Capitalising on the drive towards online product information

Earlier this year, the European authorities, EMA, the Heads of Medicines Agencies (HMA) of EU Member States and EC, published a set of key principles[1], outlining a harmonised approach to developing and delivering up-to-date information about medicines online – an important step towards making electronic product information (ePI) a reality for human medicines in the region. The development 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 making a structured electronic version of patient leaflets or healthcare professionals’ summaries available online 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.

Adding value – and trust – for patients

Although ePI is not mandatory, it could transform experiences for patients and healthcare professionals. When something changes with a medicine, for instance there is new safety data to be included, linking the 2D barcode on each medicine package to the ePI will provide patients with the  latest product information – even if they possess a version of the product which reached the market before the change. Having continuous access to the latest safety information online will reinforce public trust in manufacturers and in their products, as well as increasing patient safety.

Moving more information online is where the life sciences industry is heading strategically, too, so it makes sense to be ahead of this curve. Early providers of online product information are likely to be applauded by the market for their visible commitment to transparency and patient safety. The potential of providing product information online is being harnessed increasingly in the medical device sector too – albeit with more of a focus on electronic Instructions for Use (eIFU) materials for specific types of devices.

A plan of action

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 to prepare for  advancements to patient information delivery. Certainly, it is worth keeping track of regulatory developments around electronic patient information. 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, even before formal ePI requirements are set in stone.

About the author

Irena Milobratovic is a Senior Regulatory Affairs Manager at Arriello, having spent more than 15 years specialising in regulatory affairs, pharmacovigilance and market access in the pharmaceutical and medical device sectors. Arriello is a specialist global provider of innovative, high-impact market access, regulatory affairs & pharmacovigilance solutions and services for pharma and biotech firms in Europe and North America.

[1] Key principles for the use of electronic product information for EU medicines, EMA, January 29^th, 2020: https://www.ema.europa.eu/en/news/key-principles-use-electronic-product-information-eu-medicines