약국기반 부작용 보고 자료를 이용한 연령금기 의약품의 이상사례 보고 현황
Current State of Adverse Event Reports Concerned with Age-Contraindicated Drugs on Korea Pharmaceutical Association Database
BACKGROUNDS Inappropriate use of age-contraindicated drugs can cause serious adverse events (AEs) but information about their AE reports is limited. OBJECTIVE The aim of this study is to investigate current state of AE reports concerned with use of contraindicated drugs for specific ages submitted to pharmacies in 2018. METHODS We conducted a safety surveillance study using spontaneous reports of the Korea Pharmaceutical Association in 2018. Study drugs involved 177 age-contraindicated drugs according to the notification of Ministry of Food and Drug Safety. We calculated the proportion of AE reports induced by study drugs among all AE reports, and described their characteristics. Furthermore, we identified drug-AE pairs evaluated as certain, probable, and/or possible in causality assessment and compared them with the labeling information of Lexicomp. RESULTS Of 23,941 AE reports, 98 (0.4%) were reported with use of study drugs; there were no AE reports for study drugs in over 18 years. Among AE reports for study drugs, aged 6-12 years had the most reports (50.0%) and the proportion of AE reports was higher in male (58.7%) than in female (38.8%). When analyzing drug-AE pairs, dihydrocodeine and its AEs were most frequently reported (73.5%). We also identified 19 drug-AE pairs not included in labeling information of Lexicomp, but they were not significant results. CONCLUSION The proportion of AE reports for age-contraindicated drugs was not substantial; however, the adverse events related to dihydrocodeine were still reported. There is a need to monitor the age-contraindicated drugs where adverse events are frequently reported.
목차
Abstract 서론 연구 방법 1. 데이터원과 연구약물 2. 특정연령대 금기 의약품 이상사례 현황 분석방법 연구 결과 고찰 및 결론 감사의 말씀 참고문헌
한국보건사회약료경영학회 [Korean Academy of Social & Managed Care Phemacy]
설립연도
2009
분야
의약학>약학
소개
본 학회는 비영리 학술단체로서 환자의 삶의 질 향상을 위한 약료(pharmaceutical care)가 보장될 수 있도록 약료경영약학(managed care pharmacy)을 발전시키는 데 궁극 목적을 두고 다음과 같은 활동을 전개하여 사회에 기여하며 회원 상호간의 친목을 도모한다.
간행물
간행물명
한국보건사회약료경영학회지 [Journal of Korean Academy of Managed Care Pharmacy]