This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica...tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
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Antimicrobial resistance (AMR) is a major public health challenge, which is recognized as high priority area by the Government of India. The increasing consumption of antibiotics is one of the key drivers of antimicrobial resistance seen in bugs of public health importance. Irrational prescription o...f broad-spectrum antibiotics, poor regulations around sale of antibiotics, self-medication, lack of education and awareness regarding responsible use of antibiotics have been identified as some of the key factors driving antimicrobial resistance in our country. The ‘National Health Policy’ (2017), addresses antimicrobial resistance as one of the key issues and prioritises development of guidelines regarding antibiotic use, limiting the over-the-counter use of antibiotics, restricting the use of antibiotics as growth promoters in livestock, and pharmaco-vigilance including prescription audit inclusive of antibiotic usage in the hospital and community.
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STGs are designed to assist health care professionals in making decisions about appropriate, effective patient care. However, health managers often have trouble setting and meeting the high standards required of modern, developed health care systems. With stakeholders expressing concern over issues ...such as strength of evidence, transparency, conflicts of interest, and effective implementation, it is clear that many health care professionals need further guidance in developing and making use of STGs.
This manual guides health professionals through the process of establishing and implementing STGs, placing special emphasis on the low- and middle-income country (LMIC) context. By including tools, templates, and success stories as well as hyperlinks to useful resources, the manual helps health practitioners understand not only important concepts of treatment guidelines, but also how they can best be used in practice.
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Para a elaboração deste documento, o Grupo de Farmacovigilância da Rede Pan-americana para a Harmonização Farmacêutica (PARF) baseou-se na perspectiva da OPAS/OMS, a qual considera a Farmacovigilância como componente essencial dos programas de saúde pública (3). Trabalhou-se com a intençã...o de facilitar o desenvolvimento, melhoramento e fortalecimento de sistemas de farmacovigilância nas Américas e promover a adoção de boas práticas para aumentar a segurança dos pacientes e da população de acordo com as necessidades da região.
Este documento também está disponível em Inglês e Espanhol.
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Para la elaboración de este documento, el grupo de farmacovigilancia de la Red Panamericana para la Armonización Farmacéutica (PARF) se basó en la perspectiva de la OPS/OMS, que considera que la farmacovigilancia es un componente esencial de los programas d...e salud pública (3). Se trabajó con la intención de facilitar el desarrollo de sistemas de farmacovigilancia en las Américas, así como su mejoramiento y fortalecimiento, y promover la
adopción de buenas prácticas para aumentar la seguridad del paciente y de la población, de acuerdo con las necesidades de la región.
Este documento también está disponible en Inglés y Portugués.
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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Document No. : FDA/SMC/SMD/GL-RAR/2013/01
Therapeutics Information and Pharmacovigilance Centre | TIPC
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
STATUTORY INSTRUMENTS | SUPPLEMENT No. 8 28th March, 2014 | STATUTORY INSTRUMENTS SUPPLEMENT | to The Uganda Gazette No. 18 Volume CVII dated 28th March, 2014 | Printed by UPPC, Entebbe, by Order of the Government. | STATUTORY INSTRUMENTS | 2014 No. 37.
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, ...Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The operational handbook provides practical information and tools that complement the recommendations in the guidelines. The strategies described in the operational handbook are based on the latest WHO recommendations which were formulated by Guideline Development Groups using the GRADE approach. In many cases however, the recommendations in their current form lacked sufficient clinical and programmatic detail, which is important for implementation. This operational handbook complements the guidelines with practical advice based on best practices and knowledge from the fields such as pharmacokinetics, pharmacodynamics, microbiology, pharmacovigilance and clinical and programmatic management.
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a full range of completely free GxP training courses. They do not provide certificates but give you a quick and easy access to quality training resources wrapped in a pleasant, interactive and easy to digest form.
This course introduces participants to the foundations of vaccine pharmacovigilance. The aim of this course is to provide healthcare professionals whose work involve vaccine safety issues, with essential knowledge about vaccines and their safety aspects. These professionals can include nurses, midwi...ves, community health workers, as well as pharmacists, medical doctors and immunization programme or vaccine safety communication officers.
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DNDi is now striving to make fexinidazole available to the majority of people who have T.b. gambiense sleeping sickness. We are supporting a three-year access and pharmacovigilance study that began in 2020 and have so far carried out in-country training of relevant staff in 250 hospitals and... health centres in T.b. gambiense-endemic countries; and updated national treatment and pharmacovigilance guidelines in Angola, Central African Republic, the Democratic Republic of Congo, Equatorial Guinea, Guinea, and Chad.
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This document seeks to help health communication professionals working on the topic of immunization more effectively communicate about Events Supposedly Attributed to Vaccination and Immunization (ESAVI) by building trust in National Immunization Programs, understanding risk perceptions related to v...accination, and responding to false information related to vaccination. It includes practical dos and don’ts regarding risk communication and community engagement processes and principles, messaging, risk perceptions, handling false information, collaborating with partners, and pharmacovigilance, as well as real-world examples.
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