2025-12-11: DEUSG Virtual

Opening

2 min

Shane Byrnes

Alejandro Lopez Orsornio

Welcome & Notification of Recording

Multicomponent Clinical Drugs

15 min

Linda Bird

Semantic tag for multicomponent clinical drugs

https://forums.snomed.org/t/semantic-tag-for-multicomponent-clinical-drugs/773/12

Inert “Medicinal” Products

15 min

Linda Bird

Modelling inert tablets, diluents, and solvents

https://forums.snomed.org/t/modelling-inert-tablets-diluents-and-solvents/772

Forum Discussions

10 min

All

Dosage modelling:

• Intended Site v Route of Administration

• Adding |Dose form after transformation| to the Dose form concept model

https://forums.snomed.org/t/dose-form-intended-sites-vs-routes-of-administration/305/21

Rounding of non-terminating decimals

15 min

Francois Lavoie

AOB

2 min

Summary

Multi-Component Drug Classification Discussion

Shane led a discussion on multi-component clinical drugs and inert medicinal products from Canada, focusing on the hierarchy of medicinal products and semantic tags. Linda presented the agreed model from Antwerp, which includes a multi-component package without pack size, and proposed using "package product" and "real package product" as semantic tags. The team debated the necessity of new semantic tags and considered the needs of countries using multi-component clinical drugs.

Multi-Component Clinical Drug Package

Guillermo discussed the use of a multi-component clinical drug package, noting that the abstract nature of the semantic tag allows for its adoption by various countries and potential reuse in other scenarios. He highlighted parallel discussions involving administration devices and substances, emphasizing the need for a balance between precision and reusability. Guillermo also mentioned ongoing work with the Spanish translation team and the importance of moving forward without blockers, while acknowledging the need to explore a real multi-component clinical drug option in the future.

Semantic Tags for Multi-Component Drugs

The group discussed the use of semantic tags for multi-component clinical drugs, with Julie expressing concerns about the lack of information about the amount of product in a package. Linda explained that the decision not to use a semantic tag for multi-component products was to allow countries flexibility in using the class for both single and multi-component packages. Guillermo suggested creating as many semantic tags as necessary to clarify the model, and mentioned that the logical model would not change, but how the output is represented in format may evolve over time.

Pharmaceutical Package Modeling Discussion

The group discussed modeling inert products in pharmaceutical packages, with Linda presenting Canada's proposal to model inert tablets with a count of active ingredient equal to zero and manufactured dose form as a medicinal product. Julie emphasized the importance of documenting use cases and decisions for future reference. The group agreed to move forward with the semantic tags proposal, and Linda introduced a diagram illustrating virtual multi-component drugs and the proposed modeling approach for inert products. Feedback was mixed, with some countries supporting the proposed approach and others suggesting alternative methods. The group discussed the distinction between inert and placebo tablets, with Linda suggesting that the term "product containing no active ingredient" better reflects the definition.

Inert Ingredients Model Implementation

The group discussed various approaches to handling inert ingredients and placebos in their model, with Guillermo presenting three main options: using the "has active ingredient" role, specializing the role to define inert ingredients, or using product characteristics. Guillermo expressed concern that different countries might require different approaches, but agreed that implementing any solution was better than delaying the international release. The discussion concluded that the current model already provides flexibility through its existing inert substance capabilities, though specific implementation details would need to be determined by regulators.

Pharmaceutical Inactive Substance Classification

The group discussed the classification of inactive substances in pharmaceutical products, with Julie emphasizing the importance of using "product containing no active ingredient" as the most accurate term rather than "inert" or "placebo." Linda proposed moving forward with the FSN (Full Scientific Name) for international standardization, while allowing countries to use their preferred terms. The group agreed to proceed with Karen preparing documentation for review by Yon, with Linda coordinating the next steps for international adoption of these concepts.

Dose Form Modeling and Rounding

The group discussed two main topics: dose form modeling and strength rounding. Guillermo explained that while the dose form model aligns with IDMP, there are challenges with routes of administration, particularly for countries using less granular dose forms. The team agreed that while this is not an urgent issue, further discussion is needed. Linda then presented Canada's approach to rounding non-terminating fractions, which involves removing trailing zeros and using significant figures plus a guard digit. The group agreed this approach could be useful internationally, pending further testing and implementation considerations.