Use of prescription opioids with abuse-deterrent technology to address opioid abuse

Michna, Edward; Kirson, Noam Y.; Shei, Amie; Birnbaum, Howard G.; Ben‐Joseph, Rami

doi:10.1185/03007995.2014.915803

Cited by 15 publications

(9 citation statements)

References 7 publications

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“…Patients with at least one medical claim linked to an ICD‐9‐CM diagnosis code for opioid abuse/dependence (“abuse”) were identified in the OptumHealth database (304.0×, 304.7×, 305.5×, 965.00, 965.02, 965.09). The combination of diagnosis codes for both abuse and dependence is consistent with recent literature , as well as the new classification adopted by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM‐5) . Hereinafter we refer to “opioid abuse” for simplicity.…”

Section: Methodssupporting

confidence: 80%

The Burden of Undiagnosed Opioid Abuse Among Commercially Insured Individuals

et al. 2015

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Section: Methodssupporting

confidence: 80%

The Burden of Undiagnosed Opioid Abuse Among Commercially Insured Individuals

et al. 2015

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“…Third, demand from individuals who abused or diverted the nonabuse-deterrent oxycodone formulation might have decreased. Corroborating this hypothesis, one study 18 demonstrated that individuals with a diagnosis of substance use phene immediate-release opioids was increasing at a steady rate; afterward, the trend shifted downward and became nearly flat. This finding is surprising since we expected switching to alternative immediate-release opioids.…”

Section: Discussionmentioning

confidence: 91%

Rates of Opioid Dispensing and Overdose After Introduction of Abuse-Deterrent Extended-Release Oxycodone and Withdrawal of Propoxyphene

et al. 2015

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IMPORTANCEIn the second half of 2010, abuse-deterrent extended-release oxycodone hydrochloride (OxyContin; Purdue Pharma) was introduced and propoxyphene was withdrawn from the US market. The effect of these pharmaceutical market changes on opioid dispensing and overdose rates is unknown.OBJECTIVE To evaluate the association between 2 temporally proximate changes in the opioid market and opioid dispensing and overdose rates. DESIGN, SETTING, AND PARTICIPANTS Claims from a large national US health insurer were analyzed, using an interrupted time series study design. Participants included an open cohort of 31.3 million commercially insured members aged 18 to 64 years between January 1, 2003, and December 31, 2012, with median follow-up of 20 months (last follow-up, December 31, 2012). EXPOSURES Introduction of abuse-deterrent OxyContin (resistant to crushing or dissolving) on August 9, 2010, and market withdrawal of propoxyphene on November 19, 2010.MAIN OUTCOMES AND MEASURES Standardized opioid dispensing rates and prescription opioid and heroin overdose rates were the primary outcomes. We used segmented regression to analyze changes in outcomes from 30 quarters before to 8 quarters after the 2 interventions.RESULTS Two years after the opioid market changes, total opioid dispensing decreased by 19% from the expected rate (absolute change, −32.2 mg morphine-equivalent dose per member per quarter [95% CI, −38.1 to −26.3]). By opioid subtype, the absolute change in dispensing by milligrams of morphine-equivalent dose per member per quarter at 2 years was −11.3 (95% CI, −12.4 to −10.1) for extended-release oxycodone, 3.26 (95% CI, 1.40 to 5.12) for other long-acting opioids, −8.19 (95% CI, −9.30 to −7.08) for propoxyphene, and −16.2 (95% CI, −18.8 to −13.5) for other immediate-release opioids. Two years after the market changes, the estimated overdose rate attributed to prescription opioids decreased by 20% (absolute change, −1.10 per 100 000 members per quarter [95% CI, −1.47 to −0.74]), but heroin overdose increased by 23% (absolute change, 0.26 per 100 000 members per quarter [95% CI, −0.01 to 0.53]). CONCLUSIONS AND RELEVANCEOpioid dispensing and prescription opioid overdoses decreased substantially after 2 major changes in the pharmaceutical market in late 2010. Pharmaceutical market interventions may have value in combatting the prescription opioid overdose epidemic, but heroin overdose rates continue to increase. Complementary strategies to identify and treat opioid abuse and addiction are urgently needed.

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“…In this ‘For Debate’ paper, we examine the complexities of this issue, proposing a framework for study design, conduct, governance and reporting of pharmaceutical opioid ADF post‐marketing studies. ADFs are a relatively new strategy (at the time of preparing this manuscript, the US FDA has approved labelling describing abuse‐deterrent properties for eight opioids, including oxycodone and morphine formulations , and there has been substantial maturing of this field of research in the wealth and quality of studies conducted . However, the opportunities for new developments are great, and there is growing momentum for more comprehensive guidance for such studies.…”

Section: Introductionmentioning

confidence: 99%

Post‐marketing studies of pharmaceutical opioid abuse‐deterrent formulations: a framework for research design and reporting

et al. 2018

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Research questions for post-marketing studies on ADFs of opioids should reasonably be framed around detecting any probable intended or unintended clinical and/or meaningful changes in specific aspects of extra-medical use (e.g. injection use) and harms. Outcomes reported by prevalence and frequency of occurrence and disaggregated by specific product and route of administration can illustrate the magnitude of ADF impact. We argue that a multi-faceted approach is required, using data from both general population and sentinel high-risk cohorts and from primary and secondary data sources. The comparator (historical non-ADF formulation of that opioid, equivalent current generic or similar opioid product), duration of monitoring and analytical approach require justification and should be sufficient to add weight to conclusions of causality. To maximize transparency, we recommend explicit declarations of funding and conflict of interest, establishment of an advisory committee, publication of study protocol and access to study results.

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Use of prescription opioids with abuse-deterrent technology to address opioid abuse

Cited by 15 publications

References 7 publications

The Burden of Undiagnosed Opioid Abuse Among Commercially Insured Individuals

The Burden of Undiagnosed Opioid Abuse Among Commercially Insured Individuals

Rates of Opioid Dispensing and Overdose After Introduction of Abuse-Deterrent Extended-Release Oxycodone and Withdrawal of Propoxyphene

Post‐marketing studies of pharmaceutical opioid abuse‐deterrent formulations: a framework for research design and reporting

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