Real Medicinal Product (RMP) (closed world view)

Definition of Real Medicinal Product (RMP)

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.

Discussion of Real Medicinal Product (RMP) with examples:

Single ingredient substance branded products:

The RMP "Lipitor product" shown in Figure 2 below presents products marketed by Pfizer under a single name (Lipitor) and containing only atorvastatin as the base active ingredient substance:

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 (i.e. so called "generic products"), extensions may choose not to populate the Real Medicinal Product class, as shown below: 

 
Figure 3: Example of authorised "generic" products where a real medicinal product concept has not be authored

Alternatively, for "generic products" a national extension may choose to populate the Real Medicinal Product using the generic name, since with the manufacturer/supplier organisation, this gives a unique concept, as shown below:

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

Multi-Ingredient substance branded products

One of the definitional attributes for a Real Medicinal Product is that it represents a single set of active ingredient substances. 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.

Figure 5: Example of branded real clinical drug products sharing the same product name but not relating to a Real Medicinal Product

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:

Figure 6: Example of branded real clinical drug products relating to a Real Medicinal Product by alternative authoring of product name

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)
• Brand Name (BN) in RxNorm (possibly)

Attributes of Real Medicinal Product (RMP)

The Real Medicinal Product concept class has two attributes inherited from the Medicinal Product (only) class in the international core and two additional attributes.

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.

Example diagrams for RMP

Stated template view:

Figure 7: Real Medicinal Product (RMP) stated template view

Example: single active ingredient branded product: state view followed by the inferred view

Figure 8: Real medicinal product example stated view

Figure 9: 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:

• 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 management may have a use case for this class (for example to change presentation within a product family)
• Pharmacovigilance (abstract representation of a manufactured medicinal product)

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.