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Post-marketing studies of pharmaceutical opioid abuse-deterrent formulations: a framework for research design and reporting
Peacock, A and Larance, B and Bruno, R and Pearson, S-A and Buckley, NA and Farrell, M and Degenhardt, L, Post-marketing studies of pharmaceutical opioid abuse-deterrent formulations: a framework for research design and reporting, Addiction, 114, (3) pp. 389-399. ISSN 0965-2140 (2019) [Refereed Article]
Copyright 2018 Society for the Study of Addiction
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 on the effectiveness of pharmaceutical and opioid ADFs.
Methods: A review of current guidance documents, public work‐shops and forums and our own experience with post‐marketing studies of ADFs.
Results and conclusions: 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.
|Item Type:||Refereed Article|
|Keywords:||opioid abuse, abuse deterrent formulations (ADFs), ADF impact|
|Research Group:||Biological psychology|
|Research Field:||Behavioural neuroscience|
|Objective Division:||Expanding Knowledge|
|Objective Group:||Expanding knowledge|
|Objective Field:||Expanding knowledge in psychology|
|UTAS Author:||Peacock, A (Miss Amy Peacock)|
|UTAS Author:||Bruno, R (Associate Professor Raimondo Bruno)|
|Year Published:||2019 (online first 2018)|
|Web of Science® Times Cited:||9|
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