Editorial Advisory Group Drug Project Discussion Topics Toni Morrison, Sr. Terminologist 2016-02-29

Concepts containing product strength Pharmaceutical / biologic product hierarchy contains around 10,000 primitive concepts that include product strength in the FSN Examples: Abacavir 20mg/mL oral solution (product) Abacavir 600mg/lamivudine 300mg tablet (product) Abacavir sulfate + lamivudine + zidovudine 300mg/150mg/300mg tablet (product)

Problem with these concepts The concepts cannot be fully defined using the existing concept model because the concept model does not support concrete domains or nesting. This functionality will not be present in the International Release concept model in the foreseeable future. The modeling and terming conventions for the concepts is inconsistent. The maintenance burden to keep these concepts aligned with changes to the Substance Hierarchy and Product Hierarchy’s grouper, Medicinal Entity and Medicinal Form concept classes is significant and will require manual intervention on an ongoing basis as the classifier cannot be leveraged.

Problem with these concepts, cont. The content in the International Release is not comprehensive as new products have not been added on a regular and systematic basis over the years. The primitive nature of these concepts does not allow IHTSDO to efficiently leverage concepts created by National Release Centers to ensure the hierarchy is comprehensive and current because critical information about the product (e.g. product strength) is only available as part of a textual description in the International Release.

Solutions considered Inactivate concepts in International Release Relocate the concepts to a national extension Move the concepts from the International Release to an unmaintained extension that would be distributed by IHTSDO Move the concepts from the International Release to a minimally maintained module that would be maintained and distributed by IHTSDO Leave the concepts in the International Release with minimal maintenance, no terming normalization, and no addition of new concepts containing product strength (reassess at such time the concepts can be fully defined)

#1 - Inactivate concepts in International Release Pros Resolves maintenance concern for International Release Less effort and testing for International Release team than moving the concepts to an unmaintained extension or relocating the concepts to a national extension Cons Negatively impacts Members who are currently using the concepts because the concepts will be retired Previously presented as option to Members but was not well received because at least one Member has used these concepts for mapping and would be impacted by retirement of the concepts REJECTED

#2 - Relocate the concepts to a national extension Pros Resolves maintenance concern for International Release Cons More effort and testing for International Release than retiring the concept Negatively impacts Members who are currently using the concepts because the concepts may not be easily available to all Members if they are relocated to a national extension Requires a Member country willing to receive the concepts into their national extension; this option was previously presented to the project group and no Member was willing to receive these concepts into their extension No precedent of having moved concepts from the International Release to a national extension before on a large scale REJECTED

#3 - Move the concepts from the International Release to an unmaintained extension that would be distributed by IHTSDO Pros Resolves maintenance concern for International Release Ensures concepts remain available for Members who want to keep the content available but do not have the capability or desire to persist the content Minimizes impact if concept model evolves to support fully defining these concepts in the future Precedent of having done this before (e.g. non-human content, the now defunct US Drug extension) New extension will be distributed by IHTSDO and readily available to all Members

#3 - Move the concepts from the International Release to an unmaintained extension that would be distributed by IHTSDO Cons More effort and testing for International Release than retiring the concepts Negatively impacts Members who are currently using the concepts because the concepts will have a new concept ID assigned Requires manual cleanup of content (e.g. add missing Has active ingredient or Has dose form relationships)   Relationships that tie it to the core may become obsolete as the core evolves REJECTED

#4: Move the concepts from the International release to a minimally maintained module that would be maintained and distributed by IHTSDO Pros Ensures concepts remain available for Members who want to keep the content available but do not have the capability or desire to persist the content Minimizes impact if concept model evolves to support fully defining these concepts in the future New module will be distributed by IHTSDO and readily available to all Members

#4: Move the concepts from the International release to a minimally maintained module that would be maintained and distributed by IHTSDO Cons More effort and testing for International Release than inactivating the concepts May negatively impact Members who are currently using the concepts because the concepts will have a new module ID assigned; however, the concept ID, description ID, and attributes will remain unchanged Requires manual cleanup of content (e.g. add missing Has active ingredient or Has dose form relationships) Relationships that tie it to the core must be maintained as the core evolves UNDER CONSIDERATION

#5 - Leave the concepts in the International Release with minimal maintenance, no terming normalization, and no new concepts Pros No impact on Members Ensures concepts remain available for Members who want to keep the content available but do not have the capability or desire to persist the content Minimizes impact if concept model evolves to support fully defining these concepts in the future Reassess when/if concept model evolves to allow concepts to be fully defined Cons Requires manual cleanup of content (e.g. add missing Has active ingredient or Has dose form relationships) Relationships that tie it to the core must be maintained as the core evolves UNDER CONSIDERATION

Other options? Discussion and recommendation for next steps