What is Pharmacovigilance?

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or other problems related to drugs.

What is an adverse reaction?

"An adverse reaction is a harmful and unwanted effect resulting from the use of a medicinal product. In accordance with the directions

• contained in the marketing authorization, medication errors, uses outside the indications
• contained in the marketing authorization, including overdose, misuse, abuse of the product,
• as well as associated with occupational exposure;

What to do if you think you have had an adverse reaction to a drug?

First, contact your doctor, informing him of what happened. In case you want to also report what happened, please follow the instructions below.

Reporting

In order to increase safety it is extremely important to gather all information about adverse drug reactions and on their inadequate use.

Immediate reporting of suspected adverse reactions can be carried out both by citizens and health workers, through the ministerial forms. Also, for healthcare professionals, the Italian law establishes timings and ways for filing a report with the adequate Pharmacovigilance personnel of Hospitals or of Local Health Authorities.

All these reports will then be inserted by the various health facilities in the national database of adverse reactions to drugs called "National Network of Pharmacovigilance”.

For more insights on Pharmacovigilance:

http://www.agenziafarmaco.gov.it/it/content/modalit%C3%A0-di-segnalazione-delle-sospette-reazioni-avverse-ai-medicinali

http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000456.jsp&mid=WC0b01ac05801ae8fb