Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Comparative Analysis of Ethical-the-counter Drugs and Over-the-counter Drugs for the Adverse Events from the Community Pharmacy

지역약국에서 보고된 전문의약품과 일반의약품의 이상사례 보고현황 비교 분석

  • Lee, Mo-Se (Regional pharmacovigilance center, The Korea Pharmaceutical Association) ;
  • Park, So-Hee (School of pharmacy, Sungkyunkwan University) ;
  • Kim, Na-Young (Regional pharmacovigilance center, The Korea Pharmaceutical Association) ;
  • Oh, In-Sun (School of pharmacy, Sungkyunkwan University) ;
  • Lee, Jung-Min (Regional pharmacovigilance center, The Korea Pharmaceutical Association) ;
  • Lee, Eui-kyung (School of pharmacy, Sungkyunkwan University) ;
  • Shin, Ju-Young (School of pharmacy, Sungkyunkwan University)
  • 이모세 (대한약사회 지역의약품 안전센터) ;
  • 박소희 (성균관대학교 약학대학) ;
  • 김나영 (대한약사회 지역의약품 안전센터) ;
  • 오인선 (성균관대학교 약학대학) ;
  • 이정민 (대한약사회 지역의약품 안전센터) ;
  • 이의경 (성균관대학교 약학대학) ;
  • 신주영 (성균관대학교 약학대학)
  • Received : 2018.04.23
  • Accepted : 2018.06.14
  • Published : 2018.09.03
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Abstract

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-the-counter 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-the-counter 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.

Keywords

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