Design and Validation of a Virtual Case-Based Learning Framework for Training Pharmacists in Medical Device–Related Adverse Event Reporting and Materiovigilance Competencies.

AbstractBackground: Medical device-related adverse events (MDRAEs) are an important patient safety concern,and effective materiovigilance depends on healthcare professionals' ability to recognise, assess, document,and report suspected events. Pharmacy education has limited structured training focused specifically onpractical materiovigilance competencies. Objective: To design, develop, validate, and pilot a VirtualCase-Based Learning (VCBL) framework for training pharmacy students in medical device-relatedadverse events and materiovigilance. Methods: A prospective mixed-method educational study wasconducted over 10 months at Sri Ramakrishna Multispecialty Hospital and the Department of PharmacyPractice, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore. Development followed fivephases: literature review and competency identification; simulated-case development; VCBL frameworkdevelopment; pilot educational evaluation and feedback; and data analysis. Sixty simulated cases wereinitially developed from de-identified clinical records and relevant literature. Following expert review andrefinement, 40 standardised cases were retained. Twenty-six cases were mapped to four competencydomains, and eight unseen cases were reserved for assessment. Four instructional videos were deliveredthrough the Teachmintplatform. Knowledge was assessed using 20 objective-type questions, and practicalapplication was assessed using 8 simulated cases. Results: Forty participants were enrolled. All 40completed the four educational modules. The pre-test was completed by 31 participants (77.5%) and thepost-test by 32 (80.0%). Mean MCQ performance was 55.81% before training and 82.81% after training,an absolute difference of 27.01%. Overall competency performance increased from 46.50% to 85.47%, with domain-wise improvements of 33.94 to 41.00 percentage points. Because pre- and post-testcompletion counts differed, these results should be interpreted as an unpaired descriptive comparisonunless participant-level linkage confirms a paired dataset. Conclusion: The developed VCBL frameworkwas feasible to deliver and provided a structured, case-based approach to materiovigilance education.Preliminary learning gains support further evaluation using linked participant-level data, validatedassessment instruments, longer-term follow-up, and controlled or multicentre designs.