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Drug Safety

, Volume 25, Issue 6, pp 459–465 | Cite as

Signal Selection and Follow-Up in Pharmacovigilance

  • Ronald H.B. Meyboom
  • Marie Lindquist
  • Antoine C.G. Egberts
  • I. Ralph Edwards
Short Communication

Abstract

The detection of unknown and unexpected connections between drug exposure and adverse events is one of the major challenges of pharmacovigilance. For the identification of possible connections in large databases, automated statistical systems have been introduced with promising results. From the large numbers of associations so produced, the human mind has to identify signals that are likely to be important, in need of further assessment and follow-up and that may require regulatory action. Such decisions are based on a variety of clinical, epidemiological, pharmacological and regulatory criteria. Likewise, there are a number of criteria that underlie the subsequent evaluation of such signals. A good understanding of the logic underlying these processes fosters rational pharmacovigilance and efficient drug regulation. In the future a combination of quantitative and qualitative criteria may be incorporated in automated signal detection.

Keywords

Agranulocytosis Erythema Multiforme Proportional Reporting Ratio Individual Case Report Pharmacoepidemiological Study 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

We gratefully acknowledge the valuable discussions regarding signal detection during recent meetings of the Uppsala Monitoring Centre Signal Review Panel.

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Copyright information

© Adis International Limited 2002

Authors and Affiliations

  • Ronald H.B. Meyboom
    • 1
    • 2
    • 3
  • Marie Lindquist
    • 1
  • Antoine C.G. Egberts
    • 2
    • 4
  • I. Ralph Edwards
    • 1
  1. 1.The Uppsala Monitoring CentreUppsalaSweden
  2. 2.Department of Pharmacoepidemiology and PharmacotherapyUtrecht Institute for Pharmaceutical SciencesUtrechtThe Netherlands
  3. 3.Netherlands Pharmacovigilance Foundation Lareb’s-HertogenboschThe Netherlands
  4. 4.Hospital Pharmacy Midden-Brabant, TweeSteden Hospital and St Elisabeth HospitalTilburgThe Netherlands

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