Definition

An abstract representation of a medicinal product as it is supplied in a package for placement into the supply chain, based on description of and quantity of the clinical drug(s) contained within that package. As an abstract class, the Packaged Clinical Drug is placed on the left hand side of the overall model, relating directly to the Clinical Drug class in the international core by means of a composition relationship, but its population is the responsibility of national extensions since the amount of content needed to support this internationally would be overwhelming and unmanageable in maintenance and verification.

This definition supports the description of kit or combination products (medicinal products that are composed of more than one clinical drug - such as a package containing fluconazole oral capsules and clotrimazole cream for treatment of vaginal thrush as packaged clinical drugs, and therefore the pack size information for each clinical drug that is a component in the package is grouped together. Further detail on the description of combination products (multi-component or kit products) is given below.

Use Cases

The following use cases are supported by the Packaged Clinical Drug concept class:

• Reimbursement: national or local systems may set pricing or eligibility against an abstract representation of real packaged products (e.g. for interchangeability and substitution)
• As a linking class from the international core to the Real Packaged Clinical Drug class for any national extension that did not require a Real Clinical Drug class (i.e. if all products are authorised in their packaged form)
• To support description of combination packaged products

Discussion

Packs of medicinal products must be represented using the closed world view; they contain only the clinical drug content stated.  The packaged clinical drug class is related to the clinical drug class by a composition relationship relationship, the package contains the clinical drug.  To correctly describe this and so to ensure that pack concepts classify correctly, so that packs that contain more than one (type of) clinical drug (i.e. combination packs) do not classify as children of packs that contain only one type of clinical drug, it is necessary to use a "clinical drug count" attribute as a proxy for the closed world view, in a similar way to the use of the active ingredient count attribute used for MP only concepts, MPF only concepts and clinical drug concepts.   By using a "count" attribute in the definition of closed world concepts, the count information is machine processable and therefore if/when a more expressive description logic becomes available to properly represent the closed world view, then all the count attributes can be used to transfer to the closed world description logic consistently.

Figure 28: Diagram of the packaged clinical drug class and its composition relationship to clinical drug, with an example (Zocor)

The national extension model does not represent intermediate layers of packaging; it represents only the outer package used in the supply chain. Describing "sub-packs" (e.g. tablets within blister sleeves, which are then within a container such as a box) is complex for a description logic based model and is currently out of scope for this initial version of the national extension specification. In most nations, sub-packs are primarily used for supply chain management and reimbursement purposes, and possibly rounding of dispense amounts so that sub packs are not split. Many medicinal product terminologies do not represent sub-packs.  ISO 11615, the Medicinal Product part of the IDMP suite of standards, has a full sub-pack mode, but the sub-packs themselves are not identified concepts and so are not available for mapping etc.; however the GS1 implementation of ISO TS 16791 does include identification of sub packs. 

Existing national terminology equivalents:

• • UK's NHS dm+d this is the Virtual Medicinal Product Pack (VMPP) class
  • The AMT/NZULM it is the Medicinal Product Pack
  • In Ireland, this is in effect those packaged products on the Representative Pricing list
  • The generic pack (GPCK) class in RxNorm

Attributes

The following table describes the attributes for packaged clinical drugs that contain one type of clinical drug only. That is they are NOT combination (multi-component or kit) products. 

The packaged clinical drug class is related to the clinical drug class by a composition relationship relationship, and therefore the attribute "contains clinical drug" is used to make the association between the packaged clinical drug and the clinical drugs it contains. 

Representation of packaged medicinal products should use clinical drugs that have presentation strength (either only or in addition to concentration strength) whenever possible in order to be able to accurately describe the number of presentation units present in the package. The exception will be for continuous products such as semi-solid dose forms of creams, gels etc. where strength pattern 3a is used (see international Editorial Guidelines). In all cases the pack size and pack size unit should relate to the denominator unit of the strength.

Example Diagrams

Some examples of packaged clinical drug (PCD) concepts are shown below.

Stated template view:

Figure 29: Template for simple packaged clinical drug

Example: single active ingredient substance presentation strength packaged clinical drug: stated view followed by the inferred view

Figure 30: Example of a presentation strength packaged clinical drug - stated view

Figure 31: Example of a presentation strength packaged clinical drug - inferred view

Example: single active ingredient substance presentation strength packaged clinical drug: stated view followed by the inferred view

Figure 32: Example of a concentration strength packaged clinical drug - stated view

Figure 33: Example of a concentration packaged clinical drug - inferred view

Optional Additional Information

The following information may be additionally used to describe characteristics of the packaged clinical drug concept in a national extension:

• Package/container type (e.g. bottle, box, jar, tube) 
• Administration device supplied in the package (e.g. medicine spoon, vaginal applicator, applicator brush for cutaneous liquid products)

IDMP Compatibility

There is no representation of a class similar to the Packaged Clinical Drug concept class; the primary use case for this class beyond support for generic representation of combination products is reimbursement, which is out of scope of IDMP. Combination products in their entirety are only represented in IDMP in their authorised form; there is no PhP type representation for them.