Pharmacovigilance
Pharmacovigilance has been defined by the World Health Organization (WHO) as “the science and activities aimed at identifying, evaluating, understanding and preventing adverse reactions or any other problems related to the use of medicinal products”.
The objective of Pharmacovigilance is to continuously provide the best possible information on the safety of medicinal products, thus enabling the adoption of appropriate measures and thus ensuring that medicinal products available on the market, under the authorized conditions of use, present a favorable risk/benefit balance for the public. (Annex 1, Legislative Decree 95/03. "Implementation of Directive 2000/38/EC on proprietary medicinal products").
In compliance with current legislation, Pharmacovigilance collects and analyzes reports of adverse events and adverse reactions.
Adverse Event
This is defined as any unfavorable and unwanted medical event (sign, symptom, or disease) that may appear in a patient during treatment with a medicinal product, but which does not necessarily have a causal relationship with the medicinal product itself.
Adverse Drug Reaction (ADR)
Instead, it is defined as "a harmful and unwanted effect resulting from the use of a medicinal product" (EU Directive 84/2010).
Reports of suspected adverse reactions/adverse events are an important source of information for Pharmacovigilance activities, as they allow the detection of potential signals that could indicate possible risks deriving from the use of the medicinal product.
How to report adverse reactions?
In Italy, the authority responsible for Pharmacovigilance is the Italian Medicines Agency (AIFA).
Reporting form templates for healthcare professionals and citizens are available on the AIFA website, in the "Forms" section: https://www.aifa.gov.it/moduli-segnalazione-reazioni-avverse .
Reporting of adverse reactions can be done by healthcare professionals and citizens, using one of the following methods:
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The forms (for healthcare professionals or citizens), in Word format, can be filled out electronically and sent by email or fax to the Pharmacovigilance Manager of their respective facility https://www.aifa.gov.it/responsabili-farmacovigilanza
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Directly online on the AIFA website
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Alternatively, the report can be communicated to the Marketing Authorization Holder of the medicinal product suspected of causing the adverse reaction. Doctors, healthcare professionals, or members of the public who wish to report an adverse reaction to Dicofarm can do so using the following form.
