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

    October 24, 2013
    Shana Norris
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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%.

Image via Free Digital Photos

  • Meanwhile

    Meanwhile the flow of heroine from Afghanistan has increased 2000 percent since we occupied their country. I find everything we do in this nation to be very very very hypocritical.

    • Shhh!!!!

      Don’t confuse people with facts.

      People think we are fighting to stop terrorism and for freedom. Truth, Justice, and the American Way. All that nonsense. They don’t want to know that Oil, Drugs, and Guns are the three biggest industries in the world and that they prosper when a War is going on.

      All Americans want to know is that we are going after the “evil doers” and “bad guys”. That is how dumb Americans are. There doesn’t need to be actual objectives. Nah. We just have to stop the “evil doers”. Then when we do and dump his body in the ocean, heck, we still keep fighting.

      Americans are idiots. No freaking common sense.

  • http://bluenilescrapdesigns.blogspot.com/ Penney Nile

    Oh, just great! It’s already to the point where doctors are scared s**less to prescribe Vicodin and other similar drug to patients who need it because they fear their license being taken away. Meanwhile, for those of us with conditions like fibromyalgia and other similar diseases are left to suffer because of the many restrictions already imposed on drugs such as these. I wish that every person at Food and Drug involved in this STUPID decision had to spend a week walking in MY shoes, to cope with the pain and the accompanying problems and see how fast things would reverse themselves. They are hurting more people than they are helping.

  • http://Webproneness.com David Lafleur

    This is a dumb move , these moves are made by people who have never struggled personally with addiction. All this will no is increase the money people have to spend and lower the number of pills in a town, causing those addicts to turn to things like HEROIN , that is much more dangerous and easier to obtain because it doesn’t require going to a doctor. If they would just make drugs like hydrocodone, oxycodone available at a pharmacy without a script,only an ID or drivers license and allow only on or two tablets a day. then the street price would drop to almost nothing and in turn there would be less drug dealers because people could go to the pharmacy and get a days supply of what they take without spending all their families money( not for a buzz but just so they don’t go into detox and stay sick. Just that little amount of two Roxie’s a day (,bought at the pharmacy using your drivers license plugged into a database to prevent the patient from visiting multiple pharmacy’s) would prevent overuse. This would stop a lot of dealers and force them to work, becoming part of the productive society. The people making the rules have never struggled with drugs, so making rules and reg’s isn’t what they should be