Evidence map›Paper›PMID 33976443›Full record

ArticleGhana medical journal2020

Preliminary findings from stimulated spontaneous reporting of adverse drug reactions during COVID-19 pandemic: an experience from Ghana.

Delese A Darko, Seth K Seaneke, George T Sabblah, Adela Ashie, Abena Asamoa-Amoakohene, Jeremiah S Ewudzie, Theodora Asa-Eck, Ernest Agyei-Kwame, Felicia Dwamena, Josephine Mensah and 1 more

Abstract read
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Article in Ghana medical journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

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0cells of the map it votes in
3citing papers in PubMed
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1 · What the graph read from it

What it found

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2 · The registry

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3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

11 authors.

Delese A DarkoFood and Drugs Authority, P. O. Box CT 2783, Accra.
Seth K SeanekeFood and Drugs Authority, P. O. Box CT 2783, Accra.
George T SabblahFood and Drugs Authority, P. O. Box CT 2783, Accra.
Adela AshieFood and Drugs Authority, P. O. Box CT 2783, Accra.
Abena Asamoa-AmoakoheneFood and Drugs Authority, P. O. Box CT 2783, Accra.
Jeremiah S EwudzieFood and Drugs Authority, P. O. Box CT 2783, Accra.
Theodora Asa-EckFood and Drugs Authority, P. O. Box CT 2783, Accra.
Ernest Agyei-KwameFood and Drugs Authority, P. O. Box CT 2783, Accra.
Felicia DwamenaFood and Drugs Authority, P. O. Box CT 2783, Accra.
Josephine MensahUniversity of Ghana Medical Centre, Post Office Box LG 25, Legon, Accra.
Jennifer BoatengGreater Accra Regional Hospital, P. O. Box GP 473, Accra.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

objectiveObjective 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.

methodsThis is a study of individual case safety reports (ICSRs) received from healthcare professionals between 1

resultsInformation 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.

conclusionThis 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.

fundingNone declared.

Indexed as

COVID-19 Drug TreatmentSARS-CoV-2AdultAdverse Drug Reaction Reporting SystemsAgedDrug-Related Side Effects and Adverse ReactionsFemaleGhanaHumansMaleMiddle AgedProspective Studiesadverse drug reactionCOVID-19, pandemicspontaneous reporting

Identifiers

PMID33976443
PMCPMC8087363

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.