The concept of essential medicines: lessons for rich countries
http://www.100md.com
《英国医生杂志》
1 Drugs and Medicines Policy, World Health Organization, Geneva, Switzerland hogerzeilh@who.int
Rich countries should follow the lead of poor countries and adopt a more systematic way of controlling the cost of drugs
Introduction
These first essential medicines' lists of the 1970s were often just commonsense stock lists for supply systems for the public sector. Over the years the selection criteria have become more systematic, and currently medicines are only listed when they feature in a clinical guideline. The evidence is then linked to the treatment, not to the medicine. For example, azithromycin is now on the model list for single dose treatment of genital Chlamydia trachomatis and trachoma only and not as a general antibiotic, for which its advantages are much less clear. By the turn of the century, 135 countries had developed national clinical guidelines, mostly linked to national lists of essential medicines. Good examples are Zimbabwe,13 South Africa14 and, more recently, Delhi State Capital Territory.15
It has long been thought that national clinical guidelines were only relevant and, indeed, only possible in developing countries (perhaps with the exception of the antibiotic guidelines of Australiaw5). But in the early 1990s, discrepancies in the quality of care between the various districts and hospitals in Scotland led the Department of Health and the Royal Colleges to start the Scottish Intercollegiate Guidelines Network (SIGN). This network has now prepared over 70 guidelines for disorders where treatments showed large differences despite the availability of good clinical evidence. In other developed countries the number of clinical guidelines is also growing rapidly. Unfortunately their scientific evidence base and management of potential conflicts of interests are not always transparent. This has led to international groups, such as the AGREE (Appraisal of Guidelines Research and Evaluation) collaboration to standardise the guideline development process, GRADE (the Working Group on Grading Harmonization) to standardise the grading of evidence, and GIN (the Guidelines International Network) to exchange evidence tables. What started in New Guinea (1974)w6 and Mozambique (1981)w7 is now happening in industrialised countries.
National medicine policies
w1-w10 are on bmj.com
I thank Kath Hurst and Shalini Jayasekar for support and Richard Laing and James Tumwine for their comments. Important WHO references to support the selection of essential medicines are: 13th model list of essential medicines (www.who.int/medicines); WHO model formulary 2004 (mednet3.who.int/eml/modelFormulary.asp); and the WHO essential medicines library (mednet3.who.int/eml/).
Contributors: HVH is the sole contributor to this article.
Funding: Department of Essential Drugs and Medicines Policy, WHO.
Competing interests: None declared
References
World Health Organization. The selection and use of essential medicines. Report of the WHO Expert Committee, 2002 (including the 12th Model List of Essential Medicines). Technical Report Series No 914. Geneva: WHO, 2003.
World Health Organization. The selection and use of essential medicines. Report of the WHO Expert Committee, 2002 (including the 12th Model List of Essential Medicines). Technical Report Series No 914. Geneva: WHO, 2003: 15.
Grimshaw J, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993;342: 1317-22.
Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Clinical guidelines: potential benefits, limitations and harms of clinical guidelines. BMJ 1999;318: 527-30.
Kafuko J, Bagenda D. Impact of national standard treatment guidelines on rational drug use in Uganda health facilities. Kampala: Unicef/Uganda, 1994.
Laing RO, Hogerzeil HV, Ross-Degnan D. Ten recommendations to improve use of medicines in developing countries. Health Policy Plann 2001;16: 13-20.
World Health Organization. WHO medicines strategy 2004-2007. Geneva: WHO, 2004.
SCRIP 1994;No 1974: 21.
Drummond MF. Basing prescription drug payment on economic analysis: the case of Australia. Health Affairs 1992;11: 191-6.
Lipton HL, Gross DJ, Stebbins MR, Syed LH. Managing the pharmacy benefit in Medicare HMOs: what do we really know? Health Affairs 2000;19: 42-58.
Gold MR, Hurley R, Lake T, Ensor T, Berenson R. A national survey of the arrangements managed-care plans made with physicians. N Engl J Med 1995;333: 1678-83.
Desert-island drugs . Lancet 1978;i: 977-8.
Ministry of Health and Child Welfare. EDLIZ: 4th essential drugs list and standard treatment guidelines for Zimbabwe. Harare: Ministry of Health and Child Welfare, 2000.
Department of Health. Standard treatment guidelines and essential drugs list. Primary health care. Pretoria, South Africa: Department of Health, 2003.
Sharma S, Sethi GR, Gulati RK. Standard treatment guidelines. New Delhi: Delhi Society for Promotion of Rational Use of Drugs, 2002.
How to establish and implement a national drug policy. Geneva: WHO, 2001.
Walley T, Earl-Slater A, Haycox A, Bagust A. An integrated national pharmaceutical policy for the United Kingdom? BMJ 2000;321: 1523-6.
Commonwealth Department of Health and Aged Care. National medicines policy. Canberra: Commonwealth Department of Health and Aged Care, 2000.(Hans V Hogerzeil, directo)
Rich countries should follow the lead of poor countries and adopt a more systematic way of controlling the cost of drugs
Introduction
These first essential medicines' lists of the 1970s were often just commonsense stock lists for supply systems for the public sector. Over the years the selection criteria have become more systematic, and currently medicines are only listed when they feature in a clinical guideline. The evidence is then linked to the treatment, not to the medicine. For example, azithromycin is now on the model list for single dose treatment of genital Chlamydia trachomatis and trachoma only and not as a general antibiotic, for which its advantages are much less clear. By the turn of the century, 135 countries had developed national clinical guidelines, mostly linked to national lists of essential medicines. Good examples are Zimbabwe,13 South Africa14 and, more recently, Delhi State Capital Territory.15
It has long been thought that national clinical guidelines were only relevant and, indeed, only possible in developing countries (perhaps with the exception of the antibiotic guidelines of Australiaw5). But in the early 1990s, discrepancies in the quality of care between the various districts and hospitals in Scotland led the Department of Health and the Royal Colleges to start the Scottish Intercollegiate Guidelines Network (SIGN). This network has now prepared over 70 guidelines for disorders where treatments showed large differences despite the availability of good clinical evidence. In other developed countries the number of clinical guidelines is also growing rapidly. Unfortunately their scientific evidence base and management of potential conflicts of interests are not always transparent. This has led to international groups, such as the AGREE (Appraisal of Guidelines Research and Evaluation) collaboration to standardise the guideline development process, GRADE (the Working Group on Grading Harmonization) to standardise the grading of evidence, and GIN (the Guidelines International Network) to exchange evidence tables. What started in New Guinea (1974)w6 and Mozambique (1981)w7 is now happening in industrialised countries.
National medicine policies
w1-w10 are on bmj.com
I thank Kath Hurst and Shalini Jayasekar for support and Richard Laing and James Tumwine for their comments. Important WHO references to support the selection of essential medicines are: 13th model list of essential medicines (www.who.int/medicines); WHO model formulary 2004 (mednet3.who.int/eml/modelFormulary.asp); and the WHO essential medicines library (mednet3.who.int/eml/).
Contributors: HVH is the sole contributor to this article.
Funding: Department of Essential Drugs and Medicines Policy, WHO.
Competing interests: None declared
References
World Health Organization. The selection and use of essential medicines. Report of the WHO Expert Committee, 2002 (including the 12th Model List of Essential Medicines). Technical Report Series No 914. Geneva: WHO, 2003.
World Health Organization. The selection and use of essential medicines. Report of the WHO Expert Committee, 2002 (including the 12th Model List of Essential Medicines). Technical Report Series No 914. Geneva: WHO, 2003: 15.
Grimshaw J, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993;342: 1317-22.
Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Clinical guidelines: potential benefits, limitations and harms of clinical guidelines. BMJ 1999;318: 527-30.
Kafuko J, Bagenda D. Impact of national standard treatment guidelines on rational drug use in Uganda health facilities. Kampala: Unicef/Uganda, 1994.
Laing RO, Hogerzeil HV, Ross-Degnan D. Ten recommendations to improve use of medicines in developing countries. Health Policy Plann 2001;16: 13-20.
World Health Organization. WHO medicines strategy 2004-2007. Geneva: WHO, 2004.
SCRIP 1994;No 1974: 21.
Drummond MF. Basing prescription drug payment on economic analysis: the case of Australia. Health Affairs 1992;11: 191-6.
Lipton HL, Gross DJ, Stebbins MR, Syed LH. Managing the pharmacy benefit in Medicare HMOs: what do we really know? Health Affairs 2000;19: 42-58.
Gold MR, Hurley R, Lake T, Ensor T, Berenson R. A national survey of the arrangements managed-care plans made with physicians. N Engl J Med 1995;333: 1678-83.
Desert-island drugs . Lancet 1978;i: 977-8.
Ministry of Health and Child Welfare. EDLIZ: 4th essential drugs list and standard treatment guidelines for Zimbabwe. Harare: Ministry of Health and Child Welfare, 2000.
Department of Health. Standard treatment guidelines and essential drugs list. Primary health care. Pretoria, South Africa: Department of Health, 2003.
Sharma S, Sethi GR, Gulati RK. Standard treatment guidelines. New Delhi: Delhi Society for Promotion of Rational Use of Drugs, 2002.
How to establish and implement a national drug policy. Geneva: WHO, 2001.
Walley T, Earl-Slater A, Haycox A, Bagust A. An integrated national pharmaceutical policy for the United Kingdom? BMJ 2000;321: 1523-6.
Commonwealth Department of Health and Aged Care. National medicines policy. Canberra: Commonwealth Department of Health and Aged Care, 2000.(Hans V Hogerzeil, directo)