Zusammenfassung
In den letzten Jahren zeigt sich eine Zunahme an pharmakoepidemiologischen Studien, die auf Sekundärdaten in Form großer Gesundheitsdatenbanken zurückgreifen. Administrative Datenbanken nutzen Daten, die für die Abrechnung medizinischer Leistungen an den Leistungsträger übermittelt wurden. Arztbasierte Datenbanken verwenden stattdessen elektronisch gespeicherte Behandlungsdaten aus Arztpraxen. In beiden Fällen erfolgt die Erfassung von Verschreibungen und Krankheitsereignissen prospektiv. Je nach Datenquelle können in diesen Datenbanken Informationen zu demographischen Merkmalen, Lebensstilvariablen, ambulanten Arztkontakten, Arzneimittelverordnungen, ambulanten und stationären Diagnosen, ambulanten Leistungen, Laborwerten, Krankenhausaufenthalten und Tod enthalten sein. Damit sind sie eine wertvolle Datenquelle für die pharmakoepidemiologische Forschung, werden aber auch zunehmend für die Untersuchung der Epidemiologie von Erkrankungen eingesetzt. Für die meisten neu zugelassenen Arzneimittel in der Europäischen Union wurde in den letzten Jahren eine aktive Surveillance der Arzneimittelanwendung bzw. der Arzneimittelsicherheit im Rahmen eines Risikomanagementplanes gefordert. Dies bedingt einen erheblichen Bedarf an zuverlässigen und validen Datenquellen. Große Gesundheitsdatenbanken können hier einen wichtigen Beitrag zur Untersuchung der Arzneimittelanwendung nach Markteinführung, zur Identifizierung bislang unerkannter Arzneimittelrisiken und zur raschen Überprüfung von Risikosignalen aus dem Spontanmeldesystem leisten.
Abstract
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.
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Andersohn, F., Garbe, E. Pharmakoepidemiologische Forschung mit Routinedaten des Gesundheitswesens. Bundesgesundheitsbl. 51, 1135–1144 (2008). https://doi.org/10.1007/s00103-008-0648-9
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DOI: https://doi.org/10.1007/s00103-008-0648-9