?IMPLEMENTATION OF BLOCKCHAIN IN PHARMACEUTICAL LOGISTICS: A FIGHT AGAINST FRAUD Research Proposal submitted to MANIPAL ACADEMY OF HIGHER EDUCATION – DUBAI CAMPUS In the Partial Fulfillment of the Requirement for the Degree of MASTER OF BUSINESS ADMINISTRATION By PADMA GIRISH REG. NO: 1612155 Under the Guidance and Supervision of Dr.
JASON FITZSIMMONS center1206500 SCHOOL OF BUSINESS MANIPAL ACADEMY OF HIGHER EDUCATION-DUBAI CAMPUS ACADEMIC CITY, DUBAI, U.A.E. Dr. Jason Fitzsimmons Dean, Corporate Executive Education, and Chairperson School of Business MAHE – Dubai Campus Academic City, Dubai, U.A.E. -58102421336000 Date: April 18, 2018 CERTIFICATE This is to certify that the research proposal entitled, ‘Implementation of Blockchain in pharmaceutical logistics: A fight against fraud’, submitted to MAHE – Dubai campus for the award of the degree of Masters of Business Administration, is a record of the original work done by Ms. PADMA GIRISH during the period of her study in the School of Business, Manipal Academy of Higher Education – Dubai Campus, UAE, under my supervision and guidance, and the project work has not previously formed the basis for the award of any degree, diploma, fellowship, associate ship or any other similar title, to any candidate of any University.
Signature of the Guide DECLARATION I hereby declare that the matter embodied in this research proposal entitled ‘Implementation of Blockchain in pharmaceutical logistics: A fight against fraud’ is an original work done by me under the guidance of Dr. Jason Fitzsimmons, School of Business, Manipal Academy of Higher Education – Dubai Campus, UAE. This proposal has not previously formed the basis for the award of any degree, diploma, fellowship, associateship or any other similar title, to any candidate of any University. ACKNOWLEDGEMENT Before we get into thick of things, I would like to add a few words of appreciation for the people who have been a part of this project right from its inception.
The writing of this project has been one of the significant academic challenges I have faced and without the support, patience, and guidance of the people involved, this task would not have been completed. It is to them I owe my deepest gratitude. It gives me Immense pleasure in presenting this project report on. It has been my privilege to be given an opportunity to work with the team of Hellmann Caliper Healthcare Logistics who have assisted me from the commencement of this project. The success of this project is a result of sheer hard work, and determination put in by me with the help of my project guide.
I hereby take this opportunity to add a special note of thanks for Dr. Jason Fitzsimmons, who undertook to act as my mentor despite his many other academic and professional commitments. His wisdom, knowledge, and commitment to the highest standards inspired and motivated me. Without her insight, support, and energy, this project wouldn’t have kick-started and neither would have reached fruitfulness. I also feel the heartiest sense of obligation to my library staff members who helped me in the collection of data ; resource material ; also in its processing as well as in drafting the report. ABSTRACT The production and distribution of counterfeit medication is a pressing and progressively essential worldwide issue, particularly in developing countries.
The value of pharmaceutical counterfeiting has reached billions of greenbacks annually. One of the reasons for medication counterfeiting is that the imperfect offer chain system in the pharmaceutical business. medication amendment ownership from makers to distributer, distributer and then caregiver before it reaches the client. In current offer chain system, info isn’t shared between systems, manufacturers don’t recognize what happened to their merchandise, drugs administrative unit has no visibility of the system, recalls are difficult and dear, and corporations cannot follow-up patients. This paper speaks about the way to use blockchain technology in pharmaceutical to attain traceability, visibility, and security to the medication supply system.
The formulated system is going to be employed in pharmaceutical business to trace the medication from its producing till its delivery to the patient. After the usage of a drug, its impact on the patient is going to be recorded in a database for future statistics. A permissioned blockchain is going to be used for storing transactions and solely trusty parties are going to be allowed to join the network and push information to the blockchain. TABLE OF CONTENTS Chapter No DescriptionPage No Introduction Industry Profile Organizational Profile Research Methodology Analysis and Interpretation Findings Recommendations Conclusion Reference Appendix LIST OF TABLES Table NoDescriptionPage No Age of the Respondents 1 Ed. Qualification 3 (This page must give the details of all the tables which is used in the report with the table title and number) INTRODUCTION Originally blockchain is a continuously growing list of HYPERLINK “https://en.wikipedia.org/wiki/Record_(computer_science)” o “Record (computer science)” records, called blocks, which are linked and secured using HYPERLINK “https://en.wikipedia.org/wiki/Cryptography” o “Cryptography” cryptography. Each block typically contains a HYPERLINK “https://en.wikipedia.org/wiki/Cryptographic_hash_function” o “Cryptographic hash function” cryptographic hash of the previous block, a HYPERLINK “https://en.wikipedia.org/wiki/Trusted_timestamping” o “Trusted timestamping” timestamp, and transaction data. By design, a blockchain is resistant to modification of the data.
It is an open, HYPERLINK “https://en.wikipedia.org/wiki/Distributed_ledger” o “Distributed ledger” distributed ledger that can record transactions between two parties efficiently and in a verifiable and permanent way. For use as a distributed HYPERLINK “https://en.wikipedia.org/wiki/Ledger” o “Ledger” ledger, a blockchain is typically managed by a HYPERLINK “https://en.wikipedia.org/wiki/Peer-to-peer” o “Peer-to-peer” peer-to-peer network collectively adhering to a HYPERLINK “https://en.wikipedia.org/wiki/Protocol_(communication)” o “Protocol (communication)” protocol for inter-node communication and validating new blocks. Once recorded, the data in any given block cannot be altered retroactively without alteration of all subsequent blocks, which requires the consensus of the network majority. Blockchain was invented by HYPERLINK “https://en.wikipedia.org/wiki/Satoshi_Nakamoto” o “Satoshi Nakamoto” Satoshi Nakamoto in 2008 to serve as the public transaction HYPERLINK “https://en.wikipedia.org/wiki/Ledger” o “Ledger” ledger of the HYPERLINK “https://en.wikipedia.org/wiki/Cryptocurrency” o “Cryptocurrency” cryptocurrency HYPERLINK “https://en.wikipedia.org/wiki/Bitcoin” o “Bitcoin” bitcoin.
The invention of the blockchain for bitcoin made it the first digital currency to solve the HYPERLINK “https://en.wikipedia.org/wiki/Double-spending” o “Double-spending” double-spending problem without the need for a trusted authority or central HYPERLINK “https://en.wikipedia.org/wiki/Server_(computing)” o “Server (computing)” server. The bitcoin design has inspired other applications. For several years, this system was unnoticed by the society, but after the breakthrough of Bitcoin, many scientists and developers became interested in the technology that allowed Bitcoin be the best cryptocurrency in the market. The world of pharmaceuticals and medical devices is also warming up to the innovative possibilities that blockchain offers.
By using blockchain to maintain clinical trial protocols, revisions, and patient consent, for example, pharmaceuticals companies can better demonstrate patient safety and transparency. Data from multiple sources, such as genomics, wearables and electronic medical records, can be shared with multiple parties using blockchain’s decentralized and secure framework. Nowadays, a large number of people think that Blockchain could be as revolutionary as the Internet was. They see many ways to adopt such technology.
Therefore, many different applications appear on the market. One of such applications excited me – an application for pharmaceutical logistics and supply chain. The current situation in these industries can be described as challenging. There are many difficulties concerning the transparency, security, and visibility of various operations across the supply chain or transportation.
Therefore, I decided to study this sphere and find out what benefits blockchain could bring to these industries and which problems solve. AIM The aim of this research proposal is to analyze in depth how the introduction of the blockchain system into healthcare pharmaceutical industry, particularly in the field of logistics can improve and thereby eliminate counterfeit medicines. By the introduction of Blockchain into the pharmaceutical industry, millions of lives can be saved as the blockchain system is transparent to any changes and amendment made to it during the journey from the manufacturer to the distributor to consumer. OBJECTIVES Understanding the basic concepts and technics of Blockchain technology.
Formulating an effective & compatible logistic system for the same. Find out the main problems faced by pharmaceutical logistics industry Implement the logistic system in those areas. NEED FOR STUDY In one example, patients with acute lymphoblastic leukemia (ALL) are now benefiting from a type of immunotherapy called chimeric antigen receptor (CAR) T-cell therapy. The approach pioneered by Memorial Sloan Kettering Cancer Center involves the extraction of immune cells from a patient modified with cancer-targeting proteins and given back to the patient. These cells are “living drugs” in the patient’s body with autologous therapies tailored to each patient. Other macro life sciences influencers are driving a shift in products coming to market specifically within oncology, CNS (central nervous system), and systemic anti-infectives.
These innovative therapies challenge the traditional life sciences supply chain, increasing the need for secure and authenticated drugs that are delivered without delay and kept at a verifiable temperature. The right treatment needs to be delivered to the right patient at the right time, all through a secure supply chain. With many serializations and track ; trace regulations in the compliance period, and others (e.g., EU FMD, US DSCSA) on the horizon, life sciences companies need to think beyond serialization as a core capability and prepare for the next generation of supply chain. Verifying the provenance of a medicine—from where its ingredients were made and where the drug was manufactured, to how the medicine was handled through the end-to-end supply chain and all the way to the patient in a trusted manner, is becoming an increasingly mandatory supply chain capability. That scenario is now possible using blockchain technology. REVIEW OF LITERATURE Blockchains Everywhere – A Use-case of Blockchains in the Pharma Supply-Chain Abstract Blockchains are on the top of the Gartner Hype Cycle 2016 and many start-ups are integrating blockchains into their technology portfolio.
While blockchains have emerged in the context of financial applications, non-financial application areas are of interest as well. In this paper, modum.io is presented, a start-up that uses IoT (Internet of Things) sensor devices leveraging blockchain technology to assert data immutability and public accessibility of temperature records, while reducing operational costs in the pharmaceutical supply-chain. The medical industry has many complex and strict environmental control process (e.g., temperature and humidity) to ensure quality control and regulatory compliance over the transport of medical products. The sensor devices monitor the temperature of each parcel during the shipment to fully ensure GDP regulations. All data is transferred to the blockchain where a smart contract assesses against the product attributes.
As modum.io is not the only non-financial start-up working with blockchains, a list of areas and other start-ups is provided that aim to reduce bureaucracy, distribute the infrastructure, and saving costs using blockchains. Modum.io enables substantial cost savings in the pharmaceutical supply chain. Our GDP compliant sensor devices leverage the Blockchain technology to assert data immutability and public accessibility of all data records. Modum.io is providing a data logger system which monitors all necessary data during the shipment of medicinal products.
The records are transferred to the Blockchain where a smart contract assesses against the product attributes. Using the modum.io technology allows switching from special logistics services to standard shipment methods. Blockchain Technology in the Pharmaceutical Industry Abstract With this paper, we present a blockchain-based solution to increase supply chain security for the pharmaceutical industry. Supply chain security is one aspect that has recently won attention, when the Drug Supply Chain Security Act (DSCSA) has been implemented in the U.S too, amongst others, fight the counterfeit drug problem. During the second “{Life Science} meets IT” hackathon in Heidelberg a team of enthusiastic young professionals and students developed a prototype solution that is able to guard people’s life with a patient-empowering blockchain solution and won the first price with their prototype LifeCrypter.
Smart Containers ICO – Temperature controlled containers & IoT sensors on the blockchain. – Novartis Abstract This article will mostly focus on use-case for blockchain technology by combining IoT sensors and passive temperature-controlled containers with the blockchain to provide an immutable record of cargo temperature as it’s being transported. Smart Containers Group AG. is actually a holding company for two firms, HYPERLINK “https://www.skycell.ch/” SkyCell and HYPERLINK “https://foodguardians.ch/” FoodGuardians.
SkyCell has used cutting-edge technology to develop containers that use IoT sensors connected to their data cloud, that utilizes blockchain technology to remotely monitor each container to ensure the product temperature is consistent during transport. SkyCell transports some of the most expensive and temperature-sensitive goods in the pharmaceutical industry, this monitoring is absolutely essential as it enables companies to comply with HYPERLINK “http://academy.gmp-compliance.org/guidemgr/files/GDP%20Guide%20EU%202013_2.pdf” “_blank” legislation from the EU regarding the HYPERLINK “https://en.wikipedia.org/wiki/Good_distribution_practice” “_blank” delivery of medicinal products. There are a variety of different sized containers, all plug and dry ice-free. They’re easy to handle and made from recyclable materials. The patented-in house developed cooling technology stores five times more energy than traditional methods to keep the container at a consistent temperature.
After use, they are ‘recharged’ in a cooling chamber without any need for manual intervention, increasing the productivity of the business and reducing cost. Blockchain: A Catalyst for the Next Wave of Progress in Life Sciences Abstract This white paper explores how blockchain – the decentralized, distributed ledger infrastructure built around strong cryptography – could powerfull digital transformation across the life sciences space. This article examines key blockchain principles that we believe could be imaginatively applied to areas such as provenance, disintermediation, patient safety, secure data exchange and enhanced productivity to accelerate digital business across the pharmaceuticals and medical devices segments. We also provide guidance on how to identify the best use cases and prepare for blockchain adoption.
What if this technology could provide a mechanism for establishing the mechanisms of trust, immutability, transparency, auditability, and security that have traditionally been performed by an intermediary? Blockchain Applications and Use Cases in Health Information Technology Abstract In this article, we talk about Blockchain technology and the associated cryptocurrencies can transform industries including healthcare. We suggest the decentralized and programmable nature of blockchain applications can be used to change health information technology to gain greater efficiency in public and private healthcare systems. Current public health information technology systems such as eligibility, enrollment and electronic health records have documented issues with interoperability and are slow to adapt to changing program and technology demands. We suggest that blockchain can potentially solve these issues. We argue that a public program such as the U.S. Medicaid program with $553 Billion in total program costs and over $25 Billion spent on health information technology and administration last fiscal year could benefit from the use of blockchain based distributed ledger and smart contracts.
We finally argue that a decentralized benefits administration system can provide greater efficiency to enrollment, eligibility, claims payment and adjudication processes thus driving efficiency and reducing systemic fraud. Blockchain Technology in Pharmaceutical Industry to Prevent Counterfeit Drugs Abstract The production and distribution of counterfeit drugs is an urgent and increasingly critical worldwide issue, especially in developing countries. The market value of pharmaceutical counterfeiting has reached billions of dollars annually. One of the reasons for drugs counterfeiting is the imperfect supply chain system in the pharmaceutical industry.
Drugs change ownership from manufacturers to wholesaler, distributor and then pharmacist before it reaches the customer. In current supply chain system, information is not shared between systems, manufacturers don’t know what happened to their products, drugs regulatory authority has no visibility of the system, recalls are complicated and costly, and companies cannot follow-up patients. In this paper, we explain how to use blockchain technology in a pharmaceutical supply chain to add traceability, visibility, and security to the drugs supply system. The proposed system will be used in pharmaceutical industry to track the drugs from its manufacturing until its delivery to the patient. After the usage of a drug, its effect on the patient will be recorded to a database for future statistics.
A permissioned blockchain will be used for storing transactions and only trusted parties will be allowed to join the network and push data to the blockchain. Blockchain in Logistics and Supply Chain: Trick or Treat? Abstract The blockchain is an emergent technology concept that enables the decentralized and immutable storage of verified data. Over the last few years, it has increasingly attracted the attention of different industries. Especially in Fintech, Blockchain is hyped as the silver bullet that might overthrow today’s payment handling.
Slowly, the logistics and supply chain management community realize how profoundly Blockchain could affect their industry. To shed light on this emerging field, we conducted an online survey and asked logistics professionals for their opinion on use case exemplars, barriers, facilitators, and the general prospects of Blockchain in logistics and supply chain management. We found most of our participants are fairly positive about this new technology and the benefits it offers. However, factors like the hierarchical level, Blockchain experiences, and the industry sector have a significant impact on the participants’ evaluation. We reason that the benefits of existing IT solutions must be carved out more carefully and use cases must be further explored to get a rather conservative industry, like logistics, more excited about Blockchain. Accurate, audited and secure – How blockchain could strengthen the pharmaceutical supply chain Abstract Currently, the medicine verification system and the supply chain must meet the following criteria: • Allow multiple parties to update data; • Allow multiple parties to share data; • Verification to ensure that the information can be trusted; • Interaction with national and European medicines verification system to allow all parties to have visibility in the drug authenticity.
However, there are significant issues within the current system. Some of which are as follows: • Intermediaries add complexity – the more parties involved in handling the medication, the higher the risk of interception or damage; • Interactions are time sensitive – drugs must be delivered within a good timeframe as pharmacists need to be able to provide a quick service to patients; • Manufacturers, logistic companies, wholesale and pharmacies may not be able to offer complete visibility on the authenticity of the drug whilst ensuring quality has remained intact. This article speaks about how blockchain solution can make a substantive difference to the pharmaceutical supply chain. At every stage of the process, barcodes would be scanned and recorded onto a blockchain ledger system which, in turn, records and creates an audit trail of the drug journey. Sensors can also be incorporated into the supply chain, with temperature or humidity being recorded onto the ledger system.
This is particularly important for drugs requiring fridge storage, such as insulin or expensive specially manufactured medicines. When the drug reaches the pharmacy, the pharmacist can tell through the blockchain audit trail, if the drug has been compromised at any point of the journey. Even as the pharmacist dispenses the prescription, biometric measures can be used to record the dispenser and pharmacist checking the prescription. This can all be recorded onto the ledger, allowing drugs to be tracked from the moment of creation to the moment the patient takes the drug home. Blockchain- An enabler for life sciences and healthcare Abstract The hype surrounding blockchain’s potential has traditionally been focused on financial services; however, the life sciences and healthcare industry (LSHC) is facing surmounting challenges and experiencing new levels of scrutiny that demand a novel solution that can meet: Patient security and trust, Collaboration amongst ecosystem stakeholders, Efficient business processing of customer transactions, Delivering authentic forms of care.
The purpose of this paper is to – Define the common benefits for enterprises to adopt cloud-based blockchain solutions, define key LSHC issues that cloud-based blockchain solutions could address, Describe Deloitte’s experience and leadership in this space, Describe the value that businesses can gain by adopting Amazon Web services (AWS) for their blockchain technology and business demands. When two chains combine – Supply chain meets blockchain Abstract In this paper, Deloitte’s blockchain and supply chain professionals share insights on how blockchain-enabled technology can mitigate four cross-industry supply chain issues — traceability, compliance, flexibility and stakeholder management. The paper draws on use cases from the pharmaceutical industry (product tracking), automotive industry (purchasing platform) and food industry (know your supplier). RESEARCH METHODOLOGY STATEMENT OF THE PROBLEM UNDERTAKEN ?The pharmaceutical supply chain is a complex web of interactions that take place across multiple groups and institutions. Patients, doctors, healthcare professionals, insurance companies, and medicine manufacturers must work with each other to keep the ecosystem alive.
The industry faces challenges from all sides. Every day it must deal with the complexity of production, quality assurance, distribution and tracking of products. The pharmaceutical ecosystem is vast and complex. So, these processes can become bottlenecks for collaboration.
The drug companies also must innovate for challenges like aging population and new diseases. They must work in a highly competitive market where the landscape is changing fast and challenging their prominence. The old centralized models are just not enough to address today’s issues. The Challenges For the immediate future, the pharmaceutical companies have three important challenges they need to address: Counterfeit Drugs Over the years, counterfeiters have become sophisticated.
They have multiple ways of manufacturing fake drugs and medical products. Some inject themselves into the pharmaceutical supply chain and supply inauthentic raw materials. Others try to manufacture the drugs themselves. They can end up supplying the market with unregulated products. Some criminal organizations and groups work exclusively with real medicine, but they concentrate on counterfeiting labels to sell generic drugs under brand names. The pharmaceutical industry must adhere to strict rules and regulations. Following these rules adds to the cost of manufacturing quality products that are safe to use.
However, counterfeiters can circumvent the rules and produce the drugs without any safety measures in place. They make the drugs for a fraction of the cost of using resources from developing countries, relabel the drugs as branded products and sell them at premium prices. Drug manufacturers invest and lose large amounts of money in research and development because they know they can make up the losses with their successful products. But if they are unable to recuperate their costs due to lost revenue, it can put them out of business. Compliance Distribution of drugs is a challenge for the pharmaceutical industry.
They generally rely on logistics companies to help them gain efficiency. But storage and transportation of drugs are not trivial. Anyone involved in the process must adhere to guidelines to maintain correct temperature, humidity, air pressure and other requirements. Temperature sensitive products like vaccines need to be properly monitored throughout the supply chain. Temperature excursion or deviation from the required range can make the vaccines ineffective in the field. Monitoring pharmaceutical products have improved with technological advances.
Today drugs are monitored throughout the supply chain using smart IoT devices. But Temperature excursions are still affecting up to 5% of all medical transportation.One of the problems with temperature excursion is that there are black boxes in the supply chain that cannot be properly monitored. The unpredictable nature of transportation can lead to delays and increase the probability of product deterioration. However, if there is a problem, it can easily go unreported. The pharmaceutical supply chain requires better ways to add accountability to the transportation process.
It needs better ways to monitor the products. Traceability and Recalls The pharmaceutical supply chain is a complex web of interconnected nodes flowing like rivers across the landscape. Every product moves through multiple transactions to reach the final customer. If there is a problem with a particular product or batch, it is extremely difficult to recall it.From 2017, all HYPERLINK “https://blogs.fda.gov/fdavoice/index.php/tag/serial-number/” US prescription drug packages are required to have a unique product identifier that identifies the drug’s national drug code (NDC), serial number, lot number, and expiration date. The system will take time to become effective. In the meantime, the drug companies must still deal with the complexity of the number of transactions, technology incompatibility, and security concerns. In order to increase traceability and improve recall success, drug companies need a more comprehensive and cohesive solution.
How Blockchain Can Help Resolve the Issues ?The blockchain is a distributed digital ledger technology. Pharmaceutical companies can use blockchains to record outputs from IoT and smart devices. It will help them keep track of temperature, humidity, and pressure through every transaction. They can couple the compliance monitoring information with product and shipping details to create an end-to-end database. A key property of blockchain is that any recorded information is immutable.
So, drug companies will be able to fight counterfeits more effectively. In traditional record keeping, there is no centralized database. The manufacturer, the logistics company, the stores and the pharmacies each maintain their own information. There is no way to validate the authenticity of a drug across the whole supply chain. Because blockchain is distributed and can serve as an open ledger, it can help everyone keep track of a product through the whole life-cycle. If there is any tampering in the supply chain, consumers can easily verify using the blockchain records. The same principles apply to compliance.
Temperature, humidity and other factors can be recorded using smart devices throughout the life-cycle. Suppose, there is a temperature excursion during a transportation. With blockchain, the consumer can easily see at what point the event occurred. Similarly, traceability and recall become trivial issues.
Every move of the product is recorded. So, identifying a batch that needs to be recalled becomes a lot easier. ?In Conclusion ?Blockchain can help the pharmaceutical industry better manage its transactions. Using the distributed digital ledger, the industry can improve their record keeping capabilities across the whole supply chain. Better records will enable them to address the issues of counterfeit drugs, compliance, and traceability more effectively. RESEARCH DESIGN The research design refers to the overall strategy that you choose to integrate the different components of the study in a coherent and logical way, thereby, ensuring you will effectively address the research problem; it constitutes the blueprint for the collection, measurement, and analysis of data.
The type of research design used in this project is Descriptive Method. Descriptive research methods are pretty much as they sound — they describe situations. There are three main types of descriptive methods: observational methods, case-study methods and survey methods. This report has been carried out using the Observational Method of Research Design. DATA SOURCES Data is defined as facts and statistics collected together for reference or analysis.
There are two types of data sourcing- Primary Data and Secondary Data. Primary data sourcing is the process of gathering data directly from original sources as opposed to collecting information from research that others have done. Information can be obtained by observation, by mail and telephone surveys, or by face-to-face interviews. Secondary data sources are generally scholarly books and articles.
The data collected in this report consists of primary data and secondary data. The primary data was collected via a face-to-face interview with employees from Camelot, articles, reports and other websites available on the internet. DATA COLLECTION INSTRUMENT Accurate and systematic data collection is critical to conducting scientific research. Data collection allows us to collect information that we want to collect about our study objects. Depending on research type, methods of data collection include documents review, observation, questioning, measuring, or a combination of different methods. For this dissertation project face to face, interview method was employed.
The Questioner designed mainly focuses on key areas such as backend working, implementation, formulation of the correct blockchain system to meet the requirements of the organization, examples of use cases, limitations and issues that might occur while implantation, etc. LIMITATIONS OF THE STUDY Implementation Cost is high & time-consuming. Readiness to adopt and change into blockchain is low due to low understanding and knowledge of the system. As the topic of study is still under scrutiny, more research much be done before implementation can be done. Time is a big constraint, so more time could not be devoted in terms of finding more respondents to conduct interviews.
The busy schedule of respondents makes the collection of information difficult The blockchain is a new technology which hasn’t yet been implemented fully in the field of pharmaceutical logistics. The data obtained in some cases might be biased This is a narrow observation of a wide topic (Blockchain) ANALYSIS AND INTERPRETATION WHY BLOCKCHAIN? The blockchain is a distributed network of computers that share a secure ledger of transactions among the participants connected to the network without any central server. It stores every transaction occurs in the network with a timestamp and eliminate the need of the third party. Every node on the network maintains a local copy of the ledger, and any small change in the local ledger is replicated to the overall network, and every node on the network update their local ledger.
If one node is failed or disconnected, it doesn’t have any effect on the network. The first reason to use Blockchain technology in such a system like pharmaceutical SCM is its security. The blockchain is the best option to provide 21st-century cyber-security, and until now there is no breach found in it. It is designed to prevent any single person from modifying the data and transactions, this way blockchain can increase the trust and help to eliminate the biases found in traditional supply chain systems. Using blockchain, participants can anonymously exchange digital assets, where they don’t need to know each other and trust each other or a third participant for their transaction. Therefore, blockchain is the best option to transfer trust in a trustless world.
One of the reasons we suggest blockchain for pharmaceutical SCM system is that it’s the best option to record the journey of a product across the supply chain. Storing the history of a product make it easy to reveal its actual origin and milestones. This approach will bring more transparency to transactions in the pharmaceutical supply chain. The power of blockchain is not only limited to the creation of cryptocurrency but any type of digital asset can be created and traced.
In the context of a pharmaceutical supply chain, when a manufacturer creates a product and registers it on the network, it will become a digital asset and could be transferred to another participant just like cryptocurrency. For privacy protection, blockchain is again in the first row. In a blockchain network, every participant is assigned a key-pair as an identifier. The private data of a participant is kept secret and every transaction is done from the public key of one participant to the public key of the other.
In pharmaceutical SCM system, the private data of patients will be kept secret and their medical record will be used public – anonymously. The last and the most important reason for using blockchain in pharmaceutical SCM system is the Smart contract. A smart contract is a piece of code that contains the actual rights and obligation that include the term and conditions for the payment and delivery of goods and services agreed upon by all the signees and can be automatically executed. A smart contract can add greater intelligence and more power to the blockchain. They can be used to make state-of-the-art and cutting-edge customized blockchain based systems. IMPLEMENTATION To incorporate blockchain technology in pharmaceutical supply chain system, we should first understand how blockchain ledger works under the hood.
Blockchain has a built-in identity mechanism, a cryptographically secure key pair. These keys are used to assign each participant a specific activity on the network. A participant can be a device, person or an entity. The original identities of participants are hidden, and they are known by these keys. A key pair contains no clue about the participant, but additional information (e.g.
name, contact or professional credentials) can be associated with it. But the best approach is to keep this additional information off-chain and merge them with on-chain data (key pair) using their IDs. In the context of pharmaceutical supply chain management, the participants will be the manufacturer, packager, and doctor etc. Each of these participants will be identified by their unique key pair on the network.
Drugs will be considered as the assets, with each of them having a unique key (or hash). The ID will be attached with the drug in the form of QR Code. While keeping in mind the basic architecture, the proposed system can be implemented in different ways depending on one’s preferences. A lot of third party APIs are also available that can be used to push the data and transactions to blockchain network.
Each of these APIs provides different types of services. Regardless of which programming language or API we use, the basic architecture of our system will be the same. The selection of a specific blockchain network for storing transactions is also a crucial part, but before that, we should know the types of the blockchain. Blockchain has two main types – Public blockchain and Permissioned (or private) blockchain. In a permissioned blockchain, not everyone can write to the blockchain, only those participants who have been given access can write or access information on the blockchain. In the context of a pharmaceutical supply chain – the better option is to use a permissioned blockchain.
The next step is to use a specific blockchain network to save the transactions record, but it totally depends on the developer’s choice. Few types of blockchain networks are available in the market now, e.g. Bitcoin Blockchain that is the pioneer one, Ethereum, Hyperledger or even BigchainDB can also be used. But the one we suggest is permissioned Ethereum blockchain.
HOW does IT work? In this section, we will discuss how a blockchain based pharmaceutical supply chain management system will work. Let say we have set up a secured and trusted network, where only the trusted parties are given permission to join the network. On the backend, there is a permissioned blockchain to store all the required transactions, and once the information entered into it – can never be changed. Besides that, we have a user-friendly mobile APP that the participants will use to make transactions to the blockchain. When a factory produces a new product, they will create a unique hash and assign it to the product. The product will be registered on the blockchain using its hash (unique ID).
The product will be considered as a digital asset on the blockchain network, and its hash will be used to track it any time on the network. Any additional information of the product can be stored off-chain or on-chain depends on manufacturer’s choice. Off-chain data will be merged with on-chain data by using identifiers. Conventionally, in most blockchain-based applications a hash-digest (e.g. SHA-256) of all the off-chain data is generated and linked it to the on-chain data. But the best approach is to store large files (e.g.
images) off-chain and text data on-chain. Once the product is registered to the blockchain by the manufacturer, its ownership will be easily transferred to another participant using a user-friendly mobile app. Let say the wholesaler wants to purchase the drugs from the manufacturer, the manufacturer will physically transfer the drugs to the wholesaler and a transfer transaction will be registered to the blockchain simultaneously. The wholesaler will repeat the same process to transfer the drugs to distributer, and distributor will do the same business with the pharmacy. In Figure 1 the basic structure of a blockchain based pharmaceutical chain management is given. Figure 1 Now let’s consider Doctor Alice need some drugs and he wants to purchase it from a pharmacy.
Using the mobile app, Dr. Alice will first query for drug’s ID, to confirm all its journey from manufacturer to the pharmacy. If the product is genuine, the mobile app will show all its history and if the drug is counterfeit – no record will be displayed. Once Dr. Alice is sure about the originality of the drugs he will then purchase them.
Same as the doctor, other participants (e.g. Nurse, Family and Patient etc.) will also be able to track the journey of the drugs. A simple layout of the system’s front-end is shown in figure 2. Figure 2 FINDINGS Using blockchain, the drug journey can become more secure and streamlined. Every delivery can be tracked, with the delivery driver traced through biometric measures.
Every checkpoint involving the drug is recorded and traced via biometric measures, 2D barcode scans or sensor technology. As the drug is tracked from creation to patient, the whole of the drug journey becomes seamless, accurate, audited and secure. Following are some advantages of using blockchain integrated system: • Reduced complexity and costs: – Supply chain becomes traceable and drugs are easier to track – Information systems will hold expiry date details which improves stock control and rotation • Reduces errors: – Drugs can be verified, and authenticity can be ensured – Patient harm is reduced as drug checks are improved • Enhances security: – Counterfeit drugs are minimized – Patient harm is reduced – Data is kept safe • Proven resilience: – The system’s data will remain protected • Shared, trusted transactions: – All parties can access the drug information when needed to ensure the quality of the drug being dispensed – Parties must be able to trust the data as it determines if a drug can be dispensed • Creates an audit trail: – Drugs are easily traced making recalls easier – Parties can see if the process has become compromised at any point • Enhances transparency between authorized parties: – All parties can see every stage of the drug journey to ensure the drug authenticity – Regulators, such as pharmacy inspectors, can monitor the rate of counterfeit drugs entering the supply chain, with more accuracy. CONCLUSION In this paper, we proposed a further use case of blockchain technology in healthcare. We pointed out the issues in current pharmaceutical supply chain management and explained how blockchain can be used to add traceability and visibility to drugs supply and overcome the issue of counterfeiting.
How the identity mechanism of blockchain works and how is it helpful to share medical data while keeping the patient’s private data secrete is explained. We highlight the possible techniques, blockchain types and third-party solutions that can be used to implement a blockchain based supply chain for pharmaceuticals. In the past, we explained the working of the suggested system with an example that shows how the system will be easily used by different participants. REFERENCE Blockchains Everywhere – A Use-case of Blockchains in the Pharma Supply-Chain Thomas Bocek?†, Bruno B.
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