Drug utilisation studies are used to explore the medical, social and economic effects of the marketing, distribution, prescription and use of a medicine in society. Unlike clinical trials, these studies are performed after a treatment has already been brought to market. In the case of medicine safety in pregnancy and breastfeeding, drug utilisation studies play an important role in filling the knowledge gap, providing a firm foundation for safety studies by contextualising spontaneous reporting of serious adverse events. In a paper recently published in Journal of Pregnancy, the authors outline how these studies should be designed to be useful for this purpose.
The authors present a systematic literature review to identify post-marketing drug utilisation studies of medicines that were brought to market within the last five years and included pregnant or breastfeeding women. From the results of the review, they were able to outline and categorise the information that should be obtained from such studies to inform medicine safety for pregnant and breastfeeding women.
The authors summarise key aspects of a drug utilisation study for new medicines in pregnancy. They also emphasise that drug utilisation studies can be part of larger studies involving the general population or specific groups of women.
“We’re particularly interested in the drug safety utilisation studies for this purpose as they can quickly determine whether there is sufficient data to perform a safety study. First to determine if a new drug is being prescribed in pregnant women, and if it is, to determine which database/s is/are adequate to evaluate the safety of the drug”, says Sandra Lopez-Leon, Director Pharmacoepidemiologist, Novartis Pharma.
However, according to Sue Jordan, Professor of medicines’ management and health services’ research at Swansea University, these studies do not substitute for spontaneous reporting of unexpected, serious adverse events, such as congenital anomalies. Rather, “these studies are an important part of the whole picture of the health and wellbeing of the mother and baby”, Sue Jordan says.
According to the authors, planning drug utilisation studies for new medicines in pregnancy is crucial, preferably before the medicines are brought to market. These studies should cover the first 3 to 5 years after release, include annual reports, and be published in reputable journals. This will help provide a solid foundation for safety studies and helps make sense of reports about serious side effects.
By Anna Holm Bodin
Lopez-Leon, S., Geldhof, A., Scotto, J., Wurst, K., Sabidó, M., Mo, J., Molgaard-Nielsen, D., Bergman, JEH., Phi, XA., & and Jordan, S. Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION, Journal of Pregnancy, 2024:8862801, DOI: 10.1155/2024/8862801