• Carl L Roland, Beatrice Setnik, and David A Brown.
• a Clinical Development and Outcomes & Evidence , Pfizer Inc , Durham , NC , USA.
• Postgrad Med. 2017 Jan 1; 129 (1): 12-21.

ObjectivePrescription opioid misuse and abuse is a serious public health concern that can lead to overdose, addiction, and death. The development of opioid formulations designed to deter misuse and abuse is considered an important step towards addressing the problem, but the extent to which abuse-deterrent opioids (ADOs) actually deter abuse in the community requires confirmation through epidemiologic studies. Epidemiologic evaluations of misuse and abuse present several unique challenges related to study design, sources of data, and methodology, particularly for new entrant ADOs with low population exposure. The purpose of this article is to review the critical methodologic issues that must be considered when designing an epidemiologic evaluation of prescription opioid misuse and abuse, and deterrence for new entrant ADOs.MethodsA systematic feasibility assessment was conducted by critically evaluating and applying epidemiologic principles to combinations of epidemiology study design, study directionality, population, data source, clinical and patient-reported endpoints, type of comparator, effect size, and the ability to control for confounding variables.ResultsTen epidemiologic factors were identified that are considered key to an epidemiologic evaluation, and the issues associated with each are summarized.ConclusionGiven the low population exposure of new entrant ADOs, there is limited feasibility in conducting the epidemiologic studies necessary to evaluate the effectiveness of these products in deterring abuse. Clear regulatory guidance is needed.

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