臨床治験実施時の併用薬剤選定に関する病院薬剤師の関わり

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If drugs that must be restricted in their concomitant use with a new investigational drug are not accurately chosen, then both the ethical and scientific objectives can not be sufficiently achieved in clinical trials of new drugs. We compared the differences between the drug selections made sponsor and by a hospital pharmacist for all drugs (2,093 drugs) adopted by Osaka Medical College Hospital. Accurate selections were made in 215.82±130.21 instances of drug use by the hospital pharmacist, but oniy in 151.77±105.45 instances of drug use by the sponsor. The number of accurate selections by the hospital pharmacists was significantly lager than that of sponsor (P<0.05). Furthermore, the hospital pharmacist selected drugs that were unnecessary in the protocol in only 1.91±8. 95 instances of drug use, while the sponsor did so in 5. 59±7. 97 articles. The number of unnecessary selections by the hospital pharmacists was therefore significantly smaller than that of the sponsor (P<0.01). These results demonstrate that the ability of hospital pharmacists appears to be superior to that of the sponsor in selecting drugs which have certain restrictions. These findings thus indicate that hospital pharmacists possess sufficient drug information regarding the pharmacological action, drug interaction and pharmacodynamics of most drugs. We therefore maintain that hospital pharmacists should thus play an important role in drafting the protocol of clinical trials for new drugs. If hospital pharmacists are involved, then such clinical trials will be both more effective and more accurate.
日本医療薬学会の論文
2001-02-10

臨床治験実施時の併用薬剤選定に関する病院薬剤師の関わり

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