Introduction to Counterfeit Drugs

Résumé fourni par la source

Given the significant danger that counterfeit drugs pose to public health, combating counterfeit drugs requires ongoing cooperation and communication among numerous national and global stakeholders. This includes sharing information on counterfeit drugs with national and global regulatory authorities, customs authorities, law enforcement agencies, pharmaceutical manufacturers, pharmaceutical repackagers/distributors, healthcare providers and consumers/patients. In addition to sharing information, it is also useful and necessary to share methods of analysis that will allow others to easily detect and identify counterfeit drugs in their supply and distribution chains. Over the years, the U.S. FDA’s Forensic Chemistry Center (FCC), industry and others have identified and adopted key areas that are important for establishing a robust counterfeit drug analysis program. These include having a clear understanding of what criteria or thresholds are needed to establish that a suspect product is counterfeit, unapproved or authentic, establishing an authentic product library for use in direct comparison analysis of suspect samples, understanding a product’s manufacturing process, understanding the factors that contribute to drug counterfeiting and establishing multidisciplinary analysis techniques and methods to both identify and provide a comprehensive analysis of suspect counterfeit products. This introduction will discuss these key areas providing a segue to the additional chapters in this book.

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