Samar Osama Elsayed Gouda <br/><br/>
Review of spontaneous adverse drug reactions reporting to the Egyptian pharmaceutical vigilance center /  
 دراسة الابلاغ التطوعى لآثار الدواء الجانبية الى مركز اليقظة الدوائية المصرى 
Samar Osama Elsayed Gouda ; Supervised Samar Farid , Maggie Magdi Abbassi , Amr Abdalmonem Saad 
 - Cairo :   Samar Osama Elsayed Gouda ,   2019 
 - 76 P. :   charts ;   25cm 
<br/><br/>Thesis (M.Sc.) - Cairo University - Faculty of Pharmacy - Department of Pharmaceutics 
<br/><br/> Background : Spontaneous reporting is the backbone of Pharmacovigilance (PV). It is the main supplier of reports submitted to PV centers. The Egyptian Pharmaceutical Vigilance Center (EPVC) has started to receive adverse drug reaction (ADR) reports since 2011. Since then, the number of Individual Case Safety Reports (ICSRs) received by EPVC is on the rise. Satellite PV centres have started to conduct awareness workshops for pharmacists since their opening. OBJECTIVES: To evaluate the pattern of spontaneous reports and the features of data collected in the Egyptian pharmacovigilance system from 2011 to 2015; and to compare the Egyptian signals with international ones. METHODS: All validated spontaneous reports received by EPVC from January 2011 to December 2015 were extracted and analyzed for the characteristics of reports, reporter qualification, patient demographics, seriousness, type of suspected drugs, nature of experienced ADRs and causality. The Information Component (IC) values of the most common drug-ADR pairs in Egypt were extracted and compared with the international IC values 
<br/><br/>
<br/><br/><label>Subjects--Index Terms: </label>Adverse drug reactions  Spontaneous reporting The Egyptian pharmaceutical vigilance center