Definition

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The representation of a medicinal 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

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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 a 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 same set of active ingredient substance and marketed under the same name by the same supplier.  T

Single ingredient substance branded products:

The RMP "Zocor (product)" shown in a taxonomic view in Figure 2 below presents products marketed by Organon Pharma UK Limited under a single name (Zocor) and containing only simvastatin as the active ingredient substance, and showing the RCD concepts associated with it:

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Figure 2: Diagram showing a branded single ingredient substance real medicinal product and its supporting real clinical drug concepts (note, not all possible real clinical drug concepts shown)

Single ingredient "generic" products:

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 class, as shown below, with each RCD being associated directly with the CD in the International content: 

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Figure 4: Example of real clinical drug "generic" products where a real medicinal product concept has been authored using product and manufacturer name

Multi-Ingredient substance branded products

One of the 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 represents a single set of active ingredient substances, without dose form or strength information.

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• Trade family in NHS dm+d
• Trade Product (TP) in AMT/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 content and two additional attributes.

Semantic tag		(real medicinal product)
Definition status		Scg expression 900000000000073002  900000000000073002  |Sufficiently defined concept definition status| Exceptions None identified
Attribute  Scg expression 1142139005 |Count of base of active ingredient (attribute) |		Range INT (Integer) Cardinality 1..1 Notes This attribute provides the number of base active ingredient substances present in the medicinal product
Attribute  Scg expression 774159003 |Has supplier (attribute |		Range Scg expression < 774164004 |Supplier (supplier)| Range Extensions must author concepts to value supplier organisation information within their extension using the root of Concept t 774164004 |Supplier (supplier)| from  from the Qualifier hierarchy 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)
Attribute  Scg expression 774158006 |Has product name (attribute |		Range Scg expression < 774167006| Product name (product name)| Range Extensions must author product name concepts within their extension using the root of Concept t 774167006| Product name (product name)|  from the Qualifier hierarchy 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)
Role Group	Attribute   Scg expression 127489000 |Has active ingredient (attribute) |	Range <   Scg expression <  105590001  105590001  |Substance| Excluding concepts representing structural groupers, dispositions, or combined substances Cardinality 1..* Notes There is no technical limit on the number of |Has active ingredient|attributes that may be added to a concept; a practical limit may be imposed by national extensions.  In order to classify correctly to the international content, this attribute value should represent the base ingredient substance not a modification, unless explicitly identified as an exception and requiring an association to MP precisely concept. 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.

Note: the 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:

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Figure 8: Real Medicinal Product (RMP) stated template view

Example: single active ingredient substance branded product (Zocor): state view followed by the inferred view

Figure 9: Single active ingredient substance real medicinal product example stated view

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Figure 10: Single active ingredient substance real medicinal product example inferred view

Example: multiple active ingredient substance branded product (Inegy): state view followed by the inferred view

Figure 11: Multiple active ingredient substance real medicinal product example stated view

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Figure 12: Multiple active ingredient substance real medicinal product example inferred view

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.