The webinar will begin shortly

Transcription

1 The webinar will begin shortly You should be able to listen to the audio portion of today s event through your computer. If not, please dial: Toll Number (US/Canada): Event access code: Webinar sponsored by

2 Welcome John Miller Senior Director, Industry Relations HDMA 2

3 Before we get started Today s webinar is being recorded. All participant lines are muted. Presentation and audio replay will be made available by Friday, April 24 th. 3

4 Speaker Disclaimer This webinar is for information and educational purposes only. HDMA offers a wide range of quality programming and speakers at its webinars. Please note that the statements and speaking materials presented by speakers who are not members of HDMA staff are speaking on their own behalf and not on behalf of HDMA. The presentations here are made to inform and stimulate discussion. HDMA disclaims any or all liability arising from any speaker's statements or materials. 4

5 Q&A: Submit Your Questions Type your question into the Q&A box located on the right-hand side of your screen. Click the SEND button to submit your question. 5

6 Thank You to our Sponsor 6

7 Presenters Atif Chaughtai Director of Healthcare Solutions Axway Bruce Harold Director of EDI The Harvard Drug Group, LLC Tim Stearns Senior E-Commerce Analyst Baxter HealthCare 7

8 Today s Agenda: 1. Overview of the Drug Supply Chain Security Act (DSCSA) 2. Best Practices of Data Management 3. ASN Exceptions 4. Industry Perspectives 5. Q and A 8

9 Drug Quality and Security Act The Drug Quality and Security Act was signed by the President on November 27, Contains two main titles : Title I Drug Compounding: establishes national standards for compounding pharmacies and sterile injectable outsourcing facilities (not discussed here) Title II Drug Supply Chain Security Act (DSCSA): establishes a national system for tracing pharmaceutical products through the supply chain, sets national licensing standards for wholesale distributors and third party logistics providers, and preempts existing state pedigree and distributor/3pl licensing requirements 9

10 Drug Supply Chain Security Act Overview 1. Traceability: Establishes a phased national system for tracing pharmaceutical products through the supply chain 2. Licensing: Establishes uniform national licensing standards for wholesale distributors and third party logistics providers 3. Preemption: Immediately preempts all state laws and regulations for tracing products through the supply chain (i.e., pedigree requirements) AND state laws and regulations regarding wholesale distributor and 3PL licensure 10 10

11 11

12 Product Tracing Transaction information (TI) includes the name of the product, strength and dosage form, NDC, container size, number of containers, lot number, transaction date, shipment date and name and address of the seller and buyer. Note: Lot number, transaction date and shipment date not required for sale of direct purchase products; indicated by a direct purchase statement Transaction history (TH) paper or electronic statement that includes the TI for each prior transaction back to the manufacturer. 12

13 Product Tracing Transaction statement (TS) paper or electronic attestation by the entity transferring ownership of the product that it: Is authorized under the Act; Received the product from an authorized party; Received TI/TH/TS from the previous seller; Did not knowingly ship suspect or illegitimate product; Has systems and processes to perform verification; Did not knowingly provide false transaction information and did not alter the transaction history. 13

14 Atif Chaughtai Director of Healthcare Solutions Axway 14

15 Role of Master Data in Compliance 2013 Axway Confidential 2013 Axway Confidential 1

16 What is Master Data? Master Data is the foundational strength of an Enterprise Examples P&L, Sales reports, inventory Reporting Enterprise reporting lucidity depends on transactional activity Purchase orders, sales orders Transactional Data Transactional data depends on conditional data and master data Pricing, BOMs, routings Conditional Master Data Conditional data applies only in specific situations (if this cust. and material then this price) Material, customer, vendor, assets Master Data Stable Master data defines both the material, vendor and customer and how they will behave in the system Profit centers, Cost centers, Plant configurations Reference Data Static Defines your system and the limits of all elements 2013 Axway Confidential 2

17 The Master Data Foundation Transaction Systems (ERP,MES) & Planning, Analytics Systems Consistent Master Data Enables Faster & Better Decisions Across the Enterprise Master Data Customer Supplier Organization Product Employee Supports the universe of Transactions & Decisions Supports ALL business processes BOM Item Financial Location 2013 Axway Confidential 3

18 Why Focus on Master Data? Every Supply Chain Activity is Dependent on High Quality Master Data Visibility Planning Agility Execution COMPLIANCE 2013 Axway Confidential 4

19 John Miller Senior Director, Industry Relations HDMA 15

20 HDMA ASN Exceptions Guideline Review What is covered in the Exceptions Guideline? There are errors in the TI; the TI in the ASN does not match the product that is shipped Overages Shortages When a lot number discrepancy is found NDC number does not match Shipping and Data Transmission Errors Lost shipment Shipping error Shipment arrives with no TI/TH/TS Product arrives before data There is a buyer/seller EDI error Other Exceptions Damaged product Customer refuses order 16

21 Overages Return Overages the number of containers identified in the TI in the ASN is less than the number of containers shipped. The overage is returned. The quantity shipped is more than quantity in the ASN, and the customer does not want to keep the overage. For example, the customer orders and ASN identifies 72 bottles of 300 mg ibuprofen tablets, but customer receives 84 bottles from the supplier. Twelve bottles do not have TI, TH and TS. The customer returns the 12 bottles of 300mg ibuprofen tablets to supplier. The supplier sends the ASN to the customer. Product is shipped to the customer. The customer attempts to receive each product in the shipment against the ASN. The number of containers shipped is greater than number of containers identified in the ASN. The customer receives the quantity up to the ASN quantity. The customer returns the excess product to the supplier pursuant to normal business practices. 17

22 Overages Keep The overage is kept. The quantity shipped is more than quantity in the ASN, and the customer wants to keep the overage. For example, the customer orders 72 bottles of 300 mg ibuprofen tablets and receives 84 bottles from the supplier. Twelve bottles do not have TI, TH and TS. The customer wants to keep the 12 bottles of 300 mg ibuprofen tablets. The supplier sends the ASN to the customer. The product is shipped to the customer. The customer attempts to receive each product in the shipment against the ASN. The number of containers shipped is greater than number of containers identified in the ASN. The customer receives the quantity up to the ASN quantity. The customer quarantines the excess product. The customer creates and/or corrects Purchase Order (P.O.) (if necessary). The customer contacts the supplier s customer service and communicates the need for a correction and may provide the following: the National Drug Code (NDC), lot number, quantity and P.O. Number, ASN number, shipment date, a description of the issue and a copy of the packing list (if available). The supplier sends new TI, TH and TS for overage quantity to customer. The information will be provided based on an agreement between trading partners. 18

23 Shortages Shortage process the number of containers identified in the TI in the ASN is more than the number of containers shipped. The quantity shipped is less than the number of containers identified on the ASN. For example, the customer orders 72 bottles of 300 mg ibuprofen tablets and receives 60 bottles from the supplier. The customer will receive the 60 bottles that have TI, TH and TS and will need to resolve the 12 bottles not received pursuant to standard business processes. The supplier sends the ASN to the customer. The product is shipped to the customer. The customer attempts to receive each product in the shipment against the ASN. The number of containers shipped is less than number of containers identified in the ASN. Note: The quantity shipped has the required TI/TH/TS and can be received by the customer. Trading partners should use standard business processes to reconcile the quantity not received. The financial processes between trading partners will address assuring that the customer pay only for the number of containers received. 19

24 Lot Number Discrepancy For lot number discrepancy, there are two options: 1. Customer wants to keep product that was shipped 2. Customer does not want to keep product that was shipped 20

25 Lot Number Discrepancy The customer wants to keep the shipped product. The supplier sends the ASN to the customer. The product is shipped to the customer. The customer attempts to receive each product in the shipment against the ASN. The customer discovers that the lot number does not match the ASN for a subset of the shipped products. The customer quarantines products with incorrect lot numbers. The customer contacts the supplier and communicates the need for corrected transaction data, and may provide the following: o NDC, lot number, quantity and P.O. number, ASN number, shipment date, a description of the issue and a copy of the packing list (if available). The supplier sends new TI, TH and TS with correct lot number to customer. This information will be provided based on the agreement between trading partners. The product is removed from quarantine and is received against new TI, TH and TS. 21

26 Lot Number Discrepancy The customer wants to return the shipped product. The supplier sends the ASN to the customer. The product is shipped to the customer. The customer attempts to receive each product in the shipment against the ASN. The customer discovers that the lot number does not match the ASN. The customer returns product to supplier pursuant to normal business practices. 22

27 NDC Does Not Match For NDC that does not match, there are two options: 1. Customer wants to keep product that was shipped 2. Customer does not want to keep product that was shipped 23

28 NDC Does Not Match The customer wants to keep the shipped product. The supplier sends the ASN to the customer. The product is shipped to the customer. The customer attempts to receive each product in the shipment against the ASN. The customer discovers that the NDC number does not match the ASN for a subset of the shipped product. The customer quarantines product with an incorrect NDC number. The customer contacts the supplier and communicates the need for corrected transaction data and may provide the following: NDC, lot number, quantity and P.O. number, ASN number, shipment date, a description of the issue and a copy of the packing list if available. The supplier sends the customer a new TI, TH and TS with the corrected NDC number. Information will be provided based on the trading partner agreement. The product is removed from quarantine to the receiving dock and is received against new TI, TH and TS. 24

29 NDC Does Not Match The customer wants to return the shipped product. The supplier sends the ASN to the customer. The product is shipped to the customer. The customer attempts to receive each product in the shipment against the ASN. The customer discovers that the NDC number does not match the ASN for a subset of the shipped product. The customer returns the product to the supplier pursuant to existing standard business processes. 25

30 Other Exceptions Other exceptions can be found in the HDMA ASN Exceptions Guideline for the Drug Supply Security Act on our website at: hdma-asn-exceptions-guidelines-for-thedscsa#.vttohxffdcs 26

31 Tim Stearns Senior E-Commerce Analyst Baxter HealthCare 27

32 Manufacturer Perspective: Observations on ASN Exceptions 28 28

33 ASN Exceptions Overages (occasional) Manufacturers need to decide: if they can correct the ASN, pack slips and their DSCSA database to reflect actual container quantity shipped. The alternative is to process overages for return to the manufacturer. Baxter currently exercises this option. 29

34 ASN Exceptions Mis shipments (occasional) When a mis shipment occurs, a manufacturer will need to decide: if a corrected ASN can be sent to the physical location the product shipped to and a manufacturer s DSCSA records can be properly updated. or if the product is to be returned and the transaction cancelled. Baxter adheres to this policy regarding mis shipments. 30

35 ASN Exceptions Shorts (rare) When a short occurs, customer can: Follow up purchase order (PO) to issue the shorted quantity. 31

36 ASN Exceptions Master Data Master data exceptions can arise if HDMA New Item forms and other item master data are not communicated prior to product launch and stocking orders are placed. Avoid use of internal item numbers in favor of using NDCs or agreed UPC/GTINs where possible. Unit of measure has not been a major problem for Baxter. 32

37 ASN Exceptions Systems Integration with 3 rd Party Logistics Provider The use of a 3PL involves systems integration. This can present challenges keeping systems synchronized and transactions getting processed. Some problems that can arise are: Lot number mis match vs. what s on the label if not using automated data capture Transaction hung up inside 3PLs system in error not getting back to MFG client confirming shipment 33

38 EDI ASN Issues There has been some confusion over the use of the YNQ element 2.0. In a mixed order and shipping environment where both exempt and non exempt product appear, YNQ 2.0 = Y merely means the trade partner is complying with DSCSA as a blanket statement. It does not actively signal that either exempt or non exempt product is in the shipment. 34

39 Drop Ships Baxter has a large foot print in the cold chain and other drop shipment business models. Immediate options pack slips or ASN direct/via 3 rd party portal 2017 electronic only options in house portal systems, direct EDI, 3 rd party portal, PDF , others? 35

40 Bruce Harold Director of EDI The Harvard Drug Group, LLC 36

41 Current Options EDI ASN Packing slip PDF on portal PDF via 37

42 Why the ASN? Opportunities and Challenges Match Established usage EDI capabilities widespread Most similar data Structured data No financial data 38

43 Why the ASN? Opportunities and Challenges Mismatch Operations document as well as regulatory document Desire to minimize changes to changes to existing maps Limited functionality compared to EPCIS 39

44 Misunderstandings Group and segment repetition Direct Purchase Statement 40

45 Expectations Addresses o o Buyer and seller addresses and 3PLs Corporate addresses Multiple lines for one item/lot Multiple POs in an ASN Items that are not covered o May not have lot and expiration Timeliness 41

46 Variation Transaction Statement Content NDC 10 or 11 digits? Qualifiers o NDC Units of measure Partner specific fields Unwanted segments 42

47 Other Considerations ASNs to Retail When the recipient is not the buyer o o Shipments to a customer s 3PL Shipments to a repackaging location 43

48 Q&A: Submit Your Questions Type your question into the Q&A box located on the right-hand side of your screen. Click the SEND button to submit your question. 44

49 Closing Remarks The DSCSA is extremely complex. It contains much more than what we ve had time to cover today. Requirements vary based on individual business models, product purchasing/handling practices and other factors. We urge you to review the DSCSA in its entirety and consult with your own legal counsel and other advisors as you implement it. 45

50 HDMA FDA Traceability Resources chainsecurity/drugsupplychainsecurityact/ucm htm 46

51 Save the Date Traceability Seminar October 14 16, 2015 Arlington, VA 47

52 Thank You to our Sponsor 48

53 Contact Information Atif Chaughtai (301) Bruce Harold (734) John Miller (703) Tim Stearns (224)

54 Thank you Webinar sponsored by 50