Last week the Office of National Drug Control Policy released the Obama Administration's comprehensive action plan to address the national prescription drug abuse epidemic and announced new Federal requirements aimed at educating the medical community about proper prescribing practices.
According to the announcement, the Administration's plan, entitled Epidemic: Responding to America's Prescription Drug Abuse Crisis, is aimed at providing a national framework for reducing prescription drug diversion and abuse by:
- supporting the expansion of state-based prescription drug monitoring programs
- recommending more convenient and environmentally responsible disposal methods to remove unused medications from the home
- supporting education for patients and healthcare providers
- reducing the prevalence of pill mills and doctor shopping through enforcement efforts.
In support of the action plan, the FDA announced that it is requiring an Opioids Risk Evaluation and Mitigation Strategy (REMS) requiring manufacturers of long-acting and extended-release opioids to provide educational programs to prescribers of these medications, as well as materials prescribers can use when counseling patients about the risks and benefits of opioid use.
The new REMS plan is expected to become effective in early 2012 and focuses primarily on educating doctors about proper pain management, patient selection, and other requirements and improving patient awareness about how to use these drugs safely. As part of the plan, the FDA wants companies to give patients education materials, including a medication guide that uses consumer friendly language to explain safe use and disposal.
The new REMS plan. It will apply only to extended-release opioids known under the generic names:
- transdermal fentanyl
- transdermal buprenorphine
Although immediate-release opioids are not included in the plan, it is possible they may be added later.
The FDA will also require the risk management plan to include a way to determine if the education programs are helping to reduce problems associated with long-acting and extended-release opioids, as well as allowing patients who need opioids to get them.
If you would like to learn more about these new plans, you can:
Download and read the Administration's full Action Plan: Epidemic: Responding to America's Prescription Drug Abuse Crisis
Read the FDA's announcement regarding new opioid REMS: FDA Opioids Risk Evaluation and Mitigation Strategies (REMS)
If you are interested in my thoughts on these actions, please read: Impact Government Efforts to Reduce Prescription Drug Abuse May Have on Chronic Pain Patients
Obama Administration Releases Action Plan to Address National Prescription Drug Abuse Epidemic; Announces FDA Action Requiring Drug Makers to Develop Education Program for Prescribers About Safe Use of Opioids. Office of National Drug Control Policy. Press Release. 4/19/11.
FDA Acts to Reduce Harm from Opioid Drugs. U.S. Food and Drug Administration. 4/19/11.
Published On: April 24, 2011