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The policies and principles used to develop the mapping from EDQM to SNOMED CT pharmaceutical dose forms are described below.

Aims and Objectives

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 To produce as close as possible to a 1..1 exact semantic match mapping between the EDQM Pharmaceutical Dose Forms as source and the SNOMED the SNOMED CT descendants of 736542009 of 736542009 | Pharmaceutical dose form (dose form) | to support the use cases described above..  By aiming as much as possible for a 1..1 exact semantic match, the map reduces the risk of different implementations of it being slightly different, which would reduce its value for at least two of those use cases - for international interoperability of medication information and for facilitation of decision support.

In order to achieve that aim, the semantic of each source concept and possible target concepts has 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 Terms).

If, having undertaken that examination, if 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 for 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 is more complex for a variety of reasons, some recommendations for change to EDQM 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 has 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 meaning (for example, some languages do not have a different word for a transdermal patch, only a word for a plaster)When an exact match is not possible, further discussions will be undertaken with the relevant parties and guidance will be offered to users of the map.  

Scope

Map source: EDQM Pharmaceutical Dose Forms (PDFs)

Active PDFs at 2021-0907-07 31 that are not ‘Veterinary only’
A "snapshot" full download of EDQM PDF data was taken via the EDQM API Add table of excluded EDQM dose forms.

The following EDQM PDFs are considered "out of scope" since they either support types of products that are currently out of scope for the SNOMED CT medicinal product hierarchy (e.g. herbal products, blood products) or they are not PDFs within the SNOMED CT definition (e.g. the solvent terms, the living organisms).

EDQM IDEDQM Term
EDQM IDEDQM Term
10122000Herbal tea
11216000Solvent for parenteral use
10202000Instant herbal tea
13035000Solvent for...
13106000Oral herbal material
10608000Eye drops, solvent for reconstitution
12105000Radiopharmaceutical precursor
10611000Eye lotion, solvent for reconstitution
12106000Radionuclide generator
50076000Solvent for solution for infusion
12107000Kit for radiopharmaceutical preparation
50074000Solvent for solution for intraocular irrigation
50056500Radiopharmaceutical precursor, solution
12118000Living tissue equivalent
12102000Anticoagulant and preservative solution for blood
13115000Medicinal leech
12103000Solution for blood fraction modification
13124000Medicinal larvae
12112000Solution for organ preservation
13118000Tablet with sensor
10121500Dispersible tablets for dose dispenser


Map target: SNOMED CT 20210731 20220731 international edition

Active concepts that are < 736542009 | Pharmaceutical dose form (dose form) |

See also the "No Map" section below for further information about Scope and concepts that are marked as "No map".



Note

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 fulfil use case 1, these concepts may require addition to SNOMED CT but currently they are out of scope. 

We are not mapping the EDQM and SNOMED CT dose form attribute values, because for EDQM, these are not definitional so might give us misleading results if we then tried to do an "automatic" map based on these.  However, we are noting when the attribute values between two concepts that give an exact map based on their definition do not have an exact attribute value map.

Cardinality

...

.

Association/Correlation and Cardinality

The aim is for the source and target to be "equivalent" (i.e. an exact semantic match).

But there will be some maps that are not exact, but which we wish to make and to note that they provide enough value to the use cases to be made.  In these situations the map will have a different association.:

Narrower A narrower (than) map: Use this This association is used when the meaning of the SNOMED CT concept is narrower than the meaning of the EDQM concept concept

  • Another way of saying this is that this is a "broad-to-narrow" map (from the EDQM source concept to S-the SNOMED CT target concept); this is a 'narrower' mapping, because you're mapping the map is to a concept with a narrower meaning than the source concept
    For example, a mapping between "Intravesical solution/solution for injection" Medicated sponge"  in EDQM to "Conventional release intravesical solutioncutaneous sponge (dose form)" in S- SNOMED CT is "narrower" as the EDQM concept appears to suggest two quite different methods of administration are possibleis very generic in terms of not specifying an intended site of administration, whereas the S-CT concept is specifically a solutionSNOMED CT concept does explicitly have an intended site of administration (cutaneous)  
  • Note that when 'Narrower than Some 'Narrower target' maps may are be made, in situations where the EDQM concept is inappropriate for inclusion in SNOMED CT but alternative more granular concepts are available.  These these may give a 1..* cardinality between an EDQM concept and SNOMED CT concepts, especially when the mapping is considered in its entirety.

Broader A broader (than) map: Use this This association is used when the meaning of the SNOMED CT concept is broader than the meaning of the EDQM concept and it is not possible or considered reasonable to author new more granular SNOMED CT concepts

  • Another way of saying this is that this is a "narrow-to-broad" map (from the EDQM source concept to S-the SNOMED CT target concept); this is a 'broader' mapping, because you're mappingthe map is to a concept with a broader meaning than the source concept
    For example, a mapping between between  "CapsuleInhalation powder, softhard capsule"   in EDQM to "Conventional release oral capsulepowder for inhalation (dose form)" in S-SNOMED_CT is "broader" - as the S-CT concept encompasses both hard and soft capsule types
    the EDQM concept is precise, particularly in regard to the encapsulation of the dose form whereas the SNOMED CT concept is less explicit, with no description of encapsulation of the inhalation powder
  • Note that when "'Broader than Some 'Broader target’ maps may be made; these are likely to may give a *..1 cardinality when the mapping is considered in its entirety

In all cases where the final mapping is 'Broader target’ than’ or 'Narrower targetthan', implementation guidance is provided.

"No map" concepts

A "no map" is used when no semantically matching concept is present in SNOMED CT.  A significant number of new PDF concepts have been authored in SNOMED CT to support this map 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 be providedcategorise 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 for specifically 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:

  • PDF concepts that SHOULD be added to SNOMED CT if requested by a member to support authoring of medicinal products.  These are PDFs whose semantics can be fully defined using the SNOMED CT PDF concept model and would be clinically useful PDFs for the use cases
    • For all of these, a fully specified name and logical definition has been suggested
  • PDF concepts that COULD be added to SNOMED CT if requested by a member to support authoring of medicinal products.  These are PDFs whose semantics are not as easy to fully define in SNOMED CT and/or for which there is some reservations as to their clinical usefulness
    • For these, a fully specified name and logical definition has been tentatively suggested
  • PDF concepts that SHOULD NOT be added to SNOMED CT.  These are concepts with ambiguous semantics or significant reservations about their clinical usefulness.  There are very few of these, and they mostly occur from early, less rigorous requests to EDQM or to describe products that would now not be considered medicinal products. (for example the EDQM term "implantation tablet"; any new products would be encouraged to use the term "implant").

Administrable / Transform dose forms

As a general principle. if there is a pharmaceutical dose form that undergoes a transform to another pharmaceutical dose form, the transformed PDF concept should be available in SNOMED CT International content even if there are no CDs that directly require it.  This is because even though the RCD would use the manufactured dose form, some extensions may also model "administrable clinical drugs" or equivalent concepts and require the administrable dose form.

For example "Powder for intravesical solution" will transform to "Intravesical solution"; both must exist as PDF concepts.