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      Journal of Pain Research (submit here)

      This international, peer-reviewed Open Access journal by Dove Medical Press focuses on reporting of high-quality laboratory and clinical findings in all fields of pain research and the prevention and management of pain. Sign up for email alerts here.

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      An Examination of State and Federal Opioid Analgesic and Continuing Education Policies: 2016–2018

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          Abstract

          Introduction

          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.

          Most cited references16

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          Current perspectives on the opioid crisis in the US healthcare system: A comprehensive literature review

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            What we know, and don't know, about the impact of state policy and systems-level interventions on prescription drug overdose.

            Drug overdose deaths have been rising since the early 1990s and is the leading cause of injury death in the United States. Overdose from prescription opioids constitutes a large proportion of this burden. State policy and systems-level interventions have the potential to impact prescription drug misuse and overdose.
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              Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration

              Extended-release/long-acting (ER/LA) opioids have caused substantial morbidity and mortality in the United States, yet little is known about the efforts of the US Food and Drug Administration (FDA) and drug manufacturers to reduce adverse outcomes associated with inappropriate prescribing or use. This review of 9739 pages of FDA documents obtained through a Freedom of Information Act request aimed to investigate whether the FDA and ER/LA manufacturers were able to assess the effectiveness of the ER/LA Risk Evaluation and Mitigation Strategy (REMS) program by evaluating manufacturer REMS assessments and FDA oversight of these assessments.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                jpr
                jpainres
                Journal of Pain Research
                Dove
                1178-7090
                01 October 2020
                2020
                : 13
                : 2431-2442
                Affiliations
                [1 ]RKT Consulting, LLC , Lenexa, KS, USA
                [2 ]Behavioral Health Section, Saint Luke’s Health System , Kansas City, MO, USA
                [3 ]Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine , Kansas City, KS, USA
                [4 ]Center for Effective Regulatory Policy and Safe Access , Denver, CO, USA
                [5 ]College of Professional Studies, Purdue University , Fort Wayne, IN, USA
                [6 ]Department of Epidemiology, Janssen Research & Development , Titusville, NJ, USA
                [7 ]Department of Epidemiology, Clinical Safety and Pharmacovigilance, Daiichi Sankyo , Basking Ridge, NJ, USA
                [8 ]University of Pennsylvania Perelman School of Medicine , Philadelphia, PA, USA
                [9 ]Upsher-Smith Laboratories, LLC, Pharmacovigilance and Risk Management , Maple Grove, MN, USA
                Author notes
                Correspondence: Robert Twillman Saint Luke’s Health System , Kansas City, MO, USATel +1 913-205-3746 Email Bob.Twillman@gmail.com
                Author information
                http://orcid.org/0000-0002-3578-0196
                http://orcid.org/0000-0001-5465-0568
                http://orcid.org/0000-0002-5159-6217
                http://orcid.org/0000-0001-5417-3925
                http://orcid.org/0000-0001-5634-1558
                Article
                267448
                10.2147/JPR.S267448
                7534855
                3b7c131b-476b-408b-9561-a84f2a5d2453
                © 2020 Duensing et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 12 June 2020
                : 19 August 2020
                Page count
                Figures: 1, Tables: 4, References: 26, Pages: 12
                Categories
                Original Research

                Anesthesiology & Pain management
                opioids,fda blueprint,prescribing,law,policy,cdc,rems
                Anesthesiology & Pain management
                opioids, fda blueprint, prescribing, law, policy, cdc, rems

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