Vol.71 No.1 January 2023
The practice of antimicrobial stewardship for off-label use of antimicrobial agents in terms of dosage and usage
1)Department of pharmacy, Tokyo Women's Medical University Hospital, 8-1 Kawada, Shinjuku-ku, Tokyo, Japan
2)Department of pharmacy, Juntendo University Hospital
3)Department of Infectious Diseases, Tokyo Women's Medical University Hospital
4)AMR Clinical Reference Center, National Center for Global Health and Medicine Hospital
Abstract
The optimal indications and antimicrobial spectrum of antibiotics may be revealed after an antibiotic drug is marketed. In such a case, if there is a difference in the usage and dosage of use of an antibiotic for an indication and at a dosage different from those specified in the package insert, it would be termed off-label use. Tokyo Women's Medical University Hospital established an evaluation committee for unapproved drug/ contraindicated drug/ off-label drug use in June 2017, and managed the off-label use of antimicrobial agents. From June 2017 to December 2021, 495 cases (approval rate: 87.3%) of off-label use were approved. In the approved therapeutic category of off-label use, in 3 of the top 20 therapeutic categories, the use was related to antimicrobial agents. As of January 2020, there were 20 drugs (about 19.2%) for which there were differences between the specifications on the package inserts of antimicrobial agents and each documents with guidelines. Although it is important to avoid unnecessary antimicrobial prescriptions to avoid drug resistance, it is also necessary to create an environment in which the agents can be used at a sufficient dosage and usage as to be effective.
Key word
drug information, off-label use, drug resistance, package insert, antimicrobial stewardship
Received
May 19, 2022
Accepted
November 4, 2022
Jpn. J. Chemother. 71 (1): 99-105, 2023
