The pharmacovigilance system /from the Greek word “pharmakon” (drug) and Latin word “vigilare” (be vigilant)/ is defined according to the WHO as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”. However, it must be remembered that these are not just organizational structures in registration agencies and pharma companies. This system is to comprise several elements, the most significant of which are people – their experience, commitment, and collected over the years knowledge. The system will run smoothly as long as we have the legal possibility to take appropriate actions, and the number of people who are involved in the monitoring of adverse effects or experience them increases. The key element of the process is understanding the fact that without providing information about the adverse effect which is inseparably connected to the use of the medicinal product, there is no possibility for the pharmacovigilance system to work properly.

Regulations are prerequisite, but still inadequate to implement effective actions. A key link of this system is always a suitably-qualified medical professional. Gathering knowledge on the drug is possible thanks to the observation of patients’ reaction to a particular drug and passing this information further. It is important to realize that knowledge regarding new drug upon its registration is still incomplete. After a drug has been authorised on the market, it is applied to a broader population of patients. Hence, a physician in everyday medical practice experiences more complicated situations than those found in clinical trials prior to the registration of the drug. In the long-term perspective, we are able to observe delayed results of the treatment, identify health risks that could have an impact on the effectiveness and safety of the therapy, discover drug interactions.

Safety First

Our aim is to lead to a situation where only effective and safe drugs are available in the pharmaceutical market. Thus, we make best efforts to detect novel, potential threats, and reduce the risk associated with the use of the drug. We evaluate the value of the drug on a regular basis as our scientific knowledge about it accumulates. The risk analysis, i.e., the ratio of the benefits of using the drug to foreseeable risks, is being performed along with the availability of a given medicinal product on the market.

The data analysis is mainly conducted by regulatory agencies in relation to the products registered in a given country and pharma companies – in relation to their products. The data evaluation is also carried out at the international level. The Pharmacovigilance Risk Assessment Committee (PRAC) is a part of the European Medicines Agency (EMA) which operates within the European Union. The PRAC is responsible for assessing all aspects of risk management of human medicines.

The assessment of the drug safety profile involves not only the analysis of individual cases of adverse reactions to medicinal products but also the analysis of aggregate reports prepared by pharma companies. In accordance with the applicable provisions, responsible entities are required to prepare periodic safety reports and appropriate risk management plans (for selected medicinal products).


In some cases, the responsible entity will also conduct post-registration safety studies of the particular medicinal product in which projects and protocols are subject to approval by the President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

All of these activities shall be used to obtain the most comprehensive information about the drug. Providing up-to-date and complete information helps the physician to select the appropriate drug for a particular patient.

Additionally, learning about the adverse reactions that may accompany the use of a particular drug, in many cases allows the physician to take appropriate actions if such a reaction occurs. Such actions may reduce the risk of causing health damage as a consequence of an administered drug.

It is important to remark that learning about the risks allows a valuable medicinal product for a particular group of patients to remain in the treatment process. Thus, the detection of even serious adverse effects is not always the reason for withdrawing drug from the market, but it is always necessary to seek ways to reduce the risk. Restricting the use of drugs to a specific group of patients and adopting appropriate contradictions allows for safer administration of the drug.

We must be aware of the inevitability of the risk to which the patient is exposed by drug administration. The adverse effects may also occur when the treatment is applied correctly.

The pharmacovigilance aims to understand the risks associated with pharmacotherapy thoroughly and to restrict them as much as possible.