ArticleRisk management and healthcare policy2016
Medicine reclassification processes and regulations for proper use of over-the-counter self-care medicines in Japan.
Article in Risk management and healthcare policy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
- Review
- Expanding OTC medicine access in non-pharmacy settings for self-medication: a scoping review.Journal of pharmaceutical policy and practice · 2026Review
- Classification status of drugs generally used for self-medication in children: a targeted review of regulatory documents.Journal of pharmaceutical policy and practice · 2026Review
- A brief report of the status of self-medication with over-the-counter drugs: a pilot cross-sectional survey.BMC research notes · 2025Article
- Survey of community pharmacists' opinions on drug scheduling in Ontario and Québec.Journal of pharmaceutical policy and practice · 2024Article
- Association between health literacy and medication comprehension; attitudes toward reporting adverse events in adults using over-the-counter medicines.Journal of pharmaceutical policy and practice · 2023Article
- Over-the-Counter Drug Misuse and Dependence: Public Health Ethics' Foray into Fight against the Codeine Crisis.Pharmacy (Basel, Switzerland) · 2022Article
- Sales of Over-the-Counter Products Containing Codeine in 31 Countries, 2013-2019: A Retrospective Observational Study.Drug safety · 2022Observational
- Unprescribed and unnoticed: Retrospective chart review of adverse events of interactions between antidepressants and over-the-counter drugs.Frontiers in pharmacology · 2022Article
- A mixed-methods systematic review of the prevalence, reasons, associated harms and risk-reduction interventions of over-the-counter (OTC) medicines misuse, abuse and dependence in adults.Journal of pharmaceutical policy and practice · 2021Review
- Prescription and Non-Prescription Drug Classification Systems Across Countries: Lessons Learned for Thailand.Risk management and healthcare policy · 2020Article
- Evaluation between the Usability and Physicochemical Property of Acyclovir Ointments.Journal of pharmaceutics · 2018Article
- Medication counseling for OTC drugs using customized ChatGPT-4: Comparison with ChatGPT-3.5 and ChatGPT-4o.Digital healthArticle
- Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesJapan 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.
methodsThe 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.
resultsJapan 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.
conclusionIt 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.
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