The Korean Journal of Medicine

The Korean Association of Internal Medicine (대한내과학회)
권호 표지

Analysis of adverse drug reactions collected by an electronic reporting system in a single hospital

단일기관에서 전산을 통해 수집된 자발적 약물유해반응 보고사례들의 분석

Kim, Min-Gang;Kang, Hye-Ryun;Kim, Joo-Hee;Ju, Young-Soo;Park, Sung-Hoon;Hwang, Yong-Il;Jang, Seung-Hun;Kim, Dong-Gyu;Jung, Ki-Suck
김민강;강혜련;김주희;주영수;박성훈;황용일;장승훈;김동규;정기석

  • Published : 20091100
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Abstract

Background/Aims: The recent introduction of computerized surveillance systems has promoted the monitoring of adverse drug reactions (ADRs), a feature that facilitates voluntary reports and enables prompt feedback. To investigate the causative agents and severity of ADRs that occurred in a single hospital, we analyzed the features of 980 ADRs that occurred over 14 months after developing a computerized ADR reporting system in Hallym Sacred Heart Hospital. Methods: ADR data collected prospectively from September 2007 to October 2008 by a computerized reporting system were analyzed. The World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria were used to determinate causality for each ADR. Results: The number of ADR cases reported voluntarily increased rapidly since the introduction of the computerized ADR reporting system. Of the 980 cases, antibiotics (34.5%) were the most common causative drugs, followed by analgesics such as tramadol and its compound (15.2%), radiocontrast media (7.0%), narcotics (5.9%), and nonsteroidal anti-inflammatory drugs (NSAIDs) (5.5%). Fifty-nine (6.0%) and 206 (21.0%) cases were classified as severe and moderate reactions, respectively. The mean age was older in patients with severe ADRs than in patients with non-severe ADRs. The most common clinical features were skin manifestations, such as pruritus, skin eruptions, and urticaria. Gastrointestinal symptoms including nausea, vomiting, and diarrhea were the second most frequently reported ADRs. Among antibiotics, first-generation cephalosporins were the most frequently reported causative drugs, followed by second-generation cephalosporins, penicillin/${\beta}$-lactamase inhibitors, and third-generation cephalosporins. While 11.6% of ADRs related to penicillin/${\beta}$-lactamase inhibitors were classified as severe, there was only one severe ADR (1.1%) for first-generation cephalosporins. Most ADRs were reported equally in men and women, although female cases constituted about two thirds of ADRs associated with tramadol and NSAIDs. Conclusions: We believe that a computerized reporting and replying system promoted the monitoring of ADRs. Antibiotics were reported most frequently as the causative agent of ADRs. Elderly patients seemed to be more susceptible to severe ADRs. With the voluntary reporting system, skin manifestations and gastrointestinal symptoms were detected successfully, while laboratory abnormalities without prominent symptoms seemed to be overlooked. Further efforts to screen for automated ADR signals are required.

저자는 2007년 9월부터 2008년 10월까지 한림대 성심병원에서 보고된 약물유해반응 사례들의 원인약물과 임상양상을 분석하였다. 전산화 시스템을 도입한 이래 보다 효율적으로 약물유해반응을 수집할 수 있었으며, 병동별 약물유해반응 담당자를 정함으로써 안정적인 약물감시체계를 정착시킬 수 있었다. 보고된 1,112건 중 인과성이 있다고 평가된 사례는 980건이었으며, 이 중 원인 약물로 의심되는 약제는 항생제, tramadol, 조영제, 아편계 진통제 순이었다. 보고사례들 나이가 많을수록 증상이 심한 사례의 비율이 높았으며, 성별에 따라서는 여자들의 평균 연령이 남자들보다 높았다. Tramadol, NSAIDs로 인한 약물 유해반응 보고사례에서는 여자가 차지하는 비율이 높았다. 가장 흔한 임상양상은 피부 발진과 두드러기 등의 피부 이상반응이었고, 오심, 구토 등의 소화기계반응이 그 뒤를 이었다.

Keywords

References

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