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Drug Supply Chain Security Act: What Dispensers Need to KnowPharMEDium Lunch and Learn Series

ProCE, Inc.www.ProCE.com 1

Drug Supply Chain Security Act:What Dispensers Need to Know

LUNCH AND LEARN

July 10, 2015

Featured Speaker: Raymond Lake, M.S., R.Ph.

Corporate Director of Pharmacy OperationsMedStar Health

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CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist and Tech CE)

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Funding: This activity is self‐funded through

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g y gPharMEDium.

It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Mr. Lakehas no relevant commercial and/or financial relationships to disclose.



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Drug Supply Chain Security Act:What Dispensers Need to Know

LUNCH AND LEARN

July 10, 2015

Featured Speaker: Raymond Lake, M.S., R.Ph.

Corporate Director of Pharmacy OperationsMedStar Health 6



This presentation is not intended to constitute legal advice. Please consult your g yfacility’s legal and compliance teams before taking any action.

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Review the phase-in timeline of the Drug Supply Chain Security Act (DSCSA)pp y y

Describe preparatory tasks by Dispensers Identify the data storage requirement for

Dispensers under DSCSA List key elements of a Dispenser’s DSCSA

Policy and Procedure document

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H.R.3204 - Drug Quality and Security Act Title I: Drug Compounding or the t e ug Co pou d g o t e

Compounding Quality ActExempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements.Titl II D S l Ch i S it k D Title II: Drug Supply Chain Security aka Drug Supply Chain Security Act

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FDA desire to preserve what we know as “pedigree” and to outline a uniform, i bl d b k dinteroperable and more robust track and trace.

It sets new Federal definitions and requirements for all supply chain partners (trading partners) and replaces PDMA and state pedigree requirements

Over the next 10 years the program will verify drug movement through the supply chain at the single-package level.

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Starting Jan. 1, 2015 trading partners must quarantine product while they conduct an investigation to determine if it:

(A) is potentially counterfeit, diverted, or stolen;(B) is potentially intentionally adulterated such that

the product would result in serious adverse health consequences or death to humans;

(C) is potentially the subject of a fraudulent t titransaction; or

(D) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

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Trading Partners- drug manufacturers, wholesalers, dispensers d ug a u actu e s, o esa e s, d spe se s(pharmacies), and repackagers

Stakeholders- all of the above plus Third-party logistics providers, FDA, State officials, Others

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FDA Timeline

Manufacturer Timeline

Wholesale Distributor Timeline

Dispenser Timeline

Repackager Timeline

Third-Party Logistics Provider Timeline

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11/27/15National standards for wholesaler distributor licensure and 3PLs issuedWaiver, Exception, Exemption,Process/Guidance, Grandfathering Specifications

11/27/17Manufacturers serialize productNational standards for wholesaler distributor li ff i

11/27/19Distributor traceability

11/27/20Dispenser traceability

2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

11/27/13

1/1/15Dispensers can receive TH, TI, TS.FDA can request information from Dispensers

11/1/15Dispensers must receive TH, TI, TS

licensure effective

11/27/18Repackagers serialize product

11/27/23Unit level

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11/27/13 Obama signs DSCSA

11/27/14 Standards published for TI/TH/TS , 3PLs report licenses to FDA

FDA can request information from Dispensers.Manufacturers send, and distributors send and receive TH/TI/TSWholesale distributors report state licensure info. to FDASuspect and illegitimate product requirements in effectTrading partners must be authorized/licensed

traceability

KEYTH – Transaction HistoryTI – Transaction InformationTS – Transaction Statement3PL – 3rd Party Logistics

Adapted with permission from HDMA



Dec Jan Feb Mar Apr May Jun Jul2014 2015

January 1, 2015Dispensers can receive

bili d

Dispenser Preparation WindowExtended to Nov 1 2015

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traceability data from trading partners

Also on January 1, 2015: Manufacturers send, and distributors send and receive TH/TI/TSWholesale distributors report state licensure info. to FDASuspect and illegitimate product requirements in effectTrading partners must be authorized/licensed

1, 2015Dispensers receive TH, TI, TS.FDA can request information from Dispensers

Establishes standards for the exchange of transaction documentation, which shall include transaction information (TI), transaction history (TH), and transaction statements (TS).

Requires drug manufacturers, wholesalers, dispensers, and repackagers to ensure that all prior transaction information is provided at each transfer of ownership.p p

Requires a manufacturer, wholesale distributor, dispenser, and repackager, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, to provide within a reasonable time the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official.

Requires a manufacturer or repackager to affix or imprint a product identifier on each package and homogenous case intended to be introduced in a transaction into commerce. Excepts from this requirement with respect to unique device identifiers any products required to have a standardized numerical identifier.

Requires a manufacturer, wholesale distributor, dispenser, or repackager to ensure that each of its trading partners is authorized.

Requires a manufacturer, wholesale distributor, dispenser, and repackager to implement systems to: (1) d d ( ) h dl ll d l d h h d l dinvestigate suspect products; and (2) handle illegitimate products, including through quarantine, disposal, and

appropriate notice to the Secretary and, as necessary, trading partners.

Requires manufacturers, wholesale distributors, and repackagers to verify returned products before further distribution.

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Authorizes a dispenser to enter into a written agreement with a third party, including an authorized wholesale distributor, that requires the third party to maintain confidentially any information and statements required to be maintained. Requires the Secretary to provide for alternative methods of compliance with such additional drug distribution security requirements.

Directs the Secretar to contract ith a pri ate independent cons lting firm ith e pertise to cond ct a technolog Directs the Secretary to contract with a private, independent consulting firm with expertise to conduct a technology and software assessment that looks at the feasibility of dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level.

Requires the Secretary to: (1) establish one or more pilot projects and hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain, (2) issue a final guidance document that outlines and makes recommendations with respect to the system attributes necessary to enable secure tracing at the package level, and (3) identify and make recommendations with respect to the standards necessary for adoption in order to support the secure interoperable electronic data exchange among the pharmaceutical distribution supply chain that comply with a form and format developed by a widely recognized international standards development organization.

(Sec. 204) Requires the Secretary to establish standards for the licensing of wholesale distributors and third party logistics providers.

(Sec. 205) Preempts state and local requirements related to tracing drugs through the distribution system, and licensure of wholesale distributors and third party logistics providers.

(Sec. 206) Subjects violations of this Act to specified criminal and civil penalties.

Deems misbranded any drug failing to bear its required product identifier.

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Key elements of product selection to monitor:

Product Sourcing Product Supply/Demand Product Appearance

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Establishes standards for the exchange of transaction documentation, which shall include transaction information (TI), transaction history (TH), and transaction statements (TS).

Transaction Data Elements

transaction history (TH), and transaction statements (TS).Transaction History

(TH)Transaction

Information (TI)Transaction

Statement (TS)A statement in paper or electronic form, including the transaction information for each prior transaction

Proprietary or established name or names of the product; • strength and dosage form of the product; • NDC number of the product; • container size; • number of containers; • lot number of the product; • date of the transaction;

A statement, in paper or electronic form, that the--entity transferring ownership in a transaction is authorized as required under DSCSA; received the product from a person that is authorized as required under DSCSA; received transaction information and a transaction statement from the prior

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prior transaction going back to the manufacturer of the product.

;• date of the shipment, if more than 24 hours after the date of the transaction; • business name and address of the person from whom and to whom ownership is being transferred.

a transaction statement from the prior owner of the product, as required under the law; did not knowingly ship a suspect or illegitimate product; had systems and processes in place to comply with verification requirements under the law; did not knowingly provide false transaction information; and did not knowingly alter the transaction history.

Defined as a transfer of product where a change of ownershipoccurs Exempt transactions:Exempt transactions:

• Intracompany distributions• Distribution among hospitals under common control • Public health emergencies • Dispensed pursuant to a prescription • Product sample distribution • Blood and blood components for transfusion • Minimal quantities by a licensed pharmacy to a licensed practitioner • Charitable organization distributions

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g• Pursuant to a merger or sale • Certain combination products • Certain medical kits • Certain IV products • Medical gas distribution



Prescription drug in finished dosage form for administration to a patient without further manufacturing (such as capsules, tablets, lyophilized products before reconstitution)

Exclusions:• Blood or blood components intended for transfusion • Radioactive drugs or biologics • Imaging drugs • Certain IV products

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• Certain IV products • Medical gas • Homeopathic drugs • Compounded drugs

Requires a manufacturer, wholesale distributor, dispenser, and repackager in the event of a recall or for the purpose of

Provision of Information

and repackager, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, to provide within a reasonable time the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official.

Data Storage Data RetrievalTrading partners are required to capture the

48 hours to notify/respond to regulatory agencies

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q pproduct tracing information and maintain the applicable information for not less than 6 years after the date of the transaction.

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Authorize Trading Partners

Requires a manufacturer, wholesale distributor, dispenser, or repackager to ensure that each of its trading partners is “authorized”.

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What does that mean?• Manufacturers/repackagers – valid registration • Wholesalers/3PL – valid State or Federal license • Dispenser – valid State license

No later than 1/1/15, manufacturers, wholesaler drug distrib tors repackagers and man dispensers

Product Verification

distributors, repackagers, and many dispensers (primarily pharmacies) shall establish systems and processes to be able to comply with the verification requirements.

Must be able to respond to verification requests from the Secretary about suspect product

Quarantine and investigate suspect product to determine if illegitimate productdetermine if illegitimate product

Notify trading partners and FDA of illegitimate product Respond to notifications of illegitimate product Recordkeeping

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Verification of Returns

Requires manufacturers, wholesale distributors, and repackagers to verify returned products before further distribution.

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Establish standards for the licensing of wholesale distributors and third party logistics providers.

• No later than 11/27/15, FDA is required to develop new federal standards for licensing of wholesale drug distributors and a federal system for wholesale drug distributor licensing for use when a state system does not meet federal standards.• Beginning 1/1/2015, wholesale drug distributors shall report their licensing status and contact information to FDA. This i f ti ill th b d il bl i bli d t b

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information will then be made available in a public database.• Coordination with appropriate State officials



Per timeline – begins 2017Per timeline begins 2017 “Product identifiers” in a 2D bar code:• National Drug Code • Serial number

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Serial number • Lot number • Expiration date

Unintended consequence:

wholesalers' systems are set up to send 340B…wholesalers' systems are set up to send 340B drugs directly to the contract pharmacies, but the corresponding tracking information goes to the hospital that oversees the contract pharmacy. That means that contract pharmacies won't be able to accept shipments of 340B drugs starting July 1 because they won't have the FDA-mandated tracking information. - See more at:mandated tracking information. See more at: http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=4131#sthash.5zyyVAVq.dpuf

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Develop Compliance P & P Work with internal Information Services to

plan for storage/retrievability of TH, TI, TS Talk to your Wholesaler(s) Talk to your Direct Vendors Meet with Portal Vendors, contract if

necessary Identify/Quantify Supply Chain Entry Points Identify/Quantify Supply Chain Entry Points Educate administration Educate staff

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Regulatory compliance - KEY NDC item purchases outside of pharmacy (eg.

Materials Mgmt Lab other)Materials Mgmt, Lab, other) Loan/borrow situations external to system Data storage and retrieval requirements Receiving process Quarantine process Verification systems Notification systemsy Product returns to vendors Direct Purchasing – acquisition of TH, TI, TS Recordkeeping

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Also include FDA response process in P & P

The FDA has designated Form 3911 for Notifications (available on their website)

Must respond within 48 hours

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Internal Communications to a variety of Internal Stakeholders for an Institution

Secure Data Storage Secure Data Storage Ability to Append Tracing Files for Borrow/Loan

Situations Tracing File Acquisition/Storage for Direct

Purchases Costs Incurred to Achieve Compliance for DSCSA

StakeholdersData Portability Data Portability

Compliance Audits Lack of Tracing File Standardization

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A company which develops solutions to help members of the pharmaceutical supply chainmembers of the pharmaceutical supply chain comply with all global track & trace / serialization regulations, including DSCSA here in the United States.

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Select software vender based on key elements: ability to handle disparate product tracing files

from multiple vendorsfrom multiple vendors ability to securely store files for 6yrs ready access to upload/download file via web

portal/cloud ability to append files ability to streamline receiving ongoing updates/compliance ability to work with our system’s multiple direct

vendors training/testing resources ability to go-live in 30-60 days

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Select Consultant based on key deliverables: Creation/review of action planC eat o / e e o act o p a Review P & P document(s) to ensure key

elements are included Assistance with internal communications Specified timeframe for receipt of report/ gap

analysis Assistance with selection of portal vendor

(optional) provision of timeline

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ASHP asked for an extension for DSCSA compliance until 1/1/16 in a letter dated p6/16/15. FDA granted 4 month reprieve.

Variety of tracing documents being received from vendors

Handling large volumes of data Portal vendor contracting Compliance discussion at P & T level Large manufacturers have developed their

own T3 portals

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1. FDA http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default htminSecurity/DrugSupplyChainSecurityAct/default.htm

2. HDMAhttp://www.healthcaredistribution.org/issues/pharmaceutical-traceability

3. ASHPhttp://www.ashp.org/DocLibrary/Policy/Practice-Managers/DSCSA-Compliance.pdf

4 Portal vendors4. Portal vendors5. Wholesalers

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Q & A

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