What Pharmacovigilance is?

The WHO defines pharmacovigilance as the science and activities related to the detection, evaluation and compression and prevention of adverse effects of medications or any other related problems.

Main objectives of Pharmacovigilance:

1. Early detection of adverse reactions and interactions unknown up to that point.
2. Detection of increases in the frequency of adverse reactions.
3. Identification of risk factors and possible underlying mechanisms of adverse reactions.
4. Estimation of the quantitative aspects of the benefit / risk ratio and dissemination of the information necessary to improve drug regulation and prescription.

What are the ultimate objectives of Pharmacovigilance?

- Rational and safe use of medicines; - Evaluation and communication of the risks and benefits of marketed medicines; - Education and information to patients.

What is an adverse event?

- Known events (Prospectus) - Unknown events - Result of abnormal laboratory tests - Pregnancy / Congenital Abnormalities - Death / Fatal Outcome - Lack of effectiveness - Worsening of the underlying disease - Overdosage - Drug Interaction - Abuse / Misuse - Dependency - Mismanagement of the drug.

Further information:

http://www.controlsanitario.gob.ec http://www.fda.gov http://www.aemps.gob.es http://www.ema.europa.eu/ema/ http://www.who.int http://www.fda.gov

Pharmacovigilance - Hospital Metropolitano
T: 399 8000 Ext. 2603
M: farmacovigilancia@hmetro.med.ec