The challenges of delivering medicinal information online
In the light of new ePI guidelines in Europe for medicinal products, Irena Milobratovic, senior regulatory affairs manager at Arriello, considers the benefits and challenges associated with providing current product and safety information to patients and healthcare professionals via the web.
In late January, the first formal steps were taken towards making electronic product information (ePI) a reality for human medicines in the EU. Specifically, the European authorities, EMA, the Heads of Medicines Agencies (HMA) of EU Member States and EC, have published a set of key principles, outlining a harmonised approach to developing and delivering up-to-date information about medicines online.
This is an initiative that cannot come soon enough. A medicine’s product information comprises regulated, scientifically-validated detail which informs patients and consumers about a product and its safe use, and assists healthcare professionals in prescribing and dispensing medicines.
For regulatory reasons, this information must still be provided in paper form, but having additional structured electronic version of patient leaflets or healthcare professionals’ summaries, via a convenient and easily accessible digital platform, offers significant personalised benefits to all parties. It will make it easier to search for information on medicines of interest; to receive automatic update notifications; and to access authorised or supportive video or audio content, or other interactive materials. Meanwhile, the potential for innovations such as online reporting tools to capture information about adverse reactions is significant in a digital context.
Transforming trust & the patient experience
Though the use of ePI is not mandatory, combining this with regulated barcodes on medicines packaging, for example, offers the ability to add significant value and help patients and healthcare professionals get the most from the ePI. When something changes with a medicine, such as the addition of a new indication, both the medicine with the previous indications and the medicine with the new indications may be available on the market for an intermediate period. In situations like this, the 2D barcode on each medicine package could link to the ePI version which will include the latest, correct indications for the medicine.
In these ways, initiatives around electronic product information will also reinforce confidence and trust in products, by providing a direct, almost real-time connection to the latest available safety and efficacy information.
There is much to be gained, then, from this latest overture to digital progress by the authorities.
A sign of what’s to come
It is clear that moving more information online is where the life sciences industry is heading generally, as part of its digitalisation ambitions. The potential of providing product information online is being harnessed increasingly in the medical device sector too, even earlier in fact, albeit with more of a focus on electronic Instructions for Use (eIFU) materials for specific types of devices, such as active implantable devices or software and their users.
The question now is how organisations might start to prepare themselves to fully exploit the future reality of online product information provision. It may be early days, particularly in the pharma sector, but early providers of online product information are likely to be applauded by the market for their visible commitment to transparency and patient safety.
Even if it’s just establishing how delivery of accurate information to a portal might work, there are preliminary steps that organisations could take now. Regulatory specifications might be some way off, but it won’t hurt to reinforce companies’ commitment to greater openness and patient protection. More broadly, it is worth keeping track of regulatory developments around electronic patient information as these evolve. This will help firms devise a business case that maximises the potential of the changes for all - patients, users and companies themselves - establishing a strong brand-patient/user relationship.