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VA Drug Terminology Projects Update: NDF-RT, the New Drug Transaction, And Beyond

VA Drug Terminology Projects Update: NDF-RT, the New Drug Transaction, And Beyond. Presented to HL7 Vocabulary TC Meeting. VA: Steve Brown, Mike Lincoln Apelon: Mark Tuttle, John Carter, Mark Erlbaum October 3, 2002. Overview. NDF-RT: Current state and plans

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VA Drug Terminology Projects Update: NDF-RT, the New Drug Transaction, And Beyond

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  1. VA Drug Terminology Projects Update: NDF-RT, the New Drug Transaction, And Beyond Presented to HL7 Vocabulary TC Meeting VA: Steve Brown, Mike Lincoln Apelon: Mark Tuttle, John Carter, Mark Erlbaum October 3, 2002

  2. Overview • NDF-RT: Current state and plans • New Drug Transaction: Introduction • Interagency cooperation update HL7 Baltimore

  3. Background:VA National Drug File (NDF) • Centrally maintained and distributed, locally modified and deployed. Uses include: • VistA POE Decision Support • Mail out pharmacy (57 million in 2001) • Single-inheritance hierarchy including • VA Drug Classes (anti-hypertensives, beta-blockers) • Products (Ampicillin 250 mg tab) • Ingredients (carbidopa, codeine phosphate) • NDCs (acetaminophen 325 mg tab, bottle of 100) HL7 Baltimore

  4. NDF Reference Terminology (NDF-RT) • Explicit, multi-hierarchical model • Centered on drug ingredients for function, maintenance and economies of scale • Semi-algorithmic initialization followed by human review • Authoritative, collaborative content (FDA, NLM, HL7, others) • VA’s ERT strategy • Subject Matter Experts use COTS tools to develop, modify, & maintain enterprise standards • Abstracted terminology services HL7 Baltimore

  5. Structural ID VA Drug Classes Database Links MeSH, CUIs, … Chemical Structure Mechanism of Action Active Ingredients Physiologic Effect Strength Dose Form Route of Adm. (HL-7) Pharmacokinetics Clinical Drugs Therapeutic Intent National Drug Codes (NDCs) Packaged Drugs Simplified NDF-RT Model HL7 Baltimore

  6. NDF-RT Content • Drug Hierarchy • 3,977 Active Ingredients (incl. salts & esters) • 11,345 Orderable Drugs (= VA Products) • 87,210 Packaged Drugs (NDCs) • Initialized from … • VA National Drug File (Sept 2001) • NLM RxNorm Drug Names (Dec 2001) HL7 Baltimore

  7. NDF-RT Content • Reference Hierarchies • 3,994 Diseases & Manifestations (“Intended Therapeutic Use” hierarchy) • 489 Chemical Structure categories • 402 Mechanism of Action & Physiologic Effect categories • 154 HL7 Dose forms • 58 Clinical Kinetics categories • Initialized from MeSH & HL7 HL7 Baltimore

  8. Modeling Active Ingredients • 4000 active ingredients & 87,000 NDC level products • Descriptive aspects inherited down the hierarchy to orderable drugs & packaged NDC drug products which contain the active ingredients modeled • Increases modeling efficiency & productivity via “inheritance” HL7 Baltimore

  9. Covering Drugs Ordered in One VAMC (June 2000) • Extracted 488 active NDF-RT ingredient names from sample of ordered drugs • Modeling 488 (12.3%) of all 3977 active ingredients in NDF-RT would cover at least one ingredient in: • 63.7% (7228/11345) of all NDF-RT orderable drugs • 78.2% (68194/87210) of all NDF-RT packaged drugs (NDCs) HL7 Baltimore

  10. Est. Time to Review NDF-RT • Time & motion study • Averaged 12-13 minutes per concept, range 5-30 minutes • Est. throughput = 4 concepts per hour • Approx. 1000 person hours for ~4000 active ingredient concepts in NDF-RT HL7 Baltimore

  11. Upcoming Work • VA Contract awarded 09/2002, to be completed Spring 2003 • NIGMS • Includes support for reference hierarchy development and some human review • Focuses on meeting needs of pharmacogenomic research network HL7 Baltimore

  12. Background: VANew Drug Transaction • Thousands of NDC changes per year • Hundreds of clinical drug changes per year • Tens of New Molecular Entities per year • How to maintain? HL7 Baltimore

  13. VA Formulary Updates: Current Situation • Manual system for review and entry into national formulary • Daily entry, quarterly publication • Multiple sources of data • Commercial KB’s, FDA, trade pubs, requests from field • Local hospitals also can add updates, these are then transmitted monthly to central office for review (workload dependent) HL7 Baltimore

  14. New Drug Transaction Plan • Create an XML message based on publicly available data sources to carry drug information • Develop a semi-automated method and software tool to review and accept new drugs into the formulary HL7 Baltimore

  15. A Little Plan Detail • Multiple “levels”: NDC, Clinical drug, NME • 3 “flavors”: new, change, retire • A single new NDC may cause an upward chain of updates HL7 Baltimore

  16. New Dose Form Example: Copaxone • Generic Name: Glatiramer Acetate • Treats: Multiple Sclerosis • Currently, the only GA packaged drug in NDF-RT is: • GLATIRAMER ACETATE 20MG/ML SYR [NDC: 66914-1009- 1] • Injectable solution • Add: • GLATIRAMER ACETATE 20MG/VIL [NDC: 0480-0126-84] • Powder, lyophilized for solution HL7 Baltimore

  17. Necessary Transaction Steps • “Clinical Drug” is the level of the dose form information • “Dose form” is different (???) because existing NDC is already in solution • Potential new concepts: • Clinical drug concept (???) • NDC-level concept HL7 Baltimore

  18. HL7 Baltimore

  19. HL7 Baltimore

  20. Government Drug Terminology “Partners” Drug Company FDA NCI DEA VA CMS DoD NLM IHS In Place CDC NIGMS PTO HL7 Baltimore Drafted

  21. FDA Labeling • Being created as a Structured Document using HL7 Clinical Document Architecture • Label Warehouse System prototype in development • Selected data to be shared with NLM to help populate RxNorm HL7 Baltimore

  22. NIGMS • Helping develop reference hierarchies, especially pharmacokinetics • Tied to PharmGKB project at Stanford • Thanks to Chris Chute! HL7 Baltimore

  23. NCI Experimental Agents • Approximately 300 agents, ranging from the common to the very experimental • A separate drug class hierarchy, focused on mechanisms of action and specialized anti-neoplastic categories HL7 Baltimore

  24. Vision:Interagency Information Flow for the New Drug Transaction (Off-Label Indications, VA MoA, other VA DSS aggregations, and other usage information) (Approved Drug Information) (FDA+NLM Information) FDA NLM VA NDT Electronic Label HealthePeople& Other Federal Systems (Additional structure information) Non-Federal Users These Flows to be HL7 candidate Standards HL7 Baltimore

  25. Challenges • Delivering drug definitions and reference hierarchies with “face validity” • Managing multi-agency, multi-institution collaboration • Varying needs & expectations • Information model, terminology model, knowledge base interaction HL7 Baltimore

  26. HL7 Baltimore

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