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The following editorial guidelines apply to concepts in the International Release; editorial guidelines for concepts in national extensions may vary.

Hierarchy
Concept typeAllowed
Exception
Examples and Notes (Note: Examples are existing concepts and may not reflect the terming patterns described in the template.)
Substance baseyes
noneyes

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 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)
Substance modification
no
yes, only if identified as accepted 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:

  • 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 of the concept selected as the Causative agent in the Substance hierarchy. (Agreed 21-Jan-2019)
Multiple substanceyes
Disposition grouperyes
none

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 (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.
Substance
Role grouperno
none

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 be consistent with the modeling in the Substance hierarchy for concepts modeled with an attribute value from the Substance hierarchy
.ProductRole + Structure groupernoTBDNo 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)|
Substance
Structure grouperyes
none

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 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 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)|

    Rules for description generation:

    ...