Stream: implementers
Topic: medication manufacturer
Jose Costa Teixeira (Aug 28 2020 at 09:45):
In both Medication and Medication Knowledge resources, I still see manufacturer. I thought there was an agreement to change that...?
Jean Duteau (Aug 28 2020 at 16:39):
we have a ticket to change it but the Pharmacy WG is still driving consensus on what it will be named as it appears to be sometimes a manufacturer in some jurisdictions and sometimes not.
Jose Costa Teixeira (Aug 28 2020 at 17:01):
ok
Jose Costa Teixeira (Aug 28 2020 at 17:01):
I don't think i ever saw manufacturer in any jurisdiction (but may be that manufacturer is a common abuse of language)
Jean Duteau (Aug 28 2020 at 18:28):
New Zealand is the one jurisdiction that has voiced opposition to the change
Jose Costa Teixeira (Aug 28 2020 at 20:12):
They seem to call it "sponsor" though
Jean Duteau (Aug 28 2020 at 20:17):
no, from his comment: "The sponsor is merely a promoter and does not have responsibility for the the product in all cases. The registration applies to the manufacturer which is the company whose name is on the packaging and is responsible for the quality and manufacture of the product." As I said, we are still driving consensus but we have bigger issues to deal with at this time.
Peter Jordan (Aug 28 2020 at 20:30):
What's the JIRA Ticket Number for this issue?
Jean Duteau (Aug 28 2020 at 21:24):
Peter Jordan (Aug 30 2020 at 04:20):
It would be useful to get some Australian input into this issue... @Dion McMurtrie & @Matt Cordell .
Those transitioning from V3 & CDA will note that the Manufactured Product Class has a property called manufacturerOrganization, so I find it hard to believe that the manufacturer of a medication is an unusual concept or a linguistic challenge. Looking at some high profile legal actions involving medications - e.g. Thalidomide and OxyContin - the Manufacturer is cited. Therefore, rather than renaming and re-purposing an element in a widely-implemented R4 resource (albeit one at FMM level 3), it might be prudent to add an element for Market Authority Holder if that is required for North America and Europe.
Vassil Peytchev (Aug 30 2020 at 04:34):
Based on the comments in the ticket, should the SPL approach be given consideration?
Jean Duteau (Aug 30 2020 at 06:22):
if we were going to do that, we would probably keep the name and just provide more explanation in the definition and notes.
Jean Duteau (Aug 30 2020 at 06:24):
as the JIRA ticket describes, in many cases, the organization responsible for the medication is the manufacturer, but very often it is a representative of the manufacturer and not actual the organization that physically produces the medication. Given the wide differences across all the jurisdictions, I for one am leaning to keeping the name of manufacturer with the update definitions just because it is what people naturally think of. But we need to keep having this conversation to see if there isn't a more useful name for the data element.
Jose Costa Teixeira (Aug 30 2020 at 18:31):
I agree with @Peter Jordan that perhaps we should split it. I think that everywhere in the clinical realm (which is where Medication fits) we just need a Marketing Authorisation Holder / Sponsor / Labeler / Representative... The manufacturer indeed can be relevant for legal tracing the representative/labeler but that would be in the regulatory realm (ping @Rik Smithies )
While we are discussing, I believe the for clinical world this element name has the only name it shouldn't have.
If I want to use the name of the brand/representative/sponsor (which is most common), I will use manufacturer. And then if I want to say incidently the actual manufacturer name, I use an extension, and say "no, THIS is the manufacturer"?
Rik Smithies (Aug 30 2020 at 20:07):
Whatever name it has may not work for everyone. Seems best just to pick one, probably "manufacturer" - though it may well be a common misuse - and document it (as Melva suggests).
"Supplier" is another option, a bit more neutral perhaps.
I wouldn't think that having both a true manufacturer and an MAH is necessary, in the 80%, for this resource.
It's more distinct in the medication definition resources, where you can use RegulatedAuthorization to say all about the authorization and who the MAH is and (elsewhere) list all the different manufacturers there may be (different items, different steps).
Jose Costa Teixeira (Aug 30 2020 at 20:27):
Agree we don't need both in the clinical realm - in this realm, what matters is the ponsor, MAH, etc - NOT the manufacturer
Jose Costa Teixeira (Aug 30 2020 at 20:28):
please let me know I am incorrect. But if we agree that no name is perfect but manufacturer is bad for everyone, leaving it there is too salomonic, i guess
Jean Duteau (Aug 30 2020 at 20:30):
as I have said, manufacturer is NOT bad for everyone and in fact appears to be more commonly used than other names.
Jean Duteau (Aug 30 2020 at 20:36):
even if the field were named something else, it would many times be where the manufacturer was being sent.
Jean Duteau (Aug 30 2020 at 20:39):
Vassil Peytchev said:
Based on the comments in the ticket, should the SPL approach be given consideration?
Sorry Vassil, I missed your comment. In SPL, the organization that is normally sent is the labeler but they can also send the registrant, so we could possibly choose one of those two terms. The "registrant" is sometimes the manufacturer, sometimes the marketing holder, and sometimes the sponsor, so it might be the leading candidate since it is somewhat abstract.
Jose Costa Teixeira (Aug 30 2020 at 20:39):
As i also mentioned, it seems that when people say manufacturer, it's not really the manufacturer itself, is it?
Jose Costa Teixeira (Aug 30 2020 at 20:40):
I would agree with registrant (because it is not manufacturer which is really specific and may not be correct)
Jose Costa Teixeira (Aug 30 2020 at 20:41):
(or labeler)
Jean Duteau (Aug 30 2020 at 20:44):
when Pharmacy WG did our research, it was actually the manufacturer. It appeared that a large percentage of drugs registered in Health Canada and in the US had the actual manufacturer as the organization that was listed as responsible for the drug (I don't have the stats in front of me, but I remember it being 80+%). The next largest percentage was an closely-related agent for the manufacturer. In many cases, the agent had a similar name to the manufacturer, i.e. it was the Canadian or American subsidiary of a company. So even though the agent wasn't actually manufacturing the drug, they were closely related to the organization that was. And then we saw organizations that were sponsors but had no obvious ties to the manufacturer. I suspect that some percentage of these were agents as well, but it wasn't evident.
Peter Sergent has said that in NZ this is not the case. Although the sponsor is the organization requesting a medication be registered for use in NZ, it is the manufacturer whose name in on the packaging and who is responsible for feedback of the product. This appears to be different than the list of organizations I provided above which were US/Canada.
Jose Costa Teixeira (Aug 30 2020 at 20:50):
I just brought this up because thought this was agreed, now I see maybe it isn't. This is difficult.
I can only suggest: In many places in Europe, what matters is the MAH which may or not be the manufacturer. So there is a more comprehensive term to support all the cases, we can use that (or sponsor, labeler, or responsible, or representative, or registrant, or marketer....).
Jose Costa Teixeira (Aug 30 2020 at 20:50):
I thought we had agreed that we shouldn't have an element called "manufacturer" and then say "note that this may not be the actual manufacturer", I just find that slightly inadequate. But this is a small fish and I agree, other things are in more need of attention.
Jean Duteau (Aug 30 2020 at 20:52):
right, see the ticket for the discussion (to which I will add some of this). We had pushback on the use of the term "marketing authorization holder" since that is not actually as widespread a term as we thought it was. As I said at the beginning of this topic, the WG is currently soliciting what name should be used across all jurisdictions.
Richard Townley-O'Neill (Aug 30 2020 at 23:08):
According to the organisation that regulates medications in Australia (the Therapeutic Goods Administration), "sponsor" includes manufacturers. See https://www.tga.gov.au/role-sponsor.
Australian coding systems for medications AMT and PBS record the sponsor and not the manufacturer.
Richard Townley-O'Neill (Aug 30 2020 at 23:09):
In prescribing and dispensing it is the TGA sponsor that is shared, not the manufacturer.
Dion McMurtrie (Aug 31 2020 at 00:09):
Yes in the Australian regulatory context there is a recorded "sponsor" who get a licence from our regulator. https://www.tga.gov.au/role-sponsor
A sponsor is a person or company who does one or more of the following
- exports therapeutic goods from Australia
- imports therapeutic goods into Australia
- manufactures therapeutic goods for supply in Australia or elsewhere
- arranges for another party to import, export or manufacture therapeutic goods.
Last updated: Apr 12 2022 at 19:14 UTC
