Implementation and solutions overview from a packaging perspective
The benefits of ePI are well understood and broadly accepted. This paper examines and responds to the challenge of developing ePI solutions that add value to patients and healthcare providers alike highlighting the benefits and challenges of the broad range of factors surrounding the design and implementation of ePI, supporting the objective of finding a solution that can be implemented globally.
The benefits include:
- Benefits to the pharmaceutical industry, realized through reduction of costs and waste, higher flexibility, improved cycle times and increased speed to market
- Benefits realized through linking information to a trusted and consistent source, with facility to rapidly update information, and through reduction of paper and inventory waste
- Benefits to patients and healthcare providers, realized through improved and easier access to appropriate and current information, in the required/preferred language and format
The outstanding questions on ePI relate mainly to how ePI is applied and seeking alignment on a single approach across the pharmaceutical industry with regulatory acceptance
BioPhorum recognizes that the pharmaceutical industry would benefit from moving towards using one multipurpose code that can be used for both serialization and ePI. For that reason, the BioPhorum Secondary Packaging worksteam recommend the adoption and use of GS1 standards and recommendations to meet supply chain and point of care needs plus as a way to harmonize implementation of regulatory requirements. The pharmaceutical industry is keen to take a proactive approach to guiding how the implementation of ePI is realized. Collaboration requires some bravery, in breaking down barriers and bringing a spirit of openness to discussions. Working with other industry partners, however, rather than against each other, allows alignment around the best solutions and facilitates implementation. In the case of ePI in particular, the benefits will not just be realized by one party, but feed through the entire value chain – from the manufacturer, to the healthcare provider, and ultimately to the patient.
The package is where this story is told. ePI is an essential step on a longer journey toward a future digital health solution around patient care and treatment. With the effort and data behind the scenes and the user-facing ePI itself, it is the code on the packaging that starts the user on that journey. When the packaging works, everything else falls into place.