Jumpei Saito1,2, Hidefumi Nakamura3, Akimasa Yamatani4,3. 1. Department of Pharmacy, National Center for Child Health and Development, Okura 2-10-1, Setagaya-ku, Tokyo, 157-8535, Japan. saito-jn@ncchd.go.jp. 2. Department of Research and Development Supervision, National Center for Child Health and Development, Okura 2-10-1, Setagaya-ku, Tokyo, 157-8535, Japan. saito-jn@ncchd.go.jp. 3. Department of Research and Development Supervision, National Center for Child Health and Development, Okura 2-10-1, Setagaya-ku, Tokyo, 157-8535, Japan. 4. Department of Pharmacy, National Center for Child Health and Development, Okura 2-10-1, Setagaya-ku, Tokyo, 157-8535, Japan.
Abstract
BACKGROUND: Powders for oral solutions and suspensions (POS) are commonly used as pediatric oral medicines worldwide, except for Japan. Although global pediatric formulation development accelerates POS importation to Japan without any formulation change, oral solid multiparticulates remain to be the preferred pediatric forms in the country. This study aimed to evaluate the acceptance situation of four typical POS form products (mycophenolate mofetil, sildenafil citrate, valganciclovir hydrochloride, and voriconazole) that were recently approved in Japan. METHODS: A questionnaire on four products was completed by pharmacists in 29 children's hospitals with more than 100 beds each, between November and December of 2019. The questionnaire has six items on (#1) type of institution, (#2) formulary status, (#3) dispensing practice, (#4) reasons why POS form(s) were not selected as hospital formulary, (#5) advantages and disadvantages of POS form, and (#6) opinions for POS form. RESULTS: Of the 29 institutions, 7 (24%), 9 (31%), 4 (13%), and 10 (34%) institutions used POS of mycophenolate mofetil, sildenafil citrate, valganciclovir hydrochloride, and voriconazole, respectively. Reasons for not using these products were dispensed drug loss, formulation issues, and management issues in the pharmaceutical department and pediatric ward. Pharmacists preferred drug compounding such as tablet crushing and capsule opening to POS form use. CONCLUSIONS: POS forms might be an unsuitable formulation for the current hospital settings in Japan. Thus, appropriate dosage forms that reflect the current clinical settings are necessary.
BACKGROUND: Powders for oral solutions and suspensions (POS) are commonly used as pediatric oral medicines worldwide, except for Japan. Although global pediatric formulation development accelerates POS importation to Japan without any formulation change, oral solid multiparticulates remain to be the preferred pediatric forms in the country. This study aimed to evaluate the acceptance situation of four typical POS form products (mycophenolate mofetil, sildenafil citrate, valganciclovir hydrochloride, and voriconazole) that were recently approved in Japan. METHODS: A questionnaire on four products was completed by pharmacists in 29 children's hospitals with more than 100 beds each, between November and December of 2019. The questionnaire has six items on (#1) type of institution, (#2) formulary status, (#3) dispensing practice, (#4) reasons why POS form(s) were not selected as hospital formulary, (#5) advantages and disadvantages of POS form, and (#6) opinions for POS form. RESULTS: Of the 29 institutions, 7 (24%), 9 (31%), 4 (13%), and 10 (34%) institutions used POS of mycophenolate mofetil, sildenafil citrate, valganciclovir hydrochloride, and voriconazole, respectively. Reasons for not using these products were dispensed drug loss, formulation issues, and management issues in the pharmaceutical department and pediatric ward. Pharmacists preferred drug compounding such as tablet crushing and capsule opening to POS form use. CONCLUSIONS: POS forms might be an unsuitable formulation for the current hospital settings in Japan. Thus, appropriate dosage forms that reflect the current clinical settings are necessary.