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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Original Article
  • Shohei MAKINOSE, Daisuke FURUSHIMA, Hirotomo NAKAMURA, Keizo UMEGAKI, ...
    Type: research-article
    2021 Volume 52 Issue 3 Pages 55-61
    Published: May 31, 2021
    Released: June 23, 2021
    JOURNALS RESTRICTED ACCESS

    With an increase in the consumption of health foods, the associated adverse events have been increasing. Nevertheless, the relevant information is insufficient, and there is a lack of a standardized reporting system in Japan. In this study, we attempted to develop a standardized reporting format for the adverse events associated with health food consumption and investigated its usability in combination with a previously developed causal-relation estimation algorithm, using virtual cases, by medical staff.

    We extracted the necessary information from nine reported formats, searched from PubMed, and domestic and international websites, including the websites of pharmaceutical regulatory authorities. Using the developed format, the match rates of format items estimated by 77 medical staff(56 pharmacists, 13 physicians and 8 registered sellers)and those of the causal-relation algorithm items estimated by specialists and medical staff were determined.

    The match rates of most items in the reporting format were over 65%, but some items showed lower match rates. Furthermore, the match rates of items in the causal-relation algorithm showed a different tendency in each case.

    In conclusion, for its application in clinical practice, the standardized reporting format of adverse events associated with health food has to be improved further.

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Review Article
  • Taro ISHIBASHI, Michiyo OHSHIMA, Takayuki IMAEDA, Norisuke KAWAI
    Type: review-article
    2021 Volume 52 Issue 3 Pages 63-66
    Published: May 31, 2021
    Released: June 23, 2021
    JOURNALS RESTRICTED ACCESS

    The impact of COVID‒19 on our society is significant. To continue to offer new treatment options to society during and after the pandemic, experiences and ideas gained during this period should be utilized to transform drug development. Collaboration within the industry and with health authorities across the world is required, and now is the time to start the dialogue. To promote transformation, deploying methodologies based on high ethical standards and scientific rigor, prioritizing the safety of study participants, and securing transparency and the quality of deliverables are essential. In addition, broad acceptance of patient and public involvement is needed to promote understanding of drug development and to enable proactive participation of patients and family members. Utilization of digital tools and improving their reliability, the application of model informed drug development and real world data, improvement of regulatory procedures, continuous regulatory harmonization, and collaboration among companies and health authorities are required to continue to deliver breakthroughs that have a positive impact on society.

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Proceedings of the 27th Training Course in Clinical Pharmacology and Therapeutics “Clinical Pharmacology in Patients with Multimorbidity”
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