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StatusIn progress
Version

1.5

Previous version1.0


Descriptions:

Termdescription typeLanguage/acceptabilityLangaugeLanguage/acceptabilityCase significance

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

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 [finding site] reaction to [agent]

    See FSN re: existing patterns

    		SYNus:Pgb:Pci

    Concept model:

    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 <<   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 
     - update examples to reflect final decision re: terming patternSubstanceBaseyes
    (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)|.
    none
    Example:
    292350008 
    • 292392003 |
    Alprazolam 
    • Fluphenazine adverse reaction (disorder)|
    Expected classification
     results
    :
    • 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
    TBD
    Example:
    Expected classification results:
    SubstanceDisposition grouperyesnone
    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 
    Example:
    292736001 |Opioid antagonist 
    •  adverse reaction (disorder)|
    Expected classification
     results:
    ProductDisposition groupernononeNote: 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 Adverse reaction to disposition grouper concepts.SubstanceRole groupernononeNote: Role groupers in the Substance hierarchy will be inactivated in a future release and should no longer be used for modeling in this hierarchy.ProductRole grouperyesnone
    Example:
    Expected classification results:
    TBD if there are any restrictions on which product roles can be used in modeling in this subhierarchy
    Grouper concepts should represent only a single role; groupers that represent multiple roles (e.g. hypnotic AND/OR sedative or Chelating agents and antidotes) are out of scope.
    SubstanceStructure grouperyesnone
    Example:
    • 218638005 |Adverse reaction caused by hydantoin derivative (disorder)|
    Expected classification:
    ProductStructure groupernononeNote: 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 Adverse reaction to structure grouper concepts.Product or SubstanceBody system groupernononeNote: 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. ADD EXAMPLESProductMedicinal product-containingyesnone
    Example:
    Expected classification results:
    ProductMedicinal product-onlynononeNote: Medicinal product-containing can be used for modeling in the Adverse reaction caused by X subhierarchy. ProductMedicinal product form-containingyesnone
    Example:
    Expected classification results:
    ProductMedicinal product form-onlynononeNote: Medicinal product form-containing can be used for modeling in the Adverse reaction caused by X subhierarchy. 
    ProductClinical drugnononen/a
    :
    • 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 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: