April 28, 2011
FDA Announces Opiod Strategy
On April 19th, 2011, the White House announced a four part prescription drug prevention plan called the “Epidemic: Responding to America’s Prescription Drug Crisis” which focuses on several key areas, including:
• 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 this action plan, the Food and Drug Administration (FDA) announced on the same day, that it would require an Opioids Risk Evaluation and Mitigation Strategy (REMS). This new program will require 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 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, FDA wants opiod manufacturers to develop patient education materials, including a medication guide that uses consumer friendly language to explain safe use and disposal. FDA has asked drug makers to work together to develop a single system for implementing the REMS strategies. In an effort to meet this goal, FDA has notified opioid manufacturers through a “post-approval REMS notification” that they are required to propose a REMS plan as a supplement to their NDA within 120 days from the date in which they receive the agency’s letter.
Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research, recently stated that this risk management strategy is designed to improve pain management, while preserving patient access to these needed medications. Doctor training, patient counseling, and other risk reduction measures developed by opioid manufacturers as part of the REMS are expected to become effective by early 2012. They will be required for various brand name products known under the generic names:
• transdermal fentanyl
• transdermal buprenorphine
Click here for the complete FDA list of long acting opiod drugs that will be a part of this REMS.
Finally, the Administration plans on working with Congress to amend the “Controlled Substance Act” to require practitioners who request DEA registration to prescribe controlled substances be trained on responsible opiod prescribing practices as a pre-condition of registration.