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VA Drug Terminology Projects Update:VA Drug Terminology Projects Update: NDF-RT, the New Drug NDF-RT, the New Drug
Transaction, And BeyondTransaction, And Beyond
VA: Steve Brown, Mike Lincoln
Apelon: Mark Tuttle, John Carter, Mark Erlbaum
October 3, 2002
Presented to HL7 Vocabulary TC Meeting
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OverviewOverview
• NDF-RT: Current state and plans• New Drug Transaction: Introduction• Interagency cooperation update
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Background:Background:VA National Drug File (NDF)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)
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NDF Reference Terminology NDF Reference Terminology (NDF-RT)(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
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Simplified NDF-RT ModelSimplified NDF-RT Model
Chemical Structure
StrengthDose Form
Route of Adm.(HL-7)
National DrugCodes (NDCs)
Structural ID
Pharmacokinetics
Physiologic Effect
Mechanism of Action
Database Links MeSH, CUIs, …
Therapeutic Intent
Active Ingredients
Clinical Drugs
Packaged Drugs
VA Drug Classes
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NDF-RT ContentNDF-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)
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NDF-RT ContentNDF-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
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Modeling Active IngredientsModeling 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”
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Covering Drugs Ordered in Covering Drugs Ordered in One VAMC (June 2000)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)
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Est. Time to Review NDF-RTEst. 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
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Upcoming WorkUpcoming 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
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Background: VABackground: VANew Drug TransactionNew 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?
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VA Formulary Updates: VA Formulary Updates: Current SituationCurrent 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)
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New Drug Transaction PlanNew 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
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A Little Plan DetailA 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
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New Dose Form Example: New Dose Form Example: CopaxoneCopaxone
• 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
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Necessary Transaction StepsNecessary 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
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Government Drug Terminology Government Drug Terminology “Partners”“Partners”
NCI FDADrug Company
PTO
VA
DoD CMS
CDC
NLM
DEA
NIGMS
IHS
Drafted
In Place
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FDA LabelingFDA 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
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NIGMSNIGMS
• Helping develop reference hierarchies, especially pharmacokinetics
• Tied to PharmGKB project at Stanford• Thanks to Chris Chute!
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NCI Experimental AgentsNCI 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
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Vision:Vision:Interagency Information Flow for the Interagency Information Flow for the
New Drug TransactionNew Drug Transaction
FDA NLM
HealthePeople& Other Federal
Systems
VA
(Approved Drug
Information)
NDTElectronic Label
(FDA+NLM Information)
(Off-Label Indications, VA MoA, other VA DSS aggregations, and other usage information)
(Additional structure information)
These Flows to be HL7 candidate Standards
Non-FederalUsers
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ChallengesChallenges
• 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
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