Designing a tool allowing for a standardized assessment of resistance to drug diversion

Objectives: Drug diversion is a growing problem in numerous countries. Some laboratories have developed tamper-resistant formulations. The problem for healthcare authorities is now to assess new formulations developed to limit the risk of diversion for administration by another mode and intended mode. It would be helpful to have a pertinent panel of in vitro tests allowing assessment of how a formulation may be altered, both for healthcare authorities and for laboratories, so as to implement adequate sanitary measures. We designed a methodology/tool allowing assessment, in a standardized manner, of the formulation's resistance to drug diversion. We present the various steps leading to the construction of the scale and to its first use.Methods: Creating a Steering Committee – Choosing assays or parameters – standardized by a monograph of the European Pharmacopoeia and pragmatic assays related to users' behaviors – for the assessment of formulation resistance to drug diversion. Designing a scale: i) applyin...