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ARN14 Feb. 2002 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. 2002 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 4 - 6th leading cause of death.
ARN14 Feb. 2002 JSPS visit Showa University
HUSM experience
Errors in prescribing process;
Wrong dose
Wrong frequency
Wrong duration
Wrong administration technique
ARN14 Feb. 2002 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. 2002 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. 2002 JSPS visit Showa University
WHO Organisational Structure
Yasuhiro Suzuki
Jonathan Quick
ARN14 Feb. 2002 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. 2002 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. 2002 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. 2002 JSPS visit Showa University
Rational Use of Drugs
Ensure therapeutically sound and
cost-effective use of drugs by health
professionals and consumers
ARN14 Feb. 2002 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. 2002 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. 2002 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. 2002 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. 2002 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. 2002 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. 2002 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 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
ARN14 Feb. 2002 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. 2002 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.
ARN14 Feb. 2002 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.
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. 2002 JSPS visit Showa University
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.
ARN14 Feb. 2002 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