The Food and Drug Administration (FDA) on Thursday recommended tighter controls on how doctors prescribe the most commonly used narcotic painkillers.
The change would reduce the number of refills patients could get before going back to see their doctor. Patients also would be required to take a prescription to a pharmacy, rather than have a doctor call it in.
The move is after 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 like acetaminophen or aspirin and are sold either as generics or under such brand names as Vicodin or Lortab. Doctors use the medications to treat pain from injuries, arthritis, dental extractions and other problems.
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Dr. Janet Woodcock, director of the agency’s center for drug evaluation and research, said the new regulations could take effect as early as next year. The recommendation requires the approval of the Department of Health and Human Services and adoption by the Drug Enforcement Administration (DEA), which has been pushing for the measure.
For years, FDA officials had rejected stronger prescribing controls as a way to curb drug abuse, saying the action would create undue hardships for patients.
A number of doctors’ groups, including the American Medical Association (AMA) and pharmacy organizations, have continued to fight the measure, citing the impact on patients.
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.
“These are very difficult trade-offs that our society has to make,” Woodcock said. “The reason we approve these drugs is for people in pain, but we can’t ignore the epidemic on the other side.”
Concerns continue about the huge number of painkiller overdoses as a result of a boom in the use of prescription drugs over the past decade. Drugs containing hydrocodone frequently make their way onto the street, in part because they are easier to obtain than other narcotics. In 2011, 131 million prescriptions for hydrocodone-containing medications were written for 47 million patients, according to government estimates. That amounts to 5 billion pills.
Technically, the change involves the reclassification of hydrocodone-containing painkillers as “Schedule II” medications from their current classification as “Schedule III” drugs.
The scheduling system, overseen by the DEA, classifies drugs based on their medical use and their potential for abuse and addiction.
Schedule II drugs are those with the highest potential for abuse that can be legally prescribed. The group includes such painkillers as oxycodone, the active ingredient in OxyContin, methadone and fentanyl as well as medications like Adderall and Ritalin, prescribed for attention-deficit hyperactivity disorder, or ADHD.
Along with changing how doctors prescribe these drugs, the classification change will impose added storage and record-keeping requirements on druggists.
In some states, nurse practitioners and other health-care professionals who now can prescribe hydrocodone-containing drugs may no longer be able to do so.