Consistent data matters: lessons from the pandemic and the case for accelerating IDMP adoption
Posted: 4 December 2020 | Lise Stevens (Iperion Life Sciences Consultancy) | No comments yet
As ISO IDMP data standards gradually progress to implementation in Europe, Lise Stevens asks what bearing they might have had in the context of the global COVID-19 crisis.
In the light of the COVID-19 pandemic and the need to bring beneficial new products to market at speed, it has become increasingly clear what a difference ISO Identification of Medicinal Products (IDMP) data standards could have made to the response of drug companies and the wider supply chain and healthcare ecosystem. Once manufacturers, regulators and clinicians are all referring to consistent descriptions of the various attributes of a drug, for instance, interactions and analyses based on that data could be accelerated and decisions more confidently turned around.
Once IDMP standards have been finalised and implemented in the real world, globally recognised identifiers can be applied to drugs, their constituent parts and manufacturing processes. This will make it easier to search for, compare and monitor relative differences in product formulations, biotechnology and other production-related information that could influence patient outcomes.
The benefit of hindsight
If IDMP had been widely in use by now, agreed identifiers would be in use during drug development and comparison of vaccine characteristics across Investigational New Drug (INDs) Applications/New Drug Applications (NDAs) would be far easier.
Capturing and storing product information as globally understood, multi-dimensional datasets, made up of consistent identifiers spanning all aspects of a drug’s provenance, formulation and distribution has much broader scope too. The ability to share and integrate this data could directly help with the planning of mass immunisation programmes around the world, not least by allowing emerging issues to be spotted and addressed ahead of time; these could include potential problems with access to raw materials due to regional lockdowns, transport delays or geo-political tension between countries. The ability 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 proposed vaccines have been approved, IDMP-based data exchange would support effective and efficient reporting and analysis of adverse events (AEs) as part of ongoing pharmacovigilance efforts – cross-referenced with exact detail about the particular formulation, where it was made, its distribution, storage and so on, for maximum accuracy.
Such activity will be vital as drug companies and regulators strive to roll out products critical for combatting COVID-19 swiftly yet safely. Having this level of data granularity and traceability will also help to combat the threat of falsified medicines entering supply chains since it would be possible to cross-reference the Global Trade Item Number (GTIN) to specific IDMP identifiers (eg, substance ID, batch ID and medicinal product IDs) for a specific Marketing Authorisation Holder (MAH). This is especially important for medications obtained from the internet or in underserved populations where proliferation of counterfeit products is a major concern.
Building global knowledge
Once information is recorded consistently using IDMP data standards worldwide, the opportunity to build a rich international drug knowledge base will be substantial, with implications for more enriched clinical decision support and improved e-prescribing/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.
Closer co-operation and a shared sense of purpose will be important influencers during the next wave of IDMP progression”
Where speed is of the essence, as with new COVID-related products, global data insights will help to fill gaps where clinical trials cannot 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 drug formulations in relation to certain populations such as paediatric demographics or people with other co-morbidities. 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 website.
It has often been said that IDMP compliance should not be an end in itself. Rather, IDMP is about digital transformation – leveraging commonly understood data for the advance of healthcare and for the good of patients. In the continuing pandemic, updates about novel or expanded use of existing therapies is feeding into a common knowledge pool: a learning health system that is expanding all the time and informs adjustments to clinical trial protocols and healthcare processes and impacts patient outcomes.
In an IDMP-enabled world, this continuous learning is facilitated by the creation and use of structured, high-quality data as opposed to the transcription and reformatting of PDF documents. Where previously the link with translational science was seen as a softer benefit of IDMP, now the ability to analyse credible datasets 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. However, key stakeholders within the life sciences ecosystem need to push beyond regulatory compliance with a shared sense of urgency.
Better together: co-operation is vital
Until stakeholders globally concede some ground and work together to harmonise requirements, there will continue to be deviations in approach that threaten the speed of global conformance and the delivery of improved patient experiences. Even today, respective world regions are tailoring the ISO standards to suit themselves – for example, favouring their own data exchange formats – which should ideally be discouraged, especially given the intended use of IDMP across multiple use cases.
Failure to resolve the final details is also having an impact on optimised IT systems and the global governance that is needed to generate and maintain global IDMP identifiers, which are enormously frustrating when there is such urgency around meaningful knowledge exchange during 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 even 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, agile, matrix-based effort to secure progress – in place of siloed, serial decision-making among a closed and relatively limited group of stakeholders.
A consortium approach to driving real change is our collective responsibility during this dark period. There needs to be a much broader, proactive negotiation between global regulators to address the necessary governance, as well as the development of service-level agreements that fulfil the requirements of the pharmaceutical industry – which in turn must demonstrate an insatiable appetite for an international framework. The academic research and healthcare sector also need a seat at the negotiation table to advocate for real-world solutions that will result in better outcomes for patients.
Closer co-operation and a shared sense of purpose will be important influencers during the next wave of IDMP progression, especially during the continued fight against COVID-19. We must empower and protect the global supply chain needed to ensure that safe and effective treatments are available wherever they are needed.
About the author
Lise Stevens is Associate Director at Iperion Life Sciences Consultancy in Maryland, US. She is a specialist in project management, IDMP and ICSR training and implementation.
Drug Safety, Drug Supply Chain, Industry Insight, Labelling, Packaging, Regulation & Legislation