Preliminary findings from stimulated spontaneous reporting of adverse drug reactions during COVID-19 pandemic: an experience from Ghana
| Autor: | Jeremiah S. Ewudzie, Jennifer Boateng, George Sabblah, Seth K. Seaneke, Abena Asamoa-Amoakohene, Adela Ashie, Josephine Mensah, Felicia Dwamena, Theodora Asa-Eck, Ernest Ernest Agyei-Kwame, Delese A. Darko |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty COVID-19 pandemic Drug-Related Side Effects and Adverse Reactions adverse drug reaction spontaneous reporting 030226 pharmacology & pharmacy Ghana 03 medical and health sciences 0302 clinical medicine Pandemic Medicine Adverse Drug Reaction Reporting Systems Humans 030212 general & internal medicine Prospective Studies Summary of Product Characteristics Prospective cohort study Aged Descriptive statistics business.industry SARS-CoV-2 Hydroxychloroquine Middle Aged medicine.disease Dysgeusia COVID-19 Drug Treatment Relative risk Emergency medicine Female Original Article medicine.symptom business Adverse drug reaction medicine.drug |
| Zdroj: | Ghana Medical Journal |
| ISSN: | 2616-163X |
| Popis: | Background: The novel coronavirus disease 2019 (COVID-19) is an ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) There is limited information on the safety of drugs used for the treatment of COVID-19 Objective: Objective of this study is to describe the pattern of stimulated spontaneous adverse drug reaction (ADR) reports received from healthcare professionals for SARS-CoV-2 positive patients in Ghana and lessons learnt particularly for low- and middle-income countries Methods: This is a study of individual case safety reports (ICSRs) received from healthcare professionals between 1st April 2020 to 31st July 2020 in SARS-CoV-2 positive patients in Ghana The ICSRs were retrieved from the SafetyWatch System and descriptive statistics used to describe the ADRs by System Organ Classification and Preferred Term Results: Information was received from 40 COVID-19 Treatment Centres across the country with 9 centres submitting a total of 53 ICSRs containing 101 ADRs;approximately two ADRs per ICSR Females accounted for 29(54 7%) of the ICSRs and males 24(45 3%) Newly reported ADRs of interest were one report each of tremor for doxycycline;scrotal pain, dyspnoea, gait disturbances and dysgeusia for chloroquine;and dry throat, hyperhidrosis, restlessness and micturition frequency increased for hydroxychloroquine A strong spontaneous system with the availability of focal persons at the Treatment Centres played a key role in reporting ADRs during the pandemic Conclusion: This is the first experience with spontaneous reporting during COVID-19 pandemic in Ghana The profile of most of the ADRs reported appears consistent with what is expected from the summary of product characteristics A study with a larger sample size with well-defined denominator in future studies is paramount in determining the relative risk of these medications in SARS-CoV-2 positive patients © 2021 Bioexcel Publishing LTD All rights reserved |
| Databáze: | OpenAIRE |
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