Drug Topics® Responds: AMA Statement on Test to Treat Initiative

Members of the Drug Topics® Editorial Advisory Board joined together to respond to the recent statement¹ released by the American Medical Association (AMA) president Gerald E. Harmon, MD, criticizing the Biden Administration’s plan to include pharmacists as points of access in the Test to Treat initiative.²

“While the administration laid out promising plans…to combat COVID-19…the pharmacy-based clinic component of the test-to-treat plan flaunts patient safety and risks significant negative health outcomes,” said Harmon. “This approach, though well intentioned…simplifies challenging prescribing decisions by omitting knowledge of a patient’s medical history, the complexity of drug interactions, and managing possible negative reactions.”¹

Responses to this statement from our Editorial Advisory Board are collected below.

We know that there is a significant amount of inequality in terms of health care access, and many people in rural or inner-city areas simply don't have ready access to physicians— but they do have access to their pharmacy. These COVID-19 antivirals are time-sensitive, with a need for rapid administration following diagnosis. Delays from testing to physician access to treatment have the potential to lessen the impact of these medications.

The AMA statement that "Paxlovid is 88[%]effective at preventing hospitalization and death. But it also has 6 pages of drug interactions, including interactions that may require a patient to hold, change, or reduce doses of other medications"¹ implies that family physicians would be better resources than clinical pharmacists to best address the issue of drug interactions. A clinical pharmacist has far more pharmacology training than a family physician and likely has experience with a lot more of those drugs on that 6-page list! As stated by the American Society of Health-System Pharmacists (ASHP), "Pharmacists are clinically trained medication experts and are the primary healthcare professionals responsible for ensuring safe medication use, including identifying and mitigating drug interactions associated with oral antiviral medications for COVID-19."³

The position that physicians have a more complete medical history of the patient than a pharmacist also assumes that all patients see the same provider and provider organization, which is not the case. Patients may be accessing insta-care locations, emergency rooms, [or] unfamiliar providers who have no more access to a [patient’s] medical history than a pharmacist. It also neglects the fact that, on average, a physician has 15 minutes to spend with a patient to try and get as much information as possible to make the best-informed decisions, while a clinical pharmacist can spend much more time with a patient.

I also find it absurd that we have a known health risk with reported deaths (more than 950,000, with actual deaths likely much higher due to lack of reporting), we have a treatment option that is 88% effective but has a narrow window to treat, and yet the AMA is more concerned about the theoretical and unproven impact of pharmacist prescribing than potentially expanding access to a viable treatment. There is always risk associated with any new program, but risk must be carefully considered vs reward, and time to treatment would seem to clearly outweigh the concern over drug interaction management.

—James A. Jorgenson, RPH, MS, FASHP
CEO, Visante

Jim eloquently took the words out of my mouth! I completely agree with all your sentiments. During COVID-19, many physician clinics reduced clinic hours and resolved to simply do telehealth. Only the pharmacies remained open. We are also the main source of vaccinations in the community—not physicians—due to our access and availability. The rationale put forth by the AMA, against pharmacist access, is simply not founded.

—Ken Thai, PharmD, APh
CEO, 986 Degrees Corporation
California Pharmacists Association Immediate Past President
University of Southern California School of Pharmacy, Adjunct Assistant Professor of Clinical Pharmacy Practice
Western University of Health Sciences School of Pharmacy, Clinical Assistant Professor of Pharmacy Practice

I’m concerned to see the AMA so adamantly opposing a measure that would limit access to critical treatments for COVID-19. The AMA’s primary argument is around medical complexity, but there’s really nothing to argue: We agree that pharmacists are not qualified for complex medical decision making. But that’s not what is on the table here. What’s on the table is allowing pharmacists to follow straightforward, protocol-based medical decision-making guidelines which would expand access to this time-sensitive treatment to millions more Americans. And when the medical decision making is more complex, the pharmacist would refer the patient to a physician. So, what are we arguing about? Let’s do this!

—David Pope, PharmD, CDE
Chief Innovation Officer, OmniSYS

To add, pharmacists have already implemented a similar "test to treat” program for another recently forgotten epidemic: HIV. For example, in California or New York, pharmacists are authorized to dispense HIV medications for post-exposure prophylaxis (PEP) without a prescription.⁴ Patients are tested for HIV and hepatitis C at baseline and typically 28 days after the PEP regimen has been completed. This current model is essentially identical to the proposed test to treat program for prescribing Paxlovid.

In addition, pharmacists in California are already allowed to prescribe naloxone, birth control, smoking cessation agents, and travel health agents to provide the best care to the patient.⁵ Allowing pharmacists to help ensure that patients have access to Paxlovid would essentially be adding a single drug to the growing list of medications pharmacists can already provide to patients.

—Mohamed A. Jalloh, PharmD, BCPS
Touro University California College of Pharmacy, Assistant Professor, Clinical Sciences Department
OLE Health, Ambulatory Care Clinical Pharmacist

Do you have a response to the AMA statement? Email your thoughts to Lauren Biscaldi, Managing Editor, at lbiscaldi@mjhlifesciences.com

References

1. AMA statement on Administration’s test-to-treat COVID-19 plan. News release. American Medical Association. March 4, 2022. Accessed March 11, 2022. https://www.ama-assn.org/press-center/press-releases/ama-statement-administration-s-test-treat-covid-19-plan
2. National COVID-19 preparedness plan. The White House. Published March 2022. Accessed March 11, 2022. www.whitehouse.gov/wp-content/uploads/2022/03/NAT-COVID-19-PREPAREDNESS-PLAN.pdf
3. Pharmacist groups call on Biden Administration to remove limits on prescribing COVID treatments. News release. American Society of Health-Systems Pharmacists. March 9, 2022. Accessed March 11, 2022. https://www.ashp.org/news/2022/03/09/pharmacist-groups-call-on-biden-administration-to-remove-limits-on-prescribing-covid-treatments
4. Finding of emergency. Independent HIV preexposure and postexposure prophylaxis furnishing. California State Board of Pharmacy. Published April 10, 2020. Accessed March 11, 2022. www.pharmacy.ca.gov/laws_regs/1747_nifer.pdf
5. Pharmacist services. California State Board of Pharmacy. Updated August 2021. Accessed March 11, 2022. https://files.medi-cal.ca.gov/pubsdoco/publications/masters-mtp/part2/pharmserv.pdf