Safe medication use in pregnancy
The EUROMEDICAT (Euromedicat: Safety of medication use in pregnancy in relation to risk of congenital malformations) project's central aim was to build a system for reproductive safety evaluation. People can then identify systematically and comprehensively the possible adverse effects of a drug during pregnancy. Providing better information on teratogenicity will help women and their providers make better decisions. The project also developed and tested links between registries and women with chronic diseases. Fifteen European EUROCAT (network of population-based registries for the epidemiological surveillance of congenital anomalies) registries in 13 countries and 7 healthcare databases including prescription information in 5 countries were used and linked to generate powerful datasets. EUROMEDICAT tested innovative approaches to linking congenital anomaly registries to both exposed pregnancy cohorts and health care databases. The EUROCAT central database has been updated and now includes more than 166 000 CA registrations including terminations of pregnancy for foetal anomaly. Included are more than 36 000 ATC-coded medication exposures, from a population of 7.2 million births during the period 1995-2012. Researchers also focused on three groups with chronic conditions – epilepsy, diabetes, asthma and a fourth, a set of patients prescribed selective serotonin reuptake inhibitors (SSRIs). The large diabetic cohort has confirmed lack of increased risk of CA when taking insulin analogues compared with the human version. Data on antiasthmatics showed some signals of CA but the complex pattern of prescription means the analysis is difficult to disentangle. Results including the literature review showed the importance of managing asthma actively and avoiding the need for high dose treatment using drugs that may exacerbate CA. For SSRI, the researchers found 15 cases of specific CA caused including congenital heart defects. To address another problem — the use of the Internet to buy potentially unsafe medications without a prescription — research has been completed and a paper on this topic has been published. Online surveys and focus groups showed the importance of investigating women's medication-related behaviour and their use of the internet for information. This project has the potential to help women weigh the risks and benefits of medications. It will also establish an efficient pharmacovigilance system for medication safety in pregnancy. A set of recommendations has been published in the journal Pharmacoepidemiology and Drug Safety.
Keywords
Pregnancy, reproductive safety, CA, chronic conditions, pharmacovigilance
