Abdullah Quzmar, Mohammad Qatawneh, Sarah Al-Maaitah
Blockchain (BC) technology has revealed unusual opportunities to reduce fraud in the pharmaceutical, food and electrical equipment's, industries. Specifically, the attractive features of blockchain technology, such immutability, decentralization, distribution, and transparency, can address the issues of trustless between parties, tracking and monitoring all processes of drugs supply chain. Several research studies show that blockchain solutions help to reduce drugs counterfeiting and improve the process of monitoring and tracking all stage of supply chain, a comprehensive survey on this topic is lacking. In this survey, we provide insights into the adoption of blockchain technology to prevent counterfeiting in pharmaceutical industry, thus contributing to the improvement and management of drugs supply chain systems.
Medical health insurance fraud has been a major concern for the healthcare industry and governmental institutions. In the United States, the health insurance companies recorded a loss of tens of billions yearly due to healthcare fraud. Some types of fraud are at the risk of the patient's health. This is because the system that performs the manual processing of medical insurance claims frequently misses the endorsement of some stakeholders (such as the patient, pharmaceutical companies, wholesale dealers, and medical equipment suppliers) in a claim's validation process. Blockchain is a peer-to-peer distributed system that can enable the validation of healthcare claims in a secure, immutable, and transparent manner. We present a taxonomy of healthcare insurance claims frauds, and we propose and evaluate a blockchain-based healthcare insurance claims fraud detection framework.
The existing supply chain for the pharmaceutical industry is obsolete and lacks clear visibility over the entire system. Moreover, the circulation of counterfeit drugs in the market has increased over the years. According to the WHO report, around 10.5% of the medicinal drugs in lower / middle income countries are fake and such drugs may pose serious threats to public health, sometimes leading to death. Keeping these threats in mind, in this paper, we propose a blockchain-based model to track the movement of drugs from the industry to the patient and to minimize the chances of a drug being counterfeit. The reasons for using blockchain technology in our work include its immutability property and easy tracking of an entity in the blockchain. Through this proposed model, the manufacturer would be able to upload the details corresponding to a drug, after which it will be sent for approval to the Government. Thereafter, hospitals and pharmacies, based upon their requirements, can request the approved drugs. In the future, if a patient wants some medication, then he or she has to request it on the blockchain network. The request will be sent to the nearest hospital/pharmacy and thereafter, the patient can collect the medication. To implement this model, we have used Hyperledger fabric due to the presence of many auto-implemented features in it. Our implementation of the proposed blockchain based model highlights that the model can successfully detect any drug being counterfeit. This will be beneficial for the users getting affected with counterfeit drugs. Moreover, with the proposed model, we can also track the movement of the drug beginning from the manufacturer right up to the patient consuming that drug. Index Terms: Blockchain, Counterfeit Drugs, Drugs Tracking, Fake Medicines, Health Care.
This paper introduces an architecture to improve the pharmaceutical supply chain's security by using the Internet of Things, semantic web, and blockchain. This architecture increases transparency and visibility of drug flows and improves the representation of the increasing amounts of data that have been generated from pharmaceutical supply chain transactions. The pharmaceutical companies have problems dealing with the complexity of their supply chains, which represent the full life cycle of drugs from extracting raw materials, production, distribution, tracking of drugs, and quality assurance to use by patients. They need to create an efficient, effective, transparent, immutable, and secured supply chains to achieve a competitive advantage in a fast-changing market. A proposed architecture which applies the semantic web technology is implemented to enhance the representation capability of the IoT-blockchain based pharmaceutical supply chain data by annotating them with semantically rich languages to conduct formal reasoning, and aggregating data from heterogeneous sources in easy way and an interoperable manner. The proposed architecture integrates IoT, blockchain, and semantic web to help pharmaceutical companies improving their supply chains in transit and storage, improving patient satisfaction, trust through transparency, preventing drug counterfeit and sharing and reusing knowledge related to the pharmaceutical supply chain with other systems.
BACKGROUND: Recently, the problem of traditional Chinese medicine (TCM) safety has attracted attention worldwide. To prevent the spread of counterfeit drugs, it is necessary to establish a drug traceability system. A traditional drug traceability system can record the whole circulation process of drugs, from planting, production, processing, and warehousing to use by hospitals and patients. Once counterfeit drugs are found, they can be traced back to the source. However, traditional drug traceability systems have some drawbacks, such as failure to prevent tampering and facilitation of sensitive disclosure. Blockchain (including Bitcoin and Ethernet Square) is an effective technology to address the problems of traditional drug traceability systems. However, some risks impact the reliability of blockchain, such as information explosion, sensitive information leakage, and poor scalability. OBJECTIVE: To avoid the risks associated with the application of blockchain, we propose a lightweight block chain framework. METHODS: In this framework, both horizontal and vertical segmentations are performed when designing the blocks, and effective strategies are provided for both segmentations. For horizontal segmentation operations, the header and body of the blockchain are separated and stored in the blockchain, and the body is stored in the InterPlanetary File System. For vertical segmentation operations, the blockchain is cut off according to time or size. For the addition of new blocks, miners only need to copy the latest part of the blockchain and append the tail and vertical segmentation of the block through the consensus mechanism. RESULTS: Our framework could greatly reduce the size of the blockchain and improve the verification efficiency. CONCLUSIONS: Experimental results have shown that the efficiency improves compared with ethernet when a new block is added to the blockchain and a search is conducted.
Pedro Elkind Velmovitsky, Frederico M. Bublitz, Laura Fadrique, Plinio Pelegrini Morita
BACKGROUND: Although big data and smart technologies allow for the development of precision medicine and predictive models in health care, there are still several challenges that need to be addressed before the full potential of these data can be realized (eg, data sharing and interoperability issues, lack of massive genomic data sets, data ownership, and security and privacy of health data). Health companies are exploring the use of blockchain, a tamperproof and distributed digital ledger, to address some of these challenges. OBJECTIVE: In this viewpoint, we aim to obtain an overview of blockchain solutions that aim to solve challenges in health care from an industry perspective, focusing on solutions developed by health and technology companies. METHODS: We conducted a literature review following the protocol defined by Levac et al to analyze the findings in a systematic manner. In addition to traditional databases such as IEEE and PubMed, we included search and news outlets such as CoinDesk, CoinTelegraph, and Medium. RESULTS: Health care companies are using blockchain to improve challenges in five key areas. For electronic health records, blockchain can help to mitigate interoperability and data sharing in the industry by creating an overarching mechanism to link disparate personal records and can stimulate data sharing by connecting owners and buyers directly. For the drug (and food) supply chain, blockchain can provide an auditable log of a product's provenance and transportation (including information on the conditions in which the product was transported), increasing transparency and eliminating counterfeit products in the supply chain. For health insurance, blockchain can facilitate the claims management process and help users to calculate medical and pharmaceutical benefits. For genomics, by connecting data buyers and owners directly, blockchain can offer a secure and auditable way of sharing genomic data, increasing their availability. For consent management, as all participants in a blockchain network view an immutable version of the truth, blockchain can provide an immutable and timestamped log of consent, increasing transparency in the consent management process. CONCLUSIONS: Blockchain technology can improve several challenges faced by the health care industry. However, companies must evaluate how the features of blockchain can affect their systems (eg, the append-only nature of blockchain limits the deletion of data stored in the network, and distributed systems, although more secure, are less efficient). Although these trade-offs need to be considered when viewing blockchain solutions, the technology has the potential to optimize processes, minimize inefficiencies, and increase trust in all contexts covered in this viewpoint.
For a few decades, it is a very big challenge to monitor and keep track of genuine medicine in health care. Lacking a trust system and strong monitoring authority, syndicates can make counterfeit medicine easily. With the shifting of life-critical healthcare, it becomes an emergency to ensure substandard drugs. Because counterfeit medicine has a deadly effect on the human body and has disastrous results. To detect the falsified medicine, we proposed a drug tracing system using blockchain technology. Our system is able to detect substandard and anomaly drugs from manufacturer company to patient's hand. Also can verify the defective and expired drugs in the market using smartphones by scanning QR (Quick Response) code. Blockchain security could make the system more transparent and reliable. This paper aims to ensure drug quality, transaction security, and data safety using blockchain technology.
Pharmaceutical supply chain (PSC) consists of multiple stakeholders including raw material suppliers, manufacturers, distributors, regulatory authorities, pharmacies, hospitals, and patients. The complexity of product and transaction flows in PSC requires an effective traceability system to determine the current and all previous product ownerships. In addition, digitizing track and trace process provides significant benefit for regulatory oversight and ensures product safety. Blockchain-based drug traceability offers a potential solution to create a distributed shared data platform for an immutable, trustworthy, accountable and transparent system in the PSC. In this paper, we present an overview of product traceability issues in the PSC and envisage how blockchain technology can provide effective provenance, track and trace solution to mitigate counterfeit medications. We propose two potential blockchain based decentralized architectures, Hyperledger Fabric and Besu to meet critical requirements for drug traceability such as privacy, trust, transparency, security, authorization and authentication, and scalability. We propose, discuss, and compare two potential blockchain architectures for drug traceability. We identify and discuss several open research challenges related to the application of blockchain technology for drug traceability. The proposed blockchain architectures provide a valuable roadmap for Health Informatics researchers to build and deploy an end-to-end solution for the pharmaceutical industry.
Open access
Pharmaceutical Quality and Counterfeiting
Blockchain Technology Applications and Security
Innovative Microfluidic and Catalytic Techniques Innovation
Aim: Critically investigating the possibility of adopting blockchain technology within the Nigerian pharmaceutical supply chain to curb the supply of counterfeit drugs. Study Design: The study is qualitative in nature and the primary data were fetched through interviews. Place and Duration of the Study: Conducted within Nigeria for a period of 3 months. Methodology: A qualitative method of data collection was adopted in the study, where some stakeholders were interviewed. The interviews were conducted with employees from different pharmaceutical companies and some drug regulatory agencies in Nigeria. Result: Firstly, this study has ascertained the current prevalence of counterfeit drugs and the reasons for that. The study discovers a very high level of counterfeit drugs and some reasons behind that. Secondly, this study has also found some barriers to blockchain adoption, including the fact that the level of awareness of blockchain technology among stakeholders within the Nigerian pharmaceutical supply chain and the regulatory agencies is very low. Conclusion: It was concluded that the efforts put in developing a viable COVID-19 vaccine could be undermined due to the current nature of the Nigerian pharmaceutical supply chain, the nature of porous borders in place, absence of an apparent drug distribution system, among others. This study also concludes that the supply chain's current structure needs more regulatory and structural interventions by the Nigerian government than blockchain technology. In other words, with the current nature of the supply chain, blockchain technology adoption would not be effective in delivering the said benefits reported by scholars because the atmosphere is not conducive for successful blockchain adoption.
Background. Vaccine, as an irreplaceable means in herd immunization, is widely applied in prevention for communicable diseases. However, adverse impacts were frequently incurred by fake or expired vaccines in China. Given the necessity of vaccine anticounterfeiting, blockchain-based transaction platform could be practiced as a solution in addressing the issue; however, most of the available experiments focused on single-chain structured design with inventible limitations. Accordingly, exploration for the effectiveness and feasibility of mixed-chains structured platform for vaccine anticounterfeiting and tracing is essentially required. Methods. Both public chain and private chain were inserted in anticounterfeiting and tracing platform designing process, which were subsequently simulated in Ethereum environment. Results. By recording different information in public chain and private chain, partial information privacy protection requirements are realized. The transfer identification module realized the function of vaccine quality supervision and solves the problem of EPC label replication. Discussion. Compared with the traditional single-structured design, completeness information could be visited by all stakeholders in double-chain structure, including vaccine suppliers, National Medical Products Administration (NMPA), vaccine purchasers, and the vaccinated. Conclusion. Double-chain structured system for vaccine anticounterfeiting and tracing is more effective.
The safety of the pharmaceutical drug supply chain is a major concern for global public health as the plague of drug counterfeiting along the supply chain is an increasing threat to the health of everyone. Various solutions have been proposed to solve the problem, yet, the problem is still rife, as estimates reveal that between 10% -30% of drugs in the developed and developing countries respectively are counterfeit. This research proposes an enhanced drug anti-counterfeiting and verification system, using blockchain, to counter the plague of drug counterfeiting along the supply chain, while providing a suitable means of verifying such drugs. Two germane smart contracts -shipDrug and receiveDrugwere defined to serve as a means of safely moving drugs from one supply chain actor to the other, to secure the drug supply chain from the infiltration of counterfeit drugs. The system was implemented on the Hyperledger Fabric. The implemented system effectively secured the supply chain by allowing only the valid supply chain actors to execute the defined smart contracts. Final consumers were able to verify a drug by using a unique identifier associated with that drug to query the transaction history from the blockchain ledger. Hyperledger Caliper was used to evaluate the proposed system where it was revealed that an optimal throughput of 46 drug verifications per second was obtained, with less utilization of CPU and memory resources. The health ramifications of drug counterfeiting and the findings from this research make it imperative to consider the proposed system as an effective drug anti-counterfeiting system. Finally, it was recommended that the global health authority could implement the system on a global scale, after a smaller scale implementation, such as within countries, to determine its effectiveness in securing the drug supply chain within such jurisdictions.
Transforming a vaccine concept into a real vaccine product is a complicated process and includes finding suitable antigens and regulatory, technical, and manufacturing obstacles. A relevant issue within this scope is the clinical trial process. Monitoring and ensuring the integrity of trial data using the traditional system is not always feasible. The search for a vaccine against the coronavirus SARS-CoV-2 illustrates this situation. The scientific credibility of findings from several vaccines' clinical trials contributed to distorted perceptions concerning the benefits and risks of the drug. This scenario is ideal for applying technologies such as Blockchain and Smart Contracts in healthcare issues. This paper proposes a protocol based on Smart Contracts, named VaccSC, to enable transparency, accounting, and confidentiality to Phase III of vaccine experiments. The protocol was implemented in Solidity language, and results show that the VaccSC enables double-blindness, randomization, and the auditability of clinical data, even in the presence of dishonest participants.
Production lines in pharmaceutical manufacturing generate numerous heterogeneous data sets from various embedded systems which control the multiple processes of medicine production. Such data sets should arguably ensure end-to-end traceability and data integrity in order to release a medicine batch, which is uniquely identified and tracked by its batch number/code. Consequently, auditable computerised systems are crucial on pharmaceutical production lines, since the industry is becoming increasingly regulated for product quality and patient health purposes. This paper describes the EU-funded SPuMoNI project, which aims to ensure the quality of large amounts of data produced by computerised production systems in representative pharmaceutical environments. Our initial results include significant progress in: (i) end-to-end verification taking advantage of blockchain properties and smart contracts to ensure data authenticity, transparency, and immutability; (ii) data quality assessment models to identify data behavioural patterns that can violate industry practices and/or international regulations; and (iii) intelligent agents to collect and manipulate data as well as perform smart decisions. By analysing multiple sensors in medicine production lines, manufacturing work centres, and quality control laboratories, our approach has been initially evaluated using representative industry-grade pharmaceutical manufacturing data sets generated at an IT environment with regulated processes inspected by regulatory and government agencies.
We take a zero tolerance to any situation where fraudulent research is published in our journals. As a result, this article has been retracted by the Publisher because it is suspected to be a nonsensical computer-generated publication with a number of tortured phrases and irrelevant references. Additional measures have been implemented to prevent these issues from reoccurring. EDP Sciences is extremely grateful to anonymous whistleblowers and the Problematic Paper Screener for bringing this case to our attention for further investigations.
Blockchain, a distributed ledger technology (DLT) that sustained the creation of the first digital currency, Bitcoin, crosses many business areas, including healthcare, to promise better economic solutions. Blockchain generalized implementation is already a reality in Estonia, perhaps the most digitally advanced country globally, with proven healthcare results for its citizens. From a pharmaceutical industry perspective, blockchain offers solutions as diverse as the structuring of clinical trial protocols, the traceability of medicines along the supply chain, and intellectual property rights. Additionally, the DLT's cryptographic protocol, whose main characteristics are immutability, consensus, security, and transparency, may support both the web's decentralization and the transition to a Semantic Web, which is recognized by many as highly recommended.
Ahmad Musamih, Raja Jayaraman, Khaled Salah, Haya R. Hasan · 6 authors
Controlled drugs are open to abuse, misuse, and diversion. Therefore, they are regulated and tracked across the healthcare sector to protect the health of the general public which is a highly prioritized rule in the health professional’s code of ethics. Healthcare centers that provide controlled medication to patients are still using manual papers to record controlled drugs production, delivery, prescription, administration, and disposal which causes delays in the system. Moreover, instances of controlled drugs misuse, abuse, and diversion still exist, which shows how the currently used system is inefficient in detecting such activities. Therefore, to ensure that the public health is safe and secure, an end-to-end system that tracks the whole healthcare supply chain is necessary. In this paper, we introduce a private Ethereum blockchain-based solution for the management of controlled medication.We ensure transparency, accountability, security, and data provenance by developing smart contracts that record all actions on an immutable ledger. We utilize off-chain storage, which is represented in the IPFS to store content that is large in size such as images. We present algorithms of the different phases in the proposed solution to illustrate how each phase will be carried out. We showcase the functionality of the proposed solution by performing tests and validating the smart contracts. We assess the performance of the proposed solution by conducting privacy, security, and confidentiality analysis. Performance evaluation shows that our solution is secure against common attacks and vulnerabilities and preserves the privacy and confidentiality of the patients. The smart contracts code is made publicly available along with the testing scripts.
Ahmad Musamih, Raja Jayaraman, Khaled Salah, Haya R. Hasan · 6 authors
Distribution and delivery of Coronavirus 2019 (COVID-19) vaccines have become challenging after their emergence. Today's platforms and systems leveraged for managing data related to COVID-19 vaccines' distribution and delivery fall short in providing transparency, trackability and traceability, immutability, audit, and trust features. Also, they are vulnerable to the single point of failure problem due to centralization. Such limitations hindering the safe, secure, transparent, trustworthy, and reliable distribution and delivery process of COVID-19 vaccines. In this paper, we propose an Ethereum blockchain-based solution for managing data related to COVID-19 vaccines' distribution and delivery. We develop smart contracts to automate the traceability of COVID-19 vaccines while ensuring data provenance, transparency, security, and accountability. We integrate the Ethereum blockchain with off-chain storage to manage non-critical and large-sized data. We present algorithms and discuss their full implementation, testing, and validation details. We evaluate the proposed solution by performing cost and security analysis as well as comparing it with the existing non-blockchain and blockchain-based solutions. Performance evaluation results reveal that the proposed solution is low-cost, and our smart contracts are secure enough against possible attacks and vulnerabilities. The smart contracts code along with testing scripts is made publicly available.
Open access
Blockchain Technology Applications and Security
Pharmaceutical Quality and Counterfeiting
Innovative Microfluidic and Catalytic Techniques Innovation
Ahmad Musamih, Khaled Salah, Raja Jayaraman, Junaid Arshad · 7 authors
Healthcare supply chains are complex structures spanning across multiple organizational and geographical boundaries, providing critical backbone to services vital for everyday life. The inherent complexity of such systems can introduce impurities including inaccurate information, lack of transparency and limited data provenance. Counterfeit drugs is one consequence of such limitations within existing supply chains which not only has serious adverse impact on human health but also causes severe economic loss to the healthcare industry. Consequently, existing studies have emphasized the need for a robust, end-to-end track and trace system for pharmaceutical supply chains. Therein, an end-to-end product tracking system across the pharmaceutical supply chain is paramount to ensuring product safety and eliminating counterfeits. Most existing track and trace systems are centralized leading to data privacy, transparency and authenticity issues in healthcare supply chains. In this article, we present an Ethereum blockchain-based approach leveraging smart contracts and decentralized off-chain storage for efficient product traceability in the healthcare supply chain. The smart contract guarantees data provenance, eliminates the need for intermediaries and provides a secure, immutable history of transactions to all stakeholders. We present the system architecture and detailed algorithms that govern the working principles of our proposed solution. We perform testing and validation, and present cost and security analysis of the system to evaluate its effectiveness to enhance traceability within pharmaceutical supply chains.