title: Medicine reclassification processes and regulations for proper use of over-the-counter self-care medicines in Japan.
abstract: OBJECTIVE
  Japan has actively reclassified substances ranging from prescription drugs to over-the-counter (OTC) drugs in recent years. The sale of most OTC drugs was deregulated several times and pharmacists' supervision was deemed no longer mandatory. Japan established a new OTC evaluation system in 2015 to hear opinions from various stakeholders regarding medicine types to be reclassified. This study aimed to examine the new framework to identify candidate substances for reclassification. Moreover, we examined how to manage the safe, self-care use of OTC drugs in Japan.
  
  
  METHODS
  The necessary regulatory information on OTC approvals as of January 2015 was collected using an Internet search and relevant databases. To highlight the characteristics of OTC drugs in Japan, the UK was selected as a comparison country because it too was actively promoting the reclassification of medicines from prescription to nonprescription status, and because of economic similarity.
  
  
  RESULTS
  Japan and the UK have a risk-based classification for nonprescription medicines. Japan has made OTC drugs available with mandatory pharmacists' supervision, face-to-face with pharmacists, or online instruction, which is similar to the "pharmacy medicine" practiced in the UK. Japan recently reformed the reclassification process to involve physicians and the public in the process; some interactions were back to "prescription-only medicine" in the UK.
  
  
  CONCLUSIONS
  It is expected that the opinion of marketers, medical professionals, and the public will improve the discussion that will greatly contribute to the safe use of drugs. Monitoring the new system will be noteworthy to ensure that OTC drug users are managing their self-care properly and visiting a doctor only when necessary. The supply methods are similar in Japan and the UK; however, the expected growth in the Japanese OTC market by the Cabinet and the industry is still uncertain.
authors.affiliation: Division of Molecular Epidemiology, Jikei University School of Medicine.
authors.forename: Kaori
authors.initials: K
authors.lastname: Nomura
authors.affiliation: Faculty of Pharmacy, Musashino University, Shinmachi, Tokyo, Japan.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Kitagawa
authors.affiliation: Faculty of Pharmacy, Musashino University, Shinmachi, Tokyo, Japan.
authors.forename: Yasukatsu
authors.initials: Y
authors.lastname: Yuda
authors.affiliation: Faculty of Pharmacy, Musashino University, Shinmachi, Tokyo, Japan.
authors.forename: Hiromi
authors.initials: H
authors.lastname: Takano-Ohmuro
keywords: OTC; drug safety; health expenditure; healthcare policy; pharmacists’ role; self-medication; switch drugs