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VA Drug Terminology Projects Update: NDF-RT, the New Drug Transaction, And Beyond Presented to VA Drug Terminology Projects Update: NDF-RT, the New Drug Transaction, And Beyond Presented to HL 7 Vocabulary TC Meeting VA: Steve Brown, Mike Lincoln Apelon: Mark Tuttle, John Carter, Mark Erlbaum October 3, 2002 10/3/2002 HL 7 Baltimore

Overview NDF-RT: Current state and plans • New Drug Transaction: Introduction • Interagency cooperation Overview NDF-RT: Current state and plans • New Drug Transaction: Introduction • Interagency cooperation update • 10/3/2002 HL 7 Baltimore 2

Background: VA National Drug File (NDF) • Centrally maintained and distributed, locally modified and Background: VA National Drug File (NDF) • Centrally maintained and distributed, locally modified and deployed. Uses include: • Vist. A 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) 10/3/2002 HL 7 Baltimore 3

NDF Reference Terminology (NDF-RT) • Explicit, multi-hierarchical model • Centered on drug ingredients for 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, HL 7, others) • VA’s ERT strategy • • Subject Matter Experts use COTS tools to develop, modify, & maintain enterprise standards • Abstracted terminology services 10/3/2002 HL 7 Baltimore 4

Simplified NDF-RT Model Structural ID VA Drug Classes Database Links Me. SH, CUIs, … Simplified NDF-RT Model Structural ID VA Drug Classes Database Links Me. SH, CUIs, … Chemical Structure Mechanism of Action Active Ingredients Strength Dose Form Route of Adm. (HL-7) Clinical Drugs Physiologic Effect Pharmacokinetics Therapeutic Intent National Drug Codes (NDCs) 10/3/2002 Packaged Drugs HL 7 Baltimore 6

NDF-RT Content • Drug Hierarchy • 3, 977 Active Ingredients (incl. salts & esters) 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 Rx. Norm Drug Names (Dec 2001) 10/3/2002 HL 7 Baltimore 7

NDF-RT Content • Reference Hierarchies • 3, 994 • • • Diseases & Manifestations 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 HL 7 Dose forms 58 Clinical Kinetics categories Initialized from Me. SH & HL 7 10/3/2002 HL 7 Baltimore 8

Modeling Active Ingredients 4000 active ingredients & 87, 000 NDC level products • Descriptive 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” • 10/3/2002 HL 7 Baltimore 9

Covering Drugs Ordered in One VAMC (June 2000) Extracted 488 active NDF-RT ingredient names 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) 10/3/2002 HL 7 Baltimore 10

Est. Time to Review NDF-RT • Time & motion study • Averaged 12 -13 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 10/3/2002 HL 7 Baltimore 11

Upcoming Work VA Contract awarded 09/2002, to be completed Spring 2003 • NIGMS • 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 10/3/2002 HL 7 Baltimore 12

Background: VA New Drug Transaction Thousands of NDC changes per year • Hundreds of Background: VA New 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? 10/3/2002 HL 7 Baltimore 13

VA Formulary Updates: Current Situation • Manual system for review and entry into national 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) 10/3/2002 HL 7 Baltimore 14

New Drug Transaction Plan Create an XML message based on publicly available data sources 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 • 10/3/2002 HL 7 Baltimore 15

A Little Plan Detail Multiple “levels”: NDC, Clinical drug, NME • 3 “flavors”: new, 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 • 10/3/2002 HL 7 Baltimore 16

New Dose Form Example: Copaxone Generic Name: Glatiramer Acetate • Treats: Multiple Sclerosis • New Dose Form Example: Copaxone Generic Name: Glatiramer Acetate • Treats: Multiple Sclerosis • Currently, the only GA packaged drug in NDFRT is: • • GLATIRAMER ACETATE 20 MG/ML SYR [NDC: 66914 - 1009 - 1] • Injectable solution • Add: • GLATIRAMER ACETATE 20 MG/VIL 84] • Powder, lyophilized for solution 10/3/2002 HL 7 Baltimore [NDC: 0480 -0126 - 17

Necessary Transaction Steps “Clinical Drug” is the level of the dose form information • 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 10/3/2002 HL 7 Baltimore 18

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Government Drug Terminology “Partners” Drug Company FDA NCI VA DEA Do. D CMS IHS Government Drug Terminology “Partners” Drug Company FDA NCI VA DEA Do. D CMS IHS NLM 10/3/2002 NIGMS PTO HL 7 Baltimore CDC In Place 21 Drafted

FDA Labeling Being created as a Structured Document using HL 7 Clinical Document Architecture FDA Labeling Being created as a Structured Document using HL 7 Clinical Document Architecture • Label Warehouse System prototype in development • Selected data to be shared with NLM to help populate Rx. Norm • 10/3/2002 HL 7 Baltimore 22

NIGMS Helping develop reference hierarchies, especially pharmacokinetics • Tied to Pharm. GKB project at NIGMS Helping develop reference hierarchies, especially pharmacokinetics • Tied to Pharm. GKB project at Stanford • Thanks to Chris Chute! • 10/3/2002 HL 7 Baltimore 24

NCI Experimental Agents Approximately 300 agents, ranging from the common to the very experimental 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 antineoplastic categories • 10/3/2002 HL 7 Baltimore 25

Vision: Interagency Information Flow for the New Drug Transaction (Off-Label Indications, VA Mo. A, Vision: Interagency Information Flow for the New Drug Transaction (Off-Label Indications, VA Mo. A, other VA DSS aggregations, and other usage information) FDA (Approved Drug Information) NLM (FDA+NLM Information) Electronic Label (Additional structure information) Non-Federal Users 10/3/2002 HL 7 Baltimore NDT VA Healthe. People& Other Federal Systems These Flows to be HL 7 candidate Standards 26

Challenges Delivering drug definitions and reference hierarchies with “face validity” • Managing multi-agency, multi-institution 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 10/3/2002 HL 7 Baltimore 27

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