WHO defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. 

The scope of pharmacovigilance had grown remarkably and is now considered to include the following domains: 

  • medication errors 
  • counterfeit or substandard medicines 
  • lack of efficacy of medicines
  • misuse and/or abuse of medicines
  • interaction between medicines 
Key facts
  • Pharmacovigilance indicators are specific objective measures that allow the evaluation of the baseline situation and progress in the systems and the assessment of services and interventions 
  • Indicators measure the existence and performance of hey pharmacovigilance structures and processes and to able to identify the strengths and weaknesses, as well as revealing the achievements, growth of lack of growth of the pharmacovigilance systems. 
  • Indicators should be: simple, not require great expertise to measure, reproducible, be specific and sensitive so that they are able to detect pharmacovigilance problems needing attention as well as changes in the pharmacovigilance systems. 
What PAHO does

The World Health Organization  Pharmacovigilance team strives to ensure safer use of medicines and vaccines throughout the life cycle of the products. We produce reliable, balanced information on the benefits and risks of medicines and vaccines, which enhances people’s care and safety.

  • Developing norms, standards and guidelines.

  • Providing credible safety and regulatory information on medicines.

  • Appointing and convening global advisory committees of experts to review and provide guidance on the safety of medicines and  vaccines.

  • Hosting global networks such as the WHO Programme for International Drug Monitoring (PIDM) to promote pharmacovigilance in countries.

  • Establishing and maintaining WHO Collaborating centres (WHO CCs) to provide technical support to countries in pharmacovigilance.

  • Countering vaccine-misinformation about vaccines through the Vaccine Safety Net (VSN)which facilitates the access to reliable information on vaccine safety.

  • Providing training programmes to build and strengthen the capacity of national safety surveillance systems for  medicines and vaccines .

  • Developing innovative methods and tools to generate new evidence on the safety of medicinal products