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StatusIn progress
Version

1.5

Previous version1.0


Descriptions:

Termdescription typeLanguage/acceptabilityLangaugeLanguage/acceptabilityCase significance

Adverse [finding site] reaction to [agent] (disorder)

FSNus:Pgb:Pci

Adverse [finding site] reaction to [agent]

SYNus:Pgb:Pci

Concept model:

)| OR << 260787004|Physical object (physical object)| OR << 78621006|Physical force (physical force1
Attribute CardinalityAttributeValuerole group numberRole group cardinality
1..1


Scg expression
116680003|Is a (attribute)|



Scg expression
281647001 |Adverse reaction (disorder)|
0


N/A
1..1


Scg expression
246075003|Causative agent (attribute)|



Scg expression
[agent] << 105590001|Substance (substance)| OR << 373873005|Pharmaceutical / biologic product (product
)|


1

..1

0..1


Scg expression
363698007 |Finding site (attribute)|



Scg expression
[finding site] <123037004 |Body structure (body structure)|


Definition status:  

Scg expression
900000000000073002|Defined (core metadata concept)|

Template Language

281647001 |Adverse reaction (disorder)|: [[~1..1]] { [[~0..1]] 363698007 |Finding site (attribute)| = [[+id(< 123037004 |Body structure (body structure)|) @site]], [[~1..1]] 246075003 |Causative agent (attribute)| = [[+id( <<  105590001 |Substance (substance)|  OR <<  373873005 |Pharmaceutical / biologic product (product)|  OR <<  260787004 |Physical object (physical object)|  OR <<  78621006 |Physical force (physical force)|) @agent]] }

Applies to:

Scg expression
<< 282100009 |Adverse reaction caused by substance (disorder)| MINUS <<418634005 |Allergic reaction caused by substance (disorder)|

Editorial guidelines for selection of Causative agent attribute value:

The following editorial guidelines apply to concepts in the International Release; editorial guidelines for concepts in national extensions may vary.

HierarchyConcept
Causative agent typeAllowed
Exception
Examples and Notes (Note: Examples are existing concepts and may not reflect the terming patterns described in the template.)
Substance base
Base
yes
none

Adverse reaction concepts representing a substance base should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|.

Example:

  • 292392003 |Fluphenazine adverse reaction (disorder)|

Expected classification

(Agreed 21-Jan-2020)

:

  • Classification results are expected to be consistent with the modeling of the concept selected as the Causative agent in the Substance hierarchy.
(Agreed 21-Jan-2019)
Substance
Modification
modificationno
yes
, unless documented as exception

Adverse reaction concepts representing a substance modification should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|. Concepts representing substance modifications are exceptions and

could

may be included if

they meeting the following criteria.

the adverse reaction profile is significantly different from the substance base.

Exception examples:

  • Chemical element with multiple modifications (e.g. 422232005 |Calcium lactate gluconate (substance)|)
  • Liposome or lipid complex substances (e.g. 412088006 |Amphotericin B liposome (substance)|, 426490000 |Vincristine liposome (substance)|)
  • Pegylated substance (e.g. 385544005 |Pegfilgrastim (substance)|, 770965008 |Pegvaliase (substance)|)
  • Salt forms (e.g. 412432007 |Metoprolol succinate (substance)|, 72770009 |Metoprolol tartrate (substance)|)
Exceptions: NEED TO ADD CRITERIA

Example:

  • 292389002 |Fluphenazine decanoate adverse reaction (disorder)|
  • 292390006 |Fluphenazine enanthate adverse reaction (disorder)|

Expected classification:

  • Classification results are expected to reflect that the concept modeled with the modified substance is a descendant of the concept modeled with the base substance (if such a concept exists (e.g. 292389002 |Fluphenazine decanoate adverse reaction (disorder)| has inferred parent 292392003 |Fluphenazine adverse reaction (disorder)|).
Multiple substanceyes

Adverse reaction concepts representing multiple substances should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|; preferentially modeling with the base rather than a modification unless the adverse reaction profile is significantly different from the substance base.

Example:

  • 292984002 |Ampicillin and cloxacillin adverse reaction (disorder)|
  • 292987009 |Piperacillin and tazobactam adverse reaction (disorder)|
  • 292989007 |Ticarcillin and clavulanic acid adverse reaction (disorder)|

Expected classification (Agreed 21-Jan-2020):

  • Classification results are expected to be consistent with the modeling of the concept selected as the Causative agent in the Substance hierarchy.
(Agreed 21-Jan-2019)Substance
Disposition grouperyes
none

Adverse reaction concepts representing a disposition grouper should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|.

Example:

  • 293432006 |3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitor adverse reaction (disorder)|
  • 870376001 |Adverse reaction to dopamine receptor agonist (disorder)|

Expected classification results

(Agreed 21-Jan-2020)

:

  • Classification results are expected to
be consistent with the modeling in the Substance hierarchy for concepts modeled with an attribute value from the Substance hierarchy.SubstanceRole grouperno
  • reflect that the adverse reaction concepts are descendants of the appropriate disposition grouper based on the modeling of the 726542003 |Has disposition (attribute)| attribute in the substance hierarchy (e.g. 292113001 |Lansoprazole adverse reaction (disorder)| has inferred parent 292111004 |Proton pump inhibitor adverse reaction (disorder)|).
Role grouperyes
none

Adverse reaction concepts representing a role grouper should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|. Note that role groupers will be transitioned to the 763158003 |Medicinal product (product)| hierarchy in a future release.

Example:

  • 430136001 |Adverse reaction caused by antiparkinsonism drug (disorder)|
  • 292040004 |Analgesic adverse reaction (disorder)|

Expected classification results (Agreed 21-Jan-2020):

  • Classification results are expected to
be consistent with the modeling in the Substance hierarchy for concepts modeled with an attribute value from the Substance hierarchy.ProductRole + Structure groupernoTBD

No use case has been identified for use of this concept type for modeling in this subhierarchy. Existing groupers representing role + structure will be inactivated and replaced with structure grouper. (Agreed 11-Feb-2020)

Example:

  • 292320000 |Barbiturate antiepileptic adverse reaction (disorder)|
  • 292337007 |Barbiturate sedative
    • reflect that the adverse reaction concepts are descendants of the appropriate disposition grouper based on the modeling of the 726542003 |Has disposition (attribute)| attribute in the substance hierarchy (e.g. 292113001 |Lansoprazole adverse reaction (disorder)|
    292916005 |Benzimidazole anthelmintic
    • has inferred parent 292111004 |Proton pump inhibitor adverse reaction (disorder)
    |292343009
    • |
    Benzodiazepine sedative adverse reaction (disorder)|
    • ).

    • Classification results are expected to be consistent with the modeling in the Substance hierarchy for concepts modeled with an attribute value from the Substance hierarchy.
    Substance
    Structure grouperyes
    none

    Adverse reaction concepts representing a structure grouper should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|.

    Example:

    • 218638005 |Adverse reaction caused by hydantoin derivative (disorder)|
    • 419885006 |Beta lactam adverse reaction (disorder)|

    Expected classification (Agreed 21-Jan-2020):

    • Classification results are expected to be consistent with the modeling in the Substance hierarchy and with other existing concepts in the subhierarchy.
    Product or SubstanceBody system groupernonone

    Body system groupers in both the Substance and Product hierarchies will be inactivated in a future release and should no longer be used for modeling in this hierarchy. (Agreed 21-Jan-2020)

    Example:

    293416008 |Drug groups primarily affecting cardiovascular system
    Descendant of 373873005 |Pharmaceutical / biologic product (product)|no, unless documented as exceptionExceptions: None identified

    The following types of groupers are out of scope; existing concepts have been inactivated or will be addressed in future release:

    • Groupers based on more than one role (e.g. 292722006 |Chelating agents and antidotes adverse reaction (disorder)|

    ...

    • )
    • Groupers based on body system or intended site or route of administration (e.g. 292548001 |Drug groups primarily affecting

    ...

    • respiratory system adverse reaction (disorder)|

    ...

    Example:

    • 292984002 |Ampicillin and cloxacillin adverse reaction (disorder)
    • 292267003 |Benserazide + levodopa adverse reaction (disorder)

    Expected classification results: Needs input from Drugs WG - see DRUGS-865

    ...

    • ) or 417895009 |Topical agent adverse reaction (disorder)

    ...

    • |

    ...

    • )

    ...

    • 292968003 |Ampicillin adverse reaction (disorder)| with Causative agent = 387170002 |Ampicillin (substance)|
    • 292963007 |Cloxacillin adverse reaction (disorder)| with Causative agent = 373276005 |Cloxacillin (substance)|

    ...

    • 292266007 |Levodopa adverse reaction (disorder)| with Causative agent = 387086006 |Levodopa (substance)|
    • Note: There is not an existing concept for Adverse reaction to benserazide.

    ...

    Example:

    • 293543001 |Oral glyceryl trinitrate adverse reaction (disorder)
    • 293545008 |Parenteral glyceryl trinitrate adverse reaction (disorder)
    • 293546009 |Transdermal glyceryl trinitrate adverse reaction (disorder)

    Expected classification results: Needs input from Drugs WG - see DRUGS-866

    ...

    • 293542006 |Glyceryl trinitrate adverse reaction (disorder)| with Causative agent = 387404004 |Glyceryl trinitrate (substance)|

    ...

    • 293542006 |Glyceryl trinitrate adverse reaction (disorder)| with Causative agent = 387404004 |Glyceryl trinitrate (substance)|

    ...

    • Groupers based on disposition, role, or structure combined with an individual substance (e.g. 287177000 |Sulfonamide/trimethoprim reaction (disorder)| or 292513008 |Methyldopa and diuretic adverse reaction (disorder)|)
    • Groupers based on "combined" or "compound" substances (e.g. 292983008 |Combined penicillin preparation adverse reaction (disorder)| or 293358005 |Compound iron preparations adverse reaction (disorder)|)
    • Groupers based on disposition or structure combined with intended site or route of administration (e.g. 433494006 |Adverse effect of oral diphosphonate (disorder)|)
    • Groupers based on disposition combined with role (e.g. 292265006 |Dopaminergic drug used in parkinsonism adverse reaction (disorder)|)

    ...

    Rules for description generation:

    1. For the FSN, align terming and case sensitivity with the FSN for the concept that is selected as the attribute value, excluding the semantic tag. 
    2. For the PT, align terming and case sensitivity with the US and GB PT for the concept that is selected as the attribute value.
    3. In cases where neither the US or GB PT matches the FSN, excluding the semantic tag, a synonym corresponding to the FSN is required unless explicitly identified as an exception.
    4. Additional synonyms "[agent] adverse reaction" should be added. Other synonyms are not allowed unless explicitly identified as an exception.

    JIRA ticket for implementation: