About the project

HIWM is participating in a multistakeholder taskforce that looks to determine patient and organisation perceptions and accessibility of electronic Patient information leaflets and undertake pilot study within a specified group 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 discarding of the amended leaflet, but often whole batches of medication. Environmental benefits are further obtained by potential to reduce size and weight of products to be transported[ii]. Current Product Information can 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].

Project ambitions

HIWM is participating in a multistakeholder taskforce that looks to:

• Remove need for paper information leaflets
• Reduce carbon footprint and emissions of medication
• Provide supporting documentation for MHRA submission in order to facilitate legislative change and ascertain standards going forward
• Identify risks and issues around removal of paper medicines product information
• Improve understanding and accessibility around medicines information

References

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

[ii] Alliance to Modernize Prescribing Information

https://modernizeprescribinginfo.com/

[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