Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

The Clinical Characteristics of Adverse Drug Reactions Reported from the Community Pharmacy

지역약국에서 보고된 약물유해반응의 분석

  • Yu, Yun Mi (College of Pharmacy, Seoul National University) ;
  • Choi, Soo An (College of Pharmacy, Seoul National University) ;
  • Lee, Mo Se (Regional Pharmacovigilance center, Korean Pharmaceutical Association) ;
  • Youn, So Jung (Regional Pharmacovigilance center, Korean Pharmaceutical Association) ;
  • Kim, Mi Hye (Regional Pharmacovigilance center, Korean Pharmaceutical Association) ;
  • Choi, Kwang Hoon (Regional Pharmacovigilance center, Korean Pharmaceutical Association) ;
  • Shin, Wan Gyoon (College of Pharmacy, Seoul National University)
  • 유윤미 (서울대학교 약학대학) ;
  • 최수안 (서울대학교 약학대학) ;
  • 이모세 (대한약사회 지역의약품안전센터) ;
  • 윤소정 (대한약사회 지역의약품안전센터) ;
  • 김미혜 (대한약사회 지역의약품안전센터) ;
  • 최광훈 (대한약사회 지역의약품안전센터) ;
  • 신완균 (서울대학교 약학대학)
  • Received : 2013.12.17
  • Accepted : 2014.02.07
  • Published : 2014.03.31
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Abstract

Objective: To evaluate the clinical manifestations and causative drugs of the outpatient adverse drug reactions (ADRs) reported by community pharmacy. Methods: From April 2013 to September 2013, all outpatient ADRs reported by community pharmacy to Regional Pharmacovigilance Center of Korean Pharmaceutical Association were included. The causality of ADRs was assessed by the criteria of WHO-Uppsala Monitoring Centre. The clinical features and the offending drugs were analyzed using the WHO-Adverse Reaction Terminology and the classification of American Hospital Formulary Service Drug Information, respectively. Results: 2,826 (97.0%) of the total 2,912 ADRs had causal relationship. The 1,923 patients with mean age of 55.1 years and female fraction of 66.5% were included in the ADRs. Gastrointestinal (33.6%), nervous system (14.9%), and skin (13.5%) symptoms were common in ADRs. Analgesic drugs (19.7%), gastrointestinal drugs (17.7%), and central nervous system drugs (11.0%) were prevalent offending drugs. The leading causative generic drug was the complex of acetaminophen and tramadol. Among 203 ADRs by the nonprescription drugs, the most common clinical features were skin (37.4%) and gastrointestinal (23.6%) symptoms and the most prevalent offending drugs were analgesic drugs (40.0%) and mucocutaneous system drugs (16.3%). The combination of acetaminophen and chlorzoxazone was the leading causative generic in nonprescription drugs. Conclusion: In this study, gastrointestinal symptom was the most common manifestation and analgesic drug was the most common causative drug in outpatient ADRs reported by community pharmacy.

Keywords

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