The Clinical Research Information eXchange (CRIX) International is participating with Pfizer, Partners HealthCare and the Clinical Data Interchange Standards Consortium (CDISC) in the ASTER study to explore ways to improve the spontaneous reporting system (SRS), the primary source of information for adverse drug events.
The ASTER (Adverse Drug Event Spontaneous Triggered Electronic Reporting) study is exploring how a combination of standards, technology and a new business model could improve drug safety by helping physicians better recognize and report adverse drug events (ADEs), and by improving the quality of data in safety reports.
The healthcare industry has long understood the need for computerized monitoring and technologies that automate reporting of adverse medical reactions, according to CRIX.
“Analyzing data on adverse events is only effective if the data is accurate and complete, which is not always the case with the current SRS,” said James Bland, executive director of CRIX. “By making the reporting system easier and broadening the pool of reporters, we will create a database that will vastly improve the system.”
The study is using CDISC’s retrieve form for data (RFD) capture to recognize adverse drug events recorded in the longitudinal medical record, an EHR system currently in use at Brigham and Women’s Hospital and Massachusetts General Hospital, founding members of Partners HealthCare in Boston. The system will automatically populate an ADE report from the LMR thereby eliminating the burden of transcribing data from one system to another.
One part of the study is to pilot a new business model for safety reporting, which uses CRIX to provide the data collection, processing and reporting services. CRIX will receive the ADE reports directly from Partners and will forward them electronically to the FDA and to drug manufacturers, resulting in a “time-from-recognition” of the event until the FDA receives the report of a matter of minutes. The project will run through 2009, pending quarterly performance benchmarks.
CDISC’s work on SRS is an extension of work begun with Integrating the Healthcare Enterprise (IHE), Health Level 7 (HL7) and the Healthcare Information and Management Systems Society (HIMSS).