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.

When the manufacturer describes their product characteristics to indicate that two separate ingredients are present in their formulation, then both ingredients must be modeled separately.

For example,

The summary of product characteristics for a manufactured product for a sachet of 100mg sodium valproate prolonged-release granules contains Sodium valproate 66.66mg and Valproic acid 29.03mg that must be separately modeled as:  

    • Product containing precisely sodium valproate 66.66 milligram and valproic acid 29.03 milligram/1 sachet prolonged-release oral granules (clinical drug)

Modeling for concepts representing discrete dose forms

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

CD-precise concepts representing discrete dose form (e.g. tablets, capsules, pessaries, suppositories, sachets, ampules or vials containing solid dose forms such as powders or granules, and metered dose delivery products such as inhalers and spray) are modeled using presentation strength attributes; concentration strength attributes are not allowed for these concepts in the International Release.

For 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 afatinib (as afatinib dimaleate) 30 milligram/1 each conventional release oral tablet (clinical drug)
    • Product containing precisely aztreonam 500 milligram/1 vial powder for conventional release solution for injection (clinical drug)
    • Product containing precisely flucloxacillin (as flucloxacillin sodium) 250 milligram/1 vial powder for conventional release solution for injection (clinical drug)
    • Product containing precisely budesonide 200 microgram/1 actuation conventional release powder for inhalation (clinical drug)

When a product has a metered delivery, the strength is "per actuation" not as a concentration.

For example,

    • 1263426000 |Product containing precisely xylometazoline hydrochloride 140 microgram/1 actuation conventional release nasal spray (clinical drug)|

The following exceptions have been identified.

  • Concepts with product strength that is "not equal to":
    • Model as primitive, with attributes added as described in the following sections, except that strength numerator attributes will not be added.
    • The appropriate Medicinal Product Form-only (MPF-only) concept will infer as a parent.
Stated parent concept

763158003 |Medicinal product (product)

Semantic tag(clinical drug)
Definition status

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)|.

Attribute:

Has manufactured dose form

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

      • While the allowed range for this attribute is broader, the CD-precise discrete dose form concepts should only use <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.

Note:

  • 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)|)
  • Clinical drug concepts in the International Release are not modeled using dose forms for “lyophilized powder”, because it is not a clinically relevant distinction at the Clinical drug level.
    • Pharmaceutical dose forms referring to “lyophilized powder” will be retained in the International Release but will not be used for modeling Clinical drug concepts; they can be used for modeling in national extensions.

Attribute:

Has unit of presentation

Range: <732935002 |Unit of presentation (unit of presentation)|

Cardinality: 1..1

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 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances

Cardinality: 1..1 per relationship group

Note:

  • The PAI cannot be modeled as a substance hydrate or solvate unless the BoSS is expressed as a hydrate or solvate.
  • Concepts containing pancreatic enzymes are 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 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances
  • Cardinality: 1..1 per relationship group
  • Has presentation strength numerator value 

Concrete Type: Decimal

Range: >#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 presentation strength numerator unit

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

Cardinality: 1..1 per relationship group

  • Has presentation strength denominator value

Concrete Type: Decimal

Range: >#0..

Cardinality: 1..1 per relationship group

For this pattern, the attribute value is 1.

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: <767524001 |Unit of measure (qualifier value)| 
    • While the allowed range for this attribute is broader, the CD-precise concepts representing discrete dose forms should only use <732935002 |Unit of presentation (unit of presentation).
  • Cardinality: 1..1 per relationship group

Naming

FSN

Use the following pattern for the FSN; 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”.

Where Precise active ingredient = BoSS and Unit of presentation = discrete solid dose form (e.g. capsule, lozenge, pessary, suppository, tablet):

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

For 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 atropine sulfate 600 microgram/1 each conventional release oral tablet (clinical drug)
      • Product containing precisely codeine sulfate 15 milligram/1 each conventional release oral tablet (clinical drug)

Where Precise active ingredient <> BoSS and Unit of presentation = discrete solid dose form (e.g. capsule, lozenge, pessary, suppository, tablet):

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

For example,

      • Product containing precisely doxazosin (as doxazosin mesilate) 4 milligram/1 each conventional release oral tablet (clinical drug)
      • Product containing precisely disopyramide (as disopyramide phosphate) 150 milligram/1 each prolonged-release oral tablet (clinical drug)

Where Precise active ingredient = BoSS and Unit of presentation = other discrete dose form (e.g. actuation, vial, sachet)

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

For example,

      • Product containing precisely aztreonam 500 milligram/1 vial powder for conventional release solution for injection (clinical drug)
      • Product containing precisely budesonide 200 microgram/1 actuation conventional release powder for inhalation (clinical drug)

Where Precise active ingredient <> BoSS and Unit of presentation = other discrete dose form (e.g. actuation, vial, sachet)

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

For example,

      • Product containing precisely flucloxacillin (as flucloxacillin sodium) 250 milligram/1 vial powder for conventional release solution for injection (clinical drug)
      • Product containing precisely buserelin (as buserelin acetate) 100 microgram/1 actuation conventional release nasal spray (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 BoSS = Precise active ingredient:

  • <BoSS PT> <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <Manufactured dose form PT> <Has unit of presentation PT>

For example,

      • Abacavir 300 mg oral tablet
      • Abacavir 600 mg and lamivudine 300 mg oral tablet
      • Atropine sulfate 600 microgram oral tablet
      • Codeine sulfate 15 mg oral tablet
      • Aztreonam 500 mg powder for solution for injection vial
      • Budesonide 200 microgram/actuation powder for inhalation
      • Buserelin (as buserelin acetate) 100 microgram/actuation nasal spray

      • Ivacaftor 25 mg oral granules sachet


Where 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> <Has unit of presentation PT>

For example,

      • US PT: Doxazosin (as doxazosin mesylate) 4 mg oral tablet
      • GB PT: Doxazosin (as doxazosin mesylate) 4 mg oral tablet
      • US/GB PT: Disopyramide (as disopyramide phosphate) 150 mg prolonged-release oral tablet
      • US PT: Floxacillin (as floxacillin sodium) 250 mg powder for solution for injection vial
      • GB PT: Flucloxacillin (as flucloxacillin sodium) 250 mg powder for solution for injection vial

Exception:

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

Synonyms matching the FSN are not required.

Exemplars

The following illustrates the stated view for 318783003 |Product containing precisely doxazosin (as doxazosin mesilate) 4 milligram/1 each conventional release oral tablet (clinical drug)|:

The following illustrates the inferred view for 318783003 |Product containing precisely doxazosin (as doxazosin mesilate) 4 milligram/1 each conventional release oral tablet (clinical drug)|:

The following illustrates the stated view for 783301004 |Product containing precisely abacavir (as abacavir sulfate) 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drug)|:

The following illustrates the inferred view for 783301004 |Product containing precisely abacavir (as abacavir sulfate) 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drug)|:


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