Drugs: Greater Safety thanks to Global Standards

© GS1 Germany

© GS1 Germany

© GS1 Germany

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How can spending be reduced long term while maintaining health care quality for patients at the same time? The deficits in global health care systems have many varied reasons. But global standards can help to increase patient safety, improve efficiency in the care supply chain and counteract the counterfeiting of medical products and medications.

Imitations and forged pharmaceutical products cost international health care systems billions. This trend highlights the urgent need for globally uniform identification of individual drug packaging and the serialisation of drugs - i.e. the individual identification of products within a series of larger production units. This is the only way to reliably check whether what is labelled on the outside is actually what is contained on the inside.

Where suppliers and customers both wish to switch their successful business processes to automated and electronic ones at the same time, the electronic systems require relevant rules and shared structures for communicating the information: this framework is provided by standards.

These standards can uniquely identify products, clearly structure and describe product data, simplify transfer of the product catalogue and determine the electronic transmission format of business documents. Furthermore, they standardise business processes and can create new customer relations and fresh potential. These include as a rule identification standards, classification standards, transaction standards and catalogue exchange formats. Likewise, the use of barcodes on drug packaging for identification ensures patient safety and the optimisation of logistics processes along the entire value chain: from producers and suppliers through to forwarders and patients.

Safety and Efficiency

The traceability of origin and ingredients is a central issue for drugs: after all, this is about the safety of human health. Add to this the aspect of higher efficiency through lower warehousing costs, the avoidance of error in cross-border movement of goods and data as well as through simplified stock taking processes or improved after-sales management.

The international network Global Standards One (GS1) uniting over 100 GS1-national organisations helps companies employ state-of-the-art communication and process standards in practice thereby increasing efficiency by, for instance, the use of new technologies for fully automatic object identification such as EPC or RFID or by offering solutions for stronger customer focus such as ECR (Efficient Consumer Response). Especially for medical products a unique identifier feature is of enormous importance. For all parties involved in the sourcing process relevant standards ensure that the data transmitted is unambiguous.

A practical test in Sweden, carried out by the European Association of the Pharmaceutical Industry EFPIA in cooperation with 25 Stockholm pharmacies has shown that the 2D barcode "GS1 DataMatrix" can unambiguously prove the genuineness of drugs in daily business operations while allowing counterfeit drugs to be removed from the market rapidly. With "GS1 DataMatrix Symbology" even very small retail units can be labelled with article numbers and additional information on the packaging. In addition to the article number they also feature a batch number, the best-before date and a serial number. Once the code has been scanned the in-pharmacy IT detects whether this is the real or a counterfeit drug retrieving information from the linked database.

Automatic Identification and Data Capture

Catheter, scalpel, syringe or tablet - blister, folding box, cardboard box or pallet: which product requires which identification standard with what information on what which packaging level? This is an open issue for both manufacturers and retailers who wish to ensure optimum identification in the process chain. An answer to this question is provided by the labelling overview for the global GS1-Standard AIDC (Automatic Identification and Data Capture).

AIDC is especially geared to the automatic identification and data capture of medicinal products including drugs. It is designed to help users choose and apply appropriate data carriers - e.g. barcodes, 2D codes or RFID tags - as well as additional article and manufacturing data - e.g. shelf life or serial number. A labelling overview lists products by way of example in a chart to show which identification standard is recommendable for the various medicinal products and their relevant packaging levels. This also takes into consideration the different distribution channels and the four different degrees of labelling requirements: from the minimum to the maximum labelling requirement levels.