Reporting adverse drug reaction case study

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The prompt reporting of suspected ADRs to regulatory authorities to activate drug safety surveillance and regulation appears to be the most pragmatic measure for addressing the problem. A prospective cohort design was deployed to evaluate the outcomes of the model. The primary outcomes were knowledge gained and Individual Case Safety Reports ICSR completed adverse drug reactions monitoring forms submitted, while the secondary outcomes were facility based Pharmacovigilance Committees activated and health facility healthcare workers trained by the participants. More than three quarter of the participants have never received training on pharmacovigilance prior to the course. Yet, a significant gain in knowledge was observed after the participants completed a comprehensive training for six days. Participants gained knowledge, which tended to increase the reporting of ADRs.

CFR - Code of Federal Regulations Title 21

What’s solicited and unsolicited report in pharmacovigilance? | northminster.info

Introduction: Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries. Objective: The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana. Methods: A cross-sectional study using questionnaires administered through face-to-face interviews was carried out from 25 August, to 20 September, with patients aged 18 years and above selected by convenience sampling from two community pharmacies in urban and rural Ghana. Reasons and opinions on patients' reporting on adverse drug reactions were surveyed using a 5-point Likert scale. The Pearson chi-square test was used to determine associations between background variables and responses on knowledge of adverse drug reaction reporting. Results: Responses from patients

Case study on adverse reactions to drugs and problems with medical devices

This study was aimed to describe the main characteristics of all ADRs associated with allopurinol, analyze the proportion of serious cutaneous ADRs of total ICSRs related to allopurinol and to compare the main features age, sex, seriousness and outcome of ICSRs that reported serious cutaneous ADRs with those that did not. Serious cutaneous ADRs associated with allopurinol frequently required hospitalization or prolonged hospitalization, and almost half had an unfavorable outcome. Allopurinol, an inhibitor of xanthine oxidase, prevents the oxidation of xanthine to uric acid. It is indicated for the treatment of clinical manifestations of hyperuricemia and its complications, including chronic gout, uric acid lithiasis and acute uric acid nephropathy [ 1 ]. Hyperuricemia may have several underlying causes; the most common are diseases that induce an overproduction of urate or its inefficient excretion by the kidneys i.
Metrics details. Parkinsonism puts a high direct cost burden on both patient and caregiver. Several reports of drug-induced parkinsonism have been published, but to the best of our knowledge, there has not been any report of quinine or halothane inducing parkinsonism. We describe two cases of parkinsonism possibly caused by adverse drug reaction to quinine in a year-old black Nigerian woman and to halothane in a year-old black Hausa Nigerian man who received it as general anaesthesia for appendicectomy in our teaching hospital. These are two unusual cases of parkinsonism caused by adverse drug reactions to high-dose quinine and to halothane as general anaesthesia.

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