Bringing IDMP to life for patients: progress in 2019/2020
As IDMP proof-of-concepts start to showcase patient benefits, Frits Stulp calls for increased cooperation and a patient-centric mindsetAdd bookmark
If, in an IDMP context, 2019 was the year of progress around common definitions for medicinal substances, 2020 needs to be the year of product-related data progress – and of putting patients at the centre of all developments.
One of the important advances of the last year has been the demonstration of the impact shared definitions of substances can have internationally, via a proof-of-concept project led by the Dutch regulator. Specifically it explored 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 how describing molecules in a consistent, agreed way, with common mapping, can 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.
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. Bringing more cases to life like this could really help to drive market momentum. (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 who have reference to only limited information, such as the colour of existing pills.)
The veterinary agenda must not be a distraction
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. Yet 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.
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.
Increasing patient centricity
Something we very much need to see in 2020 is more prominent representation of the patient voice in discussions and developments - driving through improvements such as more accessible ‘instructions for use’ (IFU) content, for instance, via different media and channels.
Audio instructions, video explanations and pictograms, delivered via web sites or mobile platforms, are among the planned options. Yet, currently, the rollout of these initiatives feels too far off and the required urgency seems lacking, so someone needs to address and drive this over the year ahead.
Again, standardised approaches to data are central to progress here, not least because companies need a way to govern and trace all of the information they are putting out into the market. A common set of definitions will allow both the pharmaceutical industry and the regulator to have an agreed understanding of the product, in whatever communication may follow.
Concerted action is needed in 2020
My hope for 2020 is that it will be a year of decisive action against all of these priorities, with the patient central to all thinking.
About the author
Frits Stulp is Managing Director of Iperion Life Sciences Consultancy, and a prominent mover in IDMP circles. He was Program Manager of the first completed IDMP implementation program and is a member of the EMA ISO IDMP Task Force.
 Substance, product, organisation and referential (SPOR) master data, European Medicines Agency