[Pharmacoepidemiological research with large health databases]

Over the years there has been an increase in the number of pharmacoepidemiological studies using secondary data from large health databases. Administrative health databases consist of data recorded within the health care system for reasons of billing. Physician-based databases use data derived from electronic medical records. In both types of databases, data are recorded prospectively and may include demographic information, lifestyle information, ambulatory consultations, drug prescriptions, ambulatory and in-hospital diagnoses, ambulatory services, laboratory values, hospitalizations and information on death. Health databases are valuable for research on drug utilization and drug effects, but they are also increasingly used for disease epidemiology studies. In recent years, most new drugs within the European Union have been approved with the requirement of active post-marketing surveillance for investigation of drug utilization or monitoring of drug safety. This implies an increasing need for valid data sources. Large health databases are important instruments for the detection of unknown drug risks and for the investigation of new safety signals derived from spontaneous reporting systems.