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StatusIn progress
Version

1.5

Previous version1.0


Descriptions:

Termdescription typeLanguage/acceptabilityLangaugeLanguage/acceptabilityCase significance

Adverse reaction caused by [substance[finding site] reaction to [agent] (disorder)

Is template for 62014003 |Adverse reaction caused by drug (disorder)| managed as part of this template or separately? It is currently a subtype of Adverse reaction caused by 62014003 |Adverse reaction caused by drug (disorder)|. It would be better if they were together since part of the guidelines will be directed towards helping authors determine if concepts should be modeled with a substance vs. product concept.

Existing content has two different terming patterns - need agreement on which is preferred:

  • 292350008 |Alprazolam adverse reaction (disorder)|
  • 218620007 |Adverse reaction caused by naproxen (disorder)|
FSNus:Pgb:Pci

Adverse reaction caused by [substance]

See FSN re: existing patterns

[finding site] reaction to [agent]

SYNus:Pgb:Pci

Concept model:

[substance] 1
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
ExceptionExample - update with final decision re: termingSubstanceBaseyesnone292350008 |Alprazolam adverse reaction (disorder)|
Examples and Notes (Note: Examples are existing concepts and may not reflect the terming patterns described in the template.)
Substance baseyes

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
SubstanceDisposition grouperyesnone292736001 |Opioid antagonist
  • 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.
Modification
Substance modificationno, unless
explicitly
documented as exception
TBDTBDSubstanceStructure grouperyesnone218638005 |Adverse reaction caused by hydantoin derivative (disorder)|ProductDisposition groupernononen/aProductRole grouperyesnoneTBDProductStructure groupernononen/aProductMedicinal product-containingTBDTBDTBDProductMedicinal product-onlyTBDTBDTBDProductMedicinal product form-containingTBDTBDTBDProductMedicinal product form-onlyTBDTBDTBDProductClinical drugnononen/a

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:

  • 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.
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 (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)|.

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.
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 Substance 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 PTs PT for the Substance 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: