Changes in Misuse and Abuse of Prescription Opioids Following Implementation of Extended-Release and Long-Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy

Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1061-1070. doi: 10.1002/pds.4257. Epub 2017 Jul 31.

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.

Keywords: ER/LA; REMS; opioid abuse; pharmacoepidemiology; prescription drug abuse.

MeSH terms

  • Adolescent
  • Adult
  • Analgesics, Opioid / adverse effects*
  • Analgesics, Opioid / chemistry
  • Child
  • Delayed-Action Preparations / adverse effects
  • Delayed-Action Preparations / chemistry
  • Female
  • Humans
  • Male
  • Middle Aged
  • Opioid-Related Disorders / diagnosis
  • Opioid-Related Disorders / epidemiology*
  • Opioid-Related Disorders / prevention & control
  • Prescription Drug Misuse / prevention & control
  • Prescription Drug Misuse / trends*
  • Risk Evaluation and Mitigation*
  • Young Adult

Substances

  • Analgesics, Opioid
  • Delayed-Action Preparations