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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This manual provides a practical method for determining the pharmacovigilance indices. It is designed to be simple and can be understood by any worker in pharmacovigilance without formal training in monitoring and evaluation. Pharmacovigilance as a medical discipline is crucial in preventing medicin...e-related adverse effects in humans, promoting patient safety, and the rational use of medicines. The indicators proposed in this manual are based on the expected functions of pharmacovigilance centres as described in the WHO Mimimum Requirements for a Functional Pharmacovigilance System (1) (see Annex 1 of the manual).
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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.
Document also available in Spanish and Portuguese!
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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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22 December 2020
The COVID-19 vaccine safety guidance manual has been developed upon recommendation and guidance of GACVS members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.
For ease of use, the man...ual is available in a compiled form and in several separate modules that can be consulted individually. For each module, specific training material is also available to facilitate implementation.
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Antimicrobial resistance (AMR) surveillance plays an important role in the early detection of resistant strains of public health importance and prompt response to outbreaks in hospitals and the community. Surveillance findings are needed to inform medical practice, antibiotic stewardship, and policy... and interventions to combat AMR. Appropriate use of antimicrobials, informed by surveillance, improves patients’ treatment outcomes and reduces the emergence and spread of AMR. This protocol describes the steps and procedures to establish/enhance AMR surveillance in Latin America and the Caribbean.
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La vigilancia de la resistencia a los antimicrobianos (RAM) desempeña un papel importante en la detección temprana de cepas resistentes que revisten gran importancia para la salud pública, así como en la respuesta rápida a los brotes en los hospitales y en la comunidad. Los resultados de la vig...ilancia son necesarios para fundamentar la práctica médica, la administración de antibióticos, y las políticas e intervenciones para combatir la RAM. El uso apropiado de antimicrobianos, fundamentado en la vigilancia, mejora los resultados del tratamiento de los pacientes y reduce la aparición y propagación de la RAM.
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13 July 2021
The module provides an overview of factors to consider when monitoring the safety of COVID-19 vaccines administered to pregnant and breastfeeding women. It describes how national routine AEFI surveillance should be adapted to cater for this specific group of population using both pass...ive and active surveillance methods. Specific considerations and limitations of each method are provided as well as tools for implementation.
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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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El grupo de Farmacovigilancia de la red Panamericana para la Armonización Farmacéutica (PARF) de la Organización Panamericana de la Salud (OPS), ha desarrollado este documento desde la visión OPS/OMS, considerando que la farmacovigilancia es un componente esencial de los programas de salud públ...ica. Se trabajó con el objetivo de facilitar el desarrollo, mejorar y fortalecer los sistemas de
farmacovigilancia en la región de las Américas y promover el ejercicio de las buenas prácticas para mejorar la seguridad del paciente y de la población de acuerdo a las necesidades de la región.
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Accessed on 15.08.2022
La farmacovigilancia es una herramienta que permite la detección, evaluación, conocimiento y prevención de efectos adversos y/o inesperados de los medicamentos que se prescriben. También facilita la detección de fallas de respuesta terapéutica por deficiencias de calid...ad.
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Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure... or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval
phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.
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