Utrecht coordinates four studies on safe use of medicines during pregnancy
The European Medicines Authority grants Utrecht four projects
Safe use of medicines during pregnancy is an important topic for the European Medicines Authority (EMA). Recently, label changes concerning drug use during pregnancy have been made for valproate, a drug used in epilepsy and in bipolar disorder, and for products containing retinoids, used to treat acne. The changes involved information for doctors, pharmacists and patients, as well as a pregnancy prevention programma.
In order to assess the impact of these safety measures, EMA has requested four studies to be carried out: two aimed at assesing risk awareness and adherence to the label changes by health care professionals and patients. The other two focused on assessing utilisation as well as prescribing trends.
Awarded
The Pharmacoepidemiology and Pharmacovigilance (PE & PV) Research Network led by the division of Pharmacoepidemiology and Clinical Pharmacology at Utrecht University was awarded all four studies. The EU PE&PV Research Network brings together eighteen European research centers, including four centres from the Netherlands including the University Medical Centre Utrecht, the Dutch PHARMO institute, the National Institute of Public Health and the Environment, and the National Pharmacovigilance Foundation LAREB. The EU PE&PV Research Network gives access to medical records of more then 65 million patients and together they will carry out the four studies in eight different European countries. The EU PE&PV Research Network and EMA have a five year framework contract that enables collaboration in efficacy and safety studies of medicines.
Both projects have already started and are expected to be finished by the beginning of 2022.
More information about the new regulatory measures related valproate and retinoids: