Healthcare databases in Europe for studying medicine use and safety during pregnancy

Abstract

Purpose The aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy. Methods A sample of electronic healthcare databases that captured pregnancies and prescription data was selected on the basis of contacts within the EUROCAT network. For each participating database, a database inventory was completed. Results Eight databases were included, and the total population covered was 25 million. All databases recorded live births, seven captured stillbirths and five had full data available on spontaneous pregnancy losses and induced terminations. In six databases, data were usually available to determine the date of the woman's last menstrual period, whereas in the remainder, algorithms were needed to establish a best estimate for at least some pregnancies. In seven databases, it was possible to use data recorded in the databases to identify pregnancies where the offspring had a congenital anomaly. Information on confounding variables was more commonly available in databases capturing data recorded by primary-care practitioners. All databases captured maternal co-prescribing and a measure of socioeconomic status. Conclusion This study suggests that within Europe, electronic healthcare databases may be valuable sources of data for evaluating medicine use and safety during pregnancy. The suitability of a particular database, however, will depend on the research question, the type of medicine to be evaluated, the prevalence of its use and any adverse outcomes of interest.

Re: Antiepileptika og medfødte misdannelser

“…Her savner jeg at erfaringsperspektivet nevnes mer eksplisitt, som en viktig del av dette omfattende problemet: Det vil si hvordan skjellsettende livserfaringer i menneskers historie og nåvaerende livssituasjon kan påvirke «den levde kroppen», svekke den og gjøre den syk, for å bruke uttrykket til den franske filosofen Merleau-Ponty (2). Den mangeårige forskningen til Anna Luise Kirkengen gir en grundig dokumentasjon av dette (3).…”

“…EURAP-studien er en slik studie, og EUROmediCAT, hvor vi deltar sammen med representanter for andre EUROCAT-registre, er en annen (3). Håpet er at disse studiene vil gi resultater som kan gjøre det lettere å vurdere terapiform for kvinner med epilepsi og barneønske.…”

“…Dette blir en økning på 50 %. Dette er standarden for å angi overdiagnostikk (3,4). Alternativt kan man si at 33 % (500 av 1500) er overdiagnostikk.…”

Selective serotonin reuptake inhibitor prescribing before, during and after pregnancy: a population‐based study in six European regions

“…A more detailed description of the databases can be found elsewhere. 30 Where multiple databases were linked, such as in Denmark where the information on all pregnancies from the Danish National Patient Register was linked to the Danish National Prescription Registry, for the remainder of this paper these linked databases are referred to as a single database. Ethical and data access approvals were obtained for each database from the relevant governance infrastructures.…”

Health Data for Public Health: Towards New Ways of Combining Data Sources to Support Research Efforts in Europe

“…The heterogeneity of information across Europe has been a major concern to conduct cross-national studies. Projects like EU-ADR [11], EUROmediCAT [12], PROTECT [13], and EMIF [6] have developed their own solutions, mainly based on distributed networks and common data models like OMOP [14]. Thus, several projects in Europe allow cross-national information.…”