Drug content

Historically, the Pharmaceutical / biologic product Hierarchy was primarily comprised of primitive concepts, and in many areas, replicated the modeling of concepts in the Substance Hierarchy. Because the concepts in the hierarchy were mostly primitive concepts without attributes, the classifier could not be leveraged to support consistent modeling and ongoing maintenance of the hierarchy. Implementation of a robust concept model has provided the ability to implement consistent modeling and terming and supports quality improvement. It also provides an opportunity to leverage existing national extensions to maintain the hierarchy over time, if desired.

At the start of the project, the Pharmaceutical / biologic product Hierarchy had n≈17,500 descendants. These were mostly primitive concepts, with incomplete and inconsistent modeling and terming, and included many incomplete or out of scope concepts.

In the 2019-July Release, the Pharmaceutical / biologic product Hierarchy has n≈22,250 descendants. This includes the Medicinal product Hierarchy with n≈21,200 descendants; over 98% are sufficiently defined concepts that conform to the proximal primitive modeling pattern and templated modeling and terming.

1. Updates per SLA agreement

1. Completed Jan 2017

RFP-Drug concept model

1. Draft mode, analysis and creation of Master Position Statement. Drugs area review of the impact of EMA approach for the Medicinal Products Dictionary.

1. Completed June 2016
   
   

1. Assessment and partial cleanup of 17k Concepts (total number in product hierarchy)

1. Completed Oct 2016

Drugs Products Hierarchy Project

1.Alpha Release

There are multiple aspects to this project including:

Concepts representing product role:

Concepts representing product role need to be removed from the Product Hierarchy because the association between a product and its role represents knowledge that is outside of the scope of an ontology. The product role may not be always and necessarily true as required by the SNOMED CT concept model. The product role may vary between Member countries or be dependent on dose form or strength, resulting in incorrect inferred relationships

Groupers in Product Hierarchy:

Groupers, including concepts that represent chemical class, mechanism of action, body system, and dose form, in the Product Hierarchy are inconsistently represented. The groupers include concepts that cannot be fully defined, leading to ongoing maintenance concerns. Editorial guidance for moving forward and recommendations for existing concepts that do not conform to the editorial guidelines must be agreed upon.

a.Recommendation for retirement of Product Hierarchy concepts representing product role

b.Recommendation for representation of roles in SNOMED CT, likely via a Role Hierarchy in the Qualifier value Hierarchy

i.Recommendations to be delivered to the Editorial Advisory Group

1. Completed Jan 2017

Medicinal Entity and Medicinal Form Concepts in the Product Hierarchy:

Medicinal Entity and Medicinal Form concepts in the Product Hierarchy are inconsistently represented. They include concepts that cannot be fully defined and inconsistent terming conventions, leading to ongoing maintenance concerns. Editorial guidance for moving forward and recommendations for existing concepts that do not conform to the editorial guidelines must be agreed upon.

1.Proposal documented, with two parts:

a.Recommendation for editorial guidelines for Medicinal Entity and Medicinal Form concepts

b.Recommendation for disposition of existing concepts that do not conform to the editorial guidelines

1. Completed Jul 2017

1. Updates per SLA agreement

1. Completed Jan 2017

1. Draft Drugs Model has been completed by external Consultant. The end deliverable has been posted on the Drugs Product group and the Modelling AG confluence sites. Next steps are to progress to a draft version which can be presented at the October Conference.

1. Completed Jul 2017

1. Assessment and partial cleanup of 17k Concepts (total number in product hierarchy)

1. Completed Jan 2017

Drugs Products Hierarchy Project

Concepts representing product role:

Concepts representing product role need to be removed from the Product Hierarchy because the association between a product and its role represents knowledge that is outside of the scope of an ontology. The product role may not be always and necessarily true as required by the SNOMED CT concept model. The product role may vary between Member countries or be dependent on dose form or strength, resulting in incorrect inferred relationships

Groupers in Product Hierarchy:

Groupers, including concepts that represent chemical class, mechanism of action, body system, and dose form, in the Product Hierarchy are inconsistently represented. The groupers include concepts that cannot be fully defined, leading to ongoing maintenance concerns. Editorial guidance for moving forward and recommendations for existing concepts that do not conform to the editorial guidelines must be agreed upon.

1. Proposal documented, with two parts:
   1. Recommendation for retirement of Product Hierarchy concepts representing product role
   2. Recommendation for representation of roles in SNOMED CT, likely via a Role Hierarchy in the Qualifier value Hierarchy
      
      ii. Recommendations to be delivered to the Drug Project Group after agreement from the Editorial Advisory Group
      
      
2. Detailed deployment plans for both will be developed after the proposals are accepted and dependent on the Alpha release.
   
   
3. Proposal documented, concepts updated or inactivated as appropriate ad move to maintenance mode:
   1. Recommendation for editorial guidelines for groupers
   2. Recommendation for disposition of existing concepts that do not conform to the editorial guidelines
      
      
4. Detailed deployment plan will be developed after the proposal is accepted

1. Completed Jan 2017

2. Completed Jan 2018. Foundation is completed

3. Completed Jan 2019

 4. Completed July 2018

Medicinal Entity and Medicinal Form Concepts in the Product Hierarchy:

Medicinal Entity and Medicinal Form concepts in the Product Hierarchy are inconsistently represented. They include concepts that cannot be fully defined and inconsistent terming conventions, leading to ongoing maintenance concerns. Editorial guidance for moving forward and recommendations for existing concepts that do not conform to the editorial guidelines must be agreed upon.

1. Detailed deployment plan will be developed after the proposal is accepted

1. Completed Jan 2019

Comprehensiveness of Content:

A plan for the ongoing maintenance of the Product Hierarchy must be developed, including the ability to leverage content created by national extensions. Planning for this work will begin as the previously described aspects to the project are resolved.

1. Maintenance Plan for Product Hierarchy

1. Being planned for post Jan2019 release. Please see Jul2019

1. Medicinal product Hierarchy
   
   
2. Dose form Hierarchy

1. Medicinal product Hierarchy
   1. Creation of new attributes to support modeling of concepts in the hierarchy (n≈6)
      
   2. Medicinal product "containing" (MP-containing) concepts
      
      1. Remodel and sufficiently define existing concepts and create new concepts as needed (n≈1100)
      2. Update editorial guidelines accordingly
   3. Clinical drug "precisely" (CD-precisely) concepts
      
      1. Refine existing concepts and create new concepts as needed (n≈3000)
      2. Update editorial guidelines accordingly
         
      3. General maintenance including inactivation of out of scope concepts
   4. Project-related documentation
      
      1. Notification for Briefing Notes, Editorial Guidelines, and other documentation updates are posted on the project group website as they become available; see Drug Model Working Group - Directory for details
         
         
2. Dose form Hierarchy
   1. Development of concept model and creation of new attributes and semantic tags to support modeling of concepts in the hierarchy (n≈15)
      
   2. Remodel and sufficiently define existing concepts and create new concepts as needed, including addition of text definitions where appropriate (n≈500)
      
   3. Update editorial guidelines accordingly
      

1. Completed Jan 2018
   
   
   
   
   
   
   
   
   
   
   
   
2. Completed Jul 2018
   
   

1. Medicinal product Hierarchy

1. Medicinal product Hierarchy
   1. Creation of new attributes to support modeling of concepts in the hierarchy (n≈5)
   2. Groupers based on disposition or structure
      1. Refine existing concepts and create new concepts as needed (n≈550)
      2. New high-level groupers to support organization of hierarchy created as an incremental improvement with additional subtypes to be added in future releases (n≈3)
      3. Update editorial guidelines accordingly
   3. Groupers based on role
      1. Relocate in anticipation of future work with definition status = primitive and attributes inactivated (n≈400)
      2. Provide briefing note to MF outlining plan to use additional axioms in future modeling
   4. Medicinal product "containing" (MP-containing) concepts
      
      1. Remodel and sufficiently define existing concepts and create new concepts as needed (n≈3750)
      2. Update editorial guidelines accordingly
         
   5. Medicinal product form "containing" (MPF-containing) concepts
      1. Remodel and sufficiently define existing concepts and create new concepts as needed (n≈2100)
      2. Update editorial guidelines accordingly
   6. Clinical drug "precisely" (CD-precisely) concepts
      1. Remodel and sufficiently define existing concepts and create new concepts as needed (n≈4850)
      2. Update editorial guidelines accordingly
   7. Project-related documentation
      1. Notification for Briefing Notes, Editorial Guidelines, and other documentation updates are posted on the project group website as they become available; see Drug Model Working Group - Directory for details

1. Completed Jul 2018

1. Medicinal product Hierarchy
   
   
2. Role Hierarchy
   
   
3. National extension model
   
   

1. Medicinal product Hierarchy
   1. Medicinal product "containing" (MP-containing) concepts
      1. Refine existing concepts and create new concepts as needed (n≈3800)
      2. Update editorial guidelines accordingly
   2. Medicinal product "only" (MP-only) concepts
      
      1. Document editorial guidelines and create new concepts (n≈3800)
         
   3. Medicinal product form "containing" (MPF-containing) concepts
      1. Refine existing concepts and create new concepts as needed (n≈2800)
      2. Update editorial guidelines accordingly
   4. Medicinal product form "only" (MPF-only) concepts
      
      1. Document editorial guidelines and create new concepts (n≈2800)
         
   5. Clinical drug "precisely" (CD-precisely) concepts
      1. Refine existing concepts and create new concepts as needed (n≈4900)
      2. Update editorial guidelines accordingly
   6. Groupers based on disposition or structure
      1. Refine existing concepts and create new concepts as needed (n≈600)
      2. Update editorial guidelines accordingly
2. Role Hierarchy
   1. Initial population of Therapeutic role Hierarchy (n≈80)
   2. Initial remodel of role-based groupers in Medicinal product Hierarchy (n≈80)
   3. Associate role with selected Medicinal product form concepts (n≈250)
3. National extension model
   1. Create concepts in International Release to support national extension model (n≈20)
   2. Update project documentation and editorial guidelines accordingly

1. Completed for Jan 2019
   
   
   
   
   
   
   
   
   
   
   
   
   
   
2. Completed for Jan 2019
   
   
3. Completed for Jan 2019
   

1. Dose form Hierarchy
   
   
2. Medicinal product Hierarchy
   
   
3. Medicinal product concept vs Substance concept used to model concepts in other SNOMED hierarchies

1. 1. Dose form hierarchy
   2. Resolve remaining unremodeled concepts (n≈125)
   3. Update editorial guidelines accordingly
   4. Develop, document, and implement ongoing maintenance plan
      
      
2. Medicinal product hierarchy
   1. Resolve remaining unremodeled (clinical drug) concepts (either remodel or inactivate) (n≈2700)
   2. Implement SCA templates for authoring Medicinal product, Medicinal product form, and Clinical drug concepts concepts
      
      1. Validate existing content against new template (QI/BAU)
   3. Design and implement regularly scheduled reporting process required to support ongoing QA of hierarchy
   4. Create and publish new disposition-based and structure-based grouper concepts as needed (BAU)
   5. Update editorial guidelines and associated project documentation accordingly (BAU)
      
      
3. Medicinal product concept vs Substance concept used to model concepts in other SNOMED hierarchies
   1. Document scope and plan for future work including development of editorial guidelines and revision of existing content
      1. Further deliverables to be determined based on 3.a.
   2. Consult with Editorial Advisory Group re: refinement of editorial guidelines for representation of roles in SNOMED
      1. Further deliverables to be determined based on 3.b.

1. Completed for Jul 2019
2. 
   
   1. Completed for Jul 2019
   2. Template requests submitted and awaiting implementation
   3. Report requests submitted and awaiting implementation
   4. Completed for Jul 2019
   5. Completed for Jul 2019
3. 
   
   1. Initial content analysis completed
   2. Agreement reached re: scope and guidelines with full implementation in future release