March 31, 2017 - IDMP is the “Identification of Medicinal Products" suite of standards from ISO which have their initial implementations through the SPOR (Substance, Product, Organisation and Referential data) initiative in Europe (following on from xEVMPD) and through Structured Product Labelling (SPL) in the US, followed by other regulatory agencies. These implementations offer exciting challenges to not only achieve regulatory compliance, but also develop a master data management strategy across the enterprise.
Many companies are currently working hard to ensure that their medicinal product data is IDMP compliant, learning from the xEVMPD experience. The primary aim of the IDMP suite of standards is to produce a system of unique descriptions for all medicinal products, from the active substance(s) that make them medicines right through to each finished package that reaches the patient. Although the original driver for IDMP was pharmacovigilance—in particular, particularly the need to be able to globally detect signals based on products appearing in adverse events—the IDMP data model is also capable of providing the foundation for a single authoritative source of medicinal product information for a much wider range of uses, as in master data management. This moves the paradigm from one of “management of data for IDMP compliance" to “using IDMP as a foundation for medicinal product master data management," such that the data is both available for IDMP compliance submissions and available for use in the day to day business of the enterprise. To successfully achieve this requires vision and a good understanding of the businesses of the different stakeholder areas.
Although pharmacovigilance, regulatory affairs, and clinical are the obvious candidate areas to benefit from IDMP-based master data management, this article focuses on the supply chain and logistics area and includes some implications for labelling and packaging. It discusses specifically how IDMP compliments and supports the challenges and implications of implementing the European Falsified Medicines Directive (FMD; EU Directive 2011/62/EU) and the Registration, Evaluation, Authorization and Restriction of Chemicals regulations (REACH; EC 1907/2006).
The falsified medicines directive
The FMD comes from a similar patient safety root as its primary aim is to eliminate counterfeit, contaminated, or stolen drugs from the supply chain. To do this, it must maintain the traceability of genuine medicinal products throughout the supply chain, from manufacturer to public (patient); therefore, the focus is on active substance management, good manufacturing practice (GMP) and good distribution practice (GDP). One of the practical implications of traceability is that it requires companies to ensure that each package has serialization — a unique identifier made up of various components, including a product code, a serial number, a batch number, and an expiry date, as well as a code relating to national reimbursement programs, where required. FMD states that the product code should allow identification of (at a minimum) the name, the common name, the pharmaceutical form, the strength, the pack size, and the pack type of the medicinal product.
Companies are required to provide this unique identifier as a 2-D data matrix on the outside of each pack along with an anti-tamper device, thereby involving both labelling and packaging in the implementation of the directive. They are then required to maintain records of the journey of each pack through the supply chain, notifying the “authorities" of any suspected deviations from that standard journey from manufacturer to dispensing to the public, or to “within a healthcare institution," such as a hospital. There is a final step to verify and decommission the anti-tamper device at this point. Information from the manufacturer is communicated to a Pan-European repository, accessible to regulatory agencies: the EMVS (European Medicines Verification System) developed by the EVMO (European Medicines Verification Organisation, representing all sectors of the industry). Information from wholesaling and pharmacy supply is communicated to a national verification system in each country, which in turn shares data with the EVMO.
Throughout the distribution process, the track-and-trace systems follow each movement along the supply chain from manufacturer to distributor to wholesaler to pharmacy. This track-and-trace information is valuable to other functions within the logistics area: for example, as a means to more efficient management of safety withdrawals (should that be necessary), by knowing exactly where particular batches of a product are at a particular point in time, or as a means to address to short-term shortages in a particular location by redistribution.
The timeline for implementation commenced in February 2016. Systems should be fully operational for most European countries by February 2019, with the exception of those countries that have an existing national system—they are allowed longer to transition to the Pan-European system.
Registration, evaluation, authorization, and restriction of chemicals regulations
As with FMD, the REACH regulations have at their heart a safety focus: namely, the protection of human health and the environment from the risks posed by chemical substances. This is achieved by increasing the detail of risk and hazard data for substances that are manufactured in, or imported for use in, the European Union, and sharing this data with the European Chemicals Agency (ECHA), the agency formed to implement REACH using a registration process. Medicinal products for human or veterinary use, and the active pharmaceutical ingredient (API) and excipient substances in these products, are exempt from the regulations, because of overlapping regulations on one hand, and intermediate substances used in production of APIs not being covered (including precursor and intermediate substances, and process chemicals). The relevant information on these low-volume substances used by the pharmaceutical industry needs to be registered in the REACH process by May 2018 using an International Uniform Chemical Information Database (IUCLID) dossier.
IDMP, FMD, and REACH – Master Data Management
The contribution that IDMP can make to FMD is clear, for IDMP has all the product identification data that FMD needs: specifically, the name, the common name, the pharmaceutical form, the strength, the pack size, and the pack type of the medicinal product, centered on the PCID, the Packaged Product Identifier. While it would theoretically have been possible to use the PCID as the FMD product code, there were practical considerations within the supply chain that precluded that. Therefore, the issue became how to undertake “master data management" within the real-world constraints, by making use of the IDMP data as the single source of truth or golden record for the medicinal product information that FMD requires. In IDMP (the 11615 standard), there is a non-definitional attribute of the PCID, the “data carrier identifier," which can be used to accommodate a GTIN (Global Trade Item Number, or bar code) that is already present on most packages. Another ISO document, ISO/TS 16791 “Health informatics – Requirements for international machine-readable coding of medicinal product package identifiers," is a technical specification describing best practice for machine-readable identifiers (primarily bar codes), with the aim of making these as useful and consistent as possible around the globe throughout the life cycle of the product. This describes the various levels of GTIN in the supply chain (from pallets to packages); the GTIN for the “secondary package" is a serial number that incorporates batch number and expiry information, thereby fulfilling the requirements of the FMD serialization with the exception of the product code. In other words, by bringing together the PCID, as the product code, and the secondary package GTIN, as a data-carrier identifier, in the SPOR initiative for products, the full FMD requirement can be met without ambiguity or duplication of data management.
IDMP can also support REACH compliance. Within IDMP, there is the full definition of substances described in ISO 11238. While this focuses on all types of APIs and excipients, the principles can be easily extended to precursor and intermediate substances and process chemicals in an efficient master data management system. Many of the processes needed to maintain the currency of, and share, IDMP information, especially Chemical and Manufacturing Compliance (CMC) information, are mirrored in the processes needed to maintain currency of and share REACH information for compliance.
Benefits to the enterprise
The value of this holistic master data management approach to managing package identification founded on IDMP and implemented through FMD goes beyond the avoidance of counterfeit medicines, with all the risks they hold for patient safety, as well as the risks of damage done to company profits and reputation. It includes the value of ongoing support for the use of the package bar code as a safety check in hospital medicines administration, especially when used together with the patient's wristband, facilitated by the join between the GTIN, the PCID, and healthcare medicines terminologies, as envisioned in the "openMedicine" initiative in Europe and DailyMed/RxNorm in the United States.
The value of maintaining REACH information in harmony with IDMP information leverages the xEVMPD and IDMP investment in good business processes for maintenance of information from various sources brought together for regulatory submission and uses them in REACH submission. Managing all substance information, whether covered by REACH or not, in a single system also future-proofs against regulatory change and extension in scope of either 11238 or REACH itself, and brings together supply chain track and trace functionality for both finished goods and their constituents.
Full supply chain information is also highly valuable for business intelligence. Understanding in close to real time where the company's products are actually being used can effectively direct educational and promotional resources to both healthcare professionals and the public. Understanding more about the flow of their products through the supply chain can enhance management of the partnership between manufacturers and distributors. Each of those offer advantage to the enterprise significantly beyond the immediacy of basic compliance with IDMP and FMD regulation—advantages which can be realized only if underpinned by a robust product master data management strategy.