Extended-release/long-acting opioid REMS may fill the need for prescribers' appropriate use education

Susan C. Nicholson, MD; Kimberly Evanyo, BA; Gregory D. Salinas, PhD; Nancy Roepke, MBA; B. Stephen Burton, MS; Debi Susalka, BS

doi:10.5055/jom.2012.0118

Authors

Susan C. Nicholson, MD
Kimberly Evanyo, BA
Gregory D. Salinas, PhD
Nancy Roepke, MBA
B. Stephen Burton, MS
Debi Susalka, BS

DOI:

https://doi.org/10.5055/jom.2012.0118

Keywords:

REMS, opioids, pain treatment information

Abstract

The Food and Drug Administration (FDA) is requiring manufacturers of long-acting and extended-release opioids to have a class-wide Risk Evaluation and Mitigation Strategy (REMS). The comprehensive risk management plan will include training for prescribers on the appropriate and safe use of these pain medications. The letter dated April 19, 2011 from FDA to manufacturers outlining the REMS requirements describes voluntary training that should be certified education “where practicable.” The current report includes data from a recent comprehensive study of healthcare professionals and patients and highlights key insights that can guide the development of the opioid REMS training.

Author Biographies

Susan C. Nicholson, MD

Janssen Scientific Affairs, LLC, Titusville, New Jersey

Kimberly Evanyo, BA

Janssen Scientific Affairs, LLC, Titusville, New Jersey

Gregory D. Salinas, PhD

CE Outcomes, LLC, Birmingham, Alabama

Nancy Roepke, MBA

CE Outcomes, LLC, Birmingham, Alabama

B. Stephen Burton, MS

CE Outcomes, LLC, Birmingham, Alabama

Debi Susalka, BS

CE Outcomes, LLC, Birmingham, Alabama

References

US Department of Health and Human Services, Food and Drug Administration: Opioid REMS Meeting Invitation Template. Available at http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM163652.pdf. Accessed January 18, 2012.

US Department of Health and Human Services, Food and Drug Administration: Letter sent to opioid manufacturers outlining opioid REMS implementation. Available at http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM251595.pdf. Accessed January 18, 2012.

US Department of Health and Human Services, Food and Drug Administration: List of long-acting and extended-release opioid products required to have an opioid REMS. Available at www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251735.htm. Accessed January 18, 2012.

Accreditation Council for Continuing Medical Education: ACCME standards for commercial support: Standards to ensure the independence of CME activities. Available at http://cme.med.miami.edu/documents/scs.pdf. Accessed January 26, 2012.

Salinas GD, Susalka D, Burton BS, et al.: Risk assessment and counseling behaviors of healthcare professionals managing patients with chronic pain: A national multi-faceted assessment of physicians, pharmacists, and their patients. J Opioid Manage. 2012 (in press).