Why we all stand to gain from harmonized electronic product information
Electronic product information (ePI) is gaining increasing interest from many national and regional regulators, and there is a genuine desire to develop ePI solutions that add value to patients and healthcare providers.
For example, EU legislators and regulators have published their views of the benefits of ePI to disseminate information and complement paper package leaflets. Meanwhile, the European Medicines Agency, Heads of Medicines Agencies and European Commission have worked with global stakeholders to draft key principles for ePI.
However, as regulatory bodies determine their own packaging requirements, these may differ from country to country or region to region, with each difference adding layers of complexity to the packaging process. The introduction of serialization in many countries to trace individual units adds further complications.
Therefore, there is a risk that ePI standards will differ from market to market and that efforts by individual regulators to create bespoke solutions will lead to myriad schemes for the pharmaceutical industry to navigate and accommodate.
A single approach is needed that can be applied globally and that reduces complexity, not increases it.
This is why BioPhorum has produced Electronic product information in the pharmaceutical industry: implementation and solutions overview from a packaging perspective.
The paper discusses a structure and approach to respond to this industry-wide challenge and highlights the benefits and challenges of the factors surrounding the design and implementation of ePI.
The move to ePI and the removal of paper leaflets will realize some long-term benefits, such as reduced costs and waste, smaller physical units of sale, higher flexibility, improved cycle times, increased speed to market and generic packaging.
While stressing the benefits of ePI, the paper recognizes the challenges that need to be overcome before its implementation and use can become widespread. These include internet access, IT literacy and the availability of mobile devices. Agreement is also needed on which type of barcode to include on packaging.
Written by BioPhorum’s Secondary Packaging Workstream, the paper examines the likely impact of ePI, such as changes to package design and artwork, and the need for company-wide/industry-spanning strategies, e.g. around medical affairs, regulatory and IT practices. It also discusses creating new ePI documents, platforms, audio files, videos, mobile device apps or other electronic materials that could replace paper leaflets.
“Working in the Workstream has helped to solidify a consensus view that addresses an issue our industry will face in the near future,” said Stephen Hammond, Artwork Implementation Project Manager at Pfizer. “By working together on the same objective, we all stand to gain – pharma, health authorities and especially our customers.”
It is vital that industry and regulators do not adopt their own bespoke ePI solutions, which will only lead to multiple solutions that will require, for example, patients and healthcare providers to use more than one app to link barcodes on a package to product information. A single solution is considered the best approach, one where standardization facilitates compliance for the industry, simplifies access for end-users and provides transparency for regulators.
BioPhorum’s paper will proactively help shape standards in ePI design and implementation, with the ultimate aim of harmonizing ePI in the EU and globally.