Drug Supply Chain Security Act, Implications for the Hospital Pharmacy - PowerPoint Presentation

Slide1

Drug Supply Chain Security Act, Implications for the Hospital Pharmacy

Pamela Kindall, BBA

Pharmacy Business Specialist

Joshua Bright, PharmD

Director of Pharmacy Services

North Arkansas Regional Medical Center

September 29, 2016Slide2

Conflicts of Interest

Josh Bright and Pam Kindall declare no conflicts of interest

Josh and Pam are not lawyersSlide3

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 yearsSlide4

Quality and Security, the

Why

:

Counterfeits:

Tamiflu

(

oseltamivir)

A

A

B

BSlide5

B

A

A

B

BSlide6

Quality and Security, the

Why

:

Counterfeits:

Botox

(

onabotulinumtoxin

A)

http

://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm

A

BSlide7

B

http

://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm

A

BSlide8

Quality and Security,

t

he

Why:

2007- Crude Heparin linked to 246 deaths

“economically

motivated

adulteration1”

Heparin Supply ChainSmall 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

Http

://

www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291390.pdf

http://

www.gao.gov/assets/320/311879.pdf

Slide9

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

Slide10
Slide11

Title I Section 503(b)

FDA Registered Outsourcing Facilities

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm

ASHP

Guidelines on Outsourcing Sterile Compounding Services

http://www.ashp.org/DocLibrary/BestPractices/MgmtGdlOutsourcingSterileComp.aspx

Read 483’s and personally inspect the facilitySlide12

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 productsMore efficient and effective recall processSlide13

How

Trading Partners

(

mfg

,

repackagers

, wholesalers, dispensers, 3PLs)

Provide transaction documentation

downstreamStore 6 years (paper or electronic)Slide14

Timeline

Nov 2013

DQSA

Enacted

FDA Guidance Issued

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

July 1, 2015; November 2015… March 2016

Dispensers receive transaction information and maintain for 6 yearsSlide15

Timeline

2017-2019 Interim Period

Time for

mfgs

and

repackagers

to serialize:

Trace Lot,

Exp

, Serial number on each package

Nov 2017

Mfg

serialize product

Transaction information electronic

Nov 2018

Repackagers

serialize product

Transaction information electronic

2019

Distributors only sell serialized product

2020

Dispensers only utilize serialized product

2023

Unit-level traceability throughout the supply chainSlide16

One more example

Counterfeits:

Nicotine gum?

B

ASlide17
Slide18

DSCSA

~ Authorized Trading

P

artners

~ 3T Information

~ Exclusion List

~ Suspected or Fraudulent ProductSlide19

Authorized Trading Partners

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

repackagers

.

http://

www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm376829.htmSlide20

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)]Slide21

Authorized Trading Partners

Validate registration with the FDA

~Wholesale Distributor, Secondary Market, and 3PL’s

http://

www.accessdata.fda.gov/scripts/cder/wdd3plreporting/index.cfmSlide22

Authorized Trading PartnersSlide23

3 T’s

Entities are required to capture the 3T’s

Transaction Information

Transaction Statement

Transaction HistorySlide24

Transaction Information

Established name of the product

Strength and dosage form

NDC number

Container size

Number of units

Lot number

Date of transactionDate of shipment, if more than 24 hours after the date of the transaction

Business name and address from where the product is transferredBusiness name and address to where the product is transferredSlide25

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 historySlide26

Transaction History

This is a statement in paper or electronic form for each prior transaction going back to the manufacturer of the productSlide27

3T’s

The FDA has issued a guidanceSlide28

3T’s

The transaction information, transaction statement, and transaction history (3T’s) must be captured and maintained for each drug product received for 6 years from the date of transaction. Slide29

What products are covered

Prescription Drugs in finished dosage form for administration to a patient without further manufacturing.Slide30

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 electrolytesSlide31

Exempt Transactions

The term ‘transaction’ does not include...

Slide32

Exempt TransactionsSlide33

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 partnersSlide34

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/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM388945.pdfSlide35

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/co186 unterfeitmedicine

/default.htm http://www.fda.gov/iceci/criminalinvestigations/ucm182888.htmSlide36

Quarantine

Quarantine the suspected product and promptly conduct an investigation to determine whether the product is an illegitimate product.

HOW

WHO

POLICIES & PROCEDURESSlide37

Investigation

Closely examine the package and transport package

Closely examine the label on the package and the unit

Validate the 3T information you were given

.

Keep records of investigations for not less than 6 years after the conclusion of an investigationSlide38

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. Slide39

Notify

Entities should access the FDA’s Web page at:

http

://

www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfmSlide40

FDA Web Page

Follow the

instructions on the Web page for accessing

the

Form FDA 3911. Slide41

Form FDA 3911Slide42

Form FDA 3911

3911

  12/2015 Drug Notification to FDA (Instructions Supplement)  (PDF - 126KB

)

3911

  12/2015 Drug Notification to FDA (PDF)  (PDF - 2.1MB

)Slide43

FDA 3911Slide44

Sections

of the DSCSA

581- Definitions

582- Requirements

583- Standards for Licensure of WDs

584- National Standards for 3PL’s

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 FDASlide45

Resources and References

FDA DSCSA Main Website:

http://

www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm

FDA DSCSA Guidance Documents:

http://

www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm424963.htm

FDA DSCSA Implementation Planhttp://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/ucm382022.htm

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Resources and References

Title II of The DQSA: The DSCSA

http://

www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm376829.htm

To Report an illegitimate product to the FDA:

http://

www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm

To Validate FDA registration of a vendor:http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm Slide47

Resources and References

Title II of The DQSA: The DSCSA

http://

www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm376829.htm

To Report an illegitimate product to the FDA:

http://

www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm

To Validate FDA registration of a vendor:http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm Slide48

References

http

://

www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm376829.htm

http://

www.accessdata.fda.gov/scripts/cder/wdd3plreporting/index.cfm

http

://

www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM388945.pdf

http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/counterfeitmedicine/default.htm

http

://www.fda.gov/iceci/criminalinvestigations/ucm182888.htm

http://

www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm

http://

www.fda.gov/AboutFDA/ReportsManualsForms/Forms/HumanDrugForms/default.htm