1.1. General issues
1.1.1. Primitive concepts
Can we investigate ways to make currently primitive dose forms fully defined?
For example, for nebulizer solutions… is there the potential to add the administration device from the physical object hierarchy?
1.1.2. Irrigation as a new method of administration
"the process of washing out an organ or wound with a continuous flow of water or medication" - the concept is the "continuous flow" rather than the "apply" or the "bathe"
1.2. Specific issues
1.2.1. 38943003 | Gingival (intended site) |
Gingival intended site sits separately in the hierarchy from other oromucosal concepts; we think that "gingival" should be a child of oromucosal
1.2.2. Release Characteristics
13 January 2022 : PDF concepts should not use release characteristic concepts with more than one release characteristic (e.g. NOT gastro-resistant and prolonged release). There is some additional thinking to do around the release characteristic hierarchy and particularly "modified release" as a grouper concept
1.2.3. 385213000: Conventional release vapor solution for inhalation (dose form)
We feel this should not be “no transformation” BUT we also feel the EDQM transform of “mixing” doesn’t feel right. The AdmDF would be “vapour for inhalation”. But “mixing” is not the correct transformation as can put solution on a handkerchief and inhale the vapour directly
| Dose form | Comments |
|---|---|
| Prolonged-release solution for injection | Used for products like Buvidal, where it is the dose form (the formulation of the solution for injection) causes the prolonged release; the substance is (still) plain buprenorphine |
| Oral/rectal solution (and others) |
Multiple intended site dose forms should be included, following the pattern that already exists for eye/ear/nose drops. BUT not all EDQM should be added - there should be evaluation (e.g. EDQM have rejected a "Solution for injection/infusion/rectal use" concept because "it is not appropriate for safety reasons, owing to the different microbiological requirements for the routes of administration covered" For the decision support use case, grouping concepts by their intended site is often very helpful (for example) If there is a multiple site manufactured dose form being used by products, the appropriate administrable dose form should be created in SNOMED CT even if there are no products using this directly….since some countries/implementations will be representing the administrable concept as well as the manufactured concept. The example for this in our list is the “Powder for intravesical solution/solution for injection” with its administrable dose form of “Intravesical solution/solution for injection” |
7738
1.2.4. Implant dose forms
785910004 | Prolonged-release intralesional implant (dose form) |
This PDF is the only one (we think) using "intralesional" as the intended site. It also is used by only one CD (carmustine). EDQM does not have the "intralesional" site - it uses parenteral. Intralesional is not (currently) a child of parenteral so these would not classify up together.
We would like to discuss whether this "extra" specificity is bringing clinical value. If this could be "implant", we would have a better match with EDQM and would reflect the authorised dose form.
764842006 | Prolonged-release ocular implant (dose form) |
This PDF is used by a small number of CDs (steroid, antiviral). The EDQM PDF concept is just "implant" BUT there is a CMT in EDQM that is "intravitreal implant with applicator" that is used on the SmPC for these products (and also by the FDA). The use of "ocular" as the intended site - whilst not incorrect - does not seem to reflect the actual PDF; would intraocular have been a better choice? Would "intravitreal" be even more appropriate?
7764842006 | Prolonged-release ocular implant (dose form) |64842006 | Prolonged-release ocular implant (dose form) |764842006 | Prolonged-release ocular implant (dose form) |
73Rel8943003
| Gingival (inteRelended site) |43003 | Gingival (intended site) |8943003 | Gingival (intended site) |3738943003 | Gingival (intended site) |8943003 | Gingival (intended site) |
6 Comments
François Macary
Should we include under the "Specific issues" section the missing PDFs in SNOMED that we have identified, or shall we post them right away on CRS?
Julie M. James
I think that's something I need to check up on. I think there are two things we need to consider...
1) Making sure that we request only those things that we are sure we need....which may mean waiting to nearer the end of the "first pass" through
2) Making the requests in a way that is most efficient for SNOMED CT (Toni) to process and ourselves to do
As a start, I'll make a table to list them on this page
François Macary
We've come across a number of missing dose forms during EDQM mapping subgroup meetings.
I have posted on CRS the first list that we had. 2 basic dose forms (concentrated solution, dispersion) and 3 PDF have been rejected, for understandable reasons. And 7 multiple intende sites PDF have been placed on hold until the evolution of the PDF concept model is validated.
But I have a sense that there were more missing PDF that we saw.
As soon the table appears here, I'll post them on CRS if you agree.
Julie M. James
I'm building a full list (I hope) in the mapping spreadsheet; I think we need to discuss how we move them forward and how they fit with everyone's timelines. I'll make it a topic for our meeting
Monica Harry
François Macary- for the sake of tracking requests for change in one place etc. Please post to CRS and select topic "product". Any such requests will be reviewed as per our current policy. thanks, Monica
François Macary
OK