Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions

Eugène van Puijenbroek, Willem Diemont, Kees van Grootheest

    Research output: Contribution to journalArticleAcademicpeer-review

    126 Citations (Scopus)

    Abstract

    The primary aim of spontaneous reporting systems (SRSs) is the timely detection of unknown adverse drug reactions (ADRs), or signal detection. Generally this is carried out by a systematic manual review of every report sent to an SRS. Statistical analysis of the data sets of an SRS, or quantitative signal detection, can provide additional information concerning a possible relationship between a drug and an ADR. We describe the role of quantitative signal detection and the way it is applied at the Netherlands Pharmacovigilance Centre Lareb. Results of the statistical analysis are implemented in the traditional case-by-case analysis. In addition, for data-mining purposes, a list of associations of ADRs and suspected drugs that are disproportionally present in the database is periodically generated. Finally, quantitative signal generation can be used to study more complex relationships, such as drug-drug interactions and syndromes. The results of quantitative signal detection should be considered as an additional source of information, complementary to the traditional analysis. Techniques for the detection of drug interactions and syndromes offer a new challenge for pharmacovigilance in the near future.

    Original languageEnglish
    Pages (from-to)293-301
    Number of pages9
    JournalDrug Safety
    Volume26
    Issue number5
    Publication statusPublished - 2003

    Keywords

    • Adverse Drug Reaction Reporting Systems
    • Data Interpretation, Statistical
    • Drug Interactions
    • Humans
    • Netherlands

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