Changes in misuse and abuse of prescription opioids following implementation of Extended‐Release and Long‐Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy

Bartelson, Becki Bucher; Lait, M.C. Le; Green, Jody L.; Cepeda, M. Soledad; Coplan, Paul; Mazière, Jean-Yves; Wedin, Gregory P.; Dart, Richard C.

doi:10.1002/pds.4257

Cited by 8 publications

(5 citation statements)

References 15 publications

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“…22 Some REMS programs for opioids appear to have decreased intentional misuse of the drugs and raised awareness and appreciation of their risks. 23,24 Of course, it is not always possible to determine whether changes to prescribing or consumption patterns are based on REMS, other factors, 24 or a combination. 25 In the case of opioids, to-date REMS activities cannot be unequivocally linked to lower mortality.…”

Section: Is There a Role For Rems?mentioning

confidence: 99%

“…There have been benefits for REMS opioid programs: 46 states in the United States plus the District of Columbia now mandate some form of continuing education for opioid prescribing 22 . Some REMS programs for opioids appear to have decreased intentional misuse of the drugs and raised awareness and appreciation of their risks 23,24 . Of course, it is not always possible to determine whether changes to prescribing or consumption patterns are based on REMS, other factors, 24 or a combination 25 .…”

Section: Commentmentioning

confidence: 99%

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Benzodiazepines: Thinking outside the black box

2020

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What is known and Objective: The United States Food and Drug Administration (FDA) recently issued a Drug Safety Communication requiring Boxed Warning updating and other changes in order to improve the safe use of the benzodiazepine drug class. These changes were prompted because 'The current prescribing information for benzodiazepines does not provide adequate warnings about [the] serious risks and harms associated with these medicines so they may be prescribed and used inappropriately'. Comment:The FDA Communication points out that benzodiazepines can be an important option for treating disorders for which these drugs are indicated. However, the acknowledged problems of these drugs, which historically were considered an acceptable trade-off against their benefits, need to be reassessed in light of their widespread (over?) prescribing (for example, in 2019 an estimated 92 million benzodiazepine prescriptions were dispensed from US retail and mail-order pharmacies).

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Section: Is There a Role For Rems?mentioning

confidence: 99%

Section: Commentmentioning

confidence: 99%

Benzodiazepines: Thinking outside the black box

2020

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“…The legislative authority of FDA allows it to require the conduct of REMS, but not to require postmarketing studies, from license holders of generic products. Key components of the Opioid Analgesic REMS are to make education available to prescribers and the health-care team through accredited continuing education (CE), to provide patient educational materials, and assess the impact of such activities on health outcomes [29][30][31]. In addition to the class-wide opioid PMR studies, companies that are license holders of abuse deterrent opioids are required to conduct separate postmarketing studies to evaluate abuse deterrence in real-world use.…”

Section: Overview Of Study Planmentioning

confidence: 99%

Postmarketing studies program to assess the risks and benefits of long-term use of extended-release/long-acting opioids among chronic pain patients

Coplan

Cepeda

Petronis

et al. 2019

Postgraduate Medicine

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“…Prior assessments of the ER/LA REMS have been funded by opioid manufacturers and identified declines in ER/LA misuse. However, these declines were self-reported by clinicians and reflected population-level trends rather than direct comparisons of CE completers and noncompleters. Pre-post analyses by CE providers, which were also funded by manufacturers, suggested that CE completers had moderately greater ER/LA knowledge immediately after and 2 months after CE training.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration

et al. 2020

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IMPORTANCE 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.OBSERVATIONS The REMS program was implemented largely as planned. The FDA's goal was for 60% of ER/LA prescribers to take REMS-adherent continuing education (CE) between 2012 and 2016; 27.6% (88 316 of 320 000) of prescribers had done so by 2016. Audits of REMS programs indicated close adherence to FDA content guidelines except for financial disclosures. Nonrepresentative cross-sectional surveys of self-selected prescribers suggested modestly greater ER/LA knowledge among CE completers than noncompleters, and claims-based surveillance indicated slowly declining ER/LA prescribing, although the contribution of the REMS to these trends could not be assessed. The effectiveness of the REMS program for reducing adverse outcomes also could not be assessed because the analyses used nonrepresentative samples, lacked adequate controls for confounding, and did not link prescribing or clinical outcomes to prescribers' receipt of CE training. Although the FDA had requested studies tracking adverse outcomes as a function of CE training, the FDA concluded that these studies had not been performed as of the 60-month report in 2017.CONCLUSIONS AND RELEVANCE Five years after initiation, the FDA and ER/LA manufacturers could not conclude whether the ER/LA REMS had reduced inappropriate prescribing or improved patient outcomes. Alternative observational study designs would have allowed for more rigorous estimates of the program's effectiveness.

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Changes in misuse and abuse of prescription opioids following implementation of Extended‐Release and Long‐Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy

Cited by 8 publications

References 15 publications

Benzodiazepines: Thinking outside the black box

Benzodiazepines: Thinking outside the black box

Postmarketing studies program to assess the risks and benefits of long-term use of extended-release/long-acting opioids among chronic pain patients

Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration

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