These instructions are "for trial use" as we work on the first therapeutic area - anti-infective products. Please add comments about improving the work process in the comments section at the bottom of this page
Work process diagram
The first therapeutic area for consideration is "Anti-infectives"
A spreadsheet has been prepared by a member (in this first instance, by Norway) where they have listed all the MP only, MPF only and CD medication concepts that they have that they consider are within scope of the International Edition and which follow the Editorial Guidelines for the relevant concepts in the International Edition. These are offered to the Content Project group for further analysis and endorsement (or otherwise). If endorsed, they will go forward to the SNOMED CT Content Team for inclusion in the International Edition.
The spreadsheet is at https://docs.google.com/spreadsheets/d/1tTdjlWNWtX4qZhbvE45r5U2ylAdirOjn/edit#gid=1320004122
Project participants are invited to work with a choice from
- MP only concepts - on the first tab/worksheet (MPF only are also present)
- MPF only concepts - on the second tab/worksheet
- CD concepts - on the third tab/worksheet
Please choose which worksheet to work with based on what you have in your own local systems and what you have time/availability for, but PLEASE NOTE that for MP only and MPF only concepts, a reference to authorised product information, such as a Summary of Product Characteristics (SmPC) or Product Label is required and that will most likely describe one or more real clinical drugs.
In whichever tab/worksheet you choose to work in, please copy columns E, F and G (or if you are the first participant, take those columns).
Then for each row, please note which of the four decision categories you wish to give to that concept (note that the decision categories are also given on the fourth tab/worksheet, labelled as "Tables")
| Decision category | Explanation | |
|---|---|---|
| A | Have this CD/MP only/MPF only in national extension or MPD; support its inclusion in the international edition | |
| B | Have a concept very similar to this CD/MP only/MPF only in national extension or MPD; support its inclusion in the international edition but needs further discussion to finalise exact concept | |
| C | Do not have this CD/MP only/MPF only in national extension but do support its inclusion in the international edition | |
| D | Do not support inclusion of this CD/MP only/MPF only in the international edition |
For A or B, please provide a reference to authorised product information. If you select B, please describe the difference and any comments you may have about this (for example, that your local choice of reference strength substance is different from the concept as described in the FSN in column B)
If you select D, please give your reason for not wishing to support the inclusion of the concept in the International Edition.
If you have concepts in your local content that are in this therapeutic area and which are not in the International Edition and are not in this list, please make a note of them and provide them as a list of FSNs (and a local ID if possible) back to the Project group.
Worked Example using the MP only tab/worksheet
In this example, Spain is the first county to work in the MP only tab/worksheet, so takes columns E, F and G.
In their analysis, the Spanish team find that there is at least one product in the Spanish local data which would fulfil this MP only concept, and therefore they decide that they do support the inclusion of an MP only for "Product containing only aciclovir and hydrocortisone (medicinal product)" in the International Edition. So they put "A" in column E and a reference to authorised product information for a real medicinal product that supports this.
The product that they have selected is a cutaneous cream, so it also supports the MPF only concept, so they can support the inclusion of this too and copy the same information into row 4. Note that this is optional; participants working with MP only concepts are not obliged to fill in the corresponding MPF only row(s) on this sheet or on the MPF only sheet.
The USA is the second country to work in the MP only tab/worksheet, so the team there copy columns E, F and G into columns H,I and J and work in this area. If needed, they can "hide" columns E, F and G from Spain, especially if the worksheet is getting quite large.
In their analysis, the American team also find that there is at least one product in their local data which would fulfil this MP only concept, and they too decide that they do support the inclusion of an MP only for "Product containing only aciclovir and hydrocortisone (medicinal product)" in the International Edition. So they put "A" in column E and a reference to authorised product information for a real medicinal product that supports this. For time and resource reasons, they have not filled in row 4, even though the product they have selected to support the concept in row 3 also supports the concept in row 4.