In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
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Final Evaluation
The project objectives were to promote the conservation, sustainable use and cultivation of endangered medicinal plants in Zimbabwe, by demonstrating effective models at the local level, and developing a legal framework for the conservation, sustainable use, and equitable shari...ng of benefits from medicinal plants at the national level. After one year of implementation, the project rationale, indicators and targets were reviewed in order to make them more rigorous as per the new GEF focus on project impact. New indicators and targets were developed in December 2004. The project is composed of five closely linked output areas that have been allocated to different implementing partners to take a lead in. These include the National Herbarium and Botanical Gardens (Output 1), the University of Zimbabwe School of Pharmacy (Output 2), the Southern Alliance for Indigenous Resources (SAFIRE), a regional NGO (Output 2 and 4), and the Attorney General‟s Office (Output 5).
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Report of the 23rd WHO Expert Committee on the selection and use of essential medicines
This executive summary reports the recommendations made by the Expert Committee for the 2021 update of the WHO Model List of Essential Medicines (EML) and the Model List of Essential Medicine for Children (EMLc)....
The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and formulation on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
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The goal of this Global Action Plan is to articulate synergistic actions that will be required to prevent HIVDR from undermining efforts to achieve global targets on health and HIV, and to provide the most effective treatment to all people living with HIV including adults, key populations, pregnant ...and breastfeeding women, children and adolescents. The Global Action Plan has five strategic objectives: 1) prevention and response; 2) monitoring and surveillance; 3) research and innovation; 4) laboratory capacity; and 5) governance and enabling mechanisms.
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This guide provides practical, step-by-step guidance on how to organize, implement, and monitor community-based care for DR TB. It is equally useful for program planning or supervision. The target audience for this guide is TB Program Managers, governments, policy makers, nongovernmental organizatio...ns (NGOs), donors and TB advocates.
This guide does not replace other guidelines and documents that contain important medical information, such as Guidelines for the Programmatic Management of Drug-resistant TB (WHO, 2008 and 2011 updates), and Management of MDR-TB: A Field Guide (WHO, 2009).
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PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato...ry – the two key institutions to ensure the quality, safety, and efficacy of medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully controlling the pharmaceutical market to the extent that there is no informal medicines market in Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great strides in evidence-based medicines quality assurance in the short to medium term, provided it receives adequate technical assistance and financial support.
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The USAID | DELIVER PROJECT, Task Order 4, developed this guide for quantifying health commodities; it will assist technical advisors, program managers, warehouse managers, procurement officers, and service providers in (1) estimating the total commodity needs and costs for successful implementation... of national health program strategies and goals, (2) identifying the funding needs and gaps for procuring the required commodities, and (3) planning procurements and shipment delivery schedules to ensure a sustained and effective supply of health commodities.
The step-by-step approach to quantification presented in this guide is complemented by a set of product-specific companion pieces that include detailed instructions for forecasting consumption of antiretroviral drugs, HIV test kits, antimalarial drugs, and laboratory supplies.
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Antimicrobial resistance (AMR) is an important public health concern shared by developed and developing countries. In developing countries the burden of infectious diseases is greater and exacerbated by limited access to, and availability and affordability of, antimicrobials required to treat infect...ions caused by AMR organisms. With drugs not listed on the essential drugs list (EDL), problems of increased morbidity, costs of extended hospitalisation and mortality are extremely serious. The problem of susceptibility to and spread of infections caused by multidrug-resistant (MDR) infectious agents is fuelled by factors such as limited access to clean water and sanitation to ensure personal hygiene, malnutrition, and the HIV/TB epidemic.
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Unstable settings present challenges for the effective provision of antiretroviral treatment (ART). In this paper, we summarize the experience and results of providing ART and implementing contingency plans during acute instability in the Central African Republic (CAR) and Yemen.
Antibiotics and other antimicrobial agents are invaluable life savers, particularly in resource-limited countries where infectious diseases are abundant. Both uncomplicated and severe infections are potentially curable as long as the aetiological agents are susceptible to the ...antimicrobial drugs. The rapid rate with which antimicrobial agents are becoming ineffective due to resistance acquired as a result of unchecked overuse and misuse threatens to undo the benefit of controlling infections. The evidence for resistant microorganisms, many times to more than a single antimicrobial agent, has been observed globally. In Tanzania, there is evidence in the form of few scattered studies conducted in different parts of the country in a multitude of settings including health care facilities, the community, domesticated animals and wild animals
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In Kenya, the bacterial infections that contribute most to human disease are often those in which re-‐sistance is most evident. Examples are multidrug-‐resistant enteric bacterial pathogens such as typhoid, ... diarrhoeagenic Escherichia coli and invasive non-‐typhi salmonella, penicillin-‐resistant Streptococcus pneu-‐moniae, vancomycin-‐resistant enterococci, methicillin-‐resistant Staphylococcus aureus and multidrug-‐re-‐sistant Mycobacterium tuberculosis. Resistance to medicines commonly used to treat malaria is of particu-‐lar concern, as is the emerging resistance to anti-‐HIV drugs. Often, more expensive medicines are required to treat these infections, and this becomes a major challenge in resource-‐poor settings.
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The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug... Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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The publication provides an overview and analysis of international instruments that set standards related to the use of antimicrobials across the human, animal and plant sectors, and their release into the environment. The purpose of the document is to identify existing instruments and standards in ...order to guide both their implementation and to inform discussions and direction for future international instruments related to antimicrobial use.
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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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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