Mamoona Humayun, N. Z. Jhanjhi, Mahmood Niazi, Fathi Amsaad · 5 authors
The purpose of this study is to overcome coordination flaws and enhance end-to-end security in the drug distribution market (DDM). One of the major issues in drug market coordination management is the absence of a centralized monitoring system to provide adequate market control and offer real-time prices, availability, and authentication data. Further, tampering is another serious issue affecting the DDM, and as a consequence, there is a significant global market for counterfeit drugs. This vast counterfeit drug business presents a security risk to the distribution system. This study presents a blockchain-based solution to challenges such as coordination failure, secure drug delivery, and pharmaceutical authenticity. To optimize the drug distribution process (DDP), a framework for drug distribution is presented. The proposed framework is evaluated using mathematical modeling and a real-life case study. According to our results, the proposed technique helps to maintain market equilibrium by guaranteeing that there is adequate demand while maintaining supply. Using the suggested framework, massive data created by the medication supply chain would be appropriately handled, allowing market forces to be better regulated and no manufactured shortages to inflate medicine prices. The proposed framework calls for the Drug Regulatory Authority (DRA) to authenticate users on blockchain and to monitor end-to-end DDP. Using the proposed framework, big data generated through drug supply chain will be properly managed; thus, market forces will be better controlled, and no artificial shortages will be generated to raise drug costs.
BACKGROUND: COVID-19 is an ongoing global pandemic caused by SARS-CoV-2. As of June 2021, 5 emergency vaccines were available for COVID-19 prevention, and with the improvement of vaccination rates and the resumption of activities in each country, verification of vaccination has become an important issue. Currently, in most areas, vaccination and reverse transcription polymerase chain reaction (RT-PCR) test results are certified and validated on paper. This leads to the problem of counterfeit documents. Therefore, a global vaccination record is needed. OBJECTIVE: The main objective of this study is to design a vaccine passport (VP) validation system based on a general blockchain architecture for international use in a simulated environment. With decentralized characteristics, the system is expected to have the advantages of low cost, high interoperability, effectiveness, security, and verifiability through blockchain architecture. METHODS: The blockchain decentralized mechanism was used to build an open and anticounterfeiting information platform for VPs. The contents of a vaccination card are recorded according to international Fast Healthcare Interoperability Resource (FHIR) standards, and blockchain smart contracts (SCs) are used for authorization and authentication to achieve hierarchical management of various international hospitals and people receiving injections. The blockchain stores an encrypted vaccination path managed by the user who manages the private key. The blockchain uses the proof-of-authority (PoA) public chain and can access all information through the specified chain. This will achieve the goal of keeping development costs low and streamlining vaccine transit management so that countries in different economies can use them. RESULTS: The openness of the blockchain helps to create transparency and data accuracy. This blockchain architecture contains a total of 3 entities. All approvals are published on Open Ledger. Smart certificates enable authorization and authentication, and encryption and decryption mechanisms guarantee data protection. This proof of concept demonstrates the design of blockchain architecture, which can achieve accurate global VP verification at an affordable price. In this study, an actual VP case was established and demonstrated. An open blockchain, an individually approved certification mechanism, and an international standard vaccination record were introduced. CONCLUSIONS: Blockchain architecture can be used to build a viable international VP authentication process with the advantages of low cost, high interoperability, effectiveness, security, and verifiability.
The award was announced during the ConV2X 2021 conference, themed “Blueprint for a New Digital Health Era,” broadcast November 9-11, 2021. The winning article is titled: "The Last Mile: DSCSA Solution Through Blockchain Technology: Drug Tracking, Tracing, and Verification at the Last Mile of the Pharmaceutical Supply Chain with BRUINchain," by lead author William Chien (PharmD, MBA) and fellow authors from UCLA Health and LedgerDomain. The article is located at https://doi.org/10.30953/bhty.v3.134. The groundbreaking article was part of the FDA’s Pilot Project Program for the Drug Supply Chain Security Act (DSCSA), and centered on a healthcare center pharmacy operating solely on commercial off-the-shelf (COTS) technology. It presented the highest number of BHTY 2020 reader engagements, with the most downloads and views. The study demonstrated a 100% success rate across scanning, expiration detection, and counterfeit detection; and paperwork reduction from approximately 1 hour to less than a minute. Projecting out to 4.2 billion prescriptions being dispensed each year in the United States, the study found that distributed ledger technologies (such as blockchain) would not only save $183 million in annual labor costs, but also avert 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.
Substandard and falsified (SF) pharmaceuticals account for an estimated 10% of the pharmaceutical supply chain in low- and middle-income countries (LMICs), where a lack of regulatory and laboratory resources limits the ability to conduct effective post-market surveillance and allows SF products to penetrate the supply chain. The Distributed Pharmaceutical Analysis Laboratory (DPAL) was established in 2014 to expand testing of pharmaceutical dosage forms sourced from LMICs; DPAL is an alliance of academic institutions throughout the United States and abroad that provides high quality, validated chemical analysis of pharmaceutical dosage forms sourced from partners in LMICs. Results from analysis are reported to relevant regulatory agencies and are used to inform purchasing decisions made by in-country stakeholders. As the DPAL program has expanded to testing more than 1000 pharmaceutical dosage forms annually, challenges have surfaced regarding data management and sample tracking. Here, we describe a pilot project between DPAL and ARTiFACTs that applies blockchain to organize and manage key data generated during the DPAL workflow, including a sample’s progress through the workflow, its physical location, provenance of metadata, and lab reputability. Recording time and date stamps with this data will create a permanent and verifiable chain-of-custody for samples. This secure, distributed ledger will be linked to an easy-to-use dashboard, allowing stakeholders to view results and experimental details for each sample in real time and verify the integrity of DPAL analysis data. Introducing this blockchain-based system as a pilot will allow us to test the technology with real users analyzing real samples. Feedback from users will be recorded and necessary adjustments will be made to the system before the implementation of blockchain across all DPAL sites. Anticipated benefits of implementing blockchain for managing DPAL data include efficient management for routing work, increasing throughput, creating a chain of custody for samples and their data in alignment with the distributed nature of DPAL, and using the analysis results to detect patterns of quality within and across brands of products and develop enhanced sampling techniques and best practices.
Open access
Innovative Microfluidic and Catalytic Techniques Innovation
Kathleen L. Hayes, Natalie Meyers, Christopher Sweet, Ayenew Ashenef · 7 authors
Substandard and falsified (SF) pharmaceuticals account for an estimated 10% of the pharmaceutical supply chain in low- and middle-income countries (LMICs), where a lack of regulatory and laboratory resources limits the ability to conduct effective post-market surveillance and allows SF products to penetrate the supply chain. The Distributed Pharmaceutical Analysis Laboratory (DPAL) was established in 2014 to expand testing of pharmaceutical dosage forms sourced from LMICs; DPAL is an alliance of academic institutions throughout the United States and abroad that provides high-quality, validated chemical analysis of pharmaceutical dosage forms sourced from partners in LMICs. Results from analysis are reported to relevant regulatory agencies and are used to inform purchasing decisions made by in-country stakeholders. As the DPAL program has expanded to testing more than 1,000 pharmaceutical dosage forms annually, challenges have surfaced regarding data management and sample tracking. Here, we describe a pilot project between DPAL and ARTiFACTs that applies the blockchain to organize and manage key data generated during the DPAL workflow, including a sample's progress through the workflow, its physical location, provenance of metadata, and lab reputability. Recording time and date stamps with these data will create a permanent and verifiable chain of custody for samples. This secure, distributed ledger will be linked to an easy-to-use dashboard, allowing stakeholders to view results and experimental details for each sample in real time and verify the integrity of DPAL analysis data. Introducing this blockchain-based system as a pilot will allow us to test the technology with real users analyzing real samples. Feedback from users will be recorded and necessary adjustments will be made to the system before the implementation of blockchain across all DPAL sites. Anticipated benefits of implementing the blockchain technology for managing DPAL data include efficient management for routing work, increasing throughput, creating a chain of custody for samples and their data in alignment with the distributed nature of DPAL, and using the analysis results to detect patterns of quality within and across brands of products and develop enhanced sampling techniques and best practices.
Open access
Pharmaceutical Quality and Counterfeiting
Innovative Microfluidic and Catalytic Techniques Innovation
Nazik Zakari, Muna Al‐Razgan, Amani Alsaadi, Haya Alshareef · 9 authors
Blockchain technology is accelerating digital transformation across multiple industries, including the pharmaceutical industry. The pharmaceutical industry suffers from a lack of transparency, difficulty tracking products, lack of trust, and the shipment of expired products. Blockchain technology has been applied to solve several of these problems. In this paper, we present a systematic review of the literature focusing on the adoption of blockchain technology in the pharmaceutical industry. We collected, analyzed, qualified, and discussed studies retrieved from seven databases. The initial search yielded 2,185 papers, which were screened, discussed, voted on, critically appraised, and collected by a snowball workflow that finally yielded 38 papers. The blockchain application areas covered in the papers were classified as counterfeit drug prevention, drug distribution, tracking and tracing, and safety and security. The most frequent category was counterfeit drug prevention, which is consistent with the primary objective of the pharmaceutical industry. The newer topics discussed in this study were data governance, data quality, pharmaceutical turnover, and prescription drug monitoring. We discuss issues surrounding each of these topics and research studies, along with their limitations and solutions. We also examine the challenges and future research directions of applying blockchain technology in the pharmaceutical industry.
The integration of blockchain technology into pharmacovigilance infrastructure for national cancer registries presents a transformative approach to managing drug safety data. Traditional pharmacovigilance systems often face challenges such as fragmented data sources, delayed reporting, lack of transparency, and data security risks. Blockchain offers a decentralized, immutable, and transparent framework that can enhance the accuracy, timeliness, and reliability of adverse drug reaction (ADR) reporting. This review explores how blockchain can be applied to cancer registries to create a more efficient and trustworthy pharmacovigilance ecosystem. It highlights the key components of a blockchain-enabled infrastructure, including smart contracts for automating data validation, permissioned ledgers for maintaining patient confidentiality, and interoperability standards to facilitate seamless data exchange among stakeholders. Furthermore, it discusses the potential benefits such as improved patient safety, strengthened regulatory oversight, enhanced collaboration among healthcare providers, and empowerment of patients in the pharmacovigilance process. Despite the promising prospects, challenges including technical complexity, regulatory compliance, scalability, and stakeholder acceptance must be addressed. Overall, blockchain holds significant potential to revolutionize pharmacovigilance practices, particularly in oncology, where timely detection and response to drug-related adverse events are critical for patient outcomes and public health.
Technological acclimatization in today's healthcare industry is a subject of new inventions. The worldwide Covid-19 epidemic has led to increase in the use of technology for healthcare supply chain , patient data management , and claims settlement. Data management in healthcare industry is a complex structure where multiple organizations provide proper supply chain services in day to day life. Improper data management disrupts the supply chain, which has a long-term impact on the healthcare sector. Various issues in the present supply chain must be addressed. Blockchain-based crypto-currencies are well-known nowadays for their ability to create safe and traceable solutions. With the growing use of crypto-currencies, it also governs new range of applications and opportunities, including healthcare applications. Blockchain-based solutions are effective in the health sector for secure data retrieval and storage, resulting in more effectual product creation and tracking. Such system can provide data provenance , promotes genuine healthcare sector demands, and ensures the immutability of multi-direction transactions. In this study, we contribute a thorough overview of the literature on how Blockchain technology is changing the way healthcare supply chains operate. We looked at 61 papers from 2019 to 2021 that highlighted various difficulties with the traditional healthcare supply chain. We scrutinized different barriers and opportunity of Blockchain-based healthcare supply chain at the end of the research.
Mavis Hong-Yu Yik, Vivian C. Wong, Tin-Hang Wong, Pang-Chui Shaw
The use of medicinal plants is popular worldwide. Correct herbal authentication is of paramount importance to the safety and best interest of consumers. On the market, there is no comprehensive blockchain-based system to track the processes from plantation to manufacturing and to the sale. With the advancement of information technology, an open and transparent blockchain-based platform, HerBChain, was created to enhance the quality control of herbal products. The implementation of blockchain technology is to minimize the manipulation of recorded information. HerBChain is an information platform for recording the six important processes of herbal product manufacturing and marketing, which include plantation base, TCM processing factory, TCM manufacturer, testing laboratory, distributor and retailer. By duly recording the parameters and data essential for product quality in manufacturing and supply chain, the traceability and reliability of the products can be ensured.
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.
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.
Fátima Leal, Adriana E. Chis, Simon Caton, Horacio González–Vélez · 20 authors
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.
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.
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.