Improving safety of medicines by leveraging global standards to link ‘Medicines Management’ with the medicines supply chain
The important benefits to patients, our health system and improved health supply chain by having foundations of global standards have been well documented for many years.
Australia has adopted global data standards to support many processes already, having chosen many over a decade ago as part of our ‘eHealth’ or digital transformation. The national standardisation of medicines identification, product master data and clinical terminology are just some areas of focus.
What are the standards being used?
Identifying the product - The physical form of the product is unambiguously and uniquely identified using Global Trade Item Number (GTIN) which is one of GS1 global standards. Access to product data for management of secure supply chain and to assist a consumer in using their medications can all linked to this identifier.
Barcoding the product – The GTIN is encoded within a standardised barcode on the physical packaged product in accordance with regulations from the Therapeutic Goods Administration. The barcode used on the Consumer pack for all products in Australia is the EAN-13 barcode, another GS1 standard, though many products are also starting to introduce the GS1 DataMatrix so that more information can be added to the pack (such as Expiry Date, Batch information or a Serial number that when combined with the GTIN makes the pack globally unique in how it is identified).
Sharing the product master data – To ensure that every time the barcode is scanned the exact same information is used the GTIN and relevant data is shared from suppliers via the National Product Catalogue (NPC) which is built on Global Data Synchronisation standards, also a GS1 global standard. Having consistent data provided this way ensures that products can be managed consistently throughout the supply chain from manufacturing all the way through to the patient.
Clinical Terminology - The Australian Medicines Terminology (AMT) is the national medicines extension to SNOMED CT, a global standard for health terminology used in clinical information systems. The AMT provides clinical concepts (standardised descriptions and unique identifiers) for medicines. The AMT supports electronic medications management activities such as prescribing and dispensing, the recording and retrieval of patient medication information in electronic records and the accurate transfer and interpretation of this information between clinical information systems. To enable the clinical concept for each medicinal product to be linked to the physical packaged product within systems, the GTIN is mapped to an AMT concept called the Containered Trade Product Pack (CTPP). The CTPP is included as one of the data attributes of the product master data.
Why linking everything together and having consistent data is so important
Though it has taken a few years to reach the point of maturity where we are today, leveraging these standards will help us in many areas. To ensure that:
- All medicines can be scanned at each point in their lifecycle;
- The data related to them is consistent;
- We remove duplicated effort in sourcing and creating data;
- As a sector we continue to improve the industry’s ability to ‘talk the same language’; and
- Most importantly we support crucial patient safety improvements.
Though the implementations may be at varying pace across Australia, the national focus and consistency continues to be important and action is now being called for so that we are able to realise the goal of national interoperability and a health system that is supported by quality and consistent data across all areas.
Making sure that the linkage between the physical product and the clinical concept is accurate and available holds a key to some important next steps in our ‘digitalisation’ of medicines in Australia but does require commitment and resourcing. This means that in addition to having accurate information related to supply chain data, PBS, ARTG and data used in clinical systems, the inclusion of the AMT CTPP within the National Product Catalogue (NPC) record for each medicine is critical as a bridge between what has been traditionally separate areas of work.
With support of the National Clinical Terminology Service (NCTS) at the Australian Digital Health Agency, product sponsors are now being asked to map the AMT CTPP for all of their products so that this can then be made available for use by all those managing medicines. As data is updated within their NPC catalogue, this attribute is being requested as a part of the data for each physical product at the consumer unit level (Base Unit GTIN in NPC language). Having this data available and ensuring all product data is accurate has been highlighted by many of the state health teams and others as vital to their being able to effectively use the data in NPC to its full value and ensure together we deliver the best possible outcomes for Australian patients and consumers.
Further information will be provided by the Australian Digital Health Agency, however, to find out more you can visit the webpage or contact the NCTS team or Phone: 1300 901 001.
For assistance with loading this data into the NPC contact the NPC team or phone 1300 227 263.
Further background information:
GTIN Use Best Practice in Australian Healthcare
Australia Digital Health Agency - Linking AMT and NPC: Improving Medicines Management and Safety
Australian Digital Health Agency – Overview webinar recording
Australian Digital Health Agency – National Product Catalogue