The limitations of some European healthcare databases for monitoring the effectiveness of pregnancy prevention programmes as risk minimisation measures
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Pregnancy prevention programmes (PPPs) exist for some medicines known to be highly teratogenic. It is increasingly recognised that the impact of these risk minimisation measures requires periodic evaluation. This study aimed to assess the extent to which some of the data needed to monitor the effectiveness of PPPs may be present in European healthcare databases.
An inventory was completed for databases contributing to EUROmediCAT capturing pregnancy and prescription data in Denmark, Norway, the Netherlands, Italy (Tuscany/Emilia Romagna), Wales and the rest of the UK, to determine the extent of data collected that could be used to evaluate the impact of PPPs.
Data availability varied between databases. All databases could be used to identify the frequency and duration of prescriptions to women of childbearing age from primary care, but there were specific issues with availability of data from secondary care and private care. To estimate the frequency of exposed pregnancies, all databases could be linked to pregnancy data, but the accuracy of timing of the start of pregnancy was variable, and data on pregnancies ending in induced abortions were often not available. Data availability on contraception to estimate compliance with contraception requirements was variable and no data were available on pregnancy tests.
Current electronic healthcare databases do not contain all the data necessary to fully monitor the effectiveness of PPP implementation, and thus, special data collection measures need to be instituted.
KeywordsPregnancy Teratogen Pregnancy prevention programme Electronic health records Isotretinoin
The authors wish to thank Professor Corinne de Vries for her valuable contribution to the initial stages of this work. The authors would also like to acknowledge the input from the EUROmediCAT Steering Group members who reviewed this paper.
This study was part of the EUROmediCAT research project (www.euromedicat.eu) which has been supported by the European Commission under the 7th Framework Programme Grant agreement n° 260598.
Compliance with ethical standards
Conflicts of interest
RA Charlton, HJ Bos, E Garne, AV Hansen, LTW de Jong-van den berg, S Jordan, K Klungsøyr, A Pierini, M Sinclair, D Thayer and H Dolk had financial support from the European Union for the submitted work under the 7th Framework Programme (Grant agreement HEALTH-F5-2011-260598). AJ Neville was paid as a consultant to the Retinoids Consensus Conference and works for the IMER Registry which is financed by the Emilia Romagna Health Authority. V Bettoli, A Engeland, R Gini and A Puccini have no conflicts of interest to report relevant to the content of this manuscript.
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