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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
Base
yes
none
Adverse reaction concepts representing a substance base should 
 preferentially 
 be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|.
Expected classification (Agreed 21-Jan-2020)
Example:
  • 292392003 |Fluphenazine adverse reaction (disorder)|
Expected classification:
  • 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 
 preferentially 
 be modeled using a Causative agent that 
 represents a substance base and 
 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)|)
Expected classification (Agreed 21-Jan-2020)
Example:
  • 292389002 |Fluphenazine decanoate adverse reaction (disorder)|
  • 292390006 |Fluphenazine enanthate adverse reaction (disorder)|
Expected classification:
  • Classification results are expected to 
 be consistent 
  • reflect that the concept modeled with the 
 modeling 
  • modified substance is a descendant of the concept 
 selected as the Causative agent in the Substance hierarchy. (Agreed 21-Jan-2019)
  • 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 
SubstanceDisposition grouperyesnoneAdverse reaction concepts should preferentially 
 be modeled using a Causative agent that is a descendant of 
373873005 |Pharmaceutical / biologic product (product)|. In cases where that is not possible, then a concept from the 105590001 |Substance (substance)| may be used.
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 
Example:
  • NEED EXAMPLE WHERE SUBSTANCE WILL BE USED INSTEAD OF PRODUCT
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 
  • of the concept selected as the Causative agent in the Substance hierarchy.
Product
Disposition grouper
nononeNo 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
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 adverse reaction (disorder)|
  • 292916005 |Benzimidazole anthelmintic adverse reaction (disorder)|
  • 292343009 |Benzodiazepine sedative adverse reaction (disorder)|
yes
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:
  • 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 adverse reaction (disorder)| has inferred parent 292111004 |Proton pump inhibitor adverse reaction (disorder)|).
Role grouperyes
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 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)|).

  • 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.
Structure grouperyes
Adverse reaction concepts representing a structure grouper should be modeled using a Causative agent that is a descendant of 105590001 |Substance (substance)|.
SubstanceStructure grouperyesnone
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.
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. (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:
...
  • ) or 417895009 |Topical agent adverse reaction (disorder)
...
Expected classification results: Needs input from Drugs WG - see DRUGS-865
...
  • |
...
  • )
...
  • Groupers based on disposition, role, or structure combined with an individual substance (e.g. 287177000 |Sulfonamide/trimethoprim reaction (disorder)| or 292513008 |Methyldopa and diuretic 
  • 292968003 |Ampicillin adverse reaction (disorder)| with Causative agent = 387170002 |Ampicillin (substance)|
  • 292963007 |Cloxacillin adverse reaction (disorder)| with Causative agent = 373276005 |Cloxacillin (substance)|
...
  •  adverse reaction (disorder)|
...
  • )
...
Example:
  • Groupers based on "combined" or "compound" substances (e.g. 292983008 |Combined penicillin preparation 
...
  •  adverse reaction (disorder)
...
  • | or 293358005 |Compound iron preparations 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)|
  • 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 
...
  • 293542006 |Glyceryl trinitrate adverse reaction (disorder)| with Causative agent = 387404004 |Glyceryl trinitrate (substance)|
...
  •  adverse reaction (disorder)|
...
  • )
...
No use case has been identified for use of this concept type for modeling in this subhierarchy.
...
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: