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An Analysis of Guidance for Proper Usage Documents for Oncology Drugs in Japan

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Abstract

Background

Pharmaceutical companies in Japan often provide a unique document called the Guidance for Proper Usage (GPU) to medical oncologists, in order to promote the proper use of an approved drug.

Aim

The aim of the study was to examine the content of and current trends in the efficacy and safety data provided in GPU documents, in order to understand what pharmaceutical companies regard as important information for an oncologist to ensure proper usage of oncology drugs in Japan. Furthermore, this study analysed the influence of route of administration (oral or injection), drug class (cytotoxic or other), type of malignancy (haematological or solid malignancy) and the period of GPU publication (before and after April 2004) on the content of the GPU document.

Materials and Methods

For the 103 oncology drugs approved for use in Japan, 59 GPU documents, covering 50 drugs, were distributed to medical oncologists and were compared by multivariate analysis over two consecutive time periods, from October 1994 to March 2004 and April 2004 to December 2010. For each document, we determined the total number of pages and the proportion of pages that provided drug and toxicity information and the results of registration trials, including postmarketing surveillance.

Results

The median number of pages in the GPUs was 48 (range, 11–98). The proportion of pages providing toxicity information, drug information (e.g. warnings, contraindications, instructions, and directions for indications and usage, dosage and administration) and the results of registration trials were 30%, 26% and 11%, respectively. After April 2004, the publication of GPU documents doubled, and the proportion of pages discussing the results of registration trials significantly increased (p = 0.002). The proportions of pages discussing toxicity information and the results of registration trials in molecular-targeted drugs were significantly greater than those for other types of drugs (p < 0.001 and p = 0.008, respectively), while the proportion of pages discussing drug information was significantly lower (p = 0.001).

Conclusion

The number and length of GPU publications distributed by pharmaceutical companies in Japan has increased since 2004. Significant changes in content have included a reduction in the amount of information about drug administration and an increase in information on the results of pharmaceutical company-sponsored registrational trials. A further study is warranted to evaluate how often oncologists actually access GPU documents and what type of information could be most useful in medical practice in Japan.

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Guidance for Proper Usage
Guidance for Proper Usage
Guidance for Proper Usage
Guidance for Proper Usage
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Acknowledgements

This study was supported by a science research grant (H21-005) from the Ministry of Health, Labour and Welfare (for research on infrastructure development for clinical trials). The funding source had no involvement in the study design, conduct, data collection, management, analysis, interpretation, composition, review, or publication of this work. The following provides a list of contributions for this study by the individual authors:

Concept of study: K. Yonemori, Y. Ryushima, A. Hirakawa and Y. Fujiwara. Provision of study material: K. Yonemori, Y. Ryushima, M. Saito and H. Yamamoto. Data collection: K. Yonemori, Y. Ryushima and M. Saito. Statistical analyses: A. Hirakawa. Data interpretation: T. Hirata, H. Yamamoto, M. Ando, A. Hirakawa, C. Shimizu, K. Tamura, M. Yunokawa, M. Kodaira, Y. Fujiwara, H. Yamamoto, Y. Ryushima and M. Saito. Manuscript writing: K. Yonemori, T. Hirata, H. Yamamoto, M. Ando Y. Fujiwara, M. Saitoand Y. Ryushima. Manuscript review: C. Shimizu, K. Tamura, M. Yunokawa, M. Kodaira and H. Yamamoto. Final manuscript approval: K. Yonemori, A. Hirakawa, T. Hirata, H. Yamamoto, M. Ando, C. Shimizu, K. Tamura, M. Yunokawa, M. Kodaira, Y. Fujiwara, H. Yamamoto, Y. Ryushima and M. Saito. Financial and administrative support: Y. Fujiwara. Masashi Ando has received research funding from Sanofi-Aventis, Wyeth, Novartis and GlaxoSmithKline; Chikako Shimizuhas received honoraria from Daiichi Sankyo, Novartis, Chugai, Astra-Zeneca, Sanofi-Aventis and GlaxoSmithKline; Kenji Tamruahas received honoraria from Bristrol Myers Squibb and Chugai and a research grant from Merck Sharp and Dohme. Yasuhiro Fujiwara has received honoraria from Taiho, Sanofi-Aventis, Eli Lilly and Chugai and research funding from Pfizer, GlaxoSmithKline, Chugai, Eisai, Daiichi Sankyo, Taiho, Nihon Kayaku, Amgen, Novartis, Takeda and Astra-Zeneca. The remaining authors have no conflicts of interest to declare that are directly relevant to the content of this study.

This study was presented, in part, at the European Multidisciplinary Cancer Congress (ESMO/ECCO/ESTRO) 2011, in Stockholm, Sweden.

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Authors and Affiliations

  1. Breast and Medical Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 103-0045, Japan

    Kan Yonemori, Harukaze Yamamoto, Taizo Hirata, Masashi Ando, Makoto Kodaira, Mayu Yunokawa, Chikako Shimizu, Kenji Tamura & Yasuhiro Fujiwara

  2. Department of Management Science, Tokyo University of Science, Tokyo, Japan

    Akihiro Hirakawa

  3. Division of Pharmacy, National Cancer Center Hospital, Tokyo, Japan

    Yasuaki Ryushima, Mari Saito & Hiroshi Yamamoto

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  1. Kan Yonemori
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  2. Akihiro Hirakawa
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  3. Yasuaki Ryushima
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  4. Mari Saito
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  5. Harukaze Yamamoto
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  6. Taizo Hirata
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  7. Masashi Ando
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  8. Makoto Kodaira
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  9. Mayu Yunokawa
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  10. Chikako Shimizu
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  11. Kenji Tamura
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  12. Hiroshi Yamamoto
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  13. Yasuhiro Fujiwara
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Corresponding author

Correspondence to Kan Yonemori.

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Yonemori, K., Hirakawa, A., Ryushima, Y. et al. An Analysis of Guidance for Proper Usage Documents for Oncology Drugs in Japan. Pharm Med 26, 165–170 (2012). https://doi.org/10.1007/BF03262390

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