Pharmacy Track. The Ongoing Impact of DSCSA and USP 800. Presenters: Lindsey B. Amerine, PharmD, MS, BCPS, Dawn Wang, Senior Associate, Medical Center

Transcription

1 Pharmacy Track The Ongoing Impact of DSCSA and USP 800 Presenters: Lindsey B. Amerine, PharmD, MS, BCPS, Assistant Director, Associate Professor of Clinical Education, Department of Pharmacy, University of North Carolina Medical Center Dawn Wang, Senior Associate, Management Consulting, Life Sciences, KPMG Management Consulting

2 FACULTY DISCLOSURE The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity: Lindsey B. Amerine, PharmD, MS, BCPS, Assistant Director, Associate Professor of Clinical Education, Department of Pharmacy, University of North Carolina Medical Center- none to report Dawn Wang, Senior Associate, Management Consulting, Life Sciences, KPMG Management Consulting- none to report

3 Pharmacy Track The Ongoing Impact of DSCSA Presenter: Dawn Wang Manager, Healthcare and Life Sciences Advisory KPMG LLP The information contained herein is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act upon such information without appropriate professional advice after a thorough examination of the particular situation.

4 1 2 Agenda and Today s Topics Pharmaceutical Drug Counterfeiting Overview U.S. Drug Supply Chain Security Act (DSCSA) 3 Key Considerations and Takeaways 4 Q&A and KPMG Resources

5 About Serialization and our KPMG Practice KPMG 10,000 Stories We Protect Patients Our practice focuses on Technology Enabled Compliance Solutions for the Healthcare and Life Sciences industry. Serialization and Track & Trace Regulations in over 40 countries require / will require prescription medicines to be encoded with a globally unique identifier, or serialized. Additionally, in some markets, each serialized unit will need to be tracked as ownership changes and the serialized product is physically distributed. We support supply chain stakeholders in developing solutions to meet various global compliance requirements aimed to increase patient safety. The KPMG name and logo are registered trademarks or trademarks of KPMG International KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative ( KPMG International ), a Swiss entity. All rights reserved. [Printed in the U.S.A.].

6 How Counterfeit Drugs Can Enter the Legend of Supply Chain Participants Supply Chain Legitimate Primary Channel / Market Legitimate Independent or Secondary Market Illegitimate MFG Patient Legitimate Movement Direct Purchase Wholesale Distributor Other Other Local Pharmacy Direct Purchase Wholesale Distributor Illegitimate Product Movement Local Pharmacy Counterfeiter Paper Wholesaler Indirect Purchase Wholesale Distributor Large Chain Pharmacy 2016 KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative ( KPMG International ), a Swiss entity. All rights reserved. [Printed in the U.S.A.].

7 Global Regulatory Landscape Snapshot * Not a formal or official regulatory document Not shown: legacy government controlled label-based serialization systems (e.g., Belgium, Greece, Italy) Canada. Unit Serialization Regulation expected in European Union Unit level Serialization Pharmacy Verification Deadline Feb 2019* Turkey Unit level Serialized DataMatrix: Jul 2010 Traceability: MoH system Jan 2012 Ukraine Unit level Serialization On-hold indefinitely Russia Unit and case serialization Aggregation, Tamper Evidence Timeline TBD, expected Jan 2017 South Korea Lot-level DataMatrix Jan 2013 Serialized DataMatrix Jan 2015 (30%) Remaining 70% by Jan 2016 U.S. Manufacturers: Lot-level traceability Jan 2015 Verification of Lot Info Jan 2015 Unit and Case serialization w/o aggregation Nov 2017 Serialized Traceability Nov 2023 Jordan Unit level Serialization Egypt (P1) Unit Level Codification (P2) Serialization Timeline: P1 Expected Jan 2017 Taiwan Lot-level DataMatrix: 2016 Unit Serialization: 2018 Colombia Unit Serialization Secondary Aggregation Draft Regulation in Q1/Q Brazil Unit level Serialized DataMatrix Traceability buyer/seller ANVISA & Brazil Congress creating new timelines Chile. Unit Serialization Traceability and Gov t System Regulation expected in Q UAE Serialization Gov t Database Timing TBD Argentina Unit level Serialized DataMatrix Traceability ANMAT system (Aggregation required for high volume products for efficiency) Jan st phase products Additional Products TBD all products Saudi Arabia Lot-level DM: Mar 2015 Serialized DM: Mar 2017 India Unit, Case Serialization, Aggregation DAVA portal reporting October 2015 Primary level serialization optional SSI Exports January 2016 Non-SSI Exports January 2017 Philippines Lot-level DataMatrix: Unit Serialization: suspended China Serialized Barcode (Code 128C, not GS1) Traceability SFDA system In Effect for Some Drugs 2011/2012/2013 In Effect for All Drugs December 2015 Mandatory unit case aggregation Last Updated: March KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative ( KPMG International ), a Swiss entity. All rights reserved. [Printed in the U.S.A.].

8 U.S. DSCSA Compliance Timeline TIMELINE Product Tracing (Lot-level) Requests for Information / Verification License Authorization and Verification Serialization (Identifiers) Product Tracing (Unit-level) Jan 15 M Jul 15 R D W Jan 15 Jul 15 M D R W Jan 15 M R W D Supply Chain participants must provide or receive transaction information, history and statements for product change of ownership (can be paper at first, then to be required electronically; note exceptions/exemptions) Nov 17 Nov 18 M R Supply chain participants must provide transaction information, history and statements for potentially suspect or illegitimate product that is subject to investigation or recall no later than 48 hours after receiving request (Jan 15 and Jul 15). Manufacturers and Re-packagers must verify Standardized Numerical Identifier (SNI) for queries from downstream partners (Nov 17 and Nov 18) Nov 17 Nov 18 Nov 19 Nov 20 M R W D Supply Chain participants must have systems in place to verify potentially illegitimate product, including validation of applicable transaction histories and information (beginning Jan 15) and verification of SNI (beginning Nov 17 for Manufacturers, and beginning for others through Nov 20). Nov 17 Nov 18 Nov 19 Nov 20 M R W D Product identifier (including Standardized Numeric Identifier) required to be placed on all saleable packages and sealed homogeneous cases Transaction information and statements must be exchanged starting at point of manufacture in secure, interoperable manner for all products at unit level (including standardized numeric identifier) Nov 23 M R W D LEGEND M Manufacturer R Re-packagers W Wholesalers D Dispensers 2016 KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative ( KPMG International ), a Swiss entity. All rights reserved. [Printed in the U.S.A.].

9 Authorized Trading Partner By Jan 1, 2015: Dispensers may only conduct business with trading partners that are authorized (valid State and Federal licenses as applicable). PEOPLE Engage Stakeholders on Impacts to Roles & Responsibilities PROCESS Define Process, Update Policies and SOPs, and Conduct Training TECHNOLOGY Implement / Automate Systems based on People & Process Inputs Main Functional Area Procurement / Supplier Relations Customer Relations* Inventory Operations Main Process Supplier / Vendor License Validation Customer License Validation* Main Systems Procurement / Order Processing Customer Order Management* (System Flags) Supporting Functional Areas Receiving Operations Shipping Operations* IT / Systems Validation Quality Systems Affected Processes Supplier / Vendor Onboarding Customer Onboarding* Procurement / Order Processing Customer Order Management* Other DSCSA-related Processes Supporting Systems Supplier / Vendor Master Data System Customer Master Data System* *Applicable if Dispenser ships product 2016 KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative ( KPMG International ), a Swiss entity. All rights reserved. [Printed in the U.S.A.].

10 Lot-level Product Tracing TI / TH / TS TI / TI TH / TH / TS / TS By July 1, 2015: Dispensers must receive / provide lot-level transaction history / information / statement (TI / TH / TS) upon change of product ownership. PEOPLE Engage Stakeholders on Impacts to Roles & Responsibilities PROCESS Define Process, Update Policies and SOPs, and Conduct Training TECHNOLOGY Implement / Automate Systems based on People & Process Inputs Main Functional Area Receiving/Inventory Operations Shipping Operations* Supporting Functional Areas Quality Assurance IT / Systems Validation EDI Customer Service* Quality Systems Main Process Receiving Inventory Management Shipping* Affected Processes Verification / Investigations Requests for Information Other DSCSA-related Processes Main Systems Procurement / Order Processing Customer Order Management* Note: Dispensers Could Use Various Approaches including Modifying Existing Systems, Selecting a New Solution, or Using Supplier-provided Systems Supporting Systems EDI System *Applicable if Dispenser ships product 2016 KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative ( KPMG International ), a Swiss entity. All rights reserved. [Printed in the U.S.A.].

11 Verification Systems By Jan 1, 2015: Dispensers must have verification systems in place to quarantine and investigate suspect product, and notify FDA/trading partners of product status as appropriate. PEOPLE Engage Stakeholders on Impacts to Roles & Responsibilities PROCESS Define Process, Update Policies and SOPs, and Conduct Training TECHNOLOGY Implement / Automate Systems based on People & Process Inputs Main Functional Area Inventory Operations Quality Assurance Shipping Operations* Main Process Quarantine Verification / Investigations Shipping Operations* Main Systems Inventory Management Quality Management System Incident Reporting System Supporting Functional Areas Customer Service* Quality Systems Affected Processes Incident Management Notification to Management Requests for Information Other DSCSA-related Processes Supporting Systems N/A *Applicable if Dispenser ships product 2016 KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative ( KPMG International ), a Swiss entity. All rights reserved. [Printed in the U.S.A.].

12 Requests for Information By July 1, 2015: Dispensers must be able to respond to requests for information (RFI) made by the FDA / State Agency and provide applicable TI / TH / TS. PEOPLE Engage Stakeholders on Impacts to Roles & Responsibilities PROCESS Define Process, Update Policies and SOPs, and Conduct Training TECHNOLOGY Implement / Automate Systems based on People & Process Inputs Main Functional Area Quality Assurance Main Process Responding to Regulatory Agency Requests Main Systems Solution Used for DSCSA Lot-level Tracing Regulatory Agency Interaction System Supporting Functional Areas Quality Systems Affected Processes Verification / Investigations Other DSCSA-related Processes Supporting Systems Quality Management System Incident Reporting System *Applicable if Dispenser ships product 2016 KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative ( KPMG International ), a Swiss entity. All rights reserved. [Printed in the U.S.A.].

13 Key Considerations and Takeaways DSCSA Req s Meeting Compliance Do you have compliant solutions and systems in place? Is your organization aware and trained on impacts to their roles and responsibilities? Enhancing Solutions Are your solutions automating processes to meet compliance? Do you have a roadmap to develop solution capabilities to meet future compliance and customer requirements? Achieving Value Does your approach to meet compliance also bring value to your business operations? Has your organization aligned on the value that the solution can bring to customers? 2016 KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative ( KPMG International ), a Swiss entity. All rights reserved. [Printed in the U.S.A.].

14 Thank You Additional Information Available At: KPMG Management Consulting Serialization and UDI Services: hnology-enablement/serialization.html KPMG Healthcare and Life Sciences Institute Serialization and UDI Publications: Dawn Wang Manager Advisory Management Consulting, Health Care and Life Sciences Phone KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative ( KPMG International ), a Swiss entity. All rights reserved. [Printed in the U.S.A.].

15 Pharmacy Track The Ongoing Impact of USP 800 Presenter: Lindsey B. Amerine, PharmD, MS, BCPS, Assistant Director, Associate Professor of Clinical Education, Department of Pharmacy University of North Carolina Medical Center The information contained herein is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act upon such information without appropriate professional advice after a thorough examination of the particular situation.

16 Objectives 1. Identify the basics of DSCSA and USP List ways to best prepare for the new standards and implement a compliant program. 3. Compare and contrast the new procedures that will be required of pharmacies upon implementation of DSCSA and USP Describe the challenges inherent in the new guidelines.

17 Question #1 How ready is your department to implement all the components required in USP <800>? a. 100% - already fully compliant b % compliant c % compliant d. <50% compliant e. Have no idea

18 USP <800> Hazardous Drugs (HDs) Handling in healthcare settings Practice and quality standards for handling hazardous drugs to promote patient safety, worker safety, and environmental protection Builds upon USP <757> and <797> Final version published February 2016 Enforceable standard in July 2018 USP. (accessed 2016 Feb 1).

19 List of HDs Entity must maintain list of HDs Must include any items on current NIOSH (National Institute for Occupational Safety and Health) list that entity handles NIOSH 2014 Update Include the NIOSH criteria to identify HDs, including investigational drugs If lack of criteria is available, consider drug hazardous CDC. (accessed 2016 Feb 1).

20 NIOSH Classification of HDs Group 1 Antineoplastic drugs (AHFS Classification 10:00) Group 2 Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug Group 3 Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding CDC. (accessed 2016 Feb 1).

21 NIOSH Criteria for HDs USP <800> covers drugs: Any HD active pharmaceutical ingredient (API) Any antineoplastic requiring HD manipulation Does NOT cover: Final dosage forms that do not require any further manipulation by manufacturer other than counting or repackaging Entities allowed to perform a risk assessment for their list of HDs for other dosage forms on the NIOSH list

22 NIOSH Criteria for HDs Risk assessment must include: Type of HD (Group 1, 2, 3) Dosage form Risk of exposure Packaging Manipulation Document alternative containment strategies and work practices employed to minimize occupational exposure. Review assessment at least every 12 months with documentation of review

23 NIOSH Criteria for HDs Practical Application Two approaches 1. Treat all antineoplastics and HDs the same 2. Follow USP <800> guidelines for antineoplastics requiring manipulation AND Perform a risk assessment and develop alternative containment strategies and work practices to minimize exposure

24 Personal Protective Equipment

25 Personnel Protective Equipment Gloves Gowns ASTM-D6978 Powder-free Change every 30 minutes or when punctured Polyethylene-coated polypropylene Close in back Long sleeved Closed cuffs (elastic or knit) Change every 2-3 hours or after spill PPE Receiving Compounding Transport Administration Gloves Yes 1 pair Yes - 2 pairs sterile Yes 1 pair Yes 2 pairs Gowns Yes Yes

26 Personnel Protective Equipment Head, Hair, Shoe, & Sleeve Covers Eye and Face Protection Respiratory Protection For compounding, head, hair, and shoe covers need to be worn Second pair shoe covers while in cleanroom Remove before coming out of cleanroom Sleeve covers optional Goggles and face shields when administering in surgical suite and working at or above eye level If unpacking HD not in plastic, need elastomeric half-mask with multi-gas cartridge and P100- filter No surgical masks N-95 for administration when required by drug N-95 for spill clean-up

27 Question #2 Which of the following PPE is required for administration? a. Two pairs of sterile chemotherapy gloves b. Impermeable gown closing in the back c. Two pairs of shoe covers d. N-95 respirator Answer: B

28 Facility Design

29 Spectrum of USP <800> Facility Requirements Administration Receipt/Unpacking: Drug arrives to hospital from wholesaler Transport: Drug from receiving to pharmacy Storage: Drug stored in pharmacy HD Communication Program Medical Surveillance Transport: Drug to patient care unit Compounding Oversight & Competency

30 Facilities - Receiving Supplier/wholesaler needs to ship drug in impervious plastic separate from other drugs Unpack HDs using chemotherapy gloves Unpack HD in an area that is neutral/normal or negative pressure Not in a positive pressure area Not in sterile compounding areas

31 Facilities - Storage Antineoplastic HDs requiring manipulation must be: Stored separately from non-hds Stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour Non-antineoplastic HD, reproductive risk HD, and final dosage forms of antineoplastic HDs may be stored with other inventory if entity policy allows Sterile and nonsterile HDs can be stored together Nonsterile HDs stored in areas not designated for sterile compounding

32 Facilities - Storage Refrigerated antineoplastic HDs must be stored in dedicated refrigerator in negative pressure area with at least 12 air changes per hour Suggested to have exhaust adjacent and behind fridge s compressor if in negative pressure buffer room

33 Facilities - Compounding Sterile compounding must follow standards in USP <797> in addition to this chapter Engineering Controls Primary: Containment Primary Engineering Control (C-PEC) Ventilated device used for compounding Class I or II BSC or compounding aseptic containment isolator (CACI) Secondary: Containment Secondary Engineering Control (C-SEC) Room in which the C-PEC is placed Supplementary: Closed-system transfer devices (CSTD)

34 Facilities - Compounding C-PEC Class II BSC C-SEC

35 Facilities Compounding Primary Control: C-PEC Operate continuously Cannot use for compounding if it loses power Vented externally

36 Facilities - Compounding Primary Control: C-PEC Non-sterile and sterile C-PECs Preferred to place in separate rooms If in same room: Have to sufficiently maintain ISO 7, Place C-PECs at least 1 meter apart, and Cannot perform sterile compounding at same time as non-sterile compounding that generates particulates

37 Facilities - Compounding Secondary Control: C-SEC Externally vented through high-efficiency particulate air filtration (HEPA) Physically separated Appropriate air exchange Negative pressure between inches water column

38 Facilities - Compounding Different from USP <797> <797> allows C-PEC in positive pressure room <800> requires C-PEC in negative pressure room Removed the exemption that permitted low-volume HD sterile compounding in a positive pressure room

39 Facilities - Compounding Supplementary Control: CSTDs Mechanically prohibits transfer of environmental contaminants into the system Which one? No universal performance standard for CSTDs Evaluate performance claims based on independent, peerreviewed studies and demonstrated containment reduction Cannot be used as a substitute for a C-PEC when compounding SHOULD be used for compounding, MUST be used for administration

40 Question #3 Which of the following facility design criteria is true? a. When compounding low volumes of HDs, it can be done in a positive pressure environment b. A C-PEC does not have to be vented c. Sterile and non-sterile HDs cannot be compounded in the same C-SEC d. A C-SEC must be negative pressure and externally vented Answer: D

41 Environmental Control, Cleaning, and Medical Surveillance

42 Environmental Quality and Control Wipe samples performed every six months Perform in pharmacy and administration areas When contamination is noted, site designee identifies, documents, and contains cause of contamination Re-wipe area to validate cleaning steps are effective

43 Cleaning Steps All areas must be wiped down, not sprayed Cleaning cannot be performed while compounding Process to inactivate HD substance Peroxide, sodium hypochlorite (neutralize with sodium thiosulfate Deactivation Decontamination Remove HD residue Kills viral and fungal spores Alcohol, peroxide, sodium hypochlorite Remove organic or inorganic material Germicidal detergent Cleaning Disinfection Destroy microorganisms Sterile alcohol

44 Medical Surveillance Comprehensive exposure control program to minimize adverse health effects in healthcare workers using HDs Assess baseline health with ongoing monitoring Maintain records of surveillance Follow-up plan for employees with health changes Exit exam when employment ends

45 Records of HDs handled with quantities and dosage forms Medical Surveillance Estimated number HDs handled per week and/or month Physical assessment with labs (complete blood count) Blood or urine levels to monitor specific HDs for acute exposures

46 Resources USP practitioner-based newsletter Live webinars Professional organizations working on resource guides

47 Conclusion USP Chapter <800> represents significant standard changes for HDs Standardize HDs work practices for all healthcare personnel Begin planning now for renovations if required as chapter is enforceable in July 2018

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