Expanding test-to-treat policies is a harmful prescription

Jesse M. Ehrenfeld, MD, MPH , Immediate Past President

AMA News Wire

Expanding test-to-treat policies is a harmful prescription

Jun 10, 2024

While pharmacists and physicians each play important roles in health care delivery, the length, breadth and focus of their education and training are vastly different and prepare them for separate and distinct roles in patient care. Pharmacists are medication experts, but their clinical training does not prepare them to perform physical or mental examinations, diagnose patients, interpret test results or provide primary care services. The independent practice of medicine by pharmacists puts patient health and safety at risk.

That is why the AMA has and will continue to oppose scope of practice expansions for pharmacists who, while admirably trained in pharmaceutical and biomedical sciences, are not prepared to assume the role physicians play in the health care equation.

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Research has demonstrated that patients want and expect their health care to led by physicians, who combine the highest level of education with clinical judgment and decision-making skills honed by four years of medical school, three to seven years of accredited residency and between 12,000 and 16,000 hours of clinical training.

Delivering patient-centered, cost-effective health care is a complex and multifaceted process that requires an interdisciplinary team of health professionals, with physicians in a leadership role. Patients are at the center of everything physicians do, and ensuring their well-being in the modern health care environment continues to drive the AMA’s emphasis on physician-led teams.

The AMA has been instrumental in defeating scope expansion bills nationwide. AMA advocacy, in partnership with state and specialty medical associations, achieved more than 100 state-level victories against inappropriate scope expansions by nonphysician health care providers in 2023.

The AMA has worked with more than 35 state medical associations and national specialty societies on scope of practice issues thus far in 2024 and secured more than 50 wins. Many such advocacy wins were made possible thanks to the AMA Scope of Practice Partnership, a coalition of 111 national, state and specialty medical and osteopathic associations dedicated to fighting inappropriate scope of practice expansions and preserving patient access to physician-led care.

Physicians possess the training, experience, broad-based knowledge and clinical expertise to draw out valuable contributions from each member of the care team, including pharmacists. This approach taps the unique strengths and perspective of each health professional on a multidisciplinary team to provide the high-quality care patients deserve. In practice, collaborative practice agreements, or formal arrangements that allow physicians and pharmacists to work together to provide patient care, are a good alternative to the independent practice of medicine by pharmacists.

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While the distinction between pharmacists and physicians is an important one, it does not diminish the crucial role of pharmacists play in educating patients on the safe and effective use of medications, watching for drug-drug or drug-condition interactions, and engaging in similar medication-related activities. But a huge component of the distinction between these two professions lies with the education and clinical training each receives.

The differences are enormous. Unlike medical school, admission to pharmacy school does not require a bachelor’s degree, but only two to three years of undergraduate prerequisites. Pharmacists complete 1,740 hours of “patient- care activities” in pharmacy school, which includes educating patients on medication usage and dosing while promoting continuity of care. There is no residency requirement, however, and their training does not include making a diagnosis, developing differential diagnoses and prioritizing them, conducting physical examinations or mental health assessments, or performing primary care procedures.

In short, neither the clinical activities conducted nor the didactic curriculum of pharmacy school sufficiently prepare pharmacists to diagnose and treat patients independently.

By contrast, a candidate seeking to become a physician must first earn a standard four-year bachelors degree and then complete a four-year doctoral program to receive an MD or DO designation. This comprehensive instruction is followed by a three- to seven-year residency program. The total time required to prepare physicians to diagnose and treat patients independently typically ranges from 12 to 14 years, with up to 16,000 hours spent caring for patients directly. 

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In recent years, lawmakers in multiple states have introduced measures that would allow pharmacists to administer and evaluate certain diagnostic tests and then prescribe medications based solely on those test results. Such “test-to-treat” legislation includes lab tests with a low risk of erroneous results and approved by the Food and Drug Administration for home use, which are known as CLIA-waived tests. Examples of CLIA-waived tests include tests for influenza, strep, urinary tract infection and COVID-19, among thousands of others.

As the Centers for Disease Control and Prevention points out, waived tests can have serious health consequences if performed incorrectly. And even when pharmacists proceed to treat a condition based on the accurate results of a waived test, they are making a diagnosis without a physical exam and without a review—or, in most cases, access to—a patient’s medical history. In these circumstances, misdiagnosis is possible, and underlying health conditions that are contributing to or responsible for a patient’s health issue may go undetected.

The push to expand scope of practice for pharmacists accelerated during the COVID-19 pandemic, when federal law granted pharmacists the authority to administer point-of-care COVID-19 tests and treat patients with an antiviral, Paxlovid. Since then, multiple states—including Arizona, Illinois, Mississippi, Nevada, South Carolina, Texas, Vermont and West Virginia—have rejected pharmacist test-to-treat legislation. Washington defeated a bill that would have given that state’s Pharmacy Commission the authority to identify drugs and devices pharmacists could prescribe.

Going forward, the AMA will continue to work alongside our partners in the Federation of Medicine to stop inappropriate scope expansions by nonphysicians at both the state and federal levels, while supporting physician-led care teams at every opportunity. These efforts include model bills and legislative templates on key issues tied to scope of practice, the AMA Truth in Advertising Campaign that ensures patients know who is providing their health care, and a host of other evidence-based resources and initiatives.

One factor that should not be overlooked in this discussion is the fact that the current job responsibilities facing pharmacists can be overwhelming. The 2019 “National Pharmacist Workforce Study of more than 3,000 pharmacists showed that more than 70% of all pharmacists—and more than 90% of those employed by pharmacy chains—described their workloads as either high or excessively high.

Even if pharmacists had adequate time available to them to conduct test-to-treat activities, autonomous diagnosing and prescribing of prescription medication without the supervision of a licensed physician threatens patient health and safety. It is absolutely the wrong prescription for our nation.

Fight scope creep