抄録
GPMSP (Good Post-Marketing Surveillance Practice), a system to regulate the investigation for postmarketing drugs, was established and enforced in April 1997. In a previous report, the coordinating work of PMS (Post Marketing Surveillance) was described by pharmacists at Kinki University Hospital in October 1999.
We carried out the following coordinating work for PMS ; (1) confirmation of the state of the medication of the investigational drug, (2) confirmation of the state of the medication of the combination drugs, (3) confirmation of the state of any adverse events (include unusual change in the laboratory data), (4) posting objective data from source documents on the case report forms, and (5) the control of the daily program for investigational drugs, and so on.
The notice of an impending investigation immediately after marketing was made by the Ministry of Health and Welfare at the end of December 2000. As a result, the collection of 3, 000 examples by investigations of post-approval experiences was reduced substantially while, on the other hand, the importance of specific investigations and clinical trials after marketing are better understood.
In view of this situation, it decided to introduce data management techniques of the CRC work in the coordinating work of PMS from the viewpoint of EBM serious consideration. The CRF chart and the condition records which are in the text are specifically utilized. As a result, the PMS coordinating work has thus improved the obtaining and control of data quality after marketing.
