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
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Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs fromcommunity pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reportingdatabase, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Associationbetween January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-thecounterdrugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, seriousadverse events, and causality assessment results, where causality assessments were performed according to the World HealthOrganization-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-counterdrugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the mostfrequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, “possible” (75.4%) wasthe most commonly assigned category for ethical-the-counter drugs, while “possible” (44.0%) and “unlikely” (47.7%) were the mostcommon categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-thecounterand over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptomsfor both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse eventcharacteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.
Abstract
Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs fromcommunity pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reportingdatabase, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Associationbetween January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-thecounterdrugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, seriousadverse events, and causality assessment results, where causality assessments were performed according to the World HealthOrganization-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-counterdrugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the mostfrequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, “possible” (75.4%) wasthe most commonly assigned category for ethical-the-counter drugs, while “possible” (44.0%) and “unlikely” (47.7%) were the mostcommon categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-thecounterand over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptomsfor both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse eventcharacteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.
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