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FDA seeks more stringent controls for some pain medications

Posted in FDA Regulation, Public Health

According to a recent report by HealthToday.com, The U.S. Food and Drug Administration believes certain commonly-used drugs that should be more difficult to obtain.  Painkillers such as Lortab and Vicodin contain hydrocodone (a synthetic opiate) which is often abused and highly addictive; tighter controls on these types of prescriptions may be a good way to reduce the abuse seen with these painkillers.  The FDA would like to cut in half the number of prescription refills a patient can get before seeing their doctor, thus ensuring closer monitoring of both patients’ health and pharmaceutical requirements, allowing refills only for patients who truly require the drugs.

The FDA would also like to classify all prescription medications with hydrocodone as “Schedule II” medications.  The agency will begin to make that push next month, and will also seek to require that patients take their prescriptions to a pharmacy for refills, disallowing doctors the privilege of simply phoning prescriptions in.

In order for the recommendation to be used by the U.S. Drug Enforcement Administration, the U.S. Department of Health and Human Services must first approve the recommendation, and an FDA advisory panel held a vote which resulted in favor of the reclassification of hydrocodone.

The U.S. National Institutes of Health reports that one in five Americans have used prescription drugs in a recreational manner and since 2002, and that 22 million Americans have abused prescription painkillers in some way in the course of their lives.  NIH further reports that 47 million people were issued medications containing hydrocodone, filling around 131 million prescriptions.  The new classification will mean that less hydrocodone will be prescribed, and in turn, less available to be abused.  Patients will be required to visit the doctor’s office more frequently and the addition co-pays will increase health care costs.

Classifying hydrocodone as a Schedule II drug will allow the FDA to control hydrocodone in the same manner as other strong painkillers with high potential for abuse.  This push, however, is not only related to painkillers, and the ADD/ADHD drug Adderall would also face similar regulations.  The director of the agency’s Center for Drug Evaluation and Research has come out and explained that the push for this action has been driven by epidemic levels of prescription drug abuse.  Dennis Thompson of HealthToday.com believes that while the new changes may have some difficult implications for some people, the public health concerns have reached a point where something needs to be done.  I agree.