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The real clinical drug is the marketed (therefore "real") instantiation in any one country of the abstract clinical drug in the international edition and as such, real clinical drugs classify as child concepts of the clinical drug, as well as a child concepts of the real medicinal product, if one has been authored. This concept class is, like the clinical drug in the international edition, at the core of the way medicinal products are described and as such, should always be used in a national extension.
Existing national terminology equivalents:
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| Semantic tag | (real clinical drug) | ||||||||||
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Definition status |
This can only be the case if extensions author concepts to represent product names and manufacturer/supplier organisations | ||||||||||
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Cardinality:
Notes:
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Cardinality:
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Attribute:
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Cardinality
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Range
Cardinality (within role group)
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Attribute Attribute:
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Cardinality (within role group)
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Attribute Attribute:
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Cardinality
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Attribute: Attribute:
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Cardinality
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* Role group - for presentation strength [1..*] One role group is required for each precise active ingredient | Attribute:
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Cardinality (within role group)
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Attribute:
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Cardinality (within role group)
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Attribute:
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Cardinality (within role group)
Notes:
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Attribute:
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Cardinality (within role group)
Notes This is the unit of measure for the amount of basis of strength substance present in one unit of presentation | ||||||||||
Attribute:
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Cardinality (within role group)
Notes
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Attribute:
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Cardinality (within role group)
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* Role group - for concentration strength [1..*] One role group is required for each precise active ingredient | Attribute:
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Cardinality (within role group)
Notes
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Attribute:
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Cardinality (within role group)
Notes
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Attribute:
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Cardinality (within role group)
Notes:
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Attribute:
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Cardinality (within role group)
Notes This is the unit of measure for the amount of basis of strength substance present in one "denominator unit" | ||||||||||
Attribute:
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Cardinality (within role group)
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Attribute:
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Cardinality (within role group)
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Figure 23: Single active ingredient substance (concentration strength) real clinical example inferred view
Example: single active ingredient substance product (Gentamicin ampule (Hospira)) (concentration and presentation strength) with equivalent clinical drug: stated view followed by the inferred view
In this example, a concentration and presentation strength clinical drug has been authored in the national extension and therefore the real clinical drug classifies under this concept
Figure 24: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug real clinical example stated view
Figure 25: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug real clinical example inferred view
Example: single active ingredient substance product (
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Gentamicin vial (Hospira)) (concentration and presentation strength) without equivalent clinical drug: stated view followed by the inferred view
In this example, a concentration and presentation strength clinical drug has been NOT authored authored in the national extension and therefore the real clinical drug classifies under this the concentration strength concept in the international edition
Hospira gentamicin vial
Figure 26: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug real clinical example stated view
Hospira gentamicin vial
Figure 27: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug real clinical example inferred view
Optional Additional Information
Some or all of the following items of information may be used to additionally describe a real clinical drug concept in a national extension. The attribute concepts and values to populate these, if this data is to be held in a structured form, would need to be authored into the extension using reference sets.
National extensions that function as national medicinal product dictionaries may require information that extends beyond the characteristics of the product as described here in this specification for real clinical drugs. Product characteristics can be included within the SNOMED CT structure using attributes and values, whereas knowledge about the product should be managed alongside the SNOMED CT structure (e.g. in a reference set) and relationships between identification systems should be managed in cross maps.
- Product characteristics may include describing excipient substances to support allergy or intolerance checking. Excipient substance roles may include flavours, colours, preservatives and stabilisers/fillers
- Knowledge about the product may include usage information such as availability within the supply chain, licensing/authorization category
- Excipient substances playing some or all of the following roles, particularly for allergy or intolerance checking:
- Flavours
- Colours
- Preservatives
- Stabilisers/fillers (e.g. lactose, sodium)
- License information
- License identification ("authorisation number") Licensing class and/or legal status of supply
- Usage information
- Availability within the supply chain
- Prescribability within a particular jurisdictional context including reimbursement category
- and prescribability information including reimbursement categories
- Other identification systems for a real clinical drug may include licensing/authorization number or Global Trade Identification Number (GTIN)Formal name parts (in addition to the product name and manufacturer/supplier organisation, which are definitional attributes) to support searching for products and matching with product descriptions:
- A description of the strength of the product, which may be mathematical (e.g. "50mg" or may be descriptive (e.g. "low strength" or "adult strength")
- A description of the dose form as it appears in the name, when this is a non-standard, invented or trademarked dose form (e.g. "caplet")
- A description of the formulation (e.g. "with preservative" or "gluten free") and/or flavour information (e.g. "strawberry flavour") or, for influenza vaccines, which are currently out of scope, this may also the year/season of applicability
A description of the indication for the product (e.g. "Shingles treatment")
- A description of the intended population for the product (e.g. "for children") A description of the unit of presentation as it appears in the name, when this is a non-standard, invented or trademarked unit of presentation (e.g. "Nebule®"))
In jurisdictions where repackaging and/or "parallel importing" are authorised, a national extension may wish to consider having a relationship between the repackaged or parallel imported
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real clinical drug and the
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real clinical drug supplied by the original manufacturer, if that is present within the jurisdiction
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Product search systems and product matching systems using more detailed "name parts" may also be required.
IDMP Compatibility
For most authorised medicinal products, this class is roughly equivalent to the core Medicinal Product class, with its MPID identification in ISO 11615 of IDMP. However, the Medicinal Product class in IDMP explicitly includes combination (kit) products within it whereas this model describes combination products as packaged products only (see below). Implementation considerations may require combination products to be available to users alongside clinical drug and real clinical drug concepts; mechanisms such as the use of reference sets can support this requirement.
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