Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

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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Recent breakthroughs in science and technology have the potential to transform our ability to prevent, diagnose and treat disease. Global clinical trials are expanding. A number of difficulties emerged in conducting global clinical trials in Japan. Ethnic factors in multinational clinical trials have been apparent to determine drug dosing. Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance. It is important to promote regulatory science for establishment of evidence-based medicine.

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Oral pathogens are indigenous microorganisms and can cause bacteremia easily by tooth brushing or dental extraction. Some of them carry the pathogen Streptococcus mutans (S. mutans) with a collagen-binding protein, named Cnm, which inhibits platelet aggregation. Under permission of our ethical committee, we studied whether such S. mutans is a risk factor for stroke. From February 16 to October 6, 2010, 167 serial patients with intracerebral hemorrhage (ICH) or cerebral infarction were admitted to our stroke care center. With written informed consent, we cultured their saliva and the results were compared with those of 37 healthy volunteers. Cultured rate of all S. mutans showed no statistically significant difference, however, the incidences of Cnm positive S. mutans were significantly high in patients with ICH and cerebral embolism from cardiac origin (p 0.0073 and 0.0069 respectively (Fisher's test) ). Roughly more than 10 percent of Japanese people have Cnm positive S. mutans in their oral cavities. Cnm positive S. mutans may be a new risk factor of stroke and further study is necessary.

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