2011 - fda track and trace public workshop - day 1 slides

8/2/2019 2011 - FDA Track and Trace Public Workshop - Day 1 Slides

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Determination of System Attributes forTracking and Tracing of Prescription Drugs

FDA Track and TracePublic Workshop

February 15-16, 2011


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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.

FDA Public Workshop: Determination of System Attributes for Trackingand 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


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How a track-and-trace system would improve the security ofthe drug supply chain:

Enables identification of diversionary schemes at point ofdeparture from, and point of entry to, the supply chain. Improved identification of stolen product creates better

communications to the supply chain partners to look out for orfind the stolen product

Diversionprevention

Improved transparency and accountability throughout thesupply chain to prevent counterfeit, diverted, stolen, and othersubstandard product entry

Moreaccountability

Enhanced information and ability to isolate issues and executereverse logistics in the event that a product should not be sold tothe end consumer (e.g., recall, product defect, etc.).

Enables faster and easier recalls by collecting information aboutthe location and holder of a product

Improvedreverse logisticsmanagement


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WHO MAKES UP THE DRUG SUPPLY CHAIN?

Distributor (Primary)Pharmacy

Manufacturer

Distributor (Secondary)Repackager

Complexity of the supply chain is increased by:

Globalization of supply chains Criminal activities such as diversion, cargo theft,

and counterfeiting

Rules that vary by country and state

Example of vulnerabilities:

Goods are stolen and reintroduced into thesupply chain

Counterfeit goods are sold to suppliers and re-

enter the supply chain

ILLUSTRATIVE


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IS THE DRUG SUPPLY CHAIN SAFE? Yes, but


Manufacturer


ILLUSTRATIVE

Counterfeiter

Rogue players aresophisticated.How can a track-and-trace systemkeep them out?

Track & Trace system participantsshould be validated to keep rogue

parties out
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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


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Track-and-trace databasecentralized or decentralized (distributed)

Overview of a Track and Trace System

Distributor/intermediary

PharmacyManufacturer /packaging line

Serialize Record SNI

and productinfo

Track product Authenticate


ILLUSTRATIVE

or


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Examples of supply chain vulnerabilities


Manufacturer


ILLUSTRATIVE

CounterfeitsDivertedStolen

How would trackand trace haveprevented or

helped?


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Technologyneeds

IT steps

Track and trace system will leverage multiple hardwareand software solutions along the value chain

Serialization software

Data carriertechnology(RFID, 2D barcode)

Tag scanners

Traceability andauthentication software

Database software to storetrack and trace events

Tag scanners

Traceability andauthentication software

Database software to storetrack and trace events

Generate SNI

Apply SNI tag

Record data

Scan SNI tag

Record SNI and transaction

Authenticate

Scan SNI tag

Record SNI and transaction

Authenticate

ILLUSTRATIVE

PharmacyManufacturer Distributor


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Virginia Herold California Board of Pharmacy

(see separate slide deck)


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Track-and-trace databasecentralized or decentralized (distributed)


PharmacyManufacturer /packaging line


ILLUSTRATIVE

or

Serialization Generate the SNI Apply SNI to package Record data

Authentication Verifying legitimate SNI Verifying distribution

history (includes verifying

legitimate supply chainparticipant(s))




Serialize Record SNI

and productinfo

CONCEPTS & TERMINOLOGY

Overview of a Track and Trace System
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Key Concepts & Terminology (1)

Serialization Process of uniquely identifying a product FDA issue recommendations in the Standard Numerical Identifier (SNI)

Guidance, March 2010

Package(Drug package)

the prescription drug package [is] the smallest unit placed into interstatecommerce by the manufacturer or the repackager that is intended by thatmanufacturer or repackager, as applicable, for individual sale to thepharmacy or other dispenser of the drug product. Evidence that a unit is

intended for individual sale, and thus constitutes a separate package forpurposes of this guidance, would include the package being accompaniedby labeling intended to be sufficient to permit its individual distribution(FDA SNI Guidance)

FOR DISCUSSION ONLY

Serialized National Drug Code (sNDC)

NDC SERIAL NUMBER

55555 666 77 + 11111111111111111111

labeler code + product code + package code unique, up to 20 characters

FDA Guidance for Industry:

Standards for Securing the Drug Supply Chain Standardized Numerical Identification for Prescription Drug Packages

Standardized Numerical Identification (SNI)


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Accountability When a person or entity has to report, explain, justify, or be responsible foreffectively takes custody or ownership of a package

Interoperability establishes compatible data and process standards to enable systemparticipants to have the capability of sharing data by integrating into the

same system

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.)

Data Management provides standardized mechanisms that supply chain participants use tocapture, store, protect, and utilize track-and-trace data to facilitateauthentication and interoperability. These mechanisms may includeinformation for ensuring compliance of and accountability for established

processes, as well as corrective action if these processes are not followed.

Authentication verifying that an SNI is a valid number for the package with which it isassociated. It also involves verifying that the package was sold, purchased,traded, delivered, handled, stored, brokered by, or otherwise transferredfrom legitimate supply chain participants, and confirming that there are no

discrepancies in the distribution history.

FOR DISCUSSION ONLY

Pedigree

Distribution history of a drug package

Track-and-trace data Any information collected about each package from the point of manufactureto the point of dispense or destruction



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Attribute Properties or capabilities of the system that would allow it to meet

at least one of the stated system goals

DecentralizedSystem

System where data is stored across multipledatabases

CentralizedSystem

System where data from all stakeholders isstored in one central database

The term "counterfeit drug" means a drug which, or the containeror labeling of which, without authorization, bears the trademark,trade name, or other identifying mark, imprint, or device, or anylikeness thereof, of a drug manufacturer, processor, packer, ordistributor other than the person or persons who in factmanufactured, processed, packed, or distributed such drug andwhich thereby falsely purports or is represented to be the productof, or to have been packed or distributed by, such other drugmanufacturer, processor, packer, or distributor. (FFDC Act)

Counterfeit drug

FOR DISCUSSION ONLY

Detailsprovided onnext page



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Centralized vs. Decentralized System - Models FOR DISCUSSION ONLY

Description

Participants record data into their own localdatabase or data storage provider database Authentication and verification is performed

by querying the each databases A communications hub connects different

databases

Description

Participants record data into a centralrepository (database) Authentication and verification is performed

by querying the central repository

Decentralized (Distributed) Model Centralized Model

Central SNI data repository

Manufacturer(or repackager)

Distributors(or otherintermediaries)

Pharmacy(or other point ofdispense)

SNIdatabase

Manufacturer(or repackager)

Distributors(or otherintermediaries)

Pharmacy(or other point ofdispense)

SNIdatabase

Communication hub

SNIdatabase


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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


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Belgium Instituted an

authenticationprogram

MSI Plessey 1Dbarcode for allproducts

Private companyowns database

Governmentreimbursement ofdrugs

Sweden Piloted an

authenticationprogram

2D barcodes issuedfor select products

Industry (EFPIA)owns database

Governmentreimbursement ofdrugs

Turkey In process of rolling

out a full track-and-trace system

2D barcodes issuedfor all products

Government ownsand runs database

Governmentreimbursement ofdrugs and improvedtax collection

Examples of track and trace systems around the world

Program

Labeling

Database

Purpose


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Agenda: Day 1 - February 15, 2011Timeframe Activity Speaker

8:00 9:00 am Registration9:00 -9:10 am Welcome John Taylor, Acting Principal

Deputy Commissioner

9:10 9:40 am Importance of Track and Trace Ilisa Bernstein, Acting DeputyDirector of the Office of

Compliance, CDER9:40 10:10 am CA State Board of Pharmacy

Goals and ChallengesVirginia Herold, Executive Officer

10:10 10:40 am Concepts and Terminology Connie Jung, Senior PolicyAdvisor 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 Jung2:30 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 AssistantCommissioner for Policy

5:00 pm Adjourn


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Agenda: Day 2 - February 16, 2011Timeframe Activity Speaker

9:00 -9:10 am Welcome Janet Woodcock,Director, Center for DrugEvaluation 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, CBER9:50 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(Session 1,2, and 3)

Ilisa Bernstein

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, AssociateDirector for Policy, Centerfor Biologics Evaluationand Research

4:30 pm Adjourn

T d Di i


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Todays Discussions

The purpose of this public workshop is toexplore with supply chain partners approaches for achieving an effectiveand feasible track and trace system

identify potential system attributes and standards that would facilitateidentification, authentication, and tracking and tracing of prescription

drug packages

Discussions at the public workshop are not indicative of commitment to orselection of a particular system or design

Ideas, graphics, and comments presented are for discussion purposes andmay 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; becauseno systems or standards have been decided, they cannot answer specificquestions

F thi k h


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For this workshop:

Evaluate ideas afterbrainstorming

No complainingplease! Be solution-focused

Think outside the box Consider different

approaches

Don't disregard an idea

Initially consider all ideasas good ideas

Be open to others opinions

Add your thoughts each perspective is important

Focus on a workable solution for track-and-trace


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FDA Track and Trace

Public Workshop

February 15, 2011

Session 1

INTEROPERABILITY

Interoperability is essential to a successful track and trace system


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Interoperability is essential to a successful track and trace system

Interoperabilityrefers to ensuring compatible data and processstandards 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 needstandardized practices in data format, data communications, anddata interpretation

Interoperability will create an efficient track and trace system that willhelp 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

Full interoperability entails several elements of technology compatibility


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Full interoperability entails several elements of technology compatibility

All inputs into the data system should be of the same format andstructure to ensure compatibility of data when transmitted

All system participants should use the same communicationprotocol/standard to help ensure reliable and secure data exchangeamong participants

All data systems should refer to a common information interpretationstandard which ensures that messages are understood by recipientsin the way intended by senders

Data Format

DataCommunication

DataInterpretation

Description

1

3

2

1 ILLUSTRATIVEData format interoperability ensures compatibility of data


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Scanning system operates with12-character codes

Scanning system operates with8-character codes

{xxxx_dddd}

{xxxx_dddd_nnnn}

Mfr.

Distrib. 1 Distrib. 2Pharmacy

=

=

{xxxx_dddd_nnnn} {xxxx_dddd_nnnn} {xxxx_dddd_nnnn} {xxxx_dddd}

Information is truncated at Distributor 2.Truncated data is delivered to subsequent participants

and could complicate data interoperability.

KEY TAKEAWAY

Standardized data format can ensure thatdata is captured in the same manner and

none is lost during the exchange

Transfer of goods

Transfer of data

1 ILLUSTRATIVEData format interoperability ensures compatibility of dataand commands that are transmitted through the system

Communications interoperability ensures that data2 ILLUSTRATIVE


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XML

PharmacyManu-facturer

Pharmacy

Manu-facturer

XML

Other

Communicationachieved?System A

System BKEY TAKEAWAY

All systems in thetrack-and-trace datanetwork should speak

the same language inorder to communicatewith one another

Achieved through useof a standardizedlanguage such as

XML

Language

discrepancy thwartscommunicationwithin system

Communications interoperability ensures that datamessages are transmitted in a common languageknown by the whole system

2 ILLUSTRATIVE

3 Interpretation interoperability ensures that data ILLUSTRATIVE


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KEY TAKEAWAY

Interpretation

interoperabilityensures thatinformation

passing throughthe system is

understood in thesame manner byall participants

{xxxx_dddd_nnnn}

Mfr. ADistrib. 1

= 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} {xxxx_dddd_nnnn}

Manufacturer A enters data according to blue coding, butDistributor 1 interprets it according to green coding

The systemsinterpret n tomean differentthings, causing

Distributor 1 tomisinterpretinformationencoded by

Manufacturer A

3 Interpretation interoperability ensures that datacommunications are interpreted in the same way

ILLUSTRATIVE

Does Interoperability enables consistent response to data ILLUSTRATIVE


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Message ASNI Unknown

Message BDuplicate SNI

Does Interoperability enables consistent response to datamessages/alerts?

How would thesemessages be treated?

Are standards needed to

ensure that themessages/alerts areresponded to in aconsistent way toreduce the chance of acounterfeit or othersubstandard productdoes not continuemovement in thesupply chain?

Distributor

Message CCan not authenticate previousowner of the package

Investigate!What does this mean?

Breakout discussion questions: Interoperability


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Breakout discussion questions: Interoperability

1. How can interoperability be achieved among all track-and-traceparticipants in these key areas

a. Data formatb. Data communication

c. Data interpretation

2. Does interoperability have significantly different impacts on smallparticipants vs. large participants? If so, how can the differences beaddressed?

3. How can we ensure compliance in the interoperability areas above?

4. Are standards needed to ensure that the messages/alerts areresponded to in a consistent way? If so, how could this beaccomplished?


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FDA Track and TracePublic Workshop

February 15, 2011

Session 2

AUTHENTICATION

Terminology: What is authentication?


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gy

Authentication The verification of the standard numerical identifier (SNI) and thedistribution history

Authenticatingan SNI The verification that the SNI is a valid number for that productwith which it is associated

Authenticating adistributionhistory

The verification that the product was sold, purchased, traded,delivered, handled, stored, brokered by, or otherwise transferredfrom legitimate supply chain participants before reaching the

person who is authenticating, and That there are no discrepancies in the information on thedistribution history

Example: Authentication of an ILLUSTRATIVE EXAMPLE


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Labeledproduct arrivesat distributor

warehouse

pSNI at a distributor warehouse

SNI Database

2

Matches the SNIdatabase

Or

Does not matchthe SNI database

Computer display

3

1

Package isscanned and SNIis authenticated

Example: Authentication of distribution

ILLUSTRATIVE EXAMPLE
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SNI databaseSNI database

Labeled productarrives atpharmacywarehouse

history at a pharmacy warehouse

SNI Database

1

3

Computer display(oversimplified example)

2/6/11 11:00AM

Manufacturer2/7/11 12:03PM

Distributor 1

2/9/11 1:20PM

Pharmacy

Montville, NJ

Newark, NJ

New York, NY

SNI: NDC + SERIAL NUMBER

Product nameProduct dosage

2

Distribution history is retrievedabout that SNI and verified

Package isscanned

How SNI and distribution history authentication could work

ILLUSTRATIVE EXAMPLE
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Pros Introduces options for companies of where

to store their data; may lead to competitiveservice and pricing

Enables interoperability by using one dataformat and communication across severalmain databases

Enables full and rapid pedigree all recordsfor SNI are in one database

Cons Creates a large amount of data that should

be expertly managed and stored

Business intelligence submitted by eachparticipant would be stored in the samedatabase would need good security

Verification of SNI

Verification of distribution history

Semi-centralized model

Manufacturer 1

Manufacturer 2

Manufacturer 3

Manufacturer 4

SNIDatabase

2

SNIDatabase

1

Distributor 1

Distributor 2

Distributor 3

Pharmacy 1

Pharmacy 2

Pharmacy 3

Pharmacy 4

CommunicationHubmaybeneeded

Participant Verification ILLUSTRATIVE EXAMPLE


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Distributor 1

Pharmacy

Manuf. Distributor 2

Pharmacy

Distributor 1Manuf.

Counterfeiter

Rogue participants may besophisticatedHow can a track-and-tracesystem keep them out?

Track & Trace system participants should beverified to keep rogue parties out

Manuf. Distributor 2

Distributor 2

Breakout discussion questions: Authentication


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What changes in your business practices would be necessary in order toauthenticate products and distribution history?

What would be the implications for your business to authenticate oneparticipant before you? Every participant before you?

How can SNIs be verified?

How should participants be verified? How can it be ensured that onlylegitimate participants operate in the system?

For which authentication process(es) do we need standards?

2011 - fda track and trace public workshop - day 1 slides

Documents