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Medicine reclassification processes and regulations for proper use of over-the-counter self-care medicines in Japan

Authors Nomura K, Kitagawa Y, Yuda Y, Takano-Ohmuro H

Received 12 October 2015

Accepted for publication 11 February 2016

Published 25 July 2016 Volume 2016:9 Pages 173—183

DOI https://doi.org/10.2147/RMHP.S98099

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Mary Schmeida

Peer reviewer comments 3

Editor who approved publication: Professor Frank Papatheofanis

Kaori Nomura,1 Yuki Kitagawa,2 Yasukatsu Yuda,2 Hiromi Takano-Ohmuro2

1Division of Molecular Epidemiology, Jikei University School of Medicine, 2Faculty of Pharmacy, Musashino University, Shinmachi, Tokyo, Japan

Objectives: 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.
Conclusion: 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.

Keywords:
OTC, healthcare policy, switch drugs, drug safety, health expenditure, pharmacists’ role, self-medication

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Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

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Drug Design, Development and Therapy 2015, 9:3031-3041

Published Date: 12 June 2015