F.D.A. Urging a Tighter Rein on Painkillers

Published: October 24, 2013 
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 decade-long 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 like 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 a huge share — about 70 percent — of all opioid prescriptions, and the looser rules governing them, some experts say, have contributed to their abuse.  Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said she expected the new regulations 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, F.D.A. officials had rejected recommendations from the D.E.A. 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 telephone interview, Dr. Woodcock said that F.D.A. 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.” 
The new regulations would reduce by half, to 90 days, the supply of the drug a patient could obtain without a new prescription.  Currently, a patient 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 to be taken out of medicine chests by curious teenagers and others.  The F.D.A. recommendation is likely to have a significant impact on the availability of the drugs, as well as on how pharmacies operate and even the types of medical professionals who can prescribe the medications. 
In 2011, about 131 million prescriptions for hydrocodone-containing medications were written for about 47 million patients, according to government estimates. That amounts to about five 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, which is overseen by the Drug Enforcement Administration, classifies drugs based on their medical use and their 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 like oxycodone — the active ingredient in OxyContin — methadone and fentanyl, as well as Adderall and Ritalin, which are prescribed for attention deficit hyperactivity disorder.  In recent years, the question of whether to tighten prescribing controls over hydrocodone-containing drugs has been the subject of intense lobbying.  Last year, for example, lobbyists for druggists and chain pharmacies mobilized to derail a measure passed in the Senate that would mandate the types of restrictions that the F.D.A. is now recommending.  At the time, the lobbying arm of the American Cancer Society said that making patients see doctors more often to get prescriptions would impose added burdens and costs on them.  Senator Joe Manchin III, Democrat of West Virginia, expressed dismay when the proposal died in the House of Representatives. 
“They got their victory — but not at my expense,” said Mr. Manchin, whose state has been hard hit by prescription drug abuse. “The people who will pay the price are the young boys and girls in communities across this nation.” 
Dr. Woodcock, of the F.D.A., said that requiring patients with long-lasting pain to see a doctor after three months, rather than six, for a new prescription could benefit them. “If you are needing chronic therapy of this magnitude,” she said, “you should be seeing your prescriber.”  A D.E.A. spokeswoman, Barbara Carreno, said that agency officials would not comment on the agency’s recommendation.  One of the trade groups that opposed the change, the National Community Pharmacists Association, said in a statement on Thursday that the move would “likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain.” 
Penney Cowan, the executive director of the American Chronic Pain Association, an advocacy group, said she believed that drugs like Vicodin should be only one part of a treatment program for patients with long-term pain. But she added that the new rules could make it harder for some patients to find doctors to prescribe the drugs or pharmacies to fill the prescriptions. 
“We are hearing from more and more people having difficulty finding access to care,” Ms. Cowan said. 
Earlier this year, an expert advisory panel to the F.D.A. voted 19 to 10 in favor of reclassifying hydrocodone-containing painkillers as Schedule II drugs. While such recommendations are not binding, the agency often follows them.  Along with changing how doctors prescribe these drugs, the classification change would also impose added storage and record-keeping requirements on druggists. In some states, nurse practitioners and other health care professionals who can currently prescribe hydrocodone-containing drugs may no longer be able to do so.