ABSTRACT
Background: Package leaflet provides information about medicinal product to the user. Printed leaflet is familiar and available, however poorly legible, especially when containing multiple languages. It is resourceful to update, has potential to go missing or get damaged, and is environmentally burdensome. The pharmaceutical manufacturers in the Baltic countries have been granted permission to market selected hospital medicinal products without printed package leaflet. The industrial pilot project is expected to promote availability of medicinal products and patient safety via increased access to medicinal information. Objective: Only few countries in Europe have derogated from Article 58 of Directive 2001/83/EC. Knowledge about the effects of removal of paper package leaflet from the medicinal product is limited, and related publications are scarce. Current interview study is identifying the obstacles during the implementation of the industrial project, investigating the potential environmental impact, and searching for further opportunities for the package leaflet in development of medicinal products. Methods: Real-time person-to-person semi-structured interviews with relevant stakeholders were conducted, and transcripts were analysed by content analysis to identify themes. Results: Results demonstrated general support for removing package leaflet from selected hospital products. Main difficulties of the industrial project regarded the need for clear communication and practical disadvantages of project setup. Main benefits included educational aspect of increasing awareness about product information and strengthened collaboration. Majority of participants felt doubtful about the impact of the industrial project on people's awareness of ecological issues and they admittedly lacked sufficient information on the environmental impact of pharmaceutical packaging. Conclusion: The removal of paper leaflet could be extended to more products based on the positive feedback for the industrial pilot project. However, it is paramount that the format of electronic product information would need to be enhanced first to improve readability.
