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ISO/TR 25257 — Health Informatics: Business Requirements for an International Coding System for Medicinal Products
Unified Drug Identification Framework for Global Healthcare Interoperability and Patient Safety
1. The Case for an International Medicinal Product Coding System
ISO/TR 25257:2009, prepared by ISO/TC 215 (Health informatics), addresses a fundamental challenge in global healthcare informatics: the absence of a unified international coding system for medicinal products. As healthcare digitization advances worldwide — electronic prescribing (e-prescription), electronic health records (EHRs), pharmacovigilance, and supply chain management — the lack of a standardized drug identification system creates significant interoperability barriers, safety risks, and inefficiencies.
The Technical Report identifies that countries and organizations have developed divergent coding systems (e.g., US NDC, WHO Drug Dictionary, GS1, RxNORM), each designed for specific purposes but incompatible with each other. This forces costly and error-prone code mapping whenever medication information crosses system or national boundaries. For patients travelling internationally, clinicians managing multi-country studies, or global supply chain operators, the absence of a unified code creates concrete risks of medication errors and adverse drug events.
A unified international coding system would enable seamless exchange of medication information across borders — particularly critical for continuity of care for international travellers, multi-country drug studies, and global pharmacovigilance surveillance.
2. Business Requirements and Virtual Product Name Concept
ISO/TR 25257 defines ten specific business requirements and introduces the innovative “Virtual Product Name Concept” as the architectural foundation for the proposed coding system.
| Level | Virtual Product Name Concept | Example | Use Case |
|---|---|---|---|
| 1 | Virtual Active Ingredient Name | Warfarin Sodium | Generic substitution, formularies |
| 2 | + Virtual Product Name | Warfarin Sodium, Coumadin | Brand identification |
| 3 | + Route of Administration | Warfarin Sodium, Coumadin, Oral | Clinical drug selection |
| 4 | + Dose Form | …Oral, Tablet | Dispensing verification |
| 5 | + Strength and Strength Unit | …Oral, Tablet, 10 mg | Dose verification |
| 6 | + Country Code | …10 mg, US | National market identification |
| 7 | + Company Code | …US, Bristol Myers Squibb | Manufacturer identification |
| 8 | + Package Size | …Bristol Myers Squibb, 100 | Dispensing unit, inventory |
2.1 Hierarchical Granularity for Diverse Users
The hierarchical structure enables different stakeholders to access information at their required level of granularity. Clinicians and pharmacists typically require Level 5 (clinical drug level — active ingredient + product + route + form + strength). Supply chain operators need Level 8 (package size). Regulators may work at Level 6 (country code). Each level has its own unique identifier, enabling precise referencing without over-specification.
The document emphasizes that drug formulation codes should be unambiguous — each unique combination of attributes should map to exactly one code. This prevents the dangerous situation where a single code could refer to multiple products, reducing the risk of international medication errors.
3. Engineering Design Insights: Assessment of Existing Systems
ISO/TR 25257 provides a detailed assessment of four major existing coding systems against the defined business requirements, offering valuable insights for system architects.
3.1 Comparative Analysis
GS1 (GTIN) excels at supply chain identification with efficient code structures and global adoption, but lacks systematic ancillary clinical data. The WHO Drug Dictionary provides comprehensive global drug information including Anatomical Therapeutic Chemical (ATC) classification but has limitations in granularity for specific national products. The US NDC is widely used in the United States but does not support international requirements. RxNORM provides robust clinical drug terminology but is US-centric in scope.
3.2 Recommendations for Next Steps
The document recommends a phased approach: first, establish governance and maintenance structures; second, build on existing systems where possible rather than starting from scratch; third, develop a core data model based on the virtual product name concept; and fourth, engage international stakeholders through WHO and national regulatory agencies to ensure adoption.
3.3 Benefits Quantification
The identified benefits span clinical decision support (better allergy checking, drug-drug interaction detection), e-prescription interoperability, EHR data exchange across borders, market statistics, inventory control, supply chain efficiency, and pharmacovigilance tracking for adverse drug reaction recalls.
For health informatics architects, the most valuable contribution of ISO/TR 25257 is its demonstration that a unified coding system is achievable through hierarchical decomposition of drug product attributes — the virtual product name concept remains the most practical framework for international medicinal product identification.
4. Frequently Asked Questions
Q1: Why can’t existing systems like GS1 or NDC be used as the international standard?
Each existing system was designed for specific purposes (supply chain, national regulation, clinical research) and lacks the complete attribute coverage needed for all use cases defined in the business requirements. ISO/TR 25257 proposes building on existing systems’ strengths while filling identified gaps.
Each existing system was designed for specific purposes (supply chain, national regulation, clinical research) and lacks the complete attribute coverage needed for all use cases defined in the business requirements. ISO/TR 25257 proposes building on existing systems’ strengths while filling identified gaps.
Q2: How would an international coding system handle different brand names in different countries?
The virtual product name concept accommodates this through the country code and company code levels. The same active ingredient can be linked to different brand names in different countries, each with its own unique code at the appropriate hierarchical level.
The virtual product name concept accommodates this through the country code and company code levels. The same active ingredient can be linked to different brand names in different countries, each with its own unique code at the appropriate hierarchical level.
Q3: What is the relationship between this work and IDMP (ISO 11238)?
ISO/TR 25257 (2009) preceded and informed the development of the ISO IDMP (Identification of Medicinal Products) standards family, which provides the normative framework for medicinal product identification in regulated health contexts.
ISO/TR 25257 (2009) preceded and informed the development of the ISO IDMP (Identification of Medicinal Products) standards family, which provides the normative framework for medicinal product identification in regulated health contexts.
Q4: How would such a system be maintained and governed?
The document recommends a central maintenance agency with regional representation, similar to the WHO Drug Dictionary model but with broader scope and standardized update procedures to ensure timeliness and consistency.
The document recommends a central maintenance agency with regional representation, similar to the WHO Drug Dictionary model but with broader scope and standardized update procedures to ensure timeliness and consistency.
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