Replacing vaccine paper package inserts: a multi-country questionnaire study on the acceptability of an electronic replacement in different target groups

Abstract

Background In the European Union it is mandatory to include paper package leaflets (PPL) with all medicines, including vaccines, to inform the recipient. However, it is difficult to meet the necessity for localized PPLs in each of the 24 official European languages. Replacing PPLs with electronic versions offers many advantages including redistribution across nations, reduced storage space, accessibility by the visually impaired, easily updated information or the addition of video content. We wanted to assess the attitudes of patients (vaccine recipients or their parents) to the potential of replacing PPL with electronic versions. Methods We surveyed vaccinees or their parents in four European countries—Belgium, Italy, Bulgaria and France—for their actual use of vaccine PPLs and their opinions about switching to an electronic package leaflet. Our survey was conducted online because of the COVID-19 pandemic and resulted in 2518 responses to a questionnaire targeted at three specific groups with particular information needs: parents of young children, pregnant women and the elderly (≥ 60 years). Results Our main findings are that currently vaccine PPLs are rarely used and frequently unavailable for the vaccinee. Across the four countries surveyed 55–82% of vaccinees would accept an electronic version, as did 64% when there was an option to request a printout of the leaflet. Conclusions We found that switching to electronic versions of vaccine PPLs is an acceptable alternative for the public, potentially increasing the quality and amount of information reaching vaccinees while eliminating some barriers to redistribution of vaccines between countries.

Survey Result for E-labeling Initiatives in Asia

“…As the e-labeling system is relatively new in some markets and others are yet to begin on its implementation, challenges have been identified. For COVID-19 vaccines, instead of inserting paper labeling, e-labeling has been accepted to improve regulatory agility as an exceptional case [ 2 ]. e-labeling meets the challenges of the pandemic and is a critical method to deliver vaccines/medicines quickly and globally.…”

“… Under the COVID-19 pandemic, various electronic labeling initiatives have accelerated worldwide in the healthcare and pharmaceutical fields as part of a wider digital transformation [ 1 , 2 ]. Although there is no universal definition of electronic labeling (e-labeling) globally, it is widely understood that e-labeling refers to the product information that is distributed via electronic means.…”

Electronic Package Leaflets for Vaccines: What Are People’s Perceptions in Italy?

“…In this context, the “Package leaflet project” has been developed, and a collaboration between the University of Antwerp and the University of Florence was established in 2020 [ 13 , 14 ]. The e-leaflet represents an advanced electronic version of the PPL contained in the packaging of medicines and creates a direct channel between the pharmaceutical companies and consumers, allowing them to send and receive information in a simple, fast, and convenient form.…”