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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.
Causative agent 
HierarchyConcept 
 typeAllowed
Exception
Examples and Notes (Note: Examples are existing concepts and may not reflect the terming patterns described in the template.)
Substance base
Baseyesnone
yes
Adverse reaction concepts representing a substance base should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|.
Example:
292350008 
  • 292392003 |
Adverse 
  • Fluphenazine adverse reaction 
 to alprazolam 
  •  (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
Modification
no
TBD
Example:
, 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 may be included if 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)|)
Example:
292392003 |Fluphenazine adverse reaction (disorder)|
  • 292389002 |Fluphenazine decanoate adverse reaction (disorder)|
  • 292390006 |Fluphenazine enanthate adverse reaction (disorder)|
Expected classification
 (Agreed 21-Jan-2020)
:
  • Classification results are expected to 
 be consistent with the modeling in the Substance hierarchy based on the Is modification attribute and with other existing concepts in the subhierarchy. Concepts modeled using a modification should have the concept modeled using the base as an inferred parent 
  • 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)|
 will 
  • ).
Multiple substanceyes
Adverse reaction concepts representing multiple substances should be modeled 
 with 
using a Causative agent 
 = 372730004 |Fluphenazine 
that is a descendant of 105590001 |Substance (substance)|
 and will have the following inferred descendants:
; 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 

292389002 |Fluphenazine decanoate 
  •  adverse reaction (disorder)|
 with Causative agent = 396063006 |Fluphenazine decanoate (substance)|
  • 292987009 |Piperacillin and tazobactam 
292390006 |Fluphenazine enanthate 
  •  adverse reaction (disorder
)| with Causative agent = 111125005 |Fluphenazine enanthate (substance
Example:
292736001 |Opioid antagonist 
  • )|
SubstanceDisposition grouperyesnone
  • 292989007 |Ticarcillin and clavulanic acid 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.ProductDisposition groupernononeNo use case has been identified for use of this concept type for modeling in this subhierarchy. Disposition groupers in the Product hierarchy should only exist as SD concepts with a corresponding concept in the Substance hierarchy;  the corresponding concept in the Substance hierarchy should be used for modeling in this subhierarchy. (Agreed 21-Jan-2020)SubstanceRole groupernonone
Role groupers in the Substance hierarchy will be inactivated in a future release and should not be used for modeling in this subhierarchy. (Agreed 21-Jan-2020)
Insert examples of role grouper.
ProductRole grouperyesnone
Example:
Expected classification results:
TBD if there are any restrictions on which product roles can be used in modeling in this subhierarchy
SubstanceStructure grouperyesnone
Example:
  • of the concept selected as the Causative agent in the Substance hierarchy.
Disposition grouperyes
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 
218638005 |Adverse reaction caused by hydantoin derivative 
  •  (disorder)|
Expected classification results:
  • Classification results are expected to 
 be consistent with the modeling in the Substance hierarchy and with other existing concepts in the subhierarchy. (Agreed 21-Jan-2020)ProductStructure groupernononeNo use case has been identified for use of this concept type for modeling in this subhierarchy. Structure groupers in the Product hierarchy should only exist as SD concepts with a corresponding concept in the Substance hierarchy; the corresponding concept in the Substance hierarchy should be used for modeling in this subhierarchy. (Agreed 21-Jan-2020) 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. NEEDS INTERNAL AGREEMENT - agreed to inactivate these concepts.
Example:
293416008 |Drug groups primarily affecting cardiovascular system 
  • 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)| 
292670005 |Drug groups primarily affecting musculoskeletal system 
  • has inferred parent 292111004 |Proton pump inhibitor adverse reaction (disorder)|).
Role grouper
ProductMedicinal product-containingyesnone
yes
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 
Example:
  • 292984002 |Ampicillin and cloxacillin adverse reaction (disorder)
    • 292267003 |Benserazide + levodopa 
    •  adverse reaction (disorder)|
    Expected classification results 
    : NEEDS INTERNAL AGREEMENT - further discussion needed with Drug Project Group re: expectations for classification
    (Agreed 21-Jan-2020):
    • Classification results are expected to 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 
    292984002 |Ampicillin and cloxacillin adverse reaction (disorder) will be modeled with Causative agent = 346320003 |Product containing ampicillin and cloxacillin (medicinal product)| and will have the the following inferred parents:292968003 |Ampicillin 
    •  adverse reaction (disorder)| 
     with Causative agent = 387170002 |Ampicillin (substance)|292963007 |Cloxacillin 
    • has inferred parent 292111004 |Proton pump inhibitor adverse reaction (disorder)|).

    • Classification results are expected to be consistent with the modeling in the Substance hierarchy for concepts modeled with 
     Causative agent = 373276005 |Cloxacillin 
    • an attribute value from the Substance hierarchy.
    Structure grouperyes
    Adverse reaction concepts representing a structure grouper should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|.
    292267003 |Benserazide + levodopa adverse reaction (disorder) will be modeled with Causative agent = 418467003 |Product containing benserazide and levodopa (medicinal product)| and will have the following inferred parents:
    Example:
    • 218638005 |Adverse reaction caused by hydantoin derivative (disorder)|
    • 419885006 |Beta lactam 
    292266007 |Levodopa 
    •  adverse reaction (disorder)|
     with Causative agent = 387086006 |Levodopa (substance)|
  • Note: There is not an existing concept for Adverse reaction to benserazide.
    • ProductMedicinal product-onlynononeNo use case has been identified for use of this concept type for modeling in this subhierarchy. Medicinal product-containing concepts can be used for modeling in this subhierarchy.ProductMedicinal product form-containingyesnone
    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 INTERNAL AGREEMENT - further discussion needed with Drug Project Group re: expectations for classification
    • 293543001 |Oral glyceryl trinitrate adverse reaction (disorder) will be modeled with Causative agent = 346460001 |Product containing glyceryl trinitrate in oral dose form (medicinal product form)| and will have the following inferred parents:
      • 293542006 |Glyceryl trinitrate adverse reaction (disorder)| with Causative agent = 387404004 |Glyceryl trinitrate (substance)|
    • 293545008 |Parenteral glyceryl trinitrate adverse reaction (disorder) will be modeled with Causative agent = 346461002 |Product containing glyceryl trinitrate in parenteral dose form (medicinal product form)| and will have the following inferred parents:
      • 293542006 |Glyceryl trinitrate adverse reaction (disorder)| with Causative agent = 387404004 |Glyceryl trinitrate (substance)|
    • 293546009 |Transdermal glyceryl trinitrate adverse reaction (disorder)
      • 293542006 |Glyceryl trinitrate adverse reaction (disorder)| with Causative agent = 387404004 |Glyceryl trinitrate (substance)|
    ProductMedicinal product form-onlynononeNo use case has been identified for use of this concept type for modeling in this subhierarchy. Medicinal product form-containing concepts can be used for modeling in this subhierarchy.
    ProductClinical drugnonone
    No use case has been identified for use of this concept type for modeling in this subhierarchy.
    Extension model may provide sufficient use case for this.

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