WASHINGTON – Prescription drug manufacturers now must develop, implement and monitor education programs for their most potent painkillers, according to a new Food and Drug Administration requirement announced Tuesday.
The new requirement is part of the Obama administration’s effort to curb abuse of oxycodone, morphine and other extended-release drugs frequently prescribed to treat chronic pain.
Abuse of these drugs reached epidemic levels in recent years, Gil Kerlikowske, director of the Office of National Drug Control Policy, said at a joint press conference with the Drug Enforcement Agency, Department of Health and Human Services, and the FDA.
Deaths caused by accidental overdoses of these drugs exceeded those from gun shots, suicides and heroin overdoses according to the most recent data from the Center for Disease Control and Prevention.
The policy is designed to educate both patients and physicians of the risks of long-acting drugs like OxyContin, which contain higher concentrations of pain-fighting opioids.
Physician education will focus on identifying signs of abuse and addiction, while patient educational materials will address safe use of the drugs.
Training the doctors prescribing these drugs is critical, said FDA Commissioner Margaret Hamburg.
But physician participation in the training program is voluntary, and oversight of the program falls in the hands of the drug companies – not the government.
Pfizer spokesman Raul Damas said his company is working with other drug companies to determine how to train health care providers, and how to monitor their participation.
Damas would not comment on the cost to implement the program, but said Pfizer actively participated in developing the plan..
“We recognize our responsibility to physicians and patients and remain committed to being part of the solution to address this important public health and safety issue,” Pfizer spokesman Raul Damas said in an email.
Brand-name and generic drug manufacturers producing these drugs received letters from the FDA in February 2009 notifying them of the implementation of a Risk Evaluation and Mitigation Strategy for long-acting opioids and soliciting their input, according to the agency’s website.
The plan also includes initiatives to increase prescription tracking at the state level, facilitating convenient disposal of expired and unused medications, and stepping up enforcement efforts.
Government agencies are working on legislation to make mandatory education a condition of DEA registration for physicians.
Manufacturers impacted by the new policy include Pfizer, Purdue Pharma L.P., Orth-McNeil-Janssen Pharmaceuticals, Inc., Mallinckrodt Pharmaceuticals (Covidien), Roxane Laboratories, Actavis, Xanodyne Pharmaceuticals, Inc., Endo Pharmaceuticals, Lavipharm Laboratories, Inc., Mylan Technologies, Inc.,Noven Pharmaceuticals, Inc., Teva Pharmaceutical Industries, Ltd., Watson Pharmaceuticals, Sandoz, Endo Pharmaceuticals, KV Pharmaceuticals and Impax Laboratories, Inc.