MED-RT is the successor to NDF-RT so the article still applies based on the most recent version of the FDA TCG section 6.5.1.1
The rule checks are only considering term values that are of the following concept types:
EPC, MOA, PE, and TC
This term value of Vaccine has the concept type of APC which is why the rule checks fire as it is not found in the set of values the rule checks consider valid. As mentioned in the description for the ticket, you noticed this as well.
So this means that APC is not allowed? Even if the vaccine is not in the list?
I would suggest adjusting the wording of the error to reflect that only part of the MED-RT codelist is usable. (just to make it clear what is happening).
The latest FDA Technical Conformance Guide states that “FDA maintains a list of established pharmacologic classes of approved moieties (61)”, but when one clicks on the link of the reference, one gets a page Prescribing Information Resources | FDA that even doesn’t mention Med-RT, neither does it provide a list.
So it looks as we need to submit a value from a list that is secret?
To see the list of EPCs, on the webpage titled Prescribing Information Resources, scroll down and click on the heading “Highlights of Prescribing Information”. Continue to scroll down until you see “Established Pharmacologic Class (EPC)”, and click on the link in parentheses next to the text “FDA EPC Text Phrases for Indications and Usage Heading in Highlights”. This is the list of EPCs that is maintained and updated by FDA.
Thanks Matt!
Looks as the FDA has done its extremely best to hide this as much as possible.
When I look at this list (direct link: https://www.fda.gov/media/164568/download?attachment) I see some relationship with the Med-RT list (e.g. at https://evs.nci.nih.gov/ftp1/MED-RT/Archive/MEDRT_2023.07.03.txt), though the FDA doesn’t even mention Med-RT, but I also see that FDA changed the casing of the class names, e.g. “Calcitonin” in Med-RT and “calcinotin” at FDA.
Once again another possible cause of confusion …
Why the hell do regulatory authorities do not make RESTful Web Services for such lists available? We do live in the 21st century …
