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

Abstract

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

Acknowledgments

We would like to thank Mr Takahiro Inoue at the MHLW for advice on the Japanese regulatory framework, and Editage (www.editage.jp) for English language editing. The part of this research regarding reclassified substances in the UK and Japan is a reformed version of Yuki Kitagawa’s report that was initially conducted during an undergraduate program and reported in Japanese to the Faculty of Pharmacy, Musashino University. Moreover, her research was originally planned and conducted using OTC lists generated by the MHRA for the UK, which are not available now.⁵⁴ There was no financial support from any grant.

Disclosure

The authors report no conflicts of interest in this work.