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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) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
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:
| |||||||||
Attribute:
| Range
Cardinality
Notes
| |||||||||
Range
Cardinality (within role group)
Notes
| ||||||||||
Attribute Attribute:
| Range
Cardinality (within role group)
Notes
| |||||||||
Attribute Attribute:
| Range
Cardinality
Notes
| |||||||||
Attribute: Attribute:
| Range
Cardinality
Notes
| |||||||||
* Role group - for presentation strength [1..*] One role group is required for each precise active ingredient | Attribute:
| Range
Cardinality (within role group)
Notes
| ||||||||
Attribute:
| Range
Cardinality (within role group)
Notes
| |||||||||
Attribute:
| Range
Cardinality (within role group)
Notes:
| |||||||||
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
| |||||||||
Attribute:
| Range
Cardinality (within role group)
Notes
| |||||||||
* Role group - for concentration strength [1..*] One role group is required for each precise active ingredient | Attribute:
| Range
Cardinality (within role group)
Notes
| ||||||||
Attribute:
| Range
Cardinality (within role group)
Notes
| |||||||||
Attribute:
| Range
Cardinality (within role group)
Notes:
| |||||||||
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
| |||||||||
Attribute:
| Range
Cardinality (within role group)
Notes
| |||||||||
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 29: Multiple active ingredient substance (presentation strength) real clinical example inferred view
Example: single active ingredient substance branded product (Canesten) (concentration strength): stated view followed by the inferred view
Figure 30: Single active ingredient substance (concentration strength) real clinical example stated view
Figure 31: 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 32: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug real clinical example stated view
Figure 33: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug real clinical example inferred view
Example: single active ingredient substance product (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 in the national extension and therefore the real clinical drug classifies under this the concentration strength concept in the international edition
Figure 34: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug real clinical example stated view
Figure 35: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug real clinical example inferred view
Optional Additional Information
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 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.
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.
Definition
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 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.
Use Cases
The following use cases are supported by the Real Clinical Drug concept class:
- 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
Discussion
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 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:
- Actual Medicinal Product in NHS dm+d and Belgian SAM
- Trade Product Unit of Use in in AMT/NZULM
- Semantic Branded Drug (SBD) in RxNorm
- HPK class in the Dutch Z-Index
- Medicinal Product (MP) class in CCDD, the Canadian Clinical Drug Dataset
Attributes
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 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.
...
| Scg expression |
|---|
900000000000073002 |Sufficiently defined concept definition status (core metadata concept)| |
This can only be the case if extensions author concepts to represent product names and manufacturer/supplier organisations
...
| Scg expression |
|---|
411116001 |Has manufactured dose form| |
Range:
| Scg expression |
|---|
< 736542009 |Pharmaceutical dose form (dose form)| |
Cardinality:
- 1..1
Notes:
- This is the finished dose form that the manufactured product is presented in by the manufacturer, before any transformation into an administrable dose form has taken place.
...
| Scg expression |
|---|
42139005 |Count of base of active ingredient| |
...
Range:
- INT (Integer)
Cardinality:
- 1..1
Notes:
- This attribute provides the number of base active ingredient substances present in the real medicinal product
Attribute:
| Scg expression |
|---|
763032000 |Has unit of presentation| |
Range
| Scg expression |
|---|
< 732935002 |Unit of presentation| |
Cardinality
- 0..1
Notes
- This is the the discrete countable entity that the real clinical drug is presented in; it should be valued for all concepts where presentation strength is used and for those real clinical drugs where both concentration strength and presentation strength is required
...
| Scg expression |
|---|
1148793005 | Unit of presentation size quantity | |
...
Range
- DEC (decimal)
Cardinality (within role group)
- 0..1
Notes
- This is the volume of liquid that the unit of presentation contains. This attribute should be valued for real clinical drugs where both concentration strength and presentation strength is required
Attribute
...
| Scg expression |
|---|
320091000221107 | Unit of presentation size unit | |
Range
| Scg expression |
|---|
< 767524001 |Unit of measure (qualifier value)| |
Cardinality (within role group)
- 0..1
Notes
- This is the unit of measure for the volume of liquid that the unit of presentation contains (usually millilitres). This attribute should be valued for real clinical drugs where both concentration strength and presentation strength is required
Attribute
...
| Scg expression |
|---|
774158006 |Has product name| |
Range
| Scg expression |
|---|
< 774167006 |Product name (product name)| |
- Extensions must author product name concepts within their extension using the root of
from the Qualifier hierarchyConcept t 774167006 |Product name (product name)|
Cardinality
- 1..1
Notes
- The attribute value should represent the (authorised) product name; this may (or may not) be a trademarked name, and is often referred to as the "brand name" (see section below)
Attribute:
...
| Scg expression |
|---|
774159003 |Has supplier| |
Range
| Scg expression |
|---|
< 774164004 |Supplier (supplier)| |
- Extensions must author concepts to value supplier organisation information within their extension using the root of
from the Qualifier hierarchyConcept t 774164004 |Supplier (supplier)|
Cardinality
- 1..1
Notes
- The attribute value should represent the holder of the marketing authorisation or authorisation for supply; this may or may not be the organisation responsible for the actual manufacture of the product (see section below)
* Role group - for presentation strength
[1..*]
One role group is required for each precise active ingredient
Attribute:
| Scg expression |
|---|
762949000 |Has precise active ingredient| |
Range
| Scg expression |
|---|
< 105590001 |Substance| |
Cardinality (within role group)
- 1..1
Notes
- This is a precise active ingredient substance that the concept contains.
- In each role group, only one precise active ingredient substance is stated
Attribute:
| Scg expression |
|---|
732943007 |Has basis of strength substance| |
Range
| Scg expression |
|---|
< 105590001 |Substance| |
Cardinality (within role group)
- 1..1
Notes
- This is the basis of strength substance that the concept uses.
- In each role group, only one precise active ingredient substance is stated.
- The basis of strength substance is always stated explicitly, even when it is the same as the precise active ingredient substance
Attribute:
| Scg expression |
|---|
1142135004 |Has presentation strength numerator value| |
...
Range
- DEC (decimal)
Cardinality (within role group)
- 1..1
Notes:
- This is the amount of basis of strength substance present in one unit of presentation
Attribute:
| Scg expression |
|---|
732945000 |Has presentation strength numerator unit| |
Range
| Scg expression |
|---|
< 767524001 |Unit of measure (qualifier value)| |
Cardinality (within role group)
- 1..1
Notes
This is the unit of measure for the amount of basis of strength substance present in one unit of presentation
Attribute:
| Scg expression |
|---|
1142136003 |Has presentation strength denominator value| |
...
Range
- DEC (decimal)
Cardinality (within role group)
- 1..1
Notes
- This should be "one" since the strength numerator refers to amount of basis of strength substance present in one unit of presentation
Attribute:
| Scg expression |
|---|
732947008 |Has presentation strength denominator unit| |
Range
| Scg expression |
|---|
< 767524001 |Unit of measure (qualifier value)| |
Cardinality (within role group)
- 1..1
Notes
- This should be the unit of presentation (< 732935002 |Unit of presentation|) also valued above. All units of presentation are subtypes of 767524001 |Unit of measure (qualifier value)|
* Role group - for concentration strength
[1..*]
One role group is required for each precise active ingredient
Attribute:
| Scg expression |
|---|
762949000 |Has precise active ingredient| |
Range
| Scg expression |
|---|
< 105590001 |Substance| |
Cardinality (within role group)
- 1..1
Notes
- This is a precise active ingredient substance that the concept contains.
- In each role group, only one precise active ingredient substance is stated
Attribute:
| Scg expression |
|---|
732943007 |Has basis of strength substance| |
Range
| Scg expression |
|---|
< 105590001 |Substance| |
Cardinality (within role group)
- 1..1
Notes
- This is the basis of strength substance that the concept uses.
- In each role group, only one precise active ingredient substance is stated.
- The basis of strength substance is always stated explicitly, even when it is the same as the precise active ingredient substance
Attribute:
| Scg expression |
|---|
1142138002 |Has concentration strength numerator value| |
...
Range
- DEC (decimal)
Cardinality (within role group)
- 1..1
Notes:
- This is the amount of basis of strength substance present in one "denominator unit"
- stated view
Figure 25
Attribute:
| Scg expression |
|---|
733725009 |Has concentration strength numerator unit| |
Range
| Scg expression |
|---|
< 767524001 |Unit of measure (qualifier value)| |
Cardinality (within role group)
- 1..1
Notes
This is the unit of measure for the amount of basis of strength substance present in one "denominator unit"
Attribute:
| Scg expression |
|---|
1142137007 |Has concentration strength denominator value| |
...
Range
- DEC (decimal)
Cardinality (within role group)
- 1..1
Notes
- This should be "one" since the strength numerator refers to amount of basis of strength substance present in one "denominator unit"
Attribute:
| Scg expression |
|---|
733722007 |Has concentration strength denominator unit| |
Range
| Scg expression |
|---|
< 767524001 |Unit of measure (qualifier value)| |
Cardinality (within role group)
- 1..1
Notes
- This is the unit of the "one" denominator unit that the strength numerator refers to (usually an SI unit of mass or volume)
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 required in order to support correct relationships generated by the MRCM:
Attribute:
| Scg expression |
|---|
1142141006 |Count of base and modification pair| |
...
Range
- INT (integer)
Cardinality
- 1..1
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:
| Scg expression |
|---|
1142140007 |Count of active ingredient| |
...
Range
- INT (integer)
Cardinality
- 1..1
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.
Example Diagrams
Some examples of real clinical drug concepts are shown below.
Stated template view:
Gliffy Diagram size 1000 name RCD Stated Template pagePin 1
Figure 17: Template for a real clinical drug
Example: single active ingredient substance branded product (Zocor) (presentation strength): stated view followed by the inferred view
Figure 18: Single active ingredient substance (presentation strength) real clinical example stated view
Figure 19: Single active ingredient substance (presentation strength) real clinical example inferred view
Example: multiple active ingredient substance (presentation strength) branded product (Inegy): stated view followed by the inferred view
Figure 20: Multiple active ingredient substance (presentation strength) real clinical example stated view
Figure 21: 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 2226: Single active ingredient substance (concentration strength) real clinical drug example - stated view
Figure 2327: Single active ingredient substance (concentration strength) real clinical drug 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 authored in the national extension, and therefore, the real clinical drug classifies under this concept.
Figure 2428: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug - real clinical drug example - stated view
Figure 2529: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug - real clinical drug example - inferred view
Example: single active ingredient substance product (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 in the national extension, and therefore, the real clinical drug classifies under this the concentration strength concept in the international edition.
Figure 2630: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug - real clinical drug example - stated view
Figure 2731: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug - real clinical example - inferred view
Optional Additional Information
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.
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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