Electronic Product Information Leaflet (ePIL): Opportunities, Challenges, and Future Directions

  • Chaitanya Vitthal Shinde Dayanand Education Society's Dayanand College of Pharmacy, Latur
  • Trupti Mallikarjun Rajmanya
  • Kranti Limbajirao Satpute
  • Pratima Dattrao Shinde
  • Vishwajit Shivaji Buwa
  • Avinash Kamlakar Pandit
  • Vijay Sheshrao Utekar

Abstract

The purpose of EPILs, the electronic version of the leaflets placed in pharmaceutical packaging, is to enhance patient understanding and information access. ePILs present a chance to optimize patient safety, engagement, and adherence as digital health continues to grow. The evidence that currently exists on patient preference, eHealth literacy, and ePIL adoption is examined in the following paper together with the positive aspects, difficulties, and potential implementation strategies. A qualitative examination of research from various nations shows that while ePILs improve accessibility and user satisfaction, issues with digital literacy, user interface, and trust still exist. There is consideration of the implications both for implementation in healthcare systems and futureresearch.


Conclusion: Electronic product information leaflets, or ePILs, give patients a better understanding of their medications and boost their confidence when taking them. However, problems like workflow integration and low digital literacy can limit their efficacy. Future studies should concentrate on vulnerable populations, long-term effects, and explicit regulations. When used appropriately, ePILs can enhance health literacy, safety, and adherence.

Keywords: medication adherence, eHealth literacy, patient education, electronic product information leaflets (ePILs)

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References

1. Gustafsson J, Kälvemark S, Nilsson G, Nilsson JL. Patient information leaflets—patients’ comprehension of information about interactions and contraindications. Pharm World Sci. 2005;27(1):35–40.
https://doi.org/10.1007/s11096-004-1424-0
2. UK Electronic Patient Information Task Force. Evidence review: electronic patient information leaflets (ePILs). Regulatory Rapporteur [Internet]. n.d. [cited 2024 Feb 14]. https://www.regulatoryrapporteur.org/main-navigation/uk-epi-task-force-evidence-review-electronic-patient-information-leaflets-epils/716.article
3. Odukoya OK, Chui MA. e-Prescribing: characterisation of patient safety hazards in community pharmacies using a sociotechnical systems approach. BMJ Qual Saf [Internet]. 2013 [cited 2024 Feb 14];22(10):816–25. Available from: https://doi.org/10.1136/bmjqs-2013-001834
4. Mosa AS, Yoo I, Sheets L. A systematic review of healthcare applications for smartphones. BMC Med Inform Decis Mak [Internet]. 2012 [cited 2024 Feb 14];12:67. Available from: https://doi.org/10.1186/1472-6947-12-67
5. Raynor DK. User testing in developing patient medication information in Europe. Res Social Adm Pharm [Internet]. 2013 [cited 2024 Feb 14];9(5):640–5. Available from: https://doi.org/10.1016/j.sapharm.2013.02.007
6. European Federation of Pharmaceutical Industries and Associations (EFPIA). Position on shortcomings of the Summary of Product Characteristics and the Package Leaflet and proposals to resolve them [Internet]. Brussels: EFPIA; 2014 [cited 2024 Feb 14]. Available from:
https://www.efpia.eu/media/25687/efpia-position-paper-on-smcp-and-package-leaflet.pdf
7. European Medicines Agency. Electronic product information (ePI) for human medicines in the European Union – key principles [Internet]. Amsterdam: EMA; 2025 [cited 2024 Feb 14]. Available from:
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-key-principles_en.pdf
8. Hamrosi KK, Aslani P, Raynor DK. Beyond needs and expectations: identifying the barriers and facilitators to written medicine information provision and use in Australia. Health Expect [Internet]. 2014 [cited 2024 Feb 14];17(2):220–31. Available from:
https://doi.org/10.1111/j.1369-7625.2011.00753.x
9. Kreps GL, Neuhauser L. New directions in eHealth communication: opportunities and challenges. Patient Educ Couns [Internet]. 2010 [cited 2024 Feb 14];78(3):329–36. Available from:
https://doi.org/10.1016/j.pec.2010.01.013
10. European Public Health Alliance. Information to patients—electronic product information (ePI) [Internet]. Brussels: EPHA; 2023 [cited 2024 Feb 14]. Available from:
https://epha.org/information-to-patients-electronic-product-information-epi/
11. Scandurra I, Holgersson J, Lind T, Myreteg G. Electronic patient information leaflets: design and implementation experiences [Internet]. 2013 [cited 2024 Feb 14]. Available from:
https://oru.diva-portal.org/smash/record.jsf?pid=diva2:781175
12. Chesser A, Burke A, Reyes J, Rohrberg T. Navigating the digital divide: a systematic review of eHealth literacy in underserved populations in the United States. Inform Health Soc Care [Internet]. 2016 [cited 2024 Feb 14];41(1):1–19. Available from:
https://doi.org/10.3109/17538157.2014.948171
13. Emergo. Japan PMDA issues guidance on package insert digitalization requirements [Internet]. 2021 Apr 27 [cited 2024 Feb 14]. Available from:
https://www.emergobyul.com/news/brief-japan-pmda-issues-guidance-package-insert-digitization-requirements
14. Leck A, Lim RJ. Singapore: finalized guidance on e-labeling of therapeutic products published [Internet]. 2021 Jun 7 [cited 2024 Feb 14]. Available from:
https://www.globalcompliancenews.com/2021/06/07/singapore-finalized-guidance-on-e-labeling-of-therapeutic-products-published/
15. Food and Drug Administration. Electronic distribution of prescribing information for human prescription drugs, including biological products [Internet]. 2014 Dec 18 [cited 2024 Feb 14]. Available from:
https://www.federalregister.gov/documents/2014/12/18/2014-29522
16. Congress.gov. H.R. 1503 – Prescription Information Modernization Act of 2023 [Internet]. 2023 [cited 2024 Feb 14]. Available from:
https://www.congress.gov/bill/118th-congress/house-bill/1503
17. European Medicines Agency. European Commission workshop on electronic product information (ePI) [Internet]. 2020 [cited 2024 Feb 14]. Available from:
https://www.ema.europa.eu/en/events/european-medicines-agency-ema-heads-medicines-agencies-hma-european-commission-ec-workshop-electronic-product-information-epi
18. Bolislis WR, Mortazavi C, Riccioni R, et al. From print to screen: regulatory considerations to adopting innovative approaches for patient information and safety. Ther Innov Regul Sci. 2020;54:831–8.
https://link.springer.com/article/10.1007/s43441-019-00018-0
19. President of the Republic (Brazil). Amends Law No. 11,903 of January 14, 2009, to provide for the digital package leaflet of medicines [Internet]. Brazil: National Congress; 2022 [cited 2024 Feb 14]. Available from:
https://www.planalto.gov.br/ccivil_03/_ato2019-2022/2022/lei/L14338.htm
20. AstraZeneca. Work plan for the pilot reform of age-appropriate package inserts [Internet]. Draft for comments. 2023 [cited 2024 Feb 14]. Available from:
https://www.astrazeneca.com/content/dam/az/PDF/Work-plan-age-appropriate-package-inserts.pdf
21. European Medicines Agency. Electronic product information for human medicines in the European Union – key principles [Internet]. Amsterdam: EMA; 2020 [cited 2024 Feb 14]. Available from:
https://www.ema.europa.eu/en/electronic-product-information-human-medicines-european-union-key-principles?utm_source=chatgpt.com
22. Frisk P, Kälvemark-Sporrong S, Wettermark B. Selection bias in pharmacy-based patient surveys. Pharmacoepidemiol Drug Saf [Internet]. 2014 [cited 2024 Feb 14];23(2):128–39. Available from:
https://doi.org/10.1002/pds.3488
23. Hammar T, Nyström S, Petersson G, Åstrand B, Rydberg T. Patients satisfied with ePrescribing in Sweden: a survey of a nationwide implementation. J Pharm Health Serv Res [Internet]. 2011 [cited 2024 Feb 14];2(2):97–105. Available from:
https://doi.org/10.1111/j.1759-8893.2011.00040.x
24. Robben S, van Kempen J, Heinen M, Zuidema S, Olde Rikkert M, Schers H, et al. Preferences for receiving information among frail older adults and their informal caregivers: a qualitative study. Fam Pract [Internet]. 2012 [cited 2024 Feb 14];29(6):742–7. Available from:
https://doi.org/10.1093/fampra/cms033
25. Pan X, Kim E, Zamora J, Hata M, Wooley A, Devraj R, et al. The comprehension, cosmetics, convenience, content, and credibility of infographic patient information leaflets compared to existing PILs. Healthcare (Basel) [Internet]. 2025 [cited 2025 Jan 10];13(11):1227.
https://www.mdpi.com/2227-9032/13/11/1227
26. Skogman-Lindqvist C, Lapatto-Reiniluoto O, Sirviö M, Sivén M. Benefits and challenges of electronic package leaflet – review of ePL pilots in hospital settings in Europe. Eur J Pharm Sci [Internet]. 2023 [cited 2024 Feb 14];191:106605. https://doi.org/10.1016/j.ejps.2023.106605
27. Bejeuhr G. Electronic dissemination of product information [Internet]. Presentation. Amsterdam: European Medicines Agency; 2024 [cited 2024 Feb 14]. Available from:
https://www.ema.europa.eu/en/documents/presentation/electronic-dissemination-product-information-epi_en.pdf
28. Therapeutic Goods Administration. Product information [Internet]. Canberra: TGA; 2023 [updated 2023 Feb 16; cited 2024 Feb 14]. Available from:
https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/product-information
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Shinde CV, Rajmanya TM, Satpute KL, Shinde PD, Buwa VS, Pandit AK, Utekar VS. Electronic Product Information Leaflet (ePIL): Opportunities, Challenges, and Future Directions. Int J Drug Reg Affairs [Internet]. 2026Sep.15 [cited 2026Sep.17];14(3):18-6. Available from: https://www.ijdra.com/index.php/journal/article/view/839

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