Analysis of Docetaxel Adverse Drug Reactions: A Retrospective Study Based on Iraqi Pharmacovigilance Center Database

Ahmed M Hameed,Dheyaa J Kadhim,Manal M Younus

doi:10.31351/vol29iss2pp17-26

Abstract

Docetaxel is an effective treatment approved for many types of cancers, but its effectiveness in clinical practice can be compromised by significant occurrence of adverse drug reactions. The aim of the current study was to measure the distribution of adverse drug reactions of docetaxel reported in Iraq and to assess the causality, severity, seriousness, preventability, expectedness and outcome of these adverse reactions. A retrospective study conducted on individual case safety reports from the Iraqi Pharmacovigilance Center / Ministry of Health. The study included 118 individual case safety report containing 236 adverse drug reactions.Most of the adverse drug reactions were related to skin and subcutaneous tissue disorders(26.7%), followed by respiratory, thoracic and mediastinal disorders (20.8%), gastrointestinal disorders (17.4%) and general disorders and administration site conditions (10.6%). The majority of these reactions with possible causality (68.6%), moderate severity (75.4%), expected (80.5%), possibly preventable (93.2%), and serious (80.5%). In addition the most common outcome of adverse drug reactions was recovered / resolved (46.19%).

Highlights

According to the World Health Organization (WHO), “pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”(1)
The current study showed that most of the ADRs were among the adult age group (87.29%) (Table-5), the gender distribution showed more ADRs in the female patient group than in the male patient group this may be attributed to the greater use of docetaxel in the treatment of breast cancer which lead to the development of more ADRs for this medication in the adult and female gender
Regarding the province of reporting, Al-Najaf and Nineveh showed the most individual case safety reports (ICSR) reported across Iraq despite the unstable security situation in Nineveh and this result is consistent with result from another pharmacovigilance study in Iraq that showed that Nineveh was the major contributor to the ICSRs reporting[21], docetaxel was a single medication in around 85% of cases, the presence of concomitant anti-cancer medications in less than 20% of the total cases affected the level of final certainty

Summary

Introduction

According to the World Health Organization (WHO), “pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”(1). ADRs constitute a burden on the health care system because ADRs are a major cause of morbidity, hospital admission, increasing health care cost, and even increasing mortality rates[5]. The increase in the cost represent a huge burden on the health care system, health care facilities may spend 20% of their budget to deal with the complications encountered due to drug usage in some countries[6]. Chemotherapeutic regimens are complex approaches for the treatment of cancer and patients with cancer are generally more prone to adverse drug reactions due to their decreased immune system function compared to normal individuals or patients of other disease areas[8]. The aim of the present study was to demonstrate the distribution of docetaxel ADRs reported to the pharmacovigilance center and to analyze the causality, severity, seriousness, preventability, expectedness and outcome of these ADRs

Objectives

Results

Conclusion