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What is known and Objective: The lag in the approval and development of psychiatric drugs between Japan and other countries has been a major issue both for patients with psychiatric diseases and for psychiatrists. The objective of this study was to analyse factors contributing to delays in launching new psychiatric drugs in Japan. Methods: We analysed data from Japan, the USA, and the UK for the approval of 23 standard psychiatric drugs and examined potential factors that might have contributed the delay of their launch. Results: Of the 23 standard psychiatric drugs, all of which were approved in the USA and the UK, only 13 were introduced in Japan between September 2000 and July 2011. None of their development strategies adopted the ICH E5 guideline on simultaneous development of drugs on a global scale. Twelve of the 13 drugs (not including atomoxetine) were approved in Japan after their approval in the USA and the UK. The median review time (from approval application to approval) of these 13 drugs in Japan was 23 months, which was considerably longer than those of the US Food and Drug Administration and European Medicines Agency (10·0 and 13·5 months, respectively). The 10-13-month difference in review time cannot explain the overall 87- and 51-month delay in Japan after approval in the USA or UK. What is new and Conclusion: There remains a large gap between Japan and Western countries, such as the USA and the UK, with regard to access to standard psychiatric drugs, despite several important reforms in the Japanese drug approval system. [ABSTRACT FROM AUTHOR]

Background and objectives: Effective psychiatric care requires physicians to address the problems of patient adherence to prescribed medications. The aim of this study was to understand physician-perceived barriers to, and effective strategies for, prescribing anti-depressants in Japan. Methods: A qualitative study using semi-structured and key-informant interviews with a purposive sample of Japanese psychiatrists and key-informant physicians who had practiced in both the US and Japan. Results: Japanese psychiatrists recognize patient misperceptions, social stigma and resistance to acceptance of prescribed anti-depressant medication. Physicians also recognize that selective serotonin reuptake inhibitors (SSRIs) decrease rather than reinforce patient resistance. Physicians initially underdose, employ euphemisms and accept patient decisions to decline treatment by medication. Discussion: Even after the introduction of SSRI anti-depressants in 1999, Japanese psychiatrists’ primary adherence strategy to initially underdose prescribed anti-depressants remains. The unstated physician strategy is to allow the pharmaceutical industry to address patient misperceptions, social stigma and the resistance to prescription therapies. Conclusions: The results of this study delineate the fundamental strategies employed by Japanese physicians to address patient adherence to prescribed psychotropic medications, primarily to reduce the initial dose rather than to stress patient education. [ABSTRACT FROM AUTHOR]