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Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?
J Intern Med. 2014 Jun; 275(6):551-61.JI

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.

Authors+Show Affiliations

Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

24635221

Citation

Trifirò, G, et al. "Combining Multiple Healthcare Databases for Postmarketing Drug and Vaccine Safety Surveillance: Why and How?" Journal of Internal Medicine, vol. 275, no. 6, 2014, pp. 551-61.
Trifirò G, Coloma PM, Rijnbeek PR, et al. Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how? J Intern Med. 2014;275(6):551-61.
Trifirò, G., Coloma, P. M., Rijnbeek, P. R., Romio, S., Mosseveld, B., Weibel, D., Bonhoeffer, J., Schuemie, M., van der Lei, J., & Sturkenboom, M. (2014). Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how? Journal of Internal Medicine, 275(6), 551-61. https://doi.org/10.1111/joim.12159
Trifirò G, et al. Combining Multiple Healthcare Databases for Postmarketing Drug and Vaccine Safety Surveillance: Why and How. J Intern Med. 2014;275(6):551-61. PubMed PMID: 24635221.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how? AU - Trifirò,G, AU - Coloma,P M, AU - Rijnbeek,P R, AU - Romio,S, AU - Mosseveld,B, AU - Weibel,D, AU - Bonhoeffer,J, AU - Schuemie,M, AU - van der Lei,J, AU - Sturkenboom,M, PY - 2014/3/19/entrez PY - 2014/3/19/pubmed PY - 2014/7/25/medline KW - claims database KW - drug monitoring KW - electronic health records KW - postmarketing KW - product surveillance KW - vaccine SP - 551 EP - 61 JF - Journal of internal medicine JO - J. Intern. Med. VL - 275 IS - 6 N2 - 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. SN - 1365-2796 UR - https://www.unboundmedicine.com/medline/citation/24635221/Combining_multiple_healthcare_databases_for_postmarketing_drug_and_vaccine_safety_surveillance:_why_and_how L2 - https://doi.org/10.1111/joim.12159 DB - PRIME DP - Unbound Medicine ER -