Analysis of the National Pharmacovigilance Database in Jordan (2010-2014)
Mohammed Alsbou1, Gadeer Abdeen2, Adel Batarseh3, Nidda Bawaresh4, Jaber Jaber4, Gadeer Qawasmi4, Taqwa Maqatef4, Hayat Banat4 and Abdelrahman Batayneh41Department of Pharmacology, Faculty of Medicine, Mutah University, Jordan.
2King Hussein Medical Center (KHCC), Jordan.
3Royal Medical Services, Jordan.
4Rational Drug Use and Pharmacovigilance Department, Jordan Food & Drug Administration, Jordan.
Corresponding Author E-mail: mohsb74@yahoo.com
Abstract: The aims of this study were to analyze the adverse drug reactions reports (ADRs) submitted to the Jordan Pharmacovigilance (PV) department at Jordan Food and Drug Administration (JFDA) in the period from 2010 to 2014, determine the rate of reporting of ADRs per year, identify the most common drugs involved in ADRs, and finally the most commonly body systems implicated in ADRs. The total number of ADRs reports was 428. There was a 5-fold increase in the rate of reporting over the study period. The most commonly classes of drugs implicated in ADRs were antineoplastics (37.6%), followed by immunomodulators (14.1%), antibiotics (10.3%) and analgesics (6.6%). The most commonly reported system organ classes involved in these ADRs were skin and subcutaneous (19.2%), followed by gastrointestinal (16.5%) and nervous system (11.5%). This is the first study to analyze the Jordan national pharmacovigilance database and the results of this study are considered the cornerstone of post-marketing surveillance and it could be used an essential tool for signal generation in Jordan. More educational programs and awareness campaigns are needed to promote the concept of PV and to increase the role of healthcare professionals in the reporting of ADRs in Jordan.
Keywords: Pharmacovigilance; adverse drug reactions; Jordan Back to TOC