Evidence map›Paper›PMID 24916486›Full record

ArticlePharmacoepidemiology and drug safety2014

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

Abstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Article
  4. State-Level Prevalence and Associates of Opioid Dependence in the USA.International journal of environmental research and public health · 2022
    Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Person-level changes in oxycodone use after the introduction of a tamper-resistant formulation in Australia.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2018
    Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Tamper-resistant drugs cannot solve the opioid crisis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2015
    Article
  18. Article
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Nelson E SesslerDepartment of Risk Management and Epidemiology, Purdue Pharma L.P., Stamford, CT, USA.
Jerod M Downing
Hrishikesh Kale
Howard D Chilcoat
Todd F Baumgartner
Paul M Coplan

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAbuse 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.

methodsAll 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.

resultsReports 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.

conclusionsThese 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.

Indexed as

AdolescentAdultAgedChemistry, PharmaceuticalChildDatabase Management SystemsDelayed-Action PreparationsDosage FormsFemaleHumansMaleMiddle AgedMortalityOxycodoneUnited StatesDelayed-Action PreparationsDosage FormsOxycodoneabuse-deterrentextended-release oxycodoneoverdose deathOxyContinpharmacoepidemiologypharmacovigilance

Identifiers

PMID24916486
PMCPMC4282788

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.