title: Japanese Physicians' Views on Drug Post-Marketing Surveillance.
abstract: BACKGROUND
  Registration trials leading to the approval of drugs are paramount in drug development. After approval, continuous efforts are necessary to ensure proper use of the approved drugs. In Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated into GPSP, attention has recently been focused on disassociating them. In this study, we examined physicians' views on PMS with the aim of conducting PMS more effectively.
  
  
  METHODS
  We retrospectively reviewed records between 2009 and 2013 from the institutional review board of Tokushima University Hospital, an academic hospital in rural Japan. The annual number of times PMS was performed was then determined. Next, we assessed physicians' attitudes toward drug PMS, including ethical issues, in a cross-sectional study using a questionnaire designed for this study. Five- and two-point scales were used. The questionnaire was distributed in 2014 to 221 physicians listed as investigators in PMS contracts.
  
  
  RESULTS
  Of the 221 physicians, 103 (46.6%) responded to the questionnaire. About 50% of the respondents had experience writing PMS reports. Many of the physicians considered PMS to be important but burdensome. Furthermore, from the viewpoint of research ethics, many physicians considered it improper within the present PMS framework to collect and provide data beyond the scope of routine clinical practice without obtaining informed consent in the case of extra blood sampling, provision of images, monitoring and controlled studies.
  
  
  CONCLUSIONS
  Beyond practical factors such as workload, attention should be given to establishing an ethical infrastructure and globally harmonized system with regard to the Japanese PMS system. Given the limitations of this single-institution study, further research is needed to collect information for developing a suitable infrastructure.
authors.affiliation: Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.
authors.forename: Kazuki
authors.initials: K
authors.lastname: Maeda
authors.affiliation: Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.
authors.forename: Rumi
authors.initials: R
authors.lastname: Katashima
authors.affiliation: Institutional Review Board, Tokushima University Hospital, Tokushima, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Ishizawa
authors.affiliation: Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Yanagawa
keywords: Infrastructure; Japan; Physician; Post-marketing surveillance; Research ethics; View