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

Figures & data

Table 1 Definitions of self-care acknowledged in literature

World Health Organization (1983)^Citation3	Self-care in health refers to the activities individuals, families, and communities undertake with the intention of enhancing health, preventing disease, limiting illness, and restoring health. These activities are derived from knowledge and skills from the pool of both professional and lay experience. They are undertaken by lay people on their own behalf, either separately or in participative collaboration with professionals.
World Health Organization (1998)^Citation4	Self-care is what people do for themselves to establish and maintain health, and to prevent and deal with illness. It is a broad concept encompassing hygiene (general and personal), nutrition (type and quality of food eaten), lifestyle (sporting activities, leisure, etc), environmental factors (living conditions, social habits, etc), socioeconomic factors (income level, cultural beliefs, etc), and self-medication.
UK Department of Health (2005)^Citation5	Self-care is a part of daily living. It is the care taken by individuals toward their own health and well-being, and includes the care extended to their children, family, friends, and others in neighborhoods and local communities. Self-care includes the actions individuals and carers take for themselves, their children, their families, and others to stay fit and maintain good physical and mental health; meet social and psychological needs; prevent illness or accidents; care for minor ailments and long-term conditions; and maintain health and well-being after acute illness or discharge from hospital.
Steering Group for the Joining Up Self Care project (2006)^Citation6	Self-care is a lifelong habit and culture. It is the action individuals take for themselves and their families to stay healthy and take care of minor and long-term conditions, based on their knowledge and the information available, and working in collaboration with health and social care professionals where necessary.
WHO Regional Office for South-East Asia (2009)^Citation7	Self-care is the ability of individuals, families, and communities to promote health, prevent disease, and maintain health and to cope with illness and disability with or without the support of a health care provider.
World Self Medication Industry (2014)^Citation8	Self-care is what people do for themselves to establish and maintain health, prevent and deal with illness. It is a broad concept covering hygiene, nutrition, lifestyle, physical activity, avoiding risks (eg, smoking, obesity), and responsible self-medication with nonprescription medicines.

Notes: Adapted from Health Education in Self-Care: Possibilities and Limitations (Report of a Scientific Consultation), World Health Organization. Health Education Service, HED/84.1 Page 1, Copyright (1983), Available from http://apps.who.int/iris/bitstream/10665/70092/1/HED_84.1.pdf (Accessed June 20 2016);³ Adapted from The Role of the Pharmacists in Self-Care and Self-Medication: Report of the 4th WHO Consultative Group on the Role of the Pharmacist. WHO Consultative Group on the Role of the Pharmacist (4th: 1998: Hague, Netherlands) and World Health Organization. Dept. of Essential Drugs and Other Medicines, WHO/DAP/98.13 page 2–3. Copyright (1998). Available from: http://apps.who.int/iris/bitstream/10665/65860/1/WHO_DAP_98.13.pdf. Accessed June 20 2016.;⁴ Adapted from Self-Care – A Real Choice, the UK Department of Health. 2005. Available from: http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4101702.pdf. Accessed 20 June 2016.;⁵ Adapted from Joining Up Self- Care in the NHS, Steering Group for the Joining Up Self Care Project, 2006. Available from: http://www.selfcareforum.org/wp-content/uploads/2011/07/JUSCFullReport.pdf. Accessed December 20, 2015;⁶ reprinted from Self-Care in the Context of Primary Health Care: Report of the Regional Consultation Bangkok, Thailand, January 7–9, 2009; World Health Organization Regional Office for South-East Asia. Page 17, Copyright (2009). Available from: http://apps.searo.who.int/PDS_DOCS/B4301.pdf. Accessed June 20 2016;⁷ Adapted from the World Self Medication Industry (WSMI). The Story of Self-Care and Self-Medication: 40 Years of Progress, 1970–2010. Available from: http://www.wsmi.org/wp-content/data/pdf/storyofselfcare_brochure.pdf. Accessed December 201 2015.⁸

Table 2 Type of nonprescription medicines in UK and Japan

	Class	Distribution	Online sale
Japan^Citation32	Prescription medicines	Pharmacist	No
	Nonprescription medicines with mandatory face-to-face instruction by pharmacist (P)
	General sale with instruction by pharmacist (GSC1)		Available
	General sale, instruction recommended (GSC2)	Pharmacist
	General sale, instruction provided on request (GSC3)	Registered sales person
UK^Citation29	Prescription-only medicines	Pharmacist	No
	Medicines available under the supervision of a pharmacist (P)
	Medicines on General Sale List (GSL)	Anyone	Available

Notes: GSL, General Sale Risk Class (GSC) – available in general retail outlets, such as supermarkets. Japan’s P: drugs whose risk as over-the-counter (OTC) medicine is uncertain because they are in the early period after being reclassified from prescription medicine. GSC1: drugs whose adverse effects could cause health damage to the degree that might disturb daily life and have been designated by the Minister of Health, Labour and Welfare as the ones that require special attention for the usage; and drugs whose active ingredients are distinctly different from those of the drugs whose production and sales have been approved but not passed a certain period of time after obtaining an approval. GSC2: drugs whose adverse effects could cause health damage to the degree that might disturb daily life (excluding first-class OTC drugs) and have been designated by the Minister of Health, Labour and Welfare. GSC3: OTC drugs other than first-class and second-class OTC drugs. Adapted from the Medicines and Healthcare Products Regulatory Agency. Medicines: Reclassify Your Product; December 18, 2014. Available from: https://www.gov.uk/guidance/medicines-reclassify-your-product;²⁹ adapted from the Ministry of Internal Affairs and Communications. [The Pharmaceutical Affairs Law, Act No. 145 of 1960. 10 August 1960]. Available from http://law.e-gov.go.jp/htmldata/S35/S35HO145.html.³²

Figure 1 Approval processes in the UK and Japan.

Notes: (A) The approval processes for reclassified medicines in the UK. Source: Medicines and Healthcare Products Regulatory Agency. How to change the legal classification of a medicine in the UK: 2012. Available from: http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con213177.pdf. Accessed 5 July, 2015. (B) The approval processes for reclassified medicines in Japan, until 2014. Source: Ministry of Health, Labour and Welfare. Document No. 5 of the Committee for OTC. May 25, 2015. Available from: http://www.mhlw.go.jp/file/05-Shingikai-11121000-Iyakushokuhinkyoku-Soumuka/0000090067.pdf. Accessed July 5, 2015. (C) The approval processes for reclassified medicines in Japan, from 2015. Source: Ministry of Health, Labour and Welfare. Document No. 5 of the Committee for OTC. May 25, 2015. Available from: http://www.mhlw.go.jp/fle/05-Shingikai-11121000-Iyakushokuhinkyoku-Soumuka/0000090067.pdf. Accessed December 20, 2015. Tamura K. Regulation of OTC Drugs in Japan; In International Conference of the Non-prescription Drugs Regulation. July 22, 2015.
Abbreviations: MHLW, Ministry of Health, Labour and Welfare; OTC, over-the-counter; MHRA, Medicines and Healthcare products Regulatory Agency; PMDA, pharmaceuticals and medical devices agency.

Table 3 The list of substances reclassified from nonprescription medicines to pharmacy or general sale medicines commonly in the UK and Japan, from 1983 to January 2015

Substance	Classification
Acetoaminophen	–
Aciclovir	GSC1
Adenosine triphosphate disodium hydrate	–
Azelastine hydrochloride	–
Beclometasone dipropionate	–
Bifonazole	–
Cetirizine hydrochloride	P
Cimetidine	GSC1
Clotrimazole	GSC1
Diclofenac sodium	–
Famotidine	GSC1
Felbinac	–
Hydrocortisone butyrate	–
Ibuprofen	–
Isoconazole nitrate	GSC1
Ketoprofen	–
Loperamide hydrochloride	–
Minoxidil	GSC1
Nicotine (gum)	GSC1
Nicotine (patch)
Nizatidine	GSC1
Oxethazaine	–
Piroxicam	–
Ranitidine hydrochloride	GSC1
Sodium cromoglicate	–
Sulconazole nitrate	–
Terbinafne hydrochloride	–
Tioconazole	–
Tranexamic acid	–
Triamcinolone acetonide	–

Notes: Classification P is defined as nonprescription medicines to be sold with mandatory face-to-face instruction by a pharmacist; GSC1 (General Sale Risk Class 1) is general sale with instruction from a pharmacist; all others (–) are nonprescription medicines that can be sold by a registered sales person possibly without pharmacist supervision in Japan. Classification shows the risk class for nonprescription drugs with pharmacists’ supervision in Japan.

World Health OrganizationHealth Education in Self-Care: Possibilities and Limitations (Report of a Scientific Consultation)Geneva, Switzerland1121–251983

 Google Scholar

World Health OrganizationThe Role of the Pharmacists in Self-Care and Self-Medication: Report of the 4th WHO Consultative Group on the Role of the Pharmacist WHO/DAP/98.13The Hague, The Netherlands826–281998 Available from: http://apps.who.int/iris/bitstream/10665/65860/1/WHO_DAP_98.13.pdfAccessed July 5, 2015

 Google Scholar

UK Department of HealthSelf-Care – A Real Choice2005 Available from: http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4101702.pdfAccessed 20 June 2016

 Google Scholar

Steering Group for the Joining Up Self Care ProjectJoining Up Self-Care in the NHS2006 Available from: http://www.selfcareforum.org/wp-content/uploads/2011/07/JUSCFullReport.pdfAccessed December 20, 2015

 Google Scholar

World Health Organization Regional Office for South-East AsiaSelf-Care in the Context of Primary Health Care: Report of the Regional Consultation Bangkok, Thailand, January 7–9, 2009; India2009 Available from: http://apps.searo.who.int/PDS_DOCS/B4301.pdfAccessed December 20, 2015

 Google Scholar

World Self Medication Industry (WSMI)The Story of Self-Care and Self-Medication: 40 Years of Progress, 1970–2010 Available from: http://www.wsmi.org/wp-content/data/pdf/storyofselfcare_brochure.pdfAccessed December 20, 2015

 Google Scholar

Ministry of Internal Affairs and CommunicationsThe Pharmaceutical Affairs Law, Act No. 145 of 19601081960 Available from http://law.e-gov.go.jp/htmldata/S35/S35HO145.htmlAccessed 5 May 2016 Japanese

 Google Scholar

Medicines and Healthcare Products Regulatory AgencyMedicines: Reclassify Your Product12182014 Available from: https://www.gov.uk/guidance/medicines-reclassify-your-productAccessed December 20, 2015

 Google Scholar