hl7 vocabulary sig meeting 1/13/98 update: multilex drug knowledge base model and issues for hl7...

HL7 Vocabulary SIG Meeting 1/13/98

Update: Multilex Drug Knowledge Base Model and Issues for HL7

Carol Broverman

Director, Healthcare Informatics

First DataBank


Outline

• What are we trying to do?• What should a drug data model provide and to

whom?• Quick review of the Multilex DKB from 30K FT• Clarifications to model vis-à-vis vocabulary• Identify needs in HL7 2.3 messages• Identify related entities/attributes in V3.0 RIM• Issues we see with Multilex DKB and V3.0 RIM


Focusing on the Need at Hand

• What are we really trying to achieve?– Agree on a vocabulary to support the exchange (and

subsequent use) of information and transactions related to drugs

• How much detail of the models need to be exposed and why?– Expose what is necessary only to evaluate how

resulting vocabulary supports HL7 messaging needs, and provide hooks to applications that will send, receive, share and use information in HL7 messages.


What Does HL7 Need from a Drug Vocabulary?

• Drug concepts and meanings: sound semantic basis• Codes for concepts that are “principled”• Terms for codes that offer synonymy • “Different strokes for different folks:”

concepts/codes/terms at different abstraction levels to support a range of HL7 messaging needs and range of stakeholders

• Internationalization support• Versioning support and assurance of maintenance


HL7 Needs (continued)

• HL7 is middleware: vocabulary provides hooks to applications who are doing the “real work”

• Receiving and sending applications decode and use internally when they HL7 messages with a drug knowledge base of their choice– e.g., Decision support is a demanding application/user

• So… the “external” vocabulary must be based on well-defined internal codes and concepts– ingredient codes, therapeutic classification codes,

relationships, etc….


Drug Product Variations Representable in the MultilexMultilex DKB Data Model

Packaged Drug

Product

Clinical Drug

Manufactured Drug

Component

Manufactured Drug

single drug, non-branded product

single drug, branded product

multiple dose forms, concurrent

administration

multiple dose forms and routesmultiple drugs, non-

concurrent administration


IngredientIngredient

Ingredient: a chemical or biological component of a drug. Comparable NDDF concept: HIC

GenericGenericIngredientIngredient

SetSet

Generic ingredient set: the set of one or more therapeutically active ingredients present in a drug. Comparable NDDF concept: HICL

ClinicalClinicalDrugDrug

Clinical drug: a set of strength-specific therapeutically active ingredients intended in any single clinical circumstance for concurrent administration by one of a set of appropriate potential routes in a specific dose form. Comparable NDDF concept: GCN-SEQNO

ManufacturedManufacturedDrugDrug

Manufactured drug: one or more components which together are intended for concurrent administration. Each component is a specific clinical drug produced by a specific manufacturer. A Manufactured Drug may also optionally include an associated drug device. Most Manufactured Drugs are single-component. Comparable NDDF concept: Core-9 NDC

Packaged Packaged DrugDrug

ProductProduct

Packaged drug product: a marketed drug product as it is packaged by a specific manufacturer and sold in a specific country; contains one or more manufactured drugs. Comparable NDDF concept: NDC


Which Levels Matter Most for HL7?

• Clinical drug (aka “generic formulation”)• Packaged drug product• Manufactured drug??

• Others: dose form, route, classification scheme codes

• More on this later….


Clarifications (Multilex)


Why does a Clinical Drug Specify a Set of Routes?

• Clinical drug: a set of strength-specific therapeutically active ingredients intended in any single clinical situation for concurrent administration by one of a set of appropriate potential routes in a specific dose form.

• A drug is a static entity. It is associated with a set of appropriate routes by which that drug may be administered when being used to treat a patient

• The actual route is part of the order


Multilex Route and Dose Form Representation: Why?

• Routes are fully defined by a site of administration and a method of administration

• Site and method are related and form an association -- route is a composite entity

• Dose Form is related to route through the site of administration since they constrain each other

• Similar (but not quite) to HL7 PtRoute– more on this later


Route ofAdministration

Method ofAdministration

Site ofSite ofAdministrationAdministration

a variationspecified byPhysicalPhysical

Dose FormDose Form

applicableto

Dose FormDose FormPhysicalPhysicalModifierModifier

Dose FormDose Form

Dose FormDose FormPhysical StatePhysical State

exists in

represented in

Dose FormDose FormSiteSite

QualificationQualification

GenericIngredient Set

IngredientClinicalDrug

Dose Form Route SetTherapeutically

ActiveIngredient

applicableat

represented in

exists in

represented in

represents

represented in

Dose FormDose FormPhysicalPhysicalVariationVariation

representsrepresented in


Synonyms and Mappings (e.g.UMLS)

• Each entity has 1+ entity descriptions attached• Country-language specific• Usage type and external mapping links to each

entity description can indicate whether terms are used to:– record lexical synonymy

– record usage preference synonymy

– record mappings to UMLS (or other vocabulary identifiers)


for

ENTITY

for

ENTITYDESCRIPTION

LanguageLanguageinin

CountryCountry

represented

by

represented

by

CountryCountry LanguageLanguage

UsageUsageTypeType

long description version

short description version

other entity-specificdescriptions

Vocabulary terms:

All entities have country/language/usage-

specific entity descriptions.

Vocabulary terms:

All entities have country/language/usage-

specific entity descriptions.

EntityDescription:support terms,

synonyms, user preferences, and cross-vocabulary

mappings (e.g. UMLS)

EntityDescription:support terms,

synonyms, user preferences, and cross-vocabulary

mappings (e.g. UMLS)

EXTERNAL MAPPING

typetypeversionversion

code_valuecode_value


for

Packaged Drug Product (France)

Product Id: CIP=3111289

for

Packaged Drug Description


Country:Country:

FrenchFrench

representedby

representedby

Country:Country:

FranceFrance

Language:Language:

French French

short description: “Valium ….”

long description:

“Valium Roche comprime secable a 5mg, cpr E/40”

Example :Diazepam 5MG Tablet,

Oral


Oral

UsageUsageType:Type:

General General UsageUsage


for

Packaged Drug Product (France)

Product Id: CIP=3111289

for

Packaged Drug Description


Country:Country:

FrenchFrench

representedby

representedby

Country:Country:

FranceFrance

Language:Language:

French French

short description:“Valium….” long description:“Valium Roche comprime secable a 5mg, cpr E/40”


Oral


Oral

EXTERNAL EXTERNAL MAPPINGMAPPING::

typetype: UMLS: UMLSversion: version: 9898code_value: code_value: CUI_123CUI_123


Full Presentation of Model

• As presented to HL7 in August 1997– http://www.mcis.duke.edu/standards/HL7/pubs/

minutes/9708 --- download multilex.zip

• Current Multilex DKB incorporating feedback thus far from customers and standards community– http://www.firstdatabank.com after this week

– [email protected]


Status of MultilexMultilex DKB

• Currently building 4 international databases as Alpha Test: Belgium, Ireland, France, Germany

• Sample U.S. test DKB delayed due to some redesign and resource limitations but will be on web site ~2Q98

• USA version, including Clinical Modules, slated for availability to limited set of customers late 1998

• Feedback still welcomed and solicited


Explicit HL7 Needs

• Clinical Drug (aka Generic Formulation)• Packaged Drug Product

– Sometimes Manufactured Drug?

• Dose Form• Route

• Therapeutic classification codes, pharmaceutical classification codes needed for Master Tables


Relevant 2.3 HL7 messages

• ORC (Common order segment) may contain:– codes of interacting substances

– levels of severity of interaction (should we tackle standardizing this vocabulary too?)

• ORM (pharm tx order msg)– RXO (pharm tx segment)

• requested_give_code (identify for drug…. Clinician level?)

• requested_dispense_code (transformation of order)


Relevant HL7 2.3 Messages

• ORM (pharm tx order msg continued)– RXR (pharm tx route segment)

• route + site + admin_device + admin_method

• route (1st component) may imply the others, or may not… optionality may go away in 3.0

• We believe site and method are interrelated

– RXC (pharm tx component order)• component_id for either base or additive


HL7 2.3 Issues

• RDE/RRE (pharm tx encoded order message)– comes from pharmacy

– RXE segment (pharm tx encoded order segment)• this is at the package level: includes pkg size

• RDS/RRD (pharm tx dispense msg)– Would be routed to nursing app -- already know what’s

dispensed -- packaged product level

– RXD (pharm tx dispense segment)• has lot number, pkg size, manufacturer

– RXG (pharm tx give segment) -- also package attributes


HL7 2.3 Issues

• RAS/RRA (pharm tx administration msg)– msg created by nursing app and fed to order app or

pharm -- data used to generate medication administration reports (MAR)

• Summary: – More analysis to be done

– Clear motivation for needing different levels of drug identification to support application and messaging needs


Affected 3.0 RIM Objects

• Master_service– universal_service_id

– universal_service_identifier_coding_scheme_name

– universal_service_identifier_name

– procedure_medication_cd

• Master_treatment_service– dea_level_cd

– drug_category_cd

– medication_form_cd (continued on next page)


Affected RIM Objects (continued)

• Master_treatment_service (continued)– Pharmaceutical_class_cd

– route_cd

– therapeutic_class_cd

• Patient_service_order– service_body_site_cd

– service_body_site_modifier_code

– service_body_source_code

(continued)



• Treatment_service_dispense– dispense_package_size_amount (not a code though)

– dispense_Ptcomp

– dispense Ptroute

– indication_cd (comes from other vocab source)

– substance_manufacturer_cd

• continued…..



• Treatment_service_order– indication_cd (from other vocab)

– requested_give_strength_amt (may be code or structured)

• Treatment_service_order_revision– order_revision_Ptcomp

– order_revision_Ptrout

– ordered_administration_method_cd


Issues for the 3.0 RIM

• Identifiers for master_treatment_service id (drug) may be at different levels

• HL7 PTRoute includes device….. Why? (mismatch)• Clarify pharmaceutical_class_cd, therapeutic_class_cd,

and drug_category_code… ???• Shouldn’t dose form and route(s) be interdependent• Dea_level_code is U.S. specific• Clarify Dispense_PtComp -- only base and additive?• Service_body_source_code versus service_body_site_code ??


UMLS Issues

• From stated goals: “… meaning and use of drug codes and vocabulary as used in HL7 messages may be stated against concepts in the Metathesaurus”

• This may not be possible with Clinical Drug (Generic Formulation) only since many messages and use cases are at the packaged level and these will not be in the UMLS.– Send CUI^<vendor_pkg_level_id>^<version>^term ??


Next Steps

• Need feedback from Orders and Results to make sure we understand the issues/use cases and are in sync– Subgroup from vocabulary/medications and O&R

• Need to work with RIM harmonization group – Subgroup from vocabulary/medications

• Unify vendor perspectives – Reps from different vendors with VocabSIG oversight

• Get in sync with other SDO’s needs -- NCPDP?

hl7 vocabulary sig meeting 1/13/98 update: multilex drug knowledge base model and issues for hl7...

Documents

drug vocabulary

drug product manufactured

hl7 vocabulary sig meeting

drug concepts

specific clinical drug

hl7 messages

hl7 need

marketed drug product