SNOMED CT Editorial Guide

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Note
titleException

Pre-filled pens or cartridges are discrete dose forms as they can be counted.  In the International edition of SNOMED CT, clinical drugs presenting in pre-filled pens or cartridges are modeled with normalized concentration strength.

Example of pre-filled pen:

    • One pre-filled pen for injection contains 2 mg semaglutide in a 1.5 ml solution
    • FSN: 782102009 |Product containing precisely semaglutide 1.34 milligram/1 milliliter conventional release solution for injection (clinical drug)|

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,

...

a

...

product

...

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

...

Warning

Lyophilized dose forms are out of scope for the international edition of SNOMED CT.

Modeling

Stated parent concept

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 a definition status 900000000000074008 |Necessary but not sufficient concept definition status (core metadata concept)|of Primitive.

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

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:

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

  • 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 The denominator strength value is required for concepts in the 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 one of the following patterns for the FSN.

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 is not = 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 is not = 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 one of the following patterns for the PT.

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 is not = 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
Synonyms

Synonyms matching the FSN are not required.

...

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)|:

Sodium valproate and Valproic acid

When a manufacturer SPC label indicates that two separate ingredients, sodium valproate and valproic acid, are present in the formulation, and thus, one of the substances is a modification of the other, then each ingredient must be modeled separately within its own role group.

Two ungrouped attributes are also required:

  1. |Count of active ingredient| with the total number of active ingredients
  2. |Count of base of active ingredient| with the total number of base active ingredients

For example,

    • The summary of product characteristics for a manufactured product for a sachet of 100 mg sodium valproate prolonged-release granules contains Sodium valproate 66.66 mg and Valproic acid 29.03 mg, 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)|