Pharmacovigilance in Saudi Arabia: A Narrative Review on Adverse Drug Reaction Reporting

Abstract

Adverse drug reaction (ADR) reporting is an important aspect of pharmacovigilance (PV) in ensuring drug safety during the post-marketing surveillance phase. Currently, the National Pharmacovigilance Center (NPC) established by the Saudi Food and Drug Authority (SFDA) is the regulatory authority receiving ADR reports in Saudi Arabia. Spontaneous ADR reports from healthcare professionals and the public are received by the NPC through an electronic platform known as the Saudi Vigilance System. Signal analysis of the received ADR reports aids the decision-making initiatives related to the reported drugs. Stakeholders’ contribution to ADR reporting, and implementation of effective electronic platforms are important factors affecting the national PV performance. The concept of stakeholders reporting on ADR is relatively new in Saudi Arabia, especially to the public. In this narrative review the national studies describing the stakeholders’ knowledge, perception and barriers toward ADR reporting, and the incidence of ADR reporting by healthcare institutions in Saudi Arabia were evaluated. The findings indicate that more efforts are needed by the SFDA to educate stakeholders about the importance of ADR reporting. The study recommends ADR electronic systems integration between the SFDA and healthcare institutions to improve the frequency and quality of ADR reports, and regular feedback on decisions made about ADR reports should be provided by the SFDA to stakeholders to improve their awareness of the importance of ADR reporting and enhance their contribution to PV and ADR reporting process.