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

  • Delese A. Darko Food and Drugs Authority, P. O. Box CT 2783, Accra
  • Seth K. Seaneke Food and Drugs Authority, P. O. Box CT 2783, Accra
  • George T. Sabblah Food and Drugs Authority, P. O. Box CT 2783, Accra
  • Adela Ashie Food and Drugs Authority, P. O. Box CT 2783, Accra
  • Abena Asamoa-Amoakohene Food and Drugs Authority, P. O. Box CT 2783, Accra
  • Jeremiah S. Ewudzie Food and Drugs Authority, P. O. Box CT 2783, Accra
  • Theodora Asa-Eck Food and Drugs Authority, P. O. Box CT 2783, Accra
  • Ernest Agyei-Kwame Food and Drugs Authority, P. O. Box CT 2783, Accra
  • Felicia Dwamena Food and Drugs Authority, P. O. Box CT 2783, Accra
  • Josephine Mensah University of Ghana Medical Centre, Post Office Box LG 25, Legon, Accra
  • Jennifer Boateng Greater Accra Regional Hospital, P. O. Box GP 473, Accra
Keywords: adverse drug reaction, spontaneous reporting, COVID-19, Pandemic

Abstract

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.

Published
2020-12-31

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print ISSN: 0016-9560