US Food and Drug Administrationʼs Risk Evaluation and Mitigation Strategy for Extended-Release and Long-Acting Opioids

In response to the proliferation and abuse of opioids in the United States, the U.S. Food and Drug Administration (FDA) recently required manufacturers of extended-release and long-acting (ER/LA) opioid analgesics to provide education for prescribers of these medications through an FDA-approved risk management program. As a part of its Risk Evaluation and Mitigation Strategy (REMS), the FDA provided a blueprint for content to help accredited continuing medical education (CME) providers develop educational modules for prescribers. The University of Nebraska Medical Center (UNMC), the Federation of State Medical Boards (FSMB), the FSMB Foundation, The France Foundation, and CECity worked collaboratively to create “Extended-Release and Long-Acting Opioid Analgesics,” a prescriber education program aligned with the FDA blueprint, comprised of live meetings and web-based enduring activities that spanned April 2014 to February 2016. A total of 4,535 health care providers participated in the live and enduring REMS CME activities and completed evaluations of these activities. The evaluations were analyzed to learn more about the impact of the content on prescribers' knowledge and clinical decision-making. Results were similar for live and enduring activities. Participant-knowledge increased by 22 percentage points. Several competence measures suggest that learners returned to practice with more confidence, and 83% declared specific practice changes they planned to make to improve patient assessment and care. More than one-third of the evaluation respondents felt there were no barriers to making intended practice changes. More than 95% of the respondents said the activity increased their ability to apply knowledge, skills, and judgment in practice. Analysis suggests that live and enduring educational activities, following the FDA REMS blueprint, can impact prescriber attitudes and future care-decisions related to ER/LA opioid analgesics. These results justify additional efforts to involve more participants in these REM activities.

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Changes in Mortality Involving Extended-Release and Long-Acting Opioids After Implementation of a Risk Evaluation and Mitigation Strategy

Pain Medicine ◽

10.1093/pm/pnz031 ◽

2019 ◽

Vol 21 (1) ◽

pp. 92-100 ◽

Cited By ~ 1

Author(s):

Joshua C Black ◽

Gabrielle E Bau ◽

Travis Rosen ◽

M Soledad Cepeda ◽

Gregory P Wedin ◽

...

Keyword(s):

Mortality Rate ◽

Risk Evaluation ◽

Extended Release ◽

Opioid Analgesic ◽

Opioid Analgesics ◽

Mortality Rates ◽

Mitigation Strategy ◽

Medical Examiner ◽

Significant Heterogeneity ◽

Long Acting

Abstract Objective To assess changes in mortality rates in extended-release and long-acting (ER/LA) opioid analgesics after the implementation of the Risk Evaluation and Mitigation Strategy (REMS). Setting All drug poisoning deaths in three states: Florida, Oregon, and Washington. Data were obtained through state vital records offices and the Researched Abuse, Diversion and Addiction-Related Surveillance System Medical Examiner Program. Methods Using cause-of-death literal text from death certificates, individual opioid active pharmaceutical ingredients (APIs) involved in each death were identified using rules-based natural language processing. Population-adjusted and prescriptions dispensed–adjusted mortality rates were calculated for all ER/LA opioid analgesic and individual opioid APIs. Rates before and after implementation of the REMS were compared. Rate changes were compared with rates from two APIs with little or no inclusion in the REMS: benzodiazepines and hydrocodone. Results The mean ER/LA opioid analgesic population-adjusted mortality rate significantly decreased in all three states (FL: P = 0.003; OR: P = 0.003; WA: P < 0.001). Mortality rates for benzodiazepines and hydrocodone also decreased and were not statistically different. Significant heterogeneity in mortality rates of individual opioids was observed between the three states. When adjusted for prescription volume, the ER/LA opioid analgesic mortality rate decreased in all three states, but was significant only for Washington (P < 0.001). Conclusions The population-adjusted mortality rate of ER/LA opioid analgesics has decreased in three states. Notably, the contributions to mortality rates by individual opioid analgesics were not uniform across the three states in this study. However, these changes were not generally distinct from changes in mortality rates where comparator substances were involved.

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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

JAMA Internal Medicine ◽

10.1001/jamainternmed.2019.5459 ◽

2020 ◽

Vol 180 (2) ◽

pp. 301 ◽

Cited By ~ 7

Author(s):

James Heyward ◽

Lily Olson ◽

Joshua M. Sharfstein ◽

Elizabeth A. Stuart ◽

Peter Lurie ◽

...

Keyword(s):

Drug Administration ◽

Risk Evaluation ◽

Extended Release ◽

Food And Drug Administration ◽

Mitigation Strategy ◽

Opioid Prescribing ◽

The Us ◽

Long Acting

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First Class-Wide Risk Evaluation and Mitigation Strategy Targets Extended-Release Formulations

Topics in Pain Management ◽

10.1097/01.tpm.0000419481.01900.55 ◽

2012 ◽

Vol 28 (2) ◽

pp. 9-12

Keyword(s):

Risk Evaluation ◽

Extended Release ◽

Mitigation Strategy ◽

Extended Release Formulations

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Risk Evaluation and Mitigation Strategies (REMS) for Extended-Release and Long-Acting Opioid Analgesics: Considerations for Palliative Care Practice

Journal of Pain & Palliative Care Pharmacotherapy ◽

10.3109/15360288.2012.679724 ◽

2012 ◽

Vol 26 (2) ◽

pp. 136-143 ◽

Cited By ~ 13

Author(s):

Jeffrey Gudin

Keyword(s):

Palliative Care ◽

Risk Evaluation ◽

Extended Release ◽

Opioid Analgesics ◽

Mitigation Strategies ◽

Care Practice ◽

Long Acting

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Assessing the impact of the extended-release/long-acting opioid analgesics risk evaluation and mitigation strategies on opioid prescription volume

Journal of Opioid Management ◽

10.5055/jom.2017.0383 ◽

2017 ◽

Vol 13 (3) ◽

pp. 157 ◽

Cited By ~ 3

Author(s):

Victoria Divino, BA ◽

M. Soledad Cepeda, MD, PhD ◽

Paul Coplan, ScD, MBA, MPH ◽

Jean-Yves Maziere, MD, PhD ◽

Yingli Yuan, PhD ◽

...

Keyword(s):

Risk Evaluation ◽

Extended Release ◽

Opioid Analgesic ◽

Opioid Analgesics ◽

Patient Characteristics ◽

Mitigation Strategies ◽

Opioid Prescription ◽

Long Acting ◽

The Impact ◽

Prescription Volume

Objective: The Food and Drug Administration approved the extended-release/long-acting (ER/LA) opioid analgesics risk evaluation and mitigation strategies (REMS) in July 2012 to educate healthcare providers and patients about safe and appropriate opioid analgesic use. The authors evaluated the impact of the REMS on ER/LA opioid analgesic utilization, overall and stratified by patient characteristics and prescriber type associated with greater expected need for analgesia. Design: Retrospective repeated cross-sectional study. QuintilesIMS's National Prescription Audit™ and LifeLink™ patient-level longitudinal prescription databases measured prescription volumes, projected to national estimates.Main Outcome Measures: Changes were assessed in ER/LA opioid analgesic prescriptions dispensed from the 2-year pre-REMS implementation (July 2010 to June 2012) to the 18-month post-REMS implementation (July 2013 to December 2014) periods (with 12-month transitional implementation period in between).Results: Average quarterly ER/LA opioid prescription volume significantly decreased by 4.3 percent from Preimplementation to the Active Period (5.58 vs 5.34 million, p < 0.001). Differences in prescription volume change were observed between age, gender, and payer types. Prescription volume either significantly decreased or remained stable from Preimplementation to the Active Period among most provider specialties evaluated. The largest volume decreases were observed for dentists (–48.5 percent) and emergency medicine specialists (–25.5 percent) (both p < 0.001). The largest increases were observed for nurse practitioners (+33.7 percent) and physician assistants (+31.2 percent; both p < 0.001), whose overall prescribing of nonopioid medications also increased. Conclusions: A significant decrease in dispensed ER/LA opioid prescriptions was observed following REMS implementation compared to Preimplementation. The impact on volume varied by patient characteristics and prescriber specialty. The REMS program, in conjunction with other healthcare policies and initiatives, likely influenced these observations.

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