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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. Lazaros et. al. JAMA 279: 1200, 1998
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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.
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 4 - 6th leading cause of death.
HUSM experience • Errors in prescribing process; • Wrong dose • Wrong frequency • Wrong duration • Wrong administration technique
Patient factors: • Failure to take drug or partial compliance • Taking more drugs than instructed • Self-treatment • Wrong technique of administration • Taking expired drugs
Explanations: • Lack of knowledge • Influenced by others • Negative attitudes • Own experience • Own perceptions • Difficult/complicated regimen • Extremes of age and need for assistance
WHO Organisational Structure Yasuhiro Suzuki Jonathan Quick
WHO's mission in medicines for 2000–2003 includes four main objectives: • Policy • Access • Quality and Safety • Rational Use of Drugs
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.
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.
Rational Use of Drugs Ensure therapeutically sound and cost-effective use of drugs by health professionals and consumers
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.
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
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.
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.
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
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."
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 10th model list of essential drugs (306) • The 11th Model List -- describing just over 300 drugs -- was revised in November 1999 and published in December 1999. N.B: Malaysia’s EDL contains 419 items and a supplemental list
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.
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.
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. • 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.
Progress on PRUD activities; (cont.) 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.
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