Advancing Patient-Centric Labeling and e-Labeling Initiatives: Insights from DIA's Global Labeling Conference
Yuri Quintana, PhD, FACMI
Chief, Division of Clinical Informatics (DCI), Beth Israel Deaconess Medical Center & Harvard Medical School
As a panelist at DIA 's recent Global Labeling Conference , I had the opportunity to engage in thought-provoking discussions with industry leaders and regulators on the future of pharmaceutical labeling. The conference, held from March 14-15, 2024, brought together professionals worldwide to share best practices, explore innovative solutions, and address the challenges of developing clear, accurate, and patient-centric labeling information.
Session 7: eLabeling: Patient Interactions, Advanced e-Labeling Initiatives, and Public/Private Consortia Insights
Session Chairs:
Panelists:
Key Themes and Insights:
1. Patient-Centric Labeling: A recurring theme throughout the conference was the importance of putting patients at the heart of the labeling process. In my session on "eLabeling: Patient Interactions, Advanced e-Labeling Initiatives, and Public/Private Consortia Insights," I emphasized the need for better medication labeling and communication to ensure patient safety. By co-creating new ways to communicate medication information to patients, we can improve health literacy and patient outcomes.
2. e-Labeling Advancements: The conference highlighted the global progress and challenges in e-labeling initiatives. Giovanna Ferrari from Pfizer discussed the EU Gravitate-Health project , which aims to unlock the value of electronic product information (ePI) for patients by taking a global approach. G. Scott Gordon from the FDA shared insights on the agency's SPL-on-FHIR initiative and its opportunities for modernization and international harmonization of product information.
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3. Collaboration and Harmonization: Speakers across various sessions emphasized the importance of collaboration between industry, regulators, and patient groups in tackling complex labeling challenges. Efforts to harmonize ePI and labeling standards, such as the FDA's SPL FHIR implementation and the European Medicines Agency's ePI efforts through the Gravity project, were discussed as key steps toward improving the global labeling landscape. @Rie_Matsui, RPh, Pfizer R&D Japan, gave an excellent comprehensive review of Asian initiatives.
4. AI and Technology in Labeling: The conference also explored the role of artificial intelligence (AI) and emerging technologies in enhancing labeling accuracy and efficiency. While AI presents significant opportunities, speakers highlighted the importance of human oversight, validation, and understanding the limitations of these technologies. Artificial intelligence can bring innovations to how patients learn about their medications by personalizing the display of information, but we need a rigorous way to evaluate both the usability and safety of these systems.
5. Empowerment and Decision-Making: Panelists discussed the challenges of empowerment and decision-making in large pharmaceutical organizations, stressing the need for coaching, embracing team members' differences, and creating cohesive teams to drive labeling innovation.
As we progress, we must continue developing proof-of-concept systems demonstrating enhanced product information's value through initiatives like ePI and the Gravity project. By engaging in multistakeholder efforts, such as workshops and working groups, we can develop better ways to communicate medication information to patients, focusing on areas like visualization, AI chatbots, personalization, testing, and integration.
The DIA Global Labeling Conference was an excellent platform for exchanging ideas, sharing best practices, and fostering collaboration among labeling professionals worldwide. As we work towards a more patient-centric and harmonized labeling future, let us continue to prioritize patients' needs, leverage emerging technologies responsibly, and promote clear, accurate, and accessible medication information.
Yuri Quintana, PhD
Chief, Division of Clinical Informatics
Beth Israel Deaconess Medical Center
Assistant Professor, Harvard Medical School
Boston, Massachusetts, USA