Analysis of Antineoplastics, Immunomodulators, Antibiotics and Analgesics Adverse Drug Reactions Reports Submitted to the Pharmacovigilance Database in Jordan

Abstract

A national pharmacovigilance database was created recently at the Rational Drug Use and Pharmacovigilance Department at Jordan Food and Drug Administration (JFDA). This study was based on the analysis of the adverse drug reactions (ADRs) reports submitted to the national pharmacovigilance (PV) database in Jordan from 2010 to 2014.The aims of this study were to identify the most frequently body system classes and the most common ADRs for the four major classes of dugs implicated in the PV database and include: antineoplastics, immunomodulators, antibiotics and analgesics. The most affected systems by ADRs in our study were the skin and the gastrointestinal (GI) systems. The skin ADRs associated with the use of antineoplastics were skin rash, hand and foot syndrome and acral erythema, and the most frequent GI ADRs were vomiting and diarrhea. The most affected system by the use of the immunomodulators was the blood system and the most common ADRs were anemia, thrombocytopenia and neutropenia. The most commonly ADRs following analgesics use were GI bleeding and duodenal ulcer and the skin reactions were rash, itching and flushing. Analysis of the national PV database provides close monitoring and more information about the safety of medicine in Jordan. All Health care provider should be aware of the importance of reporting of adverse reactions and should be encouraged to report suspected ADRs and be trained in detecting, diagnosing and treating patients with adverse effects of drugs.

Assessment of Knowledge, Attitude, and Practice of Physicians toward Pharmacovigilance in Public and Private Hospitals in Jordan

“…Clinical trials are used to assess, evaluate, and confirm the safety and the efficacy of medicinal products [6][7]. When the drug leaves the controlled environment of clinical trials and is made available for consumption by the general population, many unidentifiable and unknown adverse drug reactions may occur [8][9]. An adverse drug reaction (ADR) is defined by WHO (2002) as 'A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function' [10][11].…”