Pharmacovigilance

What is pharmacovigilance?

Pharmacovigilance is the science and set of activities related to the detection, assessment, understanding and prevention of side effects or any other drug-related safety problem. Its aim is to improve the safety of the use of medicines for the protection of the patient and Public Health.
A side effect, also known as undesirable effect or adverse reaction, is a noxious and unintended response to one or more medicines.

Why notify a side effect?

New findings on drug effects are constantly being made. Although medicines are extensively tested in clinical trials before being authorized and marketed it is not possible to know all about the side effects they may cause until they are used by many people over a long period of time.
By reporting side effects, you will be helping to provide more information about the medicines and as a result, help make them safer.

How important is the information collected?

The information collected through the reporting of side effects is vital to ensure the continuous monitoring of the safety of medicines on the market. It allows to identify potential unknown side effects, to quantify and/or better characterize previously identified side effects and to implement measures to minimize the risk of their occurrence.

What situations should be notified?

Notify the side effects or any situation related to the use of the medicines, e.g. drug interaction situations, administration errors, lack of therapeutic efficacy, overdose, whether the drug has been used as indicated or not, and also in cases of occupational exposure.

What information should be notified?

Whenever a notification is made, the following information should be provided if possible:

• Information about the person who experienced the side effect (such as age and gender);
• A description of the side effect or of any situation related to the use of the medicines;
• The dose and name of the medicine suspected to have caused the side effect (both the brand name and the active substance);
• The batch number of the medicine (indicated on the package);
• Any other medicines taken at the same time (including over-the-counter medicines, herbal medicines and contraceptives);
• Any other diseases that could affect the person who experienced the side effect.

 

Pharmacovigilance contacts of Laboratórios Atral:

· Telephone: (+351) 263 856 800
· Mobile: (+351) 933 440 132

· E-mail: farmacovigilancia@atral.pt