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
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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)