Changes in misuse and abuse of prescription opioids following implementation of Extended‐Release and Long‐Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy. Issue 9 (31st July 2017)

• Record Type: Journal Article
• Authors: Bucher Bartelson, Becki; Le Lait, M. Claire; Green, Jody L.; Cepeda, M. Soledad; Coplan, Paul M.; Maziere, Jean‐Yves; Wedin, Gregory P.; Dart, Richard C.
• Is Part Of: Pharmacoepidemiology and drug safety. Volume 26:Issue 9(2017)
• Page Start: 1061
• Page End: 1070
• Publication Date: 2017-07-31
• Subjects: ER/LA -- opioid abuse -- pharmacoepidemiology -- prescription drug abuse -- REMS; Pharmacoepidemiology -- Periodicals; Chemotherapy -- Periodicals; Epidemiology -- Periodicals; 615.705
• DOI: 10.1002/pds.4257
• Languages: English
• ISSNs: 1053-8569

Abstract

Abstract: Purpose: An unintended consequence of extended‐release (ER) and long‐acting (LA) prescription opioids is that these formulations can be more attractive to abusers than immediate‐release (IR) formulations. The US Food and Drug Administration recognized these risks and approved the ER/LA Opioid Analgesic Risk Evaluation and Mitigation Strategy (ER/LA REMS), which has a goal of reducing opioid misuse and abuse and their associated consequences. The primary objective of this analysis is to determine whether ER/LA REMS implementation was associated with decreased reports of misuse and abuse. Methods: Data from the Researched Abuse, Diversion and Addiction‐Related Surveillance (RADARS(R)) System Poison Center Program were utilized. Poison center cases are assigned a reason for exposure, a medical outcome, and a level of health care received. Rates adjusted for population and drug utilization were analyzed over time. Results: RADARS System Poison Center Program data indicate a notable decrease in ER/LA opioid rates of intentional abuse and misuse as well as major medical outcomes or hospitalizations following implementation of the ER/LA REMS. Conclusions: While similar decreases were observed for the IR prescription opioid group, the decreasing rate for the ER/LA opioids exceeded the decreasing rates for the IR prescription opioids and was distinctly different than that for the prescription stimulants, indicating that the ER/LA REMS program may have had an additional effect on decreases in opioid abuse and intentional misuse beyond secular trends.