Annotation. Despite considerable progress in malaria control over the last 10 years, malaria is still a serious problem, particularly in sub-Saharan Africa where about 90 per cent of clinical cases occur. Malaria, either alone or in combination with other diseases, is estimated to kill between 1.1 and 2.7 million people worldwide each year. This report analyses the effect of health sector reforms on malaria control programmes.
Reports the recommendations and conclusions of an expert committee convened to assess progress in implementation of the Global Malaria Control Strategy adopted in 1992. Issued at a time when malaria control is one of the highest priorities at WHO the report offers expert advice on the full range of questions - from the best measures for ensuring early diagnosis and prompt treatment to strategies for the prevention of drug resistance - that can help countries strengthen programmes for control. The report opens with fact figures and maps profiling the current global malaria situation including trends in the spread and intensification of parasite resistance to antimalarial drugs. Section two considers the extent to which each of four technical elements of the global strategy has been implemented over the past decade. The relationship of malaria control programmes to health sector reforms is explored in the next section which focuses on the impact of health system decentralization reforms in health-care financing and the growth of partnerships with communities and the private sector. Against this background the components of proper disease management are presented and discussed in terms of their relevance to control programmes. Topics covered include the advantages and disadvantages of diagnosis based on clinical observations the role of microscopical and other tests for parasite detection and the factors to consider when deciding on treatment objectives and recommended drugs. The difficult question of drug supply in the absence of formal health services is also considered. Subsequent sections offer advice on techniques for monitoring drug resistance and therapeutic efficacy strategies for the containment of parasite drug resistance and methods for the prediction and control of malaria epidemics. A section on the prevention of malaria describes various approaches to vector control including the use of insecticide-treated bednets and other materials the management of malaria in development projects and the current status of drugs used for chemoprophylaxis. The remaining sections discuss information systems and operational research and describe WHO's new Roll Back Malaria initiative.
Many countries have succeeded in eliminating malaria from their territories. However, they are still at risk of reintroduction from endemic countries and areas. The malaria programs in these countries face many challenges for prevention of malaria reintroduction, including weak malaria surveillance and vigilance systems, lack of malaria awareness among health professionals and travelers, uncontrolled population movement and lack of cooperation among countries. In the WHO Eastern Mediterranean Region 13 countries either eliminated malaria many years ago or are very close to malaria elimination. The main priority for these countries is to prevent re-establishment of local malaria transmission in receptive and vulnerable areas in their territories. These guidelines on prevention of reintroduction of malaria provide information on malaria surveillance and vigilance, malaria early warning system, prevention and control of re-introduced malaria, emergency preparedness for malaria outbreaks and monitoring, and evaluation of activities. The publication is targeted at policy and decision makers, health authorities responsible for malaria at national and sub-national levels and field staff. It can also be used in training courses on planning and management of malaria elimination.
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development of revised WHO Recommendations and Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included the development of WHO guidance on the quality, safety and efficacy of poliomyelitis vaccines (oral, live, attenuated); recombinant malaria vaccines; diphtheria vaccines (adsorbed); tetanus vaccines (adsorbed); combined vaccines based on diphtheria and tetanus vaccines; and Japanese encephalitis vaccines (live, attenuated). Subsequent sections of the report then provide information on the current status and proposed development of international reference materials in the areas of vaccines and related substances; blood products and related substances; in vitro diagnostic device reagents; biotherapeutics other than blood products; and antibiotics. A series of annexes are then presented which include an updated list of WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1), followed by a series of WHO Recommendations and Guidelines adopted on the advice of the Committee (Annexes 2-7). All additions made during the meeting to the list of International Standards and Reference Reagents for biological substances maintained by WHO are then summarized in Annex 8.
WHO's international guidelines, written and physical standards developed under the aegis of this Expert Committee for more than 60 years are designed to serve all Member States, international organizations, United Nations agencies, regional and interregional harmonization efforts, and underpin important initiatives, including the prequalification of medicines, the Roll Back Malaria Programme, Stop TB, essential medicines and medicines for children. The Forty-seventh WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted 26 new monographs and general texts for inclusion in The International Pharmacopoeia,/I>. The specifications under development are internationally applicable test methodologies for anti-infective, antimalarial, antituberculosis, contraceptives and antiretroviral medicines, as well as medicines for children. In addition, the following four written standards were adopted in the area of quality assurance and are now available for implementation : * Release procedure for International Chemical Reference Substances (update); * WHO guideline on quality risk management (new) * WHO guideline on variations to a prequalified product (update) * Collaborative procedure between the WHO Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products (new).
Annotation. Despite considerable progress in malaria control over the last 10 years, malaria is still a serious problem, particularly in sub-Saharan Africa where about 90 per cent of clinical cases occur. Malaria, either alone or in combination with other diseases, is estimated to kill between 1.1 and 2.7 million people worldwide each year. This report analyses the effect of health sector reforms on malaria control programmes.
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear independent and practical standards and guidelines for medicines' quality assurance. Standards are developed by the Committee through worldwide consultation and an international consensus building process. The forty-second meeting adopted 11 new monographs for inclusion in The International Pharmacopoeia (Ph.Int.) and seven related new International Chemical Reference Standards (ICRS). The specifications currently developed are internationally applicable test methodologies for antimalarial antituberculosis antiretroviral and specifically also medicines for children. The main principles for selection of INNs for biologicals were endorsed. In order to serve the WHO-managed Prequalification Programme two new procedures were adopted namely on prequalification of intrauterine devices (IUDs) and of male latex condoms together with a new guidance on the assessment of active pharmaceutical ingredients for use in medicines. The international guidelines specifications and nomenclature developed under the aegis of the Expert Committee on Specifications for Pharmaceutical Preparations serve all Member States international organizations United Nations agencies regional and interregional harmonization efforts and underpin important initiatives including the prequalification of medicines the Roll Back Malaria Programme Stop TB essential medicines and medicines for children. The advice and recommendations provided by this Expert Committee are intended to help national and regional authorities (in particular DRAs) procurement agencies as well as major international bodies and institutions such as the Global Fund to Fight AIDS Tuberculosis and Malaria and international organizations such as the United Nations Children's Fund (UNICEF) to combat problems of counterfeit and substandard medicines and to fill the gap for medicines used in the treatment of large populations for which no international quality requirements are publicly available. WHO through this Expert Committee and with the help of many Member States' direct and indirect contributions develops independent international standards through worldwide consultation and an international consensus building process. These are free for use and are developed by WHO with no commercial interest. Special efforts are made to keep their implementation costs low but without compromising the quality for example by reducing the number of physical reference standards needed for a Ph.Int. monograph to a minimum. These independent quality standards and guidelines will enable Member States and other parties to meet the challenges created by increasing globalization and to help ensure that all including poor patient populations will receive quality medicines. The following new standards and guidelines were adopted and recommended for use List of available International Chemical Reference Substances and International Infrared Reference Spectra (Annex 1) 2. Procedure for assessing the acceptability in principle of male latex condoms for purchase by United Nations and other agencies (Annex 2) 3. Procedure for assessing the acceptability in principle of TCu380A intrauterine devices for purchase by United Nations and other agencies (Annex 3) 4. Active Pharmaceutical Ingredient Master File (APIMF) (Annex 4) 5. Main principles for selection of INNs for biologicals (Annex 5)
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