Electronic patient information leaflets

Published on 8 August 2022

About the project

The WMAHSN is scoping a project that will look to determine patient and organisation perceptions and accessibility of electronic patient information leaflets and undertake pilot studies within specified groups of medicines, such as hospital only medication or paediatric inhalers.

In England around 1.03 billion prescription items were dispensed by community pharmacies and appliance contractors in 2020/21, each of these would be accompanied by a paper patient information leaflet (PIL)[i]. Changes to licensing of medication can result in, not just replacing traditional paper patient information leaflets with electronic leaflets, but often whole batches of medication. This will also allow for further environmental benefits to be obtained by the potential to reduce the size and weight of products to be transported[ii]. Current Product Information can also be difficult for end users to read and understand often having small print and technical terms. Introduction of regulator authorised electronic dynamic Product Information has the potential to not only improve carbon footprint but to assist in accessibility of medicines information to the end users[iii],[iv],[v],[vi],[vii].

[i] NHS Business Services Authority. Available at: https://www.nhsbsa.nhs.uk/statistical-collections/general-pharmaceutical-services-england/general-pharmaceutical-services-england-201516-202021  <Accessed 28/04/2022>

[ii] Alliance to Modernize Prescribing Information

https://modernizeprescribinginfo.com/ <Accessed 28/04/2022>

[iii] Bolislis, Winona Rei R et al. “From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety.” Therapeutic innovation & regulatory science vol. 54,4 (2020): 831-838. doi:10.1007/s43441-019-00018-0 Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7362886/

[iv] Pines A. Patient information leaflets: friend or foe? Climacetric. 2015;18(5):663–665. doi: 10.3109/13697137.2015.1007697.

[v] Liu F, Abdul-Hussain S, Mahboob S, et al. How useful are medication patient information leaflets to older adults? A content, readability and layout analysis. Int J Clin Pharm. 2014;36(4):827–834. doi: 10.1007/s11096-014-9973-2.

[vi] Herber OR, Gies V, Schwappach D, et al. Patient information leaflets: informing or frightening? A focus group study exploring patients’ emotional reactions and subsequent behaviour towards package leaflets of commonly prescribed medications in family practices. BMC Fam Pract. 2014;15(1):163. doi: 10.1186/1471-2296-15-163.

[vii] Electronic product information for human medicines in the EU: key principles A joint EMA–HMA–EC collaboration © European Medicines Agency, 2020

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-key-principles_en.pdf

Project ambitions

The WMAHSN is currently scoping a project that looks to:

  • Contribute to supporting evidence to MHRA to enable regulatory change for removing paper information leaflets
  • Reduce carbon footprint and emissions of medication by use of a carbon footprint calculator
  • Identify risks and issues around removal of paper medicines product information
  • Improve understanding and accessibility around medicines information
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Project team

Anna Edwards

Innovation Project Manager

Rabia Gowa

Innovation Programme Manager

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