Electronic product information: preparing the way
SummaryProviding electronic product information, something international health authorities are steadily moving towards as a requirement, promises to be a much more efficient and user-friendly way of conveying the latest manufacturing details and safety recommendations to patients and healthcare professionals. But how ready are life sciences companies, asks Amplexor’s Agnes Cwienczek.
- Author Company: Amplexor
- Author Name: Amplexor
Providing electronic product information, something international health authorities are steadily moving towards as a requirement, promises to be a much more efficient and user-friendly way of conveying the latest manufacturing details and safety recommendations to patients and healthcare professionals. But how ready are life sciences companies, asks Amplexor’s Agnes Cwienczek.
Continued reliance on paper-based instruction leaflets to inform patients and healthcare professionals when and how to safely use medicinal products or medical devices makes increasingly less sense in the digital world.
The documents may be mislaid, for instance. The small-print may be very hard to read, and there may be several pages due to the detail that companies need are required to cover, plus different language variants of the content, making the leaflets off-putting to patients.
They soon become out-of-date too, either because new safety signals have been identified since the current batch of products went into distribution, or were sourced by the patient. Moreover, getting updated safety guidance out with products takes time.
Over-reliance on non-structured product information as the basis for creating leaflets, meanwhile, can make it difficult for companies to accurately assess the likely impact of any changes to content, to ensure compliant documentation while keeping pace with market demands.
For all of these reasons, health/regulatory agencies across the world are showing increasing interest in introducing standardised requirements for electronic product information (ePI) - including the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals.
Digital distribution is the future
There are numerous benefits to distributing product information digitally. The idea is to make all of the latest details and advice about a product readily accessible online/via a mobile phone – via a web link, or by scanning a barcode/QR code on a product label, with the ability to display the information as required by a specific context.
For human pharmaceuticals and medicinal products, providing structured electronic product information is already mandatory in the US, while countries/regions including Canada, the EU and Asia are piloting or looking at programmes too, defining guiding principles and polling the market for feedback.
Issuing product information electronically, and managing the contents in a structured way, will promote more confident decision-making among healthcare professionals, making it easier for them to search for the latest safety advice. Similarly patients will be able to more readily find the information that is relevant to their circumstances.
For life sciences manufacturers and distributors, an obvious benefit of electronic product information delivery is speed to market with the latest safety advice – and products - boosting outcomes and the patient experience. Another substantial advantage is cost efficiency as physical logistics are replaced and paper wastage is eliminated.
Even if paper leaflets persist for some time, the ability to publish updates or additional details online/digitally and easily provide access when and as required paves the way to scale back some of the busy text that is currently included in paper-based product information and IFUs. That might be different language versions, legal small-print, or tailored advice for specific patient categories.
Managing the shift
So how ready are life sciences companies to deliver digital product information? How conducive are their information/content management processes to deploying accurate, structured information and updating it at frequent intervals?
Regrettably, most life sciences organisations are not ready for this at all – certainly not pharmaceutical companies. Up to now it has seemed easier to outsource labelling management requirements if they go beyond paper than to contemplate transforming their regulatory content management backbones to better support process innovation. But this situation is unsustainable.
Successful transformation of label content lifecycle management will rely on improvements to content, technology, and processes - in concert. At a regional level, companies should start to unify as much of their information and content preparation as possible, in accordance with regional or local regulatory requirements.
Using authorities’ recommended schema and the controlled vocabularies set out by electronic submission standards (currently xEVMPD in the EU, to be succeeded by the more detailed ISO IDMP-based requirements; and Structured Product Labeling (SPL) in the US; companies should start to improve consistency in the way regulated product information is constructed. This will help them create solid content components or building blocks for all labelling.
Establishing a definitive repository for approved content assets, along with details of current product registration and marketing status, will be critical. An end-to-end regulatory information management (RIM) platform should form the backbone across which all of this can be viewed and managed.
Crucially, as they design transformation projects, life sciences companies must keep their focus on the added value they can deliver from all of this.
About the author
Agnes Cwienczek is Head of Product Management and Consulting at Amplexor.