약국기반 부작용 보고 자료를 이용한 연령금기 의약품의 이상사례 보고 현황

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.