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.

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.

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

The source populations will be those members of the selected health plans and insurance programs identified for which full demographic, provider, facility and pharmacy data are available, and in which protected health information (PHI) can be linked to death certificate information.

The four large healthcare systems that have established electronic databases for studying coded terminology outcomes selected for this study are: Kaiser Permanente Northwest; HealthCore, Inc. with access to commercial insurance data; Optum with access to commercial insurance data; and Vanderbilt University with access to Medicaid data for the State of Tennessee.