Fact Book on WHO Level I and Level II monitoring indicators - To monitor the progress of efforts to improve the global medicines situation, WHO has developed a system of indicators that measure important aspects of a country’s pharmaceutical situation. Level 1 indicators measure the existence and ...performance of key national pharmaceutical structures and processes. Level II indicators measure key outcomes of these structures and processes in the areas of access, product quality and rational use. These indicators can be used to assess progress over time; to compare situations between countries; and to reassess and prioritize efforts based on the results.
This Fact Book gives the results of the assessment of Level I indicators conducted in 2003 and of Level II indicator surveys conducted between 2002 and 2004
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Monitoring is a crucial element in any successful programme. It is important to
know if health care facilities – and ultimately countries – are meeting the agreed
goals and objectives for preventing and managing cardiovascular diseases (CVD).
Monitoring is the on-going collection, management ...and use of information to
assess whether an activity or programme is proceeding according to plan and/
or achieving defined targets. Not all outcomes of interest can be monitored. Clear
outcomes must be identified that relate to the most important changes expected to result from the project and to what is realistic and measurable within the timescale of the project. Once these outcomes have been articulated, indicators can be chosen that best measure whether the desired outcomes are being met.
To allow progress to be monitored, this module provides a set of indicators on
CVD management. Agreeing on a set of indicators allows countries to compare
progress in CVD management and treatment across different districts or
subnational jurisdictions, as well as at a facility level, identify where performance
can be improved, and track trends in implementation over time. Monitoring
these indicators also helps identify problems that may be encountered so that
implementation efforts can be redirected.
This module starts from the collection of data at facility level, which is then
“transferred up” the system: facility-level data are aggregated at subnational level
to produce reports that allow tracking of facility and subnational performance over time and allow for comparison among facilities. National-level data are obtained through population-based surveys.
Implementing a monitoring system requires action at many levels. At national and
subnational levels, staff can determine how best to integrate data elements into
existing data collection systems – such as the routine service-delivery data that are collected through facility-level Health Management Information Systems (HMIS).
In the facility setting, personnel must be aware of what data are needed. Sample
data-collection tools are included, recognizing that countries use different datamanagement systems for HMIS, so the CVD monitoring tools will be adapted to work with the HMIS system being used by the country, such that the indicators can be collected with minimal disruption/work to existing systems and tools
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There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedure is not applicable for local purchase, i.e. purch...ase of drugs within the project countries. For quality assurance principles and assessment of drugs for local purchase refer to the guideline for local pharmaceutical market assessment.
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If you work in a hospital in a low income country - providing free care - y...ou are probably intitled to FREE copies of these books. MCAI will send them to you, all you have to do is to read our Flyer and fill in the request form.
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Long-lasting insecticidal nets (LNs) constitute a core vector control intervention against malaria. A number of new LN products are under development and will require assessment of risks to humans. This document provides an updated generic model that can be used for the risk assessment of exposure t...o insecticides of individuals sleeping under LNs and during the washing of nets.
In an Annex, exposures and health risks are described for the conventional treatment or retreatment of nets (ITNs) with an insecticide considering that such practices may still be used in evaluation of ITNs and their use. The generic model does not include the risks associated with the manufacturing of LNs in a factory environment.
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The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to make safer and more effective treatment available to... patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
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This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribut...ion of pharmaceutical products.
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This technical report contains the results from the FEEDcities Project – Eastern Europe and Central Asia, a cross-sectional survey of the local urban food environment conducted in Chișinău, Republic of Moldova between June and August 2016. It characterizes the vending sites, the food offered and... the nutritional composition of both industrial and homemade street foods. It also describes the nutritional composition of foods sold in supermarkets and fast-food outlets.
The study was conducted within a bilateral partnership between the World Health Organization and the Institute of Public Health of the University of Porto, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences and the Faculty of Pharmacy of the University of Porto (WHO registration 2015/591370 and 2017/698514). The study was funded through a voluntary contribution of the Ministry of Health of the Russian Federation.
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This technical report describes the results of a cross-sectional survey conducted in Dushanbe, Tajikistan, between April and May 2016, as part of the FEEDcities Project – Eastern Europe and Central Asia. The aim was to describe the local street food environment: the characteristics of the vending ...sites, the food offered and the nutritional composition of the industrial and homemade foods usually consumed in these settings.
The study was part of a bilateral partnership between WHO and the Institute of Public Health of the University of Porto, Portugal, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences and the Faculty of Pharmacy of the University of Porto (WHO registration numbers 2015/591370 and 2017/698514).
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This technical report presents the results of a cross-sectional survey conducted in Sarajevo, the Federation of Bosnia and Herzegovina, Bosnia and Herzegovina, between June and August 2017, as part of the FEEDcities Project (Food Environment Description in cities – eastern Europe and central Asia).... The aim of the report is to describe the city’s local street food and takeaway food environment, exploring the characteristics of food vending sites, the industrially produced and homemade foods they typically offer, and the nutritional composition of these foods. Finally, the report provides guidance on how to address its findings through policy action.
The study was conducted through a bilateral partnership between the World Health Organization (WHO) and the Institute of Public Health of the University of Porto, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences, the Faculty of Pharmacy of the University of Porto (WHO registration 2015/591370 and 2017/698514) and the Institute of Public Health of the Federation of Bosnia and Herzegovina. The study was funded through a voluntary contribution of the Ministry of Health of the Russian Federation, and through a contribution made by the Swiss Agency for Development and Cooperation (SDC)/Swiss Government to a joint WHO/SDC project, “Reducing Health Risk Factors in Bosnia and Herzegovina: Developing and Advancing Modern and Sustainable Public Health Strategies, Capacities and Services to Improve Population Health”, implemented in Bosnia and Herzegovina.
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Project protocol
Introduction Ready-to-eat food sold in the street represents a global phenomenon, more common in urbanized areas, that constitutes an important dietary source in populations from low- and middle-income countries. However, research on the kind of street food offered and its composit...ion is scarce. The main objective of this study is to characterize the urban street food environment, including vending places, the food offered, its nutritional composition, food purchasing patterns and advertising.
Methods and analysis This protocol provides a framework for a stepwise, standardized characterization of the street food environment; it consists of three steps that are of increasing complexity and demand increasingly great human and technical resources. Step 1 comprises identification of street food vending sites and characterization of the products available; this stage may be complemented with an evaluation of food advertising in the streets. Step 2 comprises description of street food purchasing patterns, by direct observation. Step 3 requires collection of food samples for bromatological analysis. Different levels of data collection may be defined for each step; hereafter, these are presented as core and expanded evaluations. For the most part, data analysis involves descriptive statistics and basic spatial analysis.
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This technical report presents results from the FEEDcities Project – Eastern Europe and Central Asia, a cross-sectional survey conducted in Almaty, Aktau and Kyzylorda, Kazakhstan, between July and August 2017, to evaluate the local street food environment. It characterized the vending sites, the ...food offered and the nutritional composition of the industrial and homemade foods available in these settings. The policy implications of the findings are outlined.
The study was conducted within a bilateral partnership between WHO and the Institute of Public Health of the University of Porto, in collaboration with the Faculty of Medicine, the Faculty of Nutrition and Food Sciences and the Faculty of Pharmacy of the University of Porto (WHO registration 2015/591370 and 2017/698514). The study was funded through a biennial collaborative agreement and joint programmes between the Government of Kazakhstan and United Nations agencies in Kazakhstan for Kyzylorda and Mangystau oblasts, a voluntary contribution by the Ministry of Health of the Russian Federation and the Resolve to Save Lives project of Bloomberg Philanthropies.
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Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the various dimensions of access to HCV diagnostics and pha...rmaceutical products, including product pricing, the regulatory environment and patent status, which together shape the national hepatitis response in different settings. It highlights key areas for action by ministries of health and other government decision-makers, pharmaceutical manufacturers and technical partners.
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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This publication is a companion document to the NDVP National Deployment and Vaccination Plans guidance, which provides a framework for countries to develop their national strategies. As countries face challenges with erratic vaccine supplies, use of multiple vaccine products with different charact...eristics, and the size of populations and their diversity, this document provides operational guidance and information to support planners and immunization programme managers at the national and sub-national levels on microplanning for COVID-19 vaccination implementation.
This Guide is available in English, French, Arabic, chinese, Portuguese, Spanish, Russian
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita...ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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The environment in which young people live, learn and play significantly affects their decisions about whether to consume alcohol. Environmental factors are the main risk factors driving alcohol consumption and related harm among young people. Environments that normalize alcohol consumption – term...ed alcogenic environments – include contexts with unregulated advertising and marketing of alcoholic beverages, higher alcohol outlet density, products designed to facilitate affordability and low prices of alcoholic beverages. A recent body of research evidence has emerged related to the measurement, functional significance and consequences of living in alcogenic environments. This includes findings on the complex and bidirectional interactions among alcohol acceptability, availability and affordability and how they create and perpetuate alcogenic environments. Comprehensive and enforced alcohol control policies are effective at delaying the age of onset and lowering alcohol prevalence and frequency among young people. Evidence consistently confirms the effectiveness of designing and implementing alcohol control policies that regulate upstream the drivers of alcogenic environment, including alcohol availability, acceptability and affordability. These policies need to be multipronged and address the complex interactions between these drivers and the local alcohol culture
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