Masterstudiengang "Drug Regulatory Affairs"


Moving into future - a pure electronic package leaflet as a chance for patients, the pharmaceutical industry and health authorities

Dr. Tobias Morawe (Abschlußjahr: 2017)

Language: English
We are living in a digital age and electronic devices and services influence nearly all parts of our daily life. In regards to information the Internet is becoming a major resource. It enables a rapid and in line with mobile devices also an instant access to information. Also patients and healthcare professionals are using the Internet as a source for information since it provides a variety of healthcare details and information related to medicinal products. But still the package leaflet as the most important resource for patient information, besides the contact to the healthcare professional, is paper based and has been shown to be worthy of improvement. Therefore, along with the increasing use of electronic information the implementation of an electronic package leaflet has to be considered.
The present work focuses on the feasibility to introduce a pure electronic package leaflet as a source of patient information replacing the current paper based format in the package. It provides a high level overview of existing electronic package leaflet models and platforms based on selected examples. The thesis highlights the chances of an electronic package leaflet for the most relevant stakeholders bearing in mind that not all people are able to use electronic devices and that not everyone has access to the internet. Moreover, specific functions for a website and/or app are emphasised. Additionally, recommendations for revising regulatory requirements are given and furthermore, the need for a harmonised region-wide or global approach and options for common electronic standards are discussed.
Pages: 65