Drug Safety Matters brings you the best stories from the world of pharmacovigilance. Through in-depth interviews with our guests, we cover new research and trends, and explore the most pressing issues in medicines safety today. Produced by Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring.
The views and opinions expressed in the podcast are those of the hosts and guests respectively and, unless otherwise stated, do not represent the position of any institution to which they are affiliated.
The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund discuss the advantages and challenges of this global standardisation effort.
Tune in to find out:
What the IDMP standards cover
How Uppsala Monitoring Centre will help create and maintain them
What is expected of other key stakeholders
Want to know more?
UNICOM’s ‘IDMP in a capsule’ explains how the IDMP standards work throughout the life cycle of a medicinal product and is available as a handbook and video tutorial.
Healthcare consultant Christian Hay discusses how IDMP will improve medication safety worldwide in Uppsala Reports.
Development and implementation of the standards are led by the International Organization for Standardization (ISO), who described the key benefits of the project in this article from 2016.
You can learn more about Uppsala Monitoring Centre’s role in the IDMP project and how the standards will affect the WHODrug Global drug dictionary on our website.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
In today's globalized world, patients can travel just about anywhere to get medical treatment. And medicines are often tested, manufactured, and sold in several different countries. But even though healthcare has become globalized, the language and IT systems haven't exactly kept pace. And there has been no unified approach to identify medicines unequivocally across borders. Thankfully, the identification of medicinal products or IDMP standards are set to change that for the benefit of patients everywhere. My name is Federica Santoro, and this is Drug Safety Matters, a podcast by Uppsala Monitoring Center, where we explore current issues in pharmacovigilance and patient safety. Joining me today are my colleagues Marlene Fladwald, head of the Who Drug Product Portfolio, and Ulle Lagerlund, UMC's substance expert. For years, Marlen and Ulle have been maintaining and developing WhoDrug, UMC's drug dictionary service. But their days are increasingly filled with IDMP as plans to implement the new standards gather pace. And so I sat down with them to discuss the ins and outs of this global standardization effort. I hope you enjoy our conversation. Hi Malin Anoul, and welcome to Drug Safety Matters. We've had the pleasure to welcome a few of our colleagues to the pod before, but never someone from the Who Drug section, so a very warm welcome to you. Thank you. Thank you. Now, you're both heavily involved in the IDMP project, and there's been so much talk about these standards lately, both in and outside UMC, that we thought it would be good to shed some light on it all. What they are, how they will work, and who will be affected. But first, let's start with the big why. Marlene, why do we even need international standards for medicines?
SPEAKER_01
Well, as UMC being the WHO collaborating center for international drug monitoring and working with pharmacovigilance, the need to harmodize medicinal products in order to manage the global pharmacovigilance monitoring, that need has been for many, many years, and we worked with that with the Who Drug Global Drug Dictionary. But then with the ongoing globalization and faster development of new medicines, there has been a growing need for the regulators and the industry to exchange information on medicinal products even faster between many many countries and in different languages. So the medicinal products in one part of the world are now used much more widely in different countries, and then exchanging text format is not really okay, you need to have identifiers. In addition to this, I think that the pandemic with the fast rollout of the new COVID vaccines really showed that there was a need for even faster processes and more efficient identification of the vaccines in order to roll out the vaccine and also monitor them and ensure that everyone was safe using these medicines.
Federica Santoro
So it's important that we speak the same language, basically. Yes. Right. So, Ole, there's a lot of talk about the IDMP standards improving patient safety, but how exactly will they do that? And could you give us some concrete examples perhaps?
SPEAKER_00
Yes, at least I'll try to. I'll bring up on that you just said to Marlin, speak the same language. And that's one important thing. Because if you look today, they are the same medicines globally, but they're not always described in exactly the same way. So even if you have it in two different regions or countries, it might be difficult to connect them together. Of course, this is possible in different ways, but if you would have it more standardized, harmonized, it would be easier. One example could be like for instance cross-border prescriptions. So between countries sharing a prescription. And then you could have very similar products, but not the same, it's gonna be written in a different alphabet, for instance, in Crylic letters. And how would you know that if you don't speak the language, that you get the right prescription when you get to the pharmacy? Then maybe you have your IDMP certificate or the barcode that you can scan, for instance, and the pharmacist can get up which type of medicine, which strength, and which dose form it is. Then even if you don't know the language, for instance, you would get the correct medicine. It might seem like a small thing that you could figure out anyway, but it's the day-to-day things that can increase patient safety in a lot of things. One such case you can read upon in a Unicom publication called IDMP in a capsule, where they describe this in a bit more detail. Another thing where we also can see some increase in patient safety is slight in different research projects than how you find signals like we do on UMC. It may be not that you change the methods all that, but you will have more details compared to what you have now on reports a lot of the time. For hopefully we will have more increase in information about dosage and dose forms and strength and so on. So we will gain more knowledge in that field and thereby in the long run increase the patient's safety.
SPEAKER_01
Yeah, and I think in addition to that, what we also will gain is that we'll have more information of the actual substance that you have in the medicine. Because right now you usually know a name and it's hard to connect between regions. But what IDMP suggests and what is described in the standard is that you have a rich source of information that belongs to each substance that you then can link to other sources of information. So then you get like a network of information that you can collect globally, and that's really unique and something that we don't have today.
Federica Santoro
Sounds great. And because you mentioned substance, that leads nicely into my next question. I'd like to get a bit more into the nitty-gritty of it all. And Olle, I was hoping you could help me understand what the IDMP standards actually mean. Because I know there are five, and some of them are pretty self-explanatory, like the ones that refer to substance or dosage form or route of administration. But there's others that are not so clear. For example, I can't quite grasp the difference between medicinal product and pharmaceutical product in IDMP jargon.
SPEAKER_00
No, and that's um totally understandable. Basically, one could say that the medicinal product ID, it's the product itself, like the package you buy, more or less. You also have IDMP standards for packaging and so on. But if you take an example like Tylenol, that's a brand name, and that would be on the medicinal product ID. And that would contain like Tylenol 500 milligrams, and then a tablet, for instance. But Tylenol is just a brand name, it contains paracetamol. So paracetamol 500 milligrams tablet would be part of the PHP ID. So that would be a lumping together of like similar medicinal products. If you take the cross-border thing again, if they don't have the exact same medicine and brand name as you request when you go to the pharmacy in France, then they might have the PHP ID and they can find a similar product, and then it's also up for the pharmacists to see that yeah, this is the same uh substance, same medicine, so you can take it without fear of getting mistreated in any way.
Federica Santoro
That makes sense. So, Marlene, setting up and implementing the IDMP standards on a global scale sounds like a pretty challenging endeavor. One where I guess a lot of different organisations will be involved. What is our role, UMC's role in all this?
SPEAKER_01
Well, UMC as a WHO collaborating center have been endorsed to be the maintenance organisation for the global pharmaceutical product ID, so the PHP ID as we call it. And that means that UMC will be the organisation that creates and maintain the PHP ID.
Federica Santoro
And av all organisations, why is UMC well suited to provide the PHP IDs or pharmaceutical product identifiers? And also how will these identifiers be assigned?
SPEAKER_01
Well, UMC has for many many years worked with the Hudra Global Dictionary and have maintained that information that is basically very similar to IDMP. So, our team of pharmacists are very used to treat this kind of information. The difference with IDMP and the PHP ID are that there are different business rules that we have to apply. So, what we're currently working on is trying to figure out how these new business rules are going to work, and how are we going to apply it on the data that we get from the different countries. And we will also need to harmonise the data that we get in order to have konsistent PHP IDs. Så för exempel, if we have a creme från Sweden. X procent av sam substance. Well, if we get the same kreme från another country somewhere, it will säga att determ x milligram per milliliter. Så in diesen circumstan, GMC will be the harmonising organisation som decidering att vi ska gå för x milligram per milliliter in order to krate the same PHP ID.
SPEAKER_00
Yes, and since I'm a substance guy, so I like substances a lot. Det är också a way that vi need to harmonise samma substances. Because they are, even if you think small chemical, very nice structures should be the same. But for instance, we have this hydrates. Sometimes we have that extra waters in the molecules. And those are sometimes considered important for some countries, and for some countries they're not. So they also difference in the same name, can, for instance, be with different amounts of hydrates depending on who's setting the name or the pharmakopia you read. So where you're in the world matters, and we want to harmonize this. And maybe we can't make everyone happy, but we'll try to make it consistent. That's the goal, at least.
Federica Santoro
Sounds like there's a lot of decisions you'll have to take in the near future. Okay, back to you, Marlin. You mentioned the Who Drug Global Drug Dictionary that actually both you and Olle have been working with for many years. And as you said, Who drugrug is also a set of medicinal standards. Can we dig a little deeper into it? How does WhoDrug differ from IDMP? And actually, how is UMC gonna reconcile those two tasks of maintaining both WHODRUG and a set of IDMP standards?
SPEAKER_01
Yeah, that's a very interesting question, actually. Because WhoDrug is actually a dictionary that was born from the needs of pharmacovigilance. So it describes the medicinal product information and using the same elements as IDMP, so the substance and the dose form and the strength. And it also links the medicinal products together and also assigns an ATC code to each product. And then if you look at IDMP, it's not really a dictionary, it's more of a standard itself that could create a dictionary with these same components as we have in Hoodrug. But it will also add other things. So, as Ulle mentioned before, you have a medicinal product identifier and also a package identifier that will be assigned by the national regulator. So, moving forward, the plan is to enrich WODRAG with these new identifiers. So, adding them and kind of linking them together to create an even better product for pharmacovigilance and also for other uses, because the idea with IDMP is actually to use this in the entire life cycle of a medicinal product and not only pharmacovigilance. That was just the starting point.
Federica Santoro
So, who drugs set to become a super drug dictionary? Ulle, back to you. As we've said, the pharmaceutical product identifiers are just one of five IDMP standards. So if UMC is gonna provide the PHP IDs, who's gonna take care of the rest?
SPEAKER_00
Yes, um let's start with another one: the global substance identifier. Right now it's not decided that UMC are gonna provide that, but we need that enable to assign the PHP ID in a consistent way, then we need to have a substance identifier. And uh if we do the assignment of the PHP ID, it's natural for us to have that as well. Then, as Marlin mentioned, the medicinal product ID and the package ID, those will be signed by the local authority. And then we will also have that's not really an assignment, but the dose form, for instance, is a standard provided by the EDQM. That's the European Directorate for the Quality of Medicine and Healthcare. And they are in charge of the European Pharmacopoeia, for instance, as well. They have a set of standards for the dose form. But we also know that dose forms are very different across the world. So then we also have characteristics that describe these dose forms that's also assigned by the EDQM, but which one we should use and how to use them in the PHP ID to make it consistent throughout the world. Then we also have units that we have UCOM, it's another organization, setting the standard for international units that we try to use.
Federica Santoro
Lots of international collaboration.
SPEAKER_00
Yes, and lots of uh abbreviations, but we'll hopefully can have a list of them.
Federica Santoro
Yes, you could definitely include that in the show notes. Marlene, one of the reasons we're talking about IDMP today is because the world is actually getting ready to implement the standards. And I would add, finally, because they've been discussed for a long time. I was actually surprised to read that the standards were published for the first time 10 years ago in 2012. What's been taking so long?
SPEAKER_01
Well, just to create these standards that took more than 10 years, yet the creation process. But then I would say that the implementation process is as complex because what is really needed here is that there's a lot of data resources to actually ensure that the data are harmonized according to the standards, and then there's also a need for collaborative work to agree on this implementation. I think in the beginning one thought that each region could just have their own guidelines for implementation, but then you will probably miss some of the global harmonization. So that was not the way to go. So now I think what we're doing is that there are many different regulators that are unified to have a global implementation, and that's why we have the global IDMP working group now working in a collaborative way to figure out the ways that we can have a good implementation. Because the standards themselves are not really enough. They need to be interpreted.
Federica Santoro
It's ambitious but obviously not really easy work, and it sounds like there's a lot of effort ahead for the various stakeholders involved in the process. What are the next steps for them if we look to the immediate future?
SPEAKER_01
Yes, I think for the key regulators that only have managed large parts of the implementation. I think their next step is to ensure that they get as much benefit as possible out of their implementation both internally but also in communication with external partners. It's also very important that they can share their experiences with other regulators that hasn't come that far with their implementation yet, and also countries that want to start using IDMP that are really beginners. So each of these new countries that are new to IDMP need to assess how their current situation is regarding IDMP harmonisation, how they would best gain benefits of IDMP, and also how could they have a stepwide approach towards the implementation. Then regarding other stakeholders like the industry, they also need to prepare for the implementation, but they are very dependent on the requirements and the guidelines from the regulators. Many of them could, of course, have benefits of implementation in their internal processes, but then they need to decide on where to focus and how do they meet the requirements from the regulators.
Federica Santoro
Thank you. And I have just one final question for you, Olle. If we go back to the benefits of IDMP, we've talked about the role of the standards in pharmacovigilance, but in what other areas will they be important, do you think?
SPEAKER_00
Yes, I think we could go back to what we talked about before: the cross-border prescription. That's a typical case. And another example is drug shortages. So, for instance, if in your country you lack a specific medicine or specific brand name, you could find what other countries in the nearby vicinity, for instance, or around the world maybe have some of this medicine. Like if you have the paracetamol case we talked about before, you can't get it in Sweden right now, but you need it. How do I find it? You use the PHP ID, go and search for that globally, and then you find another brand name that you hadn't thought about that is available, for instance, in India, and then maybe you can import that instead. So that's the thought behind it. And these are probably the two most commonly mentioned cases other than PV in the IDMP community at the moment. But there are other ones as well. Like structured data for the industry to submit applications to the regulators. If they could submit the substance information, the dose form information in a structured data form and do the same to all of the different regulators, they don't have to spend hours to adjust how to do that. Maybe different applications, but the same data basically. So they really would like that. Also, when the regulatory make assessments of a new drug, then they can use this data to more easily compare substances, for instance. Have there been any substances like this before that's very like it in structure, going for the same target or something like that? And maybe they also have then confidential data that doesn't show up that easily, but they could see that this has been disapproved or cancelled, but they could see that now they get the similar structure, they have the same profile or whatever. So it could be a role for assessment. And also, like in research and development for the new drugs, and also drug-drug interactions. Like we have different systems for drug-drug interactions. If you go to pharmacy in Sweden, they have a supportive computer system for finding known interactions. But then they have another system in Denmark. And maybe those are more easy to get and work together if you have the same language, the harmonisation throughout EU. And then, yeah, of course, it's not Sweden and Denmark, they're just neighbors. But it could easily be the Philippines and Canada, for instance.
Federica Santoro
Right. And as with all things, I bet there's more benefits that we haven't thought about that we will only discover once the IDMP standards are up and running and we've had time to use them for a while.
SPEAKER_00
Yes, definitely think so. The sky's the limit.
Federica Santoro
Well, thank you very much for your time. I hope our listeners will have enjoyed this first dip in the world of IDMP. And I'll just end by saying good luck to you and everyone else who's involved in this important and ambitious project.
SPEAKER_01
Well, thank you. It was really great joining and for us to share what we're doing with the community.
SPEAKER_00
Yes, thank you a lot. I can only agree and looking forward to the next time.
Federica Santoro
That's all for now. But we'll be back soon with more conversations on medicine safety. If you'd like to know more about the IDMP standards, check out the episode show notes for useful links. If you like our podcast, subscribe to it in your favorite player so you won't miss an episode. And spread the word on social media so other listeners can find us. Apart from these in-depth conversations with experts, we host a series called Uppsala Reports Long Reads. A selection of audio stories from UMC's Pharmacovigilance magazine. So do check that out too. Uppsala Monitoring Center is on Facebook, LinkedIn, and Twitter. And we'd love to hear from you. Send us comments or suggestions for the show, or send in questions for our guests next time we open up for that. For Drug Safety Matters, I'm Federica Santoro. I'd like to thank Marlene Fladwad and Olle Lagerlund for their time, Matthew Barwick for production support, and of course you for tuning in. Till next time.
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