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Abstract

The importance of the patient information leaflet (PIL) is underlined by the fact it is the only mandatory information that patients in Europe are legislated to receive with their medicines. Issues with the PIL in its current paper format have been well documented and in recent years there has been a push to move from these paper leaflets provided in the medicine carton to the information being made available as an electronic PIL (ePIL). This paper explores the potential negative and positive consequences of ePILs and their impact on patients. In a survey of almost 600 people it was shown that people’s willingness to embrace the ePIL is very much age dependent. The survey also demonstrated that more people than expected are reading the paper PILs while it also indicated that there is higher likelihood of people reading the PIL based on the medication type, prescription versus over the counter and the frequency the medication is used by the patient. There are positives and negatives to both the ePIL and the paper PIL. When the two are compared, it is the electronic version that has the greater number of benefits for patients. The main benefit of the electronic version is that it ensures that the most current version of the PIL is available to patients – whether or not patients are aware that they are not always getting the most current version of the PIL was not assessed in this study. This paper assesses the benefits and negatives of electronic PILs versus the current PIL. Additionally, interviews with industry and regulatory subject matter experts suggest some best practices that might be considered to ensure maximum benefit for patients in the use of ePILs.

DOI

https://doi.org/10.21427/yc64-2j74

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 4.0 License.

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