Drug Supply Chain SecurityWhat You Need To Know Today & How To Be Prepared

For the Future

Dwight deVera

CEO of RXTransparent

A presentation for HealthTrust members

September 18, 2019

Disclosures

The presenter has a vested interest in RXTransparent.

This program may contain the mention of drugs or brands presented in a case

study or comparative format using evidence-based research. Such examples

are intended for educational and informational purposes and should not be

perceived as an endorsement of any particular supplier, brand or drug.

Learning Objectives for Pharmacists &

Supply Chain Professionals

At the end of this session, participants should be able to:

1. State the current and future requirements for pharmacy under the Drug

Supply Chain Security Act (DSCSA)

2. Describe current and future pharmaceutical labeling evolution and supply

chain innovations and challenges

3. Recall current enforcement initiatives, risks and impact of noncompliance.

Learning Objectives for Pharmacist

Technicians

At the end of this session, participants should be able to:

1. Recall the evolving timeline and impact of DSCSA in pharmacy

2. Identify new opportunities for supply chain transparency beyond simple

compliance

Drugs Supply Chain Security Act (DSCSA)

Shield that protects patients from counterfeit and suspect drugs

• Stepwise 10 Year Deployment

• Supersedes state regulations

• Affects all supply chain stakeholders

Enforcement Action

Not complying with DSCSA may

result in:

• Fines

• Reputational Damage

• Loss of Accreditation

• Imprisonment *

DSCSA TodayCurrent Requirements for the Pharmacy

Current Requirements for Pharmacy

Verification

Reporting

• Confirm that entities that you do business with are registered and licensed

• Receive and store product tracing information

• Provide Product Tracing Documentation within 48 hours of a request

• Report suspicious or illegitimate drug product within 24 hours of discovery

be vigilant and diligent in protecting patients in their

care

Source: Excerpted From FDA’S MAY 2018 WEBINAR: Protecting Patients – Pharmacists Requirements under the Drug Supply Chain Security Act https://ceportal.fda.gov/

Investigation &

Product Tracing

Produce Product Tracing

Information:

• TI : TH : TS

• Account for Borrow Loan Sales

• Support and investigation

• Respond within 48 Hours

• Electronic form

Transaction Information

Origination Information

Lot Number NDC Manufacturer

359762500717 059762500701 Greenstone LLC

Product Information

Product Form Strength Package

Misoprostol Tablet 100ug/1 60 Tablet in 1 Bottle

Transaction History

Transaction Date Shipment Date Destination Address Unit Qty Qty

Received

Greenstone 8225 Moorsbridge Rd 1

Portage, MI 49002

McKesson DC 5491 Electron Dr

Anchorage, AK 99518 1

2/28/2018 2/28/2018 Seattle Grace 123 Main Street 1 1

Seattle, WA

5/31/2018 5/31/2018 Sloan Memorial 987 East Street 1 1

Seattle, WA

Transaction StatementThe entity transferring ownership of the product in this transaction is authorized as required under DCSCA, and:

*Received the product from a person this is authorized as required under DSCSA.

*Received transaction information and a transaction statement from the prior owner of the product, as required under law.

*Did not knowingly ship a suspect or illegitimate product.

*Had systems and processes in place to comply with verification requirements under the law.

Accreditation

Manufacturer Accreditation:

• FDA

Wholesaler Accreditation:

• FDA

• NABP (VAWD)

Pharmacy Accreditation:

• State Boards

Suspect & Illegitimate

Suspect Product:

• Reason to believe

• Counterfeit, Diverted, Stolen

Adulterated, Fraudulent or

otherwise unfit

Illegitimate Product:

• Credible Evidence

• Counterfeit, Diverted, Stolen

Adulterated, Fraudulent or

otherwise unfit

Reporting Mechanisms:

• Form 3911

• MedWatch

DSCSA Data Retention Requirements

FDA Guidance DSCSA

Implementation Product

Tracing Requirements

Current DSCSA Interoperability

Manufacturers Distributors Facility Loading Dock

Majority

of drug

purchases

Specialty

purchases

Auxiliary

purchases

Current DSCSA Considerations

DSCSA is shared responsibility between

Covered Entities & Contract Pharmacies

First Responder Resupply Must Be Tracked

(No pedigree transmission)

Drop & Direct Shipments Increases DSCSA Complexity

How To Read A MODERN PHARMA BARCODE

2D Quick Response (QR)

Keeps track of sales and

inventory or retail products

12 Digits OTC Required

Universal Product Code (UPC)

Informational Web Site

Reference

Linear

Encodes NDC designed to

reduce medication errors

11 Digits RX & OTC

2D Data Matrix

Identify and Trace

Prescription Drugs

GS1 International

StandardGTIN

Serial Number

Manufacturing Lot

Expiration Date

Data Matrix capable of storing

8,000 % More Information

Deconstructing the New Label

NDC – 50242-044-13

Proprietary Name - Activase

Non Proprietary Name -Alteplase

Labeler Name - Genentech, Inc.

Product Type -HUMAN PRESCRIPTION DRUG

Package

1 KIT in 1 CARTON (50242-044-13) * 50 mL

in 1 VIAL, SINGLE-USE * 50 mL in 1 VIAL,

SINGLE-USE

Country – 003

Serial Number

Lot

Expiration

2 D Datamatrix

GTIN - Global Trade Identification Number

Future of Pharma Labeling & Challenges

Assessment Question 1:

Current DSCSA requirements for pharmacy include?

A. Confirm that entities that you do business with are registered and licensed

B. Receive and store product tracing information

C. Provide Product Tracing Documentation within 48 hours of a request

D. Report suspicious or illegitimate drug product within 24 hours of discovery

E. All of the above

F. None of the above

Response Question 1:

Current DSCSA requirements for pharmacy include?

A. Confirm that entities that you do business with are registered and licensed

B. Receive and store product tracing information

C. Provide Product Tracing Documentation within 48 hours of a request

D. Report suspicious or illegitimate drug product within 24 hours of discovery

E. All of the above

F. None of the above

Assessment Question 2: Product identifiers

The current DSCSA product identifier for prescription drug

products includes?

A. A link to the manufacturer’s website

B. A machine-readable barcode and human readable barcode

C. Keeps track of sales and inventory information

D.Contains serial number, expiration date, lot number, and S-GTIN

E. Both B and D

Response Question 2: Product identifiers

The current DSCSA product identifier for prescription drug

products includes?

A. A link to the manufacturer’s website

B. A machine-readable barcode and human readable barcode

C. Keeps track of sales and inventory information

D.Contains serial number, expiration date, lot number, and S-GTIN

E. Both B and D

DSCSA Timeline

“Patient safety is at the core of what we do here at the agency. Ensuring reliable patient access to safe and effective medicines requires us to maintain a closed secure US drug supply chain. Every link in that chain must be secure. FDA and stakeholders have been working towards full implementation of the Drug Supply Chain Security Act, and reaching that milestone on time is a high priority for all of us. “

Dr. Scott Gottlieb,

Commissioner, Feb2018

Product Serialization2018• 2 DataMatrix Barcode and Human Readable Elements

Verified Returns2019•Serialized verification of salable returns

Dispenser Serialization2020•Dispensers accept only serialized product

November 2019 Serialized Returns

• Complex distribution will result in

fewer credits & adversely affect

revenue cycle operations

• Failed verification requirements

are problematic

• Operational supply chain impact

• Verification

GTIN

SN

Expiration

Lot

DSCSA TOMORROW

Interoperable Future 1. Serialization of units, intermediates, shippers, and pallets using GS1

standards.

2. Capture and creation of a unique fingerprint for unit serialized barcode.

3. Aggregation of children to parents.

4. Transmission and storage of manufacturing lot data including serialized,

aggregated packaging data using GS1 messaging standards.

5. Processing and storage of supply chain events including outbound shipping

and inbound goods receipt from point of manufacture to downstream trade

partners.

6. Processing and storage of warehouse events including unpacking, picking,

and packing.

7. Processing and storage of supply chain events including outbound shipping

and inbound goods receipt from distribution trade partners to points of

dispensation.

8. Capture and storage of in-transit IoT events and data in real time using

sensors applied to shipments.

9. Capture of dose dispensing data at health systems.

10. Authentication of unique fingerprints at dispense location using mobile

technologies.

11. Connectivity to manufacturing and trade partners using a cloud-based

Internet as a Service(IaaS) solution.

12. Storage of full EPCIS payloads on a cloud-based IaaS solution, preferably

individually encrypted by respective data owners and with non-encrypted

metadata attached for cross-vendor, interoperable discovery of

provenance (“phone book”).

13. Storage of anonymous digital fingerprints (hashes) of transaction data on

any participating (vendor) blockchain for interoperable proof of

transaction data authenticity and respective immutable timestamps.

14. Optionally, storage of obfuscated transaction data and metadata on vendor

blockchain(s) in parallel as required by respective vendor solution(s).

15. Mobile distributed app-based functionality to query blockchain data for

brand inspectors.

16. Ability for FDA to audit information from the blockchain.

17. Ability to feed AI/ML models for insight and analytics.

Product Tracing Data Standards

Advanced Ship Notice ASN EDI 856 Electronic Product Code Information Services

EPCISTransactionAggregate

ProductDetailed

Geography TransactionGTIN GLN

Product Tracing Data Standards

• Interoperable Requirements

• Serialized Granularity

• Instantaneous

Traceability

• Streamlined Supply

Chain

INVOICE | McKesson Drug Company

Transaction Set Control Number: 0004

Shipment Number: 7859035881

Invoice # Purchase Invoice Date Order Date Shipment Sold By Shipped From Shipped To

Order # Date

7859035881 3118 03/01/2018 03/01/2018 03/01/2018 McKesson Drug Co Anchorage DC 8130 Seattle Grace

DUNS #177667227 DEA #RM0227430 Acct#312161

DEA#BG99514

Received Number Quantity Quantity Product Info S.W. Unit

Extended

Item Received Price Price Amount

Carton Number: 000001093216589741

S/N:

362332102303 1 1 050242008527, Activase; 1 KIT in 1 Carton

100 ml in 1 Vial, Single Use

Genetech, Inc

S/N

35511468011 1 1 050242008527, Activase; 1 KIT in 1 Carton

100 ml in 1 Vial, Single Use

Genetech, Inc

• Interoperable Requirements

Serialized granularity

Instantaneous traceability

Streamlined Supply Chain

Assessment Question 3: Data Standards

The GS1 GLN is:

A. Assigned by GPO organizations

B. Identifies a supply chain location

C. Is interchangeable with DEA number in the US drug supply chain

D. Is managed by the health care organization/pharmacy

E. Both B & D

Assessment Response 3: Data Standards

The GS1 GLN is:

A. Assigned by GPO organizations

B. Identifies a supply chain location

C. Is interchangeable with DEA number in the US drug supply chain

D. Is managed by the health care organization/pharmacy

E. Both B & D

What’s next

The Interoperable Drug Supply

Chain Will:

Streamline returns

Reduce fraud

Reduce impact of natural

disasters

Optimize inventory

Maximize product

effectiveness

Reduce waste

Thank you for carving

out time to join me

today! Dwight deVera, CEO RXTransparent

ddevera@rxtransparent.com

(646)783-3172