The Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC) are not only part of the documents required during the marketing authorisation request process in most countries but are also important documents that help professionals and patients use the medical product correctly and safely.
However, these documents are often too complex and not enough user-friendly for patients: for example, the elderly or disadvantaged persons, but in general most patients, lack understanding of basic terms such as interactions, contraindications and dosages and may put at risk their health and compromise proper adherence to the medication protocol.
Another major issue when dealing with medicines information is language compliance. This is a well known problem in countries with more than one official language (most requiring leaflets to be delivered in all the country official languages), but it is not less important in countries with one official language but with high numbers of immigrants or people with a different native languages.
The recent surge of immigration over the years and the tourism have made multilingual information essential in every market.
Adding to the complexity of the problem some languages may also require culture-specific adaptations to the translation in order to be fully effective and understood.
There are 24 official languages within Europe and some countries may require documents in multiple languages due to recognized minorities or established migration flows. A small translation error can have an enormous impact on a patients’ life, can cause production delays or even the recall of a product, in extreme cases there may also be legal consequences.
How can a pharmaceutical company reduce all those risks while addressing language-conscious market niches?
Digital Patient Leaflets are playing an important role as a de-facto solution especially in multilingual countries: for example they can provide additional information that cannot be included in the paper document due to costs of package space limitations and by allowing patients a choice of language when they access the documentation and want to get a better understanding of the product and related medical information.
The use of digital leaflets can provide to the producer support for a whole range of use cases:
With these requirements in mind myHealthbox has developed the eLeaflet solution, a new approach which supports a dramatic paradigm change in the way information is delivered in the healthcare space.
The eLeaflet is a new digital information leaflet format developed specifically for the healthcare that fulfills the requirements of users, patients and professionals.
Some of the main feature of the eLeaflet solution are:
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