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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.

The continuing need for sensitive and specific analytical methods for the detection and quantitation of cocaine is reflected by the number of publications that continue to be devoted to this topic. This review focuses on immunoassay-screening methods as well as chromatographic methods that were reported over approximately the last two decades for the determination of cocaine analytes in various biological specimens. Illicit cocaine analysis is addressed briefly in the introduction. The reviewed methods are summarized in tables to provide additional information on each assay. Solid-phase extraction was the most frequently applied technique to isolate cocaine analytes from biological matrices. Also, it was no surprise that gas chromatography-mass spectrometry operated in the positive ion–electron impact ionization mode was the most widely reported instrument used for the detection of cocaine analytes. However, other analytical methodologies, such as liquid chromatography-mass spectrometry, are becoming more important for the analysis of cocaine with the growing interest in identifying and quantitating multiple cocaine analytes with varying physiochemical properties.