Background and objective: Adverse drug reactions (ADRs) cause substantial harm, and a considerable proportion may be preventable, but under-reporting persists and weakens pharmacovigilance. Spontaneous reporting depends on clinicians, yet under-reporting persists and weakens pharmacovigilance. To map barriers to adverse drug reaction reporting among physicians, a comparison of nurses and pharmacists in single-country studies was carried out between high-income countries (HICs) and low- and middle-income countries (LMICs). Methods: A scoping review was conducted following PRISMA-ScR guidance. PubMed and Web of Science were searched for studies published from 2016 onward. Eligible studies were single-country primary empirical studies including physicians, nurses, or pharmacists and examining ADR reporting. Only barriers that were measured or explicitly explored and reported as extractable results were included. Barriers were coded into 12 domains and summarised by income group and profession. Results: A total of 44 studies were included, with 18 from HICs and 26 from LMICs. Survey designs were most common. Pharmacists were the most frequently studied cadre. Knowledge and training barriers were reported in all studies in both income groups. Fear of legal or punitive concerns was reported in 13/18 (72.2%) HIC studies and 17/26 (65.4%) LMIC studies. Time and workload barriers were reported in 10/18 (55.6%) HIC studies and 11/26 (42.3%) LMIC studies. Access barriers to tools, forms, and information technology showed the clearest income group difference: these were reported in 5/18 (27.8%) HIC studies versus 16/26 (61.5%) LMIC studies. Lack of feedback or acknowledgement was reported in 8/18 (44.4%) HIC studies and 10/26 (38.5%) LMIC studies. Conclusions: Barriers extend beyond individual knowledge in all settings. The main income group difference was the greater prominence of reporting system access barriers in LMICs compared with workflow and time pressure barriers in HICs. Addressing fear and building a supportive non-punitive reporting culture remains a cross-cutting priority because these were common issues in both income groups and can limit reporting even when infrastructure and training exist.
Ishaqui et al. (Thu,) studied this question.