Update: Multilex Drug Knowledge
Base Model and Issues for HL7
Carol Broverman
Director, Healthcare Informatics
First DataBank
HL7 Vocabulary SIG Meeting 1/13/98
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
HL7 Vocabulary SIG Meeting 1/13/98
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.
HL7 Vocabulary SIG Meeting 1/13/98
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 Vocabulary SIG Meeting 1/13/98
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….
HL7 Vocabulary SIG Meeting 1/13/98
Drug Product Variations
Representable in the Multilex DKB Data Model
multiple drugs, non-concurrent
administration
multiple dose forms and routes
multiple dose forms,
concurrent administration
Packaged
Drug
Product
Manufactured
Drug
Manufactured
Drug
Component
Clinical Drug
HL7 Vocabulary SIG Meeting 1/13/98
single drug,
branded product
single drug, nonbranded product
Packaged
Drug
Product
Manufactured
Drug
Clinical
Drug
Generic
Ingredient
Set
Ingredient: a chemical or biological component of a drug.
Ingredient
Comparable NDDF concept: HIC
Generic ingredient set: the set of one or more therapeutically active ingredients present
in a drug. Comparable NDDF concept: HICL
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
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 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
HL7 Vocabulary SIG Meeting 1/13/98
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….
HL7 Vocabulary SIG Meeting 1/13/98
Clarifications (Multilex)
HL7 Vocabulary SIG Meeting 1/13/98
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
HL7 Vocabulary SIG Meeting 1/13/98
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
HL7 Vocabulary SIG Meeting 1/13/98
Clinical
Drug
Therapeutically
Active
Ingredient
exists in
Physical
Dose Form
represented in
Dose Form
Physical State
applicable
at
Dose Form
represented in
Ingredient
Route Set
Dose Form
exists in
Generic
Ingredient Set
represented in
a variation
specified by
Dose Form
Site
Qualification
represents
Route of
Administration
applicable
to
Dose Form
Physical
Modifier
represents
represented in
Dose Form
Physical
Variation
represented in
Site of
Administration
HL7 Vocabulary SIG Meeting 1/13/98
Method of
Administration
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)
HL7 Vocabulary SIG Meeting 1/13/98
ENTITY
DESCRIPTION
ENTITY
long description version
EntityDescription:
support terms,
synonyms, user
preferences, and
cross-vocabulary
mappings (e.g.
UMLS)
short description version
other entity-specific
descriptions
Vocabulary terms:
All entities have
country/language/usagespecific entity descriptions.
Language
in
Country
for
represented
by
Country
for
represented
by
Language
HL7 Vocabulary SIG Meeting 1/13/98
Usage
Type
EXTERNAL
MAPPING
type
version
code_value
Packaged Drug Product (France)
Packaged Drug Description
short description:
“Valium ….”
Product Id: CIP=3111289
long description:
“Valium Roche comprime
secable a 5mg, cpr E/40”
Example :
Diazepam 5MG Tablet,
Oral
Language
in
Country:
for
for
General
Usage
French
represented
by
Usage
Type:
represented
by
Country:
Language:
France
French
HL7 Vocabulary SIG Meeting 1/13/98
Packaged Drug Product (France)
Packaged Drug Description
short description:
“Valium….”
Product Id: CIP=3111289
long description:
“Valium Roche comprime
secable a 5mg, cpr E/40”
Example :
Diazepam 5MG Tablet,
Oral
Language
in
Country:
for
for
French
represented
by
represented
by
Country:
Language:
France
French
HL7 Vocabulary SIG Meeting 1/13/98
EXTERNAL
MAPPING:
type: UMLS
version: 98
code_value:
CUI_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
– Carol_Broverman@firstdatabank.com
HL7 Vocabulary SIG Meeting 1/13/98
Status of Multilex 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
HL7 Vocabulary SIG Meeting 1/13/98
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
HL7 Vocabulary SIG Meeting 1/13/98
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)
HL7 Vocabulary SIG Meeting 1/13/98
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 Vocabulary SIG Meeting 1/13/98
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 Vocabulary SIG Meeting 1/13/98
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
HL7 Vocabulary SIG Meeting 1/13/98
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)
HL7 Vocabulary SIG Meeting 1/13/98
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)
HL7 Vocabulary SIG Meeting 1/13/98
Affected RIM Objects (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…..
HL7 Vocabulary SIG Meeting 1/13/98
Affected RIM Objects (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
HL7 Vocabulary SIG Meeting 1/13/98
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 ??
HL7 Vocabulary SIG Meeting 1/13/98
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 ??
HL7 Vocabulary SIG Meeting 1/13/98
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