Definition

The representation of a medicinal product marketed by a by a

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 

core.

Discussion of Real Clinical Drug (RCD)

Most but not all regulatory authorities license products at this levelThe 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).  Real medicinal products must be represented using the closed world view; they contain only the content as stated in the logical definition.  Since . 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 7.3

Concentration and Presentation Strength:

Clinical Drug concepts may have their strength expressed as “presentation strength” and/or as “concentration strength” as appropriate for different types of product (see Appendix A of the international specification). In the international release, Clinical Drug concepts are authored either using presentation strength (for discrete dose forms) or using concentration strength (for liquid dose forms and patches etc.).  In national extension terminology this may be sufficient, or their 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:

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Figure 10: 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. pf syringes) and may change for others as IDMP takes effect. Some national terminologies are working to normalise the patterns particularly for safety considerations; others are dealing with the mixed economy that exists "as is". Therefore this international specification allows for all options by having the different patterns for both Clinical Drugs and Real Clinical Drugs.  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 of Real Clinical Drug

The real clinical drug class inherits from the clinical drug Real Clinical Drug class has attributes inherited from the Clinical Drug (precisely) class in the international edition and the product name and supplier from the real medicinal product core 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 .  A and the national editorial guidelines. In order to support correct classification, 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.  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.

<  732935002 |Unit of presentation|

1148793005 | Unit of presentation size quantity |

320091000221107 | Unit of presentation size unit |

<  767524001 |Unit of measure (qualifier value)|

774158006 |Has product name|

< 774167006 |Product name (product name)|

774159003 |Has supplier|

< 774164004 |Supplier (supplier)|

762949000 |Has precise active ingredient|

< 105590001 |Substance|

732943007 |Has basis of strength substance|

< 105590001 |Substance|

1142135004 |Has presentation strength numerator value|

732945000 |Has presentation strength numerator unit|

< 767524001 |Unit of measure (qualifier value)|

1142136003 |Has presentation strength denominator value|

732947008 |Has presentation strength denominator unit|

<  767524001 |Unit of measure (qualifier value)|

762949000 |Has precise active ingredient|

<  105590001 |Substance|

732943007 |Has basis of strength substance|

<  105590001 |Substance|

1142138002 |Has concentration strength numerator value|

733725009 |Has concentration strength numerator unit|

<  767524001 |Unit of measure (qualifier value)|

1142137007 |Has concentration strength denominator value|

733722007 |Has concentration strength denominator unit|

<  767524001 |Unit of measure (qualifier value)|

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: 

1142141006 |Count of base and modification pair|

...

Range

• INT (integer)

Cardinality

• 1..1

• Name parts (in addition to the product name and manufacturer/supplier organisation, which are definitional attributes):
  
  • 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 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®")

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: 

1142140007 |Count of active ingredient|

...

Range

• INT (integer)

Cardinality

• 1..1

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 21: Template for a real clinical drug

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

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Figure 22: Single active ingredient substance (presentation strength) real clinical drug example - stated view

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Figure 23: Single active ingredient substance (presentation strength) real clinical drug example - inferred view

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

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Figure 24: Multiple active ingredient substance (presentation strength) real clinical drug example - stated view

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Figure 25: Multiple active ingredient substance (presentation strength) real clinical drug example - inferred view

Example: single active ingredient substance branded product (Canesten) (concentration strength): stated view followed by the inferred view

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Figure 26: Single active ingredient substance (concentration strength) real clinical drug example - stated view

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Figure 27: Single active ingredient substance (concentration strength) real clinical drug 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

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Figure 28: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug - real clinical drug example - stated view

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Figure 29: Single active ingredient substance (concentration and presentation strength) with equivalent clinical drug - real clinical drug 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

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Figure 30: Single active ingredient substance (concentration and presentation strength) without equivalent clinical drug - real clinical drug example - stated view

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Figure 31: 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 too.

IDMP Compatibility

...

Use cases supported by Real Clinical Drug

• 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/used
• 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