title: Reductions in reported deaths following the introduction of extended-release oxycodone (OxyContin) with an abuse-deterrent formulation.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Risk Management and Epidemiology, Purdue Pharma L.P., Stamford, CT, USA.
authors.forename: Nelson E
authors.initials: NE
authors.lastname: Sessler
authors.forename: Jerod M
authors.initials: JM
authors.lastname: Downing
authors.forename: Hrishikesh
authors.initials: H
authors.lastname: Kale
authors.forename: Howard D
authors.initials: HD
authors.lastname: Chilcoat
authors.forename: Todd F
authors.initials: TF
authors.lastname: Baumgartner
authors.forename: Paul M
authors.initials: PM
authors.lastname: Coplan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002626:Chemistry, Pharmaceutical / Q000592:standards* / Q000639:trends; D002648:Child; D003628:Database Management Systems; D003692:Delayed-Action Preparations; D004304:Dosage Forms; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009026:Mortality / Q000639:trends*; D010098:Oxycodone / Q000008:administration & dosage / Q000737:chemistry*; D014481:United States
chemical_list: D003692:Delayed-Action Preparations; D004304:Dosage Forms; D010098:Oxycodone
keywords: OxyContin; abuse-deterrent; extended-release oxycodone; overdose death; pharmacoepidemiology; pharmacovigilance