F.D.A. Seeks Tighter Control on Prescriptions for Class of Painkillers

    October 24, 2013

On Thursday, the Food and Drug Administration recommended significantly tighter controls on how doctors prescribe commonly used painkillers such as Vicodin and Lortab.

The recommendation comes amidst growing concern over abuse of prescription painkillers. It’s a debate that has raged for almost a decade, and the most recent measures focus on drugs containing the narcotic hydrocodone in combination with over-the-counter painkillers such as acetamenophin and aspirin.

The proposed changes would reduce the number of refills patients could get before needing to go back to their doctor for a new prescription. Currently, patients can refill prescriptions for this class of drugs five times over a period of six months. The new regulations would reduce that amount of time by half, to 90 days.

Additionally, these prescriptions could no longer be called in to pharmacies by doctors. Patients would be required to actually take the physical prescription to their pharmacy.

The new restrictions would come about due to a reclassification of painkillers containing hydrocodone. They are currently classified as “Schedule III” drugs. Under the new regulations, they would be “Schedule II,” a classification reserved for drugs with the highest potential for abuse that can be legally prescribed.

The more powerful painkiller oxycodone is already a Schedule II drug, as are medications such as Adderall and Ritalin.

Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, says the new regulations could take effect as soon as early 2014.

Detractors claim the new regulations will make it difficult for patients in need of painkillers to obtain the drugs they need. They cite the added trouble and expense involved with more frequent doctor visits. Doctors’ and pharmacy organizations, such as the American Medical Association, have long fought against Drug Enforcement Agency recommendations for heightened controls on these drugs. According to a statement on the FDA’s website, the DEA originally asked for this reclassification in 2009.

Robert Twillman is Director of Advocacy and Policy for the American Academy of Pain Management: “The concern we have is that it may unintentionally make access for people with pain even more of a challenge than it is now. This could necessitate millions more office visits, with attendant costs approaching a billion dollars a year.”

But Dr. Woodcock and other supporters of the increased controls believe it’s a risk we have to take in order to curb the widespread abuse of prescription painkillers.

“These are very difficult tradeoffs that our society has to make,” she said. “The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.”

According to the Centers for Disease Control, nearly three out of four prescription drug overdoses are caused by prescription painkillers. More of these overdoses occur in men than in women, but alarming statistics show that the gap is closing. The percentage increase in deaths from prescription painkiller overdose among women increased 400% in the past decade, while for men that rate was 265%.

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