JOURNAL CLUB PRESENTATION (20L81S0403-PA & QA)
The document discusses the implementation of a blockchain-based system to enhance traceability and serialization in the pharmaceutical industry, addressing counterfeiting issues and improving product safety. It includes details on the automated processes, regulatory compliance, and the use of decentralized applications (dapps) on the Ethereum blockchain for tracking pharmaceuticals during distribution. The conclusion emphasizes the advantages of blockchain technology in ensuring product integrity and facilitating regulatory synchronization.
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JOURNAL CLUB PRESENTATION (20L81S0403-PA & QA)
- 1. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1 As a part of curricular requirement for M. Pharm III semester Presented by D. RAVI SHANKAR. (20L81S0403). M.PHARM Department of Pharmaceutical Quality Assurance. Under the Mentorship of Dr.K.Vinod Kumar., Ph.D. Asssociate professor & HOD, Department of Pharmaceutical Analysis Journal Club Presentation
- 2. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2 Title, Authors & Acknowledgement Acknowledgement This research has been supported by the research agreement (2018–2021) stipulated on the 26/02/2018 between SIFI SPA and the University of Catania.
- 3. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3 Introduction The Blockchain in brief and relevant use cases Traceability Serialization technology The Blockchain enhancement Authors Conclusion My Conclusion Contents •Implementation of the smart traceability process •The Ethereum based DAPP implementation
- 4. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4 • With the growth of a global market, new regulations aiming at preventing the fraud of counterfeiting drugs have been released all over the world. In the pharma industry, an innovative technology named serialization is becoming more and more popular as it allows to implement a packaging process based on a hierarchical aggregation. • This guarantees that each box entering in the distribution network is marked with a unique identifier for an easy traceability by a central regulatory in charge to follow the life cycle of the product until given to the final patient. • To demonstrate the effectiveness of this technology, in this paper, a DAPP based on the Ethereum blockchain has been coded and tested as prototype in a pharma industry. Introduction
- 5. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5 • The pharmaceutical industries are heavily regulated to ensure their compliance to the highest quality and safety standards of the healthcare systems. The quality of their products must be guaranteed not only during the production phase inside the industrial plant but, through their entire life cycle and along the distribution network until they are sold or administered to the final patient • It has been estimated that counterfeit drugs cause over 100000 deaths annually and over than $200 billion loss in the pharmaceutical industry • In order to fight this phenomenon, the 2011/62/EU Directive introduces new regulations that can improve the effectiveness of the traceability process among the actors of the distribution network and prevent falsified medicinal products from entering into the legal distribution chain.
- 6. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6 • To this end, the European Medicines Verification Organisation (EMVO) has taken the responsibility for advancing the creation of an information system, the European Medicines Verification System (EMVS), that centralizes the operations of medicine verification and the enhancement of patient safety. • The Drug Quality & Safety Act – H.R. 3204 (Pharma Track & Trace Bill) introduced on sept 27, 2013 and the bill was passed on sept 28, 2013. • Blockchain could provide a breakthrough in this important process due to its inherent features that guarantee decentralization, immutability, privacy and security of data.
- 7. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7 • Murray says that, a blockchain is a special database shared across a network of computers (called nodes). • The blockchain is encrypted such that only its owner can access “his” information. • In fact, the blockchain technology can be used to store data safely and to eliminate the issue of the counterfeiting, since all the history of the information cannot be tampered or modified. The Blockchain in brief and relevant use cases
- 8. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8 • The great advantages that can be brought within the healthcare system through this blockchain is that, the medical treatment process can be strengthened because medical specialists can share several anonymous information and speed up the diagnosis of a patient disease. • A recent contribution presents a decentralized application for the traceability in the agri-food supply chain management the data produced by the IoT devices (Internet of things - connection between devices through sensors) into the blockchain.
- 9. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9 • Traceability is the ability to identify and trace the history of a product, keeping track of all the locations and of the users that have handled it. • In the pharma industry, traceability is an essential key at the basis of an improved trust- based relationship among consumers, pharmaceutical industries and all the actors of the distribution network. • Figure 1 shows the workflow of a distribution network process of a pharmaceutical company. It involves several actors and passages, including the dispatching to the final customer. • Before entering a new product into the distribution network, the pharmaceutical company has to communicate to a central authority (in Europe is the EMVO) all the serial numbers of the drug package units that have been produced and ready to be shipped. Traceability
- 10. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10 Fig. 1. Traceability process with a central regulatory.
- 11. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11 • Automation of the process is already in place in many pharmaceutical companies and takes the name of serialization. • Serialization is that ensemble of smart technologies that allows the packaging lines of an industrial plant to implement a packaging process based on a hierarchical aggregation. • The codification of the identifier must respect several rules that depends on the packaging level (e.g., Unit Box, Case Box, Unit-Load), on the product packaged and, more important, on the encoding specification of the country in which the product will be traded. Serialization technology
- 12. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12 Unit box Case box Unit load Serialization and packaging hierarchy (unit box, case box and pallet)
- 13. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 13 • As soon the last level of packaging has terminated (generally corresponding with the lot unit load), the serialization software sends the hierarchy matrix list to the ERP that closes the work order and elaborates the beginning of the next phases (storage, batch release, delivery/shipping). • During the batch release, the serialization software sends the official hierarchy matrix list which has to be stored permanently in the serialization software, to the central regulatory .
- 14. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14 • All the other actors of the distribution network are called to maintain information about the drugs handled for several years. • According to this principle, every actor is responsible for its data and for the synchronization process with the central regulatory that must behave as central authority. • Blockchain technology can be handled and improved through the list of key features, such as a. Ownership: every actor of the distribution network is responsible of a product as soon they receive it. b. Uniqueness: every unit box of drug that can be sold separately must be characterized by a unique identifier. The Blockchain enhancement
- 15. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15 c. Data synchronization: every actor is responsible for the synchronization process of their data with a central authority. d. Data retention: every actor (except the patients) are called to maintain for several years the process information about the products handled.
- 16. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16 Architecture of the serialization process with the blockchain enhancement
- 17. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 17 • The smart contract that encrypts all the relevant data of the serialization process has been codified in order to handle and strengthen the traceability process along all the distribution network. • The owner is in charge to update the information concerning the status of the good as long it holds the ownership. Eg - the Pharma Industry is owner of a pallet as long it is not dispatched to the next actor of the distribution network. Implementation of the smart traceability process
- 18. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18 • Any time a product is packaged, the BC Server interacts with the smart contract to create an electronic identity (i.e., digital twin) of the item that is stored and encrypted in the blockchain with all the relevant information. • Once the record is appended to the blockchain it can be retrieved and, eventually, updated using the unique identifier assigned by the smart contract and applied as a stamp with a QR code.
- 19. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 19
- 20. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 20 • The ownership responsibility enables a mechanism that improves the traceability process and reduces the success of a counterfeiting attempt. • Figure 7 shows the locking mechanism operated by the smart contract to distribute the ownership token (T) among the actors of the distribution network. In this example, it is assumed that there are four actors in the distribution network. • As soon the BC Server creates the electronic identity of an item into the blockchain, the corresponding good is packaged and labelled with the QR Code.
- 21. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 21
- 22. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 22 • With the transaction, there is a transfer of ownership of the item to the Pharma Industry (Figure 7.a) which is characterized by a public address. • In this way, only the Pharma Industry can interact with the smart contract by the means of its private key. • During the entire production and distribution process the transparency of the blockchain allows all actors to analyze the status of each product – but only if the actor has the knowledge about which blockchain address is owned by whom. This mechanism can prevent the counterfeiting attempts because only the owner has the chance of interacting with the smart contract and this mechanism is propagated forward to the final actor
- 23. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 23 • Therefore, if at a certain point of the distribution network, a counterfeited product enters in the distribution chain, the forked path will not be traced in the blockchain because the forked actor will not have the grants to interact with the smart. • In other words, the counterfeited good breaks the integrity of the distribution network. • The smart traceability process based on the proposed blockchain solution is shown in Figure 9. • Any time a product passes to a new owner, the operations of 1) tracing info 2) updating status 3) enabling the next actor of the distribution network must be undertaken.
- 24. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 24
- 25. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 25 • This guarantees the tracking, the synchronization and the integrity of all the activities in the blockchain, through which bad actors can be identified.
- 26. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 26 • The Ethereum blockchain offers several mature tools for implementing, testing and deploying a decentralized application. For example, the browser Metamask (available for smartphones and internet browsers) allows sending transactions to the blockchain. • It is possible to see that the history of a product can be tracked from the beginning to the final stage by scanning the QR code printed in the package of the box unit. • For each phase of the life cycle of a product, the DAPP shows – The status The timestamp of transition The QRCode of the public address of the owner who entered the data A link (“View Transaction”) that opens the Ethereum public webpage containing all the details of the corresponding transaction The Ethereum based DAPP implementation
- 27. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 27
- 28. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 28 • Blockchain can offer several advantages to simplify and strengthen the process of traceability throughout the life cycle of a drug and, more generally, of all the packaged units that enter in the distribution network. • This simplifies the process of synchronization with the central regulatory, reduce the counterfeiting phenomenon and increase the trust of the users. Authors Conclusion
- 29. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 29 • Through smart contract it will be easier to implement the DAPP It is a computer program / a transaction protocol which is intended to automatically execute, control and document it legally as per the agreement. • Smart contract provides “true data” –allowing to secure the digital identity of the good. My Conclusion
- 30. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 30 • Nakamoto S. Bitcoin: A peer-to-peer electronic cash system, 2008. • Ahram T, Sargolzaei A, Sargolzaei S, Daniels J, Amaba B. Blockchain technology innovations. In 2017 IEEE Technology & Engineering Management Conference (TEMSCON), 2017, (pp. 137- 141). • Sharma H, Parekh S, Shewale S. Regulatory Practice in Pharmaceutical Industry. Pharmaceutical Regulatory Affairs: Open Access. Volume 3, Issue 1, 2014. • Tian F. An agri-food supply chain traceability system for China based on RFID & blockchain technology. In 2016 13th international conference on service systems and service management (ICSSSM) (pp. 1-6), 2016 IEEE. • Abeyratne BA, Monfared RP. Blockchain ready manufacturing supply chain using distributed ledger. International Journal of Research in Engineering and Technology, 2016, eISSN: 2319-1163 ISSN: 2321- 7308. References