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Faculty of Social Sciences - Papers

2019

Abuse‐deterrent

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Full-Text Articles in Social and Behavioral Sciences

Post‐Marketing Studies Of Pharmaceutical Opioid Abuse‐Deterrent Formulations: A Framework For Research Design And Reporting, Amy Peacock, Briony K. Larance, Raimondo Bruno, Sallie-Anne Pearson, Nicholas A. Buckley, Michael P. Farrell, Louisa Degenhardt Jan 2019

Post‐Marketing Studies Of Pharmaceutical Opioid Abuse‐Deterrent Formulations: A Framework For Research Design And Reporting, Amy Peacock, Briony K. Larance, Raimondo Bruno, Sallie-Anne Pearson, Nicholas A. Buckley, Michael P. Farrell, Louisa Degenhardt

Faculty of Social Sciences - Papers

Background and aims Opioid formulations with properties to deter abuse (abuse‐deterrent formulations; ADFs) have been developed as one response to the prescription opioid 'epidemic'. As for all medicines, ADFs undergo evaluation of safety and efficacy prior to registration for marketing. However, reduced extra‐medical use (the primary intended outcome of ADFs and reason for their introduction) can only be established in post‐marketing observational studies, comparing them to opioid formulations without abuse‐deterrent properties. This has implications for various features of study design and analysis. We discuss proposals for the design, conduct, governance and reporting of post‐marketing studies ...