Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics

Study Overview
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Brief Summary
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Retrospective study to assess incidence and predictors of opioid abuse overdose and death associated with opioid overdose among patients prescribed opioid products in long-term use.

Detailed Description
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The purpose of this study is to quantify risk, and predictors of risks for opioid overdose and for death associated with opioid overdose in persons who are or have been long-term recipients of prescriptions for Schedule II opioids. The study uses coded terms in large heath databases maintained by healthcare providers and health insurers, supplemented by overdose deaths identified from the National Death Index. The terms for overdose are combined following validated rules as developed in companion studies. The study is being conducted in parallel with a prospective questionnaire-based cohort study of the same risks.

Official Title
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Incidence and Predictors of Opioid Overdose and Death Among Users of Opioid Analgesics as Measured by Diagnoses and Death Records - a Retrospective Database Study

Conditions
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Opioid Overdose

Intervention / Treatment
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* Other: Observation only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In the primary analysis, persons known to have had at least six months of no opioid dispensing who subsequently receive at least 70 days of Schedule II opioid dispensed within a 90-day period and who have not previously experienced an opioid overdose. In a secondary analysis, persons who have been long-term users of IR/SA opioids and who switch to a different Schedule II IR/SA opioid product or to an ER/LA opioid In another secondary analysis, persons with at least six months of presence in the health insurance data who have not received opioids in the preceding 30 days, and have not previously experienced an opioid overdose Exclusion Criteria: • Experience of opioid overdose in the six months preceding inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long-term opioid-use cohort<br>Persons who have received 70 or more days of Schedule II opioid dispensed in a 90-day period, after at least 183 days with no opioid dispensing. | Other: Observation only<br>* No intervention.<br>|
| IR/SA to ER/LA Switchers<br>Persons who have switched to or added on an ER/LA product after stable use of an IR/SA opioid regimen. | Other: Observation only<br>* No intervention.<br>|
| IR/SA to IR/SA Switchers<br>Persons who have switched to or added on a new IR/SA opioid after stable use of a different IR/SA opioid regimen. | Other: Observation only<br>* No intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid overdose - fatal and nonfatal | Opioid overdose as identified in insurance claims, electronic medical records and National Death Index records. | Retrospective review over period from October 1, 2006 to December 31, 2017 |