Understanding Patient Needs Regarding Adverse Drug Reaction Reporting Smartphone Applications: A Qualitative Insight from Saudi Arabia

Abstract

Background: A pragmatic shift in the healthcare sector characterized by moving from curative to preventive approaches highlights the role of pharmacovigilance in patient safety. There have been few published studies on patient reporting of adverse drug reactions (ADRs) in Saudi Arabia. This qualitative study aims to explore the community opinions and the need for patient-friendly smartphone applications (SPAs) to enhance their participation in ADR reporting. Methods: Purposeful sampling was followed to recruit study participants, a semi-structured interview guide was used to conduct interviews, and the saturation was reached after the 13th interviewer; no new information was obtained after two subsequent interviews. All the interviews were audio-recorded, transcribed verbatim, and analyzed by means of a standard content analysis framework. Results: As per the WHO guidelines, eleven participants were aware of the term “ADR.” All the participants denied receiving any prior education and attending events about ADRs and were unaware of the Saudi FDA-ADR reporting systems. The use of technologies such as SPAs has been widely accepted with a high level of concern for data confidentiality and privacy. Conclusions: These findings point out the need to build patient-oriented educational programs to increase their awareness of ADR reporting and to prioritize the use of artificial intelligence (AI) to be integrated in the Saudi healthcare system to develop future SPAs for improving both patient safety and signal detection of ADRs.

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

“…72.4% of the present study's sample was aware of the SFDA-Spontaneous ADR reporting forms. These findings differ from those reported by Kassem et al who reported that 60% of their sample was unaware of SFDA-Spontaneous ADR reporting forms ( Kassem et al, 2021 ).…”

Pharmacovigilance in low‐ and middle‐income countries: A review with particular focus on Africa

“…83,84 10 | TECHNOLOGICAL ADVANCES AND DIGITAL PHARMACOVIGILANCE SYSTEMS Patient self-reporting may be easier to implement in regions with higher mobile phone penetration. In Saudi Arabia, Kassem et al 85 found that many patients were already aware of ADRs either through personal or family experience, and wanted more information and education on these. 85 In China, an evaluation of spontaneous ADR reports from children (made by the child or their carer) were found to comprise only 2.5% of 3348 reports.…”

“…In Saudi Arabia, Kassem et al 85 found that many patients were already aware of ADRs either through personal or family experience, and wanted more information and education on these. 85 In China, an evaluation of spontaneous ADR reports from children (made by the child or their carer) were found to comprise only 2.5% of 3348 reports. 86 Whilst access to the internet and ownership of a smartphone Drug Administration and Control and are then contacted by phone.…”

Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework

“…Studies were published between 2008 and 2021, and were conducted in a range of countries; Saudi Arabia (n = 3) [ 49 , 55 , 57 ], United Kingdom (n = 4) [ 44 , 58 , 63 , 64 ], USA (n = 2) [ 52 , 53 ], Ghana (n = 3) [ 29 , 48 , 66 ] with remaining studies from South Korea [ 33 ], Netherlands [ 50 , 62 ], Thailand [ 47 ], Canada [ 49 ], and Australia [ 14 , 45 , 59 ]. Detailed study characteristics are presented in Table 1 .…”