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

We performed this survey to assess the utility and interest of vaccine recipients or their parents in the information mandated to accompany the vaccine by regulatory practice. As for many recent research projects, the COVID-19 pandemic [45, 50] has had an important impact on the performance of this research. However, rather than postponing the survey we choose to adapt our data-gathering approach to an online environment as the questionnaire itself was readily adaptable, although we are aware that using internet-based technology could bias our results [45, 51, 52]. To limit bias, we used closed internet groups in a time limited way to avoid as far as possible the distribution, redistribution or promotion of our questionnaire-link on open-ended social media such as Facebook.

The COVID-19 pandemic has illustrated the valid and important reasons for our research. The widely disseminated public discussion of availability of COVID-19 vaccines and the need for rapid deployment of vaccines supplied by different manufacturers across the EU with 24 official languages and other legal requirements applicable in each separate EU member state, highlights the consequences of needing a PPL in each box [15, 16]. Even a single vaccine may have a large number of distinctly different packaging versions [53]. This impedes the rapid redistribution of a vaccine among EU member states, an evident necessity in case of an increased regional demand or the existence of localized shortages [54], and is a time-delaying complication for the manufacturer. A similar situation presents itself in other parts of the world [55]. Adding a single, multilingual PPL with each single vaccine dose would result in a larger physical package, entailing higher manufacture, packaging, transportation, refrigeration and storage costs [53].

In these circumstances it is an appropriate time to question the status quo about PPLs in vaccines and other medicines. Change will require both a new legislative and/or regulatory framework for the PPL and a consideration of the actual value for patients or parents these leaflets are intended for. It was in consideration of this latter aspect that we implemented this survey to investigate the actual access, use and opinions about PPLs in a diverse set of vaccinees across a range of European countries. As the balance between utility and cost, both in terms of expense and time for preparation, of the PPL is even more important in the context of increased need for timely vaccination [56], we continued with our survey despite the potential biases inherent to our adapted particular survey method.

Our original intention to conduct face-to-face interviews would have introduced its own kind of bias as many vulnerable people would not have been willing to participate in such interviews during the pandemic. In contrast, although we planned to provide training and guidelines to those who would eventually have interviewed the vaccinees it is likely that using an online questionnaire may have reduced the risk of bias linked to the style and additional instructions provided by the in-person interviewer or the sensitivity of the subject [52]. However, despite the questionnaire explicitly inquiring about personal opinions it is also likely that in an online questionnaire people still answered with elderly acquaintances in mind whom they know to have limited digital skills, as other research suggests [57]. Another potential source of bias in our online survey was the language barrier as this was fixed in the four countries. For this reason, we have not discussed the survey question about the appropriateness or understandability of the PPL language. It is obvious however that an electronic version of the package leaflet could easily, and inexpensively, accommodate multiple European languages as many of these translations already exist. These potential sources of bias increase the importance of selecting different target groups and analyzing the variances between them. In general, despite differences between countries and target groups we discovered consistent trends in the answers that validate our findings.

A key observation from the survey was that patients rarely receive or infrequently read vaccine PPLs across all the settings in marked contrast to leaflets for other medicines that are read much more often [14]. As the number of respondents who read the PPL was rather limited, we do not discuss the expressed opinions about readability and understandability of the leaflet. There is a considerable amount of literature on this topic [14, 25, 58‐60] and it is safe to state that the current state of PPLs is sub-optimal.

There is a very high degree of trust in HCPs, particularly general practitioners and pediatricians, who are the most important source of information about vaccines, as reported in other studies [61‐63]. We found that HCP rarely use or promote the PPL as a tool for informing the vaccinee, despite this being its primary purpose [15]. We did not investigate the rationale for this but extending existing studies [60] in the context of vaccines does seem to be warranted. In addition, people rarely ask the HCP for the PPL and do not appear to know that they can. Rather than interpreting this as reflective of an attitude of indifference or refusal to be informed, it should be noted that a substantial number of vaccinees clearly expressed the desire to have such access. We can rationalize this attitude by conjecturing that people want easy access, just in case, or dislike not having the possibility to read the PPL, and the need to promote the existence of the PPL and a vaccinee’s right to read it are important messages in the context of the creation of the informational environment mentioned [9] in the introduction.

An overwhelming majority of respondents believed that the leaflets should be available in an electronic format and many were willing to install an app for this purpose, although the elderly were clearly more reticent to do so. The use of Google (we did not cite other internet search engines) as a generic way of looking up information is fully entrenched and any policy that wants to use the internet to provide information to patients cannot afford to ignore that. Indeed, seeking information about vaccines on the internet was the second most frequently used source, ahead of pharmacists and the PPL.

Finally, we asked about a full switch of the PPL to an electronic version. While most agreed, unsurprisingly this was not the case among the elderly [44]. However, the option of a paper printout, possibly printed at the pharmacy, markedly increased the acceptance of switching to electronic formats to a clear majority in all regions and all target groups. The consistency of these opinions in the different target groups and different regions reinforces the validity of this conclusion and counterbalances some of the biases introduced by the methods used. Nevertheless, we acknowledge that certain vulnerable groups have not participated in our survey and we must be cautious in extrapolating these results to the general public.

Balancing the risks and benefits of switching to electronic leaflets, we believe that with appropriate measures to protect the most vulnerable in society, most notably the option of a paper version, using new technology could contribute to a better informational environment and provide the leaflets with the functionality needed to fulfill their purpose as part of the measures necessary to combat vaccine hesitancy and so improve coverage.