SNOMED CT Editorial Guide

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Overview

The Clinical Drug "containing precisely" (CD-precise) concept is an abstract representation of the precise active ingredient, basis of strength substance (BoSS), strength, and manufactured dose form of a drug product. It implies that the drug product must contain only the precise active ingredient(s) specified in the FSN.

Modeling for concepts representing continuous dose forms

CD-precise concepts shall be modeled using the proximal primitive modeling pattern.

CD-precise concepts representing continuous dose Clinical drugs representing continuous dose form (e.g., solutions, suspensions, creams, ointments, patches)  will be are modeled using concentration strength attributes; presentation strength attributes are not allowed for these concepts in the International Release.Example:

For example,

    • Product containing precisely zidovudine 10 milligram/1 milliliter conventional release oral solution (clinical drug)
    • Product containing precisely amikacin (as amikacin sulfate) 250 milligram/1 milliliter conventional release solution for injection (clinical drug)
    • Product containing precisely clotrimazole 10 milligram/1 gram conventional release cutaneous cream (clinical drug)
    • Product containing precisely mupirocin (as mupirocin calcium) 20 milligram/1 gram conventional release nasal ointment (clinical drug)
    • Product containing precisely buprenorphine 70 microgram/1 hour prolonged-release transdermal patch (clinical drug)

The following exceptions have been identified.

  • Concepts with product strength that is "not equal to"
    • These concepts will be modeled as primitive, with attributes added as described in the following sections, except that strength numerator attributes will not be added.
    • These concepts will have the appropriate Medicinal Product Form-only (MPF-only) concept as an inferred parent.

Modeling

Stated parent concept
Stated parent

763158003 |Medicinal product (product)|

Semantic tag(clinical drug)
Definition status

Defined

Exception

900000000000073002 |Sufficiently defined by necessary conditions definition status (core metadata concept)|

Exceptions

:

    • Concepts with product strength that is "not equal to" (e.g. with product strength expressed as a range, greater than, or less than)
    • will have definition status 900000000000074008 |Necessary but not sufficient concept definition status (core metadata concept)
    • are primitive

Attribute:

Has manufactured dose form

Range: 736542009 |Pharmaceutical dose form (dose form)|

      • NOTE: While the allowed range for this attribute is broader, the CD-precise continuous dose from concepts should only use descendants of 736542009 <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)|).

Cardinality: 1..1

The attribute value should represent the manufactured dose form

Notes:

  • Concepts with dose form of drops will be modeled in the International Release with general Pharmaceutical dose form concepts (e.g. 385018001 |Conventional release oral drops (dose form)|).
      • More specific Pharmaceutical dose form concepts (e.g. 385019009 |Conventional release solution for oral drops (dose form)|) will be available for use to model content in national extensions.

    • Powder and granules for oral suspension, solution, etc., may be modeled using concentration strength and the administrable dose form (e.g. 1145409004 |Product containing precisely amoxicillin 25 milligram/1 milliliter and clavulanic acid (as clavulanate potassium) 6.25 milligram/1 milliliter conventional release oral suspension (clinical drug)|)

    Attribute:

    Count of base of active ingredient (attribute)

    Concrete Type: Integer

    Range: >#0..

    Cardinality: 1..1

    Relationship groupOne relationship group containing one instance of each of the following attributes is required for each precise active ingredient.
    • Has precise active ingredient

    Range: 105590001 <105590001 |Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, or combined substances

    Cardinality: 1..1 per relationship group

    Notes:

    • The Precise Active Ingredient (PAI) cannot be modeled as a substance hydrate or solvate unless the BoSS is expressed as a hydrate or solvate.
    • Concepts containing pancreatic enzymes will be modeled based on the discrete enzymes; because of variability between real clinical drugs, synonyms representing a total amount in a particular product will not be included in the International Release.
    • Has basis of strength substance

    Range: 105590001   <105590001 |Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, or combined substances

    Cardinality:  1..1 per relationship group

    • Has concentration strength numerator value

    Concrete Type:  Decimal

    Range: >#0  >#0..

    Cardinality:  1..1 per relationship group

    Expression of product strength in metric units is preferred.

    To avoid semantically equivalent concepts, product strength for metric units are normalized as follows:

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

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

    • To avoid semantically equivalent concepts, product strength for units are normalized as follows:

    • 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)|

    Repeating decimals are rounded to three decimal places (with 5 and above rounded up and 4 and below rounded down).

    • Has concentration strength numerator unit

    Range: 767524001 <767524001 |Unit of measure (qualifier value)| - descendants only

    Cardinality: 1..1 per relationship group

    • Has concentration strength denominator value

    Concrete Type: Decimal

    Range: >#0..

    Cardinality: 1..1 per relationship group

    For this pattern, the attribute value must be 38112003 |1 (qualifier value)|1.

    The Note: the denominator strength value is required for concepts in the the International Release even though the value = 1, because including denominators for only some concepts negatively affects the classification results.

    • Has concentration strength denominator unit

    Range: 767524001   <767524001 |Unit of measure (qualifier value)| - descendants only

    Cardinality:  1..1 per relationship group


    For Clinical drug concepts with:

    • liquid dose form, : the denominator unit should be 258773002 be 258773002 |Milliliter (qualifier value)|.
    • For Clinical drug concepts with semi-solid dose form, : the denominator unit should be be
      Concept
      t258682000 |gram (qualifier value)|
      for weight/weight concentration and 258773002 and 258773002 |Milliliter (qualifier value)| for weight/volume concentration. Representing semi  Representing semi-solid dose forms in weight/weight concentration is preferred.

    Naming

    ...

    Use one of the following

    ...

    patterns for the FSN and PT.  

    ; align naming and case sensitivity with the FSN for the concepts that are selected as the attribute values, excluding the semantic tag. For multiple ingredient drug products, the BoSS must be in alphabetical order and separated by the word “and”. matching the FSN are not required.
    FSN

    Where Precise active ingredient = BoSS:

    • Product containing precisely <BoSS FSN> <Concentration strength numerator value FSN> <Concentration strength numerator unit FSN>/<Concentration strength denominator value FSN> <Concentration strength denominator unit FSN> <Manufactured dose form FSN> (clinical drug)

    For example,

        • Product containing precisely amitriptyline hydrochloride 5 milligram/1 milliliter conventional release oral solution (clinical drug)
        • Product containing precisely buprenorphine 70 microgram/1 hour prolonged-release transdermal patch (clinical drug)
        • Product containing precisely clotrimazole 10 milligram/1 gram conventional release cutaneous cream (clinical drug)
        • Product containing precisely zidovudine 10 milligram/1 milliliter conventional release oral solution (clinical drug)
        • Product containing precisely lopinavir 80 milligram/1 milliliter and ritonavir 20 milligram/1 milliliter conventional release oral solution (clinical drug)

    Where Precise active ingredient <> is not = BoSS:

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

    For example,

        • Product containing precisely amikacin (as amikacin sulfate) 250 milligram/1 milliliter conventional release solution for injection (clinical drug)
        • Product containing precisely mupirocin (as mupirocin calcium) 20 milligram/1 gram conventional release nasal ointment (clinical drug)
    Preferred Term

    Use the following pattern for the PT; align naming and case sensitivity with the PT for the concepts that are selected as the attribute values. For multiple ingredient drug products, the BoSS must be in alphabetical order and separated by the word “and”.

    Where Single ingredient with BoSS = Precise active ingredient:

    • <BoSS PT> <Concentration strength numerator value PT> <Concentration strength numerator unit PT>/<Concentration strength denominator value PT> <Concentration strength denominator unit PT> <Manufactured dose form PT>

    For example,

        • Amitriptyline hydrochloride 5 mg/mL oral solution
        • Buprenorphine 70 microgram/hour prolonged-release transdermal patch
        • Clotrimazole 10 mg/g cutaneous cream
        • Zidovudine 10 mg/mL oral solution
        • Lopinavir 80 mg/mL and ritonavir 20 mg/mL oral solution

    Where Single ingredient with BoSS <> is not = Precise active ingredient:

    • <BoSS PT> (as <Precise active ingredient PT>) <Concentration strength numerator value PT> <Concentration strength numerator unit PT>/<Concentration strength denominator value PT> <Concentration strength denominator unit PT> <Manufactured dose form PT>

    For example,

        • Amikacin (as amikacin sulfate) 250 mg/mL solution for injection
        • Mupirocin (as mupirocin calcium) 20 mg/g nasal ointment

    Exception:

    • The following units of measure should not be abbreviated in descriptions; they should always be spelled out:
      • international unit
      • microequivalent
      • microliter
      • microgram
      • microliter (with GB spelling microlitre)
      • million unit
      • nanogram
      • picogram
      • unit
    SynonymsSynonyms

    Synonyms converting metric units to percent or parts per millions may be included for medical gas concepts (e.g. Helium 79% and oxygen 21% gas for inhalation,  Helium Helium 790,000 ppm and oxygen 210,000 ppm gas for inhalation).

    Exemplars

    The following illustrates the stated view for 781834001 |Product containing precisely digoxin 250 microgram/1 milliliter conventional release solution for injection (clinical drug)|:

    ...