PHARMACOVIGILANCE

 

What is Pharmacovigilance?

According to the World Health Organization (WHO) Pharmacovigilance is that science and those activities relating to the detection, assessment, understanding and prevention of adverse effects or other problems related to medicinal products.

In order to ensure safe use of medicines it is required continuous monitoring of reports of suspected adverse reactions to drugs from different sources: reports from healthcare professionals or patients, from scientific literature, from clinical trials.

Pharmacovigilance involves therefore at different levels the whole community (patients, prescribers, health professionals, pharmaceutical companies, institutions) and the alert may be issued not only by the health care professionals but also, directly, by the citizens.

The collection of this information is essential to allow the people in charge of Pharmacovigilance activities to define and keep updated the safety and tolerability profile of medicinal products  (benefits vs risks) under actual use conditions.

Pharmacovigilance is an activity required by law, provided for by Italian and international health authorities.

What do you mean by adverse reaction?

"An adverse reaction is an undesired harmful effect, resulting from the use of a medicinal product"

• in accordance with the instructions contained in the marketing authorization (ie according to the description in Leaflet and Summary of Product Characteristics)

• medication errors,

• non-compliant uses with the information present in the marketing authorization, including overdose, misuse, abuse of the medicine,

• as well as associated with occupational exposure.

In order to increase security is extremely important to gather all the information on adverse drug reactions and on their inappropriate use.

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

First of all report promptly to the treating physician or other health care professional what happened to you or to the person for whom you intend to make the report.

Then you can proceed to make the spontaneous reporting of suspected adverse reactions. This can be done directly both from individual patients/citizens and from health care professionals, using the forms downloadable from the website of the Italian Drug Agency (AIFA) in the section "Notification modality of suspected adverse reactions to medicinal products" which can be accessed via the link below:

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

If you have taken a Farmigea’s medicinal product and intend to report an adverse reaction to Farmigea’s Drug Safety Officer you can fill in the contact form by clicking here

Providing the following information:

• - Subject/patient experiencing the undesirable effect: the initials of first and last name, gender, age, city of residence

 • - Farmigea Medicinal Product: name of the medicinal product taken

 • - Adverse Reaction: description of the effect

 • - Reporting person: name and surname of the reporting person, email, profession