Opinion | A Successful ‘Test-to-Treat’ Program Requires All Hands on Deck

The development of oral COVID-19 antivirals such as nirmatrelvir/ritonavir (Paxlovid) was nothing short of pathbreaking. An oral medication that could cut the risk of hospitalization and death by nearly 90% is a formidable tool that addresses the most important task of pandemic response: preserving hospital capacity. However, this medication (along with the less potent but authorized molnupiravir) is most impactful when administered during a 5-day window after COVID-19 symptom onset. Having several days to access this medicine might sound like ample time, but most people are not diagnosed within 5 days of symptom onset, especially if it is difficult for the person to get tested as we’ve seen time and time again throughout this pandemic.

As a result of this 5-day window and generally low medication availability (with each state doling out the pills to select pharmacies), the impact of these drugs hasn’t been fully realized. However, as the country moves to treat COVID-19 much like other respiratory viruses, reliance on more nirmatrelvir/ritonavir use will be important — and we’ll need more than just increased supplies of nirmatrelvir/ritonavir. If this life-saving drug remains idle on shelves because it’s prescribed to too few patients within the therapeutic window it will do no good.

In encouraging news, President Biden just announced a new plan to increase faster access: test-to-treat. The plan will enable pharmacies to become one-stop shops for COVID-19 diagnosis and oral antiviral treatment. Having treatment available at the point-of-diagnosis has the potential to significantly improve prescribing rates, which will have the downstream impact of reducing hospitalizations. More sick patients will quickly be able to access treatment.

However, there are barriers concerning who will be prescribing the medications. Ensuring the plan is a success will require the pills are accessible through as many safe avenues as possible.

Some pharmacies have urgent care clinics within them staffed by physicians, nurse practitioners, and physician assistants, all who can prescribe the medication. However, many pharmacies do not have such providers. What all pharmacies do have are PharmDs. PharmDs, or doctors of pharmacy, are highly trained individuals who are experts in drugs. They, despite common misconceptions, do way more than just fill bottles with pills. PharmDs counsel patients, make treatment recommendations, advise regarding side effects, and — critically when it comes to medications like nirmatrelvir/ritonavir — screen for drug to drug interactions.

As a practicing infectious disease, critical care, and emergency physician, I rely on PharmDs every day and often defer to their expertise — especially when it comes to complex drug-drug interactions. I find that PharmDs often have much more knowledge of the issues relevant to nirmatrelvir/ritonavir than the average primary care physician.

PharmDs have increasingly been recognized as important components of our resiliency against infectious disease threats. PharmDs run antibiotic stewardship programs, conduct groundbreaking research, counsel patients on medication adherence, and immunize the population.

This was not always the case, but PharmDs have fought valiantly to have their expertise recognized by state regulatory agencies and their physician peers. But in some states, ridiculous prohibitions persist regarding who a PharmD can vaccinate or other roles they may perform. For example, in my home state of Pennsylvania, the state draws the unscientific conclusion that a pharmacist vaccinating an 8-year-old is somehow beyond the pale, but vaccinating a 9-year-old is perfectly fine.

Fortunately, the federal government has developed a method to overcome these state-level regulations via the Public Readiness and Emergency Preparedness Act (PREP Act). This bill, signed into law by President George W. Bush, has many exemptions including the expansion of scope of practice for healthcare professionals by preempting restrictive and onerous state laws. A PREP Act declaration allows, for example, pharmacists to vaccinate lower age groups, order diagnostic tests, or to prescribe or administer certain medications. There has been such a declaration for COVID-19 and PharmDs have contributed incalculably to the response and recovery of the country.

Unfortunately, the emergency use authorization (EUA) for nirmatrelvir/ritonavir (as well as that for molnupiravir) states it “may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which Paxlovid belongs.”

As the value of having as many prescribers as possible for COVID-19 antivirals is indisputable, it was very surprising to see the American Medical Association (AMA), of which I am member, issue a statement opposing pharmacies having the role that is absolutely necessary for test-to-treat to succeed. Citing six pages of drug interactions, which most primary care physicians probably have not read or cannot recall, the AMA’s position is that only primary care providers — and not pharmacy-based clinical staff — should have the ability to prescribe these medications. This statement is wrong on many levels. A particularly egregious aspect is that, based on their logic, emergency department physicians would also be excluded by the AMA’s wrong-headed principal because they may not have ready access to a patient’s medical history. Additionally, the AMA instructing patients to call their primary care physicians for COVID-19 antivirals is a surefire path to ensuring that the window for timely treatment only opens a crack, at best.

We can’t have a guild-like mentality that seeks to use government force to exclude qualified persons from engaging in a field for which the AMA wants physicians to be the exclusive purveyors. This has been evident in organized medicine’s general opposition to expanded practice scopes for nurse practitioners, physician assistants, psychologists, and — as is clear — pharmacists. It’s bad enough to advocate for this on a day-to-day basis. To do so during a public health emergency, where all hands are needed on deck, is destructive.

Nirmatrelvir/ritonavir should be available through as many avenues as possible, including telemedicine, emergency departments, doctor’s offices, and pharmacies. The FDA must update its EUAs for the COVID-19 antivirals and the AMA should stand down and allow it to be deployed for optimal benefit.

Amesh Adalja, MD, is a senior scholar at the Johns Hopkins Center for Health Security and a practicing infectious disease, critical care, and emergency physician in Pittsburgh.