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The Mapping Policy describes the guidelines that govern the map as a whole.
Aim and Objectives
The aim of the EDQM to SNOMED CT map is to produce as close as possible to an exact semantic match mapping between the EDQM Pharmaceutical Dose Forms in EDQM Standard Terms as the source and the SNOMED CT descendants of 736542009 | Pharmaceutical dose form (dose form) | as targets, to support the use cases described.
The map aims as much as possible for a 1..1 exact semantic match of the pharmaceutical dose forms. In order to achieve that aim, the semantics of each source concept and possible target concepts have been examined in detail, using all available information and ascertaining what within that information was definitional and what was to be considered either descriptional (only) or "implementation guidance" (the latter applying especially for the EDQM Standard Terms).
If, having undertaken that examination, an exact match was not possible, where appropriate within existing guidance, additional concepts were authored within SNOMED CT to support an exact match. For some individual concepts and some groups of concepts (for example, those with more than one intended site), this is an ongoing process and may involve further changes within the SNOMED CT dose form content.
Although the process for change within EDQM Standard Terms is more complex for a variety of various reasons, some recommendations for change to EDQM Standard Terms have also been made, especially when these are in accordance with recommendations from other groups working with the EDQM Dose Forms.
When studying fully specified names for SNOMED CT dose form concepts and particularly when requesting new concepts, the implications of different languages and the translation process have been considered in order to facilitate as much as possible clarity in the semantics of the domain in different languages. However, not all the challenges are directly resolvable, especially when a particular language does not have words to distinguish between concepts with different pharmaceutical meanings (for example, some languages do not have a different word for a transdermal patch, only a word for a plaster).
Scope
Map source: EDQM Pharmaceutical Dose Forms (PDFs)
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Definition of a pharmaceutical dose form: “the physical manifestation of a Medicinal Product that contains the active ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient” Based on the use cases, PDFs that have been inactivated in EDQM may still be used in product SmPCs; these will require a historical association to an active PDF. This should be considered once the initial scope has been completed. Patient Friendly Terms (PFT) are currently excluded; these may be used in product labelling but are not used as a definitional attribute for a medicinal product. Authorised dose forms (those that may be used in section 3 of an SmPC in Europe) include Combined Pharmaceutical Dose Forms, Combined Terms and Combination Pack concepts as well as PDFs. In order to fulfill use case 1, these concepts may require the addition to SNOMED CT, but currently they are out of scope. A map between the EDQM and SNOMED CT dose form characteristic/attribute values has not been undertaken since in EDQM the characteristics are not definitional. But as discussed in the Principles section following, consistent patterns for the characteristic/attribute values for the various groups of dose forms have been considered wherever possible. |
"No map" codes
When an EDQM Standard Terms code is in the scope of the map but no semantically matching concept is present in SNOMED CT this is considered a "No map". A significant number of new PDF concepts have been authored in SNOMED CT to resolve this "No map" situation when it has been possible to confirm that the PDF is used to describe one or more medicinal concepts authorised in member countries. As noted in the section describing the EDQM PDFs, EDQM will categorise a dose form as for "human and veterinary use" even if it is requested for initial use with a veterinary medicinal product unless the PDF is specifically for veterinary application (e.g. "Continuous-release intraruminal device"). Therefore there are EDQM PDFs that are within the scope stated above but which have never been used to describe a medicinal product for human use. Whilst it would be possible to author PDF concepts in SNOMED CT that are an exact match for many of these EDQM PDFs, having concepts in SNOMED CT that are not directly required to support patient care is not sensible. However, as each of these EDQM PDFs have been evaluated, they have been assigned an additional category:
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The assignment of intended maps to these categories will be used to inform future updates of this map.
Association/Correlation and Cardinality
The aim is for the source and target to be "equivalent" (i.e. an exact semantic match).
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