JSMI NEWSLETTER Number 71, Apr. 2009 CONTENTS 1. English version of "Self-Medication Handbook" posted on JSMI website 2. Progress of Rx-to-OTC switching is accelerated in Japan 3. JSMI’s new year press conference 4. Research Study on the feasibility of testing for detection of life-style related diseases by a self-blood collection kit at pharmacies 5. APSMI-TF held a teleconference to start ExC and RAC toward APSMI establishment in 2010   1.English version of "Self-Medication Handbook" posted on JSMI website JSMI publishes "Self-Medication Handbook" in Japanese, for consumers every year in order to enlighten Self-Medication. The handbook has been edited by Dr. Emi Nakajima, Professor of faculty of pharmacy, Keio University. The English version of the handbook 2007 edition was made by her biggest cooperation and distributed at JSMI-WSMI Tokyo conference in October, 2007. This March, JSMI uploads it on our website (http://www.jsmi.jp/english/handbook/index.html) and has transmitted the information of our activity of enlightening Self-Medication in Japan. 2. Progress of Rx-to-OTC switching is accelerated in Japan There are two major movements for progress of Rx-to-OTC switching in Japan. One is provided by Ministry of Health, Labour and Welfare (MHLW) which advocated "Progress scheme of Rx-to-OTC switching" in April 2007. The scheme comprises the evaluation of switching candidate by The Pharmaceutical Society of Japan and re-evaluation by The Japanese Association of Medical Sciences, followed by the examination by the Committee on Nonprescription Drugs in the Pharmaceutical Affairs and Food sanitation Council (PAFSC) of MHLW. The selected candidates through this scheme are to be announced every year. In August 2008, the first announcement for switching candidate of seven ingredients listed below was made by MHLW. Ingredients dosage functions Amlexanox oral anti allergy Pemirolast potassium oral anti allergy Ebastine oral anti allergy Tiaramide hydrochloride oral anti-inflammatory Ethyl icosapentate oral EPA preparation Fluticasone propionate nasal anti allergy Tocopherol nicotinate oral Vitamin E preparation The other movement is a voluntary activity by JSMI which has elaborated frameworks of Rx-to-OTC switching focusing on not only candidate ingredients but the process of examination for approval. In connection with the scheme by MHLW, JSMI announced the candidates for Rx-to-OTC switching of seventy ingredients in March 2007 and additional twenty ingredients in October 2008. The former, seventy ingredients presented in 2007, was selected on the basis of a criterion with the completion of re-evaluation as Rx products in Japan; however, the latter of twenty ingredients presented in 2008 were selected taking account of the condition of registration as Rx-to-OTC switch in other countries in addition to the completion of the above re-evaluation in Japan. The ingredients announced are listed as follows. Anatomical Classification Ingredient Form of Drug A02B Antiulcerants     A02B2 Acid Pump Inhibitors Lansoprazole Oral Omeprazole Oral Sodium Rabeprazole Oral A03A Plain Antispasmodics and Anticholinergics Mepenzolate Bromide Oral A03F Gastroprokinetics Domperidone Oral A10B Oral Antidiabetics     A10B5 Alpha-Glucosidase Inhibitor Antidiabetics Acarbose Oral Voglibose Oral A11C Vitamin A and D, including Combinations of the two     A11C2 Vitamin D Alfacalcidol Oral Calcitriol Oral C01C Cardiac Stimulants excluding Cardiac Glycosides Midodrine Hydrochloride Oral Amezinium Metilsulfate Oral C05A Topical Anti-Heamorrhoidals Tribenoside{Lidocaine Suppository C09A ACE Inhibitors, Plain Captopril Oral Enalapril Maleate Oral Alacepril Oral Delapril Hydrochloride Oral Cilazapril Hydrate Oral Lisinopril Hydrate Oral Benazepril Hydrochloride Oral Imidapril Hydrochloride Oral Temocapril Hydrochloride Oral C10A Cholesterol and Triglyceride Regulating Preparations     C10A1 Statins (HMG-CoA Reductase Inhibiturs) Pravastatin Sodium Oral C10A2 Fibrates Bezafibrate Oral C10A3 Ion-Exchange Resins Colestyramine Oral C10A9 All Other Cholesterol/Triglyceride Regulators dl]α]Tocopheryl Nicotinate Oral C10B Anti-Atheroma Preparations of Natural Origin Ethyl Icosapentate Oral D01A Antifungals, Dermatological     D01A1 Topical Dermatological Antifungals Ketoconazole Topical D03A Wound Healing Agents Tretinoin Tocoferil Topical D06A Topical Antibiotics and/or Sulphonamides Sulfadiazine Silver Topical Gentamicin Sulfate Topical D06D Topical Viral Infection Products Vidarabine Topical D07A Plain Topical Corticosteroids Alclometasone Dipropionate Topical Clobetasone butyrate Topical Flumetasone Pivalate Topical D10A Topical Anti-Acne Preparations Nadifloxacin Topical G01A Trichomonacides     G01A1 Systemic Trichomonacides Tinidazole Oral G01A2 Topical Trichomonacides Metronidazole Vaginal Tablet G01B Gynaecological Antifungals Isoconazole Nitrate Vaginal Tablet Oxiconazole Nitrate Vaginal Tablet Miconazole Nitrate Vaginal Tablet G04C Benign Prostatic Hypertrophy Products     G04C1 Benign Prostatic Hypertrophy Products Tamsulosin Hydrochloride Oral G04C8 Benign Prostatic Hypertrophy Products of Natural Origin Cernitin Pollen Extract Oral G04D Urinary Incontinence Products Propiverine Hydrochloride Oral Oxybutynin Hydrochloride Oral J01G Fluoroquinolones Norfloxacin Oral Ofloxacin Oral Levofloxacin Hydrate Oral Tosufloxacin Tosilate Hydrate Oral Lomefloxacin Hydrochloride Oral Fleroxacin Oral M01A Anti-Rheumatics, Non-Steroidal Loxoprofen Sodium Hydrate Oral Alminoprofen Oral Nabumetone Oral Emorfazone Oral Naproxen Oral Tiaramide Hydrochloride Oral Mefenamic Acid Oral M02A Topical Anti-Rheumatics Flurbiprofen Patch M03B Muscle Relaxants, Cetrally Acting Afloqualone Oral Eperisone Hydrochloride Oral Pridinol Mesilate Oral Phenprobamate Oral M05B Bone Calcium Regulators     M05B3 Bisphosphonates for Osteoprosis and Related Disorders Ipriflavone Oral P01B Anthelmintics, excluding Schistosomicides Pyrantel Pamoate Oral R01A Topical Nasal Preparations     R01A1 Nasal Corticosteroids without Anti-Infectives Beclomethasone Dipropionate Nasal Drop Fluticasone Propionate Nasal Drop Flunisolid Nasal Drop Dexamethasone Sodium m-Sulfobenzoate Nasal Drop Dexamethasone sodium phosphate Nasal Drop R01A3 Nasal Corticosteroids with Anti-Infectives Betamethasone Sodium Phosphate + Fradiomycin Sulfate Nasal Drop R03C Non-Steroidal Respiratory Anti-Inflammatories Amlexanox Oral Repirinast Oral Pemirolast Potassium Oral R03D Corticoids     R03D1 Corticoids, Inhalant Beclomethasone Dipropionate Inhaler R03J Antileukotriene Anti-Asthmatics Pranlukast Hydrate Oral R05C Expectorants Ambroxol Hydrochloride Oral R06A Systemic Antihistamines Emedastine Difumarate Oral Epinastine Hydrochloride Oral Ebastine Oral S01A Ophthalmological Anti-infectives Norfloxacin Eye Drop Ofloxacin Eye Drop Lomefloxacin Hydrochloride Eye Drop Gentamicin Sulfate Eye Drop S01G Ocular Anti-Allergics, Decongestants, Antiseptics Amlexanox Eye Drop Pemirolast Potassium Eye Drop Tranilast Eye Drop Ibudilast Eye Drop Amlexanox Nasal Drop S01N Preparations to Prevent Cataract and Anticataractogenics     S01N2 Preparations to Prevent Cataract and Anticataractogenics, Topical Pirenoxine Eye Drop Glutathione Eye Drop S01S Ophthalmological Surgical Aids     S01S1 Viscoelastic Substances Sodium Hyaluronate Eye Drop     3.JSMI’s new year press conference On 9th January 2009 in Tokyo, JSMI, Japan Self-Medication Industry held the new year press conference, where Mr. Miwa, Chairperson, Mr. Uehara, vice-chairperson and Mr. Hatori vice-chairperson made speeches. More than 80 news media attended the conference. At the beginning, Mr.Miwa addressed that JSMI, JPA (the Japan Pharmaceutical Association) and the Japanese Association of Chain Drug Stores (JACDS) had agreed to avoid unnecessary return of OTC products from the retail stores by the start of new retail system of OTC medicines and requested the media to inform consumers of the new retail system in understandable ways. He introduced three business activities which JSMI are developing as the priority issues as follows. 1. Vitalization of OTC market   The OTC medicines can contribute to the people’s health management and the reduction of medical expenses. Especially, the contribution to measures against the metabolic syndromes is important. Taking these into account, JSMI would dedicate all its strength to facilitating the Rx-to-OTC Switching. As part of this strategy, JSMI had entrusted universities with some studies to reveal scientific evidence for the social contribution of OTC medicines. Those results are expected to be disclosed this spring. 2. Enlightenment of the consumers on "Role of OTC medicines"   JSMI intends to promote Responsible Self-Medication by explaining the position and social significance of OTC medicines to consumers clearly, for example getting recognition to the difference between OTC medicines and dietary supplements, such as Food for Specified Health Uses or relevant so-called healthy foods. 3. Promotion of the Responsible Self-Medication in the Asia-Pacific Region   JSMI would like to pursue international activity to promote the Responsible Self-Medication by establishing a regional association, APSMI, Asia Pacific Self-Medication Industry. The vice-chairperson, Mr. Uehara addressed that JSMI will announce "JSMI Policy Vision" in the General Assembly of JSMI in this May, on which the Tactics Committee in JSMI has worked since last fall. The vice-chairperson, Mr. Hatori addressed that JSMI should play a leading role in establishing APSMI in 2010 and contribute to the promotion of the Responsible Self-Medication in the Asia-Pacific Region.   4.Research Study on the feasibility of testing for detection of life-style related diseases by a self-blood collection kit at pharmacies JSMI conducted the captioned research in order to be of help to develop Rx-to-OTC switching for the self-prevention and self-cure of the life-style related disease in the future. The research report, written in Japanese language, was published in the Japanese medical journal, " Rinsyo Hyoka (Clinical Evaluation) Vol.36, No.3, P.725-746 (2009)". The summary is as follows. Abstract Objective: A research study was conducted on problems associated with blood samples by a self blood collection kit at pharmacies, to confirm the effectiveness of blood testing through self-blood collection, in the development of over-the-counter (OTC) drugs that might contribute to the prevention and treatment of life-style related diseases, such as metabolic syndrome in particular. Design: The study was conducted, in full consideration of the ethics for study participants, including establishment of an ethical review board in compliance with GCP, as well as the scientific character and reliability of study results. Methodology: In those who gave consent to participation in this study among individuals who were consulted about life-style related diseases, a commercially-available, self-blood collection test kit was used at pharmacies. Blood samples were taken, and sample tubes were submitted to the testing site through pharmacists responsible for the research. After testing, the test results report was forwarded to Ubiquitous Preventive Medicine, Yokohama City University School of Medicine for the purpose of comprehensive evaluation. The results were sent by mail to each pharmacy, and then the results were handed to the study participants. Results: The study was conducted between November 21, 2007 and February 27, 2008, with a goal of recruiting 50 individuals in 14 pharmacies. Sixty-eight cases were accumulated and 66 (97.1%) of them were included in the analysis without any problems. Conclusion: It was feasible for the pharmacist to conduct research at pharmacies with the adoption of a self-blood collection kit. For the role and function of each component of the study administrative structure, the problems and improvements were confirmed.   5.APSMI-TF held a teleconference to start ExC and RAC toward APSMI establishment in 2010 Following the acceptance at the WSMI Board of Directors Meeting in Beijing last November, toward the establishment of APSMI in 2010, a teleconference was conducted by APSMI-Task Force on 5th March 2009. Five associations out of eleven in Asia Pacific region, ASMI, Australian Self-Medication Industry, KPMA, Korea Pharmaceutical Manufacturers Association, PhAMA, Pharmaceutical Association of Malaysia from Malaysia, PReMA, Pharmaceutical Research & Manufacturers Association of Thailand and JSMI, Japan Self-Medication, and WSMI, Dr. David Webber, Director General and Mr. Seiichi Sato, Vice Chair for Asia Pacific region, participated in the teleconference. Mr. Hatori, the Task Force leader facilitated proceedings in accordance with the Agenda containing 1) Membership of APSMI Executive Committee (ExC), in which the organization, rules, funding, personnel and funding will be drawn for the establishment of APSMI, and Regulatory Affairs Committee (RAC), in which collection and analysis of the regulatory information in the AP region and extraction of the issues will be conducted as a beginning activity of APSMI, 2) Working plan for ExC and RAC for 2009 and 3) Kick-off meeting of ExC and RAC. Tentative working plans for the two committees for 2009 were accepted by the participants. The plan shows that ExC works for setting APSMI mission and drawing a grand plan towards 2010 establishment General schedule, including articles of incorporation, organization, funding, rules, operations and activities. In the activity of RAC, for the purpose to address the regulatory issues in the region, which was pointed out in the questionnaire survey conducted in last year, the committee pursues building regulatory information database, collecting issues and matters in the region, investigating assignment as the supply side and proposing the way to keep the diversity in the region. About the future membership for APSMI and its activities, it was confirmed that it doesn’t fixed one representing association from each country since there could be one or more self-medication industrial associations in some countries. And as like the WSMI has the corporate member in the Board, APSMI may have such membership, and local corporations may apply to join it since they may have interests to the activities. The participants agreed the proposal to convene the kick-off meeting of ExC and RAC, tentatively scheduled on 30th April 2009 in Kuala Lumpur, Malaysia. PhAMA and JSMI will jointly arrange the meeting and provide information in detail promptly. The minutes of the teleconference was provided to the nonparticipant associations, CNMA; China Non-prescription Medicines Association, OPPI; Organisation of Pharmaceutical Producers of India, TPMMA; Taiwan Pharmaceutical Marketing & Management Association, GPFI; GP Farmasi – Indonesia, PHAP; Pharmaceutical and Healthcare Association of Philippines, NZSMI; New Zealand Self-Medication Industry Association, for sharing the information.