The Clinical Research Information eXchange (CRIX) International has announced their participation with Pfizer, Partners HealthCare and the Clinical Data Interchange Standards Consortium (CDISC) in the ASTER (Adverse Drug Event Spontaneous Triggered Electronic Reporting) study, which is exploring ways to improve the current spontaneous reporting system (SRS), the primary source of information for adverse drug events. The ASTER study is exploring how a combination of standards, technology and a new business model can improve drug safety by helping physicians better recognize and report adverse events, and by improving the quality of data in safety reports. The healthcare industry has long understood the need for computerized monitoring and technologies that ease – or automate – reporting of adverse medical reactions. “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 International. “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 Capture (RFD) standard to automatically recognize adverse drug events recorded in the Longitudinal Medical Record (LMR), an electronic health record system currently in use at Brigham and Women’s Hospital and Massachusetts General Hospital, founding members of Partners HealthCare. The system will automatically populate an ADE report from the LMR thereby eliminating the burden of transcribing data from one system to another. An essential part of the study is to pilot a new business model for safety reporting which uses CRIX International to provide the data collection, processing and reporting services. CRIX will be able to receive the ADE reports directly from Partners HealthCare and will forward them electronically to FDA and to drug manufacturers. This will result in a time from recognition of the event until FDA receives the report of a matter of minutes. The project will run through 2009 pending quarterly performance benchmarks. “Working collaboratively with Partners HealthCare and CDISC through CRIX, we are exploring innovative methods to improve the information flow about patient experiences with medicines. The goal is to advance the quality of data relating to benefits and risks of medicines, thereby giving physicians and patients better treatment options,” said Michael Ibara, Pfizer’s Head of Pharmacovigilance Information Management. “This project has the potential to greatly improve patient safety by streamlining adverse drug event reporting for all healthcare organizations while closely guarding patient privacy,” said Jeffrey A. Linder, MD, MPH, Assistant Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital and Principle Investigator of the ASTER study. 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), three of the leading healthcare industry organizations.
