[The current status of fluoroquinolones and other off-label drug use for tuberculosis in Japan].
OBJECTIVE
To clarify the present state and problems of off-label drug use in tuberculosis treatment in Japan.


METHODS
Questionnaire survey by mail to 252 hospitals with tuberculosis wards.


RESULTS
It was found that 146 out of 160 hospitals returning the questionnaire had active tuberculosis ward(s). Fluoroquinolones (FQs) were being used in 119 (81.5%) hospitals, of which 115 used levofloxacin. The reasons for using FQs were: i) adverse reactions to other antituberculosis drug(s) in 97 hospitals, and ii) drug-resistance in 80 hospitals. The perceived problems in using FQs were: i) its use for tuberculosis is not approved (often not reimbursed by medical insurance), cited by 73 hospitals; ii) increased out-of-pocket medical fees for patients (not covered by public service), cited by 48 hospitals; iii) official compensation for severe adverse reactions cannot be guaranteed for off-label use, cited by 19 hospitals. Other off-label drugs such as linezolid are also used in 37 hospitals.


CONCLUSIONS
Fluoroquinolones, especially levofloxacin, are widely used in tuberculosis treatment in Japan for patients with adverse reactions and/or drug-resistance to other antituberculosis drugs. As these drugs have not yet been approved for tuberculosis treatment and therefore are not included in "the Standards of Tuberculosis Treatment" established by the government, the costs for FQs and other off-label drugs are not covered by public subsidies for medical treatment, thus increasing the economic burden for patients, which may in turn cause drop-out, especially in cases of MDR-TB. Further, FQs are not under control of the Tuberculosis Advisory Committee of the Health Center, which has played an important role in ensuring the standard tuberculosis treatment in Japan.


CONCLUSIONS
FQs should be included in the Standards of Tuberculosis Treatment to secure adequate chemotherapy for tuberculosis.
National Hospital Organization, Higashihiroshima Medical Center, 513 Jike, Saijo-cho, Higashihiroshima-shi, Hiroshima 739-0041 Japan. eshigetou@hiro-hosp.jp
Eriko
E
Shigeto
D024841:Fluoroquinolones / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D056687:Off-Label Use / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires; D014376:Tuberculosis / Q000188:drug therapy*
D024841:Fluoroquinolones