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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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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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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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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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 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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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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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 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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This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.