The Food and Drug Administration on Thursday recommended tighter controls on how doctors prescribe the most commonly used narcotic painkillers.
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 such as OxyContin.
Enough prescription painkillers were prescribed in 2010 to medicate every American adult around-the-clock for one month, the Centers for Disease Control and Prevention reports.
In Nebraska, 4.2 kilograms of painkillers were sold for every 10,000 people. In Iowa, it was 4.6 kilograms per 10,000 people. The national average is 4.8.
Nebraska and Iowa have the lowest rates of painkiller overdose deaths among states in the nation, at 5.5 and 7.1 deaths per 100,000 residents, respectively.
Changes at a glance
The new rules would reduce the number of refills for patients. Patients could receive up to 90 days worth of medication before needing to go see their doctor again, instead of the current 180 days.
Patients would also be required to take a prescription to a pharmacy, rather than have a doctor call it in.
The drugs in question 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 a patient could get before returning to be seen by his or her doctor. A patient would also be required to take a prescription to a pharmacy rather than have a doctor call it in.
Dr. Janet Woodcock, director of the agency’s center for drug evaluation and research, said she expected that 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, which has been pushing for the measure.
For years, FDA officials had rejected recommendations from the DEA and others for stronger prescribing controls as a way to curb abuse of the drugs, saying that the action would create undue hardships for patients.
A number of doctor groups, including the American Medical Association and pharmacy organizations, have continued to fight the measure, citing the impact on patients.
Woodcock said 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.
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.
“These are very difficult tradeoffs 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 overdoses involving prescription painkillers as a result of a boom in the use of such 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.
The FDA recommendation could have a significant impact on the availability of the drugs.
In 2011, about 131 million prescriptions for hydrocodone-containing medications were written for some 47 million patients, according to government estimates. That volume of prescriptions amounts to about 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, which is overseen by the DEA, 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.
The group includes painkillers such as oxycodone, the active ingredient in OxyContin, methadone and fentanyl, as well as medications like 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 FDA is now recommending.
At the time, the lobbying arm of the American Cancer Society also said that making patients see doctors more often to get prescriptions would impose added burdens and costs on them.
Sen. Joe Manchin, D-W.Va., expressed dismay when the proposal died in the House.
“They got their victory — but not at my expense,” said Manchin, whose state has been hit hard by prescription drug abuse. “The people who will pay the price are the young boys and girls in communities across this nation.”
Woodcock said that requiring patients with long-lasting pain to see a doctor after three months, rather than six, to get a new prescription could benefit them.
“If you are needing chronic therapy of this magnitude, you should be seeing your prescriber,” she said.
This year, an expert advisory panel to the FDA voted 19-10 in favor of reclassifying hydrocodone-containing painkillers as Schedule II drugs. Though such recommendations are not binding, the agency often follows them.
Along with changing how doctors prescribe these drugs, the classification change will impose added storage and recordkeeping 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.