Case Studies

Multinational Pharmaceutical Health Care Organization

Digital Transformation for Patient Information Leaflets 

Keywords: SPC, SmPC, summary of product characteristics, package leaflet, pharma package insert, PIL, XML

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Background

A Patient Information Leaflet (“PIL” – aka “Package Insert”) is a traditional paper document distributed with medicines that states how the medicine is to be used for a specific treatment. The average PIL averages six pages in length and comprises dense material with tables, chemical formulas, images, and math.

 

A multinational pharmaceutical health care organization wanted to replace the print-based leaflet distributed in its drug packaging with a link to a digital version. The goal of this digital transformation for PILs was to provide the end-user with a better experience, enabling personalization of content, text-to-speech functionality, information search, and the addition of multimedia content.

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Solution

DCL worked with one geographic affiliate of this multinational organization to create a digital transformation workflow for PILs and other similar labeling documents. An Android and Apple app was developed to serve as the conduit between the consumer and the PIL. For the app to work properly, the content delivered to the patient had to be properly structured first in a custom XML format and then transformed to HTML. Because the content is regulatory in nature, it had to be 100% accurate after transformation.

 

DCL worked with its pharma client to create a solution to transform Microsoft Word files into XML, as well as to implement a robust validation process. DCL’s process also automatically creates HTML from the XML, which is shared with the client alongside the XML.  Using the GlobalVision inspection platform, the pharma client verifies the HTML matches the original Word document exactly.

 

Next, HTML files are loaded for access via the Android and Apple apps.   The client creates and manages a “digital twin” for each product using EVRTHNG’s Product Cloud, ultimately allowing end-users of the pharma products to use a smartphone camera to scan a GS1 Digital Link on the drug packaging to access a mobile-friendly version of the PIL.

 

Results

The World Health Organization (WHO) estimates that 10.5% of medicines worldwide are substandard or counterfeit. Delivering regulated information with 100% accuracy is one method to combat counterfeit drug distribution. Today both physicians and patients can access a mobile-friendly PIL via their smartphones. The content can also be further personalized. The pharma company pushes updates to the PIL without having to re-print them. As a result, our client is systematically planning and implementing the digital transformation for approximately 10,000 products worldwide.