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Surveillance of Drug Safety During Pregnancy: Insight in Current International Activities, Future Intentions and Need for Support of National Pharmacovigilance Centres



Surveillance of drug safety during pregnancy is a special interest of pharmacovigilance (PV). The role that national PV centres take in this field is, however, unclear.


The aim of this study was to provide insight into current activities, future intentions and need for support of national PV centres in the field of drug safety during pregnancy.


A web-based questionnaire was used to ask PV centres about their current activities concerning the surveillance of drug safety during pregnancy, their intentions to implement or improve activities and need for support. For these three main topics, questions were posed about spontaneous adverse drug reaction (ADR) reporting, additional activities to obtain information, signal detection and informing healthcare professionals and the public.


The questionnaire was sent to PV centres of 172 countries. Response was 40%. In general, the PV centres received limited numbers of reports of ADRs in the (unborn) child, related to drug exposure during pregnancy. Signal detection in pregnancy cases is carried out by 8 out of 58 PV centres (13.5%). Most PV centres mention they have intentions to implement or improve activities, mainly for spontaneous reporting (69.4%) and methods for signal detection (67.2%). Support was needed for all topics of the questionnaire.


Current activities of national PV centres concerning drug safety during pregnancy are limited. The majority of PV centres are, however, willing to improve or implement activities. Programmes should be set up in order to support and stimulate PV centres with these activities. The aim of all these activities is to increase knowledge about the safety of drugs during pregnancy.

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The authors would like to thank Dr. N. Iessa and Dr. S. Pal from the WHO for reviewing this article. The authors are indebted to the national centres that make up the WHO Programme for International Drug Monitoring and contribute reports to VigiBase. However, the opinions and conclusions of this study are not necessarily those of the various centres, nor of the WHO.

Author information




AK is responsible for the questionnaire setup, planning and critical revision of the manuscript. LV is responsible for the questionnaire setup, planning, analysis of the data and the drafting and revision of the manuscript. LR is responsible for analysis of the data and the drafting and revision of the manuscript.

Corresponding author

Correspondence to Leàn Rolfes.

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Conflicts of Interest

Agnes Kant, Loes de Vries and Leàn Rolfes declare that they have no conflicts of interest that are directly relevant to the content of this study.


Writing this article was one of the activities of Lareb as World Health Organization (WHO) Collaborating Centre for Pharmacovigilance in Education and Patient Reporting ( Lareb received support from the WHO Programme for International Drug Monitoring.

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Kant, A., de Vries, L. & Rolfes, L. Surveillance of Drug Safety During Pregnancy: Insight in Current International Activities, Future Intentions and Need for Support of National Pharmacovigilance Centres. Drug Saf 42, 35–43 (2019).

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