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VA Drug Terminology Projects Update: NDF-RT, the New Drug Transaction, And Beyond VA: Steve Brown, Mike Lincoln Apelon: Mark Tuttle, John Carter, Mark.

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Presentation on theme: "VA Drug Terminology Projects Update: NDF-RT, the New Drug Transaction, And Beyond VA: Steve Brown, Mike Lincoln Apelon: Mark Tuttle, John Carter, Mark."— Presentation transcript:

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

2 10/3/2002HL7 Baltimore 2 Overview NDF-RT: Current state and plans New Drug Transaction: Introduction Interagency cooperation update

3 10/3/2002HL7 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)

4 10/3/2002HL7 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) VAs ERT strategy Subject Matter Experts use COTS tools to develop, modify, & maintain enterprise standards Abstracted terminology services

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

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

7 10/3/2002HL7 Baltimore 7 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)

8 10/3/2002HL7 Baltimore 8 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

9 10/3/2002HL7 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 10/3/2002HL7 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)

11 10/3/2002HL7 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

12 10/3/2002HL7 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

13 10/3/2002HL7 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?

14 10/3/2002HL7 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 KBs, FDA, trade pubs, requests from field Local hospitals also can add updates, these are then transmitted monthly to central office for review (workload dependent)

15 10/3/2002HL7 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

16 10/3/2002HL7 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

17 10/3/2002HL7 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

18 10/3/2002HL7 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

19 10/3/2002HL7 Baltimore 19

20 10/3/2002HL7 Baltimore 20

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

22 10/3/2002HL7 Baltimore 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

23 10/3/2002HL7 Baltimore 23 NLM RxNorm See Stuarts talk

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

25 10/3/2002HL7 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

26 10/3/2002HL7 Baltimore 26 Vision: Interagency Information Flow for the New Drug Transaction FDANLM HealthePeople& Other Federal Systems VA (Approved Drug Information) NDT Electronic 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-Federal Users

27 10/3/2002HL7 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

28 10/3/2002HL7 Baltimore 28

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