Blog | Monday, July 16, 2012

QD: News Every Day--FDA eyes mandatory opioid training for prescribers, pushes voluntary education for now

New FDA policies on opioid prescribing seek continuing education, and eventually, mandatory training, for prescribers of opioids, the agency announced.

Training will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of opioids. Education will include information on how to recognize evidence of, and the potential for, opioid misuse, abuse, and addiction, and general and specific drug information for opioids.

It is expected that the first continuing education activities will be offered to prescribers by March 1, 2013. It can't come too soon for some internists, who often feel out of their depth when managing patients on opioids, a poll shows.

There is no mandatory requirement that prescribers take the training and no precondition to prescribing opioids to patients, for now. However, the Obama Administration endorsed a mandatory training program on responsible opioid prescribing practices in April 2011 as part of its comprehensive plan to address the epidemic of prescription drug abuse, the FDA said. The program, which would be linked to DEA registration by providers, would require legislative changes that are being pursued by the current presidential administration.

Until the legislation passes, the FDA will require companies to offer training to prescribers and assess how many participate. Companies will meet this obligation by providing educational grants to continuing education providers, who will develop and deliver the training.

The move is an attempt to address the rising rates of opioid prescribing, and the problems that occur. There were an estimated 22.9 million prescriptions dispensed in 2011, according to IMS Health, which provides services and information to the health care and pharmaceutical industries. It is estimated that more than 320,000 prescribers registered with the Drug Enforcement Administration wrote at least one prescription for opioids in 2011.

Mortality from opioids continues to rise. According to the Centers for Disease Control and Prevention, 14,800 Americans died from overdoses involving opioids in 2008. In 2009, there were 15,597 deaths involving these medications, nearly four times as many deaths compared to 1999.

More than 30% of prescription painkiller deaths involve methadone, even though only 2% of painkiller prescriptions are for it, the government reported earlier this year.

Other FDA requirements include updated patient information guides and requirement that drug makers achieve FDA-established goals for the percentage of opioid prescribers who complete the training, as well as assess prescribers' understanding of important risk information over time. The assessments also covers whether the REMS is adversely affecting patient access to necessary pain medications, which manufacturers must report to FDA as part of periodic required assessments.

More tips on safe and efficient opiate prescribing practices are available in the June issue of ACP Internist.