The reliable delivery of temperature-sensitive pharmaceuticals depends on an unbroken cold chain governed by Good Distribution Practice (GDP). As biologics, vaccines, plasma-derived products, and advanced therapy medicinal products expand their share of the global medicines market, the clinical and economic consequences of thermal excursions have intensified. This paper reviews recent advances in cold chain integrity and GDP across the regulatory and scientific foundations of temperature control, the engineering of thermal protection and monitoring, the digital transformation of distribution networks, and the systemic dimensions of equipment reliability, sustainability, economics, and equitable access. It examines how passive and active thermal protection systems have improved through vacuum insulation and engineered phase change materials, how real-time monitoring built on connected sensing has displaced retrospective data capture, and how predictive analytics, distributed ledgers, and digital twins are reshaping visibility and traceability. Focused attention is given to the ultra-cold and cryogenic chains that support messenger ribonucleic acid vaccines and cell and gene therapies, where chain of identity and chain of custody requirements compound the demands of thermal control. The paper also considers quality risk management and validation, the reliability of refrigeration assets and the role of predictive maintenance, sustainability pressures such as refrigerant phase-down and single-use packaging waste, the economics of failure and of investment in monitoring, the persistent last-mile gaps in low- and middle-income settings, and the lessons drawn from the pandemic deployment of temperature-sensitive vaccines. The central finding is that cold chain assurance is shifting from a document-centric, compliance-driven discipline toward a data-driven, predictive, and risk-based model. Integrating continuous monitoring with analytics and product specific stability budgets offers the clearest path to reducing wastage while preserving patient safety, although interoperability, validation, cybersecurity, and equitable access remain unresolved challenges.
Counterfeit and substandard medicines remain a major global public health threat, with the World Health Organization estimating that up to 10% of medicines in low- and middle-income countries are falsified or substandard, exceeding 20% for some therapeutic classes in sub-Saharan Africa. Blockchain technology, with its decentralised, immutable, and transparent digital ledger architecture, has been proposed as a promising solution for strengthening pharmaceutical supply chain traceability, yet little is known about the readiness of community pharmacies in Nigeria to adopt it. This study assessed the knowledge, current practices, and implementation readiness of blockchain-based traceability for counterfeit medicine prevention among community pharmacists in Bayelsa State, Nigeria, and examined the barriers and enablers influencing adoption. A descriptive cross-sectional survey design was employed, using a structured, validated questionnaire administered electronically through the Association of Community Pharmacists of Nigeria (ACPN), Bayelsa State Chapter. A total of 119 valid responses were obtained, exceeding the minimum sample size derived from Yamane's and Cochran's formulae, representing a 79.3% response rate. Data were analysed using descriptive and inferential statistics, including Chi-square tests. Findings revealed that although 71.4% of respondents had heard of blockchain technology, mean knowledge scores across core blockchain concepts were uniformly low (1.26-1.72 on a 5-point scale), reflecting a substantial awareness-comprehension gap. Authentication practices were overwhelmingly manual, with 77.3% relying on visual inspection of NAFDAC numbers and only 9.2% using digital scanning; 68.9% of pharmacists had encountered suspected counterfeit medicines in the past year. Implementation readiness was below average (Mean = 2.70/5.0), driven by strong training willingness (Mean = 3.74) but deficient infrastructure (Mean = 1.80). Resistance to change and high cost were the leading barriers, while user-friendly applications and mandatory regulation were the strongest enablers. The study concludes that community pharmacies in Bayelsa State are not yet structurally ready for blockchain-based traceability, although a receptive attitudinal environment and strong professional motivation exist to support a phased transition. It is recommended that NAFDAC and the Pharmacists Council of Nigeria develop a phased regulatory framework and integrate blockchain literacy into continuing professional development, that government prioritise infrastructure investment, and that technology developers design mobile-first, user-friendly, offline-capable systems, to enable a coordinated transition toward blockchain-enabled pharmaceutical traceability in Nigeria.
Counterfeit medicines, fragmented record management, limited end-to-end visibility, and dependence on centralized databases create security and traceability challenges in pharmaceutical supply chains. This article presents Pharma-Chain, a blockchain-enabled pharmaceutical supply chain management system developed to record medicine registration, stakeholder interactions, ownership transfer, and authenticity verification on an Ethereum blockchain. The system integrates a React.js frontend with Web3.js, MetaMask wallet authentication, Solidity smart contracts, Truffle deployment tools, and Ganache for local blockchain development and validation. Manufacturers register medicine batches with product and lifecycle information; distributors and retailers verify blockchain records before accepting and transferring ownership; and customers retrieve medicine details and transaction history before purchase. The implementation was tested module by module and as an integrated application in a local Ethereum environment. Testing confirmed successful authentication and role-based access, medicine registration, ownership transfer, transaction validation, blockchain record retrieval, and medicine verification. Each successful supply-chain operation generated a blockchain transaction record, providing an immutable ownership history and improving transparency and auditability. The project demonstrates a practical decentralized approach for secure pharmaceutical tracking while identifying QR-code verification, IoT monitoring, AI-assisted analytics, mobile access, and deployment on public or enterprise blockchain networks as future extensions.
Open access
2 source records
Blockchain Technology Applications and Security
Pharmaceutical Quality and Counterfeiting
Physical Unclonable Functions (PUFs) and Hardware Security
Ankit Sitaula, Ashraf Uddin, John Ayoade, Nam H. Chu · 5 authors
Counterfeit and unsafe medicines pose significant risks to patient safety and undermine trust in healthcare systems. This paper presents ACTMeds, a blockchain-supported pharmaceutical traceability and recall platform that considers pharmaceutical supply chain requirements and public health operational needs relevant to the Australian Capital Territory (ACT). The system integrates Ethereum smart contracts, developed using Ganache, with a React-based web application providing regulator, operator, pharmacy, and auditor interfaces, alongside a public verification portal leveraging QR and GS1 barcodes. In addition, role-based access control is enforced across the medicine lifecycle, including manufacture, custody transfer, dispensing, and recall, with immutable on-chain events generated to support auditability and accountability. To balance transparency with confidentiality, the platform prototypes a zero-knowledge (ZK) recall mechanism in which regulators can cryptographically prove that recall conditions meet predefined policy requirements without disclosing sensitive incident details. Threat modeling was conducted using the STRIDE framework, and security evaluation combined static application security testing (Solhint and ESLint) and dynamic testing. The paper further discusses deployment options, cost considerations, ZK recall performance analysis, ethical implications, and future enhancements. Security testing validated the platform’s resilience, with no high-severity vulnerabilities identified and medium-severity issues related to HTTP security headers addressed. The results indicate that a regulator-led, privacy-preserving, tamper-evident ledger can improve medicine authenticity verification and recall responsiveness while maintaining compliance and data protection obligations.
Dr. K. Pushpa Latha, Meghana Reddy, Dr. B. Rajalingam, Malleswari Akurati · 6 authors
The pharmaceutical supply chain is a network of various stakeholders such as manufacturers, distributors, logistics providers, pharmacies, and regulatory authorities. It is essential to ensure transparency, security, and trust among them to prevent counterfeit drugs, data manipulation, and financial fraud. Drug supply chains using traditional trade finance processes are heavily dependent on paper, based documentation and centralized systems. These practices often cause delays, result in high transaction costs, and reduce traceability. This article introduces a Trade Finance Framework Powered by Blockchain for enhancing security in the drug supply chain transactions. The framework utilizes blockchain technology to offer decentralized, tamper, proof record keeping and real, time transaction verification. Smart contracts facilitate the automation of trade finance procedures such as letter of credit validation, payment release, and compliance verification, thus cutting down on processing time and human intervention. A distributed ledger keeps a record of each transaction, which is accessible to all and cannot be altered, all while hiding the sensitive data through encrypting mechanisms. The system put forward bolsters the mutual trust of the different parties involved, increases the ability to trace pharmaceutical products, decreases the risks of fraud, and makes regulatory compliance easier. The framework, by combining blockchain with trade finance, enables secure, effective, and transparent drug supply chain management, thus leading to higher patient safety and better financial accountability.
G. Prabakaran, Dharani Priya M, Jumana Fathima S, Keerthini R · 5 authors
The pharmaceutical supply chain is complex and often faces challenges such as lack of transparency, counterfeit medicines, and inefficient tracking. This project proposes a blockchain-based pharmaceutical supply chain management system using smart contracts to ensure secure and transparent operations. Each medicine batch is recorded on the blockchain with a unique ID, allowing all transactions from manufacturer to pharmacy to be tracked in a tamper- proof manner. The system also enables patients to verify the authenticity of medicines and detect counterfeit products. Additionally, a drug recall feature allows manufacturers to mark defective batches, preventing further distribution. By using blockchain technology, the proposed system improves traceability, enhances security, and ensures trust among all participants in the supply chain
The rise of counterfeit medicines poses serious health risks to the public and threatens the credibility of pharmaceutical companies. Blockchain technology is gaining attention for its potential to enhance the security and transparency of the pharmaceutical supply chain. This study compares the performance of two blockchain platforms, Ethereum and Nexus, in detecting and preventing counterfeit drugs. A virtual observation system was used to examine how Ethereum and Nexus addressed major challenges in counterfeit drug prevention. Two specialists with expertise in both blockchain technology and healthcare evaluated the platforms using two assessment tools: The Global Quality Scale (GQS) to measure overall effectiveness and the modified DISCERN scale to assess credibility of the information. Nexus outperformed Ethereum in both effectiveness and credibility. Evaluator 1 reported median GQS scores of 4.5 for Nexus and 3.8 for Ethereum, while Evaluator 2 reported scores of 4.2 and 3.8, respectively. These findings indicate that Nexus demonstrated higher efficiency in detecting fake drugs and ensuring supply chain integrity. Blockchain technology shows promise in strengthening pharmaceutical supply chain security. Between the two platforms studied, Nexus was found to be more effective than Ethereum in preventing counterfeit drugs. These results provide valuable insights for pharmaceutical stakeholders and policymakers seeking to implement blockchain-based solutions for drug tracking and security.
Rakan B Aldosari, Farah Kalmey, Abdullah T Alanazi, Ashraf A’aqoulah
Background: Blockchain is a cutting-edge innovation being applied to offer innovative solutions in various fields, including healthcare. The healthcare industry uses blockchain networks to store and distribute patient data across hospitals, physicians, diagnostic labs, and pharmaceutical firms. Blockchain applications are essential in the healthcare industry for identifying crucial fallacies that might be fatal. The effectiveness, security, and transparency in exchanging medical data may thus be improved in the healthcare industry. This technology may also aid medical institutions in procuring information and analysing patient data. Aim: To examine the published papers that discussed the ability of utilization and probable challenges of blockchain technology in KSA's healthcare supply chain management. Methods: Until February 10, 2023, the prime databases: Pub Med, Science Direct, Scopus, Google Scholar, Web of science, Embase and The Cochrane Library were searched. Published studies (except case reports), commentaries, editorials, reviews, and meta-analysis reporting on the use of blockchain technology in healthcare supply chain management were included and a Preferred Reporting Items of systematic Reviews and Meta-analyses (PRISMA) flow diagram was used to present the process. To assess risk of bias and the quality of the included studies, the Joanna Briggs Institute's (JBI) critical evaluation tools were implemented. Results: A total of 22 studies were included and most of them used blockchain in technology for ensuring transparency, security, and storage of electronic health or medical records. Patients benefited from seamless electronic health records provided by a multi-level blockchain eHealth system. It was observed that blockchain technology effectively addresses clinical trial misconduct, and its potential in this area is to boost data productivity for the healthcare sector. The distinctive data storage pattern of blockchain offers a high-security standard that potentially reduces concerns about data tampering. It provides flexibility, accountability, connection, and data access authentication. Blockchain helps the healthcare sector avoid certain risks and offers decentralized data protection. In our study, we observed that the most preferred network for integrating the healthcare authority, manufacturer, wholesaler, retailer, and service was Ethereum (ETH). Conclusion: Healthcare policymakers should implement blockchain in Healthcare Supply Chain Management. Moreover, they need to be aware that the primary issues with blockchain technology in the healthcare industry are the lack of practical applications, the high rate of failed initiatives, and the requirement for collaboration between diverse stakeholders. However, there is a lack of studies on how to evaluate the acceptability and assist healthcare organisations in using blockchain.
Substandard medicines in Nepal represent an under-documented yet critical threat to universal health coverage (UHC) and patient safety, disproportionately impacting marginalized communities. This opinion piece seeks to illuminate the prevalence, drivers, and far-reaching consequences of compromised pharmaceuticals, drawing on both local and global evidence. This paper offers pragmatic strategies to strengthen regulatory capacity and accountability by spotlighting ethical imperatives and systemic gaps. Bridging best practices from international frameworks with Nepal's unique context, I aim to catalyze policy discourse, cultivate public awareness, and spur multi-sectoral collaboration. Ultimately, the goal is to foster equitable and high-quality healthcare for all, reinforcing the moral imperative of safeguarding the integrity of Nepal's medicine supply.Substandard medicines are a pressing, under-recognized public health crisis in Nepal. Despite expanded healthcare access, compromised pharmaceuticals undermine patient well-being and public trust (1,2). The World Health Organization (WHO) estimates that at least one in ten medicines in low-and middle-income countries (LMICs) is substandard or falsified (3). In Africa, reports indicate up to 18.7% of sampled pharmaceuticals are compromised (4). This global issue is significantly influenced by two of the world's major suppliers of medicine, both domestically and internationally: India and China (5). According to estimates from India's Health Ministry, 5% of the nation's medicines are counterfeit and 0.3% are spurious, with one study suggesting that 75% of counterfeit medicines supplied globally originate in India (6). While recent, precise prevalence data for counterfeit drugs from China is not readily available, its role as a global manufacturing powerhouse is undisputed; for example, the country produces approximately 120 billion aspirin tablets annually for the North American market alone (7). A 2024 literature review highlights the historical scale of the issue, noting that 31% of the world's falsified and counterfeit medications are produced in China and Hong Kong (8). This geopolitical context is critically important for Nepal. The country's porous borders with these major pharmaceutical producers (9), combined with its own under-regulated supply chains, significantly heighten its susceptibility to the circulation of substandard drugs (10).A Nepal Health Research Council (NHRC) study found that 15.16% of 244 tested medicine batches failed pharmacopeial standards (11). Alarmingly, 62.16% of these were government-supplied. Compromised products included essential antibiotics, analgesics, and iron supplements, with failures in dissolution, assay, fill volume, and sterility. A 2010-2020 review of drug recall notices in Nepal revealed a surge in recalled products, most frequently antimicrobials (2). These findings indicate an ethical breach: public health facilities primarily serve the underprivileged, disproportionately imposing the burden of substandard medicines on them-a direct affront to the principle of justice (12). Patients, often unaware of compromised drug quality due to identical appearance, are denied meaningful informed consent. This erodes trust in the healthcare system and fuels antimicrobial resistance, a global health security threat with severe implications (3).Limited regulatory capacity exacerbates these dangers. In the Nepalese context, chronic under-resourcing of the Department of Drug Administration (DDA) and the National Medicines Laboratory hampers rapid testing and enforcement (13,14). Testing delays can extend for months, allowing compromised medications to circulate (15). While decentralizing drug procurement to local governments was intended to improve responsiveness, this policy has inadvertently weakened quality control due to a lack of local testing facilities and specialized personnel (14).Nepal's crisis of substandard medicines undermines human rights and core ethical principles.Tolerating this compromise of patient safety is incompatible with universal health coverage (UHC) (16). In Nepal, where a significant portion of the population relies on public health facilities for essential medicines, the prevalence of substandard drugs, especially in public health facilities (17), directly undermines the core tenets of UHC. Specifically, it violates the principle of access to quality healthcare: even if services are nominally affordable or free, receiving ineffective or harmful medication means that true, effective healthcare is not being delivered. Furthermore, the consequences of substandard medicines -prolonged illness, treatment failure, or adverse drug reactions -often lead to increased financial hardship for patients who may require further treatment, hospitalization, or experience loss of income due to illness. This directly contradicts the UHC goal of protecting people from financial risks associated with healthcare (18). This creates a two-tiered system, where those with resources can seek higher-quality care in the private sector, while the most vulnerable are left exposed to potentially dangerous treatments. Addressing this inequity and ensuring the integrity of the medicine supply is not just a matter of policy but a fundamental requirement for social justice. Success requires sustained political commitment, collaboration across sectors, and a steadfast focus on the public interest. Nepal must act decisively to eliminate substandard medicines and ensure equitable, high-quality healthcare for every citizen. This is not merely a matter of improving healthcare statistics; it is about upholding the fundamental dignity and rights of every citizen of Nepal.To address this crisis comprehensively, I argue that Nepal must move beyond isolated interventions and adopt a multi-pronged, systemic approach grounded in international best practices and adapted to the local context. The solution to the challenge of substandard medicines is complex, requiring a foundational shift from reactive detection to proactive prevention and quality assurance throughout the entire supply chain.First, the cornerstone of any effective strategy must be the robust implementation of a national quality assurance framework based on established WHO principles (19). This involves the mandatory adoption and enforcement of Good Manufacturing Practices (GMP) for domestic producers, ensuring that quality is built into products from the outset (20).Critically, this must be complemented by the nationwide implementation of Good Storage Practices (GSP) and Good Distribution Practices (GDP), which are presently lacking in Nepal (2). As detailed in WHO guidelines, this requires establishing a comprehensive Quality Management System that governs every stage of the supply chain, from procurement to delivery. This includes temperature-controlled storage and transport, proper documentation to ensure traceability, and rigorous training for all personnel involved (21,22). The goal is to create a secure, transparent, and controlled environment where opportunities for degradation or the introduction of falsified products are minimized.Second, this preventative framework must be supported by strengthening practices at the point of care through the enforcement of Good Pharmacy Practices (GPP). While pharmacistled detection of visibly substandard medicines is challenging and should not be the primary line of defense, pharmacists are integral to maintaining quality assurance (23). The US Agency for International Development (USAID) funded Medicines, Technologies, and Pharmaceutical Services (MTaPS) program has already highlighted the significant impact of GPP implementation on product quality and patient safety in Nepal (24). The urgency of this is underscored by recent local evidence from the Supervision, Performance Assessment, and Recognition Strategy (SPARS) pilot. The baseline assessment from the SPARS pilot, conducted in 2022 across 284 health facilities, revealed alarmingly poor medicines management practices, with an overall median score of only 34% across key performance indicators. Particularly low scores in domains such as storage management and stock management highlight critical, systemic gaps that a robust GPP framework is precisely designed to address (25). Therefore, a renewed focus on GPP-including proper storage, inventory management using the First-Expired-First-Out (FEFO) principle, and patient counselling (26,27)-is not merely a recommendation but an evidence-based necessity to safeguard medicine quality at the final stage of the supply chain.Third, a fundamental overhaul of the national regulatory body is imperative. While establishing a new, fully autonomous commission with civil society oversight represents an ideal long-term goal, a more pragmatic and immediate strategy is to empower the existing Department of Drug Administration (DDA). Given Nepal's resource constraints, strengthening the current regulatory infrastructure is a more feasible first step. Following successful models from other nations, such as the autonomous South African Health Products Regulatory Authority (SAHPRA) (28), granting the DDA greater operational and financial autonomy would be transformative. An empowered DDA could then engage in the kind of international collaboration essential for modern pharmacovigilance, such as the recent Memorandum of Understanding between SAHPRA and Australia's Therapeutic Goods Administration (TGA) to share regulatory information and expertise (29). Recent progress within Nepal indicates a readiness for such advancement; for instance, with support from USAID MTaPS, the DDA has begun modernizing its document management system by installing secure, access-controlled repositories to increase efficiency and security (30).While these foundational improvements are commendable, they must be viewed as the first steps in a much longer journey. Full regulatory maturity requires sustained investment to build upon these gains. This must include a significant increase in the number of trained inspectors and a shift towards a risk-based inspection model that prioritizes systematic laboratory testing of products from importers and wholesalers before they enter the market, thereby ensuring quality at the source rather than attempting to recall products that have already been dispensed.Finally, these systemic and regulatory reforms should be amplified by leveraging modern technology and strengthening post-market surveillance. A vital component underpinning all these reforms is compliance with Good Practice (GxP) principles. GxP is an acronym for a collection of quality guidelines and regulations designed to ensure that products within heavily regulated industries, such as pharmaceuticals, are consistently safe, effective, and fit for their intended use (31). This framework is not a single standard but an ecosystem of practices-including GMP, GSP, and GPP-that collectively safeguard product integrity.While technology is not a panacea, rigorous track-and-trace systems-using technologies like blockchain or simple 2D barcoding-offer a powerful tool for enforcing GxP compliance and achieving end-to-end visibility. This enables regulators to verify authenticity and rapidly identify diversions in the supply chain (32,33). Such systems, proven to be cost-effective in settings like Bangladesh (34), would support the broader GxP framework (31) and provide crucial data for the empowered DDA. Within this enhanced surveillance system, pharmacists, supported by legally protected reporting mechanisms, become vital nodes for reporting suspected adverse events or quality issues, thereby creating a feedback loop that strengthens the entire regulatory ecosystem (35).The integrity of a nation's medicine supply is a direct reflection of its commitment to health equity and social justice. For Nepal, the continued presence of substandard medicines in the supply chain represents a fundamental contradiction to its goal of achieving universal health coverage. The systemic reforms proposed-implementing a robust GxP framework, empowering an autonomous regulator, and leveraging technology for surveillance-are not merely technical exercises; they are essential acts of building trust with the nation's most vulnerable citizens and affirming their right to safe, effective healthcare. Moving forward, the challenge is not one of awareness, but of political will and sustained action. Ensuring the quality of every pill and vial is not just a matter of public health policy-it is a fundamental test of Nepal's promise of equitable healthcare for all.
The manufacturing and distribution of counterfeit tablets, especially in developing countries, is an urgent and increasingly critical global problem. Falsified medicinal products may contain incorrect ingredients and doses. One of the reasons for drug counterfeiting is the imperfect supply chain system in the pharmaceutical industry. Medicinal products are moved between manufacturers, suppliers, wholesalers, retailers, and pharmaceutical firms before meeting consumers. This study proposes PharmChain, a scenario-oriented drug traceability and regulation blockchain framework that reconstructs the entire service infrastructure by splitting the service provider into three separate service components and ensuring the authenticity and privacy of traceability details. PharmChain can track medication development via patient supply in the pharmaceutical industry. An Ethereum-based blockchain stores the transactions, and only trusted parties can access the data through the chain. We create and test our smart contract code in the Remix environment. We present detailed cost and security analyses incurred by supply chain stakeholders. We also use cost analysis to assess the performance of the proposed solution and demonstrate its affordability. • Introduce PharmChain, a data-driven scenario-based drug traceability and regulation blockchain framework. • Ensure authenticity and privacy of traceability data, enhancing security. • Validate smart contract code rigorously in the Remix environment. • Show the feasibility and affordability of PharmChain through detailed analytics. • Alleviate counterfeit tablet distribution, which poses a pressing and escalating global challenge.
In recent times, the number of fake drugs has increased dramatically, which has resulted in millions of victims severely affected by poisoning and treatment failures, resulting in a need for Drug Supply Chain (DSC) traceability. The DSC is generally reluctant to share traceability data and includes several parties having heterogeneous interests. Moreover, existing provenance and traceability systems for DSCs need more trust, data sharing transparency, and separated data storage. By realizing decentralized, trustless systems, a decentralized Blockchain (BC)-based solution is proposed to tackle these constraints. BC is an immutable, decentralized, shared network that allows management directly through a peer-to-peer (P2P) network without the necessity of a central authority to check transactions. This study proposes a new Blockchain Non-Fungible Token-based Drug Traceability with Enhanced Pharmaceutical Supply Chain Management (BNFTDT-EPSCM) model. The proposed BNFTDT-EPSCM model presents transparent and more secure reporting of changes in the operating condition of transported pharmaceutical products to prevent drug recalls. The Ethereum BC enables transactions and computational services using the cryptocurrency Ether (ETH). Simultaneously, an enhanced Byzantine fault-tolerant consensus (RB-BFT) leverages a reputation system to address reliability issues of primary nodes and reduce communication complexity inherent in the Practical Byzantine algorithm (PBFT). The BNFTDT-EPSCM model presents a decentralized solution using Non-Fungible Tokens (NFTs) to improve the traceability and tracking capabilities of the standard serialization process. In addition, the BNFTDT-EPSCM model employs a Deep Belief Network (DBN) approach to perform the inbound logistics task prediction process. Finally, the Tasmanian Devil Optimization (TDO) method is utilized to enhance the hyperparameter tuning of the DBN approach. A detailed set of simulations was executed to examine the effectiveness of the BNFTDT-EPSCM approach, demonstrating a higher throughput at the highest user count of 6000 and achieving 551.22 TPS, significantly outperforming existing models.
Currently, the stakeholders involved in the pharma supply chain are manufacturers, distributors, retailers, and patients. The process is excessively complicated, offers minimum transparency and accountability, and appears poorly protected from counterfeiting. This paper proposes a novel integration of Internet of Things (IoT) sensors, blockchain technology, and Role-Based Access Control (RBAC), creating a transparent, immutable ledger that ensures the authenticity and visibility of drugs throughout the supply chain. IoT sensors provide real-time tracking of environmental conditions and moments of drugs, while blockchain technology ensures a secure, tamper-proof record of every transaction, enhancing traceability through the supply chain. Role-Based Access Control strengthens security by limiting access to sensitive data according to the roles of different stakeholders. The use of Smart contracts simplifies processes, as it removes intermediaries and ensures secure transaction histories. This integrated approach addresses counterfeiting and transforms pharmaceutical supply chain management by improving transparency, security, and efficiency. Enhanced blockchain performance facilitates more effective drug delivery, ultimately improving patient outcomes. By utilizing these advanced technologies, the proposed system significantly reduces risks associated with counterfeiting and supply chain disturbances, ensuring the delivery of safe and effective medications to patients.
Funlade Sunmola, George Baryannis, Albert Tan, Kenneth T. Co · 5 authors
The global halal market is growing, driven by rising stakeholder populations and increasing consumer interest in ethical and sustainable food choices. This surge in demand necessitates robust halal compliance throughout complex supply chains. However, there are several challenges, including fragmented information, increased understanding of halal requirements among stakeholders, and difficulties in tracing product provenance. This paper proposes a holistic framework for halal certification and compliance, addressing these challenges through the integration of artificial intelligence (AI) and blockchain technologies. AI can automate halal compliance checks, identify potential irregularities in sourcing and composition, and facilitate risk management. The blockchain offers an ideal platform for tracking product provenance throughout the halal supply chain. This ensures trust and confidence among consumers by providing verifiable information on ingredient origin and production processes. This paper further strengthens the potential of this framework by presenting an illustrative example that utilises knowledge graphs, machine learning, and smart contracts. This exemplifies the potential application of the proposed framework in the context of halal pre-certification processes. By fostering transparency and streamlining compliance procedures, the proposed holistic framework, empowered by AI and the blockchain, can significantly enhance trust and confidence among stakeholders within the halal food industry.
Counterfeit drugs represent a serious global risk, accounting for about 10% of the medicines worldwide. This per-centage increases significantly in developing countries, reaching up to 30%, and has become a major cause of child mortality in these regions. Blockchain technology provides a good solution to address this critical issue through improving transparency and traceability of pharmaceuticals from manufacturers to end users. However, traditional blockchain applications face major challenges, particularly in terms of high costs and scalability especially when handling large volumes of data and transactions such as those found in the pharmaceutical supply chain. To address these limitations, researchers have introduced Layer 2 blockchain technologies, which operate on top of standard blockchain networks to improve scalability and reduce costs. This paper aims to design an efficient, secure, and scalable framework that can support traceability in pharmaceutical supply chains and contribute to reducing counterfeit drugs. This framework lever-ages Layer 2 blockchain solutions and combines Non-Fungible Tokens (NFTs) linked to Quick Response (QR) codes to provide unique identification for each drug. Furthermore, it incorporates the InterPlanetary File System (IPFS) for off-chain storage to reduce the amount of data stored directly on the blockchain. Additionally, an access control mechanism is incorporated to ensure the protection of sensitive data by limiting access based on predefined roles. This enhances privacy and reduces the risk of data leakage or misuse. In conclusion, this work provides the global scientific community with a secure and scalable framework that can be applied internationally to strengthen pharmaceutical supply chains and reduce the risks of counterfeit drugs.
Open access
Pharmaceutical Quality and Counterfeiting
Blockchain Technology Applications and Security
Physical Unclonable Functions (PUFs) and Hardware Security
several industrial sectors including healthcare supply chain operations. The private sector works differently because blockchain technology brings better security as well as elevated accountability and enhanced transparency. The study investigates blockchain implementation in supply chains together with healthcare operations by showing its ability to track goods precisely while reducing theft and accelerating data movement. Independent research trials prove blockchain technology enhances key operational features through better medical data management and insurance claim processing and pharmaceutical supply chain monitoring. Our team observed major performance value increases through blockchain adoption which lowered patient record retrieval times by 40% in healthcare settings. The implementation of blockchain technology led to a service delivery enhancement together with a 50% reduction of administrative expenses which shortened insurance claim processing times. Blockchains reduce fraudulent pharmaceutical products by 30% thus helping the pharmaceutical industry protect both patient safety and product integrity. Through blockchain-enabled supply chain traceability operators detect and react swiftly to tainted products which decreases health hazards affecting the public. These important additions prove vital for industries focused on security because of their need for openness. The research confirms blockchain's ability to improve supply chain management through reduction of risks and increased transparency and better operational integrity and security for healthcare systems. Supply chain managers alongside healthcare providers can cut expenses while delivering faster services to patients through improved security and efficiency of their systems which results in enhanced customer protection. Supply chain operations together with the healthcare sector will operate more efficiently in a secure fiscal manner.
Blockchain technology (BT), originally developed to facilitate secure digital monetary transactions, has recently gained significant traction in various healthcare sectors. Characterized by the exponential growth of sensitive data, the healthcare sector is poised to witness the emergence of BT. This emergence is primarily driven by the pressing need to globally expose, protect against threats, ensure confidentiality, and establish traceability for the plethora of sensitive data continuously generated by the healthcare industry. The healthcare supply chain focuses on traceability due to the prevalence of counterfeit and recalled drugs. Managing operational constraints such as temperature, humidity, and air quality within specified parameters is paramount. The various processes involved in international trade transactions contribute to the creation of numerous records, each of which is meticulously entered into the systems of the companies involved. Therefore, the problem set for this study was: What are the challenges and prospects for BT in the healthcare sector? To answer this question, the following objective was set: describe and examine the challenges and prospects of BT in the healthcare sector. In addition, a key research objective was to identify specific applications and use cases that can benefit the most from this technological advancement. In line with the research objective, a systematic review of all studies BT for traceability, anti-counterfeiting, and fraud detection was conducted from January 2023 to September 2023. Using robust tools such as VosViewer, we used bibliometric metrics from the renowned medical repository PubMed to construct and visually represent data analysis networks. BT shows remarkable potential to improve traceability and optimize supply chain management within healthcare organizations. The study includes a deep analysis of blockchain capabilities, including smart contracts, identity management, access control, and zero-knowledge proofing.
Mark Gaynor, Kathleen N. Gillespie, Allison Roe, Erica F. Crannage · 5 authors
Background: In recent years, blockchain technology has made great strides in diverse industries but has fallen behind within the pharmaceutical industry. The pharmaceutical industry is complex and would benefit greatly from the distributed database and emphasis of information privacy promoted by blockchain technology. This paper identifies the potential best application for blockchain technology in the United States pharmaceutical industry by identifying current trends, companies exploring the possibilities of blockchain technology, and industry concerns with opportunities for improvement. Methods: We utilized a 4D framework using ease of implementation, novelty, necessity, and fit of the overall industry to examine the adoption of blockchain technology in the pharmaceutical industry. Based on the 2D framework of difficulty and novelty as driving factors for the development of foundational technologies in the world of business by Iansiti and Lakhani in The Harvard Business Review, each application was ranked and scored for the best potential implementation. The potential applications proposed in this paper can be grouped into two main categories. The first category, management, includes best use cases such as health records, clinical trials, and inventory systems. The second category, monitoring, highlights cases such as pharmaceutical products, preventing counterfeits, optimizing supply chains, and addressing prescription misuse and abuse.Results: Each application was ranked by the four metrics in the framework, giving the greatest weight to necessity and ease of implementation. Using the highlighted methodology above, the applications for best implementation include Prescription Drug Misuse and Abuse Prevention, Prevention of Counterfeits, Clinical Trial Outcomes, and Smart Contracts. Conclusion: Blockchain technology offers a new and promising solution to pharmaceutical industry needs. Each application of blockchain technology must fit within the framework of necessary, ease of implementation, familiarity amongst stakeholders, and fit of the overall industry to promote the most appropriate use. By using the extended framework proposed by Iansiti and Lakhani we show that blockchain, in all these domains, shows promise to improve pharmaceutical industry performance.
Currently, the halalness of a product may only be determined by the halal certificate or halal label displayed on the product packaging. Simply put, several halal-related issues, like cross-contamination, logistical issues, halal counterfeiting, global halal acceptance, and so forth, keep coming up. To address the numerous issues raised above, it is believed that a framework that can support worldwide halal provisions is necessary. The objective of this research is to create a blockchain smart contract framework for halal transparency, integrity, and traceability. Blockchain technology along with smart contracts can solve classic tracing problems including data leakage, manipulation, and invisible data. Organizational consistency across the halal production process and the availability of raw materials that adhere to sharia laws are two more basic challenges with halal certification that blockchain and smart contracts can resolve. The usual traceability problems, such as data explosion, material cross-contamination between halal and haram, and revelation of private information, can all be resolved by smart contracts that make use of on-chain, off-chain, and electronic product code information services (EPCIS).
Firoj A. Tamboli, Manasi S. Zade, Apurva A. Salunkhe, Monali D. Kore · 7 authors
Pharmacies need to manage their data effectively. A novel technology known as blockchain holds the potential to enhance transparency and safety for various pharmaceutical operations. The Drug Supply Chain Security Act (DSCSA), which was passed by the US Congress in 2013 to stop pharmaceuticals that are stolen, tainted, or counterfeit, has a response provided by blockchain technology. Blockchain technology is a decentralized distributed ledger that uses cryptographic techniques to provide security to a peer-to-peer network of transactions. These guarantee that a product is secure and suitable for consumer sale. By making sure laws are readily followed, blockchain provides solutions to improve the validity, reliability, and efficiency of medicine production. It also presents a chance to address one of the main issues, which is the surge of fake medications getting into the system and into the hands of patients or customers. According to the pharmaceutical industry, society is seriously threatened by fake medications. False medications have a direct or indirect negative impact on patients health, sometimes leading to major problems and even death. The pharmaceutical industry's inadequate supply chain management is the cause of this counterfeiting, which jeopardizes patient safety and damages the reputation of the manufacturer. Blockchain technology can be applied to supply chain management to provide assurance, security, traceability, and openness to the chain by providing visibility and immutability of each stage in the chain. A relatively new electronic data management technology called blockchain has promise for transparency and accountability. A blockchain is a ledger of transactions that is viewable by all users of a computer network, each with an identical copy of the ledger.
The pharma supply chain system utilized smart contracts aims to enhance transparency and efficiency in the drug distribution of process.Smart contracts, deployed on a blockchain, secure various supply chain stages, such as manufacturing, distribution, etc.This system ensures real-time visibility, reduces counterfeiting risks, and enables swift response to issues like recalls.Additionally, it fosters trust among stakeholders by providing an immutable record of transactions, ultimately promoting integrity and accountability within the pharma supply chain.
This paper introduces a cutting-edge smart logistics solution for Pharma Supply Chain Management (PSCM) by integrating smart contracts, logistics planning, and asset condition monitoring using Internet of Things (IoT) devices. Focused on enhancing accountability, traceability, and liability across the entire supply chain, the proposed model demonstrates realtime visibility as products move from the drug’s manufacturer to patients. In the PSCM, a critical concern is the safe and efficient delivery of medicines, particularly in maintaining precise temperature conditions. Addressing this challenge, the solution integrates blockchain, smart contracts, IoT sensors, and gas-efficient implementations. The system employs Radio Frequency (RF) sensors to collect accurately timestamped data, ensuring transparency and reliability in drug movement. Gas-efficient smart contracts streamline processes, revolutionizing pharmaceutical supply chain management and improving patient outcomes through real-time IoT monitoring, countering counterfeit drugs, and ensuring data integrity.
Open access
Blockchain Technology Applications and Security
Pharmaceutical Quality and Counterfeiting
Innovative Microfluidic and Catalytic Techniques Innovation
Today, the healthcare sector is suffering from multiple security vulnerabilities that make it vulnerable to various types of cyberattacks. Therefore, robust security solutions need to be implemented in order to resolve these vulnerabilities. In this context, blockchain technology has emerged as a promising solution in several sectors, including the healthcare sector. It ensures enhanced security and greater transparency. It also boosts patient confidence and optimizes operational efficiency. In this paper, we first present an overview of the main classic healthcare applications: medical records management, traceability of medicines, and research and clinical trials. We then present a detailed analysis of the critical security vulnerabilities threatening these applications. Afterwards, we explain how blockchain technology can help to address these vulnerabilities. Finally, we discuss the various possible methods that aim to prevent traditional blockchain-related attacks in these healthcare applications and how blockchain technology is impacting and transforming the healthcare sector.
Abeer Mirdad, Abdulaziz Khan, Farookh Khadeer Hussain
Blockchain technology has recently been used to provide a secure storage environment through a distributed ledger. Blockchain has increasingly been used in other sectors such as real estate and supply chains, where trust and transparency are paramount considerations. In the pharmaceutical industry, for operational efficiencies, information must be shared reliably between the various stakeholders. A significant limitation in the existing literature is the lack of work to address niche problems such as the just-in-time disposal of drugs that are close to expiry. To address this gap, we propose using blockchain technology. The architectural underpinning of the proposed system (PharmaBlock) is presented and discussed. The primary contribution of this paper is the use of an early warning system (EWS) coupled with marketplace to intelligently identify and dispose of near-expiry drugs. The EWS and marketplace are evaluated and benchmarked using an experimental setup. The result of this experimental has shown that over 90% of notifications were sent correctly and shown also more than 92% of the optimal prices were predicted correctly in PharmaBlock.