ARN14 Feb JSPS visit Showa University National “prescribing rule”;  Newly prescribed drugs is provided for not more than 2 weeks  Long term medications is provided for not more than 3 months  Other medications is provided for not more than 1 month  OCPs is provided for not more than 6 months.

ARN14 Feb JSPS visit Showa University Lazaros et. al. JAMA 279: 1200, 1998 Meta analysis (39 prospective studies in Toronto)  Serious ADRS requiring hospitalization or causing permanent disability or death = 6.7%  Fatal ADRS = 0.32% =  ADR  th leading cause of death.

ARN14 Feb JSPS visit Showa University HUSM experience Errors in prescribing process;  Wrong dose  Wrong frequency  Wrong duration  Wrong administration technique

ARN14 Feb JSPS visit Showa University Patient factors:  Failure to take drug or partial compliance  Taking more drugs than instructed  Self-treatment  Wrong technique of administration  Taking expired drugs

ARN14 Feb JSPS visit Showa University Explanations:  Lack of knowledge  Influenced by others  Negative attitudes  Own experience  Own perceptions  Difficult/complicated regimen  Extremes of age and need for assistance

ARN14 Feb JSPS visit Showa University 2 nd P-Drug workshop 1999

ARN14 Feb JSPS visit Showa University WHO Organisational Structure Yasuhiro Suzuki Jonathan Quick

ARN14 Feb JSPS visit Showa University WHO's mission in medicines for 2000–2003 includes four main objectives: Policy Access Quality and Safety Rational Use of Drugs

ARN14 Feb JSPS visit Showa University WHO’s Mission in Essential Drugs and Medicines Policy To help save lives and improve health by: closing the huge gap between the potential that essential drugs have to offer and the reality that for millions of people – particularly the poor and disadvantaged -- medicines are unavailable, unaffordable, unsafe or improperly used.

ARN14 Feb JSPS visit Showa University WHO’s Mission in Essential Drugs and Medicines Policy (cont.) The Organization works to fulfill its mission in essential drugs and medicines policy by: providing global guidance on essential drugs and medicines, and working with countries at their request to implement national drug policies to ensure equity of access to essential drugs, drug quality and safety, and rational use of drugs.

ARN14 Feb JSPS visit Showa University Rational Use of Drugs Ensure therapeutically sound and cost-effective use of drugs by health professionals and consumers

ARN14 Feb JSPS visit Showa University Rational Use of Drugs Improving the use of drugs by health workers and the general public is crucial to: reduce morbidity and mortality from communicable and non- communicable diseases, and contain drug expenditure.

ARN14 Feb JSPS visit Showa University Rational Use of Drugs A sound rational drug use programme in any country has three elements: Rational drug use strategy and monitoring - advocating rational drug use, identifying and promoting successful strategies, and securing responsible drug promotion. Rational drug use by health professionals Rational drug use by consumers

ARN14 Feb JSPS visit Showa University Rational drug use strategy and monitoring Support countries in implementing and monitoring a national strategy to promote rational use of drugs by health professionals and consumers.

ARN14 Feb JSPS visit Showa University Rational drug use by health professionals Develop national standard treatment guidelines, essential drugs lists, educational programmes and other effective mechanisms to promote rational drug use by health professionals.

ARN14 Feb JSPS visit Showa University Priorities for global guidance for 2000–2001 –Review of the development, dissemination and use of the WHO Model List of Essential Drugs –Review and dissemination of WHO Standard Treatment Guidelines –Training materials and curriculum review for undergraduate training –Guidelines for Drugs and Therapeutics Committees –International training materials and training in public education –International training materials and training in pharmaco- economics –Regional rational drug use training courses in French and Spanish (?for African countries) –Standard indicators and protocols to monitor drug promotion practices

ARN14 Feb JSPS visit Showa University What are essential drugs? "Essential drugs are those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in the appropriate dosage forms, and at a price that individuals and the community can afford."

ARN14 Feb JSPS visit Showa University History of Essential Drug List 1897 – Aspirin was introduced as the first synthetic pharmaceutical 1941 – Introduction of first modern antibiotics i.e Penicillin 1943 – First commercial antimalarial 1944 – First antituberculous drug 1950’s – Introduction of oral contraceptives, antidiabetics and antipsychotics 1977 – WHO published first model list of Essential drugs (208) 1997 – WHO’s 10 th model list of essential drugs (306) The 11th Model List -- describing just over 300 drugs -- was revised in November 1999 and published in December N.B: Malaysia’s EDL contains 419 items and a supplemental list

ARN14 Feb JSPS visit Showa University Progress on PRUD activities; Extensive research has shown that standard treatment guidelines, essential drugs lists and formularies do promote rational prescribing of drugs by prescribers. By the end of 1999, 157 countries had an essential drugs list. 135 countries have developed national treatment guidelines, of which 112 have been updated in the last five years. There are now more than 100 national formularies, By the end of 1999, 88 countries in all six WHO regions had introduced the essential drugs concept into curricula for medicine and pharmacy students.

ARN14 Feb JSPS visit Showa University Progress on PRUD activities; (cont.) The WHO Guide to Good Prescribing has proved to be another invaluable tool. Translated into 18 languages and now available on at least six different web-sites, it continues to be one of the Organization’s most successful publications. Primarily intended for undergraduate medical students who are about to enter the clinical phase of their studies, it provides step-by-step guidance on the process of rational prescribing.WHO Guide to Good Prescribing

ARN14 Feb JSPS visit Showa University Progress on PRUD activities; (cont.) The WHO Model List of Essential Drugs, and regional and international rational drug use courses, form a large part of ongoing WHO efforts to improve drug use by health professionals.WHO Model List of Essential Drugs International training courses for university teachers in problem-based pharmacotherapy teaching are held every year in Europe, Africa and Latin America. Two randomized controlled trials with over ten centres in developed and developing countries have shown that the teaching methods transfer lasting skills in rational prescribing.

ARN14 Feb JSPS visit Showa University Progress on PRUD activities; (cont.) WHO Monographs on Selected Medicinal Plants :WHO Monographs on Selected Medicinal Plants are also doing much to promote rational drug use, but in the area of traditional medicine. The Monographs were recently recommended by the European Commission to Member States as an authoritative reference.

ARN14 Feb JSPS visit Showa University Other Activities:  International Conference of Drug Regulatory Authorities (ICDRA)  International Conference on Harmonisation (ICH)  WHO Programme for International Drug Monitoring  UMC (Uppsala monitoring centre) – the Global Intelligence Network for Benefits and Risks in Medicinal Products  The WHO Collaborating Centre for Drug Statistics Methodology