During the last decade, research using secondary data resources has become increasingly important in the field of pharmacoepidemiology. Pharmacoepidemiological research databases allow the investigation of the effectiveness of drugs and vaccines in the daily routine of care as well as the identification of rare risks of these substances in clinical practice also over long periods of time. At the same time, they facilitate an analysis of drug and vaccine utilization after approval, thus sustainably contributing to knowledge about these substances. They also contribute valuable data for health services research. Since 2004, BIPS has been working on the establishment and maintenance of the project-based German Pharmacoepidemiological Research Database (short GePaRD). GePaRD is based on claims data from statutory health insurance providers and currently includes information on about 20 million persons who have been insured with one of the participating providers since 2004. In addition to demographic data, GePaRD contains information on drug prescriptions, outpatient and inpatient services and diagnoses. Per data year, there is information on approximately 17% of the general population from all geographical regions of Germany.
Using the database for research projects
Access to the database is granted only to BIPS employees within the framework of officially approved research projects. It is not permitted to give third parties access to the data. However, BIPS can be commissioned to carry out officially mandated projects with this data. Project approval is based on the authorization by the SHI providers and the respective governing authorities (e.g., the Federal Insurance Office for national SHI providers). For this purpose, BIPS applies for project-specific permits from the SHI providers. Upon approval, the SHI provider requests official project approval from the governing authority. This may be issued under § 75 SGB X if the interest of the project to public health is superior to the right to personal data protection. The process of approval by the SHI providers and the governing authorities may take several weeks and in some cases even longer.
We would like to thank the statutory health insurance providers AOK Bremen/Bremerhaven, DAK-Gesundheit, hkk Krankenkasse and Techniker Krankenkasse (TK) for their many years of support in establishing the Pharmacoepidemiological Research Database (GePaRD) at BIPS.