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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.
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- 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 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)|
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.
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Clinical Drugs for pre-filled pens or cartridges
In the International edition of SNOMED CT, clinical drugs presenting in pre-filled pens or cartridges will be 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)|
| Warning |
|---|
Lyophilized dose forms are out of scope for the international edition of SNOMED CT. |
Modeling
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| Stated parent concept | 763158003 |Medicinal product (product) |
|---|---|
| Semantic tag | (clinical drug) |
| Definition status | 900000000000073002 |Sufficiently defined by necessary conditions definition status (core metadata concept)|
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Attribute: Has manufactured dose form | Range: <736542009 |Pharmaceutical dose form (dose form)
Cardinality: 1..1The 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. |
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 group | One relationship group containing one instance of each of the following attributes is required for each precise active ingredient. |
| Range: <105590001 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group Note:
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| Range: <105590001 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group |
| 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:
To avoid semantically equivalent concepts, product strength for units are normalized as follows:
The following units are not allowed unless specifically noted as an exception:
Repeating decimals are rounded to three decimal places (with 5 and above rounded up and 4 and below rounded down). |
| Range: <767524001 |Unit of measure (qualifier value)| Cardinality: 1..1 per relationship group |
| 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. |
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Naming
| FSN | Use one of the following pattern patterns 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):
For example,
Where Precise active ingredient <> is not = BoSS and Unit of presentation = discrete solid dose form (e.g. capsule, lozenge, pessary, suppository, tablet):
For example,
Where Precise active ingredient = BoSS and Unit of presentation = other discrete dose form (e.g. actuation, vial, sachet)
For example,
Where Precise active ingredient <> is not = BoSS and Unit of presentation = other discrete dose form (e.g. actuation, vial, sachet)
For example,
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| Preferred Term | Use one of 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”patterns for the PT. Where BoSS = Precise active ingredient:
For example,
Where BoSS <> is not = Precise active ingredient:
For example,
Exception: |
| 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)|:
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