1. J-PEM2000 executive committee meetings:
|
The committee consists of those who represent Japan Pharmaceutical Association (JPA), Japanese Society of Hospital Pharmacies (JSHP), and Japan Medical Association Research Institute (JMARI). |
Meeting No1 7th June 2000
Attendants:
| Urushibata M, Kono Y, Kimura R, Hori M, Inoue
S (JPA) Kano H（JSHP） Okada T (JMARI) Kubota K, Kawabe E, Morita Y, Shigemi C (U-Tokyo) |
| It was agreed that to keep the activity of
J-PEM after a pilot study, under the grant of a Health Sciences Research
Project ('A pilot study of the Japanese version of Prescription-Event Monitoring'
1998.4-2001.3) supported by the Ministry of Health and Welfare, is finished
as J-PEM2000. |
Meeting No.2 5th October 2000
Attendants:
| Urushibata M, Kono Y, Abe Y, Hori M, Inoue
S (JPA) Fujigami M, Kaneko T（JSHP） Okada T (JMARI) Kubota K, Kawabe E, Morita Y, Shigemi C (U-Tokyo) |
| 1. "Test drugs" for the first two
studies of J-PEM 2000 were selected as follows Antidiabetics: Pioglitazone, Nateglinide, Glimepiride Antihyperlipidaemias: Cerivastatin, Atorvastatin, Colestimide, Fenofibrate 2. Research Protocol: Research Protocol proposed by Kubota K MD, PhD in Department of Pharmacoepidemiology, Faculty of Medicine, University of Tokyo, was approved except for ethical aspects. 3. Ethics review board: The executive committee required the organization of a ethics review board where ethical aspects for J-PEM2000 are discussed and determined. |
Meeting No.3 18th January 2001
Attendants:
| Urushibata M, Kono Y, Abe Y, Hori M, Nanaumi
A (JPA) Fujigami M, Kaneko T（JSHP） Okada T (JMARI) Kubota K, Kawabe E, Morita Y, Shigemi C, Ohashi Y, Koide D (U-Tokyo) Yoshimura I (Chairman of the Ethics Review Board) |
| The discussion was mainly on how to respond
to the requirement made by the Ethics Review Board (ERB) that individual consents from possible study subjects should be obtained. Members of the executive committee ・have accepted the need to obtain consents from study subjects, but ・have required the ERB to modify the method of obtaining consents so that those who register possible subjects in J-PEM2000 can practice. |