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.  

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:

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:

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:

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 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 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 (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 26: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug real clinical example stated view

Figure 27: 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.

Product search systems and product matching systems using more detailed "name parts" may also be required.

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.