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FDA’s Proposed “Safe-Use” Designation A Cause for Concern?

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By 2014, if the Affordable Care Act survives its Constitutional test, the U.S. Food and Drug Administration (FDA) may have the ability to apply a “safe-use” designation for some medicines, essentially making those meds available over-the-counter. Pharmacists would be able to dispense some medications to Americans who previously did not have health insurance, without prescriptions. This situation already exists in Arkansas in the case of certain medications where pharmacists are able to issue medications without prescription by a physician.

May 7, 2012, was the deadline for the public and interested parties to submit comments on a Notice that appeared in the Federal Register in February 2012. The FDA has yet to propose specific regulations that would create the “safe use” over-the-counter drug classification, however. The American Medical Association (AMA) and other medical societies are extremely concerned that the safe-use designation may constitute the erosion of physician authority in the area of prescribing medications for patients.

To date there have only been two types of medications available to patients, those prescribed by a physician and the over-the-counter medicines available without a prescription with which a patient is believed to be able to safely treat themselves. The safe-use designation would create a third type of medicines and might require a patient to perform some kind of requirements (i.e., blood test) or could mean that a pharmacist might be required to verify whether a patient had a certain condition requiring the medicine before the medicine could be dispensed. The pharmacist would then be required to decide whether the patient had any contraindications or risk factors that would prevent them from taking the particular “safe-use” medication.

Representatives of the American Medical Association (AMA) and the American College of Allergy, Asthma and Immunology (ACAAI) have gone on record objecting to the proposed new safe-use class of medications. Roland Goertz, MD, president of the American Academy of Family Physicians (AAFP), stated that the safe-use designation where pharmacists dispensed medications without a patient having to see a doctor first, “could seriously compromise the physician's ability to coordinate the care of multiple problems of many patients.”[1]

Health insurers reportedly have tentatively "approved" of the measure. Without proper safeguards, there is some concern that patients may obtain drugs that they may not need. The insurers also would have to determine how to cover drugs that fell into this category. Additionally, the health insurers were in favor of "expanding access" to helpful medications.

Because pharmacists are more easily accessible than physicians who require appointments for frequently costly office visits, the FDA believes that the “safe-use” designation may benefit many Americans who presently go untreated with legitimate medical needs. Doubtless the collection of comments and the promulgation of a new regulation on safe-use medicines by FDA (requiring additional debate) will cause more lines to be drawn in the sand of looming health issues. Is this the wave of the future for certain medications? Much of it makes sense, and ultimately would save money by preventing potentially unnecessary doctors' visits. What are the unintended consequences?

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[1] “Pharmacists Dispensing without Rx is Scary Say Medical Societies”, Lowes, Robert, MedScape, May 2, 2012, http://www.medscape.com/viewarticle/763179