DSCSA and Blockchain, Global Governmental perspective of Blockchain implementation in medtech Medtech Possibilities Information such as place of production of active substances or component parts, manufacturing locations, shipping dates, batch numbers, expiry dates, storage temperature and unique identification numbers, could all be stored and monitored on blockchain.

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DSCSA, Blockchain Medtech and Healthcare
DSCSA and Blockchain, Global Governmental
perspective of Blockchain implementation in medtech.
Hakan ATABAŞ | 2019

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NEW OFFERS
Developing proposals and imposing sanctions
in case of violation of confidentiality rules.
PLANNING
Planned distribution of each produced drug
and product to prevent waste.
NEW USERS
Providing new users and patients with this
system.
PHARMA BRAND
Strict security measures with brand controls
and authorized marks.
MAINTENANCE
Controlling on a decentralized system.
MANAGEMENT
Regardless of the management of the person
to be assigned to him and his deputy to P2P

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EVALUATION
Evaluation criteria should be left to the real
opinion of the society to ensure that correct
feedback is received.
IMPLEMENT
Application areas should be
expanded and projects that
can be applied in all areas of
life should be studied.
PLAN SOLUTION
Providing management through a single decentralized system.
IDENTITY
The use of blockchain security in the identification
process for rigor, security, privacy and more.
ANALYSIS
Ensuring that data sharing is done
without restriction with analysts for
correcting errors with correct analyzes.
FIND SOLUTION
Common areas of work to find
solutions to problems. Producing
integrity.

4. 4
Drug Quality and Security Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain
security, and for other purposes.
2015
DSCSA
Would establish
requirements to
facilitate the tracing
of prescription drug
products through
the pharmaceutical
supply distribution
chain.
2013
Overview of Product Tracing
Requirements
Verification (primarily
pharmacies) shall
establish systems and
processes to be able to
comply with the
verification
requirements
Product identification
(Serialization)
Put a unique
product identifier
on certain
prescription
drug packages
Manufacturers and
Repackagers
2017
Suspect and illegitimate
product
Suspect Product
reason to believe that
product potentially.
Counterfeit, diverted,
stolen subject of
fraudulent
transaction
2016

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Drug Quality and Security Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain
security, and for other purposes.
2019
Repackagers
Product identifier
consists of
- National Drug Code
- Serial number
- Lot Number
- Expiration Date
Data Carrier 2D bar code
2018
Wholesale distributor
Explore and evaluate
methods to enhance
the safety and
security of the
pharmaceutical
distribution supply
chain
DSCSA pilot project
Design: utilization of product
identifiers for product
tracing and verification,
improve technical
capabilities needed to utilize
product identifiers, identify
system attributes that are
necessary, other
2023
Dispensers
Enhanced product tracing by
2023 at the package-leve
FDA shall establish 1 or more
pilot projects Coordinate
with manufacturers,
repackagers,
wholesale distributors
and dispensers
2020

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DSCSA
Blockchain
I’m a manufacturer selling product
I’m a repackager selling product
I’m a repackager buying product
I’m a wholesale distributor or
dispenser buying or selling product
Which trading partner are
you under DSCSA? As of 11/27/2018 – product identifier is
required.
Products packaged before 11/27/18
do not need product identifiers and
can continue to move through the
supply chain.
I’m a repackager buying product
Determine whether the drug is a
product covered under the Drug
Supply Chain Security Act (DSCSA).
Most prescription drugs are covered
under the law, but there are a few
exceptions.
YES, the product is
covered under DSCSA
Change data, security issue, trust issue,
Personal issue, pharma security
If no blockchain what is
issue of DSCSA?
Should this drug package or case have a product identifier under the
Blockchain Drug Supply Chain Security Act?

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DSCSA pilot project(s) 2019 to 2023
FDA shall establish more pilot projects
World DSCSA
• FDA shall establish 1 or more pilot projects
• Coordinate with manufacturers, repackagers, wholesale
distributors and dispensers
• Explore and evaluate methods to enhance the safety and security
of the pharmaceutical distribution supply chain
• Design: utilization of product identifiers for product tracing and
verification, improve technical capabilities needed to utilize
product identifiers, identify system attributes that are necessary,
other
USA (DSCSA) fad.gov
TURKEY – ASIA (DSCSA)
EUROPE (DSCSA)
2013 2015 2017 2019 2023
DrugQuality&SecurityAct(DQSA)
Verification
Manufacturers–Repackagers
WholesaledistributorsandDispensers
Enhancedproducttracingby2023atthepackage-level

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DSCSA Blockchain A to Z
• Single national database Authorized Trading Partners
• Trading partners exchange transaction
information/transaction history/transaction
• Currently, lot-level (package-level by 2023)
• Paper or electronic formats
• Respond to verification requests for suspect product
• Quarantine & investigate suspect product to
determine if illegitimate product
• Notify trading partners and FDA of illegitimate
product (within 24 hours of determination)
• Respond to notifications of illegitimate product
Verification
Product Tracing
Suspect Product Illegitimate Product
• counterfeit, diverted, stolen
• subject of fraudulent transaction
• intentionally adulterated or death
to humans
The term ‘illegitimate product’
means a product for
56 which credible evidence shows
that the product.

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Title II of the bill, the Drug Supply Chain Security Act (DSCSA)
The bill would require the
Secretary to establish standards for
the exchange of transaction
documentation, which shall include
transaction information,
transaction history, and transaction
statements.
Transaction
The bill would require a
manufacturer, wholesale
distributor, dispenser, or
repackager to ensure that each
of its trading partners is
authorized.
Partners is authorized
The bill would require
manufacturers, wholesale
distributors, and repackagers
to verify returned products
before further distribution.
Further distribution
The bill would require the
Secretary to establish
standards for the licensing of
wholesale distributors and
third party logistics providers.
Logistics providers
Start DSCSA
Success
The bill would establish
requirements for drug
manufacturers,
wholesalers, dispensers,
and repackagers to
ensure that all prior
transaction information
is provided at each
transfer of ownership.
Transfer of ownership
The bill would implement
additional requirements
related to the tracing of
products at the package
level ten years after
enactment of this Act.
Anactment of this Act.
The bill would preempt state
and local requirements
related to tracing drugs
through the distribution
system, and licensure of
wholesale distributors and
third party logistics providers.
Third party logistics

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Pilot Project Program Potential Issues to Examine
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Exceptions Handling/Errors
Verification/Notification
Aggregation/Disaggregation
Data/Database/Systems
Interoperability
Barcode Quality
Product Identifier
Special Scenarios
Series 1
Series 2
Public Meeting Series
Enhanced Drug Distribution Security
Under DSCSA
• FDA intends to initiate the DSCSA pilot project program
this year.
• Announcement will be published in the Federal Register.
• Enhanced drug distribution security.
• Verification using the product identifier Identified
“guardrails” to assist stakeholders with implementation
• Prioritized guardrails

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Utilizing FDA NDC in Product Identifier (GTIN)
Unique Product Identifier (GTIN + S/N) to enableSerialization
123456789012
Serial Number
We need to uniquely identify our products
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM206075.pdf
DSCSA: Unique Identifiers

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DSCSA: Data Carriers
(21)123456789013 (?)
(21)123456789014
GTIN
Utilizing GS1 Application Identifiers
S/N Lot Expiry
(10)ABC123
(10)ABC123
(17)141023
(17)141023
Vial
(01)10361414123417
Carton
(01)00361414123414 (21)123456789012 (10)ABC123 (17)141023
Case
(01)20361414123412
(01)00361414123414
(21)123456789012
(10)ABC123
(17)141023
(01)20361414123414(21)123456789012(10)ABC123(17)141023
GS1 Data Carriers
at all packaging levels
…ensuring they can be universally interpreted...

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DSCSA: Standards in Practice
Serialized PREZISTA® 600
encoding the GTIN, Serial
Number, Expiry, and Lot in a
2D Data Matrix.
Utilizing:
1) GS1 standards,
2) FDA SNI guidance, and
3) HDMA shipper bar code
recommendations
…to bring safe medicines to our doctors, nurses, and patients.
Prezista
600mg 24
Bottles
Prezista
600mg 24
Bottles
http://www.healthcaredistribution.org/ir_issues/pedigree.asp

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Why is Blockchain Important?
Blockchain is
essential because it
allows us to own
digital goods, assets,
and data.
There are limitless opportunities for
the technology to define and shape
future innovation in both the public
and private sectors, but we must first
accurately gain an understanding of
its nature and capabilities.

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Where's the world going?
P2P
World
N
E
S
W
He wants speed, confidence,
security, robustness and ease.
Reality, reproducibility, confidentiality,
transparency, robustness, control,
change, innovation and digitization.
National And International Blockchain
CircumstancesConsumer
Economic
Social and cultural
BusinessIntelligence

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The pros and cons of the Pharmaceutical, Health and Medical World.
Pros Cons
Information sharingMobility
Theft of Information
and Ideas
Blockchain
Fear of Project
Development
Digitalization
Conflict of InterestInnovation
Data Security and
Unknown
Innovative approach

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What Are the Drug Supply Chain Security Act's Key Provisions?
First, it established product tracing, which provides a step-by-step
account of where a drug product has been located and who has
handled it. Second, the law established product verification to
ensure that a drug product is legitimate and unaltered. Third, the
law addresses detection and response, which mandates that any
party covered under this act must quarantine and investigate any
suspect drug.
The overarching purpose of this new law is to more efficiently
ensure patient safety by preventing illegitimate or recalled drug
products from entering the market. The logging and record
maintenance of all pharmaceutical products’ change-of-ownership
information initially will be maintained via paper,
Notification has also been established as a key pro- vision
of this law and is implemented by engaging in a system in
which it is mandatory to promptly report to the FDA any
illegitimate or adulterated drug products. Wholesaler
licensing and third-party logistics provider licensing are
also a component of the DSCSA
The combination of these provisions is
designed to facilitate vast decreases in
the number of adulterated and illegitimate
products on the market.
Over a 10-year period, the DSCSA should be able to
accomplish at least 3 goals, according to the FDA. First,
the system should allow for verification of the legitimacy
of a drug product down to the package level. This leads
to the second proposed accomplishment of this act:
illegitimate products in the drug supply chain should be
easily detectable. Finally, the system should aid in a
more successful drug recall situation
The purpose of the drug supply chain security act (DSCSA) was
to create an electronic system to track and trace certain
prescription drugs in the United States. The law regulates
transactions between dispensers and pharmacies and also among
manufacturers, repackagers, wholesale distributors, third-party
logistics providers, and trading partners. The enacted and newly
enforced law has a variety of key provisions.

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Medtech Possibilities
Information such as place of production
of active substances or component
parts, manufacturing locations, shipping
dates, batch numbers, expiry dates,
storage temperature and unique
identification numbers, could all be
stored and monitored on blockchain.

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Blockchain Medtech
Traceability
Storage and
comparison of X-
ray data.
Storage and
analysis of
examination and
patient data.
Storage,
confidentiality and
privacy control of
medical staff data.
Records of
equipment and
health product
data.

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Global Reach Blockchain
They listen and analyze problems and
complaints in the system and seek ways to
improve them.
United States
They can plan for next 30 years, but
Europe need have a consensus to
implement.
Europe
Switzerland has a more advanced
perspective than both Europe and
America. Neutral and successful at the
same time.
Suisse
Turkey next-generation technologies
quickly be integrated capability. It has a
promising perspective and entrepreneurial
spirit.
Turkey
Crypto Money, Health, Finance,
Security and others…
All business areas and current
users.
40% 60%
The intelligibility of
blockchain technology
worldwide.
The proportion of people who do
not understand Blockchain
technology or who look neutral.

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Process and Evaluation
Blockchain should first be
analyzed on the necessity of the
business.
Necessity analysis
HSM, LTM, LTE, Firewall,
Cryptography and much more
security think.
Scalable Data Security
Blockchain smart city initiatives
include: smart waste management,
decreased pollution, improved
mobility, increased business
productivity
Mobility and Productivity

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Demographics Blockchain
0.5% of the world's population is using
blockchain technology. Blockchain
adoption statistics show that half a
percent of the human population is
currently using blockchain technology,
or somewhere around 40 million people.
Where is it used?
60% of the world's population doesn't even
know what Blockchain is.
The other 40% is just awareness, trying to
learn and research.
60%
40%
The financial sector accounts for over 60 percent of
the market value of blockchain worldwide in 2018,
but the technology has spread to nearly every
industry.
0.5%
Obscurity
Awareness

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Contact with me
Any time
+33 623 51 92 46
hkn.atabas@gtu.edu.tr
https://hakanatabas.com
93 A Avenue General De
Gaulle 68300 St-Louis / FR

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THANK YOU