#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
Prostaglandin Eye Drop Use in Preg






Join the conversation on social mediaFollow us on
Facebook, LinkedIn, X, or Bluesky and share your thoughts about
the show with the hashtag #DrugSafetyMatters.

Got a story to share?We’re always looking for new
content and interesting people to interview. If you have a great
idea for a show, get in touch!

About UMCRead more about Uppsala Monitoring Centre
and how we work to advance medicines safety.