Pharmacovigilance

 

 

What is Pharmacovigilance?

 

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other drug-related problem, with the aim to improve the care and safety of patients and to contribute to the protection of public health.

 

In order to provide the most accurate information to doctors and consumers, it’s necessary to fully understand and continuously monitor the risk/benefit profile of medicines.

 

Bracco is responsible for collecting, processing and evaluating the information relevant to the benefit - risk profile of its products, either marketed or currently under clinical development. Any important safety issues that may arise are promptly communicated to healthcare professionals, patients and regulatory authorities concerned in accordance with current regulations.

 

 

What is an adverse drug reaction?

 

It’s a harmful and unintended response to the use of a medicinal product.

 

Adverse drug reactions may result from use of the product either within or outside the marketing authorisation,  or from occupational exposure. Conditions of use outside the authorization includes, among others, overdose, misuse, abuse and medication errors.

 

 

How can you report an adverse drug reaction?

 

Spontaneous reporting of suspected adverse reactions is an important source of information for pharmacovigilance activities; in order to correctly assess the safety and efficacy profile of medicinal products, any and all adverse reactions in the country are collected in a single database.

 

Any unusual symptoms experienced during  a therapy or diagnostic procedure must be immediately reported to the patient’s physician or pharmacist.

 

If you wish to report adverse reactions related to the use of Bracco drugs, use the contacts below:

 

e-mail: [email protected]

 

Telephone: 1-800-257-5181