=Paper= {{Paper |id=Vol-3067/paper18 |storemode=property |title=Towards a Blockchain-based approach to fight drugs counterfeit |pdfUrl=https://ceur-ws.org/Vol-3067/paper18.pdf |volume=Vol-3067 |authors=Rawya Mars,Jiddou Youssouf,Saoussen Cheikhrouhou,Mariem Turki |dblpUrl=https://dblp.org/rec/conf/tacc/MarsYCT21 }} ==Towards a Blockchain-based approach to fight drugs counterfeit == https://ceur-ws.org/Vol-3067/paper18.pdf

Towards a Blockchain-based approach to fight drugs
counterfeit
Rawya Mars1 , Jiddou Youssouf1 , Saoussen Cheikhrouhou1,2 and Mariem Turki3
1
ReDCAD, University of Sfax, Tunisia
2
Digital Research Center of Sfax, BP. 275, 3021, Tunisia
3
University of Gabes, Tunisia

Abstract
A safe supply of drugs is critical to public health. Over the past years, the world witnessed a significant
rise in the number of pharmaceutical drug frauds, causing thousands of victims who are affected by
poisoning, untreated diseases, premature deaths, and treatment failures. Blockchain technology is
currently being proposed as a way to solve the problem of counterfeit drugs by keeping track of the
drug supply chain. Blockchain is a distributed, immutable ledger shared between nodes in a peer-to-peer
network, where each node stores the same data, and coexists with other nodes without having to trust
them. Existing studies have highlighted the need for a robust, end-to-end tracking and tracing system
for the drug supply chain. Thus, an end-to-end product tracking system in the drug supply chain is
critically needed to ensure product safety and eliminate counterfeits. The majority of existing tracking
and tracing systems are centralized, leading to data privacy, transparency and authenticity issues in
healthcare supply chains. In this paper, we propose an approach based on Ethereum blockchain that
leverages smart contracts and decentralized off-chain storage to ensure efficient drugs traceability and
which monitors the consumption of these drugs by patients according to a doctor’s prescription. This
Smart Contract guarantees data provenance, excludes the middleman need, and provides a secure and
immutable transaction history to all involved participants. We introduce the system architecture and
detailed algorithms governing the operating principles behind our proposed approach. We present an
evaluation of the effectiveness of the approach, in improving traceability within drug supply chains,
through testing and validation, and analyzing the costs and security of the approach.

Keywords
Blockchain, Ethereum, Drugs counterfeit, Traceability, Healthcare, Supply chain

1. Introduction
In the Healthcare area, pharmaceutical drug fraud has become a widespread issue due to the
complexity of the drug life cycle. Following the completion of the drug manufacturing process,
the drug must be transferred from factory stocks to distributors at the wholesale level, who will
subsequently transfer it to pharmacies which sell it to patients to consume.
Drug life cycle is a complex process that includes many stakeholders like raw material
supplier, manufacturer, distributor, distribution points such as pharmacies and hospitals until
drug consumer. Due to lack of information, centralized control, and competing behavior among

Tunisian Algerian Conference on Applied Computing (TACC 2021), December 18–19, 2021, Tabarka, Tunisia
$ rawya.mars@fsegs.u-sfax.tn (. R. Mars); iddouyoussouf@gmail.com (. J. Youssouf);
saoussen.cheikhrouhou@gmail.com (S. Cheikhrouhou)
© 2021 Copyright for this paper by its authors. Use permitted under Creative Commons License Attribution 4.0 International (CC BY 4.0).
CEUR
Workshop
Proceedings
http://ceur-ws.org
ISSN 1613-0073 CEUR Workshop Proceedings (CEUR-WS.org)
stakeholders, tracking supplies through this process is not simple. This complexity can lead
to the injection of certain drugs that aren’t in the manufacturing or packaging standards,
whether voluntary or involuntary, thus constitute a danger for the consumer. These drugs
may not contain Active Pharmaceutical Ingredient (API), unapproved or poor quality of active
pharmaceutical ingredient, harmful substances, or substances which should no longer be used
because they were expired. The drugs sold in developing countries are 30% counterfeit drugs,
according to the Health Research Funding Organization [1]. Based on these statistics, it is clear
that the pharmaceutical industry is very vulnerable to counterfeit drugs. Like indicated by WHO,
counterfeit drugs are considered as one of the major causes of deaths in developing countries,
and in most cases the victims are children [2, 3]. Counterfeit drugs don’t affect human health
only, it also cause huge economic loss to the pharmaceutical industry. In America the loss in
the pharmaceutical industry is around $200 billion dollars due to counterfeit drugs[1, 4]. Drug
supply chain process is sequential. It starts with the API supplier who gives raw materials to drug
manufacturers. Drug manufacturers need regulatory agency authorization such as Directorate
of Pharmacy and Medicines in Tunisia (DPM) before starting drugs making. Subsequently,
drugs are packaged into Lots by manufacturers. Afterwards, these lots are distributed to the
pharmacies and hospitals by the distributor so that patients can buy the box. There is always a
risk of incorporating counterfeit drugs throughout this supply chain cycle [5]. This is why drug
traceability must be an integral part of the pharmaceutical supply chain. Blockchain solutions
are currently being proposed to address the problems of traceability in the healthcare area since
it can help to keep track of the manufacturing chain of the drug [6]. The blockchain ensures
that all transactions are immutable and time-stamped, thus guaranteeing that the information
cannot be tampered with or falsified. Pharmaceutical drug industries can use either public
or private blockchain systems depending on the requirements of their business. By using
blockchain technology, it is possible to obtain the complete trace of the drug. As the drug
is transported from one place to another, both its movement information, coupled with its
temperature can be stored on the blockchain, thereby improving the traceability of the drug and
reducing the risk of its counterfeiting. In this paper, we design a system that uses traceability
property of blockchain technology to ensure drugs traceability, monitor drugs temperature,
detects a potentially damaged drug and relies on an off-chain InterPlanetary File System-IPFS
storage to store user’s confidential data. This allows sensitive information to never be leaked
to others exploring the blockchain, as the only information stored on-chain is the IPFS hash.
The proposed approach pushes back the introduction of counterfeit drugs at all possible access
points. The key contributions of this paper can be summarized as follows :
1. We present blockchain based solution for counterfeit elimination in pharmaceutical sup-
ply chain management system that improves the safety, traceability, and transparency of
pharmaceutical drugs.
2. We build a set of smart contracts capable of managing various transactions between pharma-
ceutical supply chain stakeholders.
3. We introduce, implement and test the smart contracts defining the operating principles of
our proposed solution.
4. We conduct a cost analysis to evaluate the performance of the proposed solution.
This paper is structured as follows: Section 2 presents a review of existing works with respect
to traceability in the pharmaceutical supply chain. Section 3 provides a high level overview
of our drug traceability proposed approach, while Section 4 introduces the implementation
details. Section 5 provides a discussion and evaluation of the proposed approach and Section 6
concludes this work with future work.

2. Related work
In this section, it is a question of making an overview of some works that have been made with
blockchain technology in the supply chain industry. The project MediLedger is a blockchain
based network to control drug supply and reduce counterfeit drug distribution [7]. Ambrosus
ecosystem based on blockchain technology is designed to confirm manufacturing source, quality
and compliance according to product standards. It also assures the respect of good conditions
of transport and storage throughout their passage from the producer to the final consumer [8].
In [9] a secure drug supply chain based on Hyperledger Fabric to keep track of each individual
in the supply chain to counter drug counterfeiting and to allow doctors, patients, nurses, and
pharmacist to enter their data is presented. The system authors describe its performance in
terms of throughput and latency. The authors in [10] proposed blockchain platform which
offers high transparency and traceability to avoid counterfeiting in drug supply chain and
needs supply chain members authorization to create data. The Linux Foundation research on
drug counterfeiting prevention resulted in the development of drug control system based on
Hyperledger Fabric which maintains, supplies authentic drug supply in drug supply chain, and
allows administrators to manage patients and doctors [11, 12]. In [13] authors proposed a drug
traceability system called Drugledger which offers authenticity and privacy of stakeholders’
traceability information. A system to ensure the efficient traceability of products in the health-
care supply chain with the Ethereum blockchain and the IPFS[14] file storage system is being
developed in [15]. A smart contract is created for each product to record their movements with
events. An Ethereum blockchain-based system for tracing covid-19 vaccines is presented in [16].
This system creates a QR code for each vaccine and for each person who signs up to receive
the vaccine. The temperature of the vaccine is constantly checked during transport to ensure
that it is within the range of values set in the smart contract. Before injecting the vaccine, the
identity of the beneficiary must be verified and the condition of the vaccine must be checked
if it has not been damaged during transport. The beneficiary may report possible side effects
after receiving the vaccine. Some work has not contented just with ensuring the authenticity
of drugs, but also adding a module that offers the drug best suited to users. This is the case in
[17] based on blockchain using Hyperledger and machine learning (N-Gram and LightGBM
model). Blockpharma is a blockchain based system designed to reduce counterfeit products
in supply chain. This system includes a machine learning module to verify drug authenticity
before buying [18]. Authors in [19] used blockchain technology using the Hyperledger Project
and temperature sensors to track drug distribution and to know about drug status. The proposed
framework will therefore record and time stamp the various transfers.
3. Drug traceability approach overview
The present section provides a high-level overview of drug traceability’s proposed approach by
outlining drug traceability’s proposed infrastructure, the actors involved, and the main process
for achieving an efficient traceability of the pharmaceutical drug solution.
The infrastructure of the proposed approach consists of two main components: a distributed
storage system and private permissioned Blockchain.

3.1. Involved actors
The principal roles of the involved actors are detailed as follows.

• Regularity authority (DPM): is a national agency responsible for overseeing all drug
supply chain actors and all their drug-related activities. It has the power to grant or
withdraw a license to an actor wishing to participate in the supply chain. It approves the
manufacture and marketing of a drug.
• The manufacturer: is the one who produces drugs in a defined laboratory, distributes
them in batches, and puts them on the market to help the sick to be cured.
• The distributor: is responsible for the drug transportation from manufacturer to dis-
tribution points accessible to the public. Thus, it acts as an intermediary between the
manufacturers and the distribution points.
• Pharmacies: are drug distribution/sale points accessible to the public. There are pharma-
cies in every locality. Their decentralized locations allow easy access to drugs to prevent
people from traveling to the manufacturer, a trip that can also be a long journey.
• Hospitals: are also distribution points. Normally the hospital is made to treat sick
patients. But there are times when the hospital needs medicine right away. So it is
necessary that the hospital has its own drug store.
• Doctors: are the staff of a hospital. Their role is to diagnose a patient to know his anomaly
and provide him with an effective treatment to heal.
• The patient: is the client of a hospital. This one is distinguished by an illness that he
suffered in his body and decides to consult a specialist in order to get better.

3.2. Main process for drug traceability approach
Figure 1 depicts the main process of our proposed drug traceability approach along with its
different steps, which are detailed as follows. Moreover, to clarify the approach, we present the
interactions between different actors in a sequence diagram, as shown in figure 2.

(1) Registration and authorization of supply chain actors: The DPM registers each supply
chain actor in the system by assigning to him an Ethereum address which will allow him to
be identified. It also registers an image that represents the license of the actors in the supply
chain. This license is an insurance that proves that the supply chain actors are competent
in carrying out their work. The image of the actor license will be saved on the IPFS storage
system. It will return a hash code which is an identifier allowing to find the location of the
file saved on IPFS. The generated hash will be stored on the blockchain to recover the file
Figure 1: Approach overview

during the verification of a drug. The DPM can withdraw the license and cut off access
to the system to an actor who does not do his job well in the supply chain. Actors like
manufacturers, distributors, pharmacies, hospitals, and doctors must be registered on the
system and have a valid license to perform operations in the system.
(2) Manufacturing and validation of drug: The drug manufacturer must have authorization
from the DPM to begin making a drug. The manufacturer enters the characteristics of the
drug into the system and waits for DPM’s approval. After analysis of the drug, the DPM can
refuse or approve the request to manufacture the drug. In the event of a favorable opinion,
the manufacturer will be able to manufacture batches of the new drug which has been
added. Then he calls a distributor who has a valid license and who is available to transport
the batches of medication to pharmacies and hospitals where people can purchase the box.
(3) Drug distribution: The distributor schedules a shipment of drug batches in the system and
indicates which batches are affected by the transport. The lots will be loaded into the vehicle.
Some drugs need to be stored within a well-defined temperature range; their effectiveness
may decrease if their temperature exceeds the set threshold. To detect these potentially
used drugs, the vehicle of the distributor will be equipped with a temperature sensor which
will determine the temperature throughout the transport. The sensor data will be collected
by a Raspberry Pi single card computer, which will transmit them to the blockchain. The
temperature data will not be recorded but will only be used for verification. The blockchain
Figure 2: The actors interactions

matches the temperature of the transport in the temperature range of each batch of drugs
being transported. The batches which will exceed their temperature will be marked and the
consumer will have a warning during the verification indicating the conditions of transport.
The distributor at the end will mention the points of sale (pharmacies and hospitals) where
he delivered each batch.
(4) Healthcare stakeholders registration: The hospitals will manage their staff by registering
in the system the doctors who work in their homes. They will also register patients if they
have not been added previously by another hospital. This will allow to have all the medical
data of a patient in a global way and to constitute a complete medical file.
(5) Diagnosing and drug prescription: Following a medical diagnosis of a patient, the
doctor will prescribe a prescription containing the list of drugs that the patient must buy and
consume. A consumption limit will eventually be defined on each drug of the prescription.
(6) Drug purchasing: To purchase drugs, the patient must go to a pharmacy. The pharmacy
checks the patient’s prescription to make sure that he has not reached the dose prescribed
by the doctor. If this is the case the patient buys the drugs and the pharmacy accesses the
patient’s medical file to quote the drugs purchased. Otherwise, the pharmacy will refuse
the sale of drugs to the patient.
(7) Drug authenticity verification: After purchasing the medicine boxes, the patient can
verify their authenticity by indicating the name of the medicine purchased and its batch
number. If the drug batch is genuine, it will have a complete history containing the informa-
tion of the manufacturer, distributor, packaging of the batch according to temperature and
the points where the batch was delivered. Otherwise, he will have no information about the
lot.

4. System Prototype
In this section, we are implementing the drug traceability approach based on IoT and Ethereum
blockchain which is publicly available in Github repository1 . Specifically, we explain the details
of the system components, including smart contracts, and their implementations.

4.1. Drug traceability approach component
In order to realize our system, several technologies are used. The system is divided into three
parts: a user interface, an IPFS storage space, and a blockchain.

• User interface: We use the Vue.js framework [20] to develop our user interface. Vuejs is
a versatile javascript framework. It’s easy to learn and allows to make easy, testable and
maintainable code. Vuejs provides the libraries and ecosystems needed to build client-side
business logic. To build a web page with Vuejs, we split it into parts called components,
each containing their own HTML, CSS, JavaScript code.
• IPFS storage space: The players’ licenses will not be able to be put on the blockchain
because of their large size. However, the images will be saved on IPFS. The IPFS server
will return a hash that we can use to find the location of the file. In our case we will save
the hash on the blockchain. The IPFS server that we use is provided by Infura [21]. To
use it you just have to install the ipfs-http-client [22] package from Node [23].
• Blockchain : We use a test blockchain to build our framework. The blockchain used
is Truffle develop [24]. It is useful to test and debug our smart contract, or to execute
transactions by hand. The interaction with the blockchain is done with a JavaScript
library called Web3. In our project we use version 1.2.11.

4.2. Smart contracts
The smart contract is a program that runs on the blockchain. It is like a key that one must have
to manipulate data in the blockchain. We use three smart contracts developed with the Solidity
language for the realization of our system: a smart contract to manage the actors, a smart
contract to handle all the activities concerning the drugs, their batches, and their distribution
channels, a smart contract to monitor the drugs consumed by a patient. For conciseness reasons,
only a snippet of code of the implemented function which allows finding and tracing the drug
is illustrated in listing 1.

1
https://github.com/Jiddou-Youssouf/vue-app
1 f u n c t i o n f i n d D i s t r i b u t i o n s B y L o t ( d e l i v e r e d _ L o t memory _ l o t ) p u b l i c view r e t u r n s (
int256 ) {
2 f o r ( u i n t i = 0 ; i < d i s t r i b u t i o n s . l e n g t h ; i ++) {
3 f o r ( u i n t 2 5 6 j = 0 ; j < d i s t r i b u t i o n s [ i ] . d e l i v e r e d _ l o t s [ _ l o t . drug_name ] . l e n g t h
; j ++) {
4 i f ( keccak256 ( a b i . encodePacked ( d i s t r i b u t i o n s [ i ] . d e l i v e r e d _ l o t s [ _ l o t .
drug_name ] [ j ] ) ) == k e c c a k 2 5 6 ( a b i . e n c o d e P a c k e d ( _ l o t . l o t _ n u m b e r ) ) ) {
5 return int256 ( i ) ;
6 }
7 }
8 }
9 r e t u r n −1;
10 }

Listing 1: findDistributionsByLot function of DrugManagement smart contract

• Actors management smart contract : All the functions implemented in this smart
contract are totally controlled by regulatory authority. This authority registers each
actor, which is represented by a data structure, by giving a unique Ethereum address,
as an identifier. It is also charged of granting and revoking access to an actor. For the
management of actors, a data structure is built for each type of actor containing a unique
Ethereum address to connect and interact with the system and additional information to
identify the actor. The regulatory authority will be in charge of granting addresses.
• Drugs management smart contract : The smart contract for drugs and their various
treatments contains data structures related to drugs, batches, and their distribution
channels. Among the information in the data structure of a drug, we have the minimum
and maximum temperature in which the drug should be stored. The data structure of
drug batches contains the batch number, the drug to which the batch belongs, the date
of manufacture, the expiry date, and the condition of the batch that will be examined
during its transport. The last data structure for tracing the life cycle of drug lots contains
the identity of the actor who carried out the transport, the lots he transported, the list of
points where he made deliveries, and the list of delivered lots for each point. We identify
six major functions in this smart contract: a function to add drugs, a function to authorize
the manufacture of drugs, a function to refuse the manufacture of drugs, a function to
add batches to drugs, a function to record the distribution circuit of the batches and a
function to check the temperature of the transported batches.
• drugs consumption monitoring smart contract : This smart contract contains 2 data
structures. The first one is for medical prescriptions containing a unique number, the day
of the consultation, the identity of the patient, the identity of the doctor, the report of the
doctor’s consultation, the list of drugs prescribed to the patient, possibly the quantity of
the necessary dose to be consumed for each drug and the address of the points where
the drugs were purchased. The second one is for register a patient containing a identity
number, a name, a phone number, a date of birth, a nationality and a birth place. The
smart contract contains functions to add a patient, to create a new consultation for the
patient and to modify the prescription. Figure 3 shows how a patient can verify if the
drug is counterfeit or not with the two different cases.
(a) Drug traceability : Drung found. (b) Drug traceability : Drung not found.
Figure 3: drug Traceability : Found and Not Found cases

5. Discussion and Evaluation
In this section, we firstly discuss the generalization of the proposed IoT and Ethereum blockchain-
based solution, then present a cost analysis of the proposed blockchain-based pharmaceutical
drug traceability approach, and finally discuss the limitations of blockchain in the supply chain.

5.1. Generalisation
The approach proposed in this paper proves the potential application of both blockchain and
IoT technologies for drug traceability in a pharmaceutical supply chain. The functions of the
smart contract were defined to specifically meet the needs of the pharmaceutical supply chain,
although they can easily be extended for other types of supply chains since it differs in the
products/items that are shipped, distributed, sold and how they are handled throughout the
process. As an example, some drugs require highly specific conditions that include temperature
and humidity during their transfer between locations, whereas a supply chain of car components,
for example, would need extremely different conditions. Depending on the specific supply chain
application, such as food, spare parts, or any other application, the supply chain actors and
their roles need to be modified. Furthermore, using a decentralized storage system is not often
necessary where storage and access to large off-chain data files are not required. Eventually,
the resources on-chain could be adjusted to suit the needs of the specific proposed application.
For instance, setting up a reputation, payment and funds transfer system would sometimes
be useless. In such cases, on-chain storage will be widely adequate to keep transaction logs
between the involved parties. Furthermore, creating multiple products simultaneously may
require extending functions to accommodate additional products, which can be achieved by
modifying the existing smart contract, with reference to similar algorithms in various other
supply chains.

5.2. Cost analyzing
In this subsection, we provide the cost analysis of the Ethereum smart contract code and function
calls. On Ethereum blockchain, to conduct a transaction, it costs gas to send it to the Ethereum
blockchain. MetaMask wallet provides a very useful and easy-to-use way of estimating the
execution and transaction costs as the main types of costs. The execution cost corresponds to
the cost of executing the different functions of the smart contract, while the transaction cost
considers several factors such as contract deployment and data sent to the blockchain network.
Table 1 illustrates the gas costs of each function used in the smart contract, along with the
costs converted to fiat currency (USD). Table 1 shows a very low cost of the functions in USD.
The highest cost function is the Add distribution points to lots function which is executed by
the distributor . Such a relatively high cost could be explained by the changing of different
variables in the function that requires storage. Alternatively, the Remove access to the actor
function costs the lowest, since it only revoke access from an actor in the supply chain. The
above observations demonstrate that gas charges are proportional to the number of times the
smart contract status has changed, which also indicates that storage can significantly increase
costs, thus it is critically important for the user to upload the correct details, as once the function
is executed, it cannot be reversed and the gas charges are permanently lost.

6. Conclusion
In this paper, we proposed an Ethereum blockchain based approach for drug traceability in the
pharmaceutical supply chain to prevent counterfeit drug issues. Our proposed approach ensures
efficient drug traceability and which monitors the consumption of these drugs by patients
according to a doctor’s prescription. The proposed solution provides a way for the patients to
verify the authenticity of the provenance of the drug they are consuming and thus his protection
from counterfeit drugs which may cause harmful effects. Indeed, our approach relies on a
set of emerging technologies such as Blockchain and IPFS storage to guarantee the security
and the traceability for pharmaceutical supply chains. We have outlined the architecture of
the proposed approach and its components, with details of the operating principles behind it.
We have implemented and evaluated the effectiveness of this approach, including improving
traceability in pharmaceutical supply chains by conducting tests and validations, as well as
analyzing the costs. For some reasons, we couldn’t implement the IoT part and provide real
time data collected from sensors. For future work, we are continuously focusing on improving
Table 1
Gas Costs of the Smart Contracts Functions
Function caller Function name Gas used Cost in Ether Cost in USD
DPM Register an ator 423693 0.000847 $2,85
DPM Give access to an actor 48303 0.000097 $0.33
DPM Remove access to the actor 18348 0.000037 $0.12
Manufacturer Manufacturing request 190492 0.000381 $1.28
DPM Grant manufacturing request 33708 0.000067 $0.23
DPM Refuse manufacturing request 33729 0.000067 $0.23
Manufacturer Add lot for a drug 169013 0.000338 $1.14
Distributor Plan a new distribution 317590 0.000635 $2.13
Distributor Check drug temperature 95745 0.000191 $0.64
Distributor Add distribution points to lots 426031 0.000852 $2.86
Distributor Complete a distribution 47421 0.000095 $0.32
Hospital Add doctor 342041 0.000684 $2.32
Hospital Add patient 192571 0.000385 $1.31
Doctor Create medical prescription 251236 0.000502 $1.70
Pharmacy Update medical prescription 71693 0.000143 $0.49

the effectiveness of pharmaceutical supply chains and plan to focus on extending the proposed
system with an IoT layer to achieve more transparency and verifiability of drug use.

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