The Boston Collaborative Drug Surveillance Program (BCDSP) was established in 1966. In these early days, post-marketing drug safety studies conducted by BCDSP researchers were still primarily paper-based. Nurse monitors were trained to collect information on standardized forms, conducted interviews of hospitalized patients and collected information on drug exposure, medical problems, and descriptive characteristics. Information collected was then reviewed, validated, and put on computer. Although this approach was labor-intensive, by utilizing this in-hospital monitoring method the BCDSP was able to develop a program to capture all drugs used in hospital, to use this information to conduct formal epidemiology research on a large scale, and to quantify the potential adverse effects of many prescription drugs.
Some of the most clinically relevant discoveries of the BCDSP date back to these early days, including the finding of the protective effect of aspirin on cardiovascular events (PDF: Jick H, Elwood P 1974; PDF: Jick H, Miettinen OS 1976) . Ever since, the BCDSP has played a pioneering role in the development and application of methods in drug epidemiology. By the mid-1970s it became apparent that more efficient data sources would soon replace the in-hospital monitoring data as digitization of medical information became more common. We realized that this electronic data could be used to create large databases and increase the accuracy and efficiency of drug safety research.
One of the first organizations to take advantage of this development was Group Health Cooperative of Puget Sound (GHC), a health maintenance organization located in Seattle, Washington, that had been recording hospital discharge diagnoses on computer since 1972. By 1976 GHC also began recording prescription dispensations on computer. A unique identifier allowed information to be linked between files. The BCDSP began using information from GHC to conduct research in 1978. Anonymized information from GHC on demographics, hospitalizations and dispensed prescriptions was available to the researchers at the BCDSP, and the BCDSP worked with GHC data for 20 years publishing 90 studies using the GHC resource.
Further advances in the field of pharmacoepidemiology came with the collection of the most comprehensive population-based patient information from a true “gatekeeper” health system. The United Kingdom (UK) national health system, where all patient information is collected by the general practitioners, makes the UK an ideal setting to conduct epidemiologic research. In the late 1980s when computers in doctors’ offices were becoming available, BCDSP researchers worked with an organization named VAMP Health to design and implement software for general practitioners to use in maintaining their patient medical records. General practitioners were trained to use this software and agreed to allow their anonymized patient records to be used for research purposes. The resulting database, the Clinical Practice Research Datalink (CPRD) GOLD, formerly known as the General Practice Database (GPRD), is currently administered by the UK Medicines and Healthcare products Regulatory Agency (MHRA). BCDSP and others have conducted extensive and ongoing validation of CPRD GOLD which includes data on diagnoses, drug prescriptions, demographics, outpatient visits, lab data, patient characteristics, and hospitalizations. To date the BCDSP has worked with CPRD GOLD for over 30 years and has published over 200 studies using the CPRD resource. More recently another UK general practice data source, CPRD Aurum, has become available through the CPRD. BCDSP researchers are working with CPRD to conduct validation studies of this new resource.
BCDSP has also conducts study in United States (US) claims data sources including IBM Watson’s MarketScan data, IQVIA PharMetrics data, as well as data from GHC, Kaiser, the Department of Defense healthcare database, and Optum. Thus, we have breadth of experience with different electronic medical data sources and have intimate knowledge of their strengths and limitations.