A key factor in the development and use of a drug, the practice of pharmacovigilance includes all the ongoing activities aiming at collecting and evaluating information on the safety of drugs, including their suspected adverse reactions.
Hence, pharmacovigilance is essential to better know a drug, to properly inform the physicians who prescribe it and to protect the patients who take it, ensuring it is safely used over time through a close cooperation between all industry professionals involved: local, national and international authorities and pharmaceutical companies.
The ultimate goal of our pharmacovigilance activities is an ongoing evaluation of the tolerability profile of a drug throughout its use, from the first clinical trials up to and through the post-marketing stage.
WHAT IS AN ADVERSE REACTION
An adverse reaction is a harmful and unwanted effect resulting from:
- taking a drug following the provisions contained in the marketing authorisation;
- medication errors;
- a non-compliant use (including overdose, misuse, and abuse) of a drug not to the instructions contained in the marketing authorisation (off label);
- exposure due to occupational reasons.
In this context, the term “effect” identifies a situation where at least one reasonable chance of causal relationship between the drug and the event is present.
WHAT TO DO IN CASE OF A SUSPECTED ADVERSE REACTION
Suspected adverse reactions can be reported spontaneously both by citizens and healthcare professionals in one of the following ways:
- by filling out the suspected adverse drug reaction report form (electronic or hard copy) and submitting it to the Pharmacovigilance Manager of one’s facility via email or fax to the addresses listed on the following page;
- by following the wizard at www.vigifarmaco.it.
The Pharmacovigilance Manager will then proceed with the registration and/or validation of the reports in the National Pharmacovigilance Network (Rete Nazionale di Farmacovigilanza) of the Italian Medicines Agency (AIFA, Agenzia Italiana del Farmaco) connected to EudraVigilance, the EMA-managed European database for the collection of ADRs.
Alternatively, suspected adverse drug reactions can be reported to the Marketing Authorisation Holder (MAH) of the drug that is suspected to have caused the adverse reaction. The company will notify every report in compliance with the procedures and deadlines provided for by applicable laws and regulations.
Like other EU member states, Italy is also part of a European pharmacovigilance system and operates in accordance with the procedures agreed at EU level and defined by the EMA (European Medicines Agency).
Before taking any clinical treatment initiative for a suspected adverse reaction, citizens should always consult a doctor, providing all the available details about the event and their medical history.
You can find more information about pharmacovigilance by visiting the following links: