Focus

COVID-19 and the
Real-World Potential
of IDMP

Lise Stevens

Lise Stevens is associate director at Iperion Life Sciences Consultancy. She is a specialist in project management, IDMP, and ICSR training and implementation.

Lise Stevens
Lise Stevens

Lise Stevens

Lise Stevens is associate director at Iperion Life Sciences Consultancy. She is a specialist in project management, IDMP, and ICSR training and implementation.

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fter years of anticipation, it’s easy to lose sight of the real-world purpose of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) data standards. They were designed to enable reliable, efficient sharing of information about medicines on a global scale. In light of COVID-19 and the exceptional circumstances it has created in healthcare and pharma in 2020, IDMP offers transformative potential. This is true across use cases including pharmacovigilance adverse event reporting, electronic prescribing, and falsified medicines control in the supply chain.

The ISO IDMP standards will soon be a reality in support of the European Medicines Agency data management services to power EU regulatory activities. These standards were created to make it easier to identify products throughout the drug development lifecycle and especially in individual case safety reports (ICSRs). If manufacturers, regulators, and clinicians could agree on consistent representation and description of the various attributes of a drug, this would enable assignment of globally acceptable identifiers. These identifiers would make it easier to look up, compare, and monitor relative differences in product formulations, biotechnology, and other manufacturing information that may impact patient outcomes.

The implications of having internationally adopted standards in place and in use around the world are enormous. There is potential to transform not only regulatory and quality operations, but also to advance translational science, improve traceability within the global supply chain, and manage medication therapy for healthcare professionals and patients.

More collaborative research

The COVID-19 pandemic has crystallized that potential, as diverse stakeholder groups have joined forces to accelerate the preparation, validation, production, and delivery of new tests, treatments, and ultimately vaccines. If IDMP were widely in use by now, common identifiers would be used during drug development, and comparison of vaccine characteristics across new drug applications would be much easier. This is important given the need to assess clinical trial results and adverse events among vaccine manufacturers. For instance, if patient reactions to certain formulations are somewhat consistent across clinical trials, regulators may require additional monitoring, phase IV/post-market studies, or more explicit patient warnings in package inserts or promotional materials.

Registering and updating product information as globally-understood, multi-dimensional datasets comprising consistent identifiers that span all aspects of a drug’s provenance, make-up, and distribution has much broader potential, too. Being able to share and integrate such data could help directly with the planning of mass immunization programs around the world, not least by allowing emerging issues to be spotted and addressed early on. These might include potential problems with access to raw materials, due to regional lockdowns, transport delays, or geopolitical tensions. Being able to look up the status of equivalent products or similar formulations would open up alternative supply options, or at least allow stakeholders to work out contingency plans.

Once vaccines have been approved, IDMP-based data exchange would support effective and efficient reporting and analysis of adverse events as part of ongoing pharmacovigilance efforts, cross-referenced for maximum accuracy with exact detail about the particular formulation, where it was made, its distribution, storage, and so on. Such activity will be vital as drug companies and regulators strive to roll out COVID-critical products swiftly yet safely. Having this level of data granularity and traceability will also help to combat the threat of falsified medicines entering supply chains, especially in underserved populations. 

 

Continuity of care across borders

Reliable cross-border data exchange will also help where individuals have travelled between different countries or regions and need to be given the correct equivalents if they require a second vaccine or additional doses of treatment. Once all parties have begun recording information consistently using IDMP data standards, the opportunity to build a rich international drug knowledge base is substantial, with implications for more enriched clinical decision support and improved pharmacy information systems. Healthcare provider and patient access to accurate and reliable product information is crucial for reducing or eliminating patient harm, especially in cases where the use of equivalent or alternative products is warranted due to unwanted side effects.

Seen through the lens of the persisting pandemic, IDMP’s potential takes on a significance that had seemingly become lost. IDMP compliance is not an end in and of itself. It is just the beginning. This is not just about a new set of specifications about how to submit information, about replacing paper with structured data for its own sake. It is about leveraging that data for the advance of healthcare; for the good of patients.

And it is adhering to these end goals that must and will drive the next push to make IDMP a reality — use cases such as adverse effects reporting; building a definitive, detailed knowledge base and reference source for all drug profiles globally; and logging and being able to cross-reference protocols for novel therapies.

Building a global knowledge base

In the context of COVID, the benefits become much more tangible. Here is a real-life situation in which everyone is learning as they go, and (ideally) feeding into a common knowledge pool: a learning health system which is expanding all the time, in turn informing healthcare processes and potentially transforming patient outcomes. In an IDMP-enabled world, this continuous learning would be facilitated by structured, high-quality data entered and updated in real time — not painstakingly transcribed and pieced together from a backlog of static documents. Where, previously, the link with translational science was seen as a softer benefit of IDMP, the feed into learning systems becomes a critical consideration in the context of a dynamic pandemic. The ability to analyze credible big-data sets to draw important conclusions has never mattered more.

Since speed is of the essence, global data insights offer to help fill gaps where clinical trials can’t attain the diversity of general populations. They offer to inform regulators and pharma companies about what is working best for patients and to allay fears about vaccines or particular drug formulations in relation to certain populations such as pediatric demographics. A trusted feedback loop updated via multiple data sources will be crucial to building public confidence, especially where healthcare professionals are so overstretched that they might fail to report adverse effects or stay abreast of recall notices on a regulator’s web site.

Focusing next efforts

There is still work to be done to get IDMP over the line, of course. It doesn’t help, for example, that the different regions are each tailoring the ISO standards to suit themselves, favoring differing data exchange formats, for instance. Unless stakeholders globally concede some ground and work together to harmonize requirements, there will continue to be deviations in approach which threaten the speed of global conformance and the delivery of improved patient experiences. Failure to resolve the final details is also having an impact on optimized IT systems being developed and rolled out — delays that are enormously frustrating when there is such urgency around meaningful progress in life sciences linked to the current pandemic.

Yes, there is growing “COVID fatigue” now, but if the industry does not use this as leverage to accelerate transformation, IDMP will never fulfil its wider purpose and it will end up being just another costly administrative exercise which goes nowhere. No one wants that. Rather, COVID-19 should raise awareness for more targeted and proactive harmonization across geographical regions — something that has been talked about for a decade or more now! It must not take a new, future pandemic or bioterrorist event to deliver what has been promised. We need those benefits now.

Success now, while it counts, will depend on a concerted, agile, matrix-based effort to secure progress, in place of siloed, serial decision-making among a closed and relatively limited group of stakeholders. There needs to be a greater push and proactive negotiation from the pharmaceutical industry now too, so that regulators can see the industry’s appetite for an international framework.

A consortium approach to driving real change will be the most effective, but currently the healthcare profession remains a missing party at the table. As a consequence, there needs to be an effort to bring in this element which can advocate for real-world applications for standardized product data exchange as well as better outcomes for patients. Academic research centers should be party to discussions too, promoting the role of a robust learning health system and what will be needed to advance this.

These are uncertain times, but sometimes it takes a crisis to focus attention and resources. Necessity, as they say, is the mother of invention.