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Definition
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The representation of a medicinal product marketed product marketed by a single organisation (supplier) in a single jurisdiction under a single name (which may be a trade or brand name) and which contains the same set of active ingredient substances, regardless of any modification of those active ingredient substances. It is a subtype of, and real world equivalent to, the Medicinal Product Only (MP only) class in the international core.
Use Cases
The following use cases are supported by the Real Medicinal Product concept class:
- Describing medication statements for a medication profile when the detail of the exact product used is not known; e.g., "patient states they used Ventolin for 5 years in childhood"
- Decision support and protocol/guideline management may have a use case for this class (for example, to change presentation or strength within a product family)
- Pharmacovigilance (abstract representation of a manufactured medicinal product)
Discussion
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The real medicinal product class is a grouper concept for products containing the same set of active ingredient substance(s) and marketed under the same name by the same supplier.
Single ingredient substance branded products
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The RMP "Lipitor Zocor (product)" shown in a taxonomic view in Figure 2 below presents products marketed by Pfizer Organon Pharma UK Limited under a single name (LipitorZocor) and containing only atorvastatin simvastatin as the base active ingredient substance and shows the RCD concepts associated with it:
Figure 2: Diagram showing a branded single ingredient substance real medicinal product and its supporting real clinical drug concepts (note, Note: not all possible real clinical drug concepts are shown.)
Single ingredient
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generic
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products
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For those products without a unique (i.e., invented) product name, where the product uses the international non-proprietary name of the active substance as its product name (i.e., so called " generic products"), extensions may choose not to populate the Real Medicinal Product classProduct class, as shown below, with each RCD being associated directly with the CD in the International content:
Figure 3: Example of authorised real clinical drug "generic" products where a real medicinal product concept has not be authored
Alternatively, for "products without a unique (i.e. invented) product name (generic products" ) a national extension may choose to populate the Real Medicinal Product using the generic name AND supplier, since with the manufacturer/supplier organisation, this gives a unique RMP concept, as shown below:
Figure 4: Example of authorised real clinical drug "generic" products where a real medicinal product concept has been authored using product and manufacturer name
Note that here the product name attribute is valued as "simvastatin", which in text looks similar to both the substance concept 387584000 | Simvastatin (substance) | and to the two medicinal product concepts 96304005 | Product containing simvastatin (medicinal product) | and 777537002 | Product containing only simvastatin (medicinal product) |. But it is a different concept and has its own semantic tag of "product name"; it is therefore a different concept (unit of thought): Simvastatin (product name).777537002 | Product containing only simvastatin (medicinal product) |
Multi-Ingredient substance branded products
One of the definitional attributes for fundamentals of a Real Medicinal Product is that it represents a single set of active ingredient substances, reflecting its associated MP only class that also represents a single set of active ingredient substances, without dose form or strength information.
The RMP "Inegy (product)" shown in a taxonomic view in Figure 2 below presents products marketed by Organon Pharma UK Limited under a single name (Inegy) and containing only simvastatin AND ezetimibe as the active ingredient substances, and showing the RCD concepts associated with it:
Figure 5: Diagram showing a branded multi-ingredient substance real medicinal product and its supporting real clinical drug concepts (note, not all possible real clinical drug concepts are shown)
Not all authorised . Therefore not all medicinal products that share the same (invented) product name will relate to a Real Medicinal Product, especially for over the counter (OTC) medicines, where a commercial "brand family" may contain products with different active ingredient sets which would therefore have different MP only representations. For example: , some cough and cold product ranges span expectorant products, cough suppressants, antipyretics and decongestant products, with different sets of active ingredients in each , but all sharing the same brand name.
In the example below, the three real clinical drug products all share the same product name ("Benylin®") in one jurisdiction, but they do not relate to a single real medicinal product because they each relate to different Medicinal Products due to differences in their active ingredient substances.
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Figure 6Figure 5: Example of branded real clinical drug products sharing the same product name but not relating to a Real Medicinal Product due to differences in their set of active ingredient substances
A national extension may choose to populate RMPs for "brand families" that contain products with different active ingredient sets by extending the product name concept to include enough detail to scope just a single active ingredient set, as shown below:
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Figure 7Figure 6: Example of branded real clinical drug products relating to a Real Medicinal Product by alternative appropriate real medicinal products by authoring of specific product name concepts
Existing national terminology equivalents for real medicinal product:
- Trade family in NHS dm+d
- Trade Product (TP) in AMT/NZULM (possibly – AMT appears to allow strength and dose form modifiers)NZULM
- Brand Name (BN) in RxNorm (possibly)
Attributes
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The following attributes apply to Real Medicinal Product (RMP)
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The Real Medicinal Product concept class has two concepts in a national extension. The RMP class has two attributes inherited from the Medicinal Product (only) class in the international core content and two additional attributes.
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763158003|Medicinal product (product)
- Exceptions: none identified
| Semantic tag | (real medicinal product) | ||
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| Definition status |
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Note: This can only be the case if extensions author concepts to represent product names and manufacturer/supplier organisations
Attribute:
Has active ingredient
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Attribute
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Cardinality
Notes
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Attribute
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Cardinality
Notes | |||||||||
Attribute:
Count of base of active ingredient
- Range: 260299005 |Number (qualifier value)| - descendants only
- Cardinality: 1..1
Attribute:
Has product name
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- Exceptions: none identified
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Attribute
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Notes
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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)
| Role Group | Attribute
| Range
Cardinality
Notes
This attribute describes the set of active ingredient substances that the concept minimally contains. A set of active ingredient substances may well have only one member. |
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Note: The 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.
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for concepts in the RMP class. These cardinalities may be stricter than those in the MRCM, which typically apply across a broader range of concepts.
Example Diagrams
Stated template view:
Gliffy Diagram macroId 019c34b0-f383-4cc0-9237-a2a8b77b3fb7 displayName RMP Stated Template name RMP Stated Template pagePin 2
Figure 8Figure 7: Real Medicinal Product (RMP) stated template view
Example: single active ingredient substance branded product (Zocor): state view followed by the inferred view
Figure 8: Real 9: Single active ingredient substance real medicinal product example stated view
Figure 9: Real 10: Single active ingredient substance real medicinal product example inferred view
Use cases supported by Real Medicinal Product
The following use cases are supported by the Real Medicinal Product concept class:
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Example: multiple active ingredient substance branded product (Inegy): stated view followed by the inferred view
Figure 11: Multiple active ingredient substance real medicinal product example stated view
Figure 12: Multiple active ingredient substance real medicinal product example inferred view
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IDMP Compatibility
There is no identified representation of a class similar to the Real Medicinal Product concept class in IDMP , despite there being (a possible) pharmacovigilance use case for this class.
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Overview
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