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Safety Signal Detection: The Relevance of Literature Review

  • Practical Drug Safety
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Abstract

Adverse drug reactions (ADRs) represent an important risk for patients and have a significant economic impact on health systems. ADRs are the fifth most common cause of hospital death, with a burden estimated at 197,000 deaths per year in the EU. This has a societal cost of €79 billion per year. Because of this strong impact in public health, regulatory authorities (RAs) worldwide are implementing new pharmacovigilance legislation to promote and protect public health by reducing the burden of ADRs through the detection of safety signals. Although, traditionally, signal detection activities have mainly been performed based on spontaneous reporting from healthcare professionals and national health RAs, the new pharmacovigilance legislation underlines the relevance of other sources of information (such as scientific literature) for the evaluation of the benefit–risk balance of a certain product. This review aims to highlight the relevance of periodic scientific literature screening in the safety signal detection process. The authors present four practical examples where a safety signal that was detected from a literature report had an impact on the lifecycle of a drug. In addition, based on practical experience of the screening of medical and scientific literature for safety purposes, this article analyses the requirements of the new pharmacovigilance guidelines on literature screening and highlights the need for the implementation of a literature review procedure and the main challenges encountered when performing literature screening for safety aspects.

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Acknowledgments

The authors would like to thank Myrto Ioannidi, Dr. Alexis Pinçon, and Dr. François Curtin for their contribution on the review of this manuscript. No sources of funding were used to prepare this review. Dr. Helena Pontes, Dr. Mallorie Clément, and Dr. Victoria Rollason have no conflicts of interest that are directly relevant to the content of this review.

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Correspondence to Helena Pontes.

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Pontes, H., Clément, M. & Rollason, V. Safety Signal Detection: The Relevance of Literature Review. Drug Saf 37, 471–479 (2014). https://doi.org/10.1007/s40264-014-0180-9

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  • DOI: https://doi.org/10.1007/s40264-014-0180-9

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