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Presented to HL7 Vocabulary TC Meeting VA: Steve Brown, Mike Lincoln

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Presentation on theme: "Presented to HL7 Vocabulary TC Meeting VA: Steve Brown, Mike Lincoln"— Presentation transcript:

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

19 10/3/2002 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

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