국내 시판 항생제의 허가 용량 및 용법의 적정성에 대한 고찰 : 국내 약제사용설명서(package insert)와 미국 Physicians' Desk Reference의 비교

Abstract

Background The appropriate usage of antibiotics needs informations such as its effectiveness for a given infection, administration route, the amount of effective dose, and the dose intervals. In this study, in order to find any significant discrepancy regarding to the details of explanation of the necessary information for appropriate antibiotic usages, we compares informations about 51 antibiotics, one from package inserts in Korea and the other from physician's desk reference (PDR) certified by FDA in the United States of America.

Materials and Methods Package inserts about antibiotics, only oral or parenteral agent, wereperused to collect three categories of data: the recommended dosage, dose interval, and adjustment of dose to indications or the severity of infection. These data available in Korea were compared with 61 antibiotics (32 oral and 29 parenteral agents) cited in PDR.

Results Package inserts for 51 antibiotics were gathered, because the remaining 10 antibiotics in PDR are not domestically commercialized. Among data on antibiotics comparable with those in PDR, 59% (30 cases: 15 oral and 15 parenteral agents) suggested the dose similar to that of PDR, 37% (19 cases: 8 oral and 11 parenteral agents) recommend less dose, and 4% in only 2 oral agents showed more dose. About half of the drugs recommending lower dosage were imported from Japanese pharmaceutical company, and the recommended doses of these antimicrobial agents were similar to those in Japan. About 59% (30 cases: 15 oral and 15 parenteral agents) directed dose interval or duration similar to those of PDR and 17% (9 parenteral agents) suggested less administration or longer duration. Surprisingly, in contrast to only 6% (3 cases) of PDR, 24% (12 cases : 10 oral and 2 parenteral agents) recommended more administration or shorter duration. About 39% (24 cases: 13 oral and 7 parenteral agents) revealed no information for dose adjustment commons to indications or the severity of infection.

Conclusion This study revealed that many guidelines in Korea recommend lower doses and/or unreasonable dose intervals. In future studies, improved antibiotic usage guidelines should be established based on pharmacokinetic and pharmacodynamic researches, on the aspect of optimal dosage, dose interval, and dose adjustment commensurate to the indications and the severity of the infection.