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RXTransparent FDA public hearing future format NDC Nov 2018


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RXTRansparent presentation presented to the US Food and Drug Administration FDA during the November 5, 2018 Public Hearing

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RXTransparent FDA public hearing future format NDC Nov 2018

  1. 1. Future Format of the NDC FDA Public Hearing November 5, 2018 The views, thoughts, and opinions expressed in this document belong solely to the author, and not necessarily the author’s employer, organization, partners, or customers. Dwight de Vera RXTransparent Founder and CEO
  2. 2. Integrated US Drug Supply Chain Enabled By NDC NDC - Common identifier Enabling drug supply chain interoperability Supply Chain Dose Dispense Data Mfg. Creation of Digital Identity for Physical Asset : SN Commissioning & Fingerprint Capture Order Processing Aggregation To Shipper and Pallet Drop Ship / Direct Ship Wholesale Distribution Hospital/ Pharmacy Dispense Patient Authentication Wholesale Distribution Goods Receiving/ Custody transfer Shipping/ Goods transfer Goods Receiving Inspector Authority Interoperable Blockchain SN & secure fingerprint recorded on the blockchain. Goods transfer(s) recorded on the blockchain. Goods receipt(s) / custody transfer recorded on the blockchain. Fraud Prevention Insight Analytics Data Insight & BI FDA Public Hearing Future Format of NDC
  3. 3. Interoperable Progress NDC – 50242-044-13 Proprietary Name - Activase Non Proprietary Name -Alteplase Labeler Name - Genentech, Inc. Product Type -HUMAN PRESCRIPTION DRUG Package 1 KIT in 1 CARTON (50242-044-13) * 50 mL in 1 VIAL, SINGLE-USE * 50 mL in 1 VIAL, SINGLE-USE Industry Collaboration Enables • A safer, nimbler, transparent drug supply chain • Packaging inference • Agreement on standards in the US and internationally • Fewer drug expirations • Previously unavailable insight • Future value beyond compliance FDA Public Hearing Future Format of NDC
  4. 4. NDC Impact and Scope Active US Pharma Labelers < 1,000 Active US Pharma Wholesalers < 2,000 Active US Points of Dispense > 300,000 FDA Public Hearing Future Format of NDC
  5. 5. Current Practices Complete Drug Catalog Therapeutic Equivalents Therapeutic Classifications Biosimilars Patents and filings CorPharma DispensingAlgorithm CorPharma • Internally developed • Continuously updated • Cross references of all US pharmaceutical products • Algorithm accounts for all NDC permutations FDA Public Hearing Future Format of NDC
  6. 6. NDC Evolution Options No Changes Option A Option B 6 Digit labeler Future Date Option C 11 Digit Zero padding Option D Harmonized 12 Digit Definitive cutover Greater interoperability Quicker interoperability Overview Pro Con HIPAA confusion Most disruptive Least disruptive Five formats Middle ground Considerations and Value Beyond NDC • Retire labeler designations of NDCs no longer in use • Enhance the NDC to incorporate controlled substance designation • Enhance the NDC to identify hazardous material status • Enhance the NDC to accommodate current and future unit dosing practices FDA Public Hearing Future Format of NDC
  7. 7. Q & A Conclusions The national drug code (NDC) while not perfect, is the best compact identifier and final check on proper identification and administration of drug product prior to patient dosing. Any changes to the NDC format will result in additional technical complexity and costs within and through all facets of healthcare in the United States, but in collaboration with stakeholders throughout the industry we can all benefit from greater interoperability, consistency in care and greater long-term value within healthcare delivery FDA Public Hearing Future Format of NDC