Companies that manufacture powerful, long-acting opioid painkillers will have to sponsor education programs about how to appropriately prescribe their drugs, according to the FDA.
In the final version of the agency's risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioids, such as , it states that the education will follow a blueprint drafted by FDA and the drugmakers and will be created by medical education companies.
The strategy, which affects 20 manufacturers and 30 products, also stipulates a patient-education brochure and regular audits to make sure the physician education is having a wide enough impact.
"The FDA's goal is to ensure that healthcare professionals have the education they need to prescribe opioids and that patients have the know-how to safely use these drugs," FDA Commissioner Margaret Hamburg said during a press call.
But critics cite a number of problems with the guidance, including its reliance on industry sponsorship of education, even with middle-man medical education companies. Also, extended-release and long-acting opioid analgesics training will not be mandatory for prescribers.
Finally, the program will not cover powerful short-acting opioids such as hydrocodone (Vicodin) that have an equally high potential for abuse.
"These educational programs are likely going to do more harm than good," said Andrew Kolodny, MD, chair of psychiatry at Maimonides Medical Center in New York City. "Nowhere does it say that prescribers should tell patients these drugs are addictive. And these programs give the implied message that there's evidence for using opioids in long-term, noncancer chronic pain."
Kolodny noted that the final REMS is the same version that the advisory panel voted down 2 years ago, and called it a "jackpot for the medical education companies (MECs)." He said there are about five MECs that currently handle much of the industry-sponsored education for opioids.
Instead, Kolodny said, a better option is mandatory education that's either tied to DEA licensure or has a certification process similar to that for buprenorphine (Suboxone), an opiate and addiction treatment that requires completing an 8-hour class before physicians can prescribe it.
Gil Kerlikowske, director of the Office of National Drug Control Policy who was also on the press call, said that several pieces of legislation seek to make physician education mandatory for this class of drugs and that his office will "continue to work with Congress on this issue."
The physician education courses under the new REMS would last about 2 to 3 hours, according to John Jenkins, MD, director of the office of new drugs at the FDA's Center for Drug Evaluation and Research (CDER). They would cover how to weigh the risks and benefits of opioid therapy and how to recognize the potential for abuse and addiction.
The first courses are scheduled to be put in place by March 1, 2013, FDA said.
The REMS also involves a single-page patient medication guide that talks about safe use of the drugs as well as their proper storage and disposal.
To make sure it's having its intended reach, Hamburg said there will be regular audits of the programs to assess whether enough clinicians are completing the courses. According to the FDA, there are about 320,000 prescribers of long-acting opioid analgesics in the U.S., and the agency expects 25% of them to be trained at the end of the program's first year. The goal is to have 60% of prescribers trained by year three.
The FDA also will audit how well the participants understood the educational material, and these assessments will also check on whether the REMS is impacting patient access to necessary pain meds.
Kerlikowske said the REMS is part of a national strategy to curb the prescription painkiller epidemic, which was responsible for about 15,600 deaths in 2009, the latest year for which there are data.
About 23 million prescriptions for extended-release and long-acting opioids were written in 2011, FDA said.