The Nagoya University Ethics Committee (NUEC) is responsible for reviewing the appropriateness of research protocols from ethical and scientific points of view. In March 2011, to support and enrich the review process, a system of preliminary reviews was implemented. We analyzed all of the research protocol applications that were submitted to the NUEC between April 2011 and March 2012 (FY2011) and for which a result notification was issued and compared the total review times for FY2009 (between April 2009 and March 2010) and FY2011. In FY2011 and FY2009, 259 and 242 applications, respectively, were received. In 2011, the median preliminary review time and total review time were 28 days and 70 days, respectively. In FY2009, the median total review time was 58 days. The total number of queries received regarding the preliminary review in FY2011 was 5,286. The most common query was related to protocol (n=3,429; 64.9%), and the second most common was related to the informed consent form (n=1,130; 21.4%). Of the 3,429 queries related to protocol, the majority was related to the research methods (n=1,542; 45.0%) such as the evaluation items, selection criteria, and statistical methods of analysis chosen. Our results show that the necessary application materials were not submitted in many cases. Although the total time for review was increased due to the preliminary review process, our results suggest that the preliminary reviews are meaningful and that they allow the ethics committee to conduct its review based on improved applications. However, we must continue to consider how to support clinical research and reduce the total time for review.
(Jpn J Clin Pharmacol Ther 2013; 44(6): 443-450)

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Purpose: To investigate better ways of providing information in package inserts for prescription drugs to make them easier for medical staff to use.
Methods: We investigated 100 randomly selected medicines, with or without high alert, to determine how frequently the four items: lab test considerations; overdosage; clinical studies; and miscellaneous information, are printed in the package inserts. We also sent a questionnaire to physicians and pharmacists at three hospitals in Showa University to investigate how these four items are being used.
Results: Documentation for lab test considerations, overdosage, clinical studies, and miscellaneous information, was included in 7%, 58%, 71%, and 92% of inserts, respectively. Response rate for physicians was 68% (198 of 290 questionnaires were returned) and 100% for pharmacists (107 of 107 questionnaires were returned). Collected data suggested that only half of physicians who participated in the study used the four insert items being investigated in this study. One reason given for items not being used was that the clinician had no opportunity for use. Forty-three percent of physicians and 69% of pharmacists reported that they were able to access the information they needed. It was also suggested that categories for which there was no information should be listed with contact details for alternative information sources.
Conclusion: The results above demonstrate that product information is useful and itemization of practical documentation would be helpful in providing medication to patients. Numbering of each item in package inserts is also helpful, and items for which there is no clinical information should also be included and the lack of information documented.
(Jpn J Clin Pharmacol Ther 2013; 44(6): 451-458)

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Among various sources of information on ethical drugs, many medical personnel refer to the “package insert” in many occasions because of its reliability and availability. Every new drug is subject to “re-examination” usually after 8 years of marketing approval, in which its efficacy and safety are reexamined based on data obtained from post-marketing studies and others. The package insert is usually revised based on the result of re-examination and the revised insert contains information on adverse drug reactions reported both in clinical trials for marketing approval and post-marketing studies. Therefore the revision may be considered to be a major milestone, which provides a general idea of the safety profile of a new drug at marketing approval as well as after being on the market. In the present study, we compared adverse drug reaction rates at the time of new drug approval and at re-examination based on the revised package inserts to which safety information from postmarketing studies was added. The result showed that the rate of adverse drug reactions at re-examination had decreased compared to that at marketing approval for most of the new drugs investigated. In recent years, more and more new drugs are approved with less domestic clinical trial data. Therefore, pharmacists, as specialists on pharmaceuticals, are expected to understand correctly and provide safety information on pharmaceuticals based on proper understanding of the background of new drug development and not solely confined to the figures in the package inserts.
(Jpn J Clin Pharmacol Ther 2013; 44(6): 463-468)

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