FDA Track and Trace Public Workshop - Determination of System Attributes for Tracking and Tracing of Prescription Drugs - February 15-16, 2011
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Determination of System Attributes for Tracking and Tracing of Prescription Drugs FDA Track and Trace Public Workshop February 15-16, 2011
FDA Public Workshop: Determination of System Attributes for Tracking
and Tracing of Prescription Drugs
• Welcome
• The Importance of Track-and-Trace
• California State Board of Pharmacy
• Concepts and Terminology
• Potential System Attributes
• Workshop logistics
• Interoperability
• Authentication
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.
How a track-and-trace system would improve the security of
the drug supply chain:
More • Improved transparency and accountability throughout the
accountability supply chain to prevent counterfeit, diverted, stolen, and other
substandard product entry
Improved • Enhanced information and ability to isolate issues and execute
reverse logistics reverse logistics in the event that a product should not be sold to
management the end consumer (e.g., recall, product defect, etc.).
• Enables faster and easier recalls by collecting information about
the location and ‘holder’ of a product
• Enables identification of diversionary schemes at point of
Diversion departure from, and point of entry to, the supply chain.
prevention • Improved identification of stolen product creates better
communications to the supply chain partners to look out for or
find the stolen product
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.
WHO MAKES UP THE DRUG SUPPLY CHAIN? ILLUSTRATIVE
Pharmacy
Manufacturer Distributor (Primary)
Repackager Distributor (Secondary)
Complexity of the supply chain is increased by: Example of vulnerabilities:
• Globalization of supply chains • Goods are stolen and reintroduced into the
• Criminal activities such as diversion, cargo theft, supply chain
and counterfeiting • Counterfeit goods are sold to suppliers and re-
• Rules that vary by country and state enter the supply chain
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.IS THE DRUG SUPPLY CHAIN SAFE? Yes, but… ILLUSTRATIVE
Pharmacy
Manufacturer Distributor (Primary)
Repackager Distributor (Secondary)
Rogue players are
sophisticated.
How can a track-
Track & Trace system participants
and-trace system
should be validated to keep rogue
keep them out?
Counterfeiter parties out
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Track and Trace System Goals
1. Preventing the introduction of counterfeit, diverted,
subpotent, substandard, adulterated, misbranded, or
expired drugs
2. Facilitating the identification of counterfeit, diverted,
subpotent, substandard, adulterated, misbranded, or
expired drugs
3. Providing accountability for the movement of drugs
by supply chain participants
4. Improving efficiency and effectiveness of recalls
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Overview of a Track and Trace System ILLUSTRATIVE
Manufacturer / Distributor/ Distributor/ Pharmacy
packaging line intermediary intermediary
or
9
• Serialize • Track product • Track product • Track product
• Record SNI • Authenticate • Authenticate • Authenticate
and product
info
Track-and-trace database
centralized or decentralized (distributed)
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Examples of supply chain vulnerabilities ILLUSTRATIVE
Pharmacy
Manufacturer Distributor (Primary)
Repackager Distributor (Secondary)
How would track
and trace have
prevented or
Counterfeits helped?
Diverted
Stolen
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Track and trace system will leverage multiple hardware ILLUSTRATIVE
and software solutions along the value chain
Manufacturer Distributor Pharmacy
IT steps • Generate SNI • Scan SNI tag • Scan SNI tag
• Apply SNI tag • Record SNI and transaction • Record SNI and transaction
• Record data • Authenticate • Authenticate
Technology • Serialization software • Tag scanners • Tag scanners
needs
• Data carrier • Traceability and • Traceability and
technology authentication software authentication software
(RFID, 2D barcode)
• Database software to store • Database software to store
track and trace events track and trace events
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Virginia Herold – California Board of Pharmacy
(see separate slide deck)
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.CONCEPTS & TERMINOLOGY ILLUSTRATIVE
Overview of a Track and Trace System
Manufacturer / Distributor/ Distributor/ Pharmacy
packaging line intermediary intermediary
or
9
• Serialize • Track product • Track product • Track product
• Record SNI • Authenticate • Authenticate • Authenticate
and product
info
Serialization
• Generate the SNI Authentication
• Apply SNI to package • Verifying legitimate SNI
• Record data • Verifying distribution
Track-and-trace database
history (includes verifying
centralized or decentralized (distributed)
legitimate supply chain
participant(s))
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Key Concepts & Terminology (1) FOR DISCUSSION ONLY
Serialization • Process of uniquely identifying a product
• FDA issue recommendations in the Standard Numerical Identifier (SNI)
Guidance, March 2010
Package • “…the prescription drug package [is] the smallest unit placed into interstate
(Drug package) commerce by the manufacturer or the repackager that is intended by that
manufacturer or repackager, as applicable, for individual sale to the
pharmacy or other dispenser of the drug product. Evidence that a unit is
intended for individual sale, and thus constitutes a separate “package” for
purposes of this guidance, would include the package being accompanied
by labeling intended to be sufficient to permit its individual distribution…”
(FDA SNI Guidance)
FDA Guidance for Industry:
Standards for Securing the Drug Supply Chain –
Standardized Numerical Identification for Prescription Drug Packages
Standardized Numerical Identification (SNI)
Serialized National Drug Code (sNDC)
NDC SERIAL NUMBER
55555 666 77 + 11111111111111111111
labeler code + product code + package code unique, up to 20 characters
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Key Concepts & Terminology (2) FOR DISCUSSION ONLY
Interoperability • establishes compatible data and process standards to enable system
participants to have the capability of sharing data by integrating into the
same system
Authentication • verifying that an SNI is a valid number for the package with which it is
associated. It also involves verifying that the package was sold, purchased,
traded, delivered, handled, stored, brokered by, or otherwise transferred
from legitimate supply chain participants, and confirming that there are no
discrepancies in the distribution history.
Data Management • provides standardized mechanisms that supply chain participants use to
capture, store, protect, and utilize track-and-trace data to facilitate
authentication and interoperability. These mechanisms may include
information for ensuring compliance of and accountability for established
processes, as well as corrective action if these processes are not followed.
Track-and-trace data • Any information collected about each package from the point of manufacture
to the point of dispense or destruction
Pedigree • Distribution history of a drug package
Accountability • When a person or entity has to report, explain, justify, or be responsible for
effectively takes custody or ownership of a package
Status • The description of the disposition of the package as it moves through the
supply chain (e.g., recall in process, in transit, destroyed, dispense, stolen, etc.)
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Key Concepts & Terminology (3) FOR DISCUSSION ONLY
Counterfeit drug • The term "counterfeit drug" means a drug which, or the container
or labeling of which, without authorization, bears the trademark,
trade name, or other identifying mark, imprint, or device, or any
likeness thereof, of a drug manufacturer, processor, packer, or
distributor other than the person or persons who in fact
manufactured, processed, packed, or distributed such drug and
which thereby falsely purports or is represented to be the product
of, or to have been packed or distributed by, such other drug
manufacturer, processor, packer, or distributor. (FFDC Act)
Attribute • Properties or capabilities of the system that would allow it to meet
at least one of the stated system goals
Centralized • System where data from all stakeholders is
System stored in one central database Details
provided on
• System where data is stored across multiple next page
Decentralized
System databases
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Centralized vs. Decentralized System - Models FOR DISCUSSION ONLY
Decentralized (Distributed) Model Centralized Model
Communication hub
Central SNI data repository
SNI SNI SNI
database database database
Distributors Pharmacy Distributors Pharmacy
Manufacturer Manufacturer
(or other (or other point of (or other (or other point of
(or repackager) (or repackager)
intermediaries) dispense) intermediaries) dispense)
Description Description
• Participants record data into their own local • Participants record data into a central
database or data storage provider database repository (database)
• Authentication and verification is performed • Authentication and verification is performed
by querying the each databases by querying the central repository
• A communications hub connects different
databases
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Potential System Attributes
• Capable of capturing the unique identification of a product and status of the number
• Ensure interoperability to enable supply chain participants to securely capture, store,
and exchange track-and-trace data accurately and efficiently
• Authenticates the standardized numerical identifier (SNI) and entire distribution history
of each package
• Enable appropriate access to track-and-trace data necessary to achieve system goals
• Ensure security of data and systems from falsification, malicious attacks, and
breaches
• Ensure confidential commercial information is protected
• Ensure patient privacy is maintained, if applicable
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Examples of track and trace systems around the world
Belgium Sweden Turkey
Program • Instituted an • Piloted an • In process of rolling
authentication authentication out a full track-and-
program program trace system
Labeling • MSI Plessey 1D • 2D barcodes issued • 2D barcodes issued
barcode for all for select products for all products
products
Database • Private company • Industry (EFPIA) • Government owns
owns database owns database and runs database
Purpose • Government • Government • Government
reimbursement of reimbursement of reimbursement of
drugs drugs drugs and improved
tax collection
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Agenda: Day 1 - February 15, 2011
Timeframe Activity Speaker
8:00 – 9:00 am Registration
9:00 -9:10 am Welcome John Taylor, Acting Principal
Deputy Commissioner
9:10 – 9:40 am Importance of Track and Trace Ilisa Bernstein, Acting Deputy
Director of the Office of
Compliance, CDER
9:40 – 10:10 am CA State Board of Pharmacy – Virginia Herold, Executive Officer
Goals and Challenges
10:10 – 10:40 am Concepts and Terminology Connie Jung, Senior Policy
Advisor for Pharmacy Affairs
10:40 – 10:55 am Break
10:55 – 11:15 am System Attributes Ilisa Bernstein
11:15 – 11:30 am Workshop Logistics Connie Jung
11:30 – 12:45 pm Lunch
12:45 – 2:30 pm Session 1 – Interoperability Connie Jung
2:30 – 2:45 pm Break
2:45 – 4:45 pm Session 2 – Authentication Ilisa Bernstein
4:45 – 5:00 pm Closing of Day 1; Overview of Day 2 Leslie Kux, Acting Assistant
Commissioner for Policy
5:00 pm Adjourn
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Agenda: Day 2 - February 16, 2011
Timeframe Activity Speaker
9:00 -9:10 am Welcome Janet Woodcock,
Director, Center for Drug
Evaluation and Research
9:10 – 9:30 am Review System Goals, Attributes, and Terminology Connie Jung
9:30 – 9:50 am What we heard from you: Sessions 1 and 2 Outputs Jennifer Ross. Regulatory
Counsel, CBER
9:50 – 10:00 am Logistics of Day 2 Connie Jung
10:00 – 10:15 am Break
10:15 – 12:30 pm Session 3 – Data Management Connie Jung
12:30 – 1:45 pm Lunch
1:45 – 3:00 pm Session 4- Discussion of Workshop Outputs Ilisa Bernstein
(Session 1,2, and 3)
3:00 – 3:15 pm Break
3:15 –4:15 pm Group Discussion of Workshop Outputs
4:15 – 4:30 pm Closing remarks Diane Maloney, Associate
Director for Policy, Center
for Biologics Evaluation
and Research
4:30 pm Adjourn
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Today’s Discussions
• The purpose of this public workshop is to
– explore with supply chain partners approaches for achieving an effective
and feasible track and trace system
– identify potential system attributes and standards that would facilitate
identification, authentication, and tracking and tracing of prescription
drug packages
• Discussions at the public workshop are not indicative of commitment to or
selection of a particular system or design
• Ideas, graphics, and comments presented are for discussion purposes and
may be considered as possible options – not as fixed or decided-upon
• Do not expect decisions to be made at the end of the workshop
• FDA employees and moderators are here to facilitate discussion; because
no systems or standards have been decided, they cannot answer specific
questions
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.For this workshop:
• Think “outside the box” No complaining
• Consider different please!
approaches Be solution-focused
Don't disregard an idea
• Initially consider all ideas Evaluate ideas after
as good ideas brainstorming
• Be open to other’s opinions
• Add your thoughts – each perspective is important
• Focus on a workable solution for track-and-trace
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Determination of System Attributes for Tracking and Tracing of Prescription Drugs FDA Track and Trace Public Workshop February 15, 2011 Session 1 INTEROPERABILITY
Interoperability is essential to a successful track and trace system
• Interoperability refers to ensuring compatible data and process
standards to enable system participants to have the capability of
sharing data by integrating into the same system.
• Successful track-and-trace covering the entire supply chain will need
standardized practices in data format, data communications, and
data interpretation
• Interoperability will create an efficient track and trace system that will
help to improve the security of drug supply chain.
• Commonality across the system may help to lower the cost of
available solutions and ease system adoption
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Full interoperability entails several elements of technology compatibility
Description
1 All inputs into the data system should be of the same format and
Data Format structure to ensure compatibility of data when transmitted
2
All system participants should use the same communication
Data
protocol/standard to help ensure reliable and secure data exchange
Communication
among participants
3
All data systems should refer to a common information interpretation
Data
standard which ensures that messages are understood by recipients
Interpretation
in the way intended by senders
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.1 Data format interoperability ensures compatibility of data ILLUSTRATIVE
and commands that are transmitted through the system
Scanning system operates with
Transfer of goods = {xxxx_dddd_nnnn} 12-character codes
Transfer of data
Scanning system operates with
= {xxxx_dddd}
8-character codes
Mfr. Distrib. 1 Distrib. 2 Pharmacy
{xxxx_dddd_nnnn} {xxxx_dddd_nnnn} {xxxx_dddd_nnnn} {xxxx_dddd}
KEY TAKEAWAY
Information is truncated at Distributor 2. • Standardized data format can ensure that
Truncated data is delivered to subsequent participants data is captured in the same manner and
and could complicate data interoperability. none is lost during the exchange
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.2 Communications interoperability ensures that data ILLUSTRATIVE
messages are transmitted in a common language
known by the whole system
Communication
System A achieved?
Language
XML discrepancy thwarts
communication
Manu-
within system
facturer
Other
Pharmacy
KEY TAKEAWAY
System B
• All systems in the
track-and-trace data
network should speak
the same language in
XML order to communicate
with one another
Manu-
facturer Pharmacy
• Achieved through use
of a standardized
language such as
XML
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.3 Interpretation interoperability ensures that data ILLUSTRATIVE
communications are interpreted in the same way
x = SNI code \\ d = date code \\ n = scanner ID code
= {xxxx_dddd_nnnn}
x = SNI code \\ d = date code \\ n = product status
= {xxxx_dddd_nnnn}
Manufacturer A enters data according to blue coding, but
Distributor 1 interprets it according to green coding
KEY TAKEAWAY
The systems • Interpretation
interpret “n” to interoperability
mean different ensures that
Distrib. 1 things, causing
Mfr. A information
Distributor 1 to
passing through
misinterpret
information the system is
encoded by understood in the
Manufacturer A same manner by
all participants
{xxxx_dddd_nnnn} {xxxx_dddd_nnnn}
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Does Interoperability enables consistent response to data ILLUSTRATIVE
messages/alerts?
Message A
SNI Unknown
How would these
messages be treated?
Are standards needed to
ensure that the
Message B messages/alerts are
Distributor Duplicate SNI responded to in a
consistent way to
reduce the chance of a
counterfeit or other
substandard product
Message C does not continue
Can not authenticate previous movement in the
owner of the package supply chain?
Investigate!
What does this mean?
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Breakout discussion questions: Interoperability
1. How can interoperability be achieved among all track-and-trace
participants in these key areas
a. Data format
b. Data communication
c. Data interpretation
2. Does interoperability have significantly different impacts on small
participants vs. large participants? If so, how can the differences be
addressed?
3. How can we ensure compliance in the interoperability areas above?
4. Are standards needed to ensure that the messages/alerts are
responded to in a consistent way? If so, how could this be
accomplished?
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Determination of System Attributes for Tracking and Tracing of Prescription Drugs FDA Track and Trace Public Workshop February 15, 2011 Session 2 AUTHENTICATION
Terminology: What is authentication?
Authentication – The verification of the standard numerical identifier (SNI) and the
distribution history
Authenticating • The verification that the SNI is a valid number for that product
an SNI with which it is associated
Authenticating a • The verification that the product was sold, purchased, traded,
distribution delivered, handled, stored, brokered by, or otherwise transferred
history from legitimate supply chain participants before reaching the
person who is authenticating, and
• That there are no discrepancies in the information on the
distribution history
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Example: Authentication of an ILLUSTRATIVE EXAMPLE
SNI at a distributor warehouse
1
Labeled
product arrives
at distributor
warehouse
3
Computer display
Matches the SNI
2
database
Or
9
Package is
scanned and SNI Does not match
8
SNI Database is authenticated the SNI database
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Example: Authentication of distribution ILLUSTRATIVE EXAMPLE
history at a pharmacy warehouse
1
Labeled product
arrives at
pharmacy
warehouse
Computer display
(oversimplified example)
9
SNI: NDC + SERIAL NUMBER
Product name
Product dosage
Montville, NJ
2/6/11 11:00AM –
Manufacturer
Newark, NJ
2/7/11 12:03PM – 2
Distributor 1 Package is
2/9/11 1:20PM –New York, NY scanned
Pharmacy
3 Distribution history is retrieved
about that SNI and verified
SNI database
SNI database
SNI Database
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.How SNI and distribution history authentication could workILLUSTRATIVE EXAMPLE
Semi-centralized model
Verification of SNI
Verification of distribution history
Manufacturer 1 Distributor 1 Pharmacy 1
SNI
Communication Hub may be needed
Database Pros
1
• Introduces options for companies of where
to store their data; may lead to competitive
service and pricing
Manufacturer 2 Pharmacy 2
• Enables interoperability by using one data
format and communication across several
Distributor 2 main databases
• Enables full and rapid pedigree – all records
for SNI are in one database
Manufacturer 3 Pharmacy 3
SNI
Database Cons
2 • Creates a large amount of data that should
be expertly managed and stored
Distributor 3 • Business intelligence submitted by each
Manufacturer 4 Pharmacy 4
participant would be stored in the same
database – would need good security
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Participant Verification ILLUSTRATIVE EXAMPLE
Manuf. Distributor 1 Distributor 2
Pharmacy
Manuf. Distributor 1 Distributor 2
Pharmacy
Manuf. Distributor 2
Counterfeiter
Rogue participants may be
sophisticated Track & Trace system participants should be
How can a track-and-trace verified to keep rogue parties out
system keep them out?
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.Breakout discussion questions: Authentication
• What changes in your business practices would be necessary in order to
authenticate products and distribution history?
• What would be the implications for your business to authenticate one
participant before you? Every participant before you?
• How can SNIs be verified?
• How should participants be verified? How can it be ensured that only
legitimate participants operate in the system?
• For which authentication process(es) do we need standards?
For discussion purposes only. Developed for use at this public workshop.
The information should not be interpreted as a final decision or position of the FDA.You can also read
