HLS Industry Adoption RoadmapDraft v10.0Prepared by the HLS Industry Adoption Task ForceAudience: EPCglobal HLS Tri-Chairs, Co-Chairs, LegalComments Due: July 6, 2007 Note Version
Publication Plan and Timeline • June 22: GS1 starts publication-ready document, press release Send draft v9.2 to EPCglobal legal for pre-review • June 27: Finish Team Review of v9.2 (IATF Conf Call) Discuss with HUG Co-Chairs + Ulrike + Chuck • June 29: Draft v10.0 + Comment Form Completed • Forward to Team for any final comments • Forward to Tri-Chairs, Co-Chairs for approval • Forward to EPCglobal Legal for review • July 6: Draft v10.0 review ends • July 9: Resolve comments • July 10: Final Draft v11.0 + Comment Form Completed • Publish to key Industry Trade Groups for review/comments • Publish to EPCglobal HLS Community and GS1 HUG for comments • July 24: Final Draft v11.0 Review period completed • July 25: IATF Conf Call to resolve comments • July 27: Release Version 1.0 published • GS1 / EPCglobal Press Release • EPCglobal Website • GS1 HUG Website • Industry Trade Groups
Publication Plan Key Target Audiences • PhRMA • HDMA • NACDS • GS1 HUG Community • EPCglobal HLS Community • Rx Safetrack • On Track • BIO • GPHA • NCPA • Others (Hospital groups)
Table of Contents—HLS Roadmap Executive Summary • Purpose • Scope • Capabilities and Guidance • Unique Identification • Pedigree • Action Steps • Summary and Recommendations • Appendices Communications Plan (Separate Deliverable)
Notes to Reader • Although this is an EPCglobal chartered team, this document provides flexibility in selecting an appropriate data carrier. Barcodes and RFID are both represented within the document. • This document is a point-in-time snapshot of the current thinking of the EPCglobal HLS Industry Adoption Task Force. • It is intended as a starting point for the various industry trade associations. • Once the document is handed-off these industry trade associations, this document may no longer be kept current. • See the IATF Communications Plan for the handoff materials and the groups receiving the outputs. • After June 8, 2007, work through your industry trade association to obtain the latest information regarding industry adoption activities and materials for your market segment.
Disclaimer • Supply chain participants should rely upon their companies’ legal interpretations of regulatory requirements. • The Industry Adoption Task Force does not interpret legislation nor recommend compliance postures. • Guidance presented in the Roadmap and associated documents is designed to provide a starting point for industry collaboration to drive towards common solutions. • Guidance and/or other team deliverables are not to be considered as legal advice and are not intended to substitute for competent legal counsel.
Executive Summary • Mission: • Define a ‘starting set’ of guidance for industry trade associations to discuss with their members to facilitate their efforts in addressing current and emerging regulatory requirements for improving supply chain safety and security. • Work closely with EPCglobal and GS1 HUG (Healthcare User Group) to develop consensus-based guidance. • Educate and hand-off the Roadmap and other deliverables to industry trade associations. • NOTE: Not intended to be the ‘final answer’ for the industry—the Roadmap is only a starting point for more widespread debate and discussion within the various industry trade associations.
Executive Summary • Deliverables: • HLS Industry Adoption Roadmap • Capabilities • Guidance • Action Steps • Issues / Barriers / Assumptions • Rationale / Pro and Con Assessment • Communications Plan / Strategy • Outreach Message • Groups to target for feedback • Feedback mechanism and process • Process to hand-off to industry trade associations
Purpose of The Roadmap • The Roadmap provides guidance in meeting current and emerging regulatory expectations, including the direction outlined by the FDA’s “Counterfeit Drug Task Force Report: 2006 Update”, the California Pedigree Law (SB1476), and Federal PDMA law. • Pedigree and Unique Identification, deployed in a coordinated manner, are two Key Capabilities which can advance the industry towards improvements in the safety and security of the supply chain. • Serves as a starting point for broader discussions within the context of industry trade associations. • Documents the best ideas from the Industry Adoption Task Force, composed of a cross-section of knowledgeable industry representatives. • Describes the thought process and rationale of the Industry Adoption Task Force in arriving at the various guidance elements.
Purpose of The Roadmap • The Health and Life Sciences (HLS) industry shares the vision of a ‘safe and secure drug supply chain’ premised on transparency and accountability by all persons who handle the prescription drug, starting with the manufacturer and ending with the pharmacy or other healthcare points of dispense, including both forward- and reverse-logistics transactions. • Simply issuing a Pedigree or Uniquely Identifying a product alone does not improve safety nor security. The “coordinated exchange” of uniquely identified products using the concept of pedigree transactions can result in improved supply chain safety and security. • The Roadmap is constructed to balance the perceived risks and benefits. This balancing is needed to lessen the impact of incremental costs on the continued availability of affordable healthcare while still achieving the goal of ‘a safe and secure supply chain’.
Scope of The Roadmap • Addresses two Key Capabilities: • Unique Identification, including, • Serialization • Data Carriers for Serialization • RFID • Barcodes • Pedigree, which includes the secure exchange of product transactional information between trading partners using an interoperable electronic system. • Presents Guidance, Action Steps, and Issues/Barriers and Assumptions as a starting point for industry trade associations.
Scope of The Roadmap • Applies to HLS supply chains and participants. • Focus on US Rx drug supply chains and products: • Most urgent compliance requirements and dates. • California represents the most stringent set of requirements. • Designed with flexibility to address other HLS products and geographic regions as future requirements arise. • Adapts and leverages existing GS1 and EPCglobal standards and guidance from HDMA publications. • A comprehensive list of key sources is included in the Appendix.
Assess Impact on Trading Partners Introduction to This Section • As choices of data carrier, serialization scheme, pedigree and other decisions are made, those choices will necessarily impact your trading partners. • The following slides highlight some of the concerns, organized by industry segment, that should be considered as you develop strategy and plans. • This section provides only a basic awareness and a starting point for trading partner discussions. • Benefits can be more easily captured by all supply chain participants if all segments work closely together to understand and address each others’ concerns.
Assess Impact on Trading Partners Manufacturer Concerns with Options and Choices • Cost and time to implement serialization, regardless of data carrier, presents challenges to wide-scale deployment on all products and all packaging levels. • Variety of special-situation supply chains present unique challenges (cold chain, reverse logistics, vaccines, liquids, biologics, contract manufacturing, etc.) • Difficult to justify expenditures for serialization and pedigree unless it is clear that most or all trading partners will utilize this new technology. • Contract manufacturing supply chains may introduce some of the same concerns from the following Wholesaler and Retailer slides into the Manufacturer’s operations.
Assess Impact on Trading Partners Wholesaler Concerns with Options and Choices • Supporting multiple data carriers will multiply the costs and complexities for the wholesalers. • In the absence of Serialized Inference, a barcode data carrier used at lower packaging levels will significantly decrease productivity. • Mixture of pedigreed/serialized products and non-pedigreed/non-serialized products complicates operations. • Must have knowledge of the serialized hierarchy prior to receipt, for instance via an Rx ASN. • Trading partners may choose to build the serialized hierarchy and/or the pedigree in different formats, complicating operations. For instance, pedigree may be built on a per-item basis by some and on a per-lot basis by others. • Potential for throughput and inventory issues based on the combination of the above factors.
Assess Impact on Trading Partners Retailer Concerns with Options and Choices • Each choice of data carrier has its own cost-benefit implications not only for a specific company, but also for those trading partners further down the supply chain. • Supporting multiple data carriers will multiply the costs and complexities for the retail pharmacies in particular. • In the absence of Serialized Inference, a barcode data carrier used at lower packaging levels will significantly decrease the productivity of retail distribution centers and pharmacies. • Must have knowledge of the serialized hierarchy prior to receipt, for instance via an Rx ASN. • Trading partners may choose to build the serialized hierarchy and/or the pedigree in different formats, complicating operations. For instance, pedigree may be built on a per-item basis by some and on a per-lot basis by others. • Potential for throughput and inventory issues based on the combination of the above factors. • There is a compelling need for a total supply chain impact assessment comparing the costs and benefits of the current options for choice of data carrier, particularly at the item level.
Capability and Guidance Capability and Guidance slides formatted as: Capability • Identifies the capabilities needed by trading partners to address regulatory or other requirements. Guidance • Designed to address known regulatory requirements. • Identifies key dependencies of Standards-based activities. • Ability to extend to other HLS Supply Chains and jurisdictions. Other Guidance • Supplemental guidance and information. Rationale • Supporting information to understand the Team’s thought process.
Capability: Unique Identification(excerpted from SB1476) Note: California law defines ‘dangerous drug’ as a “drug that by federal or state law can be lawfully dispensed only on prescription or furnished pursuant to Section 4006”. [Section 4022] • [Section 4034(d)] “A pedigree shall track each dangerous drug at the smallest package or immediate container distributed by the manufacturer, received and distributed by the wholesaler, and received by the pharmacy or another person furnishing, administering, or dispensing the dangerous drug.” • Capability needed: identify the prescription drug at the Item level as defined in California law. • [Section 4034(i)] “…uses a unique identification number,established at the point of manufacture…that is uniformly used by manufacturers, wholesalers, and pharmacies for the pedigree of a dangerous drug.” • Capabilities needed: assign a unique identification number at point of manufacture; uniformly use that unique identification number throughout the supply chain. Ref: http://www.leginfo.ca.gov/pub/05-06/bill/sen/sb_1451-1500/sb_1476_bill_20060929_chaptered.pdf or http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf
Guidance: Unique IdentificationSerialization • Uniquely Identify – Pallets, Totes, Cases, Items. • Unique Identification should be based on Serialization. • Use current GS1 and EPCglobal serialization schemes for the chosen data carrier. • Synchronize serial numbers used on Primary and Backup data carriers: • SSCC: serial number ranges are the same for both Barcode and RFID. • SGTIN: serial number range for AI(21) when used as backup for SGTIN-96 should be limited to same range as SGTIN-96. • Avoid encoding of Lot Code and/or Expiry Date as an integral part of the serial number; instead, encode this data into RFID User Memory and/or into barcode Application Identifiers designed for this purpose. • Include backup human-readable text per GS1 standards. • Continue to partner with GS1 Serialization Team to define global solutions to meet varying serialization challenges. Draft: Pending GS1 Serialization Team Recommendation
Guidance: Unique IdentificationSerialization • Use EPCglobal, GS1, HDMA standards and guidelines as primary guidance. • Follow current GS1 and EPCglobal standards for use and/or re-use of serial numbers (standards for SSCC, SGTIN, AI(21) Serial Numbers). • Companies choosing to use other standards should be prepared to work with their trading partners to assure interoperability. • See Appendices for additional guidance on special-interest serialization topics: • Serialized Inference Guidance for inferring reads when less than 100% of data carriers are read. • NDC Masking Guidance for omitting the Item Reference portion of the NDC from RFID tags to avoid divulging product number for products with patient privacy concerns. • Barcode and RFID Co-Existence Guidance for ensuring synchronization of serial numbers for primary and backup data carriers when using RFID and Barcodes.
Guidance: Unique IdentificationData Carriers for Serialization Draft: Pending GS1 Serialization Team Recommendation
Rationale: Unique Identification • Unique Identification Based on Serialization • Serialization is the most compatible mechanism to achieve unique identification using existing standards and data carriers. • Avoid encoding of Lot and/or Expiry as an integral part of the Serial Number: • Current GS1 and EPCglobal standards support encoding of Lot and Expiry into Application Identifiers, User Memory, or other appropriate data structures. Current standards do not support combining these elements into a single string. • Current SGTIN-96 serial numbers allow only numeric values. Lot information is alphanumeric. Therefore cannot encode Lot with SGTIN-96, must instead use SGTIN-198 tag. • Current GS1 and EPCglobal standards require serial number to be transacted as a single string and disallow parsing of data. • Lot and Expiry data format and data values are not standardized across trading partners, it would be a logistical complication for every trading partner to know every other trading partner’s decode scheme. • Difficult to interpret a single data stream containing up to three separate data elements in the absence of enabling standards. Draft: Pending GS1 Serialization Team Recommendation
Rationale: Unique Identification • Uniquely Identify – Pallets, Totes, Cases, Items • California legislation requires unique identification at the Item level. • All packaging levels transacted through the supply chain must be serialized (in order to maintain the linkage between the serial numbers and the packaging level hierarchy within the pedigree systems). • RFID as primary data carrier should use an appropriate backup barcode. • On many products in HLS, there is insufficient space to print human-readable backup data for the RFID tag. • Important to provide machine-readable backup in case of failure of the RFID tag. • Also important to provide those companies without RFID capabilities a means to capture the serialized information via machine-readable methods.
Rationale: Unique Identification • Choice of HF or UHF RFID for Item-Level • UHF Gen2 standard is available now. • HF Version 2 standard scheduled for 3Q2007 with tags available later. • 2-D Data Matrix barcode as alternative for Item-Level • Provides an alternative for RFID-challenged products (e.g., liquids, biologics). • Current uncertainty in RFID Item-Level direction. • Effective use of available label space for small packaging. • Potential for compatibility with European (EFPIA) 2-D Data Matrix barcoding initiatives. • Flexibility in data carrier selection allows building of infrastructure that is data carrier agnostic.
Rationale: Unique Identification • RFID as Primary data carrier for Pallet, Tote, Case • Mirrors the path that Consumer Goods followed for adoption. • Compatible with Consumer Goods supply chain. • Well-understood processes, readily available solution providers. • Potential to derive some supply chain benefits due to lower cost hurdle. • Potential “step” improvement in supply chain security in advance of full adoption at item-level. • Need at least one redundant backup to the primary data carrier, in case the primary data carrier becomes unreadable. • Include human-readable text as backup for barcodes per GS1 standards and per recommendations on Slide 23. • If a Barcode is used as the Primary data carrier, then human readable text is highly recommended as a backup. • If possible, include the entire human-readable text string. • If that is not possible, then at minimum include the serial number portion of the string (AI 21 or AI 00)—the GTIN can be derived from the packaging. • If neither of the above are possible, then omit the human-readable text.
Rationale: Unique Identification • SSCC-18 barcode as Backup data carrier—Pallet, Tote, Case • Serial number portions of SSCC-18 and SSCC-96 are equivalent and can be easily synchronized to the same value. • SSCC-18 has been used in many industries for many years, including within HLS, to serialize various logistics units. • 2-D Data Matrix barcode as Backup data carrier— Case level in Use Cases #3 and #5 (exception-based) • Necessary due to the lack of label space on some smaller cases—the GS1 Code 128 backup barcode would be below minimum GS1 specifications or physically would not fit. • Usage of 2-D Data Matrix barcodes as backup on Totes, Cases, Pallets should be minimized—there are no standards to support this usage in logistics settings and there are few image scanners to read these barcodes.
Capability: Pedigree(paraphrased from SB1476) Summary of key language; NOT to be used as a substitute for the actual legislation. • Means a Record, in Electronic Form, • Containing information regarding each transaction • Resulting in a change in ownership • From sale by manufacturer until final sale to a pharmacy or other dispense point. • Includes all information required by law • Created / Maintained in an Interoperable Electronic System • Contained within a standardized non-proprietary data format and architecture • Uniformly used by manufacturers, wholesalers, pharmacies for the pedigree • Ensuring compatibility throughout all stages of distribution • Tracked at the Smallest Packaging Level (see Serialization Guidance) • Certifying that the Pedigree Information is True and Correct • From a Responsible Party of the source • Under penalty of perjury • Returns documented on same Pedigree as the receipt transaction Ref: http://www.leginfo.ca.gov/pub/05-06/bill/sen/sb_1451-1500/sb_1476_bill_20060929_chaptered.pdf or http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf
Guidance: Pedigree • Currently there are two Options to provide a Pedigree: • Option 1 – Drug Pedigree Standard • Option 2 –Track and Trace • Option 1: Drug Pedigree Standard is available now. • Option 2: Track and Trace in Requirements phase now. Standards will follow at a later date. • Further guidance for choosing an Option cannot be provided until the following is completed for Option 2: • Requirements • Standards • Software designed and available which meets Standards
Rationale: Pedigree • Rx ASN (modified EDI Transaction Set 856, Advance Ship Notice) does not meet California requirements for pedigree. • Cannot support ‘certification under penalty of perjury’. • Does not exist in an ‘interoperable electronic system widely used…’ • Does not meet requirement for ‘manufacturer-initiated pedigree’. • Continue use of Rx ASN to facilitate supply chain transactions. • Supply chain automation relies on continued availability of ASN’s. • Use of ASN’s will not meet pedigree obligations for jurisdictions requiring the pedigree in an ‘interoperable electronic system’.
Rationale: Pedigree At this time, the California Board of Pharmacy has no preference for either Option presented below, and the use of the terms ‘track and trace’ in the California SB1476 legislation is not intended to emphasize or endorse any particular option or technology. [Feedback from EPCglobal Pedigree Meeting with California Board of Pharmacy, Mar. 8, 2007] • Option 1 (Drug Pedigree Standard) • The California Board of Pharmacy believes the standard meets California’s electronic pedigree requirements. • However, additional work and amplification need to be done by the California BOP and Industry. • In some cases, California regulations may be necessary to provide the necessary amplification. • Option 2 (Track and Trace) • Being designed with flexibility to accommodate known requirements from California and other jurisdictions. • As with Option 1, additional work and amplification may need to be done by the California BOP, other jurisdictions, and Industry. In some cases regulations may be necessary to provide the necessary amplification.
Rationale: Pedigree • Interoperability between systems based on Option 1 or Option 2 must be addressed to prevent supply chain and pedigree disruptions. • It is likely that both Options 1 and 2 will co-exist within the supply chain. • Therefore, any pedigree initiated under either Option must be interoperable with both Options for forward- and reverse-logistics. • The EPCglobal Track and Trace Interest Group and the Supply Chain Integrity Joint Requirements Group are tasked with documenting these requirements for inclusion into: • A future revision of the Drug Pedigree Standard, and • The current requirements documents for the HLS Track and Trace Interest Group, and • Future standards developed for Track and Trace
Rationale: Pedigree • Trading Partner coordination when a pedigree solution is implemented or changed will be necessary. • It is likely that trading partners will have some level of effort to complete in order to use the information from a new pedigree solution. • Sufficient leadtime for trading partners to react should be planned and built into the implementation timelines. • Closely coordinating these types of changes should minimize problems for all parties.
Action Steps Overview • This section expands upon the ‘Begin Vendor & Industry Adoption’ activity on the following slide. • The reader will find guidance on resources available to facilitate implementation and adoption activities. • Additional details can be found in the EPCglobal Cookbook (referenced in a following slide).
Legend: Previous Progress Since March 2007 Status of Standards Requirements Dev. Standards Development Updated: June 20, 2007 6 wks 6 wks 0 wks 4 wks 10 wks 4 wks 12 wks 6 wks 4 wks 4 wks 5 wks 1 wks 16 wks 6 Tag Data Standards 5 Track & Trace 30 DAY IP Review 30 DAY IP Review 4 Supply Chain Integrity Collect Business Requests Prototype Test of Proposed Spec. Standards Development Vendor & Industry Adoption WG Review & Approve Candidate Technical WG Formation Security Board Ratification of Standard BSC/TSC Approval of EU Rqmts BSC/TSC Review of Recommended Privacy Develop EU Technical Rqmts Define Technical Rgmts w/EU IAG Business Case Dev. Form WG/ JRG IAG Business Rqmts Dev. 3 Serialization 2 Item Level Tagging 1 Pedigree Messaging Std IAG WG IAG WG/JRG TAG WG 3 Months 10 Months 5 Months
EPCglobal Post-Ratification Activities Ratified Standard ~~~~~ ~~~~~ Certified Software or Hardware ~~~~~ ~~~~~ Vendor and Industry Adoption Activities Begin Vendor and Industry Adoption(Activities may or may not be in parallel) Create Test Scripts Create Test Platform Create Test Guidelines Test and Certify Software or Hardware Capital Planning Process Re- Engineering System Integration Infrastructure Build-Out Scale up & Implement
Key Standards and Other Resources • EPCglobal • Standards are available at: http://www.epcglobalinc.org/standards/ • Drug Pedigree Standard • Tag Data Standard • Item Level Tagging Standard • Gen2 Standard • EPCIS Standard • Track and Trace Interest Group Requirements (opt-in required)http://www.epcglobalinc.org/apps/org/workgroup/hls_t_t_ig/index.php • EPCglobal Cookbook • Provides guidance on how to phase implementations, activities required, sequencing of activities, development of KPI’s and metrics, among other useful topics.http://www.epcglobalinc.org/what/cookbook
Key Standards and Other Resources • GS1 • GS1 General Specifications (via your GS1 Member Organization)http://www.gs1.org/productssolutions/barcodes/technical/genspecs/ • GS1 Serialization Team Requirements(work in progress; join at http://www.gs1.org/hug/Membership/ ) • FDA • FDA Compliance Policy Guide, “Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs”, Nov. 2004http://www.fda.gov/oc/initiatives/counterfeit/rfid_cpg.html • FDA Counterfeit Drug Task Force Report: 2006 Update, Jun. 2006http://www.fda.gov/oc/initiatives/counterfeit/report6_06.pdf
Key Standards and Other Resources • HDMA • “Guidelines for Barcoding in the Pharmaceutical Supply Chain”, December 2005 edition (available for purchase only)http://web1.hdma.net/shop/cgi-bin/shopper.exe?preadd=action&key=PUBS261
Action Steps Typical Activities For All Trading Partners • Engage with your Industry Trade Associations to ensure you have the most current information regarding policy and positions. • Work with EPCglobal and GS1 groups to obtain standards, education, and to learn from others. • Choose Serialization data carriers for every packaging level. (see Slide 23) • Choose Pedigree Option and software. (see Slide 31) • Develop scale-up and rollout-plans for Serialization and Pedigree (e.g., based on SKU counts or geographical rollout). • Work with all affected trading partners with sufficient leadtime on Serialization and Pedigree choices and options to facilitate efficient supply chain operations. • See EPCglobal Public Policy Guidelines for Healthcare Industry. • Convert operations to apply and aggregate serial numbers.
Action Steps Typical Activities For All Trading Partners • Develop, implement, and adhere to effective Privacy standards to ensure appropriate use of these technologies. • Install capability to transact serial numbers and serialized pedigrees—based on specific local regulatory requirements. • Test serialized pedigree + serialized product final configurations with trading partners. • Start shipping serialized and pedigreed products. • Pallet, Tote, Case, Item Serialization. • Transact a manufacturer-initiated pedigree. • With sufficient lead time to load the supply chain with serialized products supported by a pedigree. • Execute your Scale-Up / Rollout Plans. • Retain Pedigree data according to regulatory data retention requirements. • Respond to requests for verification of Pedigree data.
Summary • The Industry Adoption Task Force has taken the lead in synthesizing available material into a coherent, forward-looking Roadmap which can be used by industry trade associations as a starting point in their discussions with their members. • The Roadmap describes Guidance to meet the two Key Capabilities in a balanced yet effective manner. • Pedigree • Unique Identification • The Roadmap provides direction to help reconcile the varied interests of the diverse set of stakeholders toward common solutions. • Providing trading partners with agreed-upon standards and guidance reduces complexity, barriers to adoption, and lowers overall costs for all participants.
Recommendations • EPCglobal • Prepare response to California Board of Pharmacy regarding the questions raised in March 8, 2007 Drug Pedigree Standard review meeting. • Work with US Drug Enforcement Agency to resolve remaining questions and issues. • Ensure that the EPCglobal HLS Track and Trace and Supply Chain Integrity JRG groups address interoperability of Pedigree Options 1 and 2. • Work with industry to finalize User Memory requirements for HLS.
Recommendations • GS1 • Complete and implement the Barcode Data Translation Utility. • Enable interoperability of GS1 and EPCglobal data carriers to common URN (Universal Resource Name). • Common software translation is required to ensure consistency of data captured and stored within EPCIS network architectures • Interoperability between trading partners accessing shared data bases • Work with the various regulatory jurisdictions to resolve conflicting requirements for serialization and item identification (EFPIA, Japan, Belgium, Italy, California, others). Focus on EFPIA and US harmonization as a first priority. • Work with industry to understand impacts of item data synchronization (GDSN or other processes) on serialization and/or pedigree guidance presented in the Roadmap. • Consider need and timing for Pharmaceutical data attributes to facilitate data synchronization.