The pharmaceutical companies that manufacture, ship, and supply medical products face various challenges in tracing the products and identifying the counterfeit drugs in the supply chain system. Counterfeit drugs are one of the major consequences within the existing supply chain, which seriously affects human health and causes severe loss to the economy of the healthcare industry. Moreover, the traditional supply chain systems suffer from various challenges such as lack of transparency, limited tracing and tracking of products, privacy-related issues, and inaccurate information. The solution to the identified challenges is to leverage blockchain technology in the pharmaceutical system that adds traceability, visibility, privacy, and security to the drug supply chain. Blockchain technology is an advanced technology that stores medical product-related details in a completely decentralized manner and ensure transparency in the supply chain process. Thus, this chapter presents the drug discovery process, the pharmaceutical supply chain management system and its challenges, the need for clinical trials, and various preventive measures involved in the current pharmaceutical supply chain consortium. Then, we discuss the use case of a blockchain-based supply chain system for the pharmaceutical sector to track medical products and highlight its functionalities using the smart contract concept. The use case also explains the various smart contract concepts utilize to guarantee data provenance, eliminate the intermediatory authority, provide an immutability feature with security, maintain product traceability, and ensure transparency.
Health protection has always been a primary concern for mankind. Despite its important social role, current systems for managing the health records are slow, complicated, sometimes expensive and exposed to human errors and misunderstandings. In the health sector, the Medicalchain project seems to have the potential to become a new standard for managing health records using blockchain technology as a platform. In this paper, we propose a new model consisting of a permissioned blockchain to manage and store the electronic health records (EHR) of registered patients. This system guarantees transparency and especially immutability, which are essential for secure management and storage, ensuring a system that is efficient both for doctors and patients and, hopefully, bringing about renewed trust in the public health system. Our aim is that our work may contribute to gain momentum on the application of the blockchain technology to EHR and stimulate further discussion with health institutions to fully exploit the potential of the technology.
The Pharmaceutical supply chain needs a huge attention while developing technology based solutions as there is a great need of surveillance in production and distribution of fake, substandard, counterfeit and grey market medicines which account for hundreds of billions per year across the globe. Counterfeit drugs have captured the global markets over the period and affecting and risking many lives in a large [7], solutions to address these have become inevitable. Studies have uncovered a lot of pharmaceutical products, medical devices and biologics have been subject to counterfeiting the entire drug supply chain which is susceptible to lots of pharmaceutical crime. The international growth of the pharmaceutical market and a rise in global drug sales leading to emergence of various forms of technology and digital health platforms has given rise to many supply chain solutions. In addition to pharmaceutical frauds, improving security and addressing vulnerabilities of the medical commodities is a priority area. This leads to the formation of many technology solutions aimed at making supply chains secure, trustable and removing counterfeit drugs from it by applying various different methods and approaches. Our system proposes to leverage blockchain technology to make the supply chain of drugs transparent to increase trust among actors and provide security, authenticity and traceability with the help of IoT.
The utilization of blockchains in the medical domain has been discussed for quite some time, with multiple academic projects targeting various application domains in this field. Still, many countries feature underlying laws and regulations that make this utilization hard to impossible, especially when considering the sensitive nature of medical records. In this work we analyze the specific situation in Austria and analyse the two major regulations that need to be taken into account, the EU-wide GDPR and the Austria-specific ELGA, with respect to blockchain applications in the medical sector in Austria. Furthermore, we outline several additional key issues that need to be taken into consideration, as well as the problem of the most prominent solution, linking to external storage from the blockchain.
INTRODUCTION: The amount of mandatory data that needs to be analyzed as part of a medical device postmarket surveillance (PMS) system has grown exponentially in recent times. This is a consequence of increasingly demanding and complex regulatory requirements from Health Authorities, aimed at a better understanding of the medical device safety evaluation. Proactive approaches to PMS processes are becoming more necessary as regulators increase the scrutiny of device safety. New technologies have been explored to address some of the challenges associated with this changing regulatory environment. AREAS COVERED: This paper focuses on the different technical aspects of blockchain and how this new technology has the potential to support the ongoing efforts to improve the PMS system for medical devices. EXPERT OPINION: To address these challenges, we suggest to generate a private PMS data permissioned blockchain with a proof-of-authority consensus mechanism, to which only a restricted number of designated and audited participants have authorization to validate transactions and add them to the PMS data blockchain ledger. Blockchain has the potential to support a more efficient approach, which could offer many advantages to the different stakeholders involved in the PMS process, such as supporting with new regulatory initiatives.
Distribution of medicine in the public health community centers has been regulated and monitored in an official distribution channel. However, counterfeit medications still circulate in the community. Circulation of counterfeit medicines is caused by factors from businesses, consumers, and medicine distribution supervision. The use of blockchain technology in supply-chain has shown new breakthroughs to overcome these problems since it ensures immutability, transparency, and decentralization of data. In this paper, we proposed a new blockchain-based Medicine Supply Chain Management (MSCM) system. The proposed system has been applied to medicine distribution channels between public community health centers in Indonesia. To evaluate the proposed system, we used JMeter as a benchmarking tool to measure the system performance in terms of transactions per second, latency, and the utilization of resources.
This research analyzes the impact of counterfeit drugs on the health-care supply chain industry and evaluates the solutions currently in place to reduce the number of counterfeits coming to the market. Feedback information obtained from industry professionals is used to build requirements for PharmaCrypt, a new blockchain-driven tool.
Khizar Abbas, Muhammad Afaq, Talha Ahmed Khan, Wang‐Cheol Song
From the last decade, pharmaceutical companies are facing difficulties in tracking their products during the supply chain process, allowing the counterfeiters to add their fake medicines into the market. Counterfeit drugs are analyzed as a very big challenge for the pharmaceutical industry worldwide. As indicated by the statistics, yearly business loss of around $200 billion is reported by US pharmaceutical companies due to these counterfeit drugs. These drugs may not help the patients to recover the disease but have many other dangerous side effects. According to the World Health Organization (WHO) survey report, in under-developed countries every 10th drug use by the consumers is counterfeit and has low quality. Hence, a system that can trace and track drug delivery at every phase is needed to solve the counterfeiting problem. The blockchain has the full potential to handle and track the supply chain process very efficiently. In this paper, we have proposed and implemented a novel blockchain and machine learning-based drug supply chain management and recommendation system (DSCMR). Our proposed system consists of two main modules: blockchain-based drug supply chain management and machine learning-based drug recommendation system for consumers. In the first module, the drug supply chain management system is deployed using Hyperledger fabrics which is capable of continuously monitor and track the drug delivery process in the smart pharmaceutical industry. On the other hand, the N-gram, LightGBM models are used in the machine learning module to recommend the top-rated or best medicines to the customers of the pharmaceutical industry. These models have trained on well known publicly available drug reviews dataset provided by the UCI: an open-source machine learning repository. Moreover, the machine learning module is integrated with this blockchain system with the help of the REST API. Finally, we also perform several tests to check the efficiency and usability of our proposed system.
Nuraslina Zainal Abidin, Firdaus Fanny Putera Perdana
Despite rooted from Islamic needs, Halal certification also attracts both Muslims and non-Muslims. In fact, the non-Muslim players are the ones dominating the industry. It is widely known that Halal food chain is quite vulnerable due to complications in maintaining Halal integrity, the necessity to prevent doubtful materials, lack of control of food norms, and the importance to retain high quality. The presence of Halal certification is a form of consumer protection and therefore, the integrity of Halal certification must be carefully monitored. There are some Halal violation cases and this can potentially affect the reputation of the Halal food products. Therefore, it is important to develop a system that integrates a verifiable, open, and safe shared database that is not run by a centralized operator. Blockchain technology is the one that offers such. The study presents a framework for blockchain technology for Halal product verification for manufactured food products. The results are desired to help the food industry players in maintaining a system that can improve the transparency and the integrity of their Halal food chain. The system also intends to ensure the affordability and accessibility of Halal certification for as many industry players as possible as blockchain technology is believed to remove the complications in the certification process and reduce paperwork related cost.
William Chien, Josenor de Jesus, Ben Taylor, Victor Dods · 7 authors
Purpose: As part of the FDA’s DSCSA Pilot Project Program, UCLA and its solution partner, LedgerDomain (collectively referred to as the team hereafter), focused on building a complete, working blockchain-based system, BRUINchain, which would meet all the key objectives of the Drug Supply Chain Security Act (DSCSA) for a dispenser operating solely on commercial off-the-shelf (COTS) technology. Methods: The BRUINchain system requirements include scanning the drug package for a correctly formatted 2D barcode, flagging expired product, verifying the product with the manufacturer, and quarantining suspect and illegitimate products at the last mile: pharmacist to patient, the most complex area of the drug supply chain. The authors demonstrate a successful implementation where product-tracing notifications are sent automatically to key stakeholders, resulting in enhanced timeliness and reduction in paperwork burden. At the core of this effort was a blockchain-based solution to track and trace changes in custody of drug. As an immutable, time-stamped, near-real-time (50-millisecond latency), auditable record of transactions, BRUINchain makes it possible for supply chain communities to arrive at a single version of the truth. BRUINchain was tested with real data on real caregivers administering life-saving medications to real patients at one of the busiest pharmacies in the United States. Results: In addition to communicating with the manufacturer directly for verification, BRUINchain also initiated suspect product notifications. During the study, a 100% success rate was observed across scanning, expiration detection, and counterfeit detection; and paperwork reduction from approximately 1 hour to less than a minute. The authors demonstrate a successful implementation where product-tracing notifications are sent automatically to key stakeholders, resulting in enhanced timeliness and reduction in paperwork burden. At the core of this effort was a blockchain-based solution to track and trace changes in custody of drug. As an immutable, time-stamped, near-real-time (50-millisecond latency), auditable record of transactions, BRUINchain makes it possible for supply chain communities to arrive at a single version of the truth. BRUINchain was tested with real data on real caregivers administering life-saving medications to real patients at one of the busiest pharmacies in the United States. Conclusions: By automatically interrogating the manufacturer’s relational database with our blockchain-based system, our results indicate a projected DSCSA compliance cost of 17 cents per unit, and potentially much more depending on regulatory interpretation and speed of verification. We project that this cost could be reduced with manufacturers’ adoption of a highly performant, fully automated end-to-end system based on digital ledger technology (DLT). In an examination of the interoperability of such a system, we elaborate on its capacity to enable verification in real time without a human in the loop, the key feature driving lower compliance cost. With 4.2 billion prescriptions being dispensed each year in the United States, DLT would not only reduce the projected per-unit cost to 13 cents per unit (saving $183 million in annual labor costs), but also serve as a major bulwark against bad or fraudulent transactions, reduce the need for safety stock, and enhance the detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.
Blockchain and IoT technology has been gaining importance globally in different domain at future perspective. It has gained enormous attention with a great interest in a surfeit of various applications varying from financial services, security analysis, food, agriculture to health industry. Among the fast growing sectors, pharmaceutical industry acclaims to be the major forefront of the healthcare delivery in a largest aspect. There embarks the need of utilizing applications of IoT and Blockchain for safe delivery of healthcare management. The pharmaceutical sector helps in delivery of potential drugs at the outset of growth of medical science into the market. The need of safety and proper validation of the products of medical drugs sold to the consumers had to be taken care of much evaluation. Blockchain and IoT use cases provides the need of security of drugs and also delivery at the right time without the false interaction. In this review paper complete analysis of development in the healthcare associated with the pharmaceutical industry is done by the approach of implementation of Blockchain and IoT. This paper projects the applications of the domain with the future analysis and also the challenges in demand.
BACKGROUND: Personal health record (PHR) security, correctness, and protection are essential for health and medical services. Blockchain architecture can provide efficient data retrieval and security requirements. Exchangeable PHRs and the self-management of patient health can offer many benefits to traditional medical services by allowing people to manage their own health records for disease prevention, prediction, and control while reducing resource burdens on the health care infrastructure and improving population health and quality of life. OBJECTIVE: This study aimed to build a blockchain-based architecture for an international health record exchange platform to ensure health record confidentiality, integrity, and availability for health management and used Health Level 7 Fast Healthcare Interoperability Resource international standards as the data format that could allow international, cross-institutional, and patient/doctor exchanges of PHRs. METHODS: The PHR architecture in this study comprised 2 main components. The first component was the PHR management platform, on which users could upload PHRs, view their record content, authorize PHR exchanges with doctors or other medical health care providers, and check their block information. When a PHR was uploaded, the hash value of the PHR would be calculated by the SHA-256 algorithm and the PHR would be encrypted by the Rivest-Shamir-Adleman encryption mechanism before being transferred to a secure database. The second component was the blockchain exchange architecture, which was based on Ethereum to create a private chain. Proof of authority, which delivers transactions through a consensus mechanism based on identity, was used for consensus. The hash value was calculated based on the previous hash value, block content, and timestamp by a hash function. RESULTS: The PHR blockchain architecture constructed in this study is an effective method for the management and utilization of PHRs. The platform has been deployed in Southeast Asian countries via the Asia eHealth Information Network (AeHIN) and has become the first PHR management platform for cross-region medical data exchange. CONCLUSIONS: Some systems have shown that blockchain technology has great potential for electronic health record applications. This study combined different types of data storage modes to effectively solve the problems of PHR data security, storage, and transmission and proposed a hybrid blockchain and data security approach to enable effective international PHR exchange. By partnering with the AeHIN and making use of the network's regional reach and expert pool, the platform could be deployed and promoted successfully. In the future, the PHR platform could be utilized for the purpose of precision and individual medicine in a cross-country manner because of the platform's provision of a secure and efficient PHR sharing and management architecture, making it a reasonable base for future data collection sources and the data analytics needed for precision medicine.
Background: Pharmaceutical corruption is a serious challenge in global health. Digital technologies that can detect and prevent fraud and corruption are particularly important to address barriers to access to medicines, such as medicines availability and affordability, stockouts, shortages, diversion, and infiltration of substandard and falsified medicines.Objectives: To better understand how digital technologies are used to combat corruption, increase transparency, and detect fraud in pharmaceutical procurement systems to improve population health outcomes.Methods: We conducted a multidisciplinary review of the health/medicine, engineering, and computer science literature. Our search queries included keywords associated with medicines procurement and digital technology in combination with terms associated with transparency and anti-corruption initiatives. Our definition of ‘digital technology’ focused on Internet-based communications, including online portals and management systems, supply chain tools, and electronic databases.Results: We extracted 37 articles for in-depth review based on our inclusion criteria focused on the utilization of digital technology to improve medicines procurement. The vast majority of articles focused on electronic data transfer and/or e-procurement systems with fewer articles discussing emerging technologies such as machine learning and blockchain distributed ledger solutions. In the context of e-procurement, slow adoption, justifying cost-savings, and need for technical standards setting were identified as key challenges for current and future utilization.Conclusions: Though there is a significant promise for digital technologies, particularly e-procurement, overall adoption of solutions that can enhance transparency, accountability and concomitantly combat corruption, is still underdeveloped. Future efforts should focus on tying cost-saving measurements with anti-corruption indicators, prioritizing centralization of e-procurement systems, establishing regulatory harmonization with standards setting, and incorporating additional anti-corruption technologies into procurement processes for improving access to medicines and to reach the overall goal of Universal Health Coverage.
Victoria Ahmadi, Sophia Benjelloun, Michel El Kik, Tanvi Sharma · 6 authors
Pharmaceutical drugs are essential in diagnosing and treating patients. However, over the past decade, the issue of fraud and abuse drugs in the pharmaceutical supply chain has become increasingly apparent. To solve these problems, a transformation of the current pharmaceutical supply chain to include tracking technologies, from the source of the ingredients to the consumer, is recommended. In this paper, we investigate the novel pharmaceutical governance based on IoT and Blockchain technology. Internet of Things (IoT) based blockchain is a type of distributed ledger (DLT) that maintains an immutable record of all transaction information that is incapable of being falsified and is visible to all participants. Implementing an IoT-based blockchain system would provide the tools for the pharmaceutical industry to improve drug governance along the supply chain, thus making healthcare more efficient and reliable.
Medication quality and safety are crucial to the health of the public. Responding to the urgent need for medication information provenance and anti-counterfeiting, this study proposes a blockchain based method for medication information storage, inquiry, and anti-counterfeiting along a medication supply chain. Leveraging the features of decentralization, tamper-proof, traceability, and participative node maintenance of blockchain technology, the proposed method can assure the transparency and openness of medication supply chains. An access control policy model based on smart contract is designed to prevent medication information from being altered or disclosed at nodes of the blockchain. In addition, a point-accumulation upgrade/downgrade mechanism is introduced to improve the consensus mechanism. The proposed solution eliminates the needs for centralized institutions and third-party organizations, and provides a full record of the medication circulation process. Our simulation results show that efficiency and security are enhanced by the improved consensus algorithm and access control mechanism. As a result, our method can render high level of security and privacy protection that is critical to the integrity of a medication information management system.
Leveraging the transparency, immutability, and security of Blockchain technology for the drug supply chain, a variety of researches on counterfeit medicines has recently implemented. However, the majority of Blockchain-based medicine management proposals lack practicality. Additionally, the problem of cloning of drug has not yet been resolved explicitly. In this paper, we propose a novel Blockchain-based product ownership management method for anti-counterfeit medicine system to resist the cloning of drug and improve the practical applicability. Analysis and evaluation results of our proposed system outperform the related proposals based on criteria about a practical application, anti-clone, low cost, customer-oriented, and scalability. Furthermore, experimental implementation on a small scale shows that our proposed system works appropriately in a real environment.
Jan Heinrich Beinke, Christian Fitte, Frank Teuteberg
BACKGROUND: Data security issues still constitute the main reason for the sluggish dissemination of electronic health records (EHRs). Given that blockchain technology offers the possibility to verify transactions through a decentralized network, it may serve as a solution to secure health-related data. Therefore, we have identified stakeholder-specific requirements and propose a blockchain-based architecture for EHRs, while referring to the already existing scientific discussions on the potential of blockchain for use in EHRs. OBJECTIVE: This study aimed to introduce blockchain technology for EHRs, based on identifying stakeholders and systematically eliciting their requirements, and to discuss the key benefits (KBs) and key challenges (KCs) of blockchain technology in the context of EHRs. METHODS: The blockchain-based architecture was developed in the framework of the design science research paradigm. The requirements were identified using a structured literature review and interviews with nine health care experts. Subsequently, the proposed architecture was evaluated using 4 workshops with 15 participants. RESULTS: We identified three major EHR stakeholder groups and 34 respective requirements. On this basis, we developed a five-layer architecture. The subsequent evaluation of the artifact was followed by the discussion of 12 KBs and 12 KCs of a blockchain-based architecture for EHRs. To address the KCs, we derived five recommendations for action for science and practice. CONCLUSIONS: Our findings indicate that blockchain technology offers considerable potential to advance EHRs. Improvements to currently available EHR solutions are expected, for instance, in the areas of data security, traceability, and automation by smart contracts. Future research could examine the patient's acceptance of blockchain-based EHRs and cost-benefit analyses.
Drug counterfeit has become a global issue. The counterfeit problem has become so huge that it has drawn a significant attention among researchers and policy makers. The fake drug industry is worth of 10 billion dollar per year as estimated by `ASSOCHAM' in 2017. Also estimated by WHO about a million die per year due to fake drugs. The dispensation of fake drugs is the pivotal concern, specially in developing countries like India. One of main reason in drug counterfeiting is imperfect supply chain. There are many loop holes in our current policy of drug supply chain management system. In the present scenario of supply chain, either the information is not shared between the parties during the hand off process at all or a little or irrelevant information is shared. Once a party transfer the drug to another party, the first party doesn't know what happens to the drugs there after. The counterfeit drug not only affect the health condition of patient or the financial loss of genuine manufacturer but also it is posing serious threat to the socio-economic status of the society. In this paper, we explain details of the drug counterfeit along with a little history of the pharmacy industry and its impact on different areas and also to counter the counterfeits using Blockchain technology. Using Blockchain technology we explained here how to add traceability, visibility, and security to the drug supply chain. This proposed system will track the drugs from its origin from the manufacturer to the end the consumer.