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) 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 precisely) class in the international core.
Discussion of Real Clinical Drug (RCD)
Most but not all regulatory authorities license products at this level, 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. 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 section 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:
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.
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 (precisely) class in the international 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 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.
| Semantic tag | (real clinical drug) |
| Definition status | 900000000000073002|Sufficiently defined concept definition status (core metadata concept) This can only be the case if extensions author concepts to represent product names and manufacturer/supplier organisations |
Attribute: Has manufactured dose form |
This is the finished dose form that the manufactured product is presented in by the manufacturer, before any transformation into an administrable dose form has taken place. |
Attribute: Count of base of active ingredient |
|
Attribute: Has unit of presentation |
|
* Relationship group - for presentation strength | One relationship group containing only the following six attributes is required for each active ingredient
|
|
|
|
|
Attribute:
|
|
Attribute:
|
|
Attribute:
|
|
Attribute:
|
|
* Relationship group - for concentration strength | One relationship group containing only the following six attributes is required for each active ingredient
|
|
|
|
|
|
|
|
|
|
|
|
|
Attribute: Has product name |
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 10.1 below) |
Attribute: Has supplier |
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 10.2 below) |
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.
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/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
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.
Feedback
Overview
Content Tools
Apps