EMWA journal features ePI article

In an era of increasing digitization, we have an opportunity to reimagine ePI as an informative and interoperable platform linking core product information to myriad supporting medical information resources. In an article published in the EMWA journal Medical Writing, Open Pharma Co-founder Chris Winchester and co-authors explore the future of ePI and consider the pivitol role of medical writers in the flow of information from research studies to healthcare professionals, patients and other stakeholders.

Product information (PI) provides a comprehensive summary of a drug’s efficacy, safety and appropriate use, offering substantial potential to guide clinical decision-making and contribute meaningfully to patient support care. PI is steadily evolving beyond its original paper-based form, primarily driven by environmental concerns, the push for increased transparency and access, and the demand for greater user-centricity.

In this article, Behtash Bahador (Director of Health Literacy at CISCRP), Trishna Bharadia (Patient Advocate and Visiting Lecturer on Patient Engagement at the Centre for Pharmaceutical Medicine Research, King’s College London), Derek Stewart (Patient Advocate and Honorary Professor at the University of Galway) and Chris Winchester (CEO of Oxford PharmaGenesis and Associate Fellow at Green Templeton College, University of Oxford) explore the considerations, opportunities and challenges associated with electronic product information (ePI), including health literacy, digital equity, transparency and trust. The authors also offer suggestions on how ePI could benefit different stakeholders by developing a standardized ePI template to address these considerations, and they advocate for “thinking digitally from the outset” so that medical materials are designed and developed with the potential for ePI curation in mind.

The authors also spotlight the pivotal role of medical writers in shaping ePI by enhancing discoverability of information, promoting diverse communication formats, shaping best practices for developing medical materials, and advocating for open access to medical information to foster informed decision-making and transparency.

This article delivers an important message about how ePI could transform the way medical information is accessed and shared. The future success of ePI requires collaboration between medical writers, regulators and pharma companies to optimize ePI and address barriers to its widespread use.

The authors call upon medical writers to play a leading role in developing the information structure that will ultimately support the long-term optimization and widespread use of ePI. The authors hope this article resonates not only with the medical writing community but also with patients, caregivers, healthcare professionals and any other stakeholders who regularly use product information in any form. 

References

1. Bahador B. Towards electronic product information that meets the needs of everyone: implications for patients, clinicians, and medical writers. Med Writ 2025;34):21–25. https://doi.org/10.56012tcvr4151.

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