This Week's News
AMA questions proposal to expand availability of over-the-counter drugs
Testifying during a public hearing of the U.S. Food and Drug Administration (FDA) last week, the AMA pointed to patient safety concerns if certain drugs are made available over the counter.
A proposed FDA program would consider how the use of new technologies or pharmacist involvement could create conditions of safe use for drugs that otherwise would require a prescription. Possible elements of the program could include kiosks, other information technology, companion diagnostics, and counseling with or dispensing from a pharmacist. Such interventions would help patients self-diagnose and manage conditions—including such chronic diseases as hyperlipidemia, hypertension, migraine headaches and asthma—without a prescription or physician involvement.
In her testimony, Sandra Adamson Fryhofer, MD, chair-elect of the AMA Council on Science and Public Health, questioned the ability of the program to improve patient outcomes or medication adherence, which are two of the FDA's chief goals for the program.
"We … have concerns about patients taking certain drugs without physician involvement, especially for patients with chronic diseases," Dr. Fryhofer said. "This sort of self-diagnosis and treatment conflicts with the kind of care coordination and disease management that both the (Obama) administration and private sector are trying to achieve through the new health care payment and delivery models."
Dr. Fryhofer emphasized the importance of communication among patients, physicians and pharmacists and cautioned against processes that would impair the patient-physician relationship.
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