Prakt. lékáren. 2013; 9(6): 247-249
Adverse drug reactions reported to SÚKL in 2012
- Státní ústav pro kontrolu léčiv
Continuous monitoring of drug safety is the scope of pharmacovigilance. Benefit/ risk ratio of each medicinal product is reassessed
with every newly detected pharmacovigilance signal with the aim to keep on the market only medicines with treatment benefits highly
superior to possible risks. Reporting of adverse drug reactions belongs to most important sources of safety information. In 2012 State
institute for drug control received 2 033 reports of adverse drug reactions from the Czech Republic. 1 099 of these were reported directly
to SÚKL (876 from physicians, 48 from pharmacists, 85 from other health care professionals), 1 024 reports originated from medicine
authorisation holders. 3,5% of all reports were patients reports, 37 patients reported directly to SÚKL.
Keywords: adverse reaction, spontaneous report, pharmacovigilance, health care professional, patient
Published: December 1, 2013 Show citation
