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FDA Wants Tighter Controls on Some Prescription Painkillers

Update Date: Oct 25, 2013 10:24 AM EDT

With prescription drug abuse on the rise, regulating and monitoring this group of drugs is important. The U.S. Food and Drug Administration (FDA) has acknowledged this problem by recommending tighter controls for prescription painkillers that have the ingredient, hydrocodone. The FDA announced that by mid-December, it will ask for a reclassification of these types of painkillers, which include Vicodin and Lortba. The FDA hopes to group painkillers with hydrocodone under "Schedule II" medications.

If these painkillers do get reclassified, they will be subjected to stricter controls. "Schedule II" drugs, such as OcyContin, methadone, Adderall and Ritalin, are considered to have a high potential for abuse. Some of the changes include reducing the number of refills and directly taking prescriptions into the pharmacy as opposed to having a doctor call it in. Currently, patients who are prescribed painkillers with hydrocodone can refill their prescriptions five times within a six-month period. The new guidelines will force patients to see their doctors after three months in order to get a new prescription.

"This decision will mean there will be far less hydrocodone prescribed, and far less of it diverted [for abuse]," Dr. Lynn Webster, president of the American Academy of Pain Medicine, said according to HealthDay. "There will be an increase in health care costs due to more frequent office visits and co-pays, but it will take a bite out of the prescription drug crisis. We can't have status quo. We can't be doing what we have been doing for the last two decades."

"There's no question that these are important changes in the right direction. The FDA plays a critical role in helping to reduce the toll that this epidemic has taken. The clinical community and public health community will welcome these changes," said Dr. G. Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins School of Public Health in Baltimore. "The bottom line is these kind of complex policies are often hard to predict. They can have both intended or unintended consequences."

According to the U.S. National Institutes of Health, around one in every five Americans has used prescription drugs for non-medical reasons. Since 2002, around 22 million Americans have abused prescription painkillers. Before any changes are put into effect, the FDA's recommendation needs to be approved by the U.S. Department of Health and Human Services. If the agency approves it, the U.S. Drug Enforcement (DEA) will adopt the new guidelines.

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