An abstract representation of a medicinal product without reference to its dose form or its strength. This group of concepts has three types, of which is the parent is the "MP containing", with the "MP only" and the optional "MP precisely" being child concepts of that parent.
An abstract representation of a medicinal product based on description of active ingredient substance(s) that it contains (regardless of any modification of those active ingredient substance(s)), but not exclusively limited by those substances, in that other substances may be present.
For example, "Product containing amoxicillin" represents products that must contain some amoxicillin (with any type of modification, be it amoxicillin sodium or amoxicillin trihydrate, or no modification, as in amoxicillin (base)), but may also contain other active ingredients, such as clavulanic acid.
In stating “an abstract representation of a medicinal product” the concept definition implies that at least one medicinal product exists or has existed globally that has that set of active ingredient substance(s); this precludes the possibility of generating MPs representing theoretical, or indeed all possible, combinations of sets of active ingredient substances.
Stated template view:
Figure 12: Medicinal Product (containing) stated template view
Example: single active ingredient product: stated view (including therapeutic role) followed by the inferred view that shows the grouper concept associated with the product:
Figure 13: Medicinal Product (containing) example stated view
Figure 14: Medicinal Product (containing) example inferred view
Example: multiple active ingredient product: stated view followed by the inferred view that shows the single active ingredient MP concepts that are the proximal parent concepts for the multiple active ingredient product:
Figure 15: Medicinal Product (containing) example stated view - multi-ingredient concept
Figure 16: Medicinal Product (containing) example inferred view - multi-ingredient concept
The "containing Medicinal Product" (MP containing) concept is defined by a single attribute:
| Semantic tag | (medicinal product) | |||
| Definition status | Exceptions
| |||
| Role Group | Attribute
| Range
Cardinality
Notes
This attribute describes the set of active ingredient substances that the concept minimally contains. A set set of active ingredient substances may well have only one member. | ||
The main use case for describing products containing some active ingredient substance(s), is for analysis; as an aggregation concept for use in research. Details of further use cases will be added as they become available.
This class forms part of the medicinal product content provided in the international edition.
A concept at this level with the open world view does not correspond to any concept currently in the IDMP suite of standards, although it could act as a parent (higher level grouper) concept for PhP1 concepts, if use case(s) were identified to require this.
An abstract representation of a medicinal product based on description of only and exclusively the active ingredient substance(s) that it contains but regardless of any modification of those active ingredient substance(s). This is effectively the "set of active moiety(ies)" of the medicinal product.
For example, "Product containing amoxicillin only" represents products that must contain only amoxicillin ((with any type of modification, be it amoxicillin sodium or amoxicillin trihydrate, or no modification, as in amoxicillin (base)); they must not contain any other active ingredients, such as clavulanic acid.
Stated template view:
Figure 17: Medicinal Product (only) stated template view
Example: single active ingredient product: stated view followed by the inferred view that shows the proximal parent MP concept associated with the product:
Figure 18: Medicinal Product (only) example stated view
Example inferred view:
Figure 19: Medicinal Product (only) example inferred view
Example: multiple active ingredient product: stated view followed by the inferred view that shows the proximal parent MP containing concept associated with the product:
Figure 20: Medicinal Product (only) example stated view - multi-ingredient concept
Figure 21: Medicinal Product (only) example inferred view - multi-ingredient concept
The " Medicinal Product containing only" (MP only) concept is defined by two attributes describing the active ingredient(s) and the ingredient count:
| Semantic tag | (medicinal product) | |||
| Definition status | Exceptions
| |||
Attribute
| Range
Cardinality
Notes
| |||
| Role Group | Attribute
| Range
Cardinality
Notes
| ||
There are several use cases that the MP (only) concept can support:
This class forms part of the medicinal product content provided in the international edition.
Description of the MP Precisely, which is not populated in the International Edition, has moved to the National Extension model.
The MP (only) concept might be directly compatible with the ISO 11616 concept of a level 1 Pharmaceutical Product (PhPID_SUB_L1), where the "active substance set" comprises the definition of this concept. However, the granularity of description of substance for the PhP1 is not completely clear, but may be more granular than that used for the MP (only) concept. The MP (only) concept is defined by "only and exclusively the active ingredient substance(s) that it contains but regardless of any modification of those active ingredient substance(s)" whereas the PhP1 will likely use a substance description that includes any modification, including when there are multiple modifications (e.g. a solvated salt modification). See also the MP (precisely) concept below.
Note that, in IDMP, for products using adjuvants it is probable that the adjuvant would be included as part of the "active substance set" and its role explicitly identified. For example aluminium hydroxide is used as an adjuvant in several vaccine products (e.g. hepatitis A, hepatitis B) in addition to the antigen itself to enhance the immune response; it is not an active ingredient per se and it is not an inactive ingredient, it is explicitly an "adjuvant". However, this type of detail of the implementation of the abstract model of ISO 11616 remains unclear, and in its first implementation, the modelling of adjuvants in the vaccine content in the SNOMED CT international edition has not been finalised.