In a statement issued July 20, the Association of American Physicians and Surgeons (AAPS) objected to the rule issued by the Food and Drug Administration (FDA) that allows pharmacists to, in effect, practice medicine by prescribing and dispensing Pfizer’s drug Paxlovid™ on their own order.
“The FDA does not have the statutory authority to regulate the practice of medicine,” the statement reads. “It is up to the states to perform this function, which includes defining the scope of practice of various practitioners.”
“Pharmacists are not trained or qualified to diagnose or treat disease. They lack medical school and residency training. Pharmacists do not have to take a medical history, physically examine patients, coordinate their care, or maintain a medical record.
“To allow pharmacists to ‘prescribe’ Paxlovid without a physician’s prescription is an unprecedented and radical expansion of the practice of pharmacy, usurping the states’ authority to protect the public from unqualified practitioners.”
AAPS notes that Paxlovid (irmatrelvir and ritonavir) is an investigational medication available only by emergency use authorization (EUA). The AIDS drug component, ritonavir, carries a “black box” warning about severe adverse consequences, including death, from interactions with a large number of commonly used drugs.
The FDA claims that authority to expand the EUA to permit pharmacists to prescribe derives from the Public Readiness and Emergency Preparedness (PREP) Act. AAPS notes that the “PREP Act’s liability waivers also significantly reduce the ability of anyone harmed by Paxlovid to receive compensation.”
AAPS concludes that assessment of history, physical examination, and laboratory tests of liver and kidney function, as well as obtaining informed consent for an investigational drug and following patients’ response, are not part of pharmacists’ training or usual practice.
“This FDA action is harmful and should be declared an unconstitutional overreach of power, the statement concludes.”
The Association of American Physicians and Surgeons (AAPS), founded in 1943, represents physicians in all specialties nationwide.