How do Japanese children take their medicines, and what are pharmacists and paediatricians doing about it?
In Japan, powders for reconstitution are often dispensed in sachets, and parents add small amount of water or syrups to make the powders paste-like or condensed syrup and have their children take the medicines. Compounding is common just like any other parts of the world. According to the survey in 2005, most commonly compounded medicines include warfarin, digoxin and enalapril. Crushed tablets or capsules are often mixed with sucrose or starch and kept in bottles at pharmacy departments for regular use. There is no regulation so far to mandate pediatric drug/formulation development in Japan. The pediatric premium can be given to drugs whose indications and dosage are clearly for children, but this is not sufficient for many drug companies especially when their drug prices are cheap. In 2013, new MHLW grant-supported project for regulatory science in pediatric drug development started, and discussion on key issues related to pediatric drug development including formulations, modeling and simulation and neonatal drug evaluation is ongoing including the possible change on legal framework to facilitate pediatric drug development in the country. Initiation of international collaboration with global partners including the European Paediatric Formulation Initiative is to be expected.
Division for Clinical Trials, National Centre for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan. Electronic address: nakamura-hd@ncchd.go.jp.
Hidefumi
H
Nakamura
Department of Pharmacy, National Centre for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan.
Yoichi
Y
Ishikawa
D002648:Child; D004304:Dosage Forms; D004339:Drug Compounding; D006801:Humans; D007564:Japan; D010372:Pediatrics; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010595:Pharmacists; D010820:Physicians
D004304:Dosage Forms; D004364:Pharmaceutical Preparations