Blockchain Papers

Chris BONNETT, Tania Stafinski, Evelinda Trindade

Objective: overview of Canadian practices for regulating, financing, and funding prescription drugs. Canada provides universal health coverage for hospital and physician services but excludes universal insurance of prescription medicines. Public plans provide 42% of financing, while private drug insurance covers 35% of expenditures and over 60% of Canadians – mainly through their employer. Canada has relatively high out-of-pocket expenditure (19% of spending) and is currently the tenth largest pharmaceutical market, following Brazil. It is wrestling with inequitable coverage, low use of biosimilars, and affordability and sustainability issues driven by rare disease drugs. Both federal and provincial/territorial governments and their agencies have roles in setting policy and regulating drug prices and costs. These include the federal Patented Medicine Prices Review Board (PMPRB) which ensures prices of new patented drugs are not excessive; the pan-Canadian Pharmaceutical Alliance (pCPA) which negotiates lower patented, generic and biosimilar drug prices on behalf of member jurisdictions; and the Canadian Agency for Drugs and Technologies in Health (CADTH) which provides most public drug plans with robust health technology assessment (HTA), including clinical, economic and budget impact analyses of new drugs. Private drug insurers tend to follow government initiatives, including the use of HTA and confidential Product Listing Agreements. Conclusions: Pharmaceutical coverage in Canada is a “patchwork” of more than 100 public drug plans and 100,000 private insurance plans. As such, it creates gaps in coverage which result in inequitable access and high out-of-pocket drug expenses for some Canadians. Canada’s decentralized health system and the absence of universal drug insurance, among other factors, likely contribute to higher per capita drug expenditure relative to comparable nations that have broader, publicly-funded universal health insurance and more rigourous policy and program strategies.

Nathan A. Yates, Jennifer M. Hinkel

The authors review the literature surrounding the economics of rare disease drug development and access before advancing the case for novel approaches to funding treatments. To fund the next stage of rare disease drugs, which will likely center on gene therapies and molecular medicine, they discuss value frameworks as well as patient-led models of finance, and how these may fit into the existing frameworks in the US to incentivize rare disease drug development and access. “Rare Diseases”, sometimes called “Orphan Diseases”, are those with low prevalence; a systematic review comparing definitions of Rare Disease found the prevalence definition averages around one case per 1700 people, although a common US definition often cites fewer than 200,000 people must be affected by a disease for it to be considered rare.1 Despite low prevalence of each disease fitting this definition, about 1 in 10 Americans, or 30 million, are thought to have been diagnosed with a rare disease, compared to the overall prevalence of much more common diagnoses such as diabetes which affects 10.5% of the US population. Striking in contrast, though, is the consideration that within the “rare disease” population exist 7000 or more distinct diagnoses. From a drug development perspective, the primary challenge to this market remains the balance of funding R&D while market opportunities on the commercialization end remain constrained by small patient populations (i.e., small market sizes). Financial incentives for rare drug development in the US were codified in the 1983 Orphan Drug Act (ODA), which includes tax credits, waives Food and Drug Administration (FDA) user fees, and increases marketing exclusivity for rare indications. A mosaic of programs now exists in the US to de-risk and incentivize rare disease drug development, including voucher programs (e.g., for rare pediatric diseases), grant programs (e.g., enabled under the Rare Disease Act of 2002), Small Business Innovation grants/contracts, targeted research efforts (e.g., Rare Cancer Moonshot) and others mentioned below, and regulatory pathways (e.g., Accelerated Approval). Outside of the US, incentives for development, as well as patient access to resulting treatments, vary widely by country and region. To explore economics and value in rare disease drug development, the authors consider the historical context, current trends, present-day landscape, including insurance coverage and reimbursement trends and “value frameworks” as well as patient-led models of finance, and examine novel methods for rare disease funding and access as well as the “patient–economist” perspective given that both authors are economists and rare disease patients. The current trend of patient-led activism in rare disease financing and discovery is not new, and continues the work led by the National Organization for Rare Disorders (NORD) in the 1980s that resulted in passage of the ODA in 1983. Key ODA provisions include 7-year market exclusivity for orphan drugs, tax credits, development grants, fast-track approval, and waivers of PDUFA fees (a category of FDA user fees for drug developers). Some debate exists regarding whether increased development and discovery in rare disease over the past several decades, particularly with regards to repurposed molecules, is due chiefly to the ODA or to other market and landscape forces. While some researchers have argued that the ODA has not significantly impacted market exclusivity for drugs that would have patent protection regardless of the legislation, others have shown the increase of rare disease approvals as an indicator of the ODA’s relative success.2, 3 Meanwhile, as the rise of “precision medicine” based on molecular diagnostics and next-generation sequencing technologies influences clinical decision-making and patient population definition, potentially more and more diseases, including subindications of more prevalent conditions, can be categorized as “orphan”; as an example, nearly half of requested orphan designations are for rare cancers.4 Rare disease products are comparably more available to US patients than to patients in other countries (primarily due to broad FDA labeling), yet US patients still face a number of barriers, financial and otherwise, as detailed in a 2020 report commissioned by NORD. Given the rising volume of rare disease designations of drug candidates, with 753 in 2020, pressure for market and patient access to rare disease drugs is likely to accelerate in the coming years, along with significant debate as to what constitutes “value” in a rare disease drug. Haendel et al. state that there are approximately 7000 rare diseases according to common classification procedures, but the authors estimate the actual number is closer to 10,000.5 The sheer number of rare diseases, not to mention the paucity of research available on many of these illnesses, creates enormous challenges in drug development. Since much pharmacological research is undertaken by for-profit entities, a large number of rare diseases are never investigated for treatment simply because they afflict so few people. Investing millions of dollars into research to target a disorder affecting 50 people across the globe is unlikely to provide the return on investment sought by the biopharmaceutical industry. Shareholders of public biopharma firms represent another hurdle to pursuing rare disease drug development as such investors are often focused solely on financial returns. Much rare disease drug development resides within smaller biotechnology companies. These firms, often privately held, face fewer demands for immediate earnings and have lower overhead costs than global pharmaceutical companies. After developing a promising drug candidate, such a biotech may be acquired or choose to go public to access the resources necessary to complete clinical trials. Typically, though, we see rare disease treatments marketed by major pharmaceutical companies only after the acquisition of an original developer. This process is certainly unique and frequently suboptimal overall. A recent trend is in patient groups, or in some cases individual patient advocates, seeking to create their own collaborations, funds, and research networks to address rare diseases. In some cases, these patient-led models are blending “traditional” venture-backed biotech approaches with philanthropic funding, cooperatives, and other models to create new and innovative means to accelerate discovery and approval, simultaneously seeking to prioritize the patient perspective. The Rare As One Network, for example, funded by the Chan Zuckerberg Science Initiative, backs 30 grantee patient organizations that are taking on activities usually left to venture-backed biotech, such as pharma partnership development, launching and maintaining clinical registries, building biobanks and tissue repositories, and starting clinical trials. Often, these novel approaches to early-stage development financing are paired with innovations in the development pathway, including “decentralized” or “just in time” clinical trials that allow trials to be opened on a one-off basis across a network of satellite sites so that patients can be accrued without having to travel to a central location, which previously limited trial access and accrual to large research hospitals. Other patient-led innovations include networks for data sharing and analysis, including RARE-X, NORD IAMRARE, and Genetic Alliance PEER, that enable patients to share personal health data with researchers and industry. Few academic publications have thoroughly addressed US insurance coverage and reimbursement trends for rare disease, although the topic is a frequent area of focus for private-sector research and publication. A 2020 study from University of Michigan found that while spending on rare disease therapies increased from 2013 to 2018, patient out-of-pocket costs did as well, nearly doubling from $486 to $866 per year.6 However, coverage across plans is highly variable, with restriction frequency for orphan drugs ranging from 11% to 65% in a 2019 study.7 An earlier study found that 93% of orphan drug approvals are covered by payers, but formulary management and utilization management may lead to restrictions, high cost shares, and similar mechanisms that impact access to such products.8 Assessing the “value” of rare disease treatments presents numerous challenges and is a topic of debate not only in the US but in countries with more formalized Health Technology Assessment (HTA) programs that determine insurance coverage or approval for new therapies. Small population sizes in clinical trials, limited experience with the best outcomes or endpoints to measure in such trials, the lack of existing treatments for many rare diseases, limited validated quality-of-life measurement instruments for rare disease populations, and challenges to project forward how new treatments will impact health utilization and other costs make HTA particularly difficult. The rare disease community has been vocal in criticizing use of measures such as cost-per-QALY (quality-adjusted life year), a perspective that has been supported by research demonstrating the insufficiency of such metrics in rare disease and the risk that applying them will lead to unjust policies for rare disease patients.9 Health economists have encouraged the use of broader elements beyond those typically included in cost-per-QALY assessments when evaluating the value of rare disease therapeutics. Alongside innovation coming from patient-led research and development groups, a number of academic and nongovernmental organizations have proposed or pioneered innovative funding models for rare disease drug development as well as business models that reduce risk and channel financing more efficiently. As a real-world case study, academics and venture capitalists alike have pointed to BridgeBio, a rare disease drug company with a portfolio model that reduces risk of developing only one molecule as traditional biotech companies often do. Other novel methods include crowdfunding, “venture philanthropy” that blends venture capital’s search for returns with a philanthropic and social-impact mindset, incentive prizes, disease-specific venture funds, and social impact bonds (SIBs). From the pricing perspective, researchers have proposed a number of mechanisms to allow for risk sharing, including value-based or outcomes-based contracts or cost-based yardstick pricing.10 While the high price of rare disease therapies can create “sticker shock” among the public and politicians, the authors believe it is important to consider the relevant context, emphasizing previous health economic research that has cautioned against applying an overly utilitarian view to rare disease drug development and patient access. The long-term economics and value of rare disease treatments are particularly critical to understand as they evolve over time and not be measurable (although they are possible to model) at the time of drug approval. For example, the cost of a single dose of Zolgensma (onasemnogene abeparvovec-xioi) is over $2.1 million. The uproar following the approval of this drug was immediate, ferocious, and focused singularly on the price. A more comprehensive analysis, however, reveals important details about the economics of the treatment. While onasemnogene abeparvovec-xioi is a one-time treatment, the alternatives require continued doses for life. Evrysdi (risdiplam) costs $3.4 million for one decade of treatment, and Spinraza (nusinersen) costs over $4.1 million for 10 years of therapy, plus the cost of spinal injections. The full scope and cost of all available drugs to treat a disease, as well as the secondary costs and benefits such as avoiding additional hospital stays or reducing other therapies, should be fully assessed before declaring a treatment “unaffordable” in the court of public opinion. Ultimately, the authors would agree to prioritize the development of rare disease drugs that cure or significantly alter the trajectory for the most serious and debilitating conditions affecting humanity, regardless of the size of population affected. We should always value patients by putting them at the center of development, approval, and treatment decisions. On a macro level, drugs that dramatically reduce the lifetime cost of treating rare diseases are also worthwhile to pursue, as doing so could free up capital for investment in other areas of drug discovery and improve sustainability of treating rare diseases in global markets. A two-tiered system whereby some people have access to rare disease drugs and others suffer without treatment is not ethical, but the solution is not to shortsightedly restrict development/approval of expensive medications. Instead, we should focus on economic solutions and innovative outcome-based frameworks that enhance access for all while maintaining strong incentives for research, development, and commercialization of products that can have positive life-altering and life-saving impact. While investment in rare disease therapies has increased over the past four decades, both the number of new drug candidates for and the total number of investment dollars in rare disease—whether coming from “traditional” venture capital and private equity sources, or from new philanthropic, patient-led, and social-impact based backers—are likely to continue an upward trajectory. Alongside funding and development emphasis, rare disease patients and their families, with the present authors as an example, are increasingly taking roles in drug research, policy advocacy, biopharmaceutical business, market access, and financing innovation in ways that meaningfully advance the market for rare disease research, drug development, and drug commercialization. While numerous rare diseases remain without current treatment, the past decade has seen advancement for a number of conditions that were previously thought to be “untreatable”; these “moonshots”—ambitious efforts to treat rare diseases—have paved the way for more economically viable models. There is also a growing consensus that rare disease treatments bring significant value to society, despite the applicability of any one molecule to a relatively small population. With advances in financial innovation and patient-led research, these authors are optimistic that the market for rare disease drugs will continue to attract outside investment, although they acknowledge that market access innovations will increasingly be needed to meet patient demand for global access to the drugs that result from such investment. No funding was received for this work. The authors declared no competing interests for this work.

Cenaj Tory

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.

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.

Hossein Omidian, Yadollah Omidi

No abstract is available for this record.

Salvation Ifechukwude Atalor

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.

Bud Mishra, Qianru Qi

No abstract is available for this record.

Moyosore Taiwo, Adebanjo Olowu, Yusuf Olanlokun, Ojo Timothy

As healthcare systems globally transition toward patient-centered and decentralized care models, the role of pharmacists has evolved from traditional dispensing functions to more autonomous, clinically integrated responsibilities. This paradigm shift, driven by the need for efficiency, accessibility, and personalized care, positions pharmacists as critical stakeholders in therapeutic decision-making, especially within primary and community-based health systems. In decentralized healthcare structures, such as those found in integrated care networks and rural outreach programs, pharmacists are increasingly responsible for clinical judgment, medication optimization, patient education, and adverse drug reaction monitoring—functions traditionally reserved for physicians. This study explores the extent and determinants of clinical decision-making autonomy among pharmacists within decentralized healthcare models. It examines how organizational structure, regulatory frameworks, risk management policies, and interprofessional collaboration impact pharmacists’ ability to make independent clinical decisions. Particular attention is paid to the balance between autonomy and accountability, highlighting potential risks such as therapeutic errors and liability concerns, alongside opportunities for improving medication adherence and reducing hospital readmissions. Using a mixed-methods approach involving policy analysis, structured interviews, and clinical case reviews, the study uncovers significant variation in autonomy across regions and care settings. It proposes a framework for risk-informed autonomy, whereby pharmacists operate with expanded clinical responsibility under well-defined governance and support systems. Ultimately, this research underscores the importance of redefining pharmacists’ roles in modern health systems and offers strategic recommendations for empowering them within decentralized models without compromising patient safety or care quality.

Luv Sharma, John R. Olson, Abhijit Guha, Lori McDougal

No abstract is available for this record.

Abdrhman Mahmoud Gamil

Procurement is the most important part of the pharmaceutical logistic cycle. It is the process of acquiring supplies after a properly selected list of products. The procurement system or model depends on the type of organization weather it is governmental or private, centralized or decentralized, autonomous or semiautonomous. The objectives of procurement system is to make available the right drug in an appropriate quantities of adequate quality from a reliable supplier at the right time with the lowest possible prices through an ethical and legal procedures. Prequalification of suppliers is the successful quality assurance activity. Needs and funds can be reconciled and a rational cut can be done by using ABC- VAN matrix technique. Purchasing should be by transparent competition through open tender, restrictive tender, restricted competition or in certain cases by direct negotiation by transparent committee leading to transparent contract. One of the most important procurement practice for the system to succeed is the reliable payment and efficient financial management and monitoring the supplier performance. The system should have an efficient quality assurance program with annual auditing and regular reports.

Meet Kumari, Meenu Gupta, Chetanya Ved

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.

Josep Pane, Katia Verhamme, Lacey Shrum, Irene Rebollo · 5 authors

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.

Ching Lam, Michelle Helena van Velthoven, Edward Meinert

BACKGROUND: Advanced therapies, including cell and gene therapies, have shown therapeutic promise in curing life-threatening diseases, such as leukemia and lymphoma. However, these therapies can be complicated and expensive to deliver due to their sensitivity to environment; troublesome tissue, cell, or genetic material sourcing; and complicated regulatory requirements. OBJECTIVE: This study aims to create a novel connected supply chain logistics and manufacturing management platform based on blockchain, with cell and gene therapy as a use case. Objectives are to define the requirements and perform feasibility evaluations on the use of blockchain for standardized manufacturing and establishment of a chain of custody for the needle-to-needle delivery of autologous cell and gene therapies. A way of lowering overall regulatory compliance costs for running a network of facilities operating similar or parallel processes will be evaluated by lowering the monitoring costs through publishing zero-knowledge proofs and product release by exception. METHODS: The study will use blockchain technologies to digitally connect and integrate supply chain with manufacturing to address the security, scheduling, and communication issues between advanced therapy treatment centers and manufacturing facilities in order to realize a transparent, secure, automated, and cost-effective solution to the delivery of these life-saving therapies. An agile software development methodology will be used to develop, implement, and evaluate the system. The system will adhere to the EU and US good manufacturing practices and regulatory requirements. RESULTS: This is a proposed study protocol, and upon acceptance, grant funding will be pursued for its execution in 2021. CONCLUSIONS: The successful implementation of the integrated blockchain solution to supply chain and manufacturing of advanced therapies can push the industry standards toward a safer and more secure therapy delivery process. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/17005.

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.

Tim K. Mackey, Raphael Cuomo

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.

Prerna Singal, Garima Sharma, Sumanlata Gautam

Sharing medical data with numerous stakeholders for varied purposes is a perplexing problem facing healthcare systems throughout the world. All this needs to be done, whilst ensuring patient and health data privacy and data integrity. Through this paper, an attempt has been made to present a novel distributed digital health record management system. The blockchain framework has been built using the tools provided by hyper ledger, an open source project. This system empowers patients with a comprehensive, secure, immutable, and easily accessible digital record of their health. Also, this information is available across multiple practitioners and healthcare providers throughout the world. This system can therefore empower the emergence of health data economics, empowering researchers with the health data and giving patients an opportunity to share their health data without losing anonymity. The purpose of this paper is to introduce a prototype of a health data management system utilising blockchain.

Reda Moulouki, Dominique Bernard Kanga, Taif Fatima, Mohamed Azouazi

Rising global costs and the fragmented nature of the healthcare supply chain creates several challenges. The healthcare industry needs efficient solutions that can streamline supply chain operations and processes in a cost- effective manner. Leading healthcare players are exploring blockchain technologies to achieve efficiencies and gain better control over their supply chains. In this paper, we present the current state of the subject and summarize the benefits and the challenges of the distributed organization and management of supply chains management. Focusing on healthcare, and we discuss the applicability of blockchains in the supply chain domain in the healthcare.

Mohamad Kassab, Joanna F. DeFranco, Tarek Malas, Giuseppe Destefanis · 5 authors

Healthcare is a data-intensive domain, once a considerable amount of data is daily produced due to monitoring patients, managing identities, producing medical records and processing medical insurance claims. Hence, security, besides other quality requirements, is prominent to preserve the confidentiality and integrity of such data. Blockchain technology has received attention as a mean to support secure transactions and records, including in the healthcare domain. The main contribution of this paper is providing preliminary results of an investigation on the recent literature on how the inherent characteristics of blockchain can enhance or hinder particular quality requirements in healthcare systems. We provide a preliminary analysis of five essential quality requirements for healthcare domain, besides pointing for advances that must still be achieved.

Abderahman Rejeb, Liam Bell

No abstract is available for this record.

Kevin A. Clauson, Elizabeth A. Breeden, Cameron Davidson, Tim K. Mackey

Background: Effective supply chain management is a challenge in every sector, but in healthcare there is added complexity and risk as a compromised supply chain in healthcare can directly impact patient safety and health outcomes. One potential solution for improving security, integrity, data provenance, and functionality of the health supply chain is blockchain technology. Objectives: Provide an overview of the opportunities and challenges associated with blockchain adoption and deployment for the health supply chain, with a focus on the pharmaceutical supply, medical device and supplies, Internet of Healthy Things (IoHT), and public health sectors. Methods: A narrative review was conducted of the academic literature, grey literature, and industry publications, in addition to identifying and characterizing select stakeholders engaged in exploring blockchain solutions for the health supply chain. Results: Critical challenges in protecting the integrity of the health supply chain appear well suited for adoption of blockchain technology. Use cases are emerging, including using blockchain to combat counterfeit medicines, securing medical devices, optimizing functionality of IoHT, and improving the public health supply chain. Despite these clear opportunities, most blockchain initiatives remain in proof-of-concept or pilot phase. Conclusion: Blockchain technology has the unrealized promise to help improve the health supply chain, but further study, evaluation and alignment with policy mechanisms is needed. Keywords: Blockchain, Distributed Ledger, Pharmacy, Pharmaceutical, Supply chain

Patrick G. Sylim, Fang Liu, Alvin Marcelo, Paul Fontelo

BACKGROUND Drug counterfeiting is a global problem with significant risks to consumers and the general public. In the Philippines, 30% of inspected drug stores in 2003 were found with substandard/spurious/falsely-labeled/falsified/counterfeit drugs. The economic burden on the population drug expenditures and on governments is high. The Philippine Food and Drug Administration (FDA) encourages the public to check the certificates of product registration and report any instances of counterfeiting. The National Police of Philippines responds to such reports through a special task force. However, no literature on its impact on the distribution of such drugs were found. Blockchain technology is a cryptographic ledger that is allegedly immutable through repeated sequential hashing and fault-tolerant through a consensus algorithm. This project will develop and test a pharmacosurveillance blockchain system that will support information sharing along the official drug distribution network. OBJECTIVE This study aims to develop a pharmacosurveillance blockchain system and test its functions in a simulated network. METHODS We are developing a Distributed Application (DApp) that will run on smart contracts, employing Swarm as the Distributed File System (DFS). Two instances will be developed: one for Ethereum and another for Hyperledger Fabric. The proof-of-work (PoW) consensus algorithm of Ethereum will be modified into a delegated proof-of-stake (DPoS) or practical Byzantine fault tolerance (PBFT) consensus algorithm as it is scalable and fits the drug supply chain environment. The system will adopt the GS1 pedigree standard and will satisfy the data points in the data standardization guidelines from the US FDA. Simulations will use the following 5 nodes: for FDA, manufacturer, wholesaler, retailer, and the consumer portal. RESULTS Development is underway. The design of the system will place FDA in a supervisory data verification role, with each pedigree type–specific data source serving a primary data verification role. The supply chain process will be initiated by the manufacturer, with recursive verification for every transaction. It will allow consumers to scan a code printed on the receipt of their purchases to review the drug distribution history. CONCLUSIONS Development and testing will be conducted in a simulated network, and thus, results may differ from actual practice. The project being proposed is disruptive; once tested, the team intends to engage the Philippine FDA to discuss implementation plans and formulate policies to facilitate adoption and sustainability. REGISTERED REPORT IDENTIFIER RR1-10.2196/10163

George Robert Barker

No abstract is available for this record.

Vladimir Gužvić, Tarik Čatić, Marina Kostić

OBJECTIVES: The aim of this study was to describe the healthcare system and health financing in Bosnia and Herzegovina and recent trends in health technology assessment (HTA) placement in the system. METHODS: A short review of PubMed published literature has been conducted using key words related to reimbursement, HTA, and health policy. We also revised legislation in Bosnia and Herzegovina published in Official Gazettes related to healthcare financing and organization. RESULTS: A deecentralized system in Bosnia and Herzegovina led to high differences in health policy. HTA has been recognized in legislation in Bosnia and Herzegovina, but it still has not been introduced in practice in full capacity. A small number of publications are found in PubMed treating these issues, but generally the problem of introduction of HTA in Bosnia and Herzegovina is lack of experts, as well as the political environment and education in this field. CONCLUSIONS: HTA in the Federation of Bosnia and Herzegovina and the Republic of Srpska has a short history because of a huge political impact in the decision-making process, decentralized system, and multiple decision makers in these regions. Challenges remain in assessments, in development of more transparent approaches in different areas of the health system in these regions, and in consistent application of appropriate standards especially in education of professionals who will provide establishment of HTA in the health system of The Federation of Bosnia and Herzegovina and the Republic of Srpska.