著者

日野 美波理 石井 雅人 藤原 聡子 松香 直行 定金 典明 森山 雅弘 二神 幸次郎 柴田 和彦 五味田 裕

出版者

日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.30, no.7, pp.457-467, 2004-07-10

被引用文献数

7 7

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Owing to the approval of reimbursement of fees for antineoplastic chemotherapy on an outpatient basis by the national health insurance scheme in April 2002, an antineoplastic chemotherapy room was set up in the ambulatory area of our hospital in August 2000. In order to ensure the effective use of the safety cabinet and other existing equipment and the safe administration of antineoplastic agents to patients, the authors assigned a mixing pharmacist and a coordinating pharmacist who was to be in charge of antineoplastic chemotherapy for outpatients. First, the mixing pharmacist prepared IV mixtures of the antineoplastic agents and auxiliary medicines in a sterile area and then the coordinating pharmacist audited the mixtures and carried them to the antineoplastic chemotherapy room. Other functions of the coordinating pharmacist included providing pharmaceutical care to patients and cooperating with doctors, nurses and other pharmacists involved in the chemotherapy. They also searched for information on individual medical charts or in patient statements and pointed out doubtful records or potential problems that might affect chemotherapy. Coordinating pharmacists notified 50 potential problems between August 2002 and April 2003. To evaluate our pharmaceutical practices in outpatient antineoplastic chemotherapy, we conducted a questionnaire survey of the patients. Their responses indicated that our pharmaceutical care program was working well and that they hoped we would continue it. However, the usefulness of our program was not entirely clear to all patients and we recognized the need to better inform patients concerning this.

著者

二神 幸次郎 定金 典明 西原 茂樹 三牧 祐一 荒木 博陽 五味田 裕

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.28, no.6, pp.630-636, 2002-12-10 (Released:2011-03-04)

参考文献数

5

被引用文献数

2 2

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Our hospital established a Center for Clinical Research of New Drugs and Therapeutics in April 1999. The Center consists of 6 departments : i.e. departments which help to coordinate clinical research, which help to manage the investigated drugs, preview clinical research study protocols, coordinate clinical research, educate research staff and support clinical research at other medical institutions. Pharmacists are involved in all 6 departments of the Center and have been playing various roles. Under this situation, the Institutional Review Board (IRB) started to review investigator-initiated clinical research on drugs, regarding the study protocol, written information (IC) for trial subjects and other information about the drugs beginning in January 2000. All research was performed according to the new Good Clinical Practice, but studies were initiated without providing sufficient compensation in cases of severe adverse drug reactions. The IRB reviewed thirty-four clinical research protocols from January 2000 to December 2001 and an average of 1.5 cases were reviewed by the IRB per meeting. The average reviewing time was 28 minutes (max. 68 minutes). Sixteen, eight, eight and two protocols of clinical research involved Phase III, I/II and II trials and medical instruments, respectively. Considerable clinical research has been performed by such departments as Internal Medicine I, II and Urology, in particular.We recognized that considerable clinical research has been performed with unapproved drugs at our hospital. After the IRB review, pharmacists played various important roles, e.g. dispensing test drugs, preparing some manufactured drugs and confirming the written informed consent. However, up to now the clinical research coordinator (CRC) has not sufficiently supported these studies. The CRC should thus support this research by improving the quality of these studies and the safety performance for patients.

著者

二神 幸次郎 西原 茂樹 定金 典明 谷口 律子 荒木 博陽 川崎 博巳 五味田 裕

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.27, no.6, pp.589-593, 2001-12-10 (Released:2011-03-04)

参考文献数

4

被引用文献数

5 5

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During a three-week long practical training program for pharmacy students at our hospital, senior pharmacy students had a one-day observation of pharmacists performing new drug investigations. Using a questionnaire survey we investigated whether the observation of the work of clinical research coordinator (CRC) influenced the student's understanding of the new drug investigation procedures. The observation of CRC's work consisted of counseling/interviewing prior to the doctor's consultation and visiting a clinical laboratory to observe new drug investigations. The items evaluated were impressions of the clinical investigation of new drugs, precautions for preparing investigational drugs, understanding the new Good Clinical Practice (GCP) guidelines and other important aspects in the clinical investigation. Each group consisted of 26 students. Only 10 out of 26 students observed counseling/interviewing before the doctor's consultation with CRC. The impression of the clinical investigation procedure in group I, which observed the CRC's work was more favorable than in group II, which did not observe it. The understanding of the important aspects of the clinical investigation procedures in group I was markedly better than in group II. We thus consider that the observation of the CRC work is very useful for students not only to learn new drug investigation procedures, but also to understand the meaning of the new GCP guidelines.

著者

川上 英治 二神 幸次郎 定金 典明 西原 茂樹 荒木 博陽 川崎 博己 五味田 裕

出版者

一般社団法人 日本医療薬学会

雑誌

病院薬学 (ISSN:03899098)

巻号頁・発行日

vol.25, no.1, pp.69-75, 1999-02-10 (Released:2011-08-11)

参考文献数

7

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Pharmacists need to have a clear policy for managing investigational drugs under circumstances that are consistent with Good Clinical Practice. We studied the management and support system for the clinical research of investigational drugs based on the management of investigational drugs. We experienced 126 cases of pharmaceutical consultations in 650 prescriptions for investigational drugs from April 1997 to March 1998. Seven cases which might induce a patient to drop out, were included in pharmaceutical consultations. We found it was important to communicate with all investigators regarding giving adequate prior information to having a clearly defined protocol. Our pharmaceutical program for the clinical research of investigational drugs was thus found to be useful in the management of investigational drugs.

著者

川上 英治 二神 幸次郎 定金 典明 西原 茂樹 荒木 博陽 川崎 博巳 五味田 裕

出版者

日本医療薬学会

雑誌

病院薬学 = Journal of the Nippon Hospital Pharmacists Association (ISSN:03899098)

巻号頁・発行日

vol.25, no.1, pp.69-75, 1999-02-10

被引用文献数

8

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Pharmacists need to have a clear policy for managing investigational drugs under circumstances that are consistent with Good Clinical Practice. We studied the management and support system for the clinical research of investigational drugs based on the management of investigational drugs. We experienced 126 cases of pharmaceutical consultations in 650 prescriptions for investigational drugs from April 1997 to March 1998. Seven cases which might induce a patient to drop out, were included in pharmaceutical consultations. We found it was important to communicate with all investigators regarding giving adequate prior information to having a clearly defined protocol. Our pharmaceutical program for the clinical research of investigational drugs was thus found to be useful in the management of investigational drugs.