Vol.72 No.4 July 2024
Questionnaire survey on antibiotic dosages developed in Japan but not evaluated in clinical trials in the United States
1)Department of Infection Control and Prevention, Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka, Japan
2)Department of Pharmacy, Osaka University Hospital
Abstract
Introduction
Based on the pharmacokinetics/pharmacodynamics theory, there is no conclusive evidence regarding the optimal dosages of antibiotics that are developed in Japan but not evaluated in clinical trials in the United States. Therefore, we conducted this questionnaire-based survey to evaluate the extent of the establishment of specific usage guidelines by hospitals for these antibiotics and the dosages recommended in the guidelines.
Methods
We prepared questionnaires on Google Forms and distributed them to the subscribers of the mailing list of the Infectious Diseases Association for Teaching and Education in Nippon. The target antibiotics were cefmetazole (CMZ), cefotiam (CTM), flomoxef (FMOX), sulbactam/cefoperazone (SBT/CPZ), and cefozopran (CZOP). The questionnaire items were designed to inquire about the following issues: whether these antibiotics are a part of the hospital formulary; whether the hospital had specific guidelines regarding usage of these antibiotics; whether the hospital's specific antibiotic usage guidelines covered patients with renal impairment, patients on hemodialysis, and pediatric patients; and the actual dosages specified in the hospital's specific antibiotic usage guidelines.
Results
Fifty-six hospitals participated in our study, of which 52 were included in the analysis. Forty-nine (94.2%), 40 (76.9%), 25 (48.1%), 34 (65.4%), and 19 (36.5%) hospitals, respectively, had CMZ, CTM, FMOX, SBT/CPZ, and CZOP in their formularies. Specific guidelines had been most frequently established for CMZ (in 51% of hospitals that had the drug in their formulary), and least frequently established for FMOX (in 16.0% of hospitals that had the drug in their formulary). Guidelines for antibiotic usage in patients with renal impairment were commonly established in hospitals with specific guidelines for antibiotic usage (85.2%). However, the prevalence of guidelines for use in patients undergoing intermittent (56.7%) or continuous hemodialysis (20.0%) was lower, in that order. Furthermore, the specific guidelines rarely addressed pediatric dosages, and the dosages indicated in the specific guidelines varied among hospitals.
Conclusions
Our findings indicate that hospitals lack specific guidelines for the usage of domestically developed antibiotics, especially for patients undergoing hemodialysis or pediatric patients. Additionally, the antibiotic dosages specified in these guidelines varied widely among the hospitals.
Key word
usage, dose, manual, guideline, questionnaire
Received
November 16, 2023
Accepted
March 14, 2024
Jpn. J. Chemother. 72 (4): 351-357, 2024
