IDMP: delivering patient benefits – what next?
Summary
As proof-of-concept projects begin to highlight IDMP’s different real-world use cases, and illustrate the potential benefits, stakeholders must come together and give greater emphasis to patients in 2020– which starts with giving them a seat at the table, says Frits Stulp of Iperion Life Sciences Consultancy.- Author Company: Iperion Life Sciences Consultancy
- Author Name: Frits Stulp is Managing Director of Iperion Life Sciences Consultancy
As proof-of-concept projects begin to highlight IDMP’s different real-world use cases, and illustrate the potential benefits, stakeholders must come together and give greater emphasis to patients in 2020– which starts with giving them a seat at the table, says Frits Stulp of Iperion Life Sciences Consultancy.
If 2019 was the year of progress around common definitions for medicinal substances, in an IDMP context, then 2020 needs to be the year of product-related data progress – and of putting patients at the centre of 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.
Perspective matters: veterinary regulatory progress is a positive development
Standardising veterinary medicines information was always part of the EU/EMA plan, and January 2022 has now been set 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, as a result of this perceived switch in focus. 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[1], whichever angle they are coming from.
Promoting the patient agenda
More than anything, over the next year, we also need greater and more prominent representation of the patient voice in discussions and developments - driving through improvements such as more accessible ‘instructions for use’ (IFU) content 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, there are no fixed deadlines and the required urgency seems lacking, so stakeholders need to work together to proactively address 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 products, in whatever communication may follow.
2020 promises to be a pivotal year for IDMP, as long as everyone is aligned towards the same goals and actively pursuing collective progress and success.
[1] Substance, product, organisation and referential (SPOR) master data, European Medicines Agency
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.
www.iperion.nl
