Incidence of adverse drug reactions in COVID-19 hospitalised patients through the minimum basic data set

• Published in: Revista de la OFIL Vol. 33; no. 2; pp. 161 - 168
• Main Authors: Oterino-Moreira, Sanz Márquez, Zhan Zhou, Martínez Simón, JJ, Morales Catalán, MC, Lorenzo Martínez, Pérez Encinas
• Format: Journal Article
• Language: Portuguese
• Published: Organización de Farmacéuticos Ibero-Latinoamericanos 01.06.2023
• Subjects: Pharmacology & Pharmacy; reacción adversa a medicamento (RAM); terapia COVID-19; causality relationship; adverse drug reaction (ADR); Minimum basic data set (MBDS); Naranjo algorithm; algoritmo de Naranjo; relación de causalidad; COVID-19 therapy; Conjunto mínimo básico de datos (CMBD)
• ISSN: 1699-714X; 1699-714X
• DOI: 10.4321/s1699-714x2023000200011

Abstract Background: At the beginning of the COVID-19 pandemic many drugs were used with an uncertain benefit/risk profile that needed to be evaluated. The goal of this study was to analyse the incidence of adverse drug reactions (ADRs) and describe the drugs used in COVID-19 hospitalised patients at the beginning of the COVID-19 pandemic through the minimum basic data set (MBDS). Methods: Retrospective observational study that included hospitalised patients with COVID-19 at our centre between March and May 2020 who had ADRs coded in discharge/death medical reports according to the International Classification of Diseases (ICD-10). Those patients with ADRs ascribed to COVID therapy were selected and the causal relationship was evaluated using the Naranjo algorithm. Descriptive statistical analysis was used. Results: We identified 141 ADRs in 110 cases of hospitalisation due to COVID-19 that entailed an incidence of 9.66% (141/1459), CI95% 8.25-11.29. From the ADRs analysed, 60.3% (85/141) were ascribed to COVID therapy. Lopinavir/ritonavir represented 38.8% (33/85) of ADRs, glucocorticoids 23.5% (20/85) and hydroxychloroquine 9.4% (8/85) Out of the ADRs, 31.8% (27/85) were gastrointestinal disorders (probable lopinavir/ritonavir), 27.0% (23/85) blood glucose disorders (probable glucocorticoid) and 17.6% (15/85) hypertransaminasaemia (probable azithromycin, possible lopinavir/ritonavir, possible hydroxychloroquine, possible interferon). Regarding intensity, 64.7% (55/85) were mild cases, 29.4% (25/85) moderate and 5.9% (5/85) severe. The percentage of ADRs that did not require intervention were 24.7% (21/85), 32.9% (28/85) required pharmacological treatment, 40.0% (34/85) suspension of the drug, 1.2% (1/85) close monitoring and 1.2% (1/85) dose reduction. Conclusions: The incidence of ADR in COVID population that required admission at the beginning of the pandemic seems to be higher than in the general population. The MBDS proves to be a useful tool to trace ADRs.