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

Martina Bamberger,Mira Kojouharova,Paolo Bonanni,Odile Launay,Pierre Van Damme,Charlotte Marstboom,Hans De Loof,Stéphanie Oury

doi:10.1186/s12889-022-12510-8

Martina Bamberger, Mira Kojouharova + Show 6 more

Open Access

https://doi.org/10.1186/s12889-022-12510-8

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Abstract

BackgroundIn 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.MethodsWe 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).ResultsOur 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.ConclusionsWe 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.

Highlights

In the European Union it is mandatory to include paper package leaflets (PPL) with all medicines, including vaccines, to inform the recipient
The countries were selected to reflect the diversity in the structure of healthcare, web access and vaccine pricing policies in Europe, e.g. in France and Belgium many vaccinees bring along their vaccine to the healthcare provider [38]
We believe that the current European regulatory regime mandating the presence of a PPL in the local language with all vaccines does not achieve its purpose of adequately informing the vaccinee

Summary

Introduction

In the European Union it is mandatory to include paper package leaflets (PPL) with all medicines, including vaccines, to inform the recipient. The phenomenon of ‘vaccine hesitancy’ [2] is just as real and is recognized by the World Health Organization as a major public health threat [3] Vaccinees or their parents are exposed to all kinds of information from a variety of sources, not all of which are Bamberger et al BMC Public Health (2022) 22:156 regulated [4,5,6,7,8]. In the European Union, the established means of communicating such information about medicines to recipients is through the paper package leaflet (PPL) or package insert [12,13,14]. There is evidence that the current leaflets for vaccines can be improved [26, 27]

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