Stepped up measures to tack rising painkiller abuse

By Dr. Ananya Mandal, MDApr 20 2011

Prescription drug abuse is one of the largest problems in the country say experts and according to White House drug Czar Gil Kerlikowske, the Congress must require special training for doctors and other health care workers before they are allowed to prescribe powerful drugs such as OxyContin.

Prescription drug abuse has become a serious concern in recent years and was the second-biggest reason behind accidental deaths in 2007. FDA estimates that more than 33 million Americans age 12 and older misused extended-release and long-acting opioids during 2007, up from 29 million just five years earlier. According to Centers for Disease Control and Prevention data, opioid overdose killed far more people than overdose of street drugs like cocaine and heroin.

The Obama administration's Prescription Drug Abuse Prevention Plan aims to do just that. It calls on the Congress to amend the Controlled Substances Act with a new requirement that health care practitioners learn appropriate uses for opioid medicines and how to screen patients for drug abuse before they can get a Drug Enforcement Administration license to prescribe controlled substances. Many opioids that are prescribed for pain can be highly addictive.

The DEA, Food and Drug Administration and the Department of Health and Human Services endorsed the plan. When prescription drugs are abused, “they can be just as dangerous as street drugs,” DEA Administrator Michele Leonhart said. “I do believe you'll see great interest from members of Congress.” Rep. Mary Bono Mack, a California Republican, held a hearing April 14 on prescription drug abuse and has introduced legislation to tighten FDA classifications for the use of opioids. She is reviewing testimony from the hearing to determine whether to propose additional legislation, spokesman Cort Bush said.

Prescription drug abuse is “an alarming public health crisis” that is “suffocating our society,” HHS Assistant Secretary Howard Koh said. “I'm here to pledge the full power of HHS behind the plan.” The FDA also announced Tuesday that drug manufacturers need to create educational materials about their opioid painkillers. Independent medical educators will use the materials to teach doctors how to properly prescribe them, the FDA said. Extended-release and long-acting opioids, including OxyContin and 11 other painkillers, are widely mis-prescribed, misused and abused, FDA Commissioner Margaret Hamburg said. The U.S. Food and Drug Administration has also sent letters to drug makers manufacturing opioids to this effect.

Drugs that require the new educational guidelines include Johnson & Johnson's Duragesic, Pfizer Inc unit King Pharma's Avinza and Embeda, Actavis' Kadian and Endo Pharmaceuticals' Opana ER. The list also includes some generic opioid drugs made by Mylan, Teva Pharmaceutical Industries, Watson Pharmaceuticals, Novartis unit Sandoz, KV Pharmaceuticals and Impax Laboratories.

American Medical Association President Cecil Wilson added that his organization supports the intent of the drug abuse prevention plan but is concerned “that a key element of this strategy that relies on industry to develop educational materials and initiatives to train prescribers could in the future become a mandatory part of the DEA registration process for prescribing controlled substances.”

Kerlikowske, director of the White House Office of National Drug Control Policy, added that he wants every state to adopt prescription drug monitoring programs, which allow a prescriber to tap into a database to see whether a patient has several narcotic prescriptions. Thirty-five states have such databases now. The federal government cannot require states to create them but offers grants to encourage state participation.

The drug makers have 120 days to propose a plan for their drugs. FDA will be getting back to drug makers within 120 days of the plan submission. Doctor training, patient counseling, and other risk reduction measures developed by opioid makers as part of the plans, known as risk evaluation and mitigation strategies or REMS, are expected to become effective by early 2012.