Discussion of GCP Trial Drug Dispensing Workflow in PIVAS of Daytime Chemotherapy Center / 中国药房

ABSTRACT

OBJECTIVE：To explore the new management model of Good Clinical Practice （GCP）trial drug dispensing . METHODS：Base on the relevant experience of Pharmacy Intravenous Admixture Services （PIVAS）in daytime chemotherapy center（“daytime PIVAS ”for short ）of our hospital ，the nodes and other matters needing attention were discussed in the workflow of confirmation and development of drug dispensing tasks for clinical trials. RESULTS ：After the successful approval of the new clinical trial ，the supervisor of the sponsor and the principal investigator should first confirm whether the drugs involved in the project needed to be centrally dispensed in the daytime PIVAS ，and then submitted the relevant data to PIVAS for filing. Daytime PIVAS pharmacists could participate in trial drug dispensing of relevant projects only after starting training and authorization. After the doctor issued the medical order for the subjects in the hospital information system ，the research nurse took the drugs out of the GCP pharmacy and handed them to the daytime PIVAS drug receiving window. After receiving the drugs ，the pharmacist would check the dispensing ，and then the preparation pharmacist trained and authorized by the project team would mix and dispense the drugs. The reviewed pharmacist would check and label the prepared infusion. In addition ，daytime PIVAS would regularly summarize the feedback information on the trial drug dispensing and fund management in all links of dispensing process ，so as to improve the standardization of the process. CONCLUSIONS ：Daytime PIVAS for clinical trial drug can arrange batches more rationally，ensure smooth and orderly infusion ，and meet different drug stability requirements ，which can improve trial drug dispensing management and further promote the development of drug clinical trial projects in China.