The manual offer a structured method for evaluating pharmacovigilance systems. It underscores the critical role of pharmacovigilance in ensuring the safety of medicines and preventing adverse effects.
The document is divided into various sections, starting with an introduction that emphasizes the significance of pharmacovigilance as a medical discipline. It then delves into the rationale behind the pharmacovigilance indicators, their characteristics, and their classification into core and complementary indicators. Core indicators are essential for assessing the primary functions of pharmacovigilance centers, while complementary indicators provide additional, context-specific information.
The guide also highlights the context of WHO pharmacovigilance indicators, detailing the WHO strategy for monitoring a country's pharmaceutical situation and the development process of these indicators. Furthermore, the manual provides a comprehensive description of each indicator, its data sources, and how to interpret the values.
The manual concludes with annexes that include minimum requirements for a functional pharmacovigilance system, background information, and an assessment checklist.
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