Regulation of Hospital Pharmaceutical Manufacturing in Fukushima Medical University Hospital

Abstract

It is important that hospital pharmaceutical manufacturing (HPM) is used rationally for both prescription and non-prescription drugs. However, at Fukushima Medical University Hospital, the rational use of HPM was not considered to be sufficient. A new system for regulation of the HPM is thus needed because HPM has to be used under strict controls as well as investigating drugs. As a result, an institutional review board for HPM was established at our hospital and the pharmaceutical quality control of HPM regarding factors as assurance or microbial control, was improved. Furthermore, for the rational use of HPM, we prepared information leaflets for patients, package inserts for doctors, and also developed a format for the clinical evaluation of HPM. 35 kinds of HPM are now being used under this new system.
At the end of this chapter we proposed a system for the rational use of HPM at our hospital.