Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?

Authors

  • G. Trifirò,

    Corresponding author
    1. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands
    2. Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
    • Correspondence: Gianluca Trifirò, MD, PhD, Department of Medical Informatics, Erasmus University Medical Center, Dr Molewaterplein 50, 3015 GE Rotterdam, the Netherlands. (fax: +31-10-7044722; e-mail: g.trifiro@erasmusmc.nl).

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  • P. M. Coloma,

    1. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands
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  • P. R. Rijnbeek,

    1. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands
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  • S. Romio,

    1. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands
    2. Department of Clinical and Preventive Medicine, Università Milano-Bicocca, Milan, Italy
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  • B. Mosseveld,

    1. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands
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  • D. Weibel,

    1. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands
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  • J. Bonhoeffer,

    1. Brighton Collaboration Foundation, Basel, Switzerland
    2. University Children's Hospital Basel, University of Basel, Basel, Switzerland
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  • M. Schuemie,

    1. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands
    2. Janssen Research and Development LLC, Titusville, NJ, USA
    3. Observational Medical Outcomes Partnership, Foundation for the National Institutes of Health, Bethesda, MD, USA
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  • J. van der Lei,

    1. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands
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  • M. Sturkenboom

    1. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands
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Abstract

A growing number of international initiatives (e.g. EU-ADR, Sentinel, OMOP, PROTECT and VAESCO) are based on the combined use of multiple healthcare databases for the conduct of active surveillance studies in the area of drug and vaccine safety. The motivation behind combining multiple healthcare databases is the earlier detection and validation, and hence earlier management, of potential safety issues. Overall, the combination of multiple healthcare databases increases statistical sample size and heterogeneity of exposure for postmarketing drug and vaccine safety surveillance, despite posing several technical challenges. Healthcare databases generally differ by underlying healthcare systems, type of information collected, drug/vaccine and medical event coding systems and language. Therefore, harmonization of medical data extraction through homogeneous coding algorithms across highly different databases is necessary. Although no standard procedure is currently available to achieve this, several approaches have been developed in recent projects. Another main challenge involves choosing the work models for data management and analyses whilst respecting country-specific regulations in terms of data privacy and anonymization. Dedicated software (e.g. Jerboa) has been produced to deal with privacy issues by sharing only anonymized and aggregated data using a common data model. Finally, storage and safe access to the data from different databases requires the development of a proper remote research environment. The aim of this review is to provide a summary of the potential, disadvantages, methodological issues and possible solutions concerning the conduct of postmarketing multidatabase drug and vaccine safety studies, as demonstrated by several international initiatives.

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