ORIGINAL RESEARCH
Mark Gaynor, PhD1, Kathleen Gillespie, PhD1, Allison Roe1, Erica Crannage, PhD2 and J.E. Tuttle-Newhall, MD3
1College of Social Justice and Public Health, Saint Louis University, St. Louis, Missouri, USA; 2Associate Professor, Pharmacy Practice, University of Health Sciences and Pharmacy, St. Louis, Missouri, USA; 3Department Chair of Surgery, East Carolina University, Greenville, North Carolina, USA
Keywords: 4D framework, blockchain applications, blockchain technology, clinical trials, health records, inventory systems, pharmaceutical industry, prescription misuse and abuse
Methods: We utilized a 4D framework using ease of implementation, novelty, necessity, and fit of the overall industry to examine the adoption of blockchain technology in the pharmaceutical industry. Based on the 2D framework of difficulty and novelty as driving factors for the development of foundational technologies in the world of business by Iansiti and Lakhani, each application was ranked and scored for the best potential implementation. The potential applications proposed in this paper can be grouped into two main categories. The first category, management, includes best-use cases, such as health records, clinical trials, and inventory systems. The second category, monitoring, highlights cases, such as pharmaceutical products, preventing counterfeits, optimizing supply chains, and addressing prescription misuse and abuse.
Results: Each application was ranked by the four metrics in the framework, giving the greatest weight to necessity and ease of implementation. Using the highlighted methodology earlier, the applications for best implementation include Prescription Drug Misuse and Abuse Prevention, Prevention of Counterfeits, Clinical Trial Outcomes, and Smart Contracts.
Conclusion: Blockchain technology offers a new and promising solution to the pharmaceutical industry’s needs. To promote the most appropriate use, each application of blockchain technology must fit within the framework of necessity, ease of implementation, familiarity amongst stakeholders, and fit of the overall industry. By using the extended framework proposed by Iansiti and Lakhani, we show how blockchain, in all these domains, shows promise to improve pharmaceutical industry performance.
Citation: Blockchain in Healthcare Today 2024, 7: 298.
DOI: https://doi.org/10.30953/bhty.v7.298
Copyright: © 2024 The Authors. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, adapt, enhance this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0.
Received: December 12, 2023; Accepted: March 12, 2024; Published: April 30, 2024
Funding: This research is not funded by any organization or government.
Financial and non-Financial Relationships and Activities – no Financial Relationships: The authors have no conflicts of interest or financial relationships to disclose.
Corresponding Author: Mark Gaynor, Email: mark.gaynor@slu.edu
In recent years, blockchain technology has made great strides in diverse industries, but it has fallen behind within the pharmaceutical industry. The pharmaceutical industry is complex and would benefit greatly from the distributed database and emphasis on information privacy promoted by blockchain technology. Based on the 2D framework of difficulty and novelty as driving factors for the development of foundational technologies in the world of business by Iansiti and Lakhani,1 this paper identifies the potential best application for blockchain technology in the United States pharmaceutical industry by identifying current trends, companies exploring the possibilities of blockchain technology, and industry concerns with opportunities for improvement.
As society becomes more familiar with the revolution of blockchain technologies in transaction processing, record management, surveillance, and data management, blockchain will likely be implemented at greater rates into a diverse set of industries, including healthcare. This paper evaluates and discusses the ways that blockchain technology can be implemented in the pharmaceutical industry and transform multifaceted problems.
Since the invention of the cyber currency, Bitcoin, blockchain technology has been implemented across many industries to solve a plethora of problems. Blockchain technology links blocks that store transactions to one another in a distributed ledger. The use of a distributed ledger in a blockchain is crucial due to its unique security features. Distributed ledgers are “a type of database that (are) shared, replicated, and synchronized among the members of a network. The distribution ledger records the transactions, such as the exchange of assets or data, among the participants in the network.”.2 In a private ledger within a block, access is limited to authorized members, while in a public ledger, data are independently verified, and transaction participants can remain anonymous.3 A public ledger does not require membership, while a private blockchain requires contributions of a ledger to be approved by an organization to confirm the transaction is allowed. In any given network, participants interact to view, store, and exchange information. The ledger of any blockchain is permanently recorded as an incorruptible set of data.3
Figure 1 illustrates a simple blockchain. Each block holds a piece of data (e.g. a transaction), a hash of the preceding block, and a hash for the data within the block.4 The dashed lines represent the region that each block hash covers. Every block (except the root block) is linked to the previous block and each subsequent block in the secure chain. If any alterations to the data were to occur, the hash of the changed block and each hash following the chain will also be altered.5
Fig. 1. Visual representation of a simple blockchain. Comprised of a root block, a hash of the preceding block, and a hash of the data in the block. Reproduced from the author, Gaynor et al.5 B(1) etc.: abbreviation for “Block.”
Fig. 2. Blockchain functioning across the pharmaceutical industry is divided into two categories: (1) monitoring and (2) management. These categories reflect implementation strategies using different components and functions. However, when combined, they work together to support best practices and a potential framework for blockchain technology in the pharmaceutical industry.
Fig. 3. Potential opportunities for blockchain technology monitoring in the pharmaceutical industry, specifically as it relates to the prevention of counterfeits, supply chain function, prescription misuse, and warnings. Flow diagram with permission from the author, Gaynor.4
The blockchain can be viewed as a distributed ledger that is a permanently recorded set of data that is incorruptible.3 Individuals in each blockchain network interact to store, exchange, and view information. The data are confirmed and then validated as transaction blocks are linked and chained from the beginning of the chain to the most current block.2 With each transaction, the blockchain becomes increasingly difficult to alter, as each block must be verified by all users in the ledger.4 Additionally, a blockchain network will conduct automatic self-checks that decrease corruptibility and maximize the overall transparency among stakeholders in a blockchain.6 These two concepts work together to uphold the overall integrity of a blockchain.
Blockchain technology does not depend on a centralized authority. Instead, each record is accessible to all members of a blockchain and can be easily verified. However, due to security needs in health care, these blocks could operate as semipublic – using permission rights to verify data before it permanently joins a blockchain.4 This approach allows restricted access. Simultaneously, an audit trail accompanies each transaction to verify and authenticate it. Each of these records will have a corresponding timestamp and cryptographic signature.2 If a set of data were to have a private key, it would act as a password allowing specific individuals the ability to access data within a contained transaction.7 In a public key system, a user is traced by their address on the blockchain to prove original ownership. Blockchain uses both a public and private key model to ensure that the stored data are not only incorruptible but also traceable to a source while maintaining anonymity.4
A cryptographic hash acts as the digital signature to authenticate each block of data in a blockchain.2 Hashing complements the use of both private and public keys by authenticating that the information in a transaction has remained unaltered. Together, these blockchain functions support the elimination of centralized intermediaries in establishing trust.7 The elimination of a centralized authority fosters trust and facilitates more efficient data and information transfer.6
In 2023, the United States encompassed over 43% of the total global pharmaceutical industry market share.8 This is expected to continue increasing with a predicted annual growth rate of 5.96% between the years 2024 and 2028.9 Due to this, the United States will continue to grapple with complex issues related to the management of high-value pharmaceutical products. Within the United States, pharmaceuticals account for a growing share of the healthcare economy. Retail prescription expenditures accounted for over $300 billion of the $2.3 trillion spent on healthcare in 2021 or 9% of the total retail market.10
The pharmaceutical industry encompasses several key internal stakeholders, including pharmaceutical manufacturers, pharmaceutical wholesalers, health systems, pharmacies, and individual patients with prescription needs (see Appendix for greater detail). Most prescription drugs are sold by the manufacturer to a wholesaler. The wholesaler then sells the drug to pharmaceutical benefits management companies, health systems, group purchasing arrangements, and retail pharmacy companies. Prices within this market change frequently, and there is a complex practice of rebates, discounts, and chargebacks that can occur from the point of the original sale to the wholesaler until after the drug is dispensed. Thus, multiple organizations require secure access to financial transactions over time. Different organizations have different abilities to make requests to alter those transactions and then to approve or deny them.
The pharmaceutical industry also has several external stakeholders that include the general public, government entities that oversee and regulate the industry, and accreditation and trade organizations—all of which add increased regulation and verification pressure on the pharma sector. Current challenges include the ability to monitor pharmaceuticals throughout the supply chain, protection against fraud, the ability to follow a streamlined research and development process (including clinical trials), and lack of prevention for misuse and abuse of addictive substances. By implementing blockchain technology, the pharmaceutical industry can improve population health outcomes and provide better transparency among stakeholders.
Blockchain technology can be implemented to create more efficient, secure, and transparent systematic approaches within the pharmaceutical industry. By prioritizing applications that meet these needs, it is easier to create areas of possible application. These can be categorized into two main categories: monitoring and management.
Numerous companies and organizations are utilizing blockchain technology to revolutionize the pharmaceutical industry. Many of these current applications use blockchain technology to provide real-time tracking and data transparency within the pharmaceutical industry, increasing patient safety, understanding, and overall health outcomes. These applications will be expanded upon below within the outlined hierarchical structure.
The pharmaceutical industry’s ability to monitor goods and products is essential. Many stakeholders are involved in the delivery of one specific product to any individual consumer. However, given the industry’s multifaceted nature, there is a deficiency in authenticating products and preventing prescription misuse. Blockchain technology’s inherent lack of central governance can enhance visibility, authentication, and information flow, ultimately improving patient care in the context of pharmaceutical needs.
The successful implementation of blockchain technology occurs when it integrates seamlessly with existing technology systems within the pharmaceutical industry. Further analysis of potential applications for monitoring pharmaceutical products includes:
The healthcare industry, including pharmaceutical makers, generates an enormous amount of data. Personal health information includes a wide variety of data sources, such as electronic health records, wearable devices, health apps, etc. Protecting these data is essential as much of it includes high-value personal health information.
The distributed ledger and cryptographic hashing features of a blockchain allow for better data governance. The future of blockchain technology implementation within pharmaceutical industry management includes the following applications:
Blockchain technology provides a new cryptographically secure way to store, share, and manage data across the pharmaceutical industry. Similarly, blockchain technology offers a unique capability in managing inventory and supplies across hospital and healthcare systems by decentralizing management and enhancing accessibility. Figure 4 portrays a hierarchy for possible applications of blockchain technology within the management of both data and inventory in the pharmaceutical industry.
Fig. 4. Systematic analysis of Management functions of blockchain technology. Management functions can be defined as inventory management or data management. Reproduced with permission from the author, Gaynor et al.4
Our selection algorithm for technology in the pharmaceutical industry is based on the framework presented by Iansiti and Lakhani.1 Their framework presents the essential components of Ease of Implementation and Industry Familiarity. This framework was extended by Gaynor to include Necessity.4 In this article, we extend our framework to include Fit-for-Purpose.22 This extended framework enables us to rank applications of blockchain technology in the pharmaceutical industry based on essential metrics and to select the applications most likely to be adopted with this emerging technology.
Figure 5 illustrates nine potential applications for blockchain technology in the pharmaceutical industry ranked by their overall score. Applications with the highest scores are the most likely to be successfully implemented. Each of the nine applications was ranked on Ease, Familiarity, Fit, and Necessity. After this ranking, their scores were summed and given an official ranking.
Fig. 5. Selection of algorithms for the application of blockchain trichology in the pharmaceutical industry. The graph depicts the total score of each application of the nine applications based on the decision matrix of Ease, Familiarity, Fit, and Necessity.
Each of the nine applications was ranked on a scale of 1–5 in the four metrics: Ease, Familiarity, Fit, and Necessity, to select applications that can best be implemented in the pharmaceutical industry. Figure 6 presents this model. Low performers in any given category received a grade of one (furthest left), and high performers received a grade of five (furthest right). Any score of three or below can be immediately removed from consideration of possible best applications.
Fig. 6. The best applications for blockchain technology are shown by individualizing scores in the decision matrix of Ease, Familiarity, Fit, and Necessity.
The four metrics, Ease, Familiarity, Fit, and Necessity, each play a different and essential role in determining how applications could function in the pharmaceutical industry.
The four categories for best implementation are (1) Prescription Drug Misuse and Abuse Prevention, (2) Prevention of Counterfeits, (3) Clinical Trial Outcomes, and (4) Smart Contracts. These four categories ranked the overall highest in creating innovative solutions for current pharmaceutical industry needs.
Potential limitations of this analysis include the inability to perfectly predict technology implementation and outcomes. Technology has been notoriously unpredictable for decades. However, these potential limitations are addressed by emphasizing the importance of Necessary applications. Without a genuine need, the likelihood of achieving favorable outcomes is diminished.
While this analysis can identify those areas of the pharmaceutical industry where blockchain technology may be most appropriate, the adoption of blockchain is not certain. The structure of the pharmaceutical industry in the U.S. will limit the adoption of some applications. Most of the organizations involved are for-profit enterprises; all are interested in improving efficiency and minimizing costs where appropriate. Many of the applications identified above have benefits that will accrue to parties outside of the pharmaceutical industry. Such benefits are referred to by several terms. They can be called external benefits or spillover effects, or the product may be said to have public goods aspects. One example of this is the idea of Network Neutrality, which defines a free and open architectural principle where data are treated equally on a network.23–26 If the industry must bear all the costs of creating and maintaining the network but is not able to reap all of the benefits (by, for example, charging user fees), it is unlikely that network neutrality and the use of blockchain will be voluntarily adopted.
Prescription Drug Misuse and Abuse Prevention is another example where spillover effects matter. The primary benefits of reducing or preventing prescription drug misuse and abuse are the additional years of life gained by prevented overdoses and the reduced medical expenditures to treat the abuse. These benefits accrue to many people and organizations, primarily outside of the pharmaceutical industry. A for-profit pharmaceutical firm will have little economic incentive, beyond the threat of lawsuits, to develop and use programs that reduce misuse and abuse because they cannot recoup their costs. To promote the adoption of these programs, pharmaceutical firms need an incentive. The incentive can be financial (e.g. subsidies, grants, and tax benefits) or legal (e.g. legislation and regulation).27
Blockchain technology offers a new and promising solution to the pharmaceutical industry’s needs. The distributed database prioritizes privacy in the verification and authentication process. The implementation of blockchain technology must fit within a framework that supports necessity, ease of implementation, familiarity amongst stakeholders, and fit within the overall industry. Based on these four metrics, the hierarchical structure outlined throughout this paper suggests that applications that best fit these include Prescription Drug Misuse and Abuse Prevention, Prevention of Counterfeits, Clinical Trial Outcomes, and Smart Contracts. Future research in blockchain technology includes further exploring the economic impact and adoption, ethical and legal considerations for data ownership and privacy, and AI integration for potential data analysis from the blockchain.
All authors contributed to this paper. Dr. Mark Gaynor provided formatting, text context on blockchain technology and technology selection algorithms, and proofreading. Dr. Kathleen Gillespie provided text on economic evaluation and proofreading. Allison Roe constructed the context of the text along with figures. Dr. Erica Crannage provided text and proofreading on the pharmaceutical industry. Dr. J.E. Tuttle-Newhall provided a proofreading of the paper and healthcare industry context.
After completing the manuscript, the authors used ChatGPT3.5 as a corrective suggestion and proofreading tool. Some of these suggestions were incorporated into the article.
This paper was partially proofread and edited by CHATGPT.
Copyright Ownership: This is an open-access article distributed under the Creative Commons Attribution Non-Com (CC BY-NC 4.0) license. This license permits others to distribute, adapt, and enhance this work non-commercially and license their works on different terms, provided the original work is properly cited and the use is non-commercial. See http://creativecommons.org/licenses/by-nc/4.0.
There are several companies breaking into the space of blockchain solutions within the United States pharmaceutical industry. This market is new and evolving, with relatively high volatility. The following list is not comprehensive of all companies within the blockchain and pharmaceutical realm but instead is a representation of the innovative technologies that exist on the market today.