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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
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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
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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 are 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). Since 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.
Concentration and presentation strength clinical drugs in national extensions:
Clinical drug concepts in the international edition are authored either using presentation strength (for discrete dose forms) or using concentration strength (for liquid dose forms and patches etc.) as appropriate for different types of product (see Appendix A of the international specification). In national extensions this may be sufficient, or there may be a requirement to represent liquid dose form products using both concentration and presentation strength, either for the the abstract Clinical Drug or for the Real Clinical Drug, or for both. This is shown in the diagram below:
| Gliffy Diagram | ||||||||
|---|---|---|---|---|---|---|---|---|
|
Figure 13: Diagram of relationships and optionality for presentation strength and concentration strength Clinical Drug and Real Clinical Drug
Even within a single jurisdiction, authorisations are not always consistent in dealing with presentation and concentration strength. Some regulatory agencies have or are moving to licensing all parenteral liquid products using presentation strength (with the exception of some products such as insulins and large volume parenteral fluid replacement products and bulk use vials etc.); other agencies have been or are using this pattern for some products (e.g. pre-filled syringes) and may change for others as IDMP takes effect. Some national terminologies are working to normalise the patterns of strength representation particularly for safety considerations; others are dealing with the mixed economy that exists "as is". This international specification provides support for the different patterns for both clinical drugs and real clinical drugs whilst maintaining the requirement that concepts will classify correctly within the system.
Concentration and presentation strength clinical drugs for a national extension:
This is the pattern for a national extension to author a presentation strength representation of a clinical drug that is described using concentration strength in the international edition. This can be used for
- liquid parenteral products presented in units of presentation such as ampoules, vials, pre-filled syringes, cartridges or bags/bottles
- liquid oral products presented in a sachet or other unit dose unit of presentation
- liquid pulmonary products presented in a unit dose presentation unit of presentation
In addition to the usual attributes for a concentration strength clinical drug, the unit of presentation size and unit of presentation unit attributes are used. The concept will then classify correctly as a child of the existing concentration strength clinical drug. This does mean that the exact presentation strength must be authored manually as an additional description and that the exact presentation strength is not provided in the logical definition (other than via calculation) but this pattern has been found to be the most efficient method for authoring such concepts, especially when there are multiple active ingredient substances. The alternative was to author both concentration strength and presentation strength in two role groups which, whilst it does also give the correct classification, is very labour intensive.
Attributes of a concentration and presentation strength clinical drugs for a national extension:
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.
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.
| 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:
| |||||||
| 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 774159003 |Has supplier| | 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
| |||||||
Exceptions
- None identified
Range
Cardinality
- 1..1
Notes
- This attribute describes a grouping dose form concept for the medicinal product, where the grouping is the intended site for administration of the dose form of the product
Range
- INT (integer)
Cardinality
- 1..1
Note
- This attribute provides the number of base active ingredient substances present in the medicinal product
Range
Cardinality
- 0..1
Notes
- This is the unit of presentation that the liquid product is presented in
Range
- DEC (decimal)
Cardinality (within role group)
- 1..1
Range
< 767524001 |Unit of measure (qualifier
Cardinality (within role group) |
[
|
One role group is required for each precise active ingredient
Notes This is the unit of measure for the amount of basis of strength substance present in one unit of presentation | ||||
Attribute:
| Range
|
Range
< 105590001 |Substance|Cardinality (within role group)
Notes
|
| ||||||
Attribute:
| Range
Cardinality |
Range
Cardinality(within role group)
|
|
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
Notes
| ||||||
* Role group - for concentration strength [1..*] One role group is required for each precise active ingredient | Attribute:
| Range
|
|---|
Range
- DEC (decimal)
Cardinality (within role group)
- 1..1
Range
< 767524001 |Unit of measure (qualifier value)
Cardinality (within role group)
|
Range
- DEC (decimal)
Cardinality (within role group)
- 1..1
Notes
| ||||||
Attribute:
| Range
Cardinality |
Range
Cardinality(within role group)
|
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 of Real Clinical Drug
The real clinical drug class has attributes inherited from the clinical drug class in the international edition and attributes inherited 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 and the national editorial guidelines. In order to support correct classification, a liquid product being described using a presentation strength will also need its concentration strength attributes authored. For all those concepts where a presentation strength is described, the unit of presentation attribute should also be valued.
...
(real clinical drug)
...
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
...
Attribute:
Has manufactured dose form
...
- Range: 736542009|Pharmaceutical dose form (dose form) - descendants only
- Cardinality: 1..1
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.
...
Attribute:
Count of base of active ingredient
...
Attribute:
Has unit of presentation
...
- Range: 732935002 | Unit of presentation (unit of presentation) - descendants only
- Exceptions: none identified
- Cardinality: 0..1
- Not valued for those real clinical drugs that can only be described using concentration strength (e.g. semi-solids)
...
* Relationship group
- for presentation strength
...
One relationship group containing only the following six attributes is required for each active ingredient
- Cardinality: 1..*
...
- Attribute:
- Has active ingredient
...
- Range: 105590001|Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, and combined substances
- Cardinality: 1..1 (per relationship group)
...
- Attribute:
- Has basis of strength substance
...
- Range: 105590001|Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, and combined substances
- Cardinality: 1..1 (per relationship group)
...
- Has presentation strength numerator value
...
- Range: 260299005|Number (qualifier value) - descendants only
- Cardinality: 1..1 (per relationship group)
...
- Has presentation strength numerator unit
...
- Range: 258666001|Unit (qualifier value) - descendants only
- Cardinality: 1..1 (per relationship group)
...
- Has presentation strength denominator value
...
- Range: 260299005|Number (qualifier value) - descendants only
- Cardinality: 1..1 (per relationship group)
...
- Has presentation strength denominator unit
...
- Range: 258666001|Unit (qualifier value) - descendants only
- Cardinality: 1..1 (per relationship group)
...
* Relationship group
- for concentration strength
...
One relationship group containing only the following six attributes is required for each active ingredient
- Cardinality: 1..*
...
- Attribute:
- Has active ingredient
...
- Range: 105590001|Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, and combined substances
- Cardinality: 1..1 (per relationship group)
...
- Attribute:
- Has basis of strength substance
...
- Range: 105590001|Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, and combined substances
- Cardinality: 1..1 (per relationship group)
...
- Attribute:
- Has concentration strength numerator value
...
- Range: 260299005|Number (qualifier value) - descendants only
- Cardinality: 1..1 (per relationship group)
...
- Attribute:
- Has concentration strength numerator unit
...
- Range: 258666001|Unit (qualifier value) - descendants only
- Cardinality: 1..1 (per relationship group)
...
- Attribute:
- Has concentration strength denominator value
...
- Range: 260299005|Number (qualifier value) - descendants only
- Cardinality: 1..1 (per relationship group)
...
- Attribute:
- Has concentration strength denominator unit
...
- Range: 258666001|Unit (qualifier value) - descendants only
- Cardinality: 1..1 (per relationship group)
...
Attribute:
Has product name
...
- Range: Extensions must author product name concepts within their extension using the root of 774167006| Product name (product name)| from the Qualifier hierarchy
- Cardinality: 1..1
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 10.1 below)
...
Attribute:
Has supplier
...
- Range: Extensions must author concepts to value supplier organisation information within their extension using the root of 774164004| Supplier (supplier)| from the Qualifier hierarchy
- Cardinality: 1..1
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 10.2 below)
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 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 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.
Example Diagrams
Some examples of real clinical drug concepts are shown below.
Stated template view:
Gliffy Diagram macroId 8513079c-bb49-4b15-b725-161249405857 displayName RCD Stated Template 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 example inferred view
Example: single active ingredient substance branded product (Canesten) (concentration strength): stated view followed by the inferred view
Figure 22: Single active ingredient substance (concentration strength) real clinical example stated view
Figure 23: Single active ingredient substance (concentration strength) real clinical example inferred view
Example: single active ingredient substance product (Gentamicin (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 (xxxxx) (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
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.
- 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
- Formal name
Note: the cardinalities given in the above table are the business cardinalities; the MRCM will have different (usually more relaxed) cardinalities for its own purposes.
Examples
Stated template view:
Figure 11: Template for a real clinical drug
Example (stated view):
Figure 12: Example of a real clinical drug (presentation strength) - stated view
Example (inferred view):
Figure 13: Example of a real clinical drug (presentation strength) - inferred view
Example (stated view):
Figure 14: Example of a real clinical drug (presentation and concentration strength) - stated view
Example (inferred view):
Figure 15: Example of a real clinical drug (presentation and concentration strength) - inferred view
Optional additional information
Some or all of the following items of information may be used to describe the 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.
- Name parts (in addition to the product name and manufacturer/supplier organisation, which are definitional attributes)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 free") and/or flavour information (e.g. "for children")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
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®Shingles treatment"
))
- Excipient substances playing some or all of the following roles:
- Flavours
- Colours
- Preservatives
- Stabilisers
- License information
- License holding organisation
- License identification ("authorisation number")
- Licensing class and/or legal status of supply
- 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 Real Clinical Drug and the Real Clinical Drug supplied by the original manufacturer, if that is present within the jurisdiction too.
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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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