they're high risk.

This will improve over time. Biden announced that more than a million doses of the pills will be available this month. More than twice as many will be available in April.

• Authorizing pharmacists to write drug prescriptions: With over 85% of Americans living within 5 miles of a community pharmacy, pharmacists are often the closest health care provider. But currently, many pharmacists aren't empowered to give the pill.

In California, pharmacists must have a “Collaborative Practice Agreement” with a doctor to provide treatment such as hormonal contraception, smoking cessation, vaccinations and naloxone, which reverses an opioid overdose, according to Susan Bonilla, CEO of the California Pharmacists Association. COVID-19 therapy would need to be added to this list. Only pharmacists who hold an “advanced practice pharmacist” license are authorized to give therapies and must connect with the patient's doctor.

• Faster and more accurate tests: Pharmacies' quick “antigen tests,” with results available in 10 to 15 minutes, correctly detect infection in about only 72% of people with symptoms and 58% of people without symptoms. The tests are even less accurate when used in the first day or two of infection. So sick people who need Paxlovid may go home empty-handed.

PCR tests are much more sensitive, but because they must be sent to a lab for processing, they're impractical for someone waiting at a pharmacy.

• Careful screening of patients: Not everyone should get the pill, because it can cause severe interactions with many common medicines, including blood thinners, some antidepressants and cholesterol-lowering drugs like Zocor.

“Considerable effort is required to sort out these potentially dangerous drugdrug interactions,” Dr. Derek Eisnor, who serves as the Department of Health and Human Services' lead for the allocation and distribution of the COVID-19 therapeutics, said in a recent webinar.

The pill is also off-limits for patients with some kidney or liver impairments. It's not clear how pharmacists, with their limited access to medical histories, can make these calls.

• Pharmacies need to be better staffed, and better paid, for this new responsibility: There's a labor shortage at pharmacies, and employees say they're under intense strain as their workload has soared due to vaccination and testing. A January survey from the American Pharmacists Association found that 74% of respondents said they didn't have enough time to safely perform patient care and clinical duties. The number of job postings for pharmacists jumped from 12,600 in 2020 to 15,000 in 2021.

In order for pharmacists to provide more service, it's going to take — at the least — financial help.

“It will be important for the government to ensure that Medicare will reimburse pharmacists for clinical services related to this treatment,” said Bonilla.

• Pharmacies could become superspreader sites: It's a bad idea for contagious people to cluster indoors while waiting for test results — especially if they're in the company of elders, the immunocompromised and everyone else picking up a prescription. Besides, sick people want to stay home.

Pharmacies say they have safe protocols in place. Perhaps telemedicine could be used, linking treatments to at-home tests.

“It is not just one simple strategy,” said Dr. Meg Sullivan, acting chief medical officer for the Office of the Assistant Secretary for Preparedness and Response. “It is multiple different efforts.”

The initiative could help usher in a “new normal,” where treatment is routine and the virus no longer dominates everyday life, said experts. But much remains to be worked out.

“There are some regulatory hurdles, but this is a great first step,” said Gupta. “It really is a home run.”