A medicinal product may only be marketed after confirmation of its effectiveness, safety and quality, as well as after ensuring the favourable ratio between the benefits and the expected risks.
Besides the therapeutic benefits that a medicinal product can provide, it may also cause undesirable effects. Thus, the safety monitoring of the marketed medicinal products is the responsibility of the Pharmaceutical Industry through Pharmacovigilance
.What is Pharmacovigilance?
Pharmacovigilance is "the process and the science of detection and assessment of adverse reactions, in order to reduce the risks and increase the benefits of the medicinal products
." (European Commission, 2007)
Thus, activities of collection, management, analysis and assessment of safety information of medicinal products are developed. In accordance with the benefit/risk ratio of the medicinal product, decisions are taken, such as safety alerts, resizing of the packaging size, restrictions to the use of the medicinal product, withdrawn of the medicinal product from the market, etc.
With the purpose of ensuring the protection of public health and make the use of medicinal products safer and more rational, Pharmacovigilance is a responsibility shared between the several players involved:
The vigilance does not end with a clinical trial...
- INFARMED, I.P./National and International Regulatory Authorities;
- Health Professionals (doctors, pharmacists, nurses);
- Pharmaceutical Industry;
The clinical trials carried out during the development phase of a medicinal product, allow to obtain important information on the safety of medicinal products, in particular about their most common undesirable effects and the interactions with other medicinal products administered concomitantly.
However, this information is limited, due to the characteristics of the clinical trials (involvement of a limited number of patients, limited duration of the trial, fixed administered dose and very strict use conditions of the medicinal product). These trials do not always reflect the normal use conditions of a medicinal product.
Therefore, it is fundamental that during the marketing period of the medicinal product its safety is monitored, not only for the effective and early detection of adverse reactions, as well as to complete and improve the safety information of that medicinal product.