抗がん剤自主臨床研究レジメン作成·登録における薬剤師の役割
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概要
- 論文の詳細を見る
At Fukuoka University Hospital,the Chemotherapy Protocol Review Committee evaluates the appropriateness and safetyof investigator-initiated clinical study regimens involving anticancer drugs,and the Department of Pharmacy prepares thesedrugs.Before clinical studies,physicians produce regimens based on clinical study protocols,and submit these regimenswith written requests for review to the pharmacy.The Department of Pharmacy then checks regimens for any deviationsfrom protocols as well as the pharmaceutical characteristics of the drugs,makes sure that there are no problems regardingmixing procedures,and directs inquiries,if any,to the physicians concerned.We investigated the contents of inquiries addressed to physicians after submission of regimens,and evaluated the contributionof pharmacists to their production and registration.Between December 2007 and November 2009,there were 19 applicationsfor clinical studies,and the total number of submitted regimens was 56.There were 72 inquiries about regimens,of which 18.1% concerned"suspected deviations from study protocols",and 30.6%"addition of cautionary items".As a resultof the inquiries,all regimens were revised.These results suggest that at the stage of producing regimens,pharmacistscan help make sure that clinical studies on anticancer drugs are conducted properly.In addition,their interventions at thetime of regimen registration should help ensure the quality of clinical studies.
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