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Rabu, 24 Agustus 2011

TOWARDS A GLOBAL SOLUTION: a WHO initiative to improve availability of safe antisera

chapter 2 Stakeholders participating at the consultation agreed that WHO should lead a global initiative to improve access to life-saving therapeutic antisera. This effort should promote transfer of technologies and building-up of technical capacity, skills and experience of regulatory authorities and manufacturers, where needed. A pre-qualifi cation programme was considered essential to facilitate the procurement of antisera which quality and safety would be assessed by WHO.

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The collaboration of other international organizations, including nongovernmental organizations, and the identifi cation of fi nancial resources are essential for the development of this global strategy aiming to ensure access to effective and safe therapeutic sera, and as such to reduce the mortality and disease burdens of these neglected public health conditions.

The dimension and complexity of this problem requires a multifaceted strategy for its solution, which should involve many partners at national, regional and global levels coordinated by WHO. This strategy should include the following components:

(1) The development of WHO guidelines on the production, control and regulation of antisera.

These guidelines should include all aspects of antiserum manufacture and control, from the starting materials to the large-scale implementation of manufacturing steps and the control of critical parameters to release products of assured quality and safety. The elaboration of such a consensus document should be achieved through a wide consultation process of manufacturers and regulators, at global level, together with a series of technical workshops.

(2) The development of national and regional technical capacity to manufacture safe and effective antisera.

The target groups to benefi t from this initiative are the national regulatory authorities and manufacturers of antisera, especially laboratories in developing countries. This objective will be fulfi lled through the organization of regional and inter-regional workshops focusing on GMP, on good animal husbandry practices, on collection and fractionation of animal plasma, on preparation and storage of antigens (rabies virus and venoms), and on the correct implementation of manufacturing steps aimed at assuring the effi cacy and safety of the products.

(3) The implementation of an international technological cooperation strategy.

Because of the large variation in the capacities and skills of the laboratories involved in antisera production, there is a good opportunity to organize a dynamic process of innovation and transfer of technology between regions and countries. These activities may be based on training courses and exchange of information, technology and expertise among laboratories. An international distribution of tasks can be envisaged. For instance, some laboratories may be in charge of keeping collections of snakes and scorpions of medical importance, as well as preparing high quality antigens which would be used by other laboratories to immunize animals and fractionate the hyperimmune plasma for antiserum production. This type of arrangement should strengthen the parties, while guaranteeing the production of the required volumes of antisera.

(4) The implementation of a prequalifi cation scheme for antisera producers.

On the basis of the experience gained by WHO in the process of prequalifi cation of medicinal products, the implementation of such a scheme for antisera may represent an incentive towards the supply of suffi cient quality products. This process is voluntary and does not involve any direct cost to the laboratories. For laboratories aiming to contribute to the global production of antisera, this process would help them to qualify as international providers of these products through different procurement schemes.

(5) The improvement in the clinical management of rabies and envenomings.

The global initiative should include a component aimed at acquiring in-depth knowledge of the public health impact of these diseases at global, regional and national levels. This includes the promotion and development of community-based epidemiological studies on the incidence of rabid dog bites and envenomings due to snake bites or scorpion stings. In addition, preclinical assessment of antivenoms, together with well designed clinical trials are required in order to gain precise knowledge of the spectrum of effi cacy and safety of antivenoms and of the most relevant clinical manifestation of envenomings. These efforts should be linked to the development of regional guidelines for the clinical management of envenomings and rabies post-exposure prophylaxis, which should be widely distributed to the health workers in rural areas. Strategies of continuing education of health work-ers as well as public campaigns on prevention and management of the diseases should complement the guidelines.

(6) The improvement in the logistics of antiserum distribution.

A concerted effort is needed between epidemiologists at ministries of health, procurement agencies and antiserum producers to assure the design and implementation of distribu-tion strategies for these products. This should include the design and maintenance of an adequate cold chain. The use of distribution channels already developed in the health systems for other products (e.g. vaccines) should be fostered, as well as the collaboration and help of international organizations that support the distribution of other medicines.

The experiences of some countries with well-developed distribution systems should be shared, through collaborative efforts, with less developed regions.

(7) The implementation of a fi nancially-sustainable strategy.

The solution to the lack of effective and safe antivenoms on a global basis demands the fi nancial support of governments, non-governmental organizations and other international agencies. Without adequate fi nancial support it will not be possible to pursue the objectives described in this plan of action. A concerted international effort, led by WHO, will guarantee full international exposure of this problem thereby attracting the attention of agencies devoted to solutions for health problems in the developing world.

Such a concerted international effort, involving producers, regulators, researchers, national and regional health authorities, international agencies and the community organizations, under the coordination of WHO, can be expected to result in:

■ increased availability of safe and effective animal-derived antisera;

■ enhanced technical capacity of regulatory agencies and manufacturers;

■ guaranteed production of safe and effective antisera

■ improved clinical management of rabid bites and envenomings

■ optimal clinical use of antisera

■ improved health programmes in the affected countries.

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PREQUALIFICATION OF ANTISERA: the way to improve access to quality and safe products

chapter 2 WHO has developed a programme of prequalifi cation of essential medicines aimed at expanding patients’ access to drugs for the treatment of HIV/AIDS, tuberculosis and malaria. This programme ensures the quality, effi cacy and safety of medicines procured by United Nations agencies, such as UNICEF. The concept of prequalifi cation may be benefi cial in the fi eld of therapeutic antiserum as a means to assure the quality and safety of products distributed on the international market.

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Furthermore, it would stimulate antisera manufacturers, including those in developing countries, to improve their products.

The basic principles of the prequalifi cation programme of medicines are:

(a) it is voluntary, i.e. the manufacturers decide whether to participate or not;

(b) it is based on general procedures and standards approved through WHO Expert Committees involving WHO member states and WHO Governing bodies;

(c) it has been widely discussed and is supported by the International Conference of Drug Regulatory

Authorities (ICDRA);

(d) it is transparent, since all the information is available on the web site (48);

(e)

it is open to both products developers and manufacturers of generic products; (f) currently, it has no

costs for applicants;

(g) it involves a component of capacity building as a key issue in the process, which is particularly relevant in the fi eld of antiserum manufacture.

The expected outcomes of this programme of prequalifi cation, whether applied to essential medi-

cines or to antisera, include the publication of lists of products and manufacturers, which would help national, regional and large scale procurement agencies. This process will also promote capacity

building and harmonization among national drug regulatory authorities, manufacturers, WHO treatment

programmes, non-governmental organizations and procurement institutions. The programme includes continuous quality monitoring of production and control laboratories. In the long term, it is expected that such a process, applied to the fi eld of antiserum manufacturers and regulators, would result in widespread improvement in the capacity of the laboratories in developing countries, as well as in the quality and safety of available products. This will guarantee fulfi lling the needs of effective and safe rabies immunoglobulin and antivenoms procurement where they are most needed.

For the manufacturers, the prequalifi cation programme allows a free-of-charge independent review of the quality, safety and effi cacy of their antisera, together with free-of-charge training and technical assistance by international experts in the fi eld to assure production of high quality antisera. The programme will also be helpful in building up market confi dence in the quality of the products, and may contribute to the involvement of international procurement organizations in the purchase of antisera for regions whose governments are unable to obtain these life-saving products.

The processes in which the laboratories applying for prequalifi cation will be involved could also benefi t other laboratories, through transfer of technology and training workshops on manufacture, quality control and regulation, under the coordination of WHO. Therefore, if well structured, the capacity building of this initiative could have a great impact on antiserum producers worldwide.

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SCALES OF PRODUCTION: the need to strengthen capacity

chapter 2 Various types of support are needed to improve the quality and the production capacity of antisera to meet worldwide needs. Some producers are likely to have ‘global’ market perspectives, i.e. a willingness to produce antivenoms for different regions of the world, based on demand, humanitarian needs and on agreements with national and regional health authorities.

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A strategy towards the consolidation of ‘regional’ laboratories should also be considered. These regional manufacturers should have reliable manufacturing processes and ability to ensure regional distribution of antisera of consistent quality and safety, in accordance with GMP standards. They should be encouraged and supported to increase production output and to demonstrate the effi cacy of the antivenoms against the species of snakes and scorpions of greatest medical importance in the regions of distribution.

Similar objectives prevail for the manufacture of safe and effective rabies immunoglobulins. Fostering ‘regional’ producers could be complemented by the strengthening of production laboratories, at national level, willing to improve product quality and to cover the national demand. This scenario, involving local, regional and global producers alike, and supported and coordinated by national and world health authorities, would guarantee an adequate and suffi cient supply of safe and effective antisera.

THE CRITICAL CASE OF AFRICA:

need for a multifaceted approach

The crisis in antiserum supply and correct use is most critical and urgent in sub-Saharan Africa. The number of antisera manufacturers supplying this region has decreased dramatically and the total amount of antiserum being offered is insuffi cient to cover even the most basic needs in this region. Moreover, the price of a vial of antivenom ranges between $50 and $150, which often represents a high portion of the yearly income of a rural worker.

Since an average adequate treatment usually involves the administration of at least 3 vials of antivenom, plus the use of ancillary therapeutic interventions, the cost of treating a single envenomed patient in Africa may reach around $200. In addition, some products imported to Africa are inappropriate and ineffective for the treatment of envenomings by African snakes. This situation, together with the poor development of health facilities and training of doctors, nurses and dispensers responsible for treating snakebites, have deterred many people suffering a snake bite from seeking medical treatment and driven them instead, to seek the help of traditional healers. A similar situation occurs regarding the procurement of rabies post-exposure prophylaxis. This combination of factors has created a self-perpetuating vicious cycle which needs to be urgently interrupted and corrected (47).

The solution to this disastrous situation should be multifaceted, involving simultaneously the various strategies discussed above. First, there is a need to involve a number of manufac-turers, both within Africa and in other regions, to commit themselves to a quota of antivenom production for Africa. An increase in overall antivenom supply to a level of 200,000 doses per year should be achieved by the year 2010. This effort should be combined with the transfer of manufacturing technologies to countries in Africa willing to start local production. The high cost of antivenoms for national health systems is another critical issue. Antivenom prices need to be affordable and international agencies and non-governmental organizations should commit to the purchase and donation of antivenoms. Achievement of these goals would break the vicious cycle by building up confi dence in the use and supply of antivenoms. Concomitantly, antivenom distribution should be optimized and guided by appropriate epidemiological information. The development of regional treatment guidelines and the continuous training of health workers in the correct use of antivenom should complete the multifaceted strategy.

Local community organizations should participate in all these efforts. The serious current crisis in antiserum supply and use in sub-Saharan Africa should involve global, regional and local manufacturers, public-private partnerships, local and regional health authorities and health workers in coordination with WHO.

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DISTRIBUTION AND APPROPRIATE USE OF THERAPEUTIC ANTISERA: failure to supply those at greatest need

chapter 2 Failures in the distribution of antisera to places where they are needed are another factor contributing to the gravity and complexity of this public health problem. In some instances, antisera are held in the main cities, where rabies and envenomings are rare, instead of being distributed to peripheral health clinics in rural areas where dog and snake bites, and scorpion stings are frequent. This refl ects defective distribution planning which is associated with a lack of coordination between those who understand the epidemio-logical pattern of the disease and those responsible for the antiserum distribution. As a consequence, antivenoms are sent to places where there are no snake bites or where the par ticular antivenoms are inef fective. Fur thermore, rural health facilities may lack suffi cient antivenoms to treat even a single case of envenoming, because the health authorities are uninformed of treatment protocols.

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Ensuring adequate supply of antisera will inevitably incur some wastage, as products become expired. Pharmacies should have suffi cient stocks to cover contingencies such as seasonal epidemics of snake bites. In Brazil, where approximately 4% of all antivenom is misused (wrong species or non-venomous snake bite), double the expected antivenom requirement (cases x average dose) is supplied to health centres. Therefore, an adequate distribution policy of antiserum demands some form of epidemiological surveillance programme and close communication between clinicians, other health workers, epidemiologists, governmental procurement offi ces and manufacturers. Also, inadequate storage and transportation of antisera may result in physical destruction of vials and ampoules (e.g. by freezing of liquid antisera). The lack of an adequate cold chain may result in deterioration and ineffi cacy of liquid antisera and cold chain facilities created for other health needs (e.g. vaccines) should be used more thoroughly. Decisions on distribution of liquid and freeze-dried antisera, when both formulations are available, should be based on careful and detailed analysis of the prevailing conditions in each region and health clinic facilities. The design of effective strategies for distributing antisera is thus an essential component of any global effort to confront this serious crisis.

Inadequate access to therapeutic antisera is also related to the lack of health facilities in many rural regions of Africa, Asia, Latin America and New Guinea, together with a lack of adequate transportation of patients to the nearest health post. This diffi cult and dangerous situation becomes even worse when rural populations are uninformed about how to proceed when someone is bitten by a possibly rabid dog or a snake, or is stung by a scorpion. Community public education campaigns are needed to address this problem.

Besides the inadequate supply, distribution and accessibility of safe and effective antisera, another major issue is the lack of training of health workers on how to use these products and how to conduct appropriate clinical management of these medical emergencies. In many countries, medical and nursing school curricula do not include the treatment of rabies and envenomings. These subjects are also omitted from the training programmes implemented in rural hospitals where these conditions are common. The development of national and regional guidelines for the treatment of envenomings, based on consensus views, has been largely neglected; exceptions include the Guidelines from the WHO Regional Offi ce for South East Asia (SEARO) (46). Efforts need to be made for a wide distribution of guidelines among physicians and nurses in rural hospitals. The end-result of all these defi ciencies is a dearth of standardized and adequate treatment protocols and, consequently, the existence of a signifi cant diversity in clinical practice and a profusion of empirically-derived protocols.

Another problem associated with antivenom treatment is the uncertainty about the criteria for rational use and initial and repeated dosage. In some hospitals, a small dose of antivenom is given routinely to every patient presenting a snake bite, irrespective of whether there is any evidence of envenoming. This practice squanders scarce resources and unnecessarily exposes unenvenomed people to the risk of antivenom reactions. In other situations, excessive doses are administered without justifi cation, thus wasting this precious commodity. The results of any programme of medical staff training and improved access to antisera should be monitored by continuous surveillance of the appropriateness of antisera usage.

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PRODUCTION AND CONTROL OF THERAPEUTIC ANTISERA

The therapeutic use of antisera started at the end of the 19th century, following the pioneering work of von Behring, Kitasato, Roux and Calmette. The fi rst antivenoms were developed by Calmette and Phisalix and Bertrand in 1894 (21). At the dawn of immunology, it was observed that animals immunized with specifi c toxins or venoms developed an antibody response that could be benefi cial to the treatment of many different diseases, from tetanus and diphtheria to snake bite envenomings and rabies. Thereafter, passive immunization, or serotherapy, became a powerful therapeutic tool based initially on the use of non purifi ed serum that caused a high incidence of adverse effects. http://bahankuliahkesehatan.blogspot.com/

During the 20th century, with the development of methods to purify serum proteins, fractionation protocols were introduced in the production of antisera and therapeutic preparations were obtained of either intact antibodies (IgG) or antibody fragments [F(ab')2] against antigens of clinical relevance.

tabel chptr 3 CURRENT SITUATION

High quality preparations of heterologous immunoglobulins (intact IgG molecules), or products of their enzyme digestion, can now be manufactured following methods largely in the public domain. Many laboratories prepare horse-derived antisera using various modifi ca-tions of the original Pope method (22), based on pepsin digestion and ammonium sulphate precipitation, to yield F(ab')2 antibody fragments (23, 24). Other preparations consist of intact IgG molecules, purifi ed by caprylic acid precipitation of non-IgG serum proteins (25, 26). Additional steps such as ion-exchange chromatography have been incorporated by some manufacturers (23, 24).

Manufacturers therefore use very different methods, some of which are based on tra-ditional plasma fractionation protocols, others on more complex steps, as shown at a WHO workshop convened to discuss antivenom production and control procedures (27). A recent workshop of Latin American public laboratories also highlighted the variety of techniquesused in antivenom manufacture (28) and their respective impact on product yield, safety and quality. The information available showed ample opportunities for technology transfer as well as the need for improved production processes and training of manufacturers in the developing world.

A list of antivenoms available in 1995 was prepared by Meier (29) but several labora-tories have stopped manufacture since then. Currently, many laboratories face signifi cant diffi culties in pursuing the manufacture of antisera, improving the quality of the products or increasing the production capacity. Some production centres require extensive upgrading of the infrastructure, equipment and manufacturing technologies, to meet required quality and safety standards, others lack qualifi ed staff. Those with more advanced manufacturing methods require a clearer defi nition of the size and markets needs in order to design reliable long-term manufacturing strategies.

The diverse scenarios outlined above support the development of a worldwide strategy to increase antiserum production to respond to clinical needs. A detailed analysis of the situation is required together with the design and implementation of different approaches which should be adapted to product needs.

STRENGTHS AND WEAKNESSES OF CURRENT

ANTISERA MANUFACTURE

Technologies for the fractionation of animal serum and the purifi cation of intact IgG or F(ab')2 fragments are available in the public domain and production protocols have been reported in international publications. Relevant guidelines on the principles of GMP are also available (30) and can be adapted to the manufacture of animal-derived antisera. The openness of this technological fi eld, and the fact that many groups involved in research, development and production of antisera are public institutions, brings further possibilities for the establishment of a dynamic process of training and transfer of technology . In the case of envenomings by snake bites and scorpion stings, there is extensive scientifi c knowledge on the clinical, pathophysiological, biochemical and immunological characteristics of venoms. The species responsible for most snake and scorpion envenomings in the different regions of the world have been identifi ed and many of their venoms partially characterized. There is also abundant scientifi c literature on the cross-reactivity of antivenoms against ven-oms from different species of snakes within a specifi c geographical region. Such information can be directly applied to the design of immunizing mixtures to raise effective neutralizing antisera against the most relevant venoms from a given area or geographical region.

With regard to the rabies virus, this is an excellent immunogen which readily induces strong immune responses in horses, facilitating the preparation of rabies immunoglobulins. In addition, the fi eld of human immunoglobulin preparations for intravenous use has witnessed great advances in the plasma fractionation methodologies and viral reduction procedures introduced in the production processes (31, 32). This knowledge can be helpful to the manufacturers of animal-derived antisera in order to improve the quality and safety of these products.

On the other hand, the production of antisera faces diffi culties that need to be addressed and solved to guarantee adequate global supply. The most important weaknesses are:

(1) low volumes of production;

(2) poor safety and effi cacy of some products and;

(3) defi cient or non-existent regulation and control of antisera in some countries

Many manufacturers in the public sector operate on a small production scale, and, as such, are unable to satisfy the national demand. This highlights the need for substantial investment in equipment, infrastructure and training of technical and administrative staff to ensure self-suffi ciency.

ANTISERUM POTENCY

Effective treatment of rabies and envenoming is critically dependent on the availability of good quality antisera. Defi cient quality assurance and quality control practices, together with the lack of regulatory policies in some countries, result in the production or impor tation of antisera with low neutralizing potency. Ineffective antivenoms may also be prepared because of an inappropriate selection of the venoms used as immunizing mixtures. This illustrates a lack of information on the snake fauna of the area or region as well as on the composition and immunochemistry of venoms. The problem is aggravated by the lack of preclinical control of many antivenoms.

The neutralization by antivenoms of the most relevant toxic activities of the venoms with greatest medical signifi cance in a particular territory should be assessed. For example, several groups in Latin America have succeeded in the preclinical characterization of antivenoms against venoms from different areas in the region. As a result, the neutralizing ranges of many antivenoms have been established and used to support the distribution of antivenoms within, and occasionally, among countries (33, 34). However, this information is lacking for many antivenoms and venoms throughout the world.

The control of the biological activity of antivenoms depends, among others, on the preparation of representative venom pools obtained from the snakes and scorpions species targeted (27). This requires concerted efforts among zoologists, toxinologists, manufactur-ers and regulators to establish protocols for the maintenance in captivity (and ideally for the reproduction) of snakes and scorpions, the appropriate venom collection and storage, the design of representative venom pools and the testing of venoms toxicity. In order to guarantee an appropriate geographical spectrum of effi cacy of an antivenom, it is essential to know in which parts of the country or region the specifi c envenoming is predominant. The control of the neutralizing ability of an antivenom preparation should be performed using pools of well-characterized venoms, taking into account the known causes of intra-specifi c variation in venom composition and antigenicity (35). Currently, there are many lacunae in the preparation and use of venom pools for antivenom standardization and control. This explains the discrepancies in the potency tests carried out in different laboratories. To solve this problem, a network of quality control laboratories should be formed and the sharing of standard venoms for use in assays should be encouraged (36,37). The experience in Brazil, where a well-defi ned national standard venom of the jararaca snake Bothrops jararaca is prepared and distributed to manufacturers and quality control laboratories, is a good example of national and inter-laboratory coordination.

The regulatory overview and quality control of rabies immunoglobulin is poor or absent in some countries. Preclinical characterization can provide only preliminary guidance about therapeutic effi cacy which can be established only through clinical studies or post-marketing surveillance information.

ANTISERUM SAFETY

Antiserum safety is another aspect that demands careful at tention. Upon parenteral administration, antisera may induce early or late adverse reactions.

Early adverse reactions (EARs):

Intravenous administration of antisera results in EARs in a variable proportion of patients. These are best categorized as anaphylactic reactions. Clinical features include urticaria, itching, fever, tachycardia, vomiting, abdominal colic, headache, bronchospasm, hypoten-sion and angioedema (38, 6). The incidence of EARs depends on the quality, dose, protein content, route of administration and speed of intravenous injection or infusion (38). Unless patients are observed closely during at least 2 hours after intravenous antivenom administration, EARs may not be detected. This lack of surveillance leads to underreporting of side effects. With antivenoms of good quality profi le, there is a low incidence (less than 10%) of generally mild EARs, mostly urticaria and itching. However, for other products, the incidence of such reactions may be as high as 85%, including potentially life-threatening systemic disturbances such as hypotension and bronchospasm (6). EARs are attributable, in part, to the physicochemical characteristics of the particular antivenom preparation. The presence of protein aggregates is believed to contribute to complement activation (39) and to the onset of EARs (38). The formation of such aggregates often refl ects defi ciencies during fractionation or freeze-drying of products. Likewise, the presence of contaminant proteins contributes to the reactogenicity of antisera, as well as the total amount of protein administered which is related with the incidence of both EARs and late antivenom reac-tions (LAR). The incidence of EARs would not be attributable to the use of intact IgG, since antivenom immunoglobulin preparations purifi ed by caprylic acid fractionation of horse

plasma present a good safety profi le (40). Equine rabies immunoglobulin has proven extremely safe with a reaction rate of 1.13% (41) because it is never administered intravenously and the total amount of equine protein injected is relatively low. Some antisera carry the risk of causing pyrogenic reactions, implying poor manufacturing practices (6).

 

Late adverse reactions (LARs):

These resemble classical serum sickness and are also described as a consequence of antiserum therapy. Their true incidence is poorly known, mostly because patients leave health centres within the fi rst few days after treatment, and the manifestations of serum sickness do not appear until 7-14 days post-treatment. However, in one series of patients who received a poorly refi ned antivenom and where a thorough follow-up was possible, it was shown that the incidence of serum sickness increased to almost 100%, proportionally to the total dose of antivenom infused and, the interval between treatment and the appearance of symptoms decreased (42).

There have been no reports of infectious diseases transmitted to humans by the admin-istration of animal antisera, but the microbiological safety of these products is of growing concern. There is an urgent need to validate the capacity for viral removal and/or inactivation that can be achieved by currently-used manufacturing processes of antisera. Preliminary results from a limited number of studies suggest that some of the production steps currently used, such as acid pH, pepsin digestion, caprylic acid precipitation and possibly others, canbe effective in virus reduction (43, 32). However, this area requires signifi cant collaborativeefforts among manufacturing laboratories and research groups, to perform viral validation studies and transfer of know-how for correct implementation.

Problems associated with poor safety of some antisera preparations are clearly linked tofailures or lack of GMP. The principles of GMP should cover all steps in antiserum production,including the handling and care of animals used for immunization, the preparation of the appropriate venom and immunization protocols, the bleeding of horses, the blood and plasma collection procedures, the plasma fractionation process as well as the steps of aseptic fi llingand freezedrying of the fi nal product. Similarly, the production of water, the cleaning and sanitisation of equipment and clean rooms, and the design of all production systems shouldstrictly follow GMP principles. Failure to ful fi l these requirements results in poor qualityand safety profi les. These problems are also associated with defective training of the staffinvolved in antiserum production, lack of technological innovation and lack of investment inthe implementation of GMP.

There are ample opportunities for improving the production of antisera at a global level.A WHO coordinated training programme should be established for strengthening techni-cal expertise in local and regional laboratories aimed at the implementation of GMP in allmanufacturing facilities.

CLINICAL STUDIES

The serious lack of well-designed, controlled clinical trials in the evaluation of the effi cacy and safety of antivenoms is a defi ciency that needs to be addressed at a global level.Some clinical studies have been published, the fi rst in 1974 (44), and provided valuable information on relative effi cacy of various antivenoms, initial dosage, pharmacokinetics and safety profi le (40,45). Quite often, antivenoms are introduced in a given country or region without appropriate clinical validation of their effi cacy or safety and in absence of

regulatory oversight. This may have serious public health implications. The reported use of counterfeit products and imported geographically-inappropriate non-specifi c antivenoms in some countries, notably in Africa, further aggravates the problem. The therapeutic failure of these products leads to a loss in confi dence in medical treatment of envenomings within the population and a return to the use of ineffective and sometimes dangeroustraditional methods.

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EPIDEMIOLOGY: the burden of disease

chapter 2 RABIES

Globally, rabies is the tenth leading cause of death due to infection in humans. The threat of rabies exists in most parts of the world (Figure-1). Predominantly, it affects poor people in developing countries and its true incidence may be underestimated. In the year 2005, there were reports estimating that nearly 60,000 human fatalities occur each year mostly in Asia and Africa (9). A WHO-sponsored multicentric study estimated that at least 20,000 deaths occurred annually in India alone (10). In China, rabies has, since May 2006, become the leading cause of infectious disease mortality, killing 3,293 people in 2006, 27% more than in 2005.

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More than 99% of all human deaths from rabies occur in the developing world (11) and almost half of those dying of rabies and requiring rabies immunoglobulin are children less than 15 yrs old. The lack of supplies of rabies immunoglobulin and training in its correct use, condemns more than 55,000 people (90% confi dence interval (CI) = 24,000-93,000) worldwide each year to die an agonizing death from rabies. Even this fi gure underestimates the full burden of human suffering as millions of victims of potentially rabid bites suffer protracted anxiety resulting from the uncertain and sometimes very long incubation period of this infection (up to 6 years or more) (12). Deaths due to rabies are responsible for an estimated health burden of 1.74 million DALYs (‘Disability adjusted life years’) (90% CI = 0.75-2.93). Morbidity and mortality following side-effects of nervous-tissue vaccines account for an additional 0.04 million DALYs. The annual cost of rabies is estimated USD 583.5 million (90% CI = USD 540.1-626.3 million) in Asia and Africa alone (9).Assuming that 60% of post-exposure prophylaxis regimens require the administration of an average number of two vials of rabies immunoglobulin (dose according to body weight), the estimated annual requirements for this antiserum are: 1,200,000 vials for Africa, 350,000 for the Americas, 200,000 for East Mediterranean region, 4 million for the West Pacifi c, including China, and 3.2 million for South-East Asia, including India, thus resulting in a grand total need for approximately 9 million vials every year. These calculations are based on available epidemiological data that undoubtedly underestimate the size of the problem.

SNAKE BITES

Snake bites and scorpion stings are well-known medical emergencies in many par ts of the world where these animals are distributed (Figure-3). Agricultural workers (the countries' food producers) and children are the most affected. The true worldwide incidence of snake bite envenoming has proved diffi cult to estimate. It has been reported that there are 5 million snake bites, resulting in 2.5 million envenomings, 125,000 deaths and perhaps three times that number of permanent sequelae in the world each year (13). The incidence of snake bite mortality is particularly high in Africa, Asia, Latin America and New Guinea. In India alone there may be as many as 50,000 snake bite deaths each year. Many estimates of snake bite mortality and resulting permanent morbidity are based on hospital returns, which greatly underestimate the real impact of this health problem, since most people affected by snake bites do not seek hospital treatment but prefer traditional remedies (14). Snake bite victims in rural areas may die at home unrecorded (15). A number of community-based studies have begun to disclose the true burden of snake bite mortality. For example, in the

Eastern Terai region of Nepal, there were 162 snake bite deaths per 100,000 population per year (16), and in a region of Nigeria, the incidence of snakebites was 497 per 100,000 people per year, with a fatality rate of 12.2% (17). A study performed in Malumfashi, Nigeria, showed that there were 40-50 snakebite cases, with 4 deaths per 100,000 population per year. Nineteen percent of those bitten developed persistent sequelae and only 8.5% sought hospital treatment (18) while in Kilifi District in coastal Kenya, 68% of snake bite victims consulted a local muganga (“witch doctor”), only 27% went to hospital and 36% were left with permanent sequelae (19). Therefore, the actual impact of this neglected health problem on a global basis is much higher than has been previously realized. Analysis of the burden of human suffering attributable to these envenomings from a broader public health perspective reveals their greater impact. Evaluated using DALYs , the impact of envenomings is very high (estimated in 2 million DALYs per year for sub-Saharan Africa), because most victims are children or young agricultural workers, many of whom are left for the rest of their lives with permanent physical or psychological consequences of envenoming. The impact of snake bite as an occupational disease on the economy is also highly signifi cant, as many of the affected people are agricultural workers (food producers) whose families, community and country are highly dependent on the products of their physical activity.

SCORPION STINGS

The true incidence of scorpion sting envenoming is not known because many cases do not seek medical attention. However, it has been estimated that there are approximately 1 million stings per year. In Mexico alone, 250,000 scorpion stings are reported yearly, but fatalities have declined from 2,000 to less than 50 per year following widespread distribu-tion of antivenoms. In Tunisia 40,000 stings, 1,000 hospital admissions and 100 deaths are reported each year. There is a high incidence in other parts of Northern Africa, the Middle East (notably Iran), India and Latin America. In Khuzestan, south-west Iran, where scorpion stings are the fourth leading cause of death, 12% of the 25,000 stings treated each year and more than 95% of the fatalities are attributable to Hemiscorpius lepturus (Hemiscorpiidae) (20). In Brazil, 37,000 scorpion stings and 50 deaths were reported in 2005 and, in this country, scorpion stings are an emergent health problem, due to the adaptation of some scorpion species to the urban environment.

THE NEED FOR THERAPEUTIC ANTISERA

On the basis of the epidemiological fi gures presented above, the current annual need for antisera for post-exposure rabies prophylaxis and for the treatment of snake bite and scorpion sting envenomings amounts to 9 million vials of rabies immunoglobulin and 10 million vials of antivenoms. Unfortunately, the present worldwide production capacity is well below these needs. There are various reasons for this situation: governments and health authorities ignore antisera because of their neglected status; a number of private producers have stopped manufacture because of market instability and unprofi tability; the prices of some products are completely unaffordable by the health systems of developing countries; some former public manufacturers have been privatised, with a consequent drop in antiserum production because is perceived to be unprofi table. Furthermore, the weaken-ing of public health budgets has resulted in deterioration of infrastructure and equipment for antisera production in public institutions. This resulted in a global reduction in antisera production and accessibility. This trend should be reversed through concerted actions by national, regional and world health authorities and manufacturers.

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RABIES AND ENVENOMINGS: neglected diseases

Rabies and envenomings are diseases that result from bites by rabid mammals or bites and stings by venomous animals, especially snakes and scorpions. In all cases, appropri-ate early treatment, including therapeutic antisera, can prevent life-threatening systemic spread of the virus or venom toxins.

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RABIES

In most parts of the world, rabies is endemic (Figure 1). Rabies virus, a rhabdovirus present in infected animal's saliva is inoculated into the bite wounds (Figure 2a), enters peripheral nerves and spreads to the central nervous system where it causes a lethal encephalomyelitis (Figure 2b). Once clinically established, rabies encephalomyelitis is almost invariably fatal, but the disease is entirely preventable provided that complete post-exposure prophylaxis is implemented promptly (2).

The regimen of post-exposure prophylaxis for people bitten by rabid mammals that is currently recommended by WHO consists of a combination of wound cleaning, active immu-nization with a tissue culture rabies vaccine and passive immunization with equine (or, rarely, human) rabies immunoglobulin (3). This has proved highly effective in preventing infection. Inclusion of rabies immunoglobulin in the post-exposure regimen is regarded as mandatory for WHO “category 3” exposures (bites or scratches that break the skin and contamination of mucosae with saliva) which constitute about 60% of all cases. The effi cacy of equine rabies

  1

2

immunoglobulin was established by studies of Iranian patients who had been attacked by rabid wolves (4,5). Rabies immunoglobulin is infi ltrated around the bite wounds and any residual immunoglobulin solution is injected intramuscularly.

SNAKE BITES

Envenomings by snake bite create medical emergencies that involve different organs and tissues, depending on the species responsible for the bite. Most severe cases result from bites by members of the families Viperidae (pit vipers and true vipers) and Elapidae (cobras, kraits, mambas, coral snakes, Australasian species and sea snakes). Venomous snakes are widely distributed throughout the world (Figure 3) except for a few islands, frozen environments and high altitudes (6,7,8).

Life-threatening effects of snake bite envenoming include shock, spontaneous systemic bleeding, paralysis involving respiratory muscles, generalized break down of skeletal muscle (rhabdomyolysis), acute renal failure and infection of necrotic tissue at the site of the bite (Fig-ure 4a,b). Viperid snake venoms cause local extravasation of plasma and blood into the bitten limb, infl ammation and tissue damage, due to the action of toxins on muscle, skin and blood vessels, resulting in pain, oedema, blistering, bleeding and necrosis of skin, subcutaneous tissues and muscle. Some elapid snake venoms (e.g. African spitting cobras and some Asian cobras) can also cause extensive local necrosis. Viperid snake venoms induce spontaneous systemic haemorrhage (e.g. into the brain or gastrointestinal tract), secondary to microvascular damage, coagulopathy and platelet dysfunction, together with cardiovascular shock and renal failure. Elapid snake venoms usually cause neurotoxicity, in particular descending paralysis that may lead to respiratory failure. Some venoms provoke systemic myotoxicity, associated with myoglobinuria, hyperkalaemia and acute renal failure.

Since these local pathological effects develop rapidly and irreversibly after venom injection, those who survive snake bite may suffer permanent sequelae including the results of the locally necrotic effects of viper and some elapid venoms, requiring amputation of digits or limbs

3

RABIES AND ENVENOMINGS

(Figure 5a,b) and causing contractures (Figure 6a), tendon damage, arthrodeses and chronic infected ulcers and osteomyelitis that may cause malignant transformation (squamous cellcarcinoma) (Figure 6b). Chronic renal failure, chronic pituitary-adrenal failure and neurological sequelae from haemorrhagic strokes also occur.

4

The clinical management of snake bite envenoming is centred on the intravenous adminstration of antivenom, together with a series of ancillary interventions that may include entilatory support for neurotoxic envenoming, fl uid replacement for hypovolaemic shock, ialysis for acute renal failure, tetanus prophylaxis and antibiotics for local wound infection and urgical debridement of necrotic tissue, followed by rehabilitation to restore full function in the itten limb. Because of the large inter- and intra- specifi c variation in venom composition and mmunogenicity, antivenoms are manufactured using the venoms that are most relevant for given geographical region. They are therefore specifi c for snake species of a given region, nd are usually ineffective in other regions inhabited by different species of snakes

5

SCORPION STINGS

Envenomings by scorpion stings are also an impor tant, yet neglected, health issue in many parts of the world, particularly in the extreme Northern and Southern parts of Africa, the Middle East, Southern states of USA, Mexico and parts of South America, and the Indian sub-continent. Scorpion venoms, which are especially lethal in young children, release autonomic nervous system mediators causing myocardial damage, cardiac arrhythmias, pulmonary oedema, shock, paralysis, muscle spasms and pancreatitis. Early administra-tion of antivenom is highly ef fective, together with intensive care support in severe cases. However, the rapid tissue distribution of scorpion venom toxins and their ability to cause early death especially in young children, demands early treatment with antivenom and full cardio-respiratory support.

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SUCCESFULL AGING TIPS

SUCCESFULL TIPS I

TAKE CARE OF YOUR HEALTH.

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Visit your doctor regularly.

Ask about tests and immunizations that are right for your age group.

Eat a healthy diet.

Your diet should be low in fat and high in fiber.

  • Eat plenty of vegetables, fruits, beans and whole grains.
  • Eat low fat proteins in the form of lean red meat, poultry and fish.
  • Get enough calcium by drinking low fat milk and eating low fat yogurt and cheese.
  • Eat a variety of foods to get enough vitamins and minerals in your diet.
  • Drink lots of water.

Exercise to stay fit.

Be active every day at your own level of comfort.

  • Walk, dance, or swim to improve your endurance.
  • Work out with weights to increase your strength.
  • Stretch to maintain your flexibility.

Don’t drink too much alcohol.

People over the age of 65 should try not to have more than one drink per day. (A drink is

one glass of wine, one bottle of beer, or one shot of liquor.)

And remember: never drink alcohol with your medicines!

Don’t use tobacco in any form.

This means cigarettes, cigars, pipes, chew or snuff. If you need help quitting, talk to your doctor.

TIPS II

KEEP YOURSELF SAFE.

Make your home a safe place.

  • Keep your home, walkways and stairways well lit and uncluttered.
  • Keep a fire extinguisher and smoke detectors in your home. Make sure the batteries in your smoke detectors work.
  • Adjust the thermostat on your hot water tank so that you don’t burn yourself with hot water. Prevent falls.
  • Make sure all throw rugs have non-slip backs so they don’t throw you!
  • Slip-proof your bathtub with a rubber mat.

Stay safe in the car.

  • Wear your seat belt – and wear it correctly. (It should go over your shoulder and across your lap.)
  • Never drink and drive!
  • Don’t drive when you are angry, upset, sleepy, or ill.
  • If you have concerns about your driving safety, talk to your doctor.

TIPS III

TAKE CARE OF YOUR EMOTIONAL HEALTH.

Keep in touch with family and friends.

It’s important to maintain your social life!

Exercise your mind.

Keep your mind active by reading books, doing crossword puzzles, and taking classes.

Stay involved.

Join community activities or volunteer projects. Somebody

needs what you can offer!

Keep a positive attitude!

  • Focus on the good things in your life, and don’t dwell on the bad.
  • Do the things that make your happy.
  • If you’ve been feeling sad lately or no longer enjoy the things you used to, ask your doctor for help.

TIPS IV

PLAN FOR YOUR FUTURE.

Keep track of your money.

Even if someone else is helping you manage your bank accounts and investments, stay informed.

Know your own health.

This is important for receiving good medical care.

  • Know what medical conditions you have.
  • Know the names of your medicines and how often you take them.
  • Make a list of your medical conditions, medicines, drug allergies (if any), and the names of your doctors. Keep this list in your wallet.
  • Make your health care wishes known to your family and doctors.
  • Consider filling out an advance directives form. This form lets you state your health care choices or name someone to make these choices for you.
  • Give your family and doctors a copy. This way they have a written record of your choices in case you are unable to tell them when the time comes.
  • If you need help with your advance directives, talk to your doctor.

Create a transportation plan.

If you don’t drive, know how to get around.

  • Ask family and friends if they would be willing to give you a ride.
  • Find out about buses, trains, and shuttles in your area.
  • If you need help finding a ride, contact your local Area Agency on Aging.

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HOW TO HELP THE OLDER DRIVER

As experienced drivers grow older, changes in vision, attention and physical abilities may cause them to drive less safely than they used to. Sometimes these changes happen so slowly that the drivers are not even aware that their driving safety is at risk. If you have questions about a loved one’s driving safety, here’s what you can do to help him or her stay safe AND mobile.

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Is your loved one a safe driver?

If you have a chance, go for a ride with your loved one. Look for the following warning signs in his or her driving:

1. Forgets to buckle up

2. Does not obey stop signs or traffic lights

3. Fails to yield the right of way

4. Drives too slowly or too quickly

5. Often gets lost, even on familiar routes

6. Stops at a green light or at the wrong time

7. Doesn’t seem to notice other cars, walkers, or bike riders on the road

8. Doesn’t stay in his or her lane

9. Is honked at or passed often

10. Reacts slowly to driving situations

11. Makes poor driving decisions

Other signs of unsafe driving include:

1. Recent near misses or fender benders

2. Recent tickets for moving violations

3. Comments from passengers about close calls, near misses, or the driver not seeing other vehicles

4. Recent increase in the car insurance premium

Riding with or following your loved one every once in a while is one way to keep track of his or her driving. Another way is to talk to this person’s spouse or friends.

If you are concerned about your loved one’s driving,what can you do?

Talk to your loved one.

Say that you are concerned about his or her driving safety. Does your loved one share your concern?

3 Don’t bring up your concerns in the car. It’s dangerous to distract the driver! Wait until you have his or her full attention.

1. Explain why you are concerned. Give specific reasons – for example, recent fender benders, getting lost, or running stop signs.

2. Realize that your loved one may become upset or defensive. After all, driving is important for independence and self-esteem.

3. If your loved one doesn’t want to talk about his driving at this time, bring it up again later. Your continued concern and support may help him or her feel more comfortable with this topic.

4. Be a good listener. Take your loved one’s concerns seriously.

Help make plans for transportation.

When your loved one is ready to talk about his or her driving safety, you can work together to create plans for future safety.

1. Make a formal agreement about driving. In this agreement, your loved one chooses a person to tell him or her when it is no longer safe to drive. This person then agrees to help your loved one make the transition to driving retirement. You can find a sample agreement in At the Crossroads: A Guide to Alzheimer’ s Disease, Dementia and Driving. Order a free copy by writing to: At the Crossroads Booklet, The Hartford, 200 Executive Boulevard, Southington, CT 06489.

2. Help create a transportation plan (see the next page). Your loved one may rely less on driving if he or she has other ways to get around.

Encourage a visit to the doctor.

The doctor can check your loved one’s medical history, list of medicines, and current health to see if any of these may be affecting his or her driving safety. The doctor can also provide treatment to help improve driving safety.

Encourage your loved one to take a driving test.

A driver rehabilitation specialist (DRS) can assess your loved one’s driving safety through an office exam and driving test. The DRS can also teach special techniques or suggest special equipment to help him or her drive more safely. To find a DRS in your area, ask your doctor for a referral or contact the Association for Driver Rehabilitation Specialists (ADED). Contact information for ADED is listed on the back of this information sheet. If a DRS is not available in your area, contact a local driving school or your state’s Department of Motor Vehicles to see if they can do a driving test.

How to help when your loved one retires from driving.

At some point, your loved one may need to stop driving for his or her own safety and the safety of others on the road. You and your loved one may come to this decision yourselves, or at the recommendation of the doctor, driver rehabilitation specialist, driving instructor, or Department of Motor Vehicles. When someone close to you retires from driving, there are several things you can do to make this easier for him or her:

Create a transportation plan.

It’s often easier for people to give up driving if they have other ways to get around. Help your loved one create a list of “tried-and-true” ride options. This list can include:

1. The names and phone numbers of friends and relatives who are willing to give rides, with the days and times they are available.

2. The phone number of a local cab company.

3. Which bus or train to take to get to a specific place. Try riding with your loved one the first time to help him or her feel more comfortable.

4. The phone number for a shuttle service. Call your community center and regionaltransit authority to see if they offer a door-to-door shuttle service for older passengers.

5. The names and phone numbers of volunteer drivers. Call your community center,church, or synagogue to see if they have a volunteer driver program.

6. If you need help finding other ride options, contact your local Area Agency on Aging.

(The contact information is on the next page.)

If your loved one can’t go shopping, help him or her shop from home.

Arrange for medicines and groceries to be delivered. Explore on-line ordering or subscribe to catalogs and “go shopping” at home. See which services make house calls – local hair-dressers or barbers may be able to stop by for a home visit.

Encourage social activities.

Visits with friends, time spent at the senior center, and volunteer work are important for one’s health and well being. When creating a transportation plan, don’t forget to include rides to social activities. It’s especially important for your loved one to maintain social ties and keep spirits high during this time of adjustment.

Be there for your loved one.

Let your loved one know that he or she has your support. Offer help willingly and be a good listener. This is an emotionally difficult time, and it’s important to show that you care.

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TIPS FOR SAFE DRIVING

DRIVING Tips I

Drive with care.

 

 

Always

  1. Plan your trips ahead of time. Decide what time to leave and which roads to take. Try to avoid heavy traffic, poor weather, and high-speed areas.
  2. Wear your seat belt – and wear it correctly. (It should go over your shoulder and across your lap.)
  3. Drive at the speed limit. It’s unsafe to drive too fast or too slow.
  4. Be alert – pay attention to traffic at all times.
  5. Keep enough distance between you and the car in front of you.
  6. Be extra careful at intersections. Use your turn signals and remember to look around you for people and other cars.
  7. Check your blind spot when changing lanes or backing up.
  8. Be extra careful at train tracks. Remember to look both ways for trains.
  9. When you take a new medicine, ask your doctor or pharmacist about side effects. Many medicines may affect your driving even when you feel fine. If your medicine makes you dizzy or drowsy, talk to your doctor to find out ways to take your medicine so it doesn’t affect your driving.

 

Never

  1. Never drink and drive.
  2. Never drive when you feel angry or tired. If you start to feel tired, stop your car somewhere safe. Take a break until you feel more alert.
  3. Never eat, drink, or use a cell phone while driving.

 

If

1. If you don’t see well in the dark, try not to drive at night or during storms.

2. If you have trouble making left turns at an intersection, make three right turns instead of one left turn.

3. If you can, avoid driving in bad weather, such as during rain, sleet, or snow.

 

Tips II

Take care of your car.

  • Make sure you have plenty of gas in your car.
  • Have your car tuned up regularly.
  • Keep your windshields and mirrorsclean.
  • Keep a cloth in your car for cleaning windows.
  • Replace your windshield wiper blades when they become worn out.
  • Consider using Rain-X or a similar product to keep your windows clear.
  • If you are shopping for a new car,look for a car with power steeringand automatic transmission.

 

Tips III

Know where you can find a ride.

How do you get around when your car is in the shop? If you don’t know the answer to this

question, it’s time for you to put together a “transportation plan.”

A transportation plan is a list of all the ways that you can get around. Use this list when your car is in the shop or when you don’t feel safe driving. Your plan might include:

  • Rides from friends and family
  • Taxi
  • Bus or train
  • Senior shuttl

If you need help creating a transportation plan, your doctor can get you started

 

Tips IV

Take a driver safety class.

To learn how to drive more safely, try taking a class. In a driver safety class, the instructor teaches you skills that you can use when you are driving. To find a class near you, call one of the following programs:

AAFP 55 Alive Driver Safety Program

1-888-227-7669

National Safety Council Defensive Driving Course

1-800-621-7619

Driving School Association of the Americas, Inc.

1-800-270-3722

AAA Safe Driving for Mature Operators Program Call your local AAA club to find a class near you

These classes usually last several hours. They don’t cost much – some are even free. As an added bonus, you might receive a discount on your auto insurance after taking one of these classes. Talk to your insurance company to see if they offer a discount.

Selasa, 12 April 2011

NGO COALITIONS FOR GLOBAL HEALTH PROMOTION

1. Introduction – NGOs, the origins of primary health care and health promotion.

The primary health care movement sprang up in an autonomous manner in different parts of the world, in the 1960s and 1970s. Rooted in the community and voluntary sector, initiatives developed in different social and cultural situations, exhibiting a rich diversity. The movement gained global visibility and legitimacy from national governments through the World Health Assembly in 1977, and the International Conference on Primary Health Care jointly organized by WHO and UNICEF in 1978 in Alma Ata. Ever since then there have been ripple effects and cross currents in the health and health care related sectors. One of the strong positive currents that emerged was that of health promotion. It is important to recall the different collective experiences, forces and perspectives that developed the Health for All goals and strategies. Dr. Mahler, Director General of WHO at the time publicly states that it was the non-governmental organizations (NGOs) who pressed WHO strongly to move beyond a disease focused, expert dependant, techno-managerial approach, based on the dominant system of medicine, to one wherein community participation, inter-sectoral coordination and appropriate technology were important. The key underlying principles of primary health care (PHC) were social justice and equity with a shift beyond doctors, diagnostics and drugs to addressing the conditions for health. An important component was health education, which grew in strength to emerge as health promotion. NGOs, professionals and people across the globe sustained the spirit of primary health care through decades when it met with resistance and neglect. The Ottawa Charter of 1986 introduced a clear focus on fundamental conditions or basic determinants for health such as peace, shelter, education, food, income, ecosystems and resources. Ownership and initiatives by states, international bodies and experts provide a professional strategic approach and increase coverage. However communities and community based organizations (CBOs) may get excluded in decision making, while powerful interests get accommodated. Public health ethics and principles of universal human rights suggest that the challenge before the health promotion community is to build partnerships upholding the public good in health, by addressing health determinants and respecting cultural diversity in a transparent manner. The role of communities, CBOs and NGOs along with the state should be central.

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2. Contextual challenges to global health promotion

In the year 2005, despite increasing knowledge and wealth, health goals remain a distant dream for the social majority globally. Inequalities in wealth and health have grown. Efforts to medicalise health, with professional control over information, are now compounded by commercial and corporate interests in medical and health care and professional education. The stakes of multinationals, producers of pharmaceuticals, medical equipments, and medical insurance companies are at a much higher scale. Globalisation provides for free flow of information and ideas. The use of information and communication technology has benefited many. However, macro-economics, speculative financial flows and global trade policies adversely affect livelihoods, food and human security, the environment, and purchasing capacity of a significant proportion of people. While health status has improved for some, disparities are growing, health gains are being lost and new problems are emerging. Community impacts of corporate led globalization point to increasing denial of health and access to health care. Conflicts of interest that underpin many of these developments need to be clearly addressed by the health promotion community. Strategies need to address health determinants including war and conflict, unhealthy trade practices, environmental injustice, recognizing the complexities involved. Partnerships with affected communities and NGOs are critical. This paper reviews the role of NGOs, The strengths and opportunities of potential and existing partnerships and peoples movements in health promotion and in addressing health determinants.

3. NGO Partnerships for Global Health Promotion

The role of civil society organizations (CSOs) has received increasing importance in public policy and health policy over the past decade. As more financial and other resources were invested in this sector, the profile of its constituent groups changed. Different agencies define CSOs and NGOs differently. There is need for clarity in understanding the heterogeneity of this sector, and to recognize the unique roles of different constituents for global health promotion. NGOs in the 1960s and 1970s were largely not –for – profit voluntary organizations working towards integral development. In health they included medical service through hospitals, health centres, and mobile clinics run by charities, missions and philanthropic organizations. With experience and reflection this group developed a deeper community based understanding of the dynamics of health, health care and development in different socio-cultural situations. They were often able to achieve what governments in resource poor situations could not. With professional and social skills developed through working in difficult circumstances they became alternative experts, and the sector soon became an additional policy option. With growing recognition, money and influence, the profile of NGOs and new entrants to the sector changed . NGOs now include corporate NGOs, with companies setting up Trusts and Societies, building brand images, obtaining tax benefits and blurring the profit and not for profit sector. Government NGOs (GONGOs) and other new entities developed to overcome the bureaucracy of government. Professional associations’ and research bodies with a high degree of knowledge and expertise, such as the International Union for Health Promotion and Education comprise another important section. NGO networks developed at national and global levels with a specific focus on health. During the past decade a global people’s health movement emerged with a strong focus on health determinants and a right’s based approach to health care. The potential for partnerships are thus many. Including those that can impact on health determinants provide a strategic option to global health promotion.

4. Creating enabling environments for NGO coalitions for health promotion

The Millennium Development Goals (MDGs) provide a renewed framework for partnerships between governmental and nongovernmental organizations to create an environment conducive to development and elimination of poverty[1]. Investment in health is critical for development and achievement of the MDGs. Through advocacy for healthy public policy, NGOs increase community health literacy and knowledge. NGOs with diverse structures and functions are the sine quo non in health promotion due to their grass roots presence and closeness with communities, which enables them to respond to people’s health needs, concerns and aspirations.

One of the corner stones of solidarity is sharing and defining common objective, in this case the promotion of health. The objective to be attained should be time bound and measurable. It requires carefully designed strategies with each partner assuming specific roles (Berhane Ras Work, Inter Afrocan Committee)

NGOs understand that health is produced not just by hospitals and health professionals, but by individuals and families in the context of their daily lives and by influencing health determinants. NGOs are a positive force through direct health empowerment and action with people, as well as by working on the deeper issues. They apply the principles of health promotion including capacity development, knowledge transfer, community participation, empowerment, intersectoral collaboration, equity and advocacy for sustainable development.[2]

The agenda for health promotion involves tackling multiple determinants of health. No single governmental or nongovernmental organization can deal with the multiplicity of issues. This is a sound rationale for NGOs to establish networks and alliances between themselves and with academia, governmental and other organizations to maximize their resources and achieve better outcomes. Partnerships provide an opportunity to make best use of the strengths and comparative advantage of each organization. However NGO coalitions do not occur by chance.

To be effective partnerships must be planned, fostered and managed. Partnerships can be focused and time bound to achieve defined outcomes or work through long-term commitments. An example is the Geneva based NGO Ad Hoc Advisory Group on Health Promotion.

NGO Ad Hoc Advisory Group on Health Promotion

Born as an outcome of the WHO 4th International Conference on Health promotion in Jakarta in 1997, the Group supported implementation of its recommendations, and worked in partnership with others towards the Global Conference on Health Promotion in Mexico City, 2000. The Group comprises several NGOs whose activities include health promotion and education, health co-operatives, nursing, rural women; social welfare, women’s health and those whose main mandate may not be “health”.

Member’s commitment to health promotion helps pool resources and expertise in tackling health determinants. For example, Associated County Women of the World (ACWW) partners with local NGOs, and Governments to provide literacy centers in Mali. ACWW provides partial funding and expertise to help local NGOs achieve their goals with community ownership and ongoing monitoring[3].

The wide diversity of activities, international structures and grass root involvement give the NGO Ad Hoc Group its richness of approach, experience and expertise. Working collectively and individually, and in close partnership with WHO headquarters, the Group has kept the Jakarta and Mexico agendas in the forefront of the NGO community. The Group hosts briefings at the World Health Assembly on NGO and government partnerships in health promotion. This would not have been possible for any single NGO. By their work and commitment, the Ad Hoc Group contributes to the attainment of the Millennium Development Goals.

4.1. Investing in Human Resources and Capacity Building

Human resources are the lynchpin to achieve health and development goals. Distortions in health care priorities hinder progress in health promotion. Major distortions include concentration of health facilities and personnel on urban populations rather than rural, on tertiary care rather than primary, on curative care rather than on promotive and preventative services and on the middle-class and better off rather than on the poor[4].

Though the primary health care strategy promoted by WHO was designed to achieve greater equity and universal coverage, health reform and economically driven models of care reduced public spending on health and social services leading to growing inequities[5].

Besides misallocation and mal-distribution of resources, access to health care is hampered by shortage of competent health professionals capable of providing comprehensive health care. Poor investment in training, recruitment and retention, force health care workers to look for ‘greener pastures’ leading to brain drain. Nurses and physicians trained at public cost migrate from poorer countries to the developed world, leaving health care facilities in a state of collapse.

Nursing staff shortages cause closure of essential health care facilities, including emergency rooms. Serious shortages in all health professional categories in Zimbabwe resulted in closure of health facilities and reduced access to services[6]. The New York Times reported, “the nation is currently engulfed in a huge nursing shortage which is going to get worse”[7]. In the United Kingdom there is concern that: “the National Health Service (NHS) does not have enough pairs of hands to deliver the care that the nation needs… and hospitals are turning abroad to find staff”[8].

Shortages of doctors are reported in several countries including Botswana, Ghana and Guinea Bissau. In some developing countries, shortage of nurses and doctors often results in staffing rural clinics by poorly trained personnel ill-equipped to provide comprehensive services including health promotion. In these circumstances, it is likely that investment in health promotion will continue to be eroded and neglected. NGO coalitions and all stakeholders need to address this issue on priority.

Health promotion strategies draw upon multiple actors and stakeholders including multilateral organizations such as UN agencies; development banks; national and local governments; faith-based groups, citizen’s organizations; international, national and local NGOs; WHO collaborating centres; academic institutions; trade unions; the arts and entertainment industry; the private sector and others. Collaborative efforts by stakeholders who promote the public good in health is crucial for success. For example, the progress made in onchocerciacis control was only possible with committed partnerships. While reducing under-nutrition and universalizing access to water and sanitation attract less attention, regressive policies of some organizations also reverse health gains.

Community Empowerment

Different stakeholders, working with empowered communities can become a powerful voice, lobbying governments to invest in human resources particularly for health promotion training and capacity building. NGO networks have a convening power and a large outreach capacity enabling them to bring about a “paradigm shift” from the curative to the preventive, promotive and social health model.

Training and capacity building by NGOs are characterized by active community participation, empowering individuals and families to increase control over the determinants of their health, and to demand universal access to health care. NGOs and health profession associations should be enabled to become “social health activists”.

4.2. Strengths, weakness, opportunities and threats to coalition building

Strengthening NGO coalitions for health is necessary in the current landscape characterized by declining development resources, increasing privatization of services, and reverse transfer of resources from developing countries[9]. Coalitions need to be built with skill, care and mutual trust using strategies that include identifying opportunities and partners with shared goals; reaching agreements; maintaining and evaluating partnerships [10]. This takes time and resources.

Challenges faced include selecting partners, working with communities, defining partnerships goals, setting time frames, mobilising resources and keeping long term commitments to meet complex evolving needs. Often unequal distribution of power and decision-making within NGO groups or between NGOs and governments can negatively impact outcomes and sustainability of partnerships. Corporate interests working through governments and international bodies can be counterproductive. Lack of trust and suspicion between NGOs and governments is a potential threat.

Coalitions can multiply actions outlined in the Ottawa Charter: building healthy public policy, creating supportive environments, strengthening community action, developing personal skills, and reorienting health services[11].

Mutual commitments to engagement between governments, civil society and NGOs would help achieve better health. Governments need to see beyond their term in office and to see the long-term role of health promotion. NGOs and civil society need to be rooted in their reality, and to see beyond that reality and their own constituencies to engage with a wider spectrum of stakeholders. Both need to recognize barriers that prevent the realization of health promotion in the community and to undertake cooperative measures to tackle this[12].

As an intergovernmental agency, WHO has a long history of working with NGOs In health promotion WHO – NGO partnership from decision making to evaluation has been fruitful. While partnerships are strong at WHO headquarters, there is scope for improvement at country and regional levels.

5. Global coalition’s promoting health, addressing determinants

Concern about the social determinants of health, and the difficulties faced by governments and international bodies to effectively work on their own towards Health for All goals, resulted in the emergence in the late 1990s of a much broader global coalition, the Peoples Health Movement (PHM). Unlike the 1970s, health groups and NGOs are now joined by women’s movements, the science and literacy movement, the environment movement, trade unions, development groups and many community based organizations, all of whom recognize that better health is a common concern. Collective analysis, planning, action and reflections with affected communities build solidarity. Groups from varied backgrounds and cultures have become connected locally and globally through horizontal and vertical linkages. This awakening culminated in the first Peoples Health Assembly (PHA 1) in December 2000 in Savar, Bangladesh, wherein 1493 persons from 75 countries debated health related issues over five days and adopted the Peoples Charter for Health 13. Through thousands of prior community, village and town meetings, the Charter built on perspectives of people, whose voices are rarely heard. It clearly addresses health determinants, namely:

a) economic challenges posed by the global trading system, third world debt, intellectual property laws, speculative international capital flows;

b) social and political challenges, including the right to work and livelihood, gender issues, rights of expression, political participation and religious choice, the weakening of public institutions and services;

c) environmental challenges including water and air pollution, climate change, ozone layer depletion, nuclear energy and waste, toxic chemicals and pesticides, loss of bio- diversity, deforestation and soil erosion ;

d) war, violence, conflict and natural disasters.

Action points concerning these issues, and for developing a people-centered health sector with people’s participation resulted in much follow up.

Spontaneously translated into 50 languages (see www.phmovement.org) the Charter has become one of the largest consensus documents on health providing a framework for action. Since 2000, country, regional and issue based circles evolved leading to specific action such as the right to health care campaign in India; advocacy regarding global public private initiatives; policy dialogue with the WHO; a global campaign on patents; the Peoples Charter on HIV/AIDS and Asian People’s Alliance for Combating HIV/AIDS; the first Global Health Watch report; International Health Forums; state national and UNESCAP health policies; a Tsunami Watch; and most importantly advocacy, street action and community work, including training thousands of community health workers. Media strategies resulted in greater national and local reporting of health issues and controversies, including corruption. In some countries health moved higher on the public and political agenda with commitments to increase budgetary allocations. There has been support for the peace movement in the USA, Europe and Asia, and a PHM response to disasters in Iran, Sri Lanka, and India. The second Peoples Health Assembly in Cuenca, Ecuador in July 2005 raised issues and concerns of the Americas and reviewed progress since PHA I.

These activities took place without centralized funding and through a loose networking structure. Partners from the South played an important role in developing the Charter and strategies for action. The PHM identifies people, particularly those excluded, as its greatest resource and reservoir of talent and energy. Providing space for community voice and agency has brought in dynamism, diversity and focus on priorities. The health movement, along with allied movements, is a force that is part of a globalization of solidarity from below.

6. Conclusion

NGO coalitions with communities, governments and other organisations can mobilise human, political, financial and scientific resources to make health promotion the backbone of health care systems and services. There is a need for the health promotion community to develop and sustain working links with local communities, groups and movements working beyond the traditionally defined health sector in order to influence health determinants. Working for equity in health would involve challenging powerful interests. Public health ethics requires that this be done. The paper provided an overview of NGO coalitions and movements, their strengths, weaknesses, opportunities and threats, suggesting how they make a difference in the health and wellbeing of communities

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[1] General Assembly resolution 55/2, para. 12

[2] Ottawa Charter for Health Promotion, (1986).

[3] Joanna Koch, Associated County Women of the World

[4] Swedish International Development Agency (undated), Health is Wealth.

[5] Braveman, P. & Tarimo, E., Social inequalities in health within countries: not only an issue for affluent nations. Social

Science & Medicine 54 (2002):1621-1635

[6] Mutizawa-Mangiza, D (1998), The impact of health sector reform on public sector health worker motivation in Zimbabwe.

Major applied research, 5, working paper 4. Partnerships for Health Reform, Bethesda.

[7] New York Times 12 April 2001

[8] Jeremy Laurence, Health Editor, The Indipendent, 26 November 2002.

[9] United Nations Research Institute for Social Development, States of disarrary; the social effects of globalisation. London,

UNRISD, 1995.

[10] Kickbusch, I, and Quick, J 81998), Partnershps for Health in the 21st Century. World Health Statistics quarterly, 51, 61-

74.

[11] Ottawa Charter for Health Promotion, 1986

[12] Manoj Kurian, World Council of Churches, E-mail correspondence

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