Guidance for pharmacovigilance

Our mission is to support countries to establish and strengthen national pharmacovigilance systems with tools and systems and strategies.

Effective detection, assessment, understanding and preventing of the adverse effects will enhance patient care and patient safety and to support public health programmes by providing reliable, balanced information for the effective assessment of the benefit-risk profile of medicines and vaccines.

Guidance is provided either by thematic area, or by publication type.

Pharmacovigilance strategies

Pharmacovigilance operations

Reports and Newsletters

Vaccine reaction rates information sheets

Meeting reports

Recommendations from WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) - from 2003 onwards

Recommendations from WHO Global Advisory Committee on Vaccine Safety (GACVS) 

National Pharmacovigilance Centres Annual Meeting Recommendations from National Pharmacovigilance Centres Meetings - from 2010 onwards

Unmasking safety signals in an infodemic

Vaccine safety communication in the digital age: 2018 meeting report, 4-5 June 2018,  Les Pensières center for global health, Veyrier-du-Lac, France

Global vaccine safety initiative: 2018 meeting report

Global vaccine safety initiative: 2017 meeting report

Protocols

Protocol on estimation of Guillain-Barré syndrome background rates in general population in low- and middle-income countries 

Safety monitoring of mpox vaccines using cohort event monitoring: a WHO protocol

Safety monitoring of molnupiravir for treatment of mild to moderate COVID-19 infection in low and middle-income countries using cohort event monitoring: a WHO study

Protocol template to be used as template for observational study protocols for cohort event monitoring (CEM) for safety signal detection after vaccination with COVID-19 vaccines.

Protocol template to be used as template for observational study protocols for sentinel surveillance of adverse events of special interest (AESIs) after vaccination with COVID-19 vaccines.

Strategies

3S strategy

Global vaccine safety blueprint 2.0 (‎GVSB2.0)‎ 2021-2023

Safety of mass immunization campaigns

Global vaccine safety blueprint 2.0 background research

Adverse drug reactions (ADR)

Reporting and learning systems for medication errors: the role of pharmacovigilance centres

Restrictions in use and availability of pharmaceuticals 2010-2018

Safety monitoring of medicinal products: Reporting system for the general public

Safety of medicines: a guide to detecting and reporting adverse drug reactions: why health professionals need to take action

WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems

The importance of pharmacovigilance: Safety Monitoring of medicinal products

SAFETY MONITORING of MEDICINAL PRODUCTS: Guidelines for setting up and running a Pharmacovigilance Centre

Pharmacovigilance: ensuring the safe use of medicines

Introduction to drug utilization research

The safety of medicines in public health programmes: pharmacovigilance an essential tool

Other

WHO Pharmaceutical Newsletters

Adverse events following immunization (AEFI)

Brief overview of anaphylaxis as an adverse event following immunization (‎AEFI)‎ and practical guidance on its identification, case management and response in a primary care setting

Immunization stress-related response: a manual for program managers and health professionals to prevent, identify and respond to stress-related responses following immunization

Immunization stress-related response: a synopsis of the manual for program managers and health professionals to prevent, identify and respond to stress-related responses following immunization

Causality assessment of an adverse event following immunization (AEFI): user manual for the revised WHO classification, 2nd ed., 2019 update

Safety in special populations

COVID-19 vaccines surveillance manual - pregnancy

Safety of immunization during pregnancy: a review of the evidence: Global Advisory Committee on Vaccine Safety

Promoting safety of medicines for children

COVID-19 vaccines

COVID-19 vaccines surveillance manual (all modules, addendum and trainings)

Guidance for clinical case management of thrombosis with thrombocytopenia syndrome (TTS) following vaccination to prevent coronavirus disease (COVID-19)

Other vaccines

Identifying and responding to serious adverse events following immunization, following use of smallpox vaccine during a public health emergency: a guidance document for smallpox vaccine safety surveillance

HPV vaccine communication: special considerations for a unique vaccine, 2016 update

Safety of specific drugs

A practical handbook on the pharmacovigilance of antimalarial medicines 

A practical handbook on the pharmacovigilance of medicines used in the treatment of tuberculosis: enhancing the safety of the TB patient

Pharmacovigilance for antiretrovirals in resource-poor countries

A practical handbook on the pharmacovigilance of antiretroviral medicines