The ConcePTION project has validated a novel method to evaluate the quality of real-world pregnancy pharmacovigilance data. The validation is based on 186 case reports. The results are published in Drug Safety, and represents an advancement in how data on medication safety during pregnancy is collected and assessed.

Pregnant women are almost always excluded from clinical studies. This makes it challenging to gather reliable data on the safety of medications during pregnancy. Because of this, much of the available information relies on real-world reports of pregnant women’s experiences of medicine, where the information is collected from other sources than traditional clinical trials.

The researchers used quantitative methods to validate a new standardised tool to assess the quality of real-world pregnancy pharmacovigilance data. The team looked at spontaneous reports, existing literature, and data from different registries, including two Teratology Information Services in the United Kingdom and Switzerland, and the Dutch Pregnancy Drug Register.

According to Eugène van Puijenbroek, Physician and Clinical Pharmacologist at the Netherlands Pharmacovigilance Centre Lareb, the tool is the first pregnancy pharmacovigilance data method that is designed, validated and standardized specifically to assess the quality of clinical information in case reports.

“Our approach confers less inter-rater variability compared with a quality assessment by experts of pregnancy-related pharmacovigilance data,” Eugène van Puijenbroek concludes.

In short, this new method could improve the reliability of pharmacovigilance data. Ultimately enhancing the safety of medicinal products for pregnant women, and their children.

Do you want to know more? Read the paper here: van Rijt-Weetink, Y.R.J., Egberts, T.C.G., van Hunsel, F.P.A.M. et al. Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project. Drug Saf 47, 261–270 (2024). https://doi.org/10.1007/s40264-023-01389-y

By Fanny Klingvall

On 24-28 August, the International Society of Pharmacoepidemiology is organising their 40th annual ISPE Meeting. This year, experts from all across the world are gathering in Berlin, Germany to discuss essential topics in pharmacoepidemiology. Researchers from the ConcePTION project will present and discuss results on pregnancy and infant outcomes and our data-driven approaches.   

Are you attending the 2024 ISPE Annual Meeting? Don’t miss out on the results of the ConcePTION project presented by speakers Giorgio Limoncella, Maarit Leinonen and Anna Girardi, and poster by Alexis Krumme:

Monday 26 Aug, 6:30 PM (CEST)
Giorgio Limoncella is presenting on “Adjusting number of cases, risk, risk difference and risk ratio estimated through an algorithm with unknown sensitivity: a contribution from the ConcePTION project”. See more details →

Tuesday 27 Aug, 2:00 PM (CEST):
Maarit Leinonen is presenting on “Incidence and Survival of Pregnancy Associated Breast Cancer: A Contribution from the IMI ConcePTION Project Piloted in Finland and Norway“. See more details →

Tuesday 27 Aug, Poster Session B:
Alexis Krumme presents a poster on “Pregnancy and infant outcomes in gestationally-diagnosed breast cancer: A pilot study in Finland and Norway from the IMI ConcePTION project“. See more details →

Wednesday 28 Aug, 08.45 AM (CEST):
Anna Girardi is presenting on “Impact of data source diversity on the distribution of key variables in pregnancy cohorts based on the ConcePTION pregnancy algorithm leveraging a random forest imputation model“. See more details →

Do you want to know more about the event? Take part of the full programme and learn more about the 2024 ISPE Annual Meeting on their website.

Sertraline is used to manage several mental health conditions, and it is frequently prescribed during pregnancy and breastfeeding. The ConcePTION project has developed a population pharmacokinetic (popPK) model to describe how the body interacts with the drug during pregnancy and breastfeeding.

Sertraline is used to treat depression, panic attacks, obsessive-compulsive disorder, post-traumatic stress and other mental health disorders. According to the available literature, only small amounts of sertraline are transferred into breast milk and cord blood. However, the existing data is not sufficient to explain significant interindividual variability. Researchers from the ConcePTION project developed a population pharmacokinetic model that is able to characterise sertraline pharmacokinetics in cord blood and breast milk. The model is also designed to assess interindividual variability, and identify covariates responsible for variations between different individuals.

According to Anaëlle Monfort, PhD student at the Université de Montréal’s Faculty of Pharmacy, the model allowed the team to identify two covariates that can influence how much sertraline the infant is exposed to during breastfeeding: the mother’s ability to metabolise the drug (related to a specific enzyme called CYP2C19) and individual variations in the fat content in breast milk.

The model-based simulations suggested that the median daily infant dosage while a mother is being treated with 50 mg sertraline per day is 6.9 μg per kg of the infants body weight, representing 0.95% of the maternal dose adjusted to her weight. The median concentration of sertraline in umbilical cord blood could range from 3.29 to 33.23 ng/mL after maternal daily doses between 25 and 150 mg.

Women who suffer from mental health conditions need treatment during both pregnancy and breastfeeding. “Our results are in line with previous studies, and show that infant exposure is low, which is reassuring, as sertraline is widely used during pregnancy and breastfeeding”, says Anaëlle Monfort.

Want to read the paper? Monfort, A., Cardoso, E., Eap, C.B., Ansermot, N., Crettol, S., Fischer Fumeaux, C.J., Bickle Graz, M., Morisod Harari, M., Weisskopf, E., Gandia, P., Allegaert, K., Annaert, P., Nordeng, H., Hascoët, J-M., Claris, O., Epiney, M., Ferreira, E., Leclair, G., Csajka, C., Panchaud, A., Guidi, M., collaborators of the SSRI Breast Milk study, A population pharmacokinetic model for sertraline in women during the perinatal period—A contribution from the ConcePTION project. Br J Clin Pharmacol, 2024, 1-12. DOI: https://doi.org/10.1111/bcp.16177

By Josepine Fernow