#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg & Sara Vidlin

There are many reasons why use of medical products during pregnancy requires special attention. First and foremost, we want to be sure that the medicine is as safe as possible for both the pregnant person and the unborn child. Unfortunately, the safety profiles of medicines used in pregnancy are often incomplete, which makes it difficult for patients and healthcare professionals to make informed decisions.

The Research section at Uppsala Monitoring Centre has a team that is currently focussing their efforts on pregnancy-related pharmacovigilance (PV). In this episode, data scientists Sara Vidlin and Levente Papai, and senior pharmacovigilance scientist Lovisa Sandberg from this team, discuss complexities and challenges of pregnancy-related PV, and new solutions for addressing those challenges. 

Tune in to find out

• Why is the world still behind when it comes to pregnancy-related PV?
• What are the challenges faced by PV assessors wanting to look at pregnancy cases?
• How can healthcare professionals, patients and carers help assessors overcome these challenges, when reporting pregnancy-related adverse drug events?
• How can the VigiBase pregnancy algorithm, and other algorithms, support the identification of pregnancy cases?

How to use the VigiBase pregnancy algorithm

• Users of VigiLyze and VigiBase Custom Searches can use the VigiBase pregnancy algorithm as a filter when performing searches. 
• In the qualitative view in VigiLyze, click on “Filter” -> “Patient” -> “Pregnancy” to apply the filter.

Want to know more?

• Read about the VigiBase pregnancy algorithm in this Uppsala Reports article and in this poster, presented at the International Society of Pharmacoepidemiology (ISPE) 2024 annual meeting. 
• EURAP – an international prospective observational study of pregnancies with antiepileptic drugs. EURAP - International Registry of Antiepileptic Drugs and Pregnancy
• The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files
• The IMI-concePTION project
• Medical Dictionary for Regulatory Activities (MedDRA) support documentation
• Zaccaria C, Piccolo L, Gordillo-Marañón M, et al. Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance. Drug Safety. 2024
• Sakai T, Mori C, Koshiba H, et al. Pregnancy Loss Signal from

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