Common Product Model
This page will be used to discuss the content and publication of the Common Product Model.
Contents
Ambitions & Scope
The Common Product Model (CPM) will be an overarching domain information model relating to the HL7 v3 modeling of any kind (or instance) of a 'product'. The definition of the term product is intentionally kept loose at this point, but will definitely include:
- Medication, incl. vaccines
- Devices used in medical services
- Anything else a person can be exposed to
The CPM is set up as a joint initiative within HL7 project, 'sponsored' by the O&O work group.
The following stakeholders have been identified:
- Pharmacy (for Medication and possibly for devices)
- Patient Safety (for Individual Case Safety Reports)
- RCRIM (for Structured Product Labeling, Regulated Product Submissions, and Drug Product Stability)
- PHER (for vaccines used in Immunization)
Storyboards
This space will list a number of storyboards that relate to the different perspectives on what a product is and how it is used.
These storyboards are divided into groups:
- Pharmacy related storyboards
- ICSR related storyboards
- SPL related storyboards
- Regulated Product Submission Release 2 (RPS R2) Storyboards (not specific to CPM)
- Immunization related storyboards
Governance
CPM Governance as adopted during the San Diego WGM Sept 2011
The SVN repository is at http://gforge.hl7.org/svn/hl7v3/trunk/cpm
CPM Technical Corrections
Details of Current Technical Corrections and Archived Technical Corrections can be found on separate pages by clicking on the links below.
Archived CPM Technical Corrections
Storage Conditions and Shelf Life
Meeting Minutes
March 8, 2012
Attendees: Julie James, Keith Thomas, Norman Gregory, Gunther Schadow, Rob Savage, Hans Buitendijk
- Storage Conditions and Shelf Life
- eStability focuses on new products and their storage conditions
- eStability does not have shelf life, only expirationTime. Would not use shelf live.
- The Storage act contains the storage conditions as observations.
- Motion to include eStability Storage and StorageCondition into CPM model. Change class code to Storage instead of Act on Storage and change mood code to Definition on Storage. Would need to create a future harmonization proposal for a domains space on code in StorageCondition. It will be put in the Product Information choice box. Gunther Schadow, Norman Gregory.
- Against: 0; Abstain: 0; In favor: 3
- With addition of this to CPM there is a potential to deprecate existence time, but no rush. So for now will leave it as is.
- Deprecating Lot Number Text
- Julie's Questions related to Tom's comment: "sending a batch or lot ID would work by adding a 'part of' participation to a parent 'manufactured material' class, since the ID is *not* an instance identifier of the medicine (or other product) instance, but of the batch or lot that it was a part of".
- No one has picked up on this?
- Is it right that there are two alternative approaches?
- Lots are a product instance.
- Ingredients used for mixed lots, while part is used for combinations such as kits.
- Looks like we have what we need and moving towards concensus.
- Julie's Questions related to Tom's comment: "sending a batch or lot ID would work by adding a 'part of' participation to a parent 'manufactured material' class, since the ID is *not* an instance identifier of the medicine (or other product) instance, but of the batch or lot that it was a part of".
February 23, 2012
Attendees: Gunther Schadow, Keith Thomas, Hans Buitendijk, Julie James, Myron Finseth, Hugh Glover
- Harmonization Proposals
- Reconstitution Procedure - CPM24
- File:HL7 Harmonization Proposal Reconstitution Procedure CPM24.doc
- There is a variance between Gunther's original vs. the snippet in the proposal.
- Concerned that there will be a possible ripple effect to other areas where Act is used in general, but not a concern here.
- Motion to accept as proposed. Keith Thomas, Myron Finseth
- Against: 0; Abstain: 0; In Favor: 5
- Disease Qualifier - CPM25
- File:HL7 Harmonization Proposal Disease Qualifier CPM25.doc
- Where does it live in the model? In the clinical area with contraindications, indications, severity, frequency, etc.
- There is another approach possibly using Coded Data type (CD) with qualifiers.
- Problem is that pre-coordination is not available in MedDRA.
- Although there is concern that this proposal will not solve the real problem. It may have to be resolved back in the FDIS.
- Concept domain does not impact the model.
- FDIS is in ballot, so cannot change this type of issue anymore given ISO ballot process only allows minor changes at this stage.
- What happened to the CD Qualifier? Would have to be coordinated with the terminology. Suggestion was that post-coordination was to be done through implementation guidance.
- No need to change the model to accommodate CD Data Type qualifier.
- Motion to accept the proposal as is. Julie James, Gunther Schadow.
- Should not result in and create a separate class in the CPM model to accommodate.
- Suggestion to include: Terms would only be used with in post coordination within an existing CD. Concern that is too complex.
- Gunther wants the proposal as-is.
- Against: 0; Abstain: 0; In favor: 5
- Storage & Shelf Live - CPM26
- File:HL7 Harmonisation Proposal Storage and Shelf Life CPM26.doc
- e-Stability addressed this area, but did not get included in CPM.
- Julie will reach out to Norman Gregory and RCRIM to get input into this proposal with goal to conclude during next week's call.
- Reconstitution Procedure - CPM24
February 16, 2012
Attendees: Hugh Glover, Gunther Schadow, Myron Finseth, Keith Thomas, Hans Buitendijk, Rob Savage
- Agenda:
- How to tie IDMP back to CPM
- Harmonization Proposals (9 total - 3 a week)
- Technical Corrections
- IDMP to CPM
- So far we grew CPM to cover IDMP, but is becoming unwieldy.
- Primary objection/concerns that if you unroll CPM people get schemas that are new to them.
- Present CPM with CMETs, but include guidance on where things for IDMP, how to thread it together, serialization.
- Should that information in CPM or IDMP implementation documentation? Should be in IDMP documentation.
- We're reviewing it here as there will be adjustments likely.
- IDMP is on same May Ballot Cycle.
- Harmonization Proposals
- Combined Dose Form Concept Domain - CPM-21
- File:Combined Dose Form.doc
- Motion to accept as proposed. Hugh Glover, Rob Savage Against: 0; Abstain: 0; In Favor: 4
- Material Form - CPM-22
- File:Material Form.doc
- Concern that this cannot be put above Material. A Combined Dose Form could consist of multiple materials of different forms.
- Suggest to carry into OO discussion in next 2 weeks.
- Container Form Concept Definition - CPM-23
- File:Container Form.doc
- Motion to accept as is. Gunther Schadow, Hugh Glover. Against: 0; Abstain: 0; In Favor: 4
- Combined Dose Form Concept Domain - CPM-21
- RIM Proposals
- Contaminant is an Ingredient
- File:RoleClass Contaminant is an Ingredient.doc
- Motion to accept as is. Gunther Schadow, ??. • Against: 0; Abstain:0; In Favor: 4
- Living Subject
- File:Living Subject.doc
- Not yet discussed. Next week
- Contaminant is an Ingredient