Pharmacovigilance

What is pharmacovigilance?


Pharmacovigilance is a public health activity which aims to identify, evaluate and prevent the risks posed by medicines once they are on the market. Pharmacovigilance is about making decisions to maintain the positive risk-benefit ratio a drug and, if necessary, to suspend its use when this is not possible.

Why is pharmacovigilance important?


When a drug is authorized and marketed for the first time, its safety and efficacy information have only been obtained through clinical trials. These clinical trials provide important information on many of the potential risks associated with the drug but cannot detect all possible adverse effects of a drug in its actual use.

Monitoring the safety of a medicinal product once it is on the market gives us a better understanding of its safety profile and possible adverse reactions beyond the controlled environment of a clinical trial. It also provides us with data on its use in a larger number of patients, which may include the elderly, children, pregnant women and patients with other diseases or undergoing other treatments.

How can I contribute to pharmacovigilance?


The basic information that a pharmacovigilance department uses is adverse drug effects. An adverse effect is a reaction to a drug that was not expected or desired. Any medication can cause adverse reactions. The leaflet and summary of product characteristics for each drug describe those which are already known. So, if you identify a possible adverse reaction to a drug after using it, even if it is not described in the leaflet, it is important to report it properly.

How can I report an adverse reaction?


Adverse drug reactions can be reported to health care professionals, such as doctors and pharmacists, to the Spanish Medicines Agency (www.notificaram.es) or directly to pharmaceutical companies. If the medicinal product in question is owned by Ferrer, the adverse reaction can be reported to the company’s pharmacovigilance department. This can be done through Ferrer’s website (www.ferrer.com), or by calling the telephone number that can be found there.

What happens to these reports of adverse reactions?


Every adverse reaction received by the pharmacovigilance department is recorded in an internal database and analyzed periodically to identify possible risks of the drug. When a safety risk is detected, a detailed evaluation is carried out to establish the possible relationship of the drug with the adverse reaction.

These notifications help to give a better understanding of the safety profile of the drug, and may lead to updates of the leaflet and summary of product characteristics, safety information given to health professionals and even the suspension of the drug if there is a clear public health risk.

Albert García Rierola's picture
Albert García Rierola
Qualified Person Responsible for Pharmacovigilance