Objectives
The aim of EUROmediCAT is to develop a European reproductive pharmacovigilance system.
The specific objectives of the FP7 funded EUROmediCAT project were:
|
1
|
To develop and test an efficient system for safety evaluation of drugs during pregnancy. This is based on an existing network of congenital anomaly registers in Europe (EUROCAT) combined with existing healthcare databases |
| |
- To develop further the EUROCAT database for systematic case-malformed control surveillance identifying associations between specific drugs and specific malformations, for signal detection and evaluation
- To develop and test linkage between registers and population-based prescription databases for signal detection and evaluation
- To develop and test linkage between registers and cohorts of pregnancy women with chronic diseases for signal detection and evaluation
- To evaluate further healthcare databases across Europe for their potential utility for drug safety in pregnancy research
|
| 2 |
To quantity the risk of congenital anomaly related to four drug classes: |
| |
- New antiepileptics
- Insulin analogues
- Anti-asthmatics
- Antidepressants, in particular the selective serotonin re-uptake inhibitors
|
| 3 |
To develop a framework for evaluation of the efficacy of pregnancy-related drug safety measures including: |
| |
- Drug utilisation studies
- Monitoring of the effectiveness of pregnancy prevention programmes
- A scoping study of the role of internet acces by pregnant women to drugs, and to safety information
|