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지역약국에서 보고된 약물유해반응의 분석

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

최광훈|최수안|윤소정|김미혜|신완균|이모세|유윤미
한국임상약학회 (Korean College Of Clinical Pharmacy)|2014.03|한국임상약학회지 (Korean Journal of Clinical Pharmacy)|제24권 제1호|pp. 45-52

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키워드

PharmacovigilanceOutpatientsAdverse drug reactionsCommunity pharmacy
주제분류약학

초록

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 bycommunity pharmacy to Regional Pharmacovigilance Center of Korean Pharmaceutical Association were included. Thecausality of ADRs was assessed by the criteria of WHO-Uppsala Monitoring Centre. The clinical features and theoffending drugs were analyzed using the WHO-Adverse Reaction Terminology and the classification of American HospitalFormulary Service Drug Information, respectively. Results: 2,826 (97.0%) of the total 2,912 ADRs had causalrelationship. 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. Analgesicdrugs (19.7%), gastrointestinal drugs (17.7%), and central nervous system drugs (11.0%) were prevalent offendingdrugs. The leading causative generic drug was the complex of acetaminophen and tramadol. Among 203 ADRs by thenonprescription drugs, the most common clinical features were skin (37.4%) and gastrointestinal (23.6%) symptoms andthe most prevalent offending drugs were analgesic drugs (40.0%) and mucocutaneous system drugs (16.3%). The combinationof 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 commoncausative drug in outpatient ADRs reported by community pharmacy.

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 bycommunity pharmacy to Regional Pharmacovigilance Center of Korean Pharmaceutical Association were included. Thecausality of ADRs was assessed by the criteria of WHO-Uppsala Monitoring Centre. The clinical features and theoffending drugs were analyzed using the WHO-Adverse Reaction Terminology and the classification of American HospitalFormulary Service Drug Information, respectively. Results: 2,826 (97.0%) of the total 2,912 ADRs had causalrelationship. 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. Analgesicdrugs (19.7%), gastrointestinal drugs (17.7%), and central nervous system drugs (11.0%) were prevalent offendingdrugs. The leading causative generic drug was the complex of acetaminophen and tramadol. Among 203 ADRs by thenonprescription drugs, the most common clinical features were skin (37.4%) and gastrointestinal (23.6%) symptoms andthe most prevalent offending drugs were analgesic drugs (40.0%) and mucocutaneous system drugs (16.3%). The combinationof 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 commoncausative drug in outpatient ADRs reported by community pharmacy.

참고문헌 (28)

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