Surveying US Observational Data Sources and Characteristics for Drug Safety Needs
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Background: Active surveillance for potential drug safety issues requires access to observational healthcare data to identify and evaluate the association between drugs and subsequent outcomes. This study assessed the availability and content of observational data, as well as the interest of the data holder in participating in drug safety surveillance.
Methods: Between January and June 2009 we conducted a two-stage online survey of data holders.The surveys evaluated characteristics of the data sources and populations, as well as the experience of the organization in conducting drug safety evaluations and research. The first-stage ten-question survey was designed to capture basic information about the size of source population and types of data elements available and gauge interest in further participation in this research. The second-stage 70-question survey provided a comprehensive, quantitative and qualitative summary of population characteristics, data capture of drugs, health outcomes, procedures, visits and laboratory results, as well as a descriptive review of the organization’s evaluation and research experience, infrastructure and process and interest in drug safety surveillance.
Results: Of the 70 US organizations that were contacted, 37 agreed to participate in the first stage of the survey. Of these, 26 reported access to data for over 1 million persons, and 9 reported more than 10 million persons. Respondents reflected a wide range of data stakeholders, including claims data aggregators, hospital benchmarking organizations, fiscal intermediaries that reimburse claims and integrated healthcare systems. Among the 21 organizations completing the second-stage survey, the aggregate data represented 540 million persons, 257 million of them currently active. Data sources showed significant variation in size (ranging from 34 000 to 160 million lives) and demographics of underlying populations, length of follow-up and completeness of data capture. Respondents had a median of 9 years coverage across the population, with a maximum of 51 years, and databases utilizing claims data tended to have a lower average length of capture than those using electronic health records. Data holders varied in interest and ability to conduct drug safety surveillance.
Conclusions: Multiple observational databases are needed to meet the requirements for an active drug safety surveillance system. Developing a network of disparate data sources requires careful consideration of the complementary nature of the underlying data and the necessary infrastructure to support coordination across the diverse stakeholder groups.
KeywordsActive Surveillance Common Data Model Observational Database Observational Medical Outcome Partnership Data Holder
This study was sponsored by the Foundation for the National Institutes of Health. J. Marc Overhage is employed by Indiana University, which participated in the survey. The Indiana Network for Patient Care (INPC) is a project of Indiana University. Paul Stang is employed by Johnson & Johnson, one of the donors providing funding for the Observational Medical Outcomes Partnership (OMOP). Patrick Ryan is employed by GlaxoSmithKline, one of the donors providing funding for OMOP. At the time writing this article, Dr Hartzema was on sabbatical at the US Food and Drug Administration. This article expresses the views of the authors and does not necessarily represent those of their affiliated organizations.
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