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he last year has seen decent progress towards IDMP data standards implementation in the EU, particularly at a substance level, which the industry can build on in 2020. One significant development in 2019 has been the demonstration of the potential impact of internationally shared definitions of substances. A proof-of-concept project, led by the Dutch regulator (Medicines Evaluation Board), on behalf of the European regulatory network, considered the benefits of data continuity in a substances context from a scientific point of view. It looked at how agreed descriptions/coding for complex molecules would help in cross-border medicines management - for instance in scenarios where a patient loses their medication on holiday, or needs a new prescription, and a healthcare provider needs to check the active ingredients, and identify any contraindications or allergy implications.

The study highlights that describing molecules in a consistent, agreed way, with common mapping, will provide significant support for data and process interoperability. Instead of individual professionals having to sift through dossiers to confirm the constituent ingredients of equivalent products, they could simply exchange the agreed identifier -much as people use their social security number to identify themselves as individuals to different government organisations. Here, the primary benefit is reduced risk of wrong medicines being issued (though the efficiency gains for all stakeholders, and the accelerated speed of decision-making, are clear sub-benefits).

This is just one of up to 20 use cases making up the business case for IDMP – that is, for having a common method of identifying medicines. Interestingly, in the US, a project has been underway for some time looking at incorporating images of drugs into a central medicines database, with potential benefits for elderly or vulnerable patients or their carers, who have reference to only limited information, such as the known colours of pills. The aim of that particular project is to capture images of every tablet on the market, so that medication can be identified visually - as a further dimension to the common descriptions being captured. 

Unfortunately, IDMP developments in relation to substances are not yet being matched by developments around product-level descriptions. And there have been some concerns that momentum might once again be lost here, at least in relation to human medicines, as measures to address veterinary medicine data come into central focus. Standardising veterinary medicines information was always part of the EU/EMA plan, and a team is now championing the cause with January 2022 now designated as a hard deadline for compliance with standardised identifiers.

Some in the human medicines industry fear that advances with product-level data will now take a back seat, causing new delays to progress with IDMP implementation. Yet there is no reason why the two streams of work should not happen in parallel. Indeed, they could both feed off and help drive the other, as there will be considerable commonality between most of the process requirements – and one of the big points of IDMP is to foster greater efficiency/replication of proven success.

Veterinary implementations of data standards will put pressure on affected industry stakeholders to establish target operating models for product and substance data, which is something all medicines companies now need to do anyway. So if veterinary work streams move along at a slightly faster pace now, this could even help accelerate or boost the business case for broader/human medicines data transformation efforts. Certainly there is no need for working parties with interests in human and veterinary medicines to plan their projects sequentially. Parallel planning makes much more sense, especially if the respective work parties can learn from each other and accelerate overall progress. 

The target go-live date for human medicines/IDMP compliance is 2023, and it is in everyone’s interests that we keep to this deadline. So if we can harmonise the process, rather than create two sets of definitions, vocabularies and so on, so much the better for everyone concerned. With a concerted effort, I believe we can all hit our deadlines, and in 2020 it would be immensely encouraging to see all industry stakeholders - regulator, industry and technology vendors - come together to drive progress against SPOR data standards, whichever angle they are coming from.

Something else we very much need to see in 2020, in the context of human medicines, is greater and more prominent representation of the patient voice in discussions and developments. It is ironic that, despite the public being the ultimate intended beneficiaries of IDMP medicinal data standards, this important stakeholder group currently has no seat at the table. 

We all know and accept that very few patients bother to open up and read the lengthy advice leaflets included with drugs, with their microscopic print and overly-thorough detail with a strong legal leaning.

To address this, in due course patients will increasingly have access to more fit-for-purpose ‘instructions for use’ (IFU) content, and potentially broader product information, through a choice of media and distribution channels. But this too relies on common data standards, reducing the risk of meaning or accuracy being lost in translation, as critical safety information is turned into videos, audio or pictogram formats for each market.

And, at this point, the rollout of these initiatives feels too far off. It doesn’t help that there is no one specifically campaigning on patients’ behalf for these innovations to happen sooner; for a deadline for at least a first iteration of a new IFU format. As medicines become increasingly complex in their make-up, and as treatments become more personalised, the role of user-friendly content will only become more important, too. So all of this needs to have a greater focus over the coming year.

To maintain IDMP momentum, 2020 needs to be a year of decisive action, collaboration and mutual support, towards some critical goals. Stakeholders from across the life sciences industry should look at the encouraging progress and development of use cases for substance data, and accept veterinary medicine data developments as additional blocks they can build on for human medicines data developments under IDMP. There is absolutely no reason for progress to falter: and stakeholders must make sure of this.

In the meantime, all parties – industry, regulators, IT vendors - need to work together to prioritise and drive the patient agenda. This involves demanding more work towards common definitions and process flow, so that a standardised European approach to electronic patient information can take shape – and a deadline for compliance can be set. It’s time to show the world what real-life impact IDMP will have, and it is incumbent on everyone to make this a success.