Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
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Questionnaire on the Medical Professionals' Assessment of the Description Order of Package Insert Contents and Appreciation of Conditions for Drug Approval
Mariko IWASEAkemi KAWAKAMIJun-Ichiro MURAYAMAHajime YASUHARA
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2011 Volume 42 Issue 2 Pages 33-40

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Abstract
Package insert of prescription drug (PI) is a specific official document which has a legal basis for the appropriate use of the corresponding medicine. More than ten years have passed since the guideline for the PI was revised in Japan, and now, it is important to reconsider as to whether the current PI meets its users. Therefore we carried out a questionnaire survey for doctors and pharmacists working for Showa University regarding their impression of PI such as the description order of contents and the cognition of its approval condition. The reply of approximately 80% of these doctors and pharmacists indicated that the current order of contents in PI was appropriate. On the other hand, although 50% of pharmacists well understood the approval condition, 90% of the doctors did not recognize it sufficiently. This survey suggested that a significant change in the description order of contents may not be necessary. However, the necessity to distribute the presence of “approval condition”as one of the contents in PI and to facilitate doctors understanding of its contents were suggested.
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© 2011 The Japanese Society of Clinical Pharmacology and Therapeutics
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