Drug Supply Chain Security Act Implications for the

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Drug Supply Chain Security Act, Implications for the Hospital Pharmacy Pamela Kindall, BBA Pharmacy

Drug Supply Chain Security Act, Implications for the Hospital Pharmacy Pamela Kindall, BBA Pharmacy Business Specialist Joshua Bright, Pharm. D Director of Pharmacy Services North Arkansas Regional Medical Center September 29, 2016

Conflicts of Interest • Josh Bright and Pam Kindall declare no conflicts of interest

Conflicts of Interest • Josh Bright and Pam Kindall declare no conflicts of interest • Josh and Pam are not lawyers

Objectives • Describe the need for the Drug Supply Chain Security Act (DSCSA) in

Objectives • Describe the need for the Drug Supply Chain Security Act (DSCSA) in today’s pharmacy supply chain • Explain the steps that should be taken during the phases of DSCSA rollout • Outline future impacts to the industry as DSCSA becomes fully implemented over the next 10 years

Quality and Security, the Why: • Counterfeits: A B – Tamiflu (oseltamivir) A B

Quality and Security, the Why: • Counterfeits: A B – Tamiflu (oseltamivir) A B

B A A B B

B A A B B

Quality and Security, the Why: • Counterfeits: – Botox A B (onabotulinumtoxin A) http:

Quality and Security, the Why: • Counterfeits: – Botox A B (onabotulinumtoxin A) http: //www. fda. gov/Drugs/Resources. For. You/Consumers/Buying. Using. Medicine. Safely/Counterfeit. Medicine/default. htm

B A B http: //www. fda. gov/Drugs/Resources. For. You/Consumers/Buying. Using. Medicine. Safely/Counterfeit. Medicine/default. htm

B A B http: //www. fda. gov/Drugs/Resources. For. You/Consumers/Buying. Using. Medicine. Safely/Counterfeit. Medicine/default. htm

Quality and Security, the Why: • 2007 - Crude Heparin linked to 246 deaths

Quality and Security, the Why: • 2007 - Crude Heparin linked to 246 deaths – “economically motivated adulteration 1” • Heparin Supply Chain • Small pig farms in China village casing facilities Consolidators buy individual lots from village facilities Consolidators combine individual lots into single, large heparin lots mfgs buy consolidated lots and refine crude heparin into API mfgs produce product for human consumption – GAO: 100 million pigs short 2 1. 2. Http: //www. fda. gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm 291390. pdf http: //www. gao. gov/assets/320/311879. pdf

Quality and Security, the Why: • New England Compounding Center 2012 – 17, 000

Quality and Security, the Why: • New England Compounding Center 2012 – 17, 000 vials of methylprednisolone for injection contaminated with fungi – 73 facilities in 23 states – Linked to 64 deaths, 751 non-fatal injuries – https: //en. wikipedia. org/wiki/New_England_Compounding_Center_meningitis_outbreak#Cases

Drug Quality and Security Act (DQSA) November 27, 2013 Title I: The Compounding Quality

Drug Quality and Security Act (DQSA) November 27, 2013 Title I: The Compounding Quality Act Title II: Drug Supply Chain Security Act (DSCSA) Section 503(a) “Traditional Compounding” Product Track and Trace Section 503(b) “Outsourcing Facilities” Standards and Licensing for Wholesale Distributors and 3 PLs

Title I Section 503(b) • FDA Registered Outsourcing Facilities – http: //www. fda. gov/Drugs/Guidance.

Title I Section 503(b) • FDA Registered Outsourcing Facilities – http: //www. fda. gov/Drugs/Guidance. Compliance. Regulatory. I nformation/Pharmacy. Compounding/ucm 378645. htm • ASHP Guidelines on Outsourcing Sterile Compounding Services – http: //www. ashp. org/Doc. Library/Best. Practices/Mgmt. Gdl. O utsourcing. Sterile. Comp. aspx • Read 483’s and personally inspect the facility

What • DSCSA- electronic, interoperable system to track each unit of medication by 2023

What • DSCSA- electronic, interoperable system to track each unit of medication by 2023 throughout the supply chain: – Identify legitimate products to the unit level – Detect and remove illegitimate products – More efficient and effective recall process

How • Trading Partners (mfg, repackagers, wholesalers, dispensers, 3 PLs) – Provide transaction documentation

How • Trading Partners (mfg, repackagers, wholesalers, dispensers, 3 PLs) – Provide transaction documentation downstream – Store 6 years (paper or electronic)

Timeline Jan 1, 2015 • • • Mfgs send and distributors receive/pass transaction information

Timeline Jan 1, 2015 • • • Mfgs send and distributors receive/pass transaction information Mfgs, wholesalers, and dispensers verify suspect and illegitimate product Transactions made only between authorized trading partners 2013 Nov 2013 DQSA Enacted 2014 FDA Guidance Issued 2015 2016 July 1, 2015; November 2015… March 2016 Dispensers receive transaction information and maintain for 6 years

Timeline 2017 -2019 Interim Period Time for mfgs and repackagers to serialize: Trace Lot,

Timeline 2017 -2019 Interim Period Time for mfgs and repackagers to serialize: Trace Lot, Exp, Serial number on each package 2017 2018 2023 2019 Unit-level traceability throughout the supply chain • Distributors only sell serialized product 2019 2020 Wait for it… 2020 Nov 2017 • Mfg serialize product • Transaction information electronic Nov 2018 • Repackagers serialize product • Transaction information electronic • Dispensers only utilize serialized product 2023

One more example • Counterfeits: – Nicotine gum? A B

One more example • Counterfeits: – Nicotine gum? A B

DSCSA ~ ~ Authorized Trading Partners 3 T Information Exclusion List Suspected or Fraudulent

DSCSA ~ ~ Authorized Trading Partners 3 T Information Exclusion List Suspected or Fraudulent Product

Authorized Trading Partners Trading partners- Manufacturers, wholesale distributors, Third-party Logistics Provider or 3 PL’s,

Authorized Trading Partners Trading partners- Manufacturers, wholesale distributors, Third-party Logistics Provider or 3 PL’s, dispensers, and repackagers. http: //www. fda. gov/Drugs/Drug. Safety/Drug. Integrityand. Supply. Chain. S ecurity/Drug. Supply. Chain. Security. Act/ucm 376829. htm

Authorized Trading Partners Note: It is possible a trading partner will fall under more

Authorized Trading Partners Note: It is possible a trading partner will fall under more than one category. If so the entity must meet all applicable requirements. [section 582(a)(1)]

Authorized Trading Partners Validate registration with the FDA ~Wholesale Distributor, Secondary Market, and 3

Authorized Trading Partners Validate registration with the FDA ~Wholesale Distributor, Secondary Market, and 3 PL’s http: //www. accessdata. fda. gov/scripts/cder /wdd 3 plreporting/index. cfm

Authorized Trading Partners

Authorized Trading Partners

3 T’s • Entities are required to capture the 3 T’s Transaction Information Transaction

3 T’s • Entities are required to capture the 3 T’s Transaction Information Transaction Statement Transaction History

Transaction Information • • • Established name of the product Strength and dosage form

Transaction Information • • • Established name of the product Strength and dosage form NDC number Container size Number of units Lot number Date of transaction Date of shipment, if more than 24 hours after the date of the transaction Business name and address from where the product is transferred Business name and address to where the product is transferred

Transaction Statement This states the entity transferring the product: • • Is authorized (licensed)

Transaction Statement This states the entity transferring the product: • • Is authorized (licensed) as required Received the product from an authorized source Received transaction information and transaction statement from the prior owner Did not knowingly ship a suspect or illegitimate product Had systems in place to comply with verification requirements Did not knowingly provide false transaction information Did not knowingly alter the transaction history

Transaction History • This is a statement in paper or electronic form for each

Transaction History • This is a statement in paper or electronic form for each prior transaction going back to the manufacturer of the product

3 T’s The FDA has issued a guidance

3 T’s The FDA has issued a guidance

3 T’s • The transaction information, transaction statement, and transaction history (3 T’s) must

3 T’s • The transaction information, transaction statement, and transaction history (3 T’s) must be captured and maintained for each drug product received for 6 years from the date of transaction.

What products are covered • Prescription Drugs in finished dosage form for administration to

What products are covered • Prescription Drugs in finished dosage form for administration to a patient without further manufacturing.

Exempt Products • • • Blood or blood components for transfusion Radioactive drugs or

Exempt Products • • • Blood or blood components for transfusion Radioactive drugs or radioactive biological products Imaging drugs Medical gases Compounded drugs Dialysis solutions Irrigation solutions Sterile water (irrigation or injectable) IV products intended for replenishment of fluids or electrolytes

Exempt Transactions The term ‘transaction’ does not include. . .

Exempt Transactions The term ‘transaction’ does not include. . .

Exempt Transactions

Exempt Transactions

Suspected or Fraudulent Product The law, in part, requires dispensers to develop protocols to

Suspected or Fraudulent Product The law, in part, requires dispensers to develop protocols to identify suspected and illegitimate products. • Identify • Quarantine • Notify the FDA and trading partners

Identify Suspected Product – Reason to believe the product is potentially: • Counterfeit, diverted,

Identify Suspected Product – Reason to believe the product is potentially: • Counterfeit, diverted, stolen • Subject to fraudulent transaction • Intentionally adulterated or appears otherwise unfit for distribution such that would result in serious adverse health consequences or death to humans. Illegitimate Product – Credible evidence that the product actually is any of the above. http: //www. fda. gov/downloads/Drugs/Development. Approval. Process/Small. Business. Assistance/UCM 388945. pdf

Scenarios • • • Purchasing from a new source Receiving an unsolicited sales offer

Scenarios • • • Purchasing from a new source Receiving an unsolicited sales offer from an unknown source Purchasing from an unknown Internet source Purchasing from a source that the entity knows or has reason to believe has transacted business involving suspected products High demand products Products that are on the FDA’s counterfeit or cargo theft alert http: //www. fda. gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/co 186 unterfeitmedicine/default. htm http: //www. fda. gov/iceci/criminalinvestigations/ucm 182888. htm

Quarantine • Quarantine the suspected product and promptly conduct an investigation to determine whether

Quarantine • Quarantine the suspected product and promptly conduct an investigation to determine whether the product is an illegitimate product. & S E I S C E I L R U O P D E C O PR WH O W O H

Investigation • • Closely examine the package and transport package Closely examine the label

Investigation • • Closely examine the package and transport package Closely examine the label on the package and the unit Validate the 3 T information you were given. Keep records of investigations for not less than 6 years after the conclusion of an investigation

Notify • Upon determination of an illegitimate product one is to notify the FDA

Notify • Upon determination of an illegitimate product one is to notify the FDA and all immediate trading partners not later than 24 hours after making the determination. • Upon request by Federal or State officials, in the event of a recall or for the purpose of investigating a suspect or illegitimate product a dispenser shall, not later than 2 business days or in another reasonable time as determined by the Secretary after receiving the request, provide information.

Notify • Entities should access the FDA’s Web page at: http: //www. accessdata. fda.

Notify • Entities should access the FDA’s Web page at: http: //www. accessdata. fda. gov/scripts/cder /email/drugnotification. cfm

FDA Web Page Follow the instructions on the Web page for accessing the Form

FDA Web Page Follow the instructions on the Web page for accessing the Form FDA 3911.

Form FDA 3911

Form FDA 3911

Form FDA 3911 • 3911 12/2015 Drug Notification to FDA (Instructions Supplement) (PDF -

Form FDA 3911 • 3911 12/2015 Drug Notification to FDA (Instructions Supplement) (PDF - 126 KB) • 3911 12/2015 Drug Notification to FDA (PDF) (PDF - 2. 1 MB)

FDA 3911

FDA 3911

Sections of the DSCSA o 581 - Definitions o 582 - Requirements o 583

Sections of the DSCSA o 581 - Definitions o 582 - Requirements o 583 - Standards for Licensure of WDs o 584 - National Standards for 3 PL’s o 585 - Uniform national policy Additional information can be found in Sections: 203, 204, 205, 206, 207 & the various Guidance's for Industry published by the FDA

Resources and References • FDA DSCSA Main Website: – http: //www. fda. gov/Drugs/Drug. Safety/Drug.

Resources and References • FDA DSCSA Main Website: – http: //www. fda. gov/Drugs/Drug. Safety/Drug. Integrityand. Supply. C hain. Security/Drug. Supply. Chain. Security. Act/default. htm • FDA DSCSA Guidance Documents: – http: //www. fda. gov/Drugs/Drug. Safety/Drug. Integrityand. Supply. C hain. Security/Drug. Supply. Chain. Security. Act/ucm 424963. htm • FDA DSCSA Implementation Plan – http: //www. fda. gov/drugsafety/drugintegrityandsupplycha insecurity/drugsupplychainsecurityact/ucm 382022. htm

Resources and References • Title II of The DQSA: The DSCSA – http: //www.

Resources and References • Title II of The DQSA: The DSCSA – http: //www. fda. gov/Drugs/Drug. Safety/Drug. Integrityand. Supply. Chain. Se curity/Drug. Supply. Chain. Security. Act/ucm 376829. htm • To Report an illegitimate product to the FDA: – http: //www. accessdata. fda. gov/scripts/cder/email/drugnotificat ion. cfm • To Validate FDA registration of a vendor: – http: //www. accessdata. fda. gov/scripts/cder/drls/default. cfm

Resources and References • Title II of The DQSA: The DSCSA – http: //www.

Resources and References • Title II of The DQSA: The DSCSA – http: //www. fda. gov/Drugs/Drug. Safety/Drug. Integrityand. Supply. Chain. Se curity/Drug. Supply. Chain. Security. Act/ucm 376829. htm • To Report an illegitimate product to the FDA: – http: //www. accessdata. fda. gov/scripts/cder/email/drugnotificat ion. cfm • To Validate FDA registration of a vendor: – http: //www. accessdata. fda. gov/scripts/cder/drls/default. cfm

References • • http: //www. fda. gov/Drugs/Drug. Safety/Drug. Integrityand. Supply. Chain. Securit y/Drug. Supply.

References • • http: //www. fda. gov/Drugs/Drug. Safety/Drug. Integrityand. Supply. Chain. Securit y/Drug. Supply. Chain. Security. Act/ucm 376829. htm http: //www. accessdata. fda. gov/scripts/cder/wdd 3 plreporting/index. cfm http: //www. fda. gov/downloads/Drugs/Development. Approval. Process/Small Business. Assistance/UCM 388945. pdf http: //www. fda. gov/drugs/resourcesforyou/consumers/buyingusingmedicin esafely/counterfeitmedicine/default. htm http: //www. fda. gov/iceci/criminalinvestigations/ucm 182888. htm http: //www. accessdata. fda. gov/scripts/cder/email/drugnotification. cfm http: //www. fda. gov/About. FDA/Reports. Manuals. Forms/Human. Drug. F orms/default. htm