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
10/3/2002
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)
10/3/2002
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
10/3/2002
HL7 Baltimore

5. VA NDF RT Chemical Structure Therapeutic Intent VA Drug Class
Active Ingredient
Clinical
Kinetics
Mechanism
Of Action
Drug Component
Clinical Drug
Physiologic
Effect
HL7 Dosage
Form
Packaged (NDC) Drug
10/3/2002
HL7 Baltimore

6. Simplified NDF-RT Model
Chemical Structure
Strength
Dose Form
Route of Adm.
(HL-7)
National Drug
Codes (NDCs)
Structural ID
Active Ingredients
Clinical Drugs
Packaged Drugs
VA Drug Classes
Pharmacokinetics
Physiologic Effect
Mechanism of Action
Database Links
MeSH, CUIs, …
Therapeutic Intent
10/3/2002
HL7 Baltimore

7. NDF-RT Content Drug Hierarchy Initialized from …
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)
10/3/2002
HL7 Baltimore

8. NDF-RT Content Reference Hierarchies Initialized from MeSH & HL7
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
10/3/2002
HL7 Baltimore

9. 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
HL7 Baltimore

10. 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
HL7 Baltimore

11. Est. Time to Review NDF-RT
Time & motion study
Averaged minutes per concept, range 5-30 minutes
Est. throughput = 4 concepts per hour
Approx person hours for ~4000 active ingredient concepts in NDF-RT
10/3/2002
HL7 Baltimore

12. 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
HL7 Baltimore

13. 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
HL7 Baltimore

14. 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
HL7 Baltimore

15. 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
HL7 Baltimore

16. 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
HL7 Baltimore

17. 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: ]
Injectable solution
Add:
GLATIRAMER ACETATE 20MG/VIL [NDC: ]
Powder, lyophilized for solution
10/3/2002
HL7 Baltimore

18. 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
HL7 Baltimore

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HL7 Baltimore

20. 10/3/2002
HL7 Baltimore

21. Government Drug Terminology “Partners”
Drug Company
FDA
NCI VA
DEA
CMS
DoD
NLM
IHS
In Place
CDC
NIGMS
PTO
10/3/2002
HL7 Baltimore
Drafted

22. 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
10/3/2002
HL7 Baltimore

23. NLM RxNorm
See Stuart’s talk
10/3/2002
HL7 Baltimore

24. NIGMS
Helping develop reference hierarchies, especially pharmacokinetics
Tied to PharmGKB project at Stanford
Thanks to Chris Chute!
10/3/2002
HL7 Baltimore

25. 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
10/3/2002
HL7 Baltimore

26. 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
Electronic Label
NDT
HealthePeople& Other Federal Systems
(Additional structure information)
Non-Federal
Users
These Flows to be HL7 candidate Standards
10/3/2002
HL7 Baltimore

27. 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
HL7 Baltimore

28. 10/3/2002
HL7 Baltimore