Abstract
Introduction: Adverse Drug Reactions (ADRs) are among the leading causes of mortality and morbidity worldwide [1]. International organisations such as the World Health Organisation (WHO) [2] has recognised the need for detecting, assessing and understanding ADRs in order to ensure safe drug use. In Saudi Arabia (SA), the National Pharmacovigilance Center (NPC) within the Saudi Food and Drug Authority (SFDA) has been responsible for collecting, analysing and learning from ADRs reported in SA, allowing it to contribute to the global effort to minimise ADRs [3]. A recent study has analysed around17,730 ADRs reported to NPC in the period between 2015 and 2017 which found that anti-infective agents were most commonly involved with ADRs (22.27%) [4]. Whilst informative, these reports were not analysed extensively in terms of their composition, seriousness, and patient group commonly involved in these ADRs. The present study, however, presents an updated and a more extensive review of anti-infective agents involved with ADRs over the period between 2018 and 2020. Objective: The aim of this study is to analyse and characterise ADRs associated with anti-infective agents reported to the NPC within the SFDA between the years 2018 and 2020. Methods: A retrospective review was carried out of all ADRs involved with anti-infective agents submitted to the NPC between 2018 and 2020. A descriptive analysis was undertaken to determine the number of ADRs, and then to characterise them according to their Medical Dictionary for Regulatory Activities (MedDRA) classification, age and gender of patients involved, as well as seriousness and type of anti-infective class(es) involved. The SFDA's Ethics Committee has exempted this study from formal ethical approval. Results: A total of 12,567 ADRs were included, of which 53.78% occurred in males. Among all age groups, adults between the age of 45 and 64 were the ones most reported (10.89%). The most reported ADRs were classified according to the MedDRA in terms of investigations (26.76%), gastrointestinal disorders (22.76%), as well as skin and subcutaneous tissue disorders (14.88%). The level of seriousness was not specified in 91.47% of the reports. Almost two percent of ADRs were reported to require intervention to prevent permanent damage followed by ADRs that resulted in prolonged hospitalisation (1%). Antibacterials were commonly reported (83.5%), followed by antiviral (10.9%), and antifungal medications (3.8%). Conclusion: This is the first study to characterise ADRs associated with anti-infective agents. Our study showed that these anti-infective agents pose a threat to patient safety in our health care system.