Benefits and challenges of electronic package leaflet (ePL) - review of ePL pilots in hospital settings in Europe

Eur J Pharm Sci. 2023 Dec 1:191:106605. doi: 10.1016/j.ejps.2023.106605. Epub 2023 Oct 10.

Abstract

Inclusion of package leaflets in paper format is a legal requirement in European Union (EU), therefore the electronic package leaflet (ePL) is a relatively unknown phenomenon in medicinal products in Europe. Introduction of ePL only would be a more sustainable format of providing the product information than paper package leaflet. Furthermore, ePL would support health care professionals' comprehension of product use through electronic searchability and facilitate access to up-to-date product information in respective language used. It could also help us to tackle the availability issues and be a further step towards common packages. With this commentary, our aim is to review the ongoing ePL pilots in hospital settings in Europe and identify the benefits and challenges of ePL. Based on our review, there is a broad general support for the removal of paper package leaflets from hospital products. Packages without paper package leaflets are considered more sustainable due to savings in production and materials. Furthermore, ePL could be a facilitator for common packages in EU-countries with the benefit of reducing pharmaceutical waste and drug shortages. The most important benefit from both pharmaceutical industry and healthcare professionals' interest is that current and on-line updated product information is always electronically available, especially from drug safety perspective.

Keywords: digitalization; electronic package leaflet; environmental sustainability.

Publication types

  • Review

MeSH terms

  • Comprehension*
  • Drug Industry*
  • Europe
  • European Union
  • Humans