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

Adverse reaction concepts representing a substance base should preferentially 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)
SubstanceModificationnoyes

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 could be included if they meeting the following criteria.

Exceptions: NEED TO ADD CRITERIA

Example:

292389002 |Fluphenazine decanoate 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)
SubstanceDisposition grouperyesnone

Adverse reaction concepts representing a disposition grouper 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:

  • 293432006 |3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitor adverse reaction (disorder)|
  • NEED EXAMPLE WHERE SUBSTANCE WILL BE USED INSTEAD OF PRODUCT870376001 |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.
ProductSubstanceDisposition Role 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)

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 future release.

Example:

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

Expected classification results

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
  • 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 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

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 Structure 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:

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