drug supply chain security - healthtrust...
TRANSCRIPT
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
(646)783-3172