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A practical handbook on the pharmacovigilance of antiretroviral medicines

World Health Organization WHO, (2009)

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 publications 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

Indicator-Based Pharmacovigilance Assessment Tool: Manual for Conducting Assessments in Developing Countries.

Strengthening Pharmaceutical Systems (SPS) Program, (2009)

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

Good Pharmacovigilance Practices for the Americas

Pan American Health Organization (PAHO), (2011)

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!

Boas práticas de farmacovigilância para as Américas

Organização Pan-Americana da Saúde, (2011)

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 intenção 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.

Buenas Prácticas de Farmacovigilancia para las Américas

Organización Panamericana de la Salud, (2010)

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 de 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.


Eds.: World Health Organization (WHO), (2015)

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 medicine-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).


Uppsala Monitoring Centre, Eds.: World Health Organization, (2012)

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 pharmacovigilance 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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