FDA endorses tighter controls for popular narcotic painkillers

Regs would affect prescription drugs such as Vicodin

The Food and Drug Administration on Thursday recommended tighter controls on how doctors prescribe the most commonly used narcotic painkillers, changes that are expected to take place as early as next year.

The move, which represents a major policy shift, follows a decadelong debate over whether the widely abused drugs, which contain the narcotic hydrocodone, should be controlled as tightly as more powerful painkillers such as OxyContin.

The drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller such as acetaminophen or aspirin and are sold either as generics or under brand names such as Vicodin or Lortab. Doctors use the medications to treat pain from injuries, arthritis, dental extractions and other problems.

The change would reduce the number of refills patients could get before going back to see their doctor. Patients would also be required to take a prescription to a pharmacy, rather than have a doctor call it in.

Prescription drugs account for about three-quarters of all U.S. drug overdose deaths, with the number of deaths from narcotic painkillers, or opioids, quadrupling since 1999, according to federal data. Drugs containing hydrocodone represent about 70 percent of all opioid prescriptions, and the looser rules governing them, some experts say, has contributed to their abuse.

Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said she expected the new regulations, if adopted, would take effect in 2014. The recommendation requires approval by the Department of Health and Human Services and adoption by the Drug Enforcement Administration, which has long pushed for the measure.

For years, FDA officials had rejected recommendations from the DEA and others for stronger prescribing controls on the drugs, saying the action would create undue hardships for patients. A number of doctors’ groups, including the American Medical Association and pharmacy organizations, have continued to fight the measure, citing the impact on patients.

In a phone interview, Dr. Woodcock said FDA officials were aware that changing the prescribing rules would affect patients. But she said the public health impact caused by the drugs’ abuse as well as their medical use had reached a tipping point. “These are very difficult trade-offs 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.”

The new regulations would reduce by half, to 90 days, the supply of the drug a patient could obtain without a new prescription. A patient now can refill a prescription for such drugs five times over a six-month period before needing a new prescription. Federal data suggest that most patients take such medications for only 14 days, creating the potential for excess pills to be sold or taken out of medicine chests by curious teenagers and others.

The FDA recommendation is likely to have a significant impact on drugs’ availability as well as on how pharmacies operate and even which medical professionals can prescribe the medications.

In 2011, about 131 million prescriptions for hydro-codone-medications were written for about 47 million patients, according to government estimates. That amounts to about 5 billion pills.

Technically, the change involves reclassification of hydrocodone- containing painkillers as Schedule II medications from their current classification as Schedule III drugs. The scheduling system, overseen by the Drug Enforcement Administration, classifies drugs based on their medical use and potential for abuse and addiction.

Schedule II drugs are those drugs with the highest potential for abuse that can be legally prescribed. They include painkillers such as oxycodone — the active ingredient in OxyContin — methadone and fentanyl, as well as Adderall and Ritalin, which are prescribed for attention deficit hyperactivity disorder.

The question of whether to tighten prescribing controls over hydrocodone-containing drugs has been the subject of intense lobbying. Last year, lobbyists for druggists and chain pharmacies mobilized to derail a measure the Senate passed that would mandate such restrictions as the FDA is now recommending.