Medicinal Product (MP)

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.

Medicinal Product (MP containing) (open world view)

Definition of MP (containing)

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.   

Example diagrams for MP (containing)

Stated template view:

Figure 10: Medicinal Product (containing) stated template view

Example: single active ingredient product: stated view followed by the inferred view that shows the grouper concepts associated with the product:

Figure 11: Medicinal Product (containing) example stated view

Figure 12: Medicinal Product (containing) example inferred view

Example: multiple active ingredient product: stated view followed by the inferred view that shows the grouper concepts associated with the product:

Figure 13: Medicinal Product (containing) example stated view - multi-ingredient concept

Figure 14: Medicinal Product (containing) example inferred view - multi-ingredient concept

Attributes of MP (containing)

The "containing Medicinal Product" (MP containing) concept is defined by a single attribute:

Use case(s) supported by MP (containing)

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.

Availability of MP (containing) concepts in the international release

This class forms part of the medicinal product content provided in the international release.

IDMP Compatibility for MP (containing)

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. 

Medicinal Product (MP only) (closed world view)

Definition of MP (only)

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. 

Example diagrams for MP (only)

Stated template view:

Figure 15: Medicinal Product (only) stated template view

Example: single active ingredient product: stated view followed by the inferred view that shows the grouper concepts associated with the product: 

Figure 16: Medicinal Product (only) example stated view

Example inferred view: 

Figure 17: Medicinal Product (only) example inferred view

Example: multiple active ingredient product: stated view followed by the inferred view that shows the MP (containing) parent concept associated with the product:

Figure 18: Medicinal Product (only) example stated view - multi-ingredient concept

Figure 19: Medicinal Product (only) example inferred view - multi-ingredient concept

Attributes of MP (only)

The " Medicinal Product containing only" (MP only) concept is defined by two attributes describing the active ingredient(s) and the ingredient count:

Use case(s) supported by MP (only)

There are several use cases that the MP (only) concept can support:

• In national extensions; where it is useful for various clinical purposes, such as prescribing scenarios (so called "abstract" or "non-product-based" prescribing) and in medication history and in Medication Profiles
• Internationally and nationally in decision support and in protocols and treatment guidelines
• Internationally and nationally for interoperability of patient medication information such as in patient summaries
• Internationally and nationally for recording adverse events and/or sensitivities to medication, particularly for multi-ingredient preparations where there will be no appropriate single substance concept and it is not possible to say which particular active ingredient is responsible for the issue
• In pharmacovigilance, especially for description of concomitant medications where less information may be available (see also below in IDMP Compatibility)
• In analysis and research
• As a supporting attribute for other concepts elsewhere in SNOMED CT

Availability of MP (only) concepts in the international release

This class forms part of the medicinal product content provided in the international release.

IDMP Compatibility

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, vaccines are out of scope for the Medicinal Product hierarchy model in SNOMED CT.

Medicinal Product (MP precisely) (closed world view) - optional concept class - not populated in the International Release

Definition of MP (precisely)

An abstract representation of a medicinal product based on description of only and exclusively the precise active ingredients it contains.

For example, "Product containing amoxicillin sodium precisely" represents products that must contain precisely amoxicillin sodium not amoxicillin trihydrate nor a substance that is any further modification of amoxicillin sodium, should one exist; and they must not contain any other active ingredients, such as clavulanic acid. 

A Medicinal Product (MP precisely) concept may be created in national extensions when use case(s) require this (see below) and for those national extensions where products exist such that the Active Ingredient Count attribute for the MP precisely has a different value from the Active Ingredient Count of the parent Medicinal Product (MP only) concept.  It is described here for completeness and to acknowledge that this is a key issue for many national terminologies.  For further details and examples, see the Ingredient Count attribute section below.

Example diagrams for MP (precisely)

Example: product with a "multiple modified" active ingredient substance (dexamethasone phosphate is the modified concept that has a further modification to give dexamethasone sodium phosphate): stated view,  showing both the count of the base active ingredient and the count of base and modification pair are present, as the substance has a multiple modification (dexamethasone phosphate is the modified concept that has a further modification to give dexamethasone sodium phosphate) and there are multi-ingredient concepts that contain this multiple modified substance and at least one other modified ingredient substance that shares the same base substance (dexamethasone) (see next examples). The multi-ingredient concept is "dexamethasone sodium phosphate and dexamethasone acetate".  As described in the MRCM rules, the additional ingredient count attributes have to be applied iteratively.  The following inferred view shows the correct dexamethasone moiety MP (only) parent concept.

Figure 20:  Single Ingredient Medicinal Product (precisely) example stated view 

Figure 21: Single Ingredient Medicinal Product (precisely) example inferred view 

Example: multi-ingredient concept, where both precise active ingredient substances share the same base moiety substance, showing requirement for two ingredient count attributes; note that because these attributes must be applied iteratively, the MP precisely concepts exist for each single ingredient product

Figure 22: Medicinal Product (precisely) example stated view - multi-ingredient concept 

Figure 23: Medicinal Product (precisely) example inferred view - multi-ingredient concept 

The count of base and modification pair ensures that this multi-ingredient product does not incorrectly subsume under either of the single ingredient products, since they have a base and modification pair count of one and this has a base and modification pair count of two. It can subsume under the parent "Product containing only dexamethasone" as shown in the diagram above, as "Product containing only Dexamethasone" has a Count of base of active ingredient of 1, and that one is dexamethasone (substance), which is the same as for the "Product containing only Dexamethasone acetate and Dexamethasone sodium phosphate".

The requirement for all the three ingredient count attributes depends significantly on how the substance hierarchy is modelled.  For example, with calcium products (calcium lactate and calcium lactate gluconate) if both are considered modifications of "calcium (substance)" then for multi-ingredient products containing both, the three ingredient counts would be required to obtain correct classification for MP only and MP precisely concepts. 

For further details, see the Ingredient Count attributes below.

Attributes of MP (precisely)

The " Medicinal Product containing precisely" (MP precisely) concept is defined by two groups of attributes; to describe the precise active ingredient(s) and the ingredient count(s).  The ingredient count attributes are applied incrementally, as the requirement arises for MP precisely concepts; this is a pragmatic and incremental approach to maintenance of the hierarchy.  Although it is desirable for attributes to be applied globally, this would introduce a significant maintenance burden for what is required in only a minority, although a significant minority, of cases.  They are applied when the requirement to describe products that contain two or more active ingredients that are modifications of the same base and are applied from the top down (i.e. from the MP precisely class, down to the clinical drug class, including the MPF precisely if required) within the particular sub-hierarchy base ingredient concept.

In national extensions using the MP precisely concept where there is no MP precisely concept in the international and CD concepts do not have multiple ingredient counts so that classification results are not as expected, it may be necessary to override the international definition of some concepts in the sub-hierarchy in the national extension (e.g. if a CD containing one of the precise ingredient substances has only one count attribute in the international, but requires two or three count attributes in the national in order to get correct classification into an MP precisely concept).

Use case(s) supported by MP (precisely)

The use case for the MP (precisely) concept is primarily to provide a more exact and explicit medicinal product concept for use in those scenarios where different modifications of the base active ingredient have clinical significance - usually because of different potency and different dosing schedules. There are several groups of products where this is the case, for example the corticosteroids, various of the anti-epileptic medications (e.g. phenytoin and valproic acid), and insulins.  The the MP (precisely) class can be deployed in national extensions for those use cases that need it, such as prescribing scenarios (so called "abstract" or "non-product-based" prescribing where no product and no dose form are specified by the prescriber) and in medication history and in medication profiles, and in decision support, in protocols and treatment guidelines.  However, all the use cases described for MP (only) could use MP (precisely) as necessary when more exact and explicit representation is required.

Availability of MP (precisely) concepts in the international release

This class will not form part of the medicinal product content provided in the international release.  National extensions may require this subclass for certain use cases for particular types of products, as described above.

IDMP Compatibility for MP (precisely)

The MP (precisely) concept may also be directly compatible with the ISO 11616 concept of a level 1 Pharmaceutical Product (PhPID_SUB_L1), especially if the "active substance set" is likely to be described including all modifications.  However, since SNOMED CT model use cases suggest that MP (precisely) concepts are created only when different modifications of the base active ingredient have clinical significance, the number of MP (precisely) concepts that will exist in SNOMED CT is likely to be far less than the number of PhPID_SUB_L1 concepts. 

It would theoretically be possible to create MP (precisely) concepts for a larger set of modified active ingredient substances, even if the modification had no clinical significance, in order to map to more IDMP PhPID_SUB_L1 concepts.  However, this may create issues elsewhere, particularly since it is known that having a large number of similar concepts available in a selection list increases safety risks for patient care.  Therefore, the use of MP (precisely) should be limited to only those situations where different modifications of the base active ingredient have clinical significance.