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Kathryn Duensing,1 Robert Twillman,1– 3 Stephen Ziegler,4,5 M Soledad Cepeda,6 David Kern,6 Maribel Salas,7,8 Gregory Wedin9 1RKT Consulting, LLC, Lenexa, KS, USA; 2Behavioral Health Section, Saint Luke’s Health System, Kansas City, MO, USA; 3Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine, Kansas City, KS, USA; 4Center for Effective Regulatory Policy and Safe Access, Denver, CO, USA; 5College of Professional Studies, Purdue University, Fort Wayne, IN, USA; 6Department of Epidemiology, Janssen Research & Development, Titusville, NJ, USA; 7Department of Epidemiology, Clinical Safety and Pharmacovigilance, Daiichi Sankyo, Basking Ridge, NJ, USA; 8University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA; 9Upsher-Smith Laboratories, LLC, Pharmacovigilance and Risk Management, Maple Grove, MN, USACorrespondence: Robert TwillmanSaint Luke’s Health System, Kansas City, MO, USATel +1 913-205-3746Email Bob.Twillman@gmail.comIntroduction: Opioid overdose deaths in the United States have climbed sharply over the past two decades. Simultaneously, increased awareness of inadequately treated chronic pain has resulted in increased opioid analgesic prescribing. The correlation between these two phenomena has led policymakers to posit that they are causally linked, and to implement policy changes supporting safe opioid prescribing.Purpose: To evaluate the impact of its Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program, the US Food and Drug Administration (FDA) requested the opioid manufacturers responsible for implementing that program provide information regarding opioid policy changes from 2016 to 2018. FDA also requested a survey of state requirements for pain and opioid prescribing continuing education (CE), the number of prescribers affected by those requirements, the extent to which a REMS-compliant CE program would meet each state’s requirements, and the number of relevant CE programs available.Results: Results indicate that 527 federal and state opioid-related policies (statutes, rules/regulations, and guidelines) were approved during the 2016– 2018 study period. While the largest number of these policies focused on prescription drug monitoring programs, 170 specifically imposed limits on opioid prescribing and an additional 35 specifically referred to, or incorporated, the Centers for Disease Control and Prevention opioid prescribing guideline. We also found that 46 states and the District of Columbia mandated some amount of pain or opioid prescribing CE for prescribers renewing their licenses. These mandates potentially affected as many as 1.7 million prescribers. In 69% of cases, a REMS-compliant CE program would fully meet the state mandates for various types of prescribers.Conclusion: The severity and complexity of the problems of pain management and opioid overdose have led to large-scale intervention by policymakers. Assessing the impact of these changes is difficult, at best, but will be necessary if interventions are to be refined to increase their effectiveness.Keywords: opioids, FDA blueprint, prescribing, law, policy, CDC, REMS |
