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Improving Pharmacovigilance Beyond Spontaneous Reporting

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Abstract

About forty years ago pharmacovigilance started as a formal public health practice with the setting up of spontaneous reporting schemes. This can be recognised as the first generation of progress in this discipline. Since then, along with the consolidation of such programmes around the world, important new developments have taken place, reinforcing our ability to identify and characterise drug safety issues earlier and on more scientific grounds.

The application of pharmacoepidemiological methods to drug safety evaluation has been crucial in this process, marking the second generation of progress. The conceptual evolution has been immense but there is still a lot of work to be done to transfer it into routine practice, in particular when the aim is to be proactive in anticipating and minimising drug safety issues. Patient risk management can be recognised as the third generation of progress and the new challenge for the first decades of the 21st century.

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Acknowledgements

The author wishes to thank Luis A. García Rodríguez, Dolores Montero and Mariano Madurga for their useful comments. The author would also like to thank the peer reviewers who refereed this paper.

The author is an employee of the Spanish Agency for Medicines and Healthcare Products. The views expressed are those of the author and not necessarily those of the Agency.

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  1. Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Healthcare Products, Madrid, Spain

    Francisco J. de Abajo

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Correspondence to Francisco J. de Abajo.

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de Abajo, F.J. Improving Pharmacovigilance Beyond Spontaneous Reporting. Int J Pharm Med 19, 209–218 (2005). https://doi.org/10.2165/00124363-200519040-00002

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