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Pharmacovigilance in a genomic era

The Pharmacogenomics Journal volume 6, pages 158–161 (2006)Cite this article

Pharmacovigilance involves the continual monitoring of drugs which are already in the market, for detection, assessment, understanding and prevention of short-term and long-term adverse effects of medicines.1 It is essential for ensuring that there is an appropriate balance between the risks and benefits of drugs used in community and hospital practice. When drugs are approved for marketing, knowledge regarding their safety is incomplete. The clinical trials that assess a drug's efficacy and safety profile use a sample size that is inadequate to detect uncommon, albeit important adverse drug reactions or drug interactions. Furthermore, the participants in clinical trials are often selected through inclusion/exclusion criteria and may not adequately represent patients in clinical practice who have multiple medical problems and are using numerous concomitant medical products. As a result, the subsequent population experience with a product will be much broader than that derived from the clinical trials.1

Adverse drug reactions impose a remarkable burden on the health care system. The Canadian Adverse Drug Reaction Monitoring Program (CADRMP) received 4663 reports of adverse drug reactions in 1998, with 2079 (45%) classified as serious.2 Serious ADRs are the sixth leading cause of death in the United States,3 and result in billions of dollars in health care costs.4, 5 Failure to effectively manage drug safety data and the pharmacovigilance processes can affect patient well-being, jeopardize a drug's potential for benefit, and create a regulatory nightmare.

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Authors and Affiliations

  1. Centre for Evaluation of Medicines, St Joseph's Hospital, McMaster University, Hamilton, ON, Canada

    P Farahani & M Levine

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Correspondence to P Farahani.

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Farahani, P., Levine, M. Pharmacovigilance in a genomic era. Pharmacogenomics J 6, 158–161 (2006). https://doi.org/10.1038/sj.tpj.6500370

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