Reductions in reported deaths following the introduction of extended-release oxycodone (OxyContin) with an abuse-deterrent formulation

Nelson E. Sessler, Jerod M. Downing, Hrishikesh Kale, Howard D. Chilcoat, Todd F. Baumgartner, Paul M. Coplan

Research output: Contribution to journalArticle

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 3years 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.

Original languageEnglish (US)
Pages (from-to)1238-1246
Number of pages9
JournalPharmacoepidemiology and Drug Safety
Volume23
Issue number12
DOIs
StatePublished - Dec 1 2014

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Oxycodone
Opioid Analgesics
Morphine
Tablets

Keywords

  • Abuse-deterrent
  • Extended-release oxycodone
  • Overdose death
  • OxyContin
  • Pharmacoepidemiology
  • Pharmacovigilance

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Epidemiology

Cite this

Reductions in reported deaths following the introduction of extended-release oxycodone (OxyContin) with an abuse-deterrent formulation. / Sessler, Nelson E.; Downing, Jerod M.; Kale, Hrishikesh; Chilcoat, Howard D.; Baumgartner, Todd F.; Coplan, Paul M.

In: Pharmacoepidemiology and Drug Safety, Vol. 23, No. 12, 01.12.2014, p. 1238-1246.

Research output: Contribution to journalArticle

Sessler, Nelson E. ; Downing, Jerod M. ; Kale, Hrishikesh ; Chilcoat, Howard D. ; Baumgartner, Todd F. ; Coplan, Paul M. / Reductions in reported deaths following the introduction of extended-release oxycodone (OxyContin) with an abuse-deterrent formulation. In: Pharmacoepidemiology and Drug Safety. 2014 ; Vol. 23, No. 12. pp. 1238-1246.
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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{\circledR}]) 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 3years 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.",
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AU - Baumgartner, Todd F.

AU - Coplan, Paul M.

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AB - 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 3years 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.

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