Image: Atomwise CEO and co-founder Abraham Heifets
Image: Atomwise CEO and co-founder Abraham Heifets
The benefit of hindsight: what the pandemic highlights about IDMP’s potential
What difference might the ISO IDMP data standards, if they had been widely in use today, have made in helping pharmaceutical companies navigate the disruption caused by Covid-19? Lise Stevens of Iperion Life Sciences Consultancy reflects on the lessons of the last year.
Lise Stevens is associate director at Iperion Life Sciences Consultancy in Maryland, US. Credit: Iperion Life Sciences Consultancy
ISO Identification of Medicinal Products (IDMP) data standards hold substantial potential, which will hopefully be realised once they are finally implemented in Europe. But what a shame that this wasn’t the case before the current Covid-19 pandemic broke out.
Once manufacturers, regulators and clinicians all agree on consistent representation and description of the various attributes of a drug, it will be possible to assign globally acceptable identifiers to medicinal products, their constituent parts and manufacturing processes. This, in turn, will make it easier to look up, compare and monitor relative differences in formulations, biotechnology and other production-related information which could influence patient outcomes.
In the context of the continuing Covid-19 pandemic and the rush to bring beneficial new products to market, the potential for common identifiers is magnified. If IDMP had been widely in use by now, agreed identifiers would be in use during drug development, and comparison of vaccine and other therapeutics’ characteristics across investigational new drug (INDs) applications/new drug applications (NDAs) would be much easier to achieve. Capturing and storing product information as globally understood, multi-dimensional datasets, made up of consistent identifiers spanning all aspects of a drug’s provenance, make-up and distribution, has much broader scope too.
The ability to share and integrate this data is relevant to the planning of mass immunisation programmes and distribution networks around the world. The ability to identify and mitigate global supply chain risks, such as access to raw materials, regional lockdowns, transport delays or geo-political tension between countries is vital. The ability to assess the availability of equivalent products or similar formulations would open up alternative supply options, as well as support better stakeholder decision-making and contingency planning.
Once proposed vaccines and other therapeutics are approved, IDMP-based data exchange will support more efficient reporting and analysis of adverse events (AEs) and medication errors as part of ongoing pharmacovigilance efforts. AE risk assessments could be greatly enhanced by access to and comparison of IDMP identifiers (e.g., batch/lot ID, package ID), and regional lot distribution and product utilisation data.
Such activity will be vital as drug companies and regulators swiftly roll out Covid-critical products internationally. Having this level of data granularity and traceability to the Global Trade Item Number (GTIN) will help to combat the threat of falsified medicines entering supply chains, especially in underserved populations.
Pooling knowledge across borders
Once information is being recorded consistently using IDMP data standards across country boundaries, the opportunity to build and data-mine a rich international drug knowledge base is substantial. This in turn enriches clinical decision support tools and helps improve e-prescribing/pharmacy information systems. Healthcare provider and patient access to accurate and reliable product information is crucial for mitigating patient harm, especially in cases where the use of equivalent or alternative products is warranted due to unwanted side effects or limited supply.
Where speed is of the essence, as with critical new Covid-related products, 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 what is working best for patients, and to allay fears about vaccines or particular drug formulations in relation to certain populations such as paediatric 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 AEs or stay abreast of recall notices on a regulator’s web site.
Clearly, now, IDMP compliance should not be seen as an end in itself: a next set of specifications about how to submit information; a means of replacing paper with structured data for its own sake. Rather, this is an opportunity to accelerate learning for the advancement of healthcare. The continuing pandemic provides a unique opportunity to leverage and integrate bedside experience from frontline healthcare providers. This real-time experience can be transformed into knowledge to inform and help empower a learning health system, informing healthcare processes and potentially improving patient outcomes.
In an IDMP-enabled world, this continuous learning is facilitated by structured, high-quality data entered and updated in real time. Analysis datasets can be immediately available for translational science researchers, which historically was seen as a softer benefit of IDMP; however, the ability to analyse credible big-data sets to draw important conclusions has never mattered more.
It is keeping real-world end goals in mind that will drive the next push to make IDMP a reality. But everyone needs to buy into this, and approach next developments with a shared sense of urgency.
Working together to maximise the benefits
Until key stakeholders globally concede some ground and work together to harmonise requirements, there will continue to be deviations in approach, which threaten the speed of global conformance and the delivery of improved patient experiences. Still today, respective world regions are tailoring the ISO standards to suit themselves - favouring their own data exchange formats, for example – something which should ideally be discouraged. The intended benefits of IDMP cannot be fully realised without consistent adoption of the international standards.
Failure to resolve the final details, especially terminology maintenance and governance is having an impact on implementation planning and development of optimised IT systems – delays which are enormously frustrating when there is such urgency around meaningful progress in life sciences linked to the current pandemic. For IDMP to fulfil its wider purpose, stakeholders around the world must view Covid-19 as a driver for more targeted and proactive harmonisation across the geographical regions. It must not take a future pandemic or bioterrorist event to deliver what has been promised for years. We need those benefits now.
Success today, while it counts, will depend on a concerted commitment and more transparent action from global regulators, industry, academic research and the healthcare sector - in place of siloed implementations and decision-making among a closed and relatively limited group of stakeholders.
Lessons from lockdown
These may be uncertain times, but often it takes a crisis to really focus attention and resources. A consortium approach to driving real change will be most effective going forward. There needs to be a greater push from regulators to resolve terminology differences and create the needed governance to support generation and use of global IDMP identifiers. This includes proactive negotiation with the pharmaceutical industry and the healthcare sector – a vital partner in advocating for real-world solutions that result in better outcomes for patients. Academic research centres are other critical partners to discussions, promoting the role of a robust learning health system and what will be needed to advance knowledge.
Closer cooperation and a shared sense of purpose will be important influencers during the next wave of IDMP progression. With further disruption inevitable, we cannot wait and it is the surest way to move forward and deliver lasting progress and improved access to quality products.