"Grouper" Intended site concepts
Cutaneous/Transdermal and Intravesical/Urethral are concepts whose roots are in the history of Standard Terms, where they were used as search terms in (paper) documents. Now, they are being used as descriptive (even definitional) attributes for the pharmaceutical dose form concept and therefore using more granular/individual concepts would be appropriate. The Standard Terms Working Group is informed about mapping initiatives such as this one with SNOMED CT and is open to discussing changes to the Standard Terms that would be of benefit to this, and to other similar initiatives.
From the perspective of this mapping, having the ST change to use individual intended sites in PDFs rather than than the dual grouper concepts would be beneficial and we would support that change.
General issues
Local/systemic effect
Should "local effect" (or systemic effect) be part of the definition of a dose form, or even part of the comments about it? We feel not. The definition of a PDF is the “physical manifestation of a Medicinal Product that contains the active ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient” – it’s about the thing that formulates or encapsulates or contains the active and inactive ingredient substances. So, a dose form is not about what happens once the administration has been made…or about the effect of the medicine that the dose form contains. There are oral tablets that have no systemic effect (e.g. nystatin)
EDQM is going to discuss this further with the Standard Terms Expert Working Group
Oromucosal dose forms and other grouping concepts
The is no intended site of "sublingual" in EDQM yet many dose forms are "sublingual" but have the intended site given as "oromucosal". Yet in other situations, EDQM excludes SL from oromucosal preparations e.g. 10308300 - Oromucosal spray, suspension.
SNOMED CT has a formal hierarchy of oromucosal dose forms that may be helpful to share
EDQM uses oromucosal as a grouping concept, similar to Cutaneous/Transdermal and Intravesical/Urethral. The latter two may be considered for splitting in future work at EDQM. The "oromucosal" will remain as a grouping concept, accepting that there are some translation issues (e.g. for Spain).
Lacquer as a basic dose form
“A type of liquid pharmaceutical dose form consisting of one or more substances dissolved or suspended in a volatile solvent that evaporates to leave a hard coating. “ Is the "to leave a hard coating" enough to justify a separate basic dose form? Is what happens after the dose form is administered part of the definition of a dose form? There appear to be only two "lacquer" dose forms, and one is questionable (see below - medicated nail lacquer)
2022:01:27 - Will request a "Lacquer" basic dose form for SNOMED CT as the "drying to leave a hard coating" is important
Dispersion as a basic dose form
See slides from 7th October for detail - use of dispersion does not feel to be helpful - 2022-02-10: Dispersion discussion - understand the EDQM rationale; need to consider how to map this to SNOMED CT concepts
Specific issues
11114000: Inhalation vapour, solution
Mixing – is not the correct transformation as can put solution on a handkerchief and inhale the vapour directly; the AdmDF would be “vapour for inhalation”
10521000 : Medicated nail lacquer
Why was “Nail solution” (10521500) rejected by EDQM but Nail lacquer is a standard term? In the rejection, it says “Term rejected. 'Cutaneous use' includes application to the nails.” 2022:01:27 - is an old term; SNOMED CT will author as "cutaneous lacquer"
11002000 : Rectal gel
EDQM to request Standard Terms Expert Working Group to examine the method of administration for this term; administer might be more appropriate (note, is an exact map for S-CT concept at present) as the gel is not placed or spread onto a surface but is administered using an applicator
Laryngopharyngeal Concepts
Laryngopharyngeal dose forms e.g. 3016000 Laryngopharyngeal solution could/should be considered for having the explicit intended site; this would be helpful for making the characteristics more definitional and for things like the FDA mapping