Abstract
Patient information leaflets (PILs) differ across regulatory jurisdictions—its form and structure are dependent on the regulations it conforms to. Yet, physical or paper-based documents remain to be the most prevalent way of delivering important information to patients. As technology continues to enhance our daily activities, patients are increasingly utilizing digital platforms to facilitate access to relevant product information, hence questioning the continuous viability of physical PILs. This paper aims to present the growing importance of transitioning from print to screen via dynamic electronic product information, as a way of expanding access and utility of patient information. It provides considerations or reflection points for regulators when adopting digital platforms to ensure that stakeholders, especially patients, receive trusted and real-time information on available and approved medicinal products. We underscore these with examples and case studies from countries and businesses that have adopted or are transitioning to such platforms.
Highlights
A patient information leaflet (PIL) is a document that provides detailed information for patients or caregivers on the use, administration, risks, storage, and disposal of a medicine
The need to guarantee patient safety has led to increasing regulations that require additional information and notices to be included in the PIL—often resulting in a lengthy document that is difficult to read by the patient or caregiver
Ensuring access and availability of the information and digital platform is important when transitioning to the dynamic electronic patient information leaflets (e-PILs)
Summary
A patient information leaflet (PIL) is a document that provides detailed information for patients or caregivers on the use, administration, risks, storage, and disposal of a medicine. Ensuring access and availability of the information and digital platform is important when transitioning to the dynamic e-PIL This entails guaranteeing that the patients know how and where to find the needed information on the medical product, and creating sufficient awareness on the platform’s availability. While this paper focuses on the transition and adoption of dynamic e-PILs, more tailored approaches to providing patient information are emerging This includes increasing personalized services that are available 24/7 to guide and inform the patient on the safe use and administration of specific medicinal products. Setting up personal notifications tailored on individual circumstances, such as drug interactions, disease history, or child-bearing potential, could be enabled so that immediate information can be highlighted and received by the patient As these chatbot services become increasingly used, the sector could learn from experience gained and even further improve content provided and its presentation (Box 7). Other available online chatbots educates patients about diabetes [20], provides information for people living with skin conditions (e.g. psoriasis or chronic urticaria) [21], and provides training and self-assessment to sales representatives [22]
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