Pharmacovigilance landscape – Lessons from the past and opportunities for future

Balázs Máté Ádám, Dank Magdolna
Semmelweis Egyetem, Belgyógyászati és Onkológiai Klinika, Onkológiai Profil, Gyógyszer- és Betegbiztonsági Kutatócsoport

Pharmacovigilance is a dynamically developing new scientific field as well as an important industrial and regulatory field. The development of pharmacovigilance was facilitated by incidents such as the disaster of thalidomide in the 1950s and 1960s or the scandal of fatal drug side effects caused by benoxaprofen in 1982. These events highlighted the need to set up systems which can detect the risks related to medicine use in time and can response to them accordingly. Modern pharmacovigilance has the essential part of robust risk management systems and drug safety database in which the drug safety information is collected and analysed. Oncology is at the highest risk from drug safety perspective. Beside the common drug side effects other adverse events can occur in the everyday oncological practice for instance medication errors, which can cause potential harm to the patients. Pharmacovigilance is not only a tool to minimise or prevent the risk of patient harm during medication use, but it can be a precision asset to find patient subpopulations in which the respective drug is neither safe nor effective based on the safety data evaluation. Nevertheless, to set up such a pharmacovigilance system above mentined high quality and appropriate amount of safety data is unequivocally necessary. Source of safety information can be health care professionals besides the patients, thus all parties has the responsibility to report safety information to the health authorities.

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