Rehabilitating Opioid Regulation: A Prescription for the FDA's Next Proposal of an Opioid Risk Evaluation and Mitigation Strategy (REMS)

Health Matrix: The Journal of Law-Medicine, Dec 2012

By Hilary Homenko, Published on 01/01/12

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Rehabilitating Opioid Regulation: A Prescription for the FDA's Next Proposal of an Opioid Risk Evaluation and Mitigation Strategy (REMS)

Rehabilitating Opioid Regulation: A Prescription for the FDA's Next Proposal of an Opioid Risk Evaluation and Mitigation Strateg y (REMS) Hilary Homenko 0 1 0 Hilary Homenko, Rehabilitating Opioid Regulation: A Prescription for the FDA's Next Proposal of an Opioid Risk Evaluation and Mitigation Strategy (REMS), 22 Health Matrix 273 (2012) Available at: https://scholarlycommons.law.case.edu/healthmatrix/vol22/iss1/10 1 Thi s Note is brought to you for free and open access by the Student Journals at Case Western Reserve University School of Law Scholarly Commons. It has been accepted for inclusion in Health Matrix: The J ournal of Law-Medicine by an authorized administrator of Case Western Reserve University School of Law Scholarly Commons - REGULATION: A PRESCRIPTION FOR THE FDA’S NEXT PROPOSAL OF AN OPIOID RISK EVALUATION AND MITIGATION STRATEGY (REMS) Hilary Homenko† “We are going to need to find a balance between ensuring patients can achieve adequate pain control with access to opioid therapies while taking steps to protect against addiction and death.”1 “FDA is not going to be able to do this alone.”2 TABLE OF CONTENTS Introduction ...................................................................................274 I. Problems Endemic to Opioid Use ..............................................277 A. Abuse and Misuse by Chronic and Acute Pain Patients......277 1. Early Opioid Regulation ...............................................277 3. Clinical Origins of Opioid Abuse and Misuse ..............279 4. Potential Magnitude of Opioid Abuse and Misuse .......281 5. Financial Impact of Opioid Abuse and Misuse.............283 B. Opioid Diversion .................................................................285 C. Undertreatment of Pain........................................................286 II. Changes to FDA Authority ........................................................288 A. FDA Authority Prior to the FDAAA ...................................288 B. FDA Authority After the FDAAA.......................................290 1. General Overview of REMS Content ...........................290 2. Initial Opioid REMS Proposal ......................................294 III. Opioid REMS: Learning from the Past and Identifying Future Opportunities ..................................................................296 A. Lessons From Initial Opioid REMS Proposal .....................296 1. Voluntary Prescriber Training ......................................296 2. Public Education ...........................................................299 3. Drug Diversion..............................................................300 4. Data Collection .............................................................301 5. Pilot Study.....................................................................302 B. Opportunities Under the FDAAA........................................303 1. Certification ..................................................................303 2. Dispensing Locations ....................................................305 3. Patient Monitoring ........................................................305 4. Drug Registries .............................................................307 IV. Recommended Strategy for the FDA and State Medical Boards ...................................................................................308 A. Training Program.................................................................308 B. State-Enforced Training Requirement.................................310 C. Data Sharing ........................................................................311 D. Other Recommendations .....................................................312 Conclusion ........................................................................................312 INTRODUCTION Abuse and dependence on prescription pain relievers has reached epidemic proportions in the United States.3 In 2010, a study published by the Substance Abuse and Mental Health Services Administration estimated that 5.1 million persons, aged twelve or older, use prescription pain relievers non-medically.4 Within this population, approximately 1.9 million persons have dependence on or abuse prescription pain relievers.5 While prescription pain relievers, commonly 3 See Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings, SAMHSA.GOV, 1 (Sept. 2011), http://oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf. 4 Id. at 12. 5 Id. at 70. referred to as opioids, effectively reduce chronic and acute pain, no one seems spared from the health risks associated with them.6 Between 1998 and 2008, the percentage of hospital admissions involving opioid abuse increased by 7.6 percent, with significant increases across every age cohort and racial category.7 In 2007, Congress passed the Food and Drug Administration Amendment Act (FDAAA), which gave the U.S. Food and Drug Administration (FDA) greater (...truncated)


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Hilary Homenko. Rehabilitating Opioid Regulation: A Prescription for the FDA's Next Proposal of an Opioid Risk Evaluation and Mitigation Strategy (REMS), Health Matrix: The Journal of Law-Medicine, 2012, pp. 273, Volume 22, Issue 1,