Real Clinical Drug (RCD) (closed world view)

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 supported by Real Clinical Drug

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 of Real Clinical Drug (RCD)

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 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).  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.

Concentration and presentation strength clinical drugs in national extensions:

Clinical drug concepts in the international edition are authored either using presentation strength (for discrete dose forms) or using concentration strength (for liquid dose forms and patches etc.) as appropriate for different types of product (see Appendix A of the international specification).  In national extensions this may be sufficient, or there 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:

Figure 13: 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. pre-filled syringes) and may change for others as IDMP takes effect. Some national terminologies are working to normalise the patterns of strength representation particularly for safety considerations; others are dealing with the mixed economy that exists "as is". This international specification provides support for the different patterns for both clinical drugs and real clinical drugs whilst maintaining the requirement that concepts will classify correctly within the system.  

Concentration and presentation strength clinical drugs for a national extension:

This is the pattern for a national extension to author a presentation strength representation of a clinical drug that is described using concentration strength in the international edition.  This can be used for

• liquid parenteral products presented in units of presentation such as ampoules, vials, pre-filled syringes, cartridges or bags/bottles 
• liquid oral products presented in a sachet or other unit dose unit of presentation
• liquid pulmonary products presented in a unit dose presentation unit of presentation

In addition to the usual attributes for a concentration strength clinical drug, the unit of presentation size and unit of presentation unit attributes are used.  The concept will then classify correctly as a child of the existing concentration strength clinical drug.  This does mean that the exact presentation strength must be authored manually as an additional description and that the exact presentation strength is not provided in the logical definition (other than via calculation) but this pattern has been found to be the most efficient method for authoring such concepts, especially when there are multiple active ingredient substances.  The alternative was to author both concentration strength and presentation strength in two role groups which, whilst it does also give the correct classification, is very labour intensive.

Attributes of a concentration and presentation strength clinical drugs for 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 has attributes inherited from the clinical drug class in the international edition 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 and the national editorial guidelines. In order to support correct classification, a liquid product being described using a presentation strength 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.

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.

Examples

Stated template view:

Figure 11: Template for a real clinical drug

Example (stated view):

Figure 12: Example of a real clinical drug (presentation strength) - stated view

Example (inferred view):

Figure 13: Example of a real clinical drug (presentation strength) - inferred view

Example (stated view):

Figure 14: Example of a real clinical drug (presentation and concentration strength) - stated view

Example (inferred view):

Figure 15: Example of a real clinical drug (presentation and concentration strength) - inferred view

Optional additional information

Some or all of the following items of information may be used to describe the Real Clinical Drug concept in a national extension. The attribute concepts and values to populate these, if this data is to be held in a structured form, would need to be authored into the extension using reference sets.

• 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 indication for the product (e.g. "Shingles treatment")

  • 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®"))
• Excipient substances playing some or all of the following roles:
  • Flavours
  • Colours
  • Preservatives
  • Stabilisers
• License information
  • License holding organisation
  • License identification ("authorisation number")
  • Licensing class and/or legal status of supply
• Usage information (prescribability within a particular jurisdictional context) including legal status and licensed indications
• 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

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.