8^th Annual Pharma Middle East Congress

Biography

Biography: Rania Al Dweik

Abstract

Aim: The objective of this study is to evaluate the importance of patient ADR reporting on Pharmacovigilance activites. Method: Phase I is systematic review to identify factors influancing patients reporting. Phase II is descriptive analysis of all ADRs reports received by Health Canada over the last 10 years. Phase III, aninterpretative descriptive will be used to explore usability of the Canadian Vigilance systems by patients. Results: Of 1435 citation reviewed, 22 studies published in 26 papers were appraised. These studies mainly focused on factors affecting patients reporting of ADRs. None of thes studies conducted at North America. Sixteen out of 22 reviewed studies described barriers to the reporting process included: Poor awareness of ADR reporting systems; difficulties with reporting procedure and forms; lack of feedback to ADRs submitted by the patients; confusion as to who reports ADRs and to whom they are reported; poor economic status; ADRs resolved; and prior negative reporting experience. Another 11 out of the 22 reviews studies described the motives for reporting ADRs by patients and those included: prevent others from similar ADRs; inform regulatory bodies, drug manufacturer, HCPs, and public; improve drug safety and medication leaflet and enhance scientific knowledge; (4) improve HCP practices; (5) failure of HCPs to report their ADRs; asked to report ADRs by HCPs; it was serious ADRs; and desire for personal feedback and want more information about the ADRs. Conclusion: Findings from this research anticipate to make three significant contributions: highlight the role of patients in directly reporting ADRs; provide new information that may help us provide guidance to streamline and optimize patient ADR reporting; and provide policy makers, public health officials, and regulatory agencies with this critical information in order to improve medication safety in Canada.