Incidence and Risk Factors of Adverse Drug Reactions in Patients with Coronavirus Disease 2019: A Pharmacovigilance Experience Utilizing An ADR Trigger Tool

Abstract

Background

Since the World Health Organization declared coronavirus disease (COVID-19) as a pandemic, most countries started treating their patients with various therapies. However, the data regarding their safety and effectiveness is still lacking.

Objectives

We aimed to evaluate the adverse drug reactions (ADRs) incidence and their predisposing factors among COVID-19 patients.

Methods

A retrospective observational study that was conducted at a tertiary academic hospital from March – June 2020. Patients were included if they were ≥18 years old, inpatient, had a reverse transcriptase-polymerase chain reaction (PCR) positive for COVID-19, and were treated with; (lopinavir-ritonavir, hydroxychloroquine, chloroquine, favipiravir, ribavirin, or interferon-ß) either as monotherapy or combination therapy for three days or longer. The data of eligible patients were retrieved from the electronic medical records. A standardized data collection form was designed to collect patient demographics, COVID-19 severity based on the Saudi Ministry of Health management protocols, antiviral therapies, duration of therapy, and length of stay (LOS). The ADRs were identified via conducting a comprehensive review using predefined triggers and were evaluated using Naranjo Score.

Results

A total of 155 patients were included of which 123 (79.4%) were males. In our sample, the incidence proportion of ADRs per patient was 72.3%. A total of 287 ADRs were identified most of them were hepatic (n= 101, 35.2%), gastrointestinal (n= 59, 20.6%), hematological (n= 47, 16%), and endocrine (n= 45, 15%). Hydroxychloroquine was the most common drug associated with ADRs (n= 155). The length of stay (10 – 20 days) was the only statistically significant with the ADR incidence (p-value=0.008; 95%CI 1.216:3.568).

Conclusions

The ADRs are prevalent among COVID-19 patients, which assure the importance of implementing active hospital-based pharmacovigilance systems.