• MOHAMMED GHANIM SULAIMAN Pharmacist, Mosul University - College of Pharmacy, University of Mosul
  • FOUAD KASIM MOHAMMAD Professor, Pharmacology & Toxicology, Ministry of Higher Education & Scientific Research, Baghdad, Iraq
  • ANSAM NAJI ALHASSANI Assistant Professor, Toxicology, College of Pharmacy, Hawler Medical University,Erbil, Kurdistan Region, Iraq
Keywords: Adverse Drug Reaction, Hospital Based Monitoring, Pharmacovigilance


Background and objectives: Adverse drug reactions (ADRs) are recognized as a common cause of hospital admissions and they constitute a significant economic burden for the hospitals. Many disasters caused by drugs occurred in the past, after that regulation for drug approval has taken place. The aim of this study was to evaluate ADRs and assess their causality, severity and preventability in Erbil and Duhok main hospitals.

Methods: This is a retrospective cross-sectional, hospital-based study, conducted at Rizgary hospital in Erbil and Azadi hospital in Duhok from January to October 2016. Each Adverse reaction was assessed for its causality, severity and preventability using Naranjo, Hartwig and Siegel, and Schumock and Thornton assessment scales, respectively. Data were analyzed using descriptive analysis.

Results: A total of 378 patients with ADRs were reported, 57.7% females and 42.3% males. The maximum percentage of ADRs was noted in patient's age 21-40 years, 66.4% occurred in patients taking two or more medications. Common ADRs were allergic reactions (30.2%) and these involved with the gastrointestinal tract (20.6%). Antimicrobials (30.7%) and analgesics (9.0%) were the common causes of ADRs. Oral (49.47%) and intravenous (37.30%) routes of drug administration were responsible for most of ADRs. Of these cases, 47.9% were preventable, of moderate severity (52.9%), while 7.7% hospitalized, 1.1% needed surgical intervention and 2.4% died from ADRs.

Conclusions: ADRs can be frequently detected; they increase cost of treatment although about half can be prevented. These problems are essential to be reported, analyzed and interpreted, then effectively communicated with health authorities.


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