WASHINGTON – Physicians who prescribe extended-release opioid prescription drugs may be required to undergo training before obtaining or renewing their registration with the Drug Enforcement Agency, according to new policies announced April 19 by the White House Office of National Drug Control Policy and the Food and Drug Administration.
The FDA announced that it will require the 16 prescription drug manufacturers that sell long-acting or extended-release opioids to provide educational materials for physicians and patients regarding the risks of opioid drug use.
The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program would require prescribers to learn how to identify appropriate patients, how to monitor patients and how to counsel them on safe use of opioids, and the risks and benefits of opioid therapy. Prescribers would also be trained on how to recognize opioid abuse and addiction.
"We feel the prescribers are really critical in managing this," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press briefing. She acknowledged, however, that there could be a burden for both drug makers and physicians. "This is in some ways the most far-reaching REMS program the FDA has instituted," she said.
Dr. Woodcock said the program would not interfere with access to the drugs for patients with legitimate needs but defended the program’s necessity.
She cited data that the number of Americans in 2009 aged 12 and older abusing pain relievers has increased by 20% since 2002—from 29 million to 37 million. The long-acting forms are complex and present more risk than short-acting formulations, said Dr. Woodcock. There were 12,000 overdose deaths from prescription pain relievers in 2009, she said.
Prescription drugs are the second-most abused category of drugs after marijuana, according to a 2009 study on illicit drug use in teens by the University of Michigan. Drug-induced deaths are second only to motor vehicle fatalities, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.
The FDA says it has given drug manufacturers 120 days to develop educational materials for the agency to review. The aim is for the programs to be administered by organizations that conduct continuing medical education. The agency plans to have the REMS in place by early 2012, said Dr. Woodcock.
Prescriber training is essential to combat prescription drug abuse, said Dr. Howard Koh, assistant secretary for the Department of Health and Human Services, at a press briefing.
"As a physician who has spent over 30 years caring for patients, I am also very aware that we physicians and we providers have had too little opportunity for education on proper prescribing and dispensing of opioid medication," Dr. Koh said, adding that the plan provides an opportunity for early prevention instead of belated treatment.
The administration’s plan, known as Epidemic: Responding to America’s Prescription Drug Abuse Crisis, also includes state-based drug-monitoring programs, environmentally responsible at-home drug disposal, and enforcement efforts to reduce pill mills and "doctor shopping." In addition, the Office of National Drug Control Policy is requesting an increase in funding of $123 million for drug prevention and $99 million for treatment programs for fiscal year 2012.
As a part of the plan, the DEA will be working "to reduce doctor shopping, to aggressively shut down pill mills and to investigate those who abuse their responsibilities as medical professionals, violate the controlled substances act and break their pledge to the public to do no harm," said DEA administrator Michele Leonhart at the press conference.
Opioids included in the REMS plan include methadone (Dolophine); the morphine formulations MS Contin, Kadian, Avinza, Embeda, and Oramorph; oxycodone (OxyContin); hydromorphone (Exalgo); transdermal fentanyl (Duragesic); buprenorphine (Butrans);, and oxymorphone (Opana ER). Short-acting formulations are not covered but could eventually fall under this policy, said Dr. Woodcock.