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. 2018 Sep 13;7(9):e10163.
doi: 10.2196/10163.

Blockchain Technology for Detecting Falsified and Substandard Drugs in Distribution: Pharmaceutical Supply Chain Intervention

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Free PMC article

Blockchain Technology for Detecting Falsified and Substandard Drugs in Distribution: Pharmaceutical Supply Chain Intervention

Patrick Sylim et al. JMIR Res Protoc. .
Free PMC article

Abstract

Background: Drug counterfeiting is a global problem with significant risks to consumers and the general public. In the Philippines, 30% of inspected drug stores in 2003 were found with substandard/spurious/falsely-labeled/falsified/counterfeit drugs. The economic burden on the population drug expenditures and on governments is high. The Philippine Food and Drug Administration (FDA) encourages the public to check the certificates of product registration and report any instances of counterfeiting. The National Police of Philippines responds to such reports through a special task force. However, no literature on its impact on the distribution of such drugs were found. Blockchain technology is a cryptographic ledger that is allegedly immutable through repeated sequential hashing and fault-tolerant through a consensus algorithm. This project will develop and test a pharmacosurveillance blockchain system that will support information sharing along the official drug distribution network.

Objective: This study aims to develop a pharmacosurveillance blockchain system and test its functions in a simulated network.

Methods: We are developing a Distributed Application (DApp) that will run on smart contracts, employing Swarm as the Distributed File System (DFS). Two instances will be developed: one for Ethereum and another for Hyperledger Fabric. The proof-of-work (PoW) consensus algorithm of Ethereum will be modified into a delegated proof-of-stake (DPoS) or practical Byzantine fault tolerance (PBFT) consensus algorithm as it is scalable and fits the drug supply chain environment. The system will adopt the GS1 pedigree standard and will satisfy the data points in the data standardization guidelines from the US FDA. Simulations will use the following 5 nodes: for FDA, manufacturer, wholesaler, retailer, and the consumer portal.

Results: Development is underway. The design of the system will place FDA in a supervisory data verification role, with each pedigree type-specific data source serving a primary data verification role. The supply chain process will be initiated by the manufacturer, with recursive verification for every transaction. It will allow consumers to scan a code printed on the receipt of their purchases to review the drug distribution history.

Conclusions: Development and testing will be conducted in a simulated network, and thus, results may differ from actual practice. The project being proposed is disruptive; once tested, the team intends to engage the Philippine FDA to discuss implementation plans and formulate policies to facilitate adoption and sustainability.

Registered report identifier: RR1-10.2196/10163.

Keywords: blockchain; counterfeit drugs; information systems; supply and distribution.

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Two distinct distribution subchains within the blockchain network, highlighted blue and orange. The diagram on the left shows a distribution chain for a drug product, with blue lines representing distribution contracts. The diagram on the right shows a second distribution chain for another drug product within the same network, with orange lines representing distribution contracts. Client applications installed on nodes monitor transactions and track product movement. FDA: Food and Drug Administration; MAN: manufacturer; WS: wholesaler; RET: retailer.
Figure 2
Figure 2
Possible branching and merging patterns in the drug distribution chain.
Figure 3
Figure 3
Example of anomalies that can be detected. Top row, information added by a node contains the wrong certificate. Middle row, information is missing from the block. Bottom row, drug product information is different from previous records or does not match the record in the distribution contract registry.
Figure 4
Figure 4
Log-in interface with two-factor authentication.
Figure 5
Figure 5
Transaction history, listing transactions made by the participant using the node.
Figure 6
Figure 6
The timeline dashboard to visualize transactions along a distribution chain to highlight manufacturer shipment time to consumer purchase at a retailer. Diamond markers signifying transactions. A red diamond denotes a possible problem based on the information distributed on the network.
Figure 7
Figure 7
Contract registry interface only installed on the Food and Drug Administration (FDA) node and accessible to the FDA account.
Figure 8
Figure 8
Participant and drug product registries. The corresponding forms for adding participants and drug products into the network are shown. These interfaces will only be accessible by the Food and Drug Administration.

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References

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