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Descriptions:

Termdescription typeLanguage/acceptabilityLangauge/acceptabilityCase significance

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

FSNus:Pgb:Pci

Adverse [finding site] reaction to [agent]

SYNus:Pgb:Pci

Concept model:

Definition status:  

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:

<<  282100009 |Adverse reaction caused by substance (disorder)|

Editorial guidelines for selection of Causative agent attribute value:

HierarchyConcept typeAllowedExceptionExamples and Notes (Note: Examples are existing concepts and may not reflect the terming patterns described in the template.)
SubstanceBaseyesnone

Adverse 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.

Example:

  • NEED EXAMPLE WHERE SUBSTANCE WILL BE USED INSTEAD OF PRODUCT

Expected classification (Agreed 21-Jan-2020):

  • Classification results are expected to be consistent with the modeling in the Substance hierarchy. (Agreed 21-Jan-2019)
SubstanceModificationnoTBD

Adverse 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.

Example:

  • NEED EXAMPLE WHERE SUBSTANCE MODIFICATION WILL BE USED INSTEAD OF PRODUCT

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 if such a concept exists.
SubstanceDisposition grouperyesnone

Adverse 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.

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 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

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)|
SubstanceStructure grouperyesnone

Example:

  • 218638005 |Adverse reaction caused by hydantoin derivative (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 adverse reaction (disorder)|
  • 292670005 |Drug groups primarily affecting musculoskeletal system adverse reaction (disorder)|
ProductMedicinal product-containingyesnone

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

  • 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 adverse reaction (disorder)| with Causative agent = 373276005 |Cloxacillin (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:
    • 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. (Agreed 21-Jan-2020)
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 input from Drugs WG - see DRUGS-866

  • 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) will be modeled with Causative agent = 346462009 |Product containing glyceryl trinitrate in transdermal dose form (medicinal product form)|
    • 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. (Agreed 21-Jan-2020)
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.


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:


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