Monitoring of drug safety during pregnancy


Lareb performed a web-based questionnaire study to gain insight in current international practices in the monitoring of drug use during pregnancy and its risks. Also future plans and need for support of nationals pharmacovigilance (PV) centres in this field was investigated. It was concluded that PV centres activities concerning monitoring the risk of drug use during pregnancy are limited. The lack of signal detection in many of the PV centres show that there is a need to increase the analysis capacity.

The questionnaire was sent to 172 PV centres and had a response rate of 40%. There is a large difference in current practice regarding the monitoring of the safe use of drugs during pregnancy between the national PV centres. Signal detection, with focus on the pregnant woman, is carried out by 8 out of 58 PV centres (13.8%). Most PV centres mention they have the intention to implement or improve their activities, mainly in spontaneous reporting (69.4%) and methods for signal detection (67.2%). 

It is important that PV centres are supported in order to achieve their intention to improve their systems and implement new activities. This study demonstrated that support is needed for the entire process of monitoring the safety of drug use during pregnancy from collecting the right information, performing signal detection and informing healthcare professionals and the public about drug use during pregnancy. Programs 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 safe use of drugs during pregnancy.

In order to support PV centres, the Netherlands Pharmacovigilance Centre Lareb, under the guidance of WHO, is developing a Pregnancy PV Toolkit. This toolkit will provide a collection of resources and information which will aid countries who wish to develop their surveillance of drug use during pregnancy.

Reference: 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 Safety (2019) 42:35–43