WHO urges countries to take measures to combat antimicrobial resistance
Antimicrobial resistance (AMR) – the ability of micro-organisms to find ways to evade the action of the drugs used to cure the infections they cause – is increasingly recognised as a global public health issue which could hamper the control of many infectious diseases. Some bacteria have developed mechanisms which render them resistant to many of the antibiotics normally used for their treatment (multi-drug resistant bacteria), so pose particular difficulties, as there may be few or no alternative options for therapy. They constitute a growing and global public health problem. The World Health Organization (WHO) suggests that countries should be prepared to implement hospital infection control measures to limit the spread of multi-drug resistant strains and to reinforce national policy on prudent use of antibiotics, reducing the generation of antibiotic resistant bacteria.
An article published in The Lancet on 11 August 2010 identified a new gene that enables some types of bacteria to be highly resistant to almost all antibiotics. The article has drawn attention to the issue of AMR, and, in particular, has raised awareness of infections caused by multi-drug resistant bacteria.
While multi-drug resistant bacteria are not new and will continue to appear, this development requires monitoring and further study to understand the extent and modes of transmission, and to define the most effective measures for control.
Those called upon to be alert to the problem of antimicrobial resistance and take appropriate action include consumers, prescribers and dispensers, veterinarians, managers of hospitals and diagnostic laboratories, patients and visitors to healthcare facilities, as well as national governments, the pharmaceutical industry, professional societies, and international agencies.
WHO strongly recommends that governments focus control and prevention efforts in four main areas:
- surveillance for antimicrobial resistance;
- rational antibiotic use, including education of healthcare workers and the public in the appropriate use of antibiotics;
- introducing or enforcing legislation related to stopping the selling of antibiotics without prescription; and
- strict adherence to infection prevention and control measures, including the use of hand-washing measures, particularly in healthcare facilities.
Successful control of multidrug-resistant microorganisms has been documented in many countries, and the existing and well-known infection prevention and control measures can effectively reduce transmission of multi-drug resistant organisms if rigorously and systematically implemented.
WHO will continue to support countries to develop relevant policies, and to coordinate international efforts to combat antimicrobial resistance. Antimicrobial resistance will be the theme of WHO’s World Health Day 2011.
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Global forum to improve developing country access to medical devices
More than 350 leading health experts from over 100 countries are meeting today at a World Health Organization (WHO) forum in Bangkok, Thailand to review new evidence and agree ways to improve developing country access to life-saving medical devices.
“The medical device industry holds great promise for public health, sometimes spectacular promise, sometimes seductive promise,” said Dr Margaret Chan, WHO Director-General. “Health officials and hospital managers in all countries, at all levels of development, need guidance. We are also holding this forum because the unquestionable benefits of medical devices are so unevenly and unfairly distributed.”
Today there are some 10,500 different types of medical devices on the market. They range from high-cost, high-tech diagnostic and therapeutic equipment such as linear accelerators to treat cancer to stethoscopes and other basic technologies that help doctors and nurses provide health care on a daily basis. They also include devices that improve millions of people’s lives such as wheelchairs, hearing aids, eyeglasses, pacemakers and prostheses. A new WHO study, Medical devices: managing the mismatch; and an ongoing survey that has so far mapped medical device use in 140 countries, reveal that too many people are currently excluded from their benefits.
Revenue from sales of medical devices worldwide was estimated at around US$ 210 billion for 2008. Four fifths of that revenue comes from sales in the Americas and Europe. The ongoing WHO survey reveals that the average availability of computed tomography (CT) scanners is one per 64,900 people in average in high-income countries, but one per 3.5 million people in low-income countries. Ten countries have so far reported to WHO that they have no radiotherapy unit at all, depriving almost 100 million people of access to cancer treatment.
Affordability is one problem. Worldwide, annual government expenditure on health ranges from well over US$ 7,000 per person to less than US$ 10. Low levels of expenditure on health in general lead to low levels of expenditure on medical devices. This, in turn, leads to inadequate investment in all forms of medical devices: in some countries, shortages of needles, syringes, and sterilizing equipment mean that up to 40% of injections are unsafe.
A second problem is that most medical equipment used in low-resource settings is imported or donated from industrialized countries. Many of these devices do not function properly.
A third problem is lack of capacity. In many areas, devices are not used to full effect because of erratic power supplies, uncertain water quality, a shortage of health personnel, limited training capacity, difficulties in getting spare parts, and poor or inadequate maintenance.
A fourth challenge is the absence of a single naming system, harmonized regulatory processes and universally standardized medical devices. This is often exacerbated by the lack of effective management of medical devices at government level and within health-care facilities.
The fifth issue is the need to focus more on ensuring that medical devices fulfil their potential to improve public health. This means increasing access to the medical devices that are required to deliver basic services: blood transfusion equipment to prevent women experiencing complications in labour, anaesthesia machines, oxygen supplies and basic surgical equipment. It also means addressing new challenges in public health, notably the ongoing rise of chronic diseases such as cardiovascular disease, stroke, cancers and diabetes, and providing medical devices enabling patients to self-monitor their health.
To have public health impact, devices need to be safe, affordable, accessible and appropriate. The new study highlights the advantages of technologies that use alternative power supplies, resist heat, humidity, and dust, relieve the workload, require little maintenance, and can be operated, with no risk to patient safety, by personnel with little specialized training. These include devices like simple glucose meters and test strips for diabetes patients that perform well even in hot and humid homes.
The meeting will focus firmly on improving needs assessment and increasing access to priority devices, especially in low-resource settings. It will aim to agree a set of recommended actions to improve availability, accessibility, appropriateness and safety, and produce a compilation of best practices, available resources, tools and guidelines for integrating medical devices into national health plans, as well as regulation and enforcement.
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Maternal deaths worldwide drop by third
UN estimates reveal fewer women dying from pregnancy-related causes, but 1000 still die a day and more needs to be done to achieve set targets
The number of women dying due to complications during pregnancy and childbirth has decreased by 34% from an estimated 546 000 in 1990 to 358 000 in 2008, according to a new report, “Trends in maternal mortality”, released by the World Health Organization (WHO), the United Nations Children’s Fund (UNICEF), the United Nations Population Fund (UNFPA) and the World Bank.
The progress is notable, but the annual rate of decline is less than half of what is needed to achieve the Millennium Development Goal (MDG) target of reducing the maternal mortality ratio by 75% between 1990 and 2015. This will require an annual decline of 5.5%. The 34% decline since 1990 translates into an average annual decline of just 2.3%.
“The global reduction in maternal death rates is encouraging news,” says Dr Margaret Chan, the Director-General of WHO. “Countries where women are facing a high risk of death during pregnancy or childbirth are taking measures that are proving effective; they are training more midwives, and strengthening hospitals and health centres to assist pregnant women. No woman should die due to inadequate access to family planning and to pregnancy and delivery care.”
Pregnant women still die from four major causes: severe bleeding after childbirth, infections, hypertensive disorders, and unsafe abortion. Every day, about 1000 women died due to these complications in 2008. Out of the 1000, 570 lived in sub-Saharan Africa, 300 in South Asia and five in high-income countries. The risk of a woman in a developing country dying from a pregnancy-related cause during her lifetime is about 36 times higher compared to a woman living in a developed country.
“To achieve our global goal of improving maternal health and to save women’s lives we need to do more to reach those who are most at risk,” says Anthony Lake, Executive Director of UNICEF. “That means reaching women in rural areas and poorer households, women from ethnic minorities and indigenous groups, and women living with HIV and in conflict zones.”
The new estimates show that it is possible to prevent many more women from dying. Countries need to invest in their health systems and in the quality of care.
“Every birth should be safe and every pregnancy wanted,” says Thoraya Ahmed Obaid, the Executive Director of UNFPA. “The lack of maternal health care violates women’s rights to life, health, equality, and non-discrimination. MDG5 can be achieved,” she adds, “but we urgently need to address the shortage of health workers and step up funding for reproductive health services.”
UN agencies, donors and other partners have increasingly coordinated their assistance to countries. WHO, UNICEF, UNFPA and the World Bank are focusing on the countries with the greatest burden and help governments to develop and align their national health plans in order to accelerate progress in maternal and newborn health.
“Maternal deaths are both caused by poverty and are a cause of it. The costs of childbirth can quickly exhaust a family’s income, bringing with it even more financial hardship,” says Tamar Manuelyan Atinc, Vice President for Human Development at the World Bank. “Given the weak state of health systems in many countries, we must work closely with governments, aid donors and agencies, and other partners to strengthen these systems so that women gain significantly better access to quality family planning and other reproductive health services, skilled midwives at their births, emergency obstetric care, and postnatal care for mothers and newborns.”
The report that covers the period from 1990 to 2008 also highlights the following:
- Ten out of 87 countries with maternal mortality ratios equal to or over 100 in 1990, are on track with an annual decline of 5.5% between 1990 and 2008. At the other extreme, 30 made insufficient or no progress since 1990.
- The study shows progress in sub-Saharan Africa where maternal mortality decreased by 26%.
- In Asia, the number of maternal deaths is estimated to have dropped from 315 000 to 139 000 between 1990 and 2008, a 52% decrease.
- 99% of all maternal deaths in 2008 occurred in developing regions, with sub-Saharan Africa and South Asia accounting for 57% and 30% of all deaths respectively.
“We still need to do more to strengthen national data collection systems,” says Dr Chan. “It is vital to support the development of complete and accurate civil registration systems that include births, deaths and causes of death. Every maternal death needs to be counted,” she adds.
The UN maternal mortality estimates are developed in close collaboration with an international expert group and use all available country data on maternal mortality, as well as improved methods of estimation. The intensive country consultation carried out as part of the development of these estimates has been instrumental in identifying increased data collection efforts in recent years including the special systems to capture data on maternal deaths. There are however major gaps in the availability and quality of data for many countries where maternal mortality levels are high, and only through statistical modelling is it possible to obtain an understanding of the trend.
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WHO urges development programmes to INCLUDE People with mental and psychosocial disabilities
People with mental and psychosocial disabilities are among the most marginalized groups in developing countries. Even though development actors have pledged to focus their work on the most vulnerable in a community, many programmes continue to ignore and exclude this vulnerable group.
This is the message of a new World Health Organization (WHO) report on mental health and development – Targeting people with mental health conditions as a vulnerable group – which is being launched today at the United Nations in New York.
According to the report, the majority of development and poverty alleviation programmes do not reach persons with mental or psychosocial disabilities. For example, between 75% and 85% do not have access to any form of mental health treatment. Mental and psychosocial disabilities are associated with rates of unemployment as high as 90%. Furthermore people are not provided with educational and vocational opportunities to meet their full potential.
“A greater attention from the development community is needed to reverse this situation”, says Dr Ala Alwan, Assistant Director-General for Non-Communicable Diseases and Mental Health at WHO. “The lack of visibility, voice and power of people with mental and psychosocial disabilities means that an extra effort needs to be made to reach out to and involve them more directly in development programmes.”
The challenge is enormous. An estimated one in four people globally will experience a mental health condition in their lifetime. Mental health conditions are responsible for a great deal of mortality and disability, accounting for 8.8% and 16.6% of the total burden of disease due to health conditions in low- and middle-income countries, respectively. Depression will be the second highest cause of disease burden in middle-income countries and the third highest in low income countries by 2030.
The report calls for development actors to address the needs of people with mental and psychosocial disabilities in development work by:
- Recognizing the vulnerability of this group and including them in all development initiatives.
- Scaling up services for mental health in primary care.
- Including people in income generating programmes and providing social and disability benefits.
- Involving people themselves in the design of development programmes and projects.
- Incorporating human rights protections in national policies and laws.
- Including children and adolescents with mental and psychosocial disabilities in education programmes.
- Improving social services for people with mental and psychosocial disabilities.
WHO is working jointly with the UN Department of Economic and Social Affairs (UNDESA) in order to integrate mental health into the development agenda and programmes at national level.
“We need to break down the barriers that continue to exclude persons with mental or psychosocial disabilities” says Mr Sha Zukang, Under-Secretary General of UNDESA. “In order for them to have access to better opportunities and to benefit from the fruits of development, they must also be involved in the design of policies and programmes related to development.”
The WHO report stresses that investing in people with mental health conditions, development outcomes can be improved. Mental health priority conditions include depression, psychoses, suicide, epilepsy, dementia, conditions due to the use of alcohol and drugs and mental health conditions in children.
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Phase III randomised controlled trial confirms clinical efficacy and safety of radioembolisation using 90Y-resin microspheres for patients with inoperable colorectal cancer liver metastases that have failed chemotherapy
Using the innovative technique of radioembolisation to treat patients with inoperable colorectal cancer liver metastases who have failed all standard-of-care chemotherapy options can more than double the time until their disease progresses, according to the final results of a Phase III randomised controlled trial published in the prestigious Journal of Clinical Oncology.1
The prospective, randomised trial compared a protracted infusion of 5-fluorouracil (5FU) chemotherapy to the same chemotherapy in combination with radioembolisation, also known as selective internal radiation therapy (SIRT), using 90Y-resin microspheres (SIR-Spheres; Sirtex Medical, Sydney, Australia). The trial was designed to assess the efficacy and safety of this combination in patients with liver metastases from colorectal cancer and was conducted at three Belgian university hospitals.2
The trial recruited 46 patients who had failed all other standard-of-care treatments. The time to the progression of liver metastases – the primary endpoint of the study – increased significantly from a median of 2.1 months in patients receiving 5FU alone to 5.5 months in patients receiving radioembolisation plus 5FU. The risk of progression was 62% lower in patients receiving radioembolisation plus 5FU (hazard ratio 0.38; p=0.003). The time to progression of disease anywhere in the body was also significantly longer, from a median of 2.1 months in the 5FU control arm to 4.5 months in patients in the radioembolisation/5FU arm (hazard ratio 0.51; p=0.03). Control of liver metastases was also significantly increased in patients receiving radioembolisation plus 5FU, from 35% to 85% (p=0.001). More patients in the 5FU-only control arm experienced severe side effects than those receiving radioembolisation plus 5FU (26% versus 5%; p=0.10).
The ability to show a difference in the overall survival of patients was blunted by the ethical design of the study, since patients receiving 5FU alone were reassessed once their cancer progressed, and, if possible, were treated with radioembolisation alone. Ten patients in the control arm later received radioembolisation and 6 received further chemotherapy, as did 9 patients in the radioembolisation plus 5FU group. Median overall survival was 7.3 months in the patients receiving 5FU alone, compared to 10.0 months in patients receiving radioembolisation plus 5FU, a difference that was not statistically significant.
“The combination of radioembolisation using 90Y-resin microspheres and 5FU chemotherapy was well tolerated and significantly improves the outcomes for patients compared with 5FU alone,” said Dr Alain Hendlisz, chief of the gastroenterology unit at Institut Jules Bordet in Brussels, Belgium, and lead investigator of the trial. “The results of this randomised controlled trial provide Level 1 evidence that radioembolisation with 90Y-resin microspheres is a valid therapeutic option for patients with colorectal cancer liver metastases that have failed chemotherapy.”
Large international randomised controlled trials are currently evaluating the effectiveness of radioembolisation using 90Y-resin microspheres with first-line chemotherapy in the treatment of patients with colorectal cancer liver metastases compared to chemotherapy alone in order to assess whether the combination should be used as an early intervention for liver tumours.
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Health Robotics released the results of the first 20 financial i.v.STATION studies conducted by selected North American channel partners at various Academic, Community, Pediatric, and Oncology hospitals in Alabama, California, Florida, Illinois, Louisiana, Massachusetts, Michigan, Ohio, Ontario, Pennsylvania, Quebec, and Texas. These studies compared the direct costs of i.v.STATION-produced sterile doses to compounded IVs manufactured by 6 Pharmacy Outsourcing and Pre-Mix/Frozen solutions companies. Health Robotics’ web-registered authorized users may access i.v.STATION’s ROI case studies and custom Microsoft Excel tools at http://www.health-robotics.com/en/solutions/i-v-station/
“i.v.STATION’s $300,000 price, combined with its plug-and-play installation, flexibility of IV Bags/Vials/Syringes, ISO-5 controlled environment, and unprecedented robotic throughput, has already revolutionized Non-Hazardous Sterile Compounding in North America. Multiple hospital studies have proven an i.v.STATION’s 3-to-1 cost advantage over Pre-Mix/Frozen solutions by Baxter, B. Braun, and Hospira, resulting on an average 8-month payback period to American hospitals utilizing between 1,200 and 1,400 median Minibag Plus, Duplex, or ADD-Vantage IV doses per month. As many North American hospitals have lately been forced towards increased IV Outsourcing as a result of recent IV drug shortages, i.v.STATION arrives at the right place and at the right time, offering a much more cost effective solution to the widespread scarcity problem in selected antibiotics, pain therapy, and other IV drug classes, while providing Health-System Pharmacies with much more control over Batch IV production and reduced IV waste,“ stated Gaspar DeViedma, Health Robotics’ Executive Vice President.
i.v.STATION represents a revolutionary approach in the quest for safe, accurate, efficient, cost effective, and ready-to-administer intravenous patient doses. i.v.STATION offers unprecedented reduction of IV medication errors, USP 797 compliance, compatibility with 75+ different Syringe and IV Bags brands/sizes, reduction of IV waste, and significant labor savings: all within a scalable, cost-effective, distributed, and fail-safe architecture.
“i.v.STATION has also consistently revealed a 6-to-1 cost advantage over outsourced custom IV manufacturing offered by Ameridose, CAPS, and PharMEDium in multiple North American local markets, yielding an average 6-month payback period to North American Health-System Pharmacies that typically custom-outsource between 600 and 800 IV doses per month, and a 12-month payback period for those hospitals outsourcing approximately 350 IV doses per month. These outstanding results amply justify Health Robotics’ prior announcement that it had ended its 2010 i.v.STATION early-adopter discount program in North America this Summer. It is extremely rare these days to find technologies with hard-dollar cost-justification cycles of less than 12 months. We look forward to continue these studies over the next three months at North American Health-Systems that exclusively compound sterile IV doses in-house without custom-IV-outsourcing or Pre-Mix solutions.”, concluded Mr. DeViedma.