Stream: Medication
Topic: Scope of Medication.manufacturer
Richard Townley-O'Neill (May 10 2019 at 04:40):
In Australia the manufacturer of registered medicines is not generally exchanged, however the sponsor of registration with the Therapeutic Good Administration (TGA) (a govt body) is widely exchanged. The sponsor is often called the manufacturer (once upon a time codes for manufacturers were exchanged) , but the TGA makes it clear that what is exchanged is the sponsor.
- Can this scoping organisation be recorded in Medication.manufacturer, or does it need an extension?
- If it should be in an extension, do other jurisdictions require a compatible extension?
Richard Townley-O'Neill (May 10 2019 at 04:41):
The current definition of Medication.manufacturer excludes using it to hold scoping organisations that are not manufacturers.
Richard Townley-O'Neill (May 10 2019 at 04:43):
This was previously discussed in threads Does Medication.manufacturer include the sponsor? and PBS Manufacturer Code
Jose Costa Teixeira (May 10 2019 at 06:23):
@Richard Townley-O'Neill can "sponsor" be called "Marketing authorisation holder"? that is the standard term
Jose Costa Teixeira (May 10 2019 at 06:25):
i think "manufacturer" is not the right attribute name and intent of the field should be reviewed. it does not matter that much who made the drug, but who is legally responsible for the drug. at least for 80+% of the cases
Jose Costa Teixeira (May 10 2019 at 06:26):
@Melva Peters @Jean Duteau ?
Richard Townley-O'Neill (May 15 2019 at 04:25):
"Marketing authorization holder" sounds similar.
According to the TGA
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.
That is supported by the PBS glossary entry for manufacturer.
Richard Townley-O'Neill (May 31 2019 at 01:38):
@Melva Peters @Jean Duteau
Richard Townley-O'Neill (Jun 03 2019 at 04:49):
Richard Townley-O'Neill (Jun 04 2019 at 00:47):
To close this off, the Meds working group confirm that sponsor is outside the intended scope of manufacturer. I'll need an extension.
Jose Costa Teixeira (Jun 04 2019 at 01:51):
That is strange... in most places (and in IDMP) the manufacturer is less than relevant.
Richard Townley-O'Neill (Jun 04 2019 at 01:53):
What do people actually put in the element?
Jose Costa Teixeira (Jun 04 2019 at 01:53):
which element?
Richard Townley-O'Neill (Jun 04 2019 at 01:53):
Medication.manufacturer
Jose Costa Teixeira (Jun 04 2019 at 01:55):
i have no idea. I was actuallly misusinging it, because I was using it for the MAH.
Jose Costa Teixeira (Jun 04 2019 at 01:55):
i will have to wait again until things are clarified.
Richard Townley-O'Neill (Jun 04 2019 at 01:57):
The WG confirmation is on #22652
Jose Costa Teixeira (Jun 04 2019 at 01:57):
@Melva Peters @Jean Duteau can we look at this again? Can't we get something that works also for IDMP? In Europe manufacturer is not nearly in the 80% AFAIK.
Jose Costa Teixeira (Jun 04 2019 at 01:59):
the MAH is the entity that is clinically and legally relevant.
Jean Duteau (Jun 04 2019 at 05:12):
For now, we decided that it should be an extension, but I was tasked with asking about the use cases that we had for manufacturer. The specific use case that we have is when the name of the medication is not unique and you need to add a company name to it, eg. Acetaminophen 325mg [Nutricorp International] vs Acetaminophen 325mg [Jamieson Laboratories]. I just received one confirmation that this company is the Market Authorization Holder, so it appears that we may change this element away from manufacturer and to be the MAH. I have one more clarification to get.
Melva Peters (Jun 04 2019 at 13:34):
My only concern with MAH is that it isn't a term that is widely used in all parts of the world from a clinical perspective.
Jose Costa Teixeira (Jun 04 2019 at 13:56):
then we can have a term like Responsible.
Jose Costa Teixeira (Jun 04 2019 at 13:57):
what I would suggest avoiding is a precise word like Manufacturer
Jose Costa Teixeira (Jun 04 2019 at 13:57):
MAH is being standardized in IDMP, so I am not too worried - it is a term that should be OK to use and it has a clear, global definition, even if it is less used now.
Jose Costa Teixeira (Jun 04 2019 at 13:58):
i'd rather have a term that requires people to look it up than one that is bound to be misused
Jose Costa Teixeira (Jun 04 2019 at 13:59):
So I agree with the concern, but we can solve that by using IDMP term or finding a broader one.
Melva Peters (Jun 04 2019 at 14:02):
We should be consistent with what is used in the resources Rik has created - he has called it "holder". I'm not sure if that works.
Richard Townley-O'Neill (Jun 05 2019 at 00:31):
the MAH is the entity that is clinically and legally relevant.
In Australia sponsor is the entity that is clinically and legally relevant. It is the organisation responsible for the item. See here and here.
While I prefer 'sponsor', 'responsible organization' seems quite suitable.
Jose Costa Teixeira (Jul 22 2019 at 19:32):
@Lloyd McKenzie as discussed. Where we have "manufacturer" we should end up with "responsible" or something similar. "manufacturer" is a precise word and at least in Europe it is not really used. In fact where we have "Bayer Aspirin" it does not mean it is manufactured by Bayer, it means Bayer is the responsible.
Jean Duteau (Jul 22 2019 at 19:43):
Yes, we are going to change it to responsibleParty or authorizationHolder or productSponsor. The last two were the names that I received when I reached out to my regulatory colleagues.
Lloyd McKenzie (Jul 22 2019 at 20:06):
That's what's relevant on the regulation/registration side. Is that's what's conveyed if you capture manufacturer when sending a prescription or dispense? (And do most systems support sending manufacturer in those cases?)
Jean Duteau (Jul 22 2019 at 20:07):
The information that we have in SK is just what Health Canada provides us and that is not the manufacturer but basically the responsible organization (DIN Owner in Health Canada speak)
Jean Duteau (Jul 22 2019 at 20:09):
FDB calls it the Labeler (well, I'm assuming that from the table name of LBLR_DESC).
Jose Costa Teixeira (Oct 21 2019 at 19:49):
Note that we had the same question on device, and a gforge is created. to consider changing manufacturer
GF#25036
Jose Costa Teixeira (Oct 21 2019 at 19:49):
@Lloyd McKenzie I think this should be in the pattern
Jose Costa Teixeira (Oct 21 2019 at 19:49):
@Jean Duteau not sure this is already the case in Pharmacy, so here's a ping.
Last updated: Apr 12 2022 at 19:14 UTC
