• Bucher Bartelson Becki B Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO, USA., M Claire Le Lait, Jody L Green, M Soledad Cepeda, Paul M Coplan, Jean-Yves Maziere, Gregory P Wedin, and Richard C Dart.
• Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO, USA.
• Pharmacoepidemiol Drug Saf. 2017 Sep 1; 26 (9): 1061-1070.

PurposeAn 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.MethodsData 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.ResultsRADARS 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.ConclusionsWhile 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.Copyright © 2017 John Wiley & Sons, Ltd.

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