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

Abstract

Background Only 5–10% of all adverse drug reactions (ADRs) are reported. Mechanisms to support patient and public reporting offer numerous advantages to health care systems including increasing reporting rate. Theory-informed insights into the factors implicated in patient and public underreporting are likely to offer valuable opportunity for the development of effective reporting-interventions and optimization of existing systems. Aim To collate, summarize and synthesize the reported behavioral determinants using the theoretical domains framework (TDF), that influence patient and public reporting of ADRs. Method Cochrane, CINAHL, Web of science, EMBASE and PubMed were systematically searched on October 25th, 2021. Studies assessing the factors influencing public or patients reporting of ADRs were included. Full-text screening, data extraction and quality appraisal were performed independently by two authors. Extracted factors were mapped to TDF. Results 26 studies were included conducted in 14 countries across five continents. Knowledge, social/professional role and identity, beliefs about consequences, and environmental context and resources, appeared to be the most significant TDF domains that influenced patient and public behaviors regarding ADR reporting. Conclusion Studies included in this review were deemed of low risk of bias and allowed for identification of key behavioural determinants, which may be mapped to evidence-based behavioral change strategies that facilitate intervention development to enhance rates of ADR reporting. Aligning strategies should focus on education, training and further involvement from regulatory bodies and government support to establish mechanisms, which facilitate feedback and follow-ups on submitted reports.

Exploring the Perceptions and Behaviours of UK Prescribers Concerning Novel Lipid-Lowering Agent Prescriptions: A Qualitative Study

“…The importance of pharmacovigilance and error reporting with newer agents was considered by prescribers, where the underreporting of potential side-effects was a significant concern, especially amongst certain patient groups. A potential solution included educating patients on the significance of ADR self-reporting systems, which is in line with a systematic review of 26 studies that found patient knowledge to be an impactful factor [ 32 ]. A previous qualitative study highlighted GPs’ and primary care organisations’ perspectives on cost, which displayed greater leniency than what was found in this study [ 33 ].…”