Stream: BRR - Pharmacy model
Topic: Mapping IDMP/SPOR Medicinal Product
Stine Johansen (Jun 18 2020 at 11:07):
Hi, when mapping our implementation of IDMP/SPOR to FHIR R4, we have a question regarding Authorized Authorized Pharmaceutical Dose form which is part of IDMP, but I cant see it in neither R4 or R5 of FHIR. Can anyone comment on why the authorized dose form is not present in the FHIR resource?
Rik Smithies (Jun 18 2020 at 11:36):
hi Stine, IDMP has several dose forms:
Medicinal Product.Combined Pharmaceutical Dose Form which is at MedicinalProduct.combinedPharmaceuticalDoseForm
(in R5 at MedicinalProductDefinition.combinedPharmaceuticalDoseForm)
Pharmaceutical Product.Administrable Dose Form which is at MedicinalProductPharmaceutical.administrableDoseForm
(in R5 at AdministrableProductDefinition.administrableDoseForm)
and
Manufactured Item.Manufactured Dose Form which is at MedicinalProductManufactured.manufacturedDoseForm
(in R5 at ManufacturedItemDefinition.manufacturedDoseForm)
Stine Johansen (Jun 18 2020 at 12:23):
Yes, I am aware, but isn't also "Authorised Pharmaceutical Dose Form" connected to/on Medicinal Product, as in the dose form that was approved?
Rik Smithies (Jun 18 2020 at 13:09):
hmm, where are you seeing that name? The product as a whole gets authorised, and the form is one of its defining attributes, but not with that name in IDMP. The authorisation itself is in a RegulatedAuthorization resource (in R5), which points in to the product, and so is not shown (though its a key thing).
Stine Johansen (Jun 19 2020 at 05:40):
Its in the PMS Logical Data Model from EMA. I see now that in an email I're received from someone working with SPOR and the EU IG is having a discussion on this, they say the authorized form is not in IDMP, so I guess it's a SPOR detail. Are the FHIR resources being created directly from IDMP, or is the SPOR work also being taken into account?
Rik Smithies (Jun 19 2020 at 10:53):
The FHIR resources intend to cover all the requirements for this domain industry wide, and are no way limited to IDMP or SPOR. I don't think any new form is needed above what is in IDMP, it's just a matter of the form being licensed (via the product). It's not a different form.
I worked to map the whole of SPOR and the EMA PMS LDM and the EU IG to FHIR, so I know it is all covered. Let's discuss off line to see where the wires are getting crossed.
Last updated: Apr 12 2022 at 19:14 UTC
