Internationally adopted standards play a crucial part in underpinning regulatory and quality operations. Additionally, they help advance translational science and improve traceability within the global supply chain. The International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards are designed to make it easier to identify products throughout the global drug development lifecycle. Yet, progress towards global consistency of IDMP standards and the delivery of improved patient experiences has not been as speedy as hoped. Repercussions of this lack of progress include the inability to compare pre-market versus post-market formulations and adverse events (AEs), and reconciliation of product identifiers among different regions. This has made it difficult to implement fully effective and optimized IT systems to support IDMP use cases related to pharmacovigilance (PV), electronic prescribing and supply chain management.
During the COVID-19 crisis, diverse groups have joined forces to accelerate the preparation, validation, production and delivery of new tests, treatments and vaccines. However, consistent application of ISO 11238 concepts to register and generate a global vaccine substance identifier is still lacking. ISO 11238 describes requirements to define and identify substances within medicinal products or substances used for medicinal purposes. The standard provides guidance for describing substances at different levels of granularity (referred to as Specified Substance) using additional defining characteristics such as grade, manufacturer, manufacturing information and specifications.
Vaccine manufacturers have a pressing need to assess clinical trial results and adverse events (AEs). Consistent representation and description of the various attributes of a drug is a first step in assigning identifiers that would make it easier to look up, compare and monitor relative differences in product formulations, biotechnology and other manufacturing information. ISO 11615 (Regulated Medicinal Product Identification) describes data elements and terminology requirements applicable to both investigational and marketed products, and includes clinically relevant information such as indication, target population, side effects and contraindications. This information is used to create product labeling and promotional materials, and is also used for PV purposes. If IDMP had been widely in use by now, common identifiers and the related clinical particulars would make it much easier to compare vaccine characteristics and AEs across investigational new drug (INDs) applications.
The ability to register and update product information in globally understood, multi-dimensional datasets, comprising consistent identifiers is increasingly vital due to the need to cross-reference and reconcile domestic versus foreign products referenced in AE reports. The ability to verify different vaccine formulations and manufacturers will help support mass immunization programs and electronic prescribing by allowing emerging issues to be spotted and addressed. These might include access to raw materials during regional lockdowns, transport delays or geopolitical tensions that impact the supply chain. The ability to locate equivalent products or similar formulations during drug shortages, and allow stakeholders—especially healthcare providers—to work out contingency plans, is crucial.
Combating the Threat of Falsified Medicines
IDMP-based data exchange would support effective and efficient analysis of adverse events linked to product problems or supply chain issues. It would allow AE data to be cross-referenced with detail about a product’s formulation, its manufacture, distribution and storage, for example. Relevant ISO IDMP identifiers used to support supply chain management, such as substance IDs, regional product IDs, batch and package IDs, would be able to be linked to the Global Trade Item Number (GTIN), an identifier for trade items developed by GS1.
The GTIN is used for products or services that are priced, ordered or invoiced at any point in the supply chain. IDMP identifiers would be able to be integrated with the GTIN to help combat the threat of falsified medicines entering supply chains. 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, or in cases involving the adulteration or contamination of a product. And, since healthcare providers and patients need the facility to identify immediate options in response to product recalls, IDMP-based, standardized data would greatly enhance an efficient and timely public health response.
Data Insights Fill Clinical Trials Gaps
In an IDMP-enabled world, continuous learning driven by health crises such as COVID-19 would be facilitated by structured, high-quality data entered and updated in real time. There is no time to extract and re-key data from a backlog of static documents. Where, previously, the link with translational science was seen as a softer benefit of IDMP, the data flow into learning systems becomes a critical consideration during a fast-moving pandemic. Being able to analyze credible datasets to draw important conclusions has never mattered more.
Data from electronic health records (EHRs) can help fill gaps where clinical trials can’t attain the diversity of general populations, and these insights can contribute toward improved clinical trial protocols that help inform regulators and pharmaceutical companies about what is working best for patients based on frontline, practical experience. These data insights can also help allay fears about new vaccines and other therapeutics in relation to certain populations, such as pregnant women. A trusted feedback loop updated via multiple data sources will be crucial to building public confidence in emerging products.
Advocating for Patient Benefits
IDMP still faces a range of barriers to widespread, useful adoption, however. Unfortunately, it remains the case that different regions are tailoring the ISO standards to suit their own purposes, including adherence to regional identifiers and using differing data exchange formats. Unless stakeholders across the world concede some ground and work together to harmonize requirements, deviations in approach will continue to delay the delivery of IDMP benefits.
IDMP compliance is not an end in itself. It is just the beginning. Automating paper systems, standardizing data, and leveraging that data, is a starting point in a process that will ultimately benefit patients. Healthcare professionals have a role to play, advocating for real-world applications for standardized product data exchange as well as better outcomes for patients. The pharmaceutical industry must get behind a concerted push and some proactive negotiation right now, if IDMP is to reach its potential and deliver the advances the world needs.