Chapter 11 - Risk Management Implications of Abuse Potential Assessment

Abstract

Pharmaceutical risk management can be considered to be any strategies for minimizing risks and enabling the realization of the benefits of medications. Historically, risk management has been achieved through the drug label, which includes the US Controlled Substances Act (CSA) drug scheduling placement if abuse and dependence are considered sufficiently serious to warrant special restrictions. Since the late 1990s, additional strategies for addressing abuse- and dependence-related risks have been developed, including various postmarketing requirements for surveillance and reporting to the Food and Drug Administration. These strategies have been described in guidance documents and include risk assessment, risk management, and postmarketing surveillance. Preclinical abuse potential assessment provides early signals of potential risks and scheduling. Such studies are also considered in the premarket risk evaluation that guides recommendations concerning risk management strategies that go beyond drug scheduling along with the evaluation of abuse-deterrent drug products and how such evaluation might be informed by preclinical studies.