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The representation of a medicinal product marketed by a by a single organisation (supplier) in a single jurisdiction under a single name (which may be a trade or brand name or a generic/non-proprietary name) and which contains the same set precise set precise active ingredient substances and strengths in a single manufactured dose form. It is a subtype of and real world equivalent to the Clinical Drug (CD) class in the international edition of SNOMED CT.
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- Supporting medication process activities: prescribing, dispensing, administration and medication statements
- In prescribing and in medication statements, especially in situations where the patient should always use a particular Manufactured Product, for reasons of bioavailability (such as a lithium product) or use of administration system (such as an insulin pen)
- In dispensing and administration, to identify exactly which product was provided/administered
- Reimbursement: national or local systems may set pricing or eligibility against particular manufactured products, regardless of how they are supplied (i.e., with no reference to pack size)
- Allergy checking of specific excipients (if described)
- Pharmacovigilance
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The real clinical drug represents the product as most (but not all) regulatory authorities grant the marketing authorisation, with the individual packaged products that are marketed into the supply chain in any jurisdiction included within that authorisation. A small number of regulatory authorities license each package of a medicinal product separately which is represented by the real packaged clinical drug (see below). Real medicinal products must be represented using the closed world view; they contain only the content as stated in the logical definition. Since this class represents real products as authorised in a jurisdiction, description of additional non-defining information, such as excipient substances (flavours, preservatives, sweeteners, etc.) or details about the product name parts or product authorisation information and product availability information can be attached to Real Clinical Drug concepts, should a national extension wish to do this. For further details, see the section on Optional Additional Information below.
The real The real clinical drug is the marketed (therefore 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.
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The real clinical drug class inherits from the clinical drug class in the international edition, and the product name and supplier from the real medicinal product class.
In the following table, two relationship groups (marked with an *) are described: one for presentation strength, and one for concentration strength; the . The appropriate relationship group type(s) should be selected based on the real product being described. A liquid product being described using a presentation strength in a national extension should follow the pattern used for "concentration and presentation strength clinical drugs in the national extension" in this specification.
| 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. | |||||||||
| Range:
Cardinality:
Notes:
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| Range:
Cardinality:
Notes:
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Attribute:
| Range
Cardinality
Notes
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Range
Cardinality (within role group)
Notes
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Attribute Attribute:
| Range
Cardinality (within role group)
Notes
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Attribute Attribute:
| Range
Cardinality
Notes
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Attribute: Attribute:
| Range
Cardinality
Notes
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* Role group - for presentation strength [1..*] One role group is required for each precise active ingredient | Attribute:
| Range
Cardinality (within role group)
Notes
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Attribute:
| Range
Cardinality (within role group)
Notes
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Attribute:
| Range
Cardinality (within role group)
Notes:
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Attribute:
| Range
Cardinality (within role group)
Notes This is the unit of measure for the amount of basis of strength of strength substance present in one unit of presentation. | |||||||||
Attribute:
| Range
Cardinality (within role group)
Notes
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Attribute:
| Range
Cardinality (within role group)
Notes
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* Role group - for concentration strength [1..*] One role group is required for each precise active ingredient | Attribute:
| Range
Cardinality (within role group)
Notes
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Attribute:
| Range
Cardinality (within role group)
Notes
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Attribute:
| Range
Cardinality (within role group)
Notes:
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Attribute:
| Range
Cardinality (within role group)
Notes This is the unit of measure for the amount of basis of strength of strength substance present in one "denominator unit". | |||||||||
Attribute:
| Range
Cardinality (within role group)
Notes
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Attribute:
| Range
Cardinality (within role group)
Notes
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For real clinical drugs that have two or more active ingredient substances that are modifications of the same base substance and where MP precisely concepts are required in the national extension, and for single ingredient product concepts where the active substance is an ingredient in these multiple modification multi-ingredient products, the following extra ingredient count attribute will be is required in order to support correct relationships generated by the MRCM:
Attribute:
| Range
Cardinality
|
|---|
For concepts that have two or more active ingredient substances that are modifications of the same base active ingredient substance (i.e. parent ingredient substance) and where one is a further modification of the other (for example, a multi-ingredient product containing both dexamethasone phosphate and dexamethasone sodium phosphate, where the dexamethasone phosphate is a modification of dexamethasone (base) and dexamethasone sodium phosphate is a further modification of the dexamethasone phosphate) and where MP precisely concepts are required in the national extension, and for single ingredient product concepts where the active substance is an ingredient in these multiple modification multi-ingredient products, the following extra ingredient count attribute will be required in order to support correct relationships generated by the MRCM:
Attribute:
| Range
Cardinality
|
|---|
Note: The cardinalities given in the above table are for concepts in the RCD class. These cardinalities may be stricter than those in the MRCM, which typically apply across a broader range of concepts.
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Gliffy Diagram size 1000 name RCD Stated Template pagePin 1
Figure 2521: Template for a real clinical drug
Example: single active ingredient substance branded product (Zocor) (presentation strength): stated view followed by the inferred view
Figure 2622: Single active ingredient substance (presentation strength) real clinical drug example - stated view
Figure 2723: Single active ingredient substance (presentation strength) real clinical drug example - inferred view
Example: multiple active ingredient substance (presentation strength) branded product (Inegy): stated view followed by the inferred view
Figure 2824: Multiple active ingredient substance (presentation strength) real clinical drug example - stated view
Figure 2925: Multiple active ingredient substance (presentation strength) real clinical drug example - inferred view
Example: single active ingredient substance branded product (Canesten) (concentration strength): stated view followed by the inferred view
Figure 3026: Single active ingredient substance (concentration strength) real clinical drug example - stated view
Figure 3127: Single active ingredient substance (concentration strength) real clinical drug example - inferred view
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In this example, a concentration and presentation strength clinical drug has been authored authored in the national extension, and therefore, the real clinical drug classifies under this concept.
Figure 3228: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug - real clinical drug example - stated view
Figure 3329: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug - real clinical drug example - inferred view
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In this example, a concentration and presentation strength clinical drug has been NOT authored in the national extension, and therefore, the real clinical drug classifies under this the concentration strength concept in the international edition.
Figure 3430: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug - real clinical drug example - stated view
Figure 3531: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug - real clinical example - inferred view
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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 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 and/or legal status of supply 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)
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 real clinical drug and the real clinical drug supplied by the original manufacturer, if that is present within the jurisdiction.
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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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