Farmakovigilance: Systémy spontánního hlášení

• Main Author: Srba, Jindřich
• Other Authors: Vlček, Jiří
• Format: Doctoral Thesis
• Language: English
• Published: 2014
• Online Access: http://www.nusl.cz/ntk/nusl-332351

Pharmacovigilance: Spontaneous reporting systems Srba J. Abstract Introduction: Pharmacovigilance system is consisted of several approaches used for drug safety surveillance. Spontaneous reporting systems in European countries have been established in the second half of the 20th century. Originally, spontaneous collection of adverse drug reactions was designed for healthcare professionals. Under-reporting was in general considered as the main weakness of spontaneous reporting system. To increase the reporting activity, direct patient reporting has been included in spontaneous reporting system at national competent authorities. Aims: The aim of this work was to characterize spontaneous reporting system. Subsequently, we focused on the evaluation of position of patient-reported outcomes of adverse events (PRO-AE) in established systems of the European countries. In particular, we i) characterized reporting activity within European countries, ii) evaluated the position of adverse drug reaction (ADR) reports directly submitted by patients to national competent authorities, and iii) overviewed of the processing of PRO- AEs. Methodology: Practical part was based on questionnaires distributed to national competent authorities and literature search of electronic databases with relevant published articles. Results:...