Data safety and drug safety in Germany: a closing gap?
Pharmacoepidemiology and drug utilization research are more and more involved in a fundamental conflict with data privacy regulations in Germany. In an attempt to close this gap, a working group of German data protection commissioners and representatives from epidemiologic research societies published guidelines on epidemiology and data protection, which are briefly reviewed. There are several data sources for drug utilization research and pharmacoepidemiology in Germany (national health surveys, routine data from hospitals, general practitioners, or statutory health insurance companies) allowing descriptive and analytic epidemiologic studies. Furthermore, since 1980 a random sample of all prescriptions of patients from statutory health insurances (GKV-Arzneimittelindex) is analysed to produce an annual report on prescription drug use. More intensive use of health insurance data for evaluation of medical care including drug prescriptions is in discussion. The MediPlus (IMS HEALTH) database on 400 general and internal medicine practices provides an example to close the gap between the current demand for drug safety studies and data privacy issues. Finally, large provider systems with enormous data storage and data flow are emerging. Therefore, a further development of policies to guarantee ethically correct use of personally identifiable health data in the changing health care environment is urgently required.
Rathmann
W
W
Diabetes Research Institute, Department of Biometrics and Epidemiology, Auf'm Hennekamp 65, D-40225 Düsseldorf, Germany. rath@ddfi.uni-duesseldorf.de
D001675:Bioethics; D016208:Databases, Factual / Q000592:standards* / Q000706:statistics & numerical data; D004363:Drug Utilization; D064420:Drug-Related Side Effects and Adverse Reactions; D005858:Germany / Q000453:epidemiology; D006801:Humans; D017891:Pharmacoepidemiology / Q000379:methods* / Q000592:standards; D018907:Privacy / Q000331:legislation & jurisprudence*; D012107:Research Design