Electronic product information: Preparing to go digital-first
Electronic product information promises to be a much more efficient and patient-friendly way of disseminating up-to-date manufacturing details and safety advice to patients and health professionals. But how prepared is the European pharmaceutical industry to deliver regulated product information in this way? Amplexor’s Agnes Cwienczek considers how companies might best prepare for delivering reliable electronic product information.
Reliance on printed, paper-based instruction leaflets to inform patients and healthcare professionals when and how to use medicinal products or medical devices, and advise them about any safety considerations, makes little sense in the digital world.
Although printed patient information leaflets may remain an important option for older generations or populations without ready access to the internet, leaflets are far from the most effective or efficient means of disseminating critical information. The documents may be mislaid, for instance. The small-print may be very hard to read, and there may be several pages to plough through because of the detail companies need to cover – not to mention the multiple languages that may need to be included.
The risk is that people won’t bother reading the advice, or find it difficult to identify the parts that are relevant and important to their circumstances. More critically, paper-based product information/instructions-for-use can soon go out of date, either because new safety signals have been identified since the current batch of products went into distribution, or because pills have been languishing in a patient’s medicine cabinet. Getting updated safety guidance out with products can take months or even years, depending on companies’ cycle times and how much stock is already out in markets.
Standardising requirements for electronic product information
Recognising the issues, health and 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. Issuing product information electronically will promote more confident decision-making among healthcare professionals, for instance, making it easier for them to search for the latest safety advice. Patients, too, will be able to more readily find the information that matters to them – the correct dosage information for their needs, any contra-indications or adverse reactions to look out for, and so on.
The goal 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. Medical device manufacturers shipping to the EU are already required to publish up-to-date product and safety information online if they have a web site. Publishing electronic product information for human pharmaceuticals is already mandatory in the US, while Canada, Brazil, the EU and Asia are piloting or looking at programmes too.
In the pharmaceutical sector, a gradual shift towards digital product information delivery would be a positive development. An obvious benefit is accelerating time to market with the latest safety advice, boosting the patient experience and patient outcomes, not to mention public trust. Another substantial advantage is cost efficiency. As long as organisations have streamlined and reliable means of managing and approving changes to content, being able to publish this online will due course relieve the pressure on paper-based information publishing – and all of the logistics involved, not to mention the potential for label/leaflet wastage each time information or messaging changes.
Even if paper leaflets persist for some time, the ability to publish updates or additional detail online paves the way to scale back some of the busy text that is currently included in paper IFUs. That might be different language versions, legal small-print, or tailored advice for specific patient categories.
Readiness for labelling transformation
With so much to gain from the digitalisation of product information, pharmaceutical companies should embrace the potential at their earliest opportunity. But most do not have information or content management processes suitable for rolling out accurate information and updating this at frequent intervals, as needs dictate, across global markets.
The capabilities of pharmaceutical companies for publishing regulated content are so constrained that larger companies especially those dealing in generics typically outsource their labelling management requirements. It feels easier to send data and get print-ready files back two or three times a year, than to contemplate transforming their regulatory content management backbones to better support process innovation.
Before companies can deliver electronic product information, there must be a process for structured content authoring, where companies can confidently assemble the latest, correct information (which has been approved for use), for the current purpose. This requires a content management backbone, extending from one end of the organisation to the other, able to work with approved core data assets which had been captured in a structured way to enable easy re-use. This would have the potential to transform labelling management and facilitate changes to information provided online. Any investment in technology to support digital transformation must be matched by measures to assess, connect, clean up and restructure current data sources.
At a regional level companies should start to unify as much of their information and content preparation as possible, in accordance with common regulatory requirements. Using 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: regulatory agencies can provide the recommended schema), they can start to impose improved 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 correct, current, approved content assets is essential too - along with details of current product registration status and submission activity globally, including information about which labels are in circulation where. So, an end-to-end regulatory information management (RIM) platform will play an important part, forming the backbone across which all active and historic content, along with associated status information, can be viewed and managed.
Focus on adding value
Continuing with current labelling practices and product information delivery is unsustainable. But this is not just about gaining efficiencies from a digital-first approach. A key consideration is identifying the added value this transformation can deliver, for internal operations and for partners and patients. This is likely to include greater information accuracy, easier content validation, accelerated regulatory processes and rapid safety updates. It will also enable the phasing out of frequent print updates and reduce wastage each time information changes. Transforming to digital-first electronic product information delivery will deliver on all this value and more.