Reductions in Reported Deaths Following the Introduction of Extended-Release Oxycodone (OxyContin) With an Abuse-Deterrent Formulation

Pharmacoepidemiol Drug Saf. 2014 Dec;23(12):1238-46. doi: 10.1002/pds.3658. Epub 2014 Jun 11.

Abstract

Purpose: Abuse of opioid analgesics for their psychoactive effects is associated with a large number of fatalities. The effect of making opioid tablets harder to crush/dissolve on opioid-related fatalities has not been assessed. The objective of this study was to assess the impact of introducing extended-release oxycodone (ERO [OxyContin(®) ]) tablets containing physicochemical barriers to crushing/dissolving (reformulated ERO) on deaths reported to the manufacturer.

Methods: All spontaneous adverse event reports of death in the US reported to the manufacturer between 3Q2009 and 3Q2013 involving ERO were used. The mean numbers of deaths/quarter in the 3 years after reformulated ERO introduction were compared with the year before. Changes in the slope of trends in deaths were assessed using spline regression. Comparison groups consisted of non-fatal reports involving ERO and fatality reports involving ER morphine.

Results: Reports of death decreased 82% (95% CI: -89, -73) from the year before to the third year after (131 to 23 deaths per year) reformulation; overdose death reports decreased 87% (95% CI: -93, -78) and overdose deaths with mention of abuse-related behavior decreased 86% (95% CI:-92, -75). In contrast, non-fatal ERO reports did not decrease post-reformulation, and reported ER morphine fatalities remained unchanged. The ratio of ERO fatalities to all oxycodone fatalities decreased from 21% to 8% in the year pre-reformulation to the second year post-reformulation.

Conclusions: These findings, when considered in the context of previously published studies using other surveillance systems, suggest that the abuse-deterrent characteristics of reformulated ERO have decreased the fatalities associated with its misuse/abuse. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

Keywords: OxyContin; abuse-deterrent; extended-release oxycodone; overdose death; pharmacoepidemiology; pharmacovigilance.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Chemistry, Pharmaceutical / standards*
  • Chemistry, Pharmaceutical / trends
  • Child
  • Database Management Systems
  • Delayed-Action Preparations
  • Dosage Forms
  • Female
  • Humans
  • Male
  • Middle Aged
  • Mortality / trends*
  • Oxycodone / administration & dosage
  • Oxycodone / chemistry*
  • United States

Substances

  • Delayed-Action Preparations
  • Dosage Forms
  • Oxycodone