A Drug Utilization Study on Off-Label Uses
10.3820/jjpe1996.4.9
- VernacularTitle:院内製剤 (適応外使用医薬品) に関する実態調査
- Author:
Nobuyuki GOTO
;
Kazuo SATO
;
Masaki SHIRAHASE
;
Hisao HATTA
;
Mikio MASADA
;
Kazuhisa MATSUBA
;
Yoshihiro KATAGIRI
;
Masahiro NAKANO
;
Keizo ISHIMOTO
;
Takeo MINAMI
;
Shikifumi KITAZAWA
- Publication Type:Journal Article
- Keywords:
hepatocellular carcinoma;
ethanol injection;
questionnaire;
drug utilization;
off-label uses
- From:Japanese Journal of Pharmacoepidemiology
1999;4(1):9-19
- CountryJapan
- Language:Japanese
-
Abstract:
Objective : Percutaneous ethanol injection (PEIT) for hepatocellular carcinoma is basic treatment of hepatocellular carcinoma. However, it is off-label uses to use ethanol for this treatment in the current state. Then, we executed the drug utilization study of Absolute ethanol injections at this time.
Methods : We executed the drug utilization study of Absolute ethanol injections at this time.
Results : The recovery of the questionnaire was high with 84.4% (151/179 medical institutions). The ethanol injections was made by 85% (129/151 facilities). Facilities where 100 or more ethanol injections was made annually were 76%. The raw material for making the ethanol injections was the reagent which was not the medicine in 44% of facilities. Information on safety and effectiveness concerning the ethanol injections was hardly offered from pharmacy. Finally, 96% (124/129 facilities) demanded marketing the ethanol injections.
Conclusion : We investigated the research report number by using “ICHUSHI” CD-ROM version (1988-1998) which was the medical literature data base. We were able to collect reports concerning PEIT of hepatocellular carcinoma of 636 reports. We were able to collect reports which used PEIT as a treatment method of hepatocellular carcinoma by as many as 636 reports. It has been understood that PEIT is enforced in Japan. Next, we reviewed the document and collected and evaluated information on effectiveness and safety concerning the ethanol injections used for PEIT. The treatment object, the usage, and the dosage have been decided at the relating academic meeting. Moreover, there was a report concerning a lot of effectiveness and safety in the PEIT treatment method of hepatocellular carcinoma. The ethanol injections used for PEIT is one of the medicines where information and scientific evidence concerning effectiveness and safety are accumulated. Moreover, a large amount of ethanol injections are nationally made in the pharmacy in the hospital. However, it has been proved that there are a lot of problems about the making. The ethanol injections is the medicine which should be supplied and made by the pharmaceutical company.
