Patterns of adverse drug reactions (ADRs) in Saudi Arabia

Abstract

Background Pharmacovigilance enhances post-market drug safety. However, analytical reports of a pattern of adverse drug reactions (ADRs) experienced by patients in Saudi Arabia are demanded. Objective To describe patterns of ADRs submitted to the Saudi Central National Pharmacovigilance and Drug Safety Center (NPC), Saudi Food and Drug Administration (SFDA), from its inception in 2015 until the end of 2017 to understand the pattern of ADR reporting in Saudi Arabia. Methods In this retrospective study, data from cases reported to the NPC were used to determine ADRs and identify the most common associated drug classes based on anatomical therapeutic chemical (ATC) classification system. Result A total of 17,730 ADR cases were reported during study period. An annual increase in ADRs was clearly evident. Approximately 54% of the total ADRs reported were serious. Most commonly reported ATC drug classes were anti-infective agents for systemic use (22.27%), antineoplastic and immunomodulating agents (21.49%), alimentary tract and metabolism (15.48 %), cardiovascular system (11.11%) and nervous system (10.23%). Vancomycin (2.7%), ceftiraxone (1.8%), fingolimod (1.4%) and paracetamol (1.4%) were the most common drugs associated with serious ADRs. Conclusion This study provide valuable insights in hypothesis generation for future studies on drug-event interactions and amplification studies. The NPC educational programs and awareness campaigns to promote systematic reporting of ADRs among healthcare professionals and general public should be continued.

Healthcare Professionals and Undergraduate Students’ Knowledge Toward Drug-Food Interactions in the Eastern Region of Saudi Arabia

“…In KSA, the Saudi Food and Drug Administration (SFDA) established pharmacovigilance activities to oversee the risk–benefit balance of all registered products during their active marketing cycle in in Saudi Arabia. 22 …”

“…In KSA, the Saudi Food and Drug Administration (SFDA) established pharmacovigilance activities to oversee the risk-benefit balance of all registered products during their active marketing cycle in in Saudi Arabia. 22 An earlier study performed on 211 primary healthcare (PHC) physicians in three cities, Dammam, Al-Khobar, and Qatif, revealed that PHC had low knowledge of DFIs. This study suggested that the cause of this low knowledge was that PHC were not adequately trained in DFIs.…”

Exploring the knowledge, perception, and practice of community pharmacists in Saudi Arabia toward pharmacovigilance and adverse drug reaction reporting. A nationwide survey

“…The SFDA accepted the spontaneous reporting of post-marketed medications from healthcare professionals, manufacturers, and patients 5 . Meanwhile, the NPC announced and launched several initiatives, including reaching 30,000 ADR reports in 2018 4 ; however, a recent study reported that 17,736 reports were submitted to SFDA in 2017 6 . Furthermore, a previous study revealed that there is still an underreporting of ADRs by HCPs; for example, 10.2% of community pharmacists in Saudi Arabia admitted to submitting an ADR report to NPC 7 .…”

Healthcare professionals' awareness, attitudes and practices towards pharmacovigilance and spontaneous adverse drug reaction reporting in Jazan Province, Saudi Arabia: A survey study

“…Additionally, in 2009 SFDA became a member of the Uppsala Monitoring Centre in Sweden to contribute to global drug safety efforts ( Aljadhey et al, 2015 ). In order to promote and achieve effective national ADR reporting, the Saudi Pharmacovigilance Guidelines relating to Good Pharmacovigilance Practices (GVP) were put forth by the SFDA in 2015, which illustrate the different roles as well as responsibilities of all stakeholders, including the HCPs ( Bin Yousef et al, 2022 ).…”