A framework for enhancing pharmaceutical integrity and patient safety: novel mobile health solution integrating smart packaging and computer vision.

Counterfeit and substandard pharmaceuticals represent a critical global health crisis, with the World Health Organisation (WHO) reporting that falsified medicines comprise 10% of the global pharmaceutical trade, constituting one of the fastest-growing grey economies worldwide. This illicit market affects all regions, including high-income countries, causing devastating health and economic consequences that contribute to increased mortality and morbidity rates. The problem is particularly severe in developing nations with inadequate regulatory systems. Mobile health (mHealth) technologies have emerged as promising solutions for enhancing pharmaceutical supply chain integrity. However, comprehensive frameworks that integrate multiple authentication mechanisms remain limited in addressing the growing counterfeit drug crisis. The primary objective of this study is to design and implement a novel mobile health framework that integrates innovative packaging technology and computer vision to enhance pharmaceutical integrity and patient safety. This innovative approach enables consumers to authenticate genuine drugs and detect counterfeit/spurious products through advanced Quick Response (QR) code verification systems and artificial intelligence- powered tablet recognition capabilities. The proposed system utilises individual strip QR codes that enable real-time scanning at the point of sale to verify drug authenticity, directly addressing critical gaps identified in current pharmaceutical authentication methods. To overcome the practical challenge of expiration date loss when medication strips are cut at pharmacies, we developed a computer vision-based Artificial Intelligence (AI) model that automatically recognises the number of tablets remaining in a strip and correlates this information with the unique Identifier (ID). This approach leverages recent advances in computer vision for pharmaceutical applications and automated packaging inspection technologies. Each medication strip is assigned to an individual customer at the time of purchase, with pharmacists recording detailed customer information to ensure comprehensive tracking and accountability throughout the pharmaceutical supply chain. The integrated mobile application creates a robust anti-counterfeiting ecosystem by combining secure QR code authentication with intelligent visual recognition capabilities. The computer vision model provides accurate tablet counting and strip identification, maintaining continuity of medication tracking even when packaging is modified during dispensing processes, thus significantly enhancing supply chain transparency. This dual-authentication approach builds consumer confidence in pharmaceutical authenticity while directly addressing critical vulnerabilities identified in current regulatory frameworks. This comprehensive mobile health solution provides a scalable, evidence-based approach to pharmaceutical authentication that can be readily implemented across diverse healthcare systems globally, offering substantial potential for reducing the circulation of falsified medicines and improving patient safety outcomes in the ongoing battle against the pandemic of counterfeit pharmaceuticals. To overcome the practical challenge of expiration date loss when medication strips are cut at pharmacies, we developed a computer vision-based Artificial Intelligence (AI) model that automatically recognises the number of tablets remaining in a strip and correlates this information with the unique Identifier (ID). This approach leverages recent advances in computer vision for pharmaceutical applications and automated packaging inspection technologies. Each medication strip is assigned to an individual customer at the time of purchase, with pharmacists recording detailed customer information to ensure comprehensive tracking and accountability throughout the pharmaceutical supply chain. The integrated mobile application creates a robust anti-counterfeiting ecosystem by combining secure QR code authentication with intelligent visual recognition capabilities. The computer vision model provides accurate tablet counting and strip identification, maintaining continuity of medication tracking even when packaging is modified during dispensing processes, thus significantly enhancing supply chain transparency. This dual-authentication approach builds consumer confidence in pharmaceutical authenticity while directly addressing critical vulnerabilities identified in current regulatory frameworks. This comprehensive mobile health solution provides a scalable, evidence-based approach to pharmaceutical authentication that can be readily implemented across diverse healthcare systems globally, offering substantial potential for reducing the circulation of falsified medicines and improving patient safety outcomes in the ongoing battle against the pandemic of counterfeit pharmaceuticals.