The objective is to study possible side effects related to drug use during pregnancy using classical epidemiological designs. The study will focus upon asthma drugs, antibiotics benzodiazepines, non-steroidal anti-inflammatory drugs, neuroleptic and antidepressant drugs and ovulation-induced treatment of infertility. A number of different data sources are used.
Proposal summary pregnant women are usually excluded from medical trials and results from animal studies need not apply to human populations. Treating pregnant women with some drugs is thus often a problem and most clinicians have a rather restricted approach to use of drugs during pregnancy. On the other hand, there are situations where treatment cannot and should not always be avoided.
Existing adverse drug reaction monitoring systems based on spontaneous reporting do not provide data which allows risk assessment and large scale follow-up studies are very difficult if not impossible to conduct in most European countries. In this respect the Scandinavian countries and Hollanc offer a unique opportunity to set up large scale studies which use the existing population registers and health monitoring systems to provide data on the short-term and long-term safety of over-the-counter and prescribed drugs in pregnancy. Still, very large-scale studies in this field have not been conducted within a proper epidemiological framework in the last 40 years, and recent small-scale studies indicate side effects related to commonly used drugs in pregnancy presently in Europe. The present application is collaboration between a number of European research teams with access to a number of existing data sets and studies in progress. The purpose of this collaboration is to exploit the joint knowledge of the research teams in order to solve two fundamental problems in epidemiological studies on consequences of drug intake in pregnancy: the problems concerning sample size and control for confounding. The existing datasets include the North Jut land Prescription Data base, Denmark and the Norwegian Birth Registry and the Norwegian Medical Birth Registry routine notification of exposure, nested case control data on exposure), the Jamt land data base and the Medical Birth Registry in Sweden, EUROCAT (European Registration of Congenital Anomalies) and the Hungarian Case control Surveillance of Congenital Abnormalities. Moreover, two new prospective cohorts will be established in Denmark and Norway including 200,000 pregnancies.
Exposure data will be collected in telephone interviews twice during pregnancy and by means of a self-administered questionnaire covering the last trimester. These cohorts provide opportunities for following the children over many years through existing registries aiming at e.g. chronic diseases, cancer and neurological development. Establishing funds for the proposed concerted action will make joint analyses possible and add analytical skills to data analyses and detailed project planning. The study would permit Europe to take a leading position in screening safe use of drugs in pregnancy. The studies will focus on a number of outcomes besides congenital malformations and deal primarily with drugs in the following groups: asthma drugs, antibiotics, benzodiazepines, NSAIDs, neuroleptics and antidepressants and ovulation-induced treatment for infertility.
Keywords: Drug, Pharmacoepidemiology, Pregnancy, Drug utilization, Druc Safety, Post-marketing surveillance.