Association of American Physicians (AAPS) Objects to FDA’s Dangerous Rule Allowing Pharmacists to Prescribe Paxlovid™

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The U.S. Food and Drug Administration (FDA) revised its Emergency Use Authorization of Paxlovid™ on July 6, 2020, to allow pharmacists to practice medicine by prescribing and dispensing Pfizer’s drug on their own order.

The FDA does not have the statutory authority to regulate the practice of medicine. It is up to the states to perform this function, which includes defining the scope of practice of various practitioners. Authority to expand the EUA in this way is claimed to be derived from the Public Readiness and Emergency Preparedness (PREP) Act, which the U.S. Department of Health and Human Services has also used to improperly permit pharmacists to order and administer COVID vaccines.

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.

Further, Paxlovid (irmatrelvir and ritonavir) is an investigational medication available only by emergency use authorization. It has not been determined to be safe and effective.

In fact, Paxlovid has been determined to be so unsafe as to require a “black box” warning about severe adverse consequences, including death, from interaction of the AIDS drug ritonavir component with a large number of commonly used drugs.

The FDA says that “pharmacists should refer the patients to a healthcare professional licensed to prescribe drugs if there is not sufficient information to assess kidney or liver function, or if modifications are needed due to a potential drug reaction.” Side effects include liver toxicity, kidney toxicity, allergic reactions, high blood pressure and multiple complex drug interactions.

Many cases of rebound of symptoms have been reported. But Paxlovid is authorized for only five days, so a repeated course would be “off label.”

Not only is the FDA overreach dangerous to the patient, but the PREP Act’s liability waivers also significantly reduce the ability of anyone harmed by Paxlovid to receive compensation.  Patients seeking redress are forced into the Countermeasures Injury Compensation Program, which currently is, as Reuters reports, “drowning in a 16-fold spike in claims with more than 8,000 cases pending.

In summary, it is impossible for pharmacists to formally, responsibly, and properly assess the patient history; perform a physical examination, which is not part of their training; obtain and evaluate needed laboratory tests; synthesize a treatment plan; discuss risks, benefits, and alternatives to obtain informed consent; and follow the patient. This FDA action is harmful and should be declared an unconstitutional overreach of power.