National Drug Extension Model

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Definition

The representation of a medicinal product as it is supplied in a package that contains within the package more than one type of clinical drug. 

Use Cases

The use cases supported by the Combination (Real) Packaged Clinical Drug concept type are the same as those for the basic real packaged clinical drug, with the additional detail that administration records may wish to identify which of the particular component clinical drugs were administered at any particular point in time administration event (using AIDC or similar).

Discussion

For abstract concepts, the combination packaged clinical drug, contains two or more different clinical drugs.

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Gliffy Diagram
macroId2aa7a840-f5c1-40c9-8baf-6db72049f8ab
displayNameCombination PCD
nameCombination PCD
pagePin1


Figure 3945: Diagram of options for a national extension describing combination real packaged clinical drugs

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For those combination packages that contain a diluent as an item in the package, national extensions may decide not to explicitly describe the diluent as a component, but merely to describe its presence in the text of the fully specified name for the real packaged medicinal product; alternatively the national extension may author a "diluent" clinical drug concept and use that as one of the components of the combination product. If the constitution of the diluent is known (e.g. water for injections, 0.9% sodium chloride solution for injection), the clinical drug for the diluent can be explicitly described.  Dual chamber products containing the two components (where one is the diluent) in a single unit of presentation can be described as combination products if required.

Attributes

The following table describes the attributes for combination (real) packaged clinical drugs in a national extension.

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Semantic tag

(packaged clinical drug)

OR

(real packaged clinical drug)

Definition status


Scg expression
900000000000073002 |Sufficiently defined concept definition status (core metadata concept)

Note: This can only be the case if extensions author concepts to represent real clinical drugs and/or product names and manufacturer / supplier organisations

Attribute: 


Scg expression
1142143009 |Count of clinical drug type|


Range

  • INT (integer)

Cardinality

  • 1..1

Note

  • This attribute provides the number (count) of distinct clinical drug (concepts) present in the package.  For combination packages, this value should be greater than one

Attribute 

Attribute: 
Scg expression
774158006 |Has product name|



  • Scg expression
    < 774167006 |Product name (product name)|


    • Extensions must author product name concepts within their extension using the root of 
      Concept
      t774167006 |Product name (product name)|
       from the Qualifier hierarchy

Cardinality

  • 0..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)
  • This attribute should only be valued in the rare circumstances when the product name for the combination product is known to be different from the product name of the component real clinical drugs

Attribute: 

Attribute:
Scg expression
774159003 |Has supplier|



  • Scg expression
    < 774164004 |Supplier (supplier)|


    • Extensions must author concepts to value supplier organisation information within their extension using the root of 
      Concept
      t774164004 |Supplier (supplier)|
       from the Qualifier hierarchy

Cardinality

  • 0..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)
  • This attribute should only be valued in the rare circumstances when the supplier for the combination product is known to be different from the supplier of component real clinical drugs
Role Group 
1..* for combination packaged clinical drugs

Attribute:


Scg expression
774160008 |Contains clinical drug|



  • Scg expression
    < 763158003 |Medicinal product (product)|


Cardinality

  • 1..1

Note

  • This attribute value represents the real clinical drug that is contained in the packaged product
    It is currently not possible to explicitly specify an expression to describe the range of (real) clinical drugs from a national extension to populate this attribute, since a range cannot currently recognise a set of concepts with a particular semantic tag - in this case "(real clinical drug)".  For the interim, the range is specified as the descendants of the root medicinal product concept: 763158003 |Medicinal product (product)|. 

Attribute: 


Scg expression
1142142004 |Has pack size|


Range

  • INT (integer)

Cardinality

  • 1..1

Note

  • This attribute represents the amount or quantity of the clinical drug in the role group present in the package; for presentation strength it is the number of countable units of presentation in the package; for concentration strength it is the mass or volume of the continuous dose form in the package

Attribute: 


Scg expression
774163005 |Has pack size unit|



  • Scg expression
    <  767524001 |Unit of measure (qualifier value)|


Cardinality

  • 1..1

Note

  • This attribute value represents the unit of measure of the pack size in the role group;  for presentation strength it is the unit of presentation in the package; for concentration strength it is the unit of mass (e.g. gram) or volume (e.g. millilitre) of the continuous dose form in the package. 
    More specific range expressions such as "One of EITHER 732935002 | Unit of presentation (unit of presentation) - descendants only OR 258680008 | Unit of mass (qualifier value) - descendants only OR 258769000 | Unit of volume (qualifier value) - descendants only" are currently not supported, nor are rules based on the strength patterns that (for example) assert "if the clinical drug has a unit of presentation of 'tablet' then the Has_pack_size_unit will be valued as 'tablet").


Example Diagrams

Example: combination packaged clinical drug: stated view followed by the inferred view

Figure 4046: Example of a combination packaged clinical drug - stated view

Figure 4147: Example of a combination packaged clinical drug - inferred view

Example: combination real packaged clinical drug: stated view followed by the inferred view

Figure 4248: Example of a combination real packaged clinical drug - stated view

Figure 4349: Example of a combination real packaged clinical drug - inferred view

IDMP Compatibility

Since the ISO 11615 standard treats all Packaged Medicinal Products in the same manner, whether they are standard products or combination products, because the associations between the manufactured item(s) present in the package are described using recursive relationships, the Combination Real Packaged Medicinal Product is equivalent to a Packaged Medicinal Product identified by a PCID. As with the Real Packaged Medicinal Product. the Combination Real Packaged Medicinal Product  is a representation of the "real world product" authorised for sale and/or supply that exists for all jurisdictions and which is marketed into the supply chain for use, it is a concept that should form the 1:1 join between representation in the regulatory domain (IDMP) and representation in the clinical domain (SNOMED CT and national medicinal product terminologies), even if some national medicinal product terminologies choose not to represent it.

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