National plan to reduce prescription drug abuse includes opioid REMS

Last week, the White House Office of National Drug Control Policy (ONDCP), U.S. Department of Health and Human Services, FDA, and DEA released the Obama administration’s comprehensive action plan to address the national prescription drug abuse epidemic, “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.” The plan provides a national framework for reducing prescription drug diversion and abuse by focusing on education, prescription drug monitoring programs, medication disposal, and enforcement on pill mills and doctor shopping.

Marcie Bough, our Senior Director of Government Affairs, attended the press conference on April 19 during which ONCDP also announced efforts to pursue legislation to amend the Controlled Substances Act by requiring prescriber education upon DEA registration and reregistration. We should expect to see such legislation introduced in a month or so.

As part of this coordinated intergovernmental effort, FDA also announced the final Risk Evaluation and Mitigation Strategies (REMS) for long-acting and extended-release opioid medications as one step in addressing prescription drug abuse and better ensuring safe use of opioids. FDA expects the REMS to become effective in 2012.

The opioid REMS will require manufacturer-developed prescriber education that addresses proper pain management, patient selection and education, and information on proper storage and disposal; Medication Guides for patients; and assessment of prescriber education and patient access. The prescriber education component will be voluntary at this time. A future mandatory hook is tied to DEA registration.

FDA had reached out to us in advance of the announcement to provide us with some background. I was pleased to join Marcie on that call with FDA Center for Drug Evaluation and Research (CDER) Deputy Director Doug Throckmorton, MD. He focused on how REMS fits into the overall action plan, which we support. He specifically expressed FDA’s appreciation for all the work that APhA has done on the REMS issue and in helping FDA better understand the impact of REMS on pharmacy. Marcie does a nice job of managing this relationship.

On a final note, FDA also held a stakeholder call to further discuss the REMS. When asked by a caller about the REMS not requiring pharmacist education, Marcie reports that CDER Director Janet Woodcock, MD, said that at FDA they already think that pharmacists are the most educated on these medications and that this program is focused on the prescribers. Then she said that FDA fully supports the role of pharmacists in counseling patients and in discussing proper storage and disposal of all medications. This was a good plug for pharmacists!