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A four-page FDA proposal could revamp relationships with doctors

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iStockphoto The Food and Drug Administration is weighing policy changes that could make some of America’s most commonly used medications -- drugs to control cholesterol, diabetes and asthma -- available over the counter. The proposal would make accessing drugs significantly easier -- and, in the eyes of some, perhaps make doctors less necessary.

The idea, from the FDA’s point of view, is to take away obstacles that keep Americans from managing their own health care. About 20 percent of prescriptions written in the United States go unfilled, indicating to regulators that a trip to the pharmacy may be an obstacle for Americans seeking health care.

The FDA contends that some consumers may not even go as far as getting a prescription because of the “cost and time required to visit a health-care practitioner.” Right now, they’re looking at possible scenarios where a prescription could be required for the first round of medication or that a pharmacist could offer counseling at point-of-purchase.

There is precedent for what the FDA wants to do. In 2003 the agency cleared heartburn drug Nexium to be sold without prescription. It’s made similar switches for heavily-used allergy medications like Claritin and Zyrtec, also in the early 2000s.

Doctors are not thrilled with the idea, contending that patients should be consulting with their doctors as they manage chronic conditions.

“Self-diagnosis and treatment conflict with the care coordination and disease management that new health care payment and delivery models are trying to achieve,” contends American Medical Association president Peter Carmel.

Carmel, in a USA Today op-ed, goes on to argue that without the guidance from doctors, patients will be less likely “to take the medicine they need when they need.” Most insurers do not cover over-the-counter medications in their benefit packages, creating the possibility of a financial roadblock.

At the heart of this discussion is a fundamental disagreement over what role doctors play in managing patient care. The FDA proposal views a trip to the physician that it says is unnecessary as a hindrance to care.

Doctors see themselves as enablers: They can help Americans manage their health care, a crucial task as chronic conditions become increasingly prevalent.

The FDA proposal is still in formative stages -- a request for comment in the Federal Register — which means there’s a lot of space for this debate to evolve. Where the discussion heads on this particular issue could end up guiding a lot of U.S. health policy on what role doctors play in managing patient care - and, at what point, the patient takes charge.

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