Observable and Investigation Model Project

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Overview

The following modeling and terming guidelines apply to concepts in the International Release; editorial guidelines for concepts in national extensions will be documented separately.The

Clinical Drug "containing precisely" (CD) concept is an abstract representation of the precise active ingredient(s), BoSS, strength, and pharmaceutical dose form for a medicinal product. It means that the medicinal product must contain only the precise active ingredient(s) specified in the FSNA diagnostic product is a product with substance ingredients used in the diagnostic process, to aid the observation of phenomena which might otherwise be hard or impossible to observe. A typical example of a diagnostic product is the antibiotic product used in susceptibility testing, which is distinct from the pharmaceutical antibiotics products used for infection treatment of patients.

Example:

  • Product containing precisely abacavir 300 milligram/1 each conventional release oral tablet (clinical drugamoxicillin and clavulanic acid, test disc (diagnostic product)
  • Product containing precisely abacavir 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drugamoxicillin 20 microgram and clavulanic acid 10 microgram, test disc (diagnostic product)
  • Product containing precisely amoxicillin and clavulanic acid, etest strip (diagnostic product)
  • Product containing precisely amoxicillin and clavulanic acid, 2 : 1 ratio, etest strip (diagnostic product)
  • Product containing precisely streptomycin 2 microgram/milliliter (diagnostic product abacavir 300 milligram and lamivudine 150 milligram and zidovudine 300 milligram/1 each conventional release oral tablet (clinical drug)

Modeling

CD concepts representing discrete solid dose forms Diagnostic products concepts shall be modeled using the proximal primitive modeling pattern ("full modeling pattern."??)

Exceptions: none identified

Stated parent concept
763158003|Medicinal product (product)

xxx|Diagnostic product (product)|

Possibly also 63653004 | Biomedical device (physical object) | or xxx|Diagnostic product| is also a descendant of 63653004 | Biomedical device (physical object) |. Cf. <<411115002 | Drug-device combination product (product) |

E.g. 708548003 | Test strip (physical object) |

  • Exceptions: none identified
Semantic tag(
clinical drug
diagnostic product)
Definition status

900000000000073002 | Sufficiently defined concept definition status (core metadata concept)

  • Exceptions: none identified

Attribute:

Has

manufactured dose form

count of base of active ingredient

  • Range:
736542009
  • <260299005 |
Pharmaceutical dose form (dose form)
  • Number (qualifier value) | - descendants only
  • NOTE: While the allowed range for this attribute is broader, the Clinical Drug - Discrete Solid Dose Form concepts should only use descendants of 736542009 | Pharmaceutical dose form (dose form), excluding grouper concepts based on intended site (e.g. 740596000 |Cutaneous dose form (dose form)|, 385268001 |Oral dose form (dose form)|).
  • Exceptions: none identified
    • Cardinality: 1..1 0 for groupers?

    Attribute:

    Has manufactured dose form

    DO WE NEED TO REPRESENT THE PHYSICAL FORM, E.G. TEST DISC, STRIP, FLUID, ETC?? LOINC uses method axis for this information, e.g. Gradient strip.

  • Cardinality: 1..1
    • Attribute value must represent the manufactured dose form

    Attribute:

    Has unit of presentation

  • Range: 732935002 | Unit of presentation (unit of presentation) - descendants only
    • Exceptions: none identified
    • Cardinality: 1..1

  • Attribute value must represent the basic manufactured dose form


    • Relationship group

     One relationship group containing one instance of each of the following attributes is required for each precise active ingredient.

    • |Has precise active ingredient|
    • Range:
    105590001|Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, roles, and combined substances
  • Cardinality: 1..1 per relationship group
    • |Has basis of strength substance|
    Range: 105590001|
    • <105590001|Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, roles, and combined substances
    • Cardinality: 1..1 per relationship group
    • |Has presentation strength numerator value|
    • Range:
    260299005
    • <260299005|Number (qualifier value)
    • Cardinality:
    1
    • 0..1 per relationship group

    Product strength normalization for metric units:

    • Use picogram if value is <1000; if if > then convert to nanogram
    • Use nanogram if value is <1000; if > then convert to microgram
    • Use microgram if value is <1000; if > then convert to milligram
    • Use milligram if value is <1000; if > then convert to gram

    Product strength normalization for units:

    • Use million unit if value is >1000000 unit

    The following units are not allowed unless specifically noted as an exception:

    • 408165007 |Mega u (qualifier value)|
    • |Has presentation strength numerator unit|
    • Range:
    258666001
    • <258666001|Unit (qualifier value) - descendants only
    • Cardinality:
    1
    • 0..1 per relationship group. 0 to allow representation of ratios, if needed. Or use xxx | Unit one |?
    • |Has presentation strength denominator value|

    Needed?

    • Range:
    260299005
    • <260299005|Number (qualifier value)
    • Cardinality:
    1
    • 0..1 per relationship group
  • For this pattern the attribute value must be 38112003 |1 (qualifier value)|
    • Note: the
    • denominator
    strength value is required for concepts in the International Release even if the value = 1 because including denominators for only some concepts negatively affects the classification results.|Has presentation strength denominator
    • unit|
    • Range:
    732935002
    • <732935002|Unit of presentation (unit of presentation) - descendants
    onlyNOTE: While the allowed range for this attribute is broader, the Clinical Drug - Discrete Solid Dose Form concepts should
    • only
    use descendants of 732935002|Unit of presentation (unit of presentation).
      • Exceptions: none identified
    • Cardinality:
    1
    • 0..1 per relationship group

    Terming

    FSN

    Use the following pattern for the FSN; align terming and case sensitivity with the FSN for the concepts that are selected as the attribute value. For multiple ingredient

    drug

    diangostic products, the

    BoSS

    ingredients must be in alphabetical order and separated by the word “and”.

    Single

    ingredient with BoSS = Precise active

    ingredient:

    • Product containing precisely
    <BoSS
    • <Precise active ingredient FSN> [<Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>
    /1 each
    • [/<Presentation strength denominator unit>]] each [<Manufactured dose form FSN>] (
    clinical drug
    • diagnostic product)

    Example:

    • Product containing precisely
    abacavir 300 milligram/1 each conventional release oral tablet (clinical drug)
  • Product containing precisely abacavir 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drug)
  • Product containing precisely abacavir 300 milligram and lamivudine 150 milligram and zidovudine 300 milligram/1 each conventional release oral tablet (clinical drug)
    • streptomycin 2.0 microgram/milliliter (diagnostic product)

    Multi

    Single ingredient with BoSS <> Precise active

    ingredient:

    • Product containing precisely
    <BoSS FSN> (as
    • <Precise active ingredient
    FSN>)
    • FSN 1> [<Presentation strength numerator value
    FSN>
    • FSN 1> <Presentation strength numerator unit
    FSN>/1 each <Manufactured dose form FSN> (clinical drug)

    Example:

    • Product containing precisely doxazosin (as doxazosin mesylate) 4 milligram/1 each conventional release oral tablet
    • Product containing precisely disopyramide (as disopyramide phosphate) 150 milligram/1 each prolonged-release oral capsule
    Preferred Term

    Preferred Term should reflect US/GB Preferred Terms consist with the component concepts (e.g. presentation strength numerator unit, precise active ingredient, manufactured dose form).

    Exceptions: none identified.

    Single ingredient with BoSS = Precise active ingredient:

    • <BoSS PT> <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <manufactured dose form PT>

    Exception:

    The following units of measure should not be abbreviated in descriptions; they should alwasy be spelled out:
  • international unit
  • microgram
  • million unit
  • nanogram
    • unit

    Example:

    • FSN 1>[/<Presentation strength denominator unit 1>]] and ... <Precise active ingredient FSN n> [[<Presentation strength numerator value FSN n> <Presentation strength numerator unit FSN n>[/<Presentation strength denominator unit n>]], [<Manufactured dose form FSN>] (diagnostic product)

    Example:

    • Product containing precisely amoxicillin and clavulanic acid, test disc (diagnostic product)
    • Product containing precisely amoxicillin 20 microgram and clavulanic acid 10 microgram, test disc (diagnostic product)
    Preferred Term
    • Abacavir 300 mg oral tablet
    • Abacavir 600 mg and lamivudine 300 mg oral tablet
    • Abacavir 300 mg and lamivudine 150 mg and zidovudine 300 mg oral tablet

    Single ingredient with BoSS <> Precise active ingredient:

    • <BoSS PT> (as <Precise active ingredient PT>) <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <manufactured dose form PT>

    Example:

  • Doxazosin (as doxazosin mesylate) 4 mg oral tablet
    • Disopyramide (as disopyramide phosphate) 150 mg prolonged-release oral capsule


    Synonyms

    Synonyms corresponding to the FSN are not allowed unless explicitly identified as an exception.

    • Exceptions: Existing instances of synonyms exactly matching the FSN will be retained until time and opportunity allows for their removal. Note that not all language reference set variations of the FSN were included as synonyms.

    Additional synonyms are not allowed unless explicitly identified as an exception.

    • Exceptions: none identified

    Exemplars

    The following illustrates the stated view:

    ...