Introduction

The SNOMED CT terminology provides a common language that enables a consistent way of indexing, storing, retrieving, and aggregating clinical data across specialties and sites of care. The International Health Terminology Standards Development Organisation (IHTSDO^®) maintains the SNOMED CT technical design, the content architecture, the SNOMED CT content, and related technical documentation. 

EDQM (the European Directorate for the Quality of Medicines & HealthCare - a directorate of the Council of Europe) is a leading organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use. These quality standards are recognised as a scientific benchmark and applied worldwide.

This document is intended as release notes for the EDQM Dose Forms map to SNOMED CT map release. This document is a complement to the more general EDQM Dose Form Map User Guide, which describes the map use cases, principles and implementation guidance in detail.

Audience for this document

This document should be read by all those (National Release Centers, vendors of electronic health records, terminology developers and regulators) with an interest in the usage of the EDQM Dose Forms map to SNOMED CT. 

Background

The EDQM Standard Terms Database is a set of concepts used in the definition and description of medicinal products; these include the Pharmaceutical dose form (i.e. the dosage form), Route or method of administration, and certain important Packaging items such as the Container, Closure and Administration device.  These Terms were initially produced by the European Pharmacopoeia (Ph. Eur.) Commission following a request from the EU Commission prior to being overseen by EDQM.  Now, Standard Terms are managed by EDQM in compliance with the ISO 11239 standard for the description of pharmaceutical dose forms, which is itself part of the IDMP (IDentification of Medicinal Products) suite of standards, and as such, gives them global applicability as opposed previously a European focus.  Regulatory agencies beyond Europe may submit requests to EDQM for new Terms; supporting evidence for all requests for new Terms must be provided.

The Terms are designed to be used in marketing authorisation applications, medicinal product labelling (including the summary of product characteristics (SmPC) and in electronic communications about medicines.  Additionally, in the last 5 years, the Standard Terms have been used for related purposes such as adverse event reporting (pharmacovigilance) and clinical trials.  But, whilst the primary use is in the regulatory domain, the Standard Terms bring information to the patient/user/prescriber through their use in SmPC, and it is this that underpins the requirement to map the EDQM Pharmaceutical Dose Forms to the Pharmaceutical Dose forms in SNOMED CT, where dose form is one of the definitional attributes of the Clinical Drug and Real Clinical Drug concepts.

For further information on EDQM and Standard Terms, please see https://standardterms.edqm.eu/

Scope and Purpose of the collaborative work

Use cases

The scope of the EDQM Dose Forms to SNOMED CT map project was the delivery of a linkage table that would support the following use cases:

1. Authoring a SNOMED CT drug extension based on authorised medicinal product information (e.g. SmPC) that uses EDQM dose forms.
2. Mapping a national Medicinal Product Dictionary (MPD) to international SNOMED CT medicine concepts for patient care.
3. Facilitating international interoperability of medication information.
4. Maintaining decision support.
5. Mapping an IDMP-compliant regulatory database to SNOMED CT.

A more detailed description of the use cases is available in the User Guide.

The map is distributed as a Simple map with correlation to SNOMED CT type reference set.

The directionality of the map is from EDQM Dose Forms to SNOMED CT.

The User Guide describes the policies and principles used as guidance to produce the mappings.

Scope: Map Source and Target

Map source: EDQM Pharmaceutical Dose Forms (PDFs). The Map Source is represented in the mapSource column in the reference set distribution file.

• Active PDFs at 2021-07-31 that are not ‘Veterinary only’
• A "snapshot" full download of EDQM PDF data was taken via the EDQM API 

Some 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). For a complete list of the excluded PDFs you can refer to the map user guide.

Map target: SNOMED CT 20220731 international edition. The Map Target is represented in the referencedComponentId column in the reference set distribution file.

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

Release content

Overview

The EDQM Dose Forms map derivative content is released under a project-specific module (1237620007 |European Directorate for the Quality of Medicines & Healthcare module (core metadata concept)|) with component identifiers that are within the main IHTSDO (International Release) namespace. The content links into the main International Release dose forms hierarchy, and therefore all the fully specified names in target concepts have a ("physical object") semantic tag. 

Content detail

This release includes 310 map rows, with correlations between the EDQM map source and the SNOMED CT map target defined as either "Equivalent", "Narrower than", or "Broader than".

This is an increase of 24 records as compared to the Alpha release.  In addition to these new records, the UUID's and effectiveTimes of the records from the Alpha release have been refreshed for this first Production release.  Going forward however, these UUID's will be retained in order to provide a historical audit trail of any changes to the published map records.

When an EDQM code was in the scope of the map but no semantically matching concept is present in SNOMED CT this is considered a "No map". In the cases when it has been possible to confirm that the Dose forms were used in pharmaceutical products authorised in member countries this was resolved by creating new content in SNOMED CT during the mapping process. The remaining cases are not part of the release map, these source terms were logged as "No maps" and categorised based on possible mapping approaches in future versions of this product.

Versions of the dependent content

The content in the May 2023 EDQM Dose Forms to SNOMED CT Map package has been updated in line with updates received from EDQM in March 2023, and so the version of EDQM that this PRODUCTION release is based upon is March 2023.  

EDQM has been mapped to the January 2023 International Edition of SNOMED CT.   Therefore, all component states in the May 2023 EDQM Dose Forms to SNOMED CT Map package have been assigned an effectiveTime of 20230131.   

The package will be published by the end of May 2023, and so the version of the Package itself is "PRODUCTION_20230531" - this is to distinguish the Published date (20230531) from the effectiveTime of the underlying dependent content (20230131).

Technical Notes

RF2 package format

The RF2 package convention dictates that it contains all relevant files, regardless of whether or not there is content to be included in each particular release.  Therefore, the package contains a mixture of files which contain both header rows and content data, and also files that are intentionally left blank (including only a header record).  The reason that these files are not removed from the package is to draw a clear distinction between:

1. ...files that have been deprecated (and therefore removed from the package completely), due to the content no longer being relevant to RF2 in this or future releases, and 
2. ...files that just happen to contain no data in this particular release (and are therefore included in the package but left blank, with only a header record), but are still relevant to RF2, and could therefore potentially contain data in future releases.

This allows users to easily distinguish between files that have purposefully been removed or not, as otherwise if files in option 2 above were left out of the package it could be interpreted as an error, rather than an intentional lack of content in that release.

Metadata now incorporated into the Derivative Packages

After consultation in 2023, SNOMED International are in the process of migrating the Metadata components for Derivative product from the International Edition to the Derivative release packages themselves.

These Derivatives are solely single refsets/maps, and so don’t mean anything to end users without the supporting terms and other components from the International content.  The nature of these products is therefore such that we necessarily create Derivative packages that are inherently dependent on the relevant International Edition content.  Previously, therefore, we have always created the metadata components (refset/module concepts, descriptions, relationships, etc) in the International Edition release packages, with the Derivative products being dependent on the relevant International content. 

Whilst this dependency on the International content would continue, the transition would include the metadata components in the Derivative packages themselves, rather than in the International Edition packages – this will involve:

• Inactivation (but not complete removal) of the current components in the International Edition
• Activation of the Metadata components in each of the Derivative release packages

The consensus is that moving the Metadata components into the Derivative packages will bring benefits to both the Derivative maintainers, and also to the end users who will no longer need to pull this particular data down from the dependent International Edition in order to use the Derivative products.   It enables maintainers to move to a more efficient model of hosting the Derivative content in termServer branches, rather than importing Delta files from external tools.

Therefore in this EDQM Map release, we are including the following components in the Derivative release package:

• #####################################
• #####################################

• #####################################
• #####################################

• #####################################
• #####################################

• #####################################
• #####################################

• #####################################