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FDA mulls over making some prescription drugs available over the counter

Drugs would be available under specific conditions

SILVER SPRING, Md. — The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.

The FDA will have a meeting on March 22 to collect public opinion regarding what it called a "new paradigm" under which drugs for such conditions as cholesterol and diabetes that normally require prescriptions would be available without them under "conditions of safe use" that would be specific to each drug, such as assisting patients in drug selection, providing followup monitoring or requiring pharmacist intervention to ensure appropriate use.

Another possibility suggested was the use of technologies such as diagnostics used in the pharmacy or other settings. In the meeting notice, published in the Federal Register, the FDA said it was aware of new technologies that allow patients to self-screen for certain diseases. "For example, kiosks or other technological aids in pharmacies or on the Internet could lead consumers through an algorithm for a particular drug product," the notice read. "Such an algorithm could consist of a series of questions that help consumers properly self-diagnose certain medical conditions, or determine whether specific medication warnings contraindicate their use of a drug product."

Pharmacist intervention could include requiring confirmation of a diagnosis or routine monitoring using a diagnostic test such as a blood test for cholesterol levels or liver function that could be available in a pharmacy.

The announcement noted that "eliminating or reducing" the number of routine visits that patients must often make to their physicians, such as checkups for certain drug therapies, would allow those physicians to spend more time with more seriously ill patients, thereby reducing the burden on the healthcare system and reducing healthcare costs.

"In some cases, a visit to a practitioner would be required for the initial prescription, but a certain number of refills could be authorized beyond those that would normally be authorized without a return visit under specialized conditions of safe use," the notice read, mentioning rescue medications such as asthma inhalers or epinephrine for allergic reactions.


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