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The following sections discuss the attribute concepts used to represent the ingredient substances of concepts in the medicinal product hierarchy.
Ingredient Substances
Gliffy Diagram size 800 displayName Ingredient substance attributes name Ingredient substance attributes pagePin 1
Figure 46: Ingredient role attributes
The diagram above shows the relationship of the various attribute roles that a substance can play in the definition of MP, MPF and CD description of medicinal products. Any concept from the Substance hierarchy may play one or more of these roles within a product. In all of the descriptions below, when the phrase "a set of substances" is used, the set may have only one member.
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The Medicinal Product and Medicinal Product Form use the active ingredient attribute, which will have a role chain attached to it, so that it can use the Substance hierarchy as a hierarchy through the "is modification" relationship. This allows the classifier to make the appropriate relationships between MPs, MPFs and CDs based on their active ingredient substances. The role chain is a characteristic that is not inherited, so the precise active ingredient attribute does not inherit this characteristic. The Clinical Drug uses the precise active ingredient attribute/relationship which will use the Substance hierarchy as a flat list without role chaining, so that a clinical drug containing a modified substance is not subsumed under a clinical drug containing the unmodified substance, thereby unintentionally adding more recursion to the clinical drug class (for example: so that a morphine (base) precise clinical drug does not subsume a clinical drug containing precisely morphine sulphate).
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Figure 47: Ingredient role chaining
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Figure 48: Ingredient role chaining example
IDMP Compatibility
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Figure 49: Ingredient role in ISO 11615 of IDMP
Ingredient role is a specific attribute in ISO 11615 in IDMP, but no vocabulary/value set was specified in the conceptual standard for the ingredient roles. Examples that have been given include "active", "inactive" and "adjuvant". This supports the regulatory listing of all the substances present in a product, with their basic role (therapeutic or otherwise).
The explicit use of ingredient roles in the medicinal product model is compatible with the IDMP conceptual model; however, the relationship of ingredient role to substance strength is still being elucidated in IDMP. Note that the concept of "basis of strength substance", in the very few cases where it is not actually a substance present in the product, is managed by the use of the Reference Substance class in IDMP. See also IDMP Compatibility for Clinical Drug (Clinical Drug (CD)).
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