Digital transformation of electronic patient information leaflets (ePIL): the case of multinational pharmaceutical manufacturers

Patient information leaflets (PILs) are vital for conveying treatment details and ensuring patient safety and adherence. Traditional paper-based PILs fall short due to their complexity, specific national requirements, and dated content, posing challenges for pharmaceutical manufacturers such as supply flexibility, resource-intensive updates, and environmental impact. The rapidly evolving digital technologies provide promising opportunities for transforming traditional paper-based PIL into electronic PIL (ePIL), addressing the current limitations and creating value-adding propositions for involved stakeholders. This paper examines digital transformation of ePIL within a highly regulated environment from the perspective of multinational pharmaceutical manufacturers. We use a hybrid Delphi approach, merging reviews and interviews, to explore the dynamic capability microfoundations involved when transitioning from paper-based to digital systems from an operations management perspective. A maturity model is introduced to gauge the extent of transformation maturity in a regulated setting. This paper offers valuable insights for managers and policymakers seeking to develop dynamic capabilities for ePIL digital transformation and evaluate operational maturity. Additionally, benchmarking current and future states of ePIL transformation across participating companies highlights the importance of collaborative efforts to expedite this transformation.