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Annual Report 2003 - Essential Drugs and Medicines Policy
(2004; 24 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentThe year in focus: medicines for HIV/AIDS, tuberculosis and malaria
View the documentPolicy
View the documentAccess
View the documentQuality and Safety
View the documentRational Use
View the documentManagement
View the documentBack Cover

Rational Use

Traditional medicine vs. SARS: expert meeting backs integrated treatment

In July 2003, WHO announced that it had broken the chain of human-to-human transmission of the SARS (severe acute respiratory syndrome) coronavirus. In an epidemic that started in China and lasted a little over 12 months, more than 8400 cases of SARS were reported in 29 countries. Within a few months of the end of the epidemic, it was recognized by a meeting of experts that traditional Chinese medicine (TCM) had helped fight the SARS battle. Why and how was TCM integrated with western medicine (WM) to achieve this success?

A long history of use

China has a long history of traditional medicine use, which often includes herbal medicines, acupuncture or acupressure and spiritual therapies. TCM is frequently used to meet primary health care needs.

When SARS broke out, the Chinese State Administration of Traditional Chinese Medicine (SATCM) initiated clinical research projects on integrated TCM and WM. A total of 21 projects were set up focusing on prevention, treatment and rehabilitation. (More than half of all SARS patients in China were treated with TCM.) At the request of the Chinese Government, and with financial support from the Nippon Foundation, WHO guided SATCM on 13 clinical trials. Working together, WHO and SATCM later organized the International Expert Meeting on Review of Treatment of SARS and the Integration of Traditional Chinese Medicine with Western Medicine. The meeting was held in Beijing, China, in October 2003, and reviewed the reports of the 13 clinical trials.

Dangerous conditions

In all, 68 experts from seven countries attended the meeting. They paid tribute to the TCM professionals who treated SARS patients. They were recognized as having carried out vital data collection in dangerous conditions. They are estimated to have participated in the treatment of SARS in 102 of the 195 SARS-specific hospitals in China.

For SARS patients, data collected indicated that TCM could potentially alleviate fatigue, shortness of breath and other clinical symptoms and enhance immune system functioning. The 13 clinical reports indicated that no negative side-effects on heart, liver or kidney functioning were observed, suggesting that TCM treatment was safe. Moreover, for a group of early-stage SARS patients treated only with TCM, all recovered, without the need for corticoids, antiviral agents or antibiotics. Additionally, no SARS cases were observed among health workers who had been exposed to SARS but who had taken TCM for the purpose of prevention. The meeting report (in press) comments, "TCM is the accumulation of thousands of years of experience of the Chinese nation in fighting against diseases. Facing unknown reasons or complicated pathological causes of diseases, traditional Chinese differentiation cognition theory and treatment principles have obvious advantages."

However, the experts who attended the meeting noted that the data in the reports were inconclusive. Accordingly, their recommendations were to: continue follow-up of SARS cases, and observation and comparison of the long-term effects of various treatments; improve clinical research design; and strengthen research on health economics and SARS.

Further information:
Xiaorui Zhang - zhangx@who.int

Communicable Diseases Hospital, Beijing, China

PHOTO: WHO/Pierre Virot

One pill to be taken 2 x daily: ground-breaking industry-public health meeting on fixed-dose combinations

"It was a unique and important meeting. By bringing together the large pharmaceutical companies, the generic manufacturers and disease control experts, we were able to get a consensus on the way forward. It was an opportunity for disease control specialists to say to the pharmaceutical industry - this is what we want. And there was a clear willingness by the industry to focus on global public health needs," comments Dr Richard Laing, of the Medicines Policy, Access and Rational Use team at WHO Headquarters. He is describing the meeting on fixed-dose combinations (FDCs) for HIV/AIDS, tuberculosis (TB) and malaria, organized by WHO in December 2003 and supported by the Rockefeller Foundation. Attended by WHO medicines and disease control programmes, nongovernmental organizations, medicines regulatory agencies, and representatives of the pharmaceutical industry, the meeting brought together the full range of stakeholders in FDCs.

FDCs have a long history of development and use. The combined contraceptive pill and the treatment of cancer, infectious diseases, hypertension and neurological disorders, are well-known examples of FDC use. In fact, in the 1960s, in the USA, they accounted for over half of all pharmaceutical products and for 40% of the best-selling medicines. But then followed controversy. Because there were many "irrational" combination products on the market, FDCs fell out of favour with medicines regulators.

"It became clear that FDCs should be used only where combination treatment offered a clear advantage. Since the 1990s we have become increasingly concerned about the rise of antimicrobial resistance. Now we are also concerned about how best to promote AIDS/TB/malaria treatment adherence. In both areas, FDCs have obvious advantages," continues Dr Laing.

"Instead of asking someone to take 12 or 13 tablets a day, if he or she can just take one or two, then there is a much greater chance of compliance. We have seen this in TB control with use of FDCs in DOTS4 programmes. And when we consider the high interaction of TB and AIDS infection, it's clear that FDCs will become increasingly important to public health programmes."

4 Directly observed treatment, short-course.

"The meeting was a key point in time. WHO was a forum for all those people to come together, to get a synthesis of ideas. We were able to bring these different groups together because they share the same problems. The consensus was that FDCs are the way forward for HIV/AIDS, TB and malaria treatment, where possible. That is the first choice. If that is not possible, then we use blister packs, which also simplify patient adherence," says Dr Laing.

FDCs also help streamline medicines supply management - theft, wastage and misuse can all be minimized. However, these three- or four-drug combinations can be difficult to produce to quality-assured standards.

The value of FDCs for 3 by 5

Commenting on the use of FDC antiretroviral (ARV) medicines within WHO's 3 by 5 strategy to fight HIV/AIDS, Dr Vladimir Lepakhin, WHO Assistant Director-General for Health Technology and Pharmaceuticals, emphasizes that the ease of compliance and distribution would prove invaluable. "The 3 by 5 strategy recommends simplified AIDS treatment regimens," he continues. "These new FDCs will help the countries which are hardest hit by the AIDS epidemic to provide easy-to-take AIDS medicines to the people who need them most urgently."

Médecins Sans Frontières is currently providing ARV treatment to more than 11 000 people living with HIV/AIDS in over 20 countries. It is a strong advocate of triple-FDCs and comments that, "Compared to ARV drugs used as separate products, triple-FDCs have clear advantages, such as ease of use, reduced risk of drug resistance, competitive prices and the easing of pressure on the supply chain."

Further information:
Richard Laing - laingr@who.int

PHOTO: Irene R Lengui/L'IV Com

Local data for local action to fight antimicrobial resistance

"Until now, surveillance work aimed at understanding and tackling antimicrobial resistance (AMR) was carried out largely at national level, with little local input or feedback. The new approach being developed by WHO, is to gather local data for local action," explains Dr Kathleen Holloway, medical officer with the Policy, Access and Rational Use team at WHO Headquarters. One of Dr Holloway's tasks is to encourage rational use of antibiotics to help slow development of AMR. But doing this demands understanding of why and how it develops in the first place.

Dr Holloway continues, "The problem has been that little evidence has so far been collected as to which AMR interventions are the most effective and feasible. Instead, attempts to tackle AMR have tended to be hospital-based, involving only surveillance by microbiologists. Samples analysis has remained at the level of the sample (i.e. bacteria), and has been linked to neither patients nor type of antimicrobial use. Antimicrobials are used not just in hospitals though, but also widely within communities. So what is needed is a broad-based analysis.

"This in turn means using a multidisciplinary approach, whereby health professionals experienced in rational use of medicines and antimicrobial resistance, work with anthropologists and sociologists experienced in working with communities. Only then can we work out the how and why of antimicrobial use. After that, we can choose interventions for containing AMR that are likely to be locally appropriate and feasible."

But developing countries often lack multidisciplinary capacity. Dr Holloway has therefore assembled a team of researchers, and is supporting five pilot projects in India and South Africa, to encourage its development. Based around local institutions, the projects are helping experts of different disciplines to pool their expertise to collect a wide variety of data on AMR and antibiotic use. The projects have gathered one year's worth of data from all levels of the health care system, both public and private. These data will be used to formulate local action plans.

Problems and progress

Each project experienced difficulties in getting started, including problems in creating a multidisciplinary team, insufficient sample size of patients, logistical problems in collecting medicines use data and difficulties in performing adequate data analysis. That said, at every project site, project participants have found project involvement to be an invaluable learning experience. "Not only are we creating a standard method for multidisciplinary research into AMR - suitable for use in any country - but we are building understanding about how to do it," comments Dr Holloway. Initial results from all projects show an association between high antimicrobial use and resistance, and significant over-use of antimicrobials in the community. Alarmingly, some results demonstrate that trends in increasing use are associated with trends in increasing resistance.

Phase II will broaden this programme of work, so as to identify interventions that can most effectively slow resistance to treatment for HIV/AIDS, tuberculosis (TB) and malaria. Failure to do so could threaten achievement of Millennium Development Goal 4 - to reduce child mortality - and Goal 6 - to combat HIV/AIDS, malaria and other diseases. AMR could also undermine global initiatives such as 3 by 5, Roll Back Malaria and Stop TB, as well as national efforts to tackle infectious diseases.

Dr Kurien Thomas, a collaborator with WHO in gathering local data for to tackle antimicrobial resistance

PHOTO: WHO/Kath Hurst

In describing the project he supervises in Vellore, India, Dr Kurien Thomas, Professor of Medicine at the Christian Medical College, comments that working with WHO has, "helped us to determine our directions in tackling AMR". For his clinical pharmacologist colleague, Dr Sujith Chandy, the WHO AMR project has presented, "WHO - a wonderful holistic opportunity. The value of linking data on AMR and on medicines use at local level, of working in urban and rural areas and of bringing colleagues from different disciplines within the hospital to work together on the project is proving to be a great experience for all involved."

Further information:
Kathleen Holloway - hollowayk@who.int

Where the money went: financial information 2002-2003

Funding sources for essential drugs and medicines policy activities continue to be very diverse. In 2002-2003, in addition to regular budget funds - which accounted for 17% offunds available for the Department of Essential Drugs and Medicines Policy at WHO Headquarters - important extrabudgetary contributions were received from a number of governments (Australia, Denmark, Germany, Italy, Japan, Luxembourg, the Netherlands, Norway, Sweden, the United Kingdom and the USA). Extrabudgetary contributions also came from the Regional Government of Lombardy (Italy), UNAIDS, the European Medicines Evaluation Agency, and the Nippon and Rockefeller Foundations. Income was received too from fees paid by pharmaceutical manufacturers for the assigning of International Nonproprietary Names (US$ 723 000). For 2004-2005, significant support is also anticipated from the European Commission, and the Bill and Melinda Gates Foundation.

Other human and financial support was leveraged by arranging co-sponsoring of technical meetings, including workshops and training seminars, contribution of technical expertise to specific projects, and co-funding of technical publications.

Areas of experience

For the 2002-2003 biennium, the budget for essential drugs and medicines policy activities at WHO Headquarters was US$ 34.9 million. Funds transferred from WHO Headquarters to supplement funding for medicines activities in countries and regions amounted to US$ 5.8 million. Funds were spent in line with the objectives and targets of the WHO Medicines Strategy 2000-2003. The largest share of the funding supported objectives relating to development, implementation and monitoring of national medicines policies, safe use of medicines, and medicines regulation and quality assurance.

Sources of extrabudgetary revenue received in 2002-2003 (US$)

Into the future

Diversity of funding and in-kind support will be maintained. Indeed, it is absolutely crucial given the volatility of distribution of funds for health, and increased competition for those funds. Loss of a source of funding could have a heavily negative impact on the direction and implementation of the WHO Medicines Strategy for 2004-2007.

Funding is still a concern, however. Growing country requirements for pharmaceutical technical support - particularly following extended efforts to increase access to medicines for HIV/AIDS, malaria and tuberculosis - mean that funds available do not match need. Thus at the end of 2003, the shortfall for the 2004-2005 biennium was calculated at US$ 9.1 million for WHO Headquarters and US$ 6.8 million for WHO regions and countries. Should this shortfall not be covered, a number of activities would have to be reduced in scope, delayed or cancelled.

Needless to say, given the need to maximize funds for health, increased efforts are being made to ensure timely liaison with donors, and careful matching of WHO and donor priorities and policies within the wider development context. Greater priority is also being given to monitoring and evaluation of medicines activities at country level, to help ensure that resources are applied where most needed and where they can be used to optimal effect.

Further information:
Jacqueline Sawyer - sawyerj@who.int


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