1. INTRODUCTION:

Nowadays, all people have the right to access high-quality healthcare services. The appearance of every day, a growing number of disorders have also led to the introduction of new medications under various brand names onto the market. Although These drugs help the patient feel better right away by relieving their discomfort, Despite their benefits, many medications have drawbacks. These medications are produced by several pharmaceutical businesses, the legitimacy of which is questionable. The World Health Organization (WHO) reports that counterfeit pharmaceuticals kill tens of thousands of people annually in underdeveloped nations, with children making up a large portion of the casualties^1,2.

Statistics show that medicine counterfeiting costs the US pharmaceutical sector over $200 billion in lost revenue each year^3,4.

The following elements might be seen in a medical blockchain concept for smart hospital medication supply chain integrity management:

Blockchain Network:

Provide an example of a decentralized blockchain network with mutually exclusive connections among the nodes (pharmacies, manufacturers, and hospitals).

Smart Contracts:

Consider smart contracts as self-executing software that is implemented on a blockchain to streamline and automate several medication supply chain procedures including order confirmation, shipment monitoring, and payment handling.

Data Encryption:

Describe how encryption methods are used to protect sensitive data, guaranteeing the privacy and confidentiality of information about patients and medications.

Supply Chain Steps:

Divide the medication supply chain into its component parts, such as production, distribution, transportation, and dispensing. Demonstrate how the blockchain records every action for traceability and transparency.

Integration with IoT Devices:

Show how Internet of Things (IoT) devices, including RFID tags and temperature sensors, are integrated to track and record location and environmental conditions across the supply chain.

User Interfaces:

Show user interfaces to various stakeholders, such manufacturers, pharmacists, and hospital administrators, so they can track and validate transactions and have real-time insight into the medication supply chain.

Audit Trail:

Draw attention to the blockchain's immutability and the permanent mark that each transaction makes, which forms an open and impenetrable audit trail.

The primary cause is not counterfeiting per se; rather, the adverse effects of these counterfeit medications on human health differ from those of traditional pharmaceuticals. These medications may not even partially benefit patients; rather than improving their condition, they have an adverse effect on health, and the side effects pose an even greater risk to an individual's immune system cells.

Because these medications flow via several intricately spread networks, making it possible for counterfeits to infiltrate the real supply chain, it is challenging to identify counterfeits. In the United States, healthcare spending hit a record $3.2 trillion in 2016⁵.

Approximately 25% of this total is anticipated to go toward managerial expenses. Using the cryptographic hash function, a number of innovative businesses, such as Hashed Health, are attempting to revolutionize the healthcare sector in order to drastically cut redundancy while maintaining privacy⁶.

These days, a person visits a doctor when they have an illness. After the patient's examination, the doctor may, if necessary, recommend a medicine that the patient may buy from a pharmacy or retail store. The doctor often signs or stamps the prescription, which is a specific piece of paper with a list of all the medications on it. After that, the medical staff takes the prescription to the pharmacy.

After interpreting the prescription, the pharmacist gives the medical personnel the necessary medication.

Because it is very easy to counterfeit a prescription, the entire procedure is risky. Since everyone's health is their top priority, a lot of healthcare organizations place a strong emphasis on medication traceability in order to prevent medicine counterfeiting by utilizing the newest IT technologies .

All users of the network share a decentralized ledger called blockchain. It is theoretically impossible to change an existing ledger due to its nature. Cryptographic algorithms are used to do this. A collection of time-stamped, immutable, and strictly ordered data blocks makes up a blockchain data structure¹⁰.

Data immutability is achieved by the use of hashes, or digital fingerprints. Because each block contains a reference to the hash of a previous block, the blockchain is strictly arranged. Block 0, sometimes referred to as the genesis block, is where the hashes from the current block cease.

This is the initial block on a particular blockchain to be produced. A record of the transactions is included in blocks. Provenance, or a singular point of origin for every transaction, is made possible by this kind of data structure. Since every transaction on the blockchain is time stamped and unchangeable, it is simple to identify dishonest drug dealers. Blockchains come in two varieties: public and private. To guarantee the dependability and quality of their products, reputable healthcare firms must register them in private blockchain platforms¹¹.

The legitimacy of the so-called drug blockchain is demonstrated by the fact that it is housed by a central organization and that only It is available to a certain manufacturer or provider.

This blockchain's openness is incredibly beneficial. Following manufacturing and the transfer of the Relevant data is added to the blockchain upon delivery of a drug or medication from the producer to the seller.

Checking the medication is a pretty simple operation, and any link in the chain may be found at any moment. Many blockchain systems from the past were constructed on a permission less network, which made it impossible to maintain user data privacy and security. Anyone may create their own address and communicate with the network in a permission less blockchain. The permission less blockchain network, however, was unable to maintain the confidentiality and integrity of patient data, medication administration, and medical report data in the healthcare industry. Since maintaining the security and transparency of medical data is the core objective of healthcare-based solutions, many permission less healthcare blockchains are built by implementing extra access control policies to preserve data integrity.

Nevertheless, the effectiveness of these healthcare systems is impacted by these extra access control regulations.The native cryptocurrency, token, is used by many of the current systems, which raises the cost of mining. As the complexity of the supply chain increases, visibility in readily accessible, trustworthy, and safe supply networks is becoming more and more important which increases compared to ten years ago. Moreover, the price of goods and their accessibility to customers are impacted by this growing complexity. Advancements in blockchain technology and information systems have caused a paradigm shift in the pharmaceutical supply chain strategy in the healthcare industry, moving toward automated and secure solutions.Smart contracts and Hyperledger Fabric can be used to allow a software platform that can be used independently of a reliable third party. Among the newest is the Hyperledger Fabric, an open-source platform; Smart contracts are created using a modular approach that incorporates conventional programming languages.¹²

This creates a plethora of opportunities for the use of product-centric enterprise solutions. The primary goal of this article is to build and construct a blockchain-based safe medication distribution system in a smart hospital utilizing Hyperledger Fabric.The system will demonstrate how drug delivery record information may be safely shared and controlled across hospital departments through the use of blockchain and Hyperledger Fabric technologies. An outline of the contributions made is provided below: Initially, we created a revolutionary medicine delivery blockchain technology that allows electronic prescriptions, drug dosages, doctor, and patient data to be securely stored and transmitted between hospital departments in an effective manner via a permissioned chain of network.

This blockchain platform is utilizing front-end programming languages like HTML5 and JavaScript to move toward a new web-based architecture for an intuitive user interface. This will improve the usability of managing participants and assets inside the company. Additionally, we visualized the product-specific services using the Composer REST APIs. Additionally, smart contracts were utilized to supply medication data consistency and additional health-related data. The proposed system's access control policy was established to verify and approve requests for transactions.

Figure 1: Present-day blockchain challenges.

2. ASSOCIATED WORK:

Among the most innovative technologies of the future is blockchain. It records and transmits transparent, secure, controlled, and fault-tolerant data via distributed ledger technology.Organizations may become decentralized, transparent, efficient, democratic, and safe with the help of blockchain. Over time, Numerous blockchain platforms have been introduced in scholarly works.Three categories could be used to categorise these blockchain applications: consortium blockchain, private blockchain, and public blockchain.¹¹

This study's main objective is to discuss how the blockchain can be applied to supply chains for drugs and healthcare. Supply chain management, banking and payments, insurance, forecasting, online data storage, real estate, government, charity, health, and energy management are a few of the sectors that have been taken aback by blockchain technology. The author presented MedRec, a blockchain-based decentralised distributed ledger system for exchanging and safeguarding patient health data. A bitcoin-based solution called MedRec seeks to address problems with system interoperability, sluggish access to medical data, fragmentation of patients and agencies, etc. Immutable records between providers and full access to medical information are provided to patients by the innovative blockchain-based technology¹³.

The MEdRec platform delivers real-time health record sharing, confidentiality, and accountability while also managing to keep patients' medical information safe. MedRec block data is owned and seen jointly by users of a peer-to-peer private network.. Proof-of-work is the consensus process used by the MedRec, a platform with smart contract functionality¹⁴.

To safeguard patient health records' integrity and confidentiality, the smart contract makes use of a cryptographic hash function. The two parts of MedRec's smart contract framework are the registration contract (RC), patient-provider relationship contract (PPR), and summary contract (SC). Identity registration falls within the purview of the RC, While SC is in charge of maintaining patient medical histories and current status data in the system, PPR is in charge of ownership, access information, queries of EMR and hashes, mining bounty and permissions.

One of the primary issues facing the healthcare industry today is the large number of disparate and disjointed patient health records that organizations maintain.¹⁵ MedicalChain launched a smart contract that allows patients to have time-limited access to their electronic health information in order to address these problems by utilising blockchain technology to build a smart healthcare ecosystem. Doctors scan lab findings and take notes, both of which are logged as transactions. In addition to dispensing medication, pharmacies also log the transaction on blockchain.

The patient grants their insurance temporary access to confirm treatment and repay payments. The patient grants their insurance temporary access to confirm treatment and repay payments. Patients can authorize doctors to remotely check their medical records and offer advise or a second opinion through the use of smart contracts. In order to evaluate their fitness improvement and get tokens or a reduction in insurance rates, patients grant insurers access to their health records.

In exchange for granting research organizations temporary access to their medical records for clinical trials, patients are also compensated. Patients may utilize the Med Tokens that MedicalChain provides to store data from wearable fitness devices, electronic health records, and payments and value transfers on the blockchain. Additionally, MedicalChain will serve as a platform for developers to create intelligent apps that evaluate all of this data and offer advice on things like diet and exercise regimens. MeFy is a subscription-based business strategy wherein MeMe Care users join up for an annual membership, which covers any number of tests over the course of the year for the price of just consumables. MeFy solves accessibility problems by linking physicians and patients internationally. It also gives the test it conducts legitimacy through the use of its MeMe Edge gadget. MeMe Edge, which is AI-powered, will be able to provide auto prescriptions for over-the-counter medications by analyzing patient histories, current medical conditions, and local environmental elements that may have an influence on health. Mefy solves accessibility issues by connecting physicians and patients globally through its eConsult feature. It also uses the MeMe Edge gadget to verify the validity of the test that is done¹⁶.

A blockchain-based initiative called MedicoHealth aims to enhance the disjointed healthcare system. Leading doctors around the globe may be reached via safe, totally anonymous client communication on the MedicoHealth platform. Updates to physician credentials and licence validity information are stored in an immutable decentralised database. Only a restricted number of doctors get access to anonymously stored patient data for a set period of time. Every payment is totally tokenized and anonymous. Tokens power the system and are also used to pay for platform, underlying protocol, service supplier and use of the blockchain layer.¹⁷

Built on blockchain technology, Clinicians, researchers, and patients may access a personal data environment through MediBloc's healthcare information platform.¹⁸ Our objective is to redistribute the value associated with personal ownership of healthcare data, making medicine easier for patients, clinicians, and researchers. With MediBloc, you can efficiently control your medical records, healthcare professionals can cut out unnecessary procedures to better serve patients, and researchers may accelerate the progress of medical research with the use of your priceless data. The author clarified the difficulties with the blockchains used in healthcare today. According to the research, one of the most important industries that require attention is the pharmaceutical supply chain.

The World Health Organisation estimates that each year, $200 billion worth of inferior, fake, and fraudulent medications are provided to the global market.⁵ To safeguard the pharmaceutical supply chain, many blockchain-based healthcare systems have been launched, such as farmatrust²¹, documented²⁰, block verify¹⁹, and many more.

A secure and effective technique for sharing medication histories between several healthcare facilities was proposed by the author in²². This experiment built a decentralised medication management system (DMMS), where a physician evaluates the patient and provides a prescription. Without the patient's private key, patient's information is much secured unauthorized person cannot access since it is necessary to decode the prescription. With the patient's consent, the patient and the doctor can review the patient's record at the same time, who can view it from various angles. The suggested solution guarantees the privacy, security, integrity, and validity of prescription histories across various healthcare facilities. HDG (Healthcare Data Gateway) is a blockchain-based application that combines a standard database and a gateway to provide patients control over how their healthcare data is shared. The intelligent program keeps track of medical patient data in a storage system or blockchain ledger. The HDG-centric healthcare ecosystem consists of three levels: storage, data management, and data consumption. Using the storage layer, healthcare data may be independently and extremely securely stored. The private blockchain, which is secured using several cryptographic algorithms, is where the medical data are kept. As a gateway, the data management layer assesses all incoming and exiting data access.²³

Blockchain-based firm Healthbank is renowned for its ability to govern, manage, and share data. pertaining to patient care throughout various healthcare institutions. With consent from the patient, Healthbank, a Swiss digital business, provides the patient's personal medical history and information.patient in a safe manner. The decentralized program is reliable, efficient, and safe.²⁴

3. BLOCK DESIGN OF PHARMACEUTICAL SUPPLY CHAIN MANAGEMENT:

Blockchain's distinct decentralized distributed technology has completely changed the healthcare sector. The suggested blockchain-based medication supply chain management scenario is displayed. The whole supply chain is monitored and updated via the medical blockchain and stores information on drugs, pharmacies, pharmacists, medical prescriptions, doctors, patients, nurses, and drug dosages, is depicted graphically in the description.

The drug delivery data lakes serve as autonomous storage, which is also known as a stored-off blockchain. For medical reporting, analytics, and data visualisation, the data lake is a useful tool.

Hospitals and other healthcare-related businesses would benefit from it as well, as the sharing of medical data is essential to their daily operations. Additionally, Patients who consent may share their information with any physician in the network, doctors can review patient data. By specifying the smart contract's access control policy, these permissions may be set to safeguard the confidentiality and integrity of patient data.

Figure 2: A scenario for managing the medication distribution supply chain using a blockchain.

Reliable nodes in the established system are in charge of carrying out a consensus process to maintain distributed ledger consistency. First, the physician assesses the patient and creates an electronic prescription that includes a therapy plan, medication dosage, and other recommendations. The pharmacy staff then receives the automated prescription, verifies its legitimacy, and asks the pharmacist to fill the prescription cart. The drug cart is then turned over by the pharmacist to the pharmacy staff so that it may be cross-checked with the computerized prescription. After receiving the prepared medicine cart and the electronic prescription, the head nurse changes the drug information records on the ward, examines it, and requests that The patient therapy procedure is started by the nurse. Finally, the nurse treats the patient by according to the doctor's instructions. Figure 3 shows the proposed medicine supply chain management system's overall structure.

Figure 3 Demonstrates the structure of the suggested medicine supply chain management system.

3.1. Suggested Drug Supply Chain Integrity Management System Architecture

A distributed record of information is the main goal of a blockchain network. A number of hashed and encrypted transactions make up each block. The suggested framework for managing the medication supply chain based on blockchain technology. The created application is built on top of a user service architecture that acts as middleware between distributed ledgers and smart contracts. The proposed system involves the end user, which includes doctors, nurses, chemists, and patients, sending a transaction proposal through the application to access backend services offered by the proposed blockchain network, such as medical prescriptions, profile management, appointments, electronic drug record, sharing of the data, management of pharmacy.

Complete create, read, update, and delete as CRUD actions are included in the blockchain transaction, which modifies the current data being sent between the linked nodes. To differentiate the whole network into a distinct private network, we provide the subnetwork idea in situations involving secure and private transactions. This private network's primary goal is to exchange private information with the relevant department directly, shielding it from view by other departments. For safe data exchange, the suggested medication distribution system enables each department to establish its own subnetworks.

Unlike previous blockchain-based systems, the suggested system is constructed on a permissioned network, which sets it apart from others. With the deployment of a user identity manager, this feature restricts participation in the blockchain network to legitimate users only. For user identification and enrollment, the user identity management offers certificates. Additionally, these services pertain to the production of signatures, user identity validations, and verification for specific users that engage with the blockchain network.

The consensus that is in charge of managing the transaction order and establishing a connection between a department and a subnetwork via an interface is represented by the consent manager. In a medicine distribution blockchain, a distributed ledger and nodes are present in every department. In addition to having data storage capabilities, the node has a smart contract that approves transaction proposals and adds transaction blocks to the ledger. Ensuring that the transaction history is unique and devoid of contradictory or erroneous transactions is the aim of the consensus method. Distributed ledger technology is used to store all of the events and actions histories, logs, and immutable and transparent transactions into the network. Digital signatures and hashing are two examples of the various cryptographic and consensus procedures that have been used to maintain the consistency of each ledger copy.

Figure 4: Shows the suggested medication supply chain management system design.

A node's job in a network is to maintain the blockchain replica while simultaneously handling transaction processing. A smart contract, blocks, a state database, and regulations make up a blockchain node. The ledger's current state at any one time is represented and stored in the state database.

Drug properties are kept with their respective values, such as name, amount, expiration date, etc. The initial block in the blockchain ledger is referred to as the genesis block, and subsequent blocks in the ledger state indicate the transactions associated with pharmaceuticals, such as (Tnx1, drug1), (Tnx2, drug2), (Tnx3, drug3), and (Tnxn, drugn). The final section is the endorsement policy, which determines which transaction, based on node agreement, should be added to the ledger. Specifically, AND ('Department1. member,' Department 2.member'); both departments have to accept their transaction, OR ('Department 1.member,' Department2.member'); only one department the transaction must be accepted.

3.2 Medication Supply Chain Management's Smart Contract

It is an application that is kept in a dispersed database. Transactions can have limitations, validations, and business logic added to them thanks to smart contracts. They could be compared to triggers in databases. A smart contract is an arrangement between parties rather than merely a computer program. It is divided into sections for signing the contract, carrying out the work, and leaving. When creating smart contracts, blockchain developers encounter a few major difficulties. For example, Solidity, one of the relatively newer programming languages used to build smart contracts, has a high learning curve and requires a lot of upkeep.

Moreover, because transactions are carried out sequentially by all nodes, transaction execution speed is severely constrained. To address these problems, we deployed smart contracts that define subsets of nodes rather than all nodes. As a result, transactions are only carried out on the nodes that are designated as the set. This method will increase concurrency and parallelism for the network while also enhancing The recommended system's execution size and performance. Java and Node.js programming used for smart contract written the function which creates the smart ledger.

Stated differently, the user can do all CRUD actions and can only query data that they are authorised to access. The doctor can review all medication-related information, including inventory supply, and the patient can verify their prescription. By consenting to a transaction to the smart contract, users can obtain their data.

Figure 5. Ledger operations using a smart contract.

3.3 Management of Drug Supply Chain Transaction Process

The task of managing transactions is divided between orderers and peers. This gives the network more concurrency and parallelism. Every transaction is carried out utilizing the global state in the peer. The transaction is signed with a Peers certificate if it is successful. Each node can process many transactions at once if transactions are executed before ordering. The orderer will just place the order and not keep track of the ledger; they won't re-execute the transaction. In order for the peers to function autonomously, this also gives them the capacity to have faith in every orderer and vice versa. the operation of every network node and every step of the transaction process inside the suggested supply chain management system based on blockchain for pharmaceuticals. The client application received credentials from the user manager authorizing the sending of transaction proposals.

Queries in Hyperledger Composer are also built in a custom query language and defined in a separate file. Data may be retrieved from a world state via queries. The two sections of the query are the description and the statement. The description provides an explanation query of function, which is a alphanumeric and string. The declaration defines specific rules in a query defined such as SELECT * FROM <table>, WHERE <fieldname> AND, OR, CONTAINS, and ORDER BY <parameters>. Questions about medicine Management of the supply chain on the medical blockchain.

The physical network design for a medical blockchain platform's medication supply chain management. The proposed system designed, as explained in Figure 4, was created using the essential design elements woven into the Hyperledger Fabric. The core component of the blockchain network is the point to point, which is in charge of maintaining a ledger and executing smart contracts to carry out standard ledger functions (like READ and WRITE). Additionally, Hyperledger Fabric allows for the creation of many channels, or blockchains. A channel is a safe blockchain that is intended to offer data separation and secrecy. The nodes in charge of placing the transactions in a block are known as the ordering service.

Table 1. Data definition in blockchain of Drug supply chain management

Data Field	Data Type
Drug_ID	String-Char
Drug_Name	String-Char
Expirey_Date	Date
Unit	Enum
Drugs	String-Char
Prescription_ID	String-Char
Doctor_Notes	String-Char
Patient_ID	String-Char
Pharmacist_ID	String-Char
Doctor_ID	String-Char
Nurse_ID	String-Char
Drug_order_status	Enum
Repository_ID	String-Char

4. CONCLUSION:

A New Blockchain-Based Medical Model for Smart Hospital Integrity Management of the Drug Supply Chain has the potential to completely transform the healthcare sector. This creative strategy makes use of blockchain technology to improve security, traceability, and transparency throughout the whole pharmaceutical supply chain, guaranteeing the integrity of drugs from production to patient delivery.A decentralized blockchain network linking several stakeholders, the use of smart contracts to automate and secure procedures, and the incorporation of Internet of Things sensors for real-time location and environmental monitoring are some of this model's salient characteristics. In order to address privacy issues in the healthcare industry, data encryption is used to guarantee the confidentiality of patient and medication-related information.This model's capacity to provide a tamper-proof audit trail makes it possible to easily verify each transaction that is recorded on the blockchain, which is one of its main advantages. In addition to increasing responsibility, this openness makes it easier to quickly identify and address any problems that could occur in the medication supply chain. Additionally, the user interfaces created for various stakeholders give manufacturers, pharmacists, and hospital administrators access to real-time analytics that help them react quickly to supply chain events and make well-informed decisions. A high degree of data integrity is provided by the immutable nature of the blockchain, which guarantees that once information is recorded, it cannot be changed. All things considered, the use of this medical blockchain model may lessen medication fraud, cut down on supply chain mistakes, and improve patient safety. The establishment of trust and collaboration among stakeholders facilitates the development of a medication supply chain that is more dependable, secure, and efficient in smart hospitals. The use of blockchain technology in healthcare is a shining example of how technology is developing and holds the promise of a day when providing patients with high-quality healthcare services will depend heavily on the integrity of the medication supply chain.

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Received on 20.10.2023 Modified on 17.11.2023

Research J. Pharm. and Tech 2024; 17(2):885-892.

DOI: 10.52711/0974-360X.2024.00137