실시간 약물이상반응 감시체계 구축 및 평가

Abstract

To implement the concurrent CSS in Samsung Medical Center (SMC), we developed signals from the published literatures and evaluated them for identifying inpatients ADRs through ADRs signal-based retrospective reviews in 2004. From this study, we found preventable ADRs was 19~38% of total ADRs. Based on this result, preventable ADRs was focused on. The aims are to introduce the process of developing the concurrent CSS for preventing ADRs, signals, systems for ADRs reports in SMC and communication with clinicians and outcomes from the system during 6 months. The first signals were from the retrospective study in 2004, reevaluation of signals were required for using prospectively. From July 2005 after we modified them, we sent them to 7 physicians, members of ADR monitoring committee in SMC for reviewing, then revised again based on their opinions. Concurrent CSS was applied to Samsung Medical Information System (SMIS) for test at Sept. 2005, the signals were remodified and specified based on the alerted cases to increase the specificity. Finally 37 signals as potential indicators of ADRs were generated by this project. Also for reporting ADRs and for proper communication with clinicians, clinical system in SMIS were developed. During the 6 months, the alert system fired 3,073 times and 487 cases(16%) were classified as preventable ADRs. After notified physicians, 487 cases were reviewed by physicians, and positive predictive value (PPV) of this tool was 44%. ADRs incidence on inpatients is higher than outpatients(3:1). CSS can be used to identify opportunities to prevent or reduce patient injury associated with a preventable ADRs and increase patient safety, increase quality of drug therapy and decrease the extra-cost of the treatment for ADRs. This is the first study to evaluate a CSS prospectively with real-time intervention for reducing injury from a preventable ADRs in Korea. In the future, increasing utilization of this concurrent CSS should have an enormous beneficial impact on the quality of medical care.