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From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety
Patient information leaflets (PILs) differ across regulatory jurisdictions—its form and structure are dependent on the regulations it conforms to. Yet, physical or paper-based documents remain to be the most prevalent way of delivering important information to patients. As technology continues to en...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7362886/ https://www.ncbi.nlm.nih.gov/pubmed/32557303 http://dx.doi.org/10.1007/s43441-019-00018-0 |
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author | Bolislis, Winona Rei R. Mortazavi, Charlie Riccioni, Rossana Schaeffer, Paul-Etienne Kühler, Thomas C. |
author_facet | Bolislis, Winona Rei R. Mortazavi, Charlie Riccioni, Rossana Schaeffer, Paul-Etienne Kühler, Thomas C. |
author_sort | Bolislis, Winona Rei R. |
collection | PubMed |
description | Patient information leaflets (PILs) differ across regulatory jurisdictions—its form and structure are dependent on the regulations it conforms to. Yet, physical or paper-based documents remain to be the most prevalent way of delivering important information to patients. As technology continues to enhance our daily activities, patients are increasingly utilizing digital platforms to facilitate access to relevant product information, hence questioning the continuous viability of physical PILs. This paper aims to present the growing importance of transitioning from print to screen via dynamic electronic product information, as a way of expanding access and utility of patient information. It provides considerations or reflection points for regulators when adopting digital platforms to ensure that stakeholders, especially patients, receive trusted and real-time information on available and approved medicinal products. We underscore these with examples and case studies from countries and businesses that have adopted or are transitioning to such platforms. |
format | Online Article Text |
id | pubmed-7362886 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-73628862020-07-20 From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety Bolislis, Winona Rei R. Mortazavi, Charlie Riccioni, Rossana Schaeffer, Paul-Etienne Kühler, Thomas C. Ther Innov Regul Sci Commentary Patient information leaflets (PILs) differ across regulatory jurisdictions—its form and structure are dependent on the regulations it conforms to. Yet, physical or paper-based documents remain to be the most prevalent way of delivering important information to patients. As technology continues to enhance our daily activities, patients are increasingly utilizing digital platforms to facilitate access to relevant product information, hence questioning the continuous viability of physical PILs. This paper aims to present the growing importance of transitioning from print to screen via dynamic electronic product information, as a way of expanding access and utility of patient information. It provides considerations or reflection points for regulators when adopting digital platforms to ensure that stakeholders, especially patients, receive trusted and real-time information on available and approved medicinal products. We underscore these with examples and case studies from countries and businesses that have adopted or are transitioning to such platforms. Springer International Publishing 2019-12-09 2020 /pmc/articles/PMC7362886/ /pubmed/32557303 http://dx.doi.org/10.1007/s43441-019-00018-0 Text en © The Author(s) 2019 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Commentary Bolislis, Winona Rei R. Mortazavi, Charlie Riccioni, Rossana Schaeffer, Paul-Etienne Kühler, Thomas C. From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety |
title | From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety |
title_full | From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety |
title_fullStr | From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety |
title_full_unstemmed | From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety |
title_short | From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety |
title_sort | from print to screen: regulatory considerations to adopting innovative approaches for patient information and safety |
topic | Commentary |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7362886/ https://www.ncbi.nlm.nih.gov/pubmed/32557303 http://dx.doi.org/10.1007/s43441-019-00018-0 |
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