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
- 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.