According to the World Health Organization, Pharmacovigilance is defined as the area of knowledge specifically dedicated to the detection, evaluation, understanding and prevention against adverse reactions or other safety issues related to the medicine.
The term ”adverse reaction” comprehends any harmful and involuntary reaction that results from the intake of a medicine in a dosage generally used in human beings for a prophylactic or diagnostic end, as well as for the treatment of current or recovering conditions, correction or modification of physiological functions.
The Pharmacovigilance system plays a paramount role in continuously monitoring the safety of medicines. Upon entering the market, it is possible to know their safety profile by constantly and systematically assessing the risk/benefit relation in regular conditions of use. This permanent observation of a medicine is done mainly through the “spontaneous notification” of adverse reactions.
The success of all this process strictly depends upon the active participation and joint effort of all the parties involved: the Regulatory Agency (Infarmed), Health Professionals, the Patients and the General Public.
Bluepharma has always set as a major priority its ethical and legal responsibility and its commitment to the patient. It thus adopts a pro-active attitude as far as the Pharmacovigilance of its medicines is concerned.
To notify us about an adverse reaction deriving from the intake of a Bluepharma medicine, please use the form.
