The WHO (World Health Organization) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Main objectives of Pharmacovigilance
- Early detection of adverse effects and unknown interactions.
- Detection of increases in the frequency of adverse reactions (known).
- Identification of risk factors and the possible underlying mechanisms of adverse reactions.
- Estimation of the quantitative aspects of the benefit / risk ratio and dissemination of the necessary information to improve the regulation and drugs prescriptions.
Wich are the final goals of Pharmacovigilance?
- A rational and safe use of drugs.
- The assessment and communication of risks and benefits of commercialized drugs.
- The education and information to patients.
What is an adverse event?
- Known event (Prospect)
- Unknown event
- Result of laboratory tests
- Pregnancy/Congenital abnormalities
- Death/Fatal result
- Lack of effectiveness
- Worsening of the underlying disease
- Drug interaction
- Abuse / Misuse
- Poor administration of medication
Unid of Pharmacovigilance
For more information: