Drug Model Editorial Guide

Received 51 comments from six countries on the initial draft of the editorial guidelines for modeling and terming drugs. All issues identified were resolved or deferred.

Second iteration of guidelines released in early March.

Existing tracker: "In remission" disorders

Hold over item from initial meeting in Uruguay. Has been brought up again with a large number of requests for addition of "X in remission" concepts.

Existing Inception document: Modeling "disease in remission"

Document definition: "The period in the course of a disease/condition during which there is temporary lessening or abatement of signs and/or symptoms of the disease."

Based on historical view of "Disease in remission" there are some assumptions:

1. The disease condition is still present.
2. The disease is chronic and/or progressive

Prior proposals:

• Model as situations with the reactivation of 278174000 | Disease phase (attribute) | with allowed values >303105007 | Disease phases (qualifier value) | with necessary changes to this set to align with standard representation of disease phases
• Leave the concepts in the disorder hierarchy and create a new attribute such as disease activity and include as its range, qualifier values that specifically represent disease activities such as remission, recurrent, relapsing, active, relapsing/remitting, etc.
• Model disorder X in remission as a child of disorder X and a child of disorder in remission (the latter as a replacement for patient in remission).
• Extend the set of values under "Courses" to include disease phases and model "Disease in remission" as a subtype of "Disease"

One related issue is the current overlap of concepts under "Courses" and "Disease phases".

Challenge is that disease phases differ with the "type" of disease.

• Infectious disease
• Malignant disease
• Mental an and behavioral disorders

Question: Pros and cons of creating type specific phases?

The result of this discussion should be extensible to other patterns of "Disease in X" (e.g. latent disease, relapse, etc.) for which there are several CRS requests outstanding.

Related issue: IHTSDO-407 Frequencies and Courses

Discussion:

BGO reviewed the document and asked about the relationship of remission to "disposition". He sees overlap between those notions. Favors making disease in remission as a subtype of the disease. Also favored a separate "disease in remission" hierarchy (primitive parent). Needs additional discussion in London

Initially discussed in Uruguay, postponed to future meeting

Existing tracker item: IHTSDO-604 Extend the range of "Specimen substance"

Use cases:

• Physical object as a specimen for environmental and epidemiologcal testing
• Pharmaceutical/biological products as specimens for sterility and quality assurance

Earlier discussion points:

• "Device specimen" already allowed and fully defined but uses SPECIMEN SOURCE IDENTITY as the defining relationship. This scenario may work if the range for SPECIMEN SOURCE IDENTITY is extended to Physical object (<)