Darko Delese A, Seaneke Seth K, Sabblah George T, Ashie Adela, Asamoa-Amoakohene Abena, Ewudzie Jeremiah S, Asa-Eck Theodora, Agyei-Kwame Ernest, Dwamena Felicia, Mensah Josephine, Boateng Jennifer
Food and Drugs Authority, P. O. Box CT 2783, Accra.
University of Ghana Medical Centre, Post Office Box LG 25, Legon, Accra.
Ghana Med J. 2020 Dec;54(4 Suppl):62-70. doi: 10.4314/gmj.v54i4s.10.
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 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.
This is a study of individual case safety reports (ICSRs) received from healthcare professionals between 1 April 2020 to 31 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.
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.
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.
None declared.
2019年新型冠状病毒病（COVID-19）是由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引发的一场持续的大流行病。关于用于治疗COVID-19的药物安全性的信息有限。
本研究的目的是描述加纳医疗保健专业人员收到的针对SARS-CoV-2阳性患者的激发性自发药物不良反应（ADR）报告模式，以及特别是从中低收入国家吸取的经验教训。
这是一项对2020年4月1日至2020年7月31日期间加纳SARS-CoV-2阳性患者从医疗保健专业人员处收到的个体病例安全报告（ICSR）的研究。ICSR从安全观察系统中检索，并使用描述性统计按系统器官分类和首选术语来描述ADR。
收到了来自全国40个COVID-19治疗中心的信息，其中9个中心共提交了53份ICSR，包含101例ADR；每份ICSR约有两例ADR。女性占ICSR的29份（54.7%），男性占24份（45.3%）。新报告的有意义的ADR包括：多西环素引起震颤的报告各1例；氯喹引起阴囊疼痛、呼吸困难、步态障碍和味觉障碍的报告各1例；羟氯喹引起咽干、多汗、烦躁不安和排尿频率增加的报告各1例。在大流行期间，治疗中心有专人负责的强大自发报告系统在ADR报告中发挥了关键作用。
这是加纳在COVID-19大流行期间自发报告的首次经验。报告的大多数ADR情况似乎与产品特性总结中预期的一致。在未来研究中，以明确界定的分母进行更大样本量的研究对于确定这些药物在SARS-CoV-2阳性患者中的相对风险至关重要。
未申报。
