March 21, 2012
Kiosks may soon dispense a variety of prescription drugs after first allowing consumers to self-diagnose ailments for specific conditions through an algorithm-based survey on a kiosk. The U.S. Food and Drug Administration is considering the process this week in public hearings, where consumers may weigh in on potential benefits and costs.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), prescription drugs are deemed not safe for use except under the supervision of a practitioner licensed by law to administer the drug, making it only dispensable via a physician, nurse practitioner or physician assistant. Non-prescription drugs fall under a second category that don't meet the statutory criteria for prescription products and are considered safe and effective for use in self-diagnosis or self-medication as directed in the product's labeling.
Where the kiosk comes in
Under the potential new program, the FDA would create a third category of approved drugs, those that would generally require a prescription, but that the agency will allow to be distributed on a non-prescription basis when used consistent with product-specific conditions of safe use. That includes the consumer's use of a kiosk.
"FDA is aware that industry is developing new technologies that consumers could use to self-screen for a particular disease or condition and determine whether a particular medication is appropriate for them," the notice states. "For example, kiosks or other technological aids in pharmacies or on the Internet could lead consumers through an algorithm for a particular drug product."
It goes on to say that 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. In addition, for some drug products that require an initial prescription, the product could be made available as a nonprescription product with a condition of safe use for the purpose of product refills.
Read more about kiosks in health care settings.
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