The Heightened Case for IDMP in the Light of COVID-19

Lise Stevens of Iperion Life Sciences Consultancy explores what difference the ISO IDMP data standards, now slowly surfacing in Europe, would have made in the context of the continuing pandemic, in applications ranging from adverse event reporting and electronic prescribing to the control of falsified medicines.

Once manufacturers, regulators and clinicians agree on consistent representation and description of the various attributes of a drug – the promise of ISO IDMP (Identification of Medicinal Products) data standards – it will be possible to assign globally-acceptable identifiers to drugs, their constituent parts and manufacturing processes. This, in turn, will make it easier to look up, compare and monitor relative differences in product formulations, biotechnology and other production-related information which could influence patient outcomes. Real-world Impact In the light 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, globally-agreed identifiers, such as substance/specified substance ID (SSID) and pharmaceutical product ID (PhPID), would be in use during drug development, and comparison of vaccine and therapeutic product 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, multidimensional 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 could help directly with the reconciliation of the global trade item number (GTIN), and IDMP identifiers such as the PhPID, medicinal product ID (MPID), package ID (PCID) and batch ID (BAID) assigned to new vaccines. This would enhance planning of mass immunisation programmes around the world and help mitigate potential supply chain issues ahead of time. Myriad supply chain challenges could emerge, such as the lack of access to critical manufacturing raw materials due to regional lockdowns, distribution delays or geopolitical tension between countries. The ability to quickly assess the marketing status and availability of equivalent products or similar formulations would help stakeholders better negotiate agreements with alternative suppliers in advance and work out contingency plans.

Once novel vaccines and other therapeutics are approved in a region, IDMP-based data exchange would support more effective and efficient reporting and analysis of adverse events (AEs) and/ or medication errors as part of ongoing pharmacovigilance efforts. For example, the ICH E2B (R3) individual case safety report (ICSR) specification was purposely harmonised to use IDMP identifiers and terminology for active ingredients, PhPID, dosage form, route of administration and units of measurement. This information is used to identify and reconcile domestic vs foreign products in ICSRs, and also supports traceability throughout the global supply chain.

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. Improving International Collaboration Once information is being recorded consistently using IDMP data standards across country boundaries, the opportunity to build a rich international drug knowledge base is substantial, with implications for more enriched clinical decision support and improved e-prescribing/pharmacy information systems.

The ISO 11615 specification provides a data exchange format and information models that can be leveraged to create more robust drug knowledge-bases for regulated medicinal products. For example, one of the core classes of ISO 11615 is the clinical particulars class. This captures clinicallyrelevant information about a product, such as indication, target population, side-effects and contraindications. This information can be repurposed to populate drug formularies, medication management and usage guidelines in ePrescription/ eDispense applications. Healthcare providers and patients deserve access to accurate and reliable product information. This 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.

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, especially in vulnerable populations. A trusted feedback loop between clinicians, industry and regulators will be crucial to building public confidence, especially as new therapies are developed, approved and used to combat the pandemic. Accelerating Global Learning The COVID pandemic has illuminated the importance to move beyond regulatory compliance as the driving force for IDMP implementation. The pandemic offers us an opportunity to apply the ‘bedside-tobench’ approach as healthcare workers strive to reduce COVID mortality and glean new insights about the longer-term effects of the disease. In the continuing pandemic, 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 will 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, now the ability to analyse credible big-data sets to draw important conclusions has never mattered more. The Criticality of a Concerted Effort 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.

Until 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. The IDMP standards are already undergoing systematic review in ISO, a process that occurs every five years. Similar to the learning health system, standardsdeveloping organisations (SDOs) need feedback from implementers to understand adoption challenges and stay current with evolving technology. Yet, to date in the case of IDMP, the different global regions have deviated from the intent of the standards and are choosing their own formats and terminology – something which should ideally be discouraged.

Failure to resolve the final details, such as establishing the needed governance structure to facilitate terminology harmonisation and data exchange profiles, is having an impact on optimised IT systems being developed and rolled out – 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 new, 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 federated approach similar to that which enabled the world wide web. We need a concerted effort led by global regulators, working together, to establish the governance structure and agreements needed to address the legislative barriers that prevent migration to global identifiers, terminology and greater alignment with healthcare.

These are uncertain times, but sometimes it takes a crisis to focus attention and resources. A consortium approach to driving real change will be the most effective going forward. There needs to be a greater push and cooperation for an international framework with equal stakeholder representation. Regulators, biopharma, healthcare providers and academic researchers must each have a seat at the table with the common goal to advance real-world solutions, empowered by standardised product data exchange that results in better outcomes for patients.

Closer cooperation and a shared sense of purpose will be important influencers during the next wave of IDMP progression, especially over the next two years as the specifications open for systematic review. With so much disruption and uncertainty still ahead, we need to incorporate IDMP data exchange into our global public health response planning as the surest way to harness the standards to meaningful and useful effect.

Lise Stevens

Lise Stevens is Associate Director at Iperion Life Sciences Consultancy in Rockville, Maryland in the US. She is a specialist in project management, IDMP and ICSR training and implementation. Iperion, which operates globally, is paving the way to digital healthcare through its proactive support for standardisation and by ensuring the right technology, systems and processes are in place to facilitate process innovation. Email: lise.stevens@iperion.com