Earticle

약물요법에 있어 약물이상반응은 환자의 사망률과 이환율에 영향을 미치는 중요한 요인이다. 약물이상반응 발생시 이를 신속히 보고하는 것과 함께 약물치료과정에서 일어날 수 있는 약물 관련부작용을 조기에 인지하고 능동적으로 조치함으로써 환자에게 가해지는 위해를 최소화하는 것 또한 실제 환자치료의 질적인 관리에서 중요한 부분이다. 본연구에서는 의료기록의 전산화에 따른 전산데이터들을 활용한 약물이상반응감시방법 중 하나로 평가 받고 있는Computerized surveillance system (CSS)에 대한 사례 연구들의 방법들을 비교해 보고, 제시된 관련 시그널들 중약물이상반응을 능동적인 방법 즉 실시간 혹은 예방적으로 적용 가능한 시그널들을 찾아 정리해 보고자 하였다. 이를 위해 가장 대표적인 연구가 진행되었던 연구사례들을 분석하였고 약 20여 개의 시그널들을 선정하여 분야별로 제시하였다.

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.

A computerized surveillance system is the most recent tool to monitor, identify and prevent ADEs, based on alerts generated by matching signals such as abnormal lab data with electronic medical records (EMRs). Since this system has been proven to be simple and cost-effective in detecting ADEs, there is a growing trend towards routine application. The objectives of this study were to implement the system in Samsung Medical Center (SMC), a 1300-bed tertiary hospital, and evaluate its applicability and validity in terms of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). The retrospective analysis was performed using 1-month EMRs in 598 discharged patients from 2 ICUs and 5 general wards. Alerts as potential indicators of ADEs were generated by this system using our modified signals. Patient charts were carefully reviewed by clinical pharmacists to detect ADEs and to verify whether these ADEs were also recognized by the signals. A total of 718 alerts were generated by the system and 187 ADEs were detected by chart review. One hundred forty eight alerts were found to be associated with ADEs. The sensitivity of the modified signals for identifying ADEs was estimated to be 79.1 (95% confidence interval [CI], 73.3~85.0) percent, and the estimated specificity was 29.2 (95% CI, 26.1~32.3) percent. The PPV and the NPV were 20.6 (95% CI, 17.7~23.6) percent and 85.8 (95% CI, 81.6~89.9) percent, respec tively. Our computerized surveillance system showed that the sensitivity value was higher (79.1% vs. ca 50%) and the specificity was lower (29.2% vs. ca 70~80%) than those reported in the literature. It would be necessary to further modify the signals to improve the specificity and rate of ADE detection. More studies will be needed to confirm the usefulness and cost-effectiveness of this system.

Background: Although, in Korea, adverse event would be a serious healthcare problem like many western countries, patient safety is not a major concern among medical informaticist, clinicians, and policy makers. We need to understand the utility of the computerized adverse events surveillance system(AESS) which is the most cost-effective method to detect and prevent patient injury. Objective: To review methodologies of detecting adverse events using information technology, adverse drug event surveillance system, critical laboratory alerting system, and adverse medical device event surveillance system. Methods: Recent studies on adverse event surveillance using information technology were reviewed. Results: For each system, the author reviewed essential concepts, signals and rules, software system architectures, review processes, and effect of system implementations related to AESS. Conclusion: If the utility of AESS is proved and professional consensus is formulated among medical informaticist, computerized detection of adverse events could be practical on a widespread basis in Korea.