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StatusIn progress
Version

1.5

Previous version1.0

Descriptions:

Termdescription typeLanguage/acceptabilityLanguage/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)|  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 typeAllowedExamples 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 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.
Substance modificationno, unless documented as 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:

  • 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:


10 Comments

    1. 218620007 |Adverse reaction caused by naproxen (disorder)| is consistent with naming of other disorders with causative agents.
    2. Should causative agent range be expanded to include physical object and physical force?


  1. I agree that "Adverse reaction caused by [agent]" is consistent with the existing naming convention. The range needs to be expanded to include both Physical object and Physical force because they have been used for the existing content.

    1. Hi Yongsheng Gao

      As noted, this template specifically applies to <<  282100009 |Adverse reaction caused by substance (disorder)| so I'm a bit confused about why we would expand the range for the Causative agent - can you please clarify? I'm still trying to understand the QI project/process so I might missing something.

      Thanks,

      Toni

  2. This touches upon the concern I brought up yesterday in the QI call re. how generic should these templates be. I am wondering why we need  X caused by substance rather than a more general template for X caused by material agent as I am encountering X caused by physical objects and physical forces in my complex association work. In other words would it not be better to have just one template rather than 3?


    Bruce

    1. My concern is that I'm not reviewing those concepts that don't fall under "substance" so I don't know if this template applies or if there are other variables that would need to be considered. I'm trying not to extend the scope of my QI assignment beyond the subhierarchy I'm tasked to work on whilst also trying to understand out the QI process.

      1. Oh I was thinking about this last night but my phone wouldn't let me reply.    The thing that defines the work you're doing is the ticket assigned to you.   Many tickets could potentially refer to the same template, and if we have one template that covers several scenarios without becoming dangerously generic, then that makes everyone's lives easier.   We see this in the Degenerative Disorders where we have many authors breaking those up into separate subhierarchies/tickets but all using the same basic template.

  3. Yes, I agree. The single adverse reaction caused by [agent] would be effective and sufficient since the model would not be different for physical object and physical force. 

  4. Based on feedback, extended range for Causative agent to include Physical object and Physical force. Content using attribute values from these subhierarchies is beyond the scope of the current QI work that I am tasked to complete.

    1. Toni Morrison,

      Looks like you extended the range in the template language but not in the table.

  5. Hi Toni MorrisonYongsheng GaoShould the FSN for this template be Adverse [finding site] reaction caused by [agent] (disorder)? X to Y (as opposed to X caused by Y) imo should only be used for the disposition classes such as allergy to substance where the substance does not directly cause the allergy disposition but rather its realization which is the reaction.