IDMPrimer: What we don’t know


It seems the first rule of IDMP Club is the same as Fight Club: Don’t talk about IDMP Club (it’s probably the second rule too).

I’m a member of some of the branches of IDMP Club, but not all. IRISS Forum probably has the most open exchange of information. I’d highly recommend joining if you want to keep track of what’s going on in the IDMP world, but they’re limited to what has been made public by other groups. On December 14, 2017, they had a presentation from Health Canada on their plans – the main takeaway there is that Canada’s full plans will be distributed in the fourth quarter of 2018.

I’m not a member of the ISO standard committee, but even there, only what is published is available to the public (and only when you license the documents). The only agency to publish any information about IDMP implementation to date is the European Medicines Agency (EMA), and they have a very strict policy of only distributing what is final, not what is still being negotiated. Even there, I’m only a member of some of the teams.

There are a couple areas of the IDMP standard that I’d like to talk about today, and about where there are gaps in the knowledge for implementation.

The first is the Pharmaceutical Product ID (PhPID). In my mind, this is one of the more critical parts of IDMP, as it provides a common ID for all products that match characteristics, on four levels:

  • Products sharing the same active ingredients
  • Products sharing the same active ingredients and dose form
  • Products sharing the same active ingredients and strengths
  • Products sharing the same active ingredients, dose form, and strength

By having these common IDs, it becomes much easier to track adverse experiences across products, as safety databases can then be searched across matching products using a single search parameter.

However, neither the ISO standard (ISO 11616:2017) nor the implementation guide (ISO Technical Specification 20541) give enough information to create this ID. Generalities are known: the ID is created from an MD5 checksum of a concatenation of all of the ingredients, strengths and dose form (or some of those items). The specification is not complete, though, as the text says to use “their substance code (eg UNII)” – it’s not an international standard. Similarly, the strength of each active ingredient is supposed to be normalized to avoid having one product with 2000mg, and another 2g, but that normalization is not specified either.

There is time for these details to be hammered out, but until they’re published, software vendors can’t provide validated software guaranteed to perform correctly. The PhPID could also be left out of the implementation in various countries, if the specifications aren’t final. I think it would be a shame to lose that search power, but at least there is the knowledge that the PhPID is completely calculated, meaning that it can always be added later.

The other area I want to talk about is things that sponsors know about their products, but IDMP doesn’t. Specifically, some of the parts and pieces aren’t connected to each other.

Packages contain “Manufactured Items”: the delivered parts of a medicinal product such as a tablet, or a sachet of powder and a vial of diluent. Each Manufactured Item has a list of ingredients. The Medicinal Product also details information about the Pharmaceutical Product and its ingredients. In simple cases such as tablets, the Manufactured Item and Pharmaceutical Product are the same thing. In reconstituted products such as a solution for injection, it isn’t necessarily clear which manufactured items, and how much of each, goes into the pharmaceutical product. There may be multiple powders that use the same diluent for separate injections, or there may be different concentrations created from those same items.

Those details are known – they’re part of the instructions for use in any product’s label. There isn’t any logical connection, though, between the manufactured items and the pharmaceutical products in the IDMP standard. Most of the time, this can be deduced logically, but it should probably be more explicit. That relationship is expected to be present in the ARIM Formulation when we deliver full IDMP capabilities. This probably has little effect on safety tracking, though, so its omission from IDMP isn’t fatal.

As IDMP implementation becomes clearer, and as ARIM evolves, we will publish more information on how the two will interact. For now, contact ACUTA to learn more about how ARIM and ACUTA consulting can help you prepare for IDMP compliance.

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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