A Principles Framework for Digital Provision of Medical Information for Healthcare Professionals

Pharmaceutical Medicine - Tập 37 - Trang 103-109 - 2023
Susan Mohamed1, Sarah Dunnett2, Angela Flores3, Eva Loew4, Stefne Pienaar5
1Pfizer, Capelle aan den Ijssel, The Netherlands
2Sarah Dunnett Consulting Ltd., Newbury, UK
3Lilly, Madrid, Spain
4Novartis Pharma, Nuremberg, Germany
5Pfizer, Tadworth, UK

Tóm tắt

European pharmaceutical companies have a legal requirement to provide non-promotional medical information (MI) services to support healthcare professionals (HCPs) using their medicinal products. While we are seeing an increased HCP preference and expectation towards digital channels, the lack of a compliance framework relating to the provision of non-promotional MI services is a key factor complicating and compromising the ability for companies to meet this need. Meanwhile, the internet is dominated by a large volume of unregulated, easy access, and potentially low-quality information from diverse sources. The Medical Information Leaders in Europe (MILE) association is therefore proposing a framework of principles to support pharmaceutical companies with the digital provision of MI services; these relate to digital access to non-promotional, medicinal product information to support clinical decision making and patient care. The three established European national MI associations have already considered the framework and expressed their endorsement. MILE continues to invite stakeholders, including pharmaceutical companies, regulators, national industry associations and healthcare professional bodies to engage and help refine and implement this framework. This publication does not constitute legal advice; decision making and accountability remains with each pharmaceutical company.

Tài liệu tham khảo

European Parliament and the Council of the European Union. Directive 2001/83/EC. 2001. https://www.legislation.gov.uk/eudr/2001/83/2019-07-26. Accessed 15 Feb 2023. European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Practice—2019. 2019. https://www.efpia.eu/media/676434/220718-efpia-code.pdf. Accessed 15 Feb 2023. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice—2019. 2019. https://ifpma.org/publications/ifpma-code-of-practice-2019/. Accessed 15 Feb 2023. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) Joint Note for Guidance on social media and digital channel. 2022. https://ifpma.org/publications/joint-note-for-guidance-on-social-media-and-digital-channels/. Accessed 15 Feb 2023. Associación de Medicina de la Industria Farmacéutica Medical Information Forum. ‘Good Medical Information Practice Guidelines in the Spanish Pharmaceutical Industry’, 2017. Guía de buenas prácticas de Información Médica en la industria farmacéutica española. Documenta Universitaria. 2023. https://www.documentauniversitaria.com/en/products/gua-de-buenas-prcticas-de-informacin-mdica-en-la-industria-farmacutica-espaola/. Accessed 15 Feb 2023. Die forschenden Pharma-Unternehmen (vfa), the German Association of Research-Based Pharmaceutical Companies. ‘Positionspapier - Medizinische Information durch die forschenden Pharma-Unternehmen in Deutschland‘. 2020. https://www.vfa.de/download/positionspapier-medizinische-information.pdf. Accessed 15 Feb 2023. Pharmaceutical Information and Pharmacovigilance Association. ‘Guidelines on Standards in Medical Information’. 2022. https://pipaonline.org/wp-content/uploads/2022/02/Pipa-MI-Guideline-Document_Jan-2022_final.pdf. Accessed 15 Feb 2023. Pienaar S, Dunnett S, Flores A, et al. The critical need to build a european governance model for online access to medical information services: A position paper. Pharm Med. 2021;35:147–55. Hristoskova S, Milligan J, De Wit J, et al. Principles and considerations for responsible sharing of safety information via the medical information channel. Ther Innov Regul Sci. 2020;54:939–46. MILE (Medical Information Leaders in Europe). Technology Benchmarking Survey—2021. 2022. https://www.mile-association.org/wp-content/uploads/2022/04/MILE-2021-technology-benchmarking-survey-summary-for-website.pdf. Accessed 15 Feb 2023.