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 like OxyContin.
The drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller like 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 drug overdose deaths in the United States, 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.
Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said she expected the new regulations, if adopted, to go into effect in 2014. The recommendation requires the approval of 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 that 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 telephone interview, Woodcock said that FDA officials were aware that changing the prescribing rules would affect patients. She said, however, that the impact on public health caused by the abuse of the drugs 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.”