Original Article

지역약국에서 보고된 전문의약품과 일반의약품의 이상사례 보고현황 비교 분석


Comparative Analysis of Ethical-the-counter Drugs and Over-the-counter Drugs for the Adverse Events from the Community Pharmacy

이모세, 박소희, 김나영, 오인선, 이정민, 이의경, 신주영

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Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs from community pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reporting database, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Association between January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-thecounter drugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, serious adverse events, and causality assessment results, where causality assessments were performed according to the World Health Organization-The Uppsala Monitoring Centre’s system. Results: We included 17,570 reports (75,451 drug-adverse event pairs). Ethical-the-counter and over-the-counter drugs accounted for 81.4% and 18.6% of the total adverse event reports, respectively. The use of over-the-counter drugs was higher in females and patients aged <18 years, whereas the use of ethical-the-counter drugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the most frequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, “possible” (75.4%) was the most commonly assigned category for ethical-the-counter drugs, while “possible” (44.0%) and “unlikely” (47.7%) were the most common categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-thecounter and over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptoms for both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse event characteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.


연구 방법
전문의약품과 일반의약품의 구분
환자 기본정보 분류
이상사례 증상 분류
원인약물의 분류
이상사례의 인과성 평가
중대 이상사례 존재 여부 분석
처방일반의약품과 비처방일반의약품의 이상사례 보고 양상 비교
연구 결과
전문의약품, 일반의약품 간 인구통계학적 특징
전문의약품, 일반의약품 간 WHO-ART 기관분류 기준 다빈도 부작용 분포
전문의약품, 일반의약품 간 ATC 약물코드 기준 다빈도 의약품 계열 분포
전문의약품, 일반의약품 간 인과성 평가 결과 및 중대 이상사례
일반의약품 처방, 비처방 보고 양상 비교
감사의 말씀


  • 이모세 Mo-Se Lee. 대한약사회 지역의약품 안전센터, 성균관대학교 약학대학
  • 박소희 So-Hee Park. 성균관대학교 약학대학
  • 김나영 Na-Young Kim. 대한약사회 지역의약품 안전센터
  • 오인선 In-Sun Oh. 성균관대학교 약학대학
  • 이정민 Jung-Min Lee. 대한약사회 지역의약품 안전센터
  • 이의경 Eui-kyung Lee. 성균관대학교 약학대학
  • 신주영 Ju-Young Shin. 성균관대학교 약학대학


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