Journal of Pharmacovigilance

Jiri Vlcek

Publications

• Research Article
  Position and Processing of Adverse Drug Reactions Directly Submitted by Patients to National Regulatory Authorities in Europe
  Author(s): Jindrich Srba and Jiri VlcekJindrich Srba and Jiri Vlcek
  
  Introduction: Adverse drug reaction (ADR) reports submitted by patients to national regulatory authorities should be directly accepted since July 2012 when new pharmacovigilance legislation was implemented. This questionnaire based analysis and review was conducted to evaluate the position of ADR reports submitted by patients and to compare ADR reporting by patients and healthcare professionals (HPs). Materials and Methods: Questionnaires were provided to national regulatory authorities in 2011 to evaluate their attitudes toward the ADR reports submitted directly by patients. In addition, electronic databases (2003–2011) were searched, including MEDLINE and EMBASE, and reference lists of included studies were reviewed, to compare data from ADR reports sent by patients and HPs. Results: Of the 30 questionnaire.. View More»
  DOI: 10.4172/2329-6887.1000122

  Abstract PDF