Results

In order to allow a scaled implementation scheme, the system takes into account the different categories of drug products and the means and technological systems available, whilst reducing any obstacles that the patient may face. Implementation started with a wide list of costly critical drugs and have then been extended to all new drugs registered and launched in the market. From December 2011 until end 2014, this includes more than 111 million logistic events, which correspond to more than 25 million individual units of medicine (GTIN + Serial Number).

Situation

In 2011, the National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT) introduced a catalogue of drugs covered by its national drug traceability scheme, listing more than 3.000 medicines that require the placing of unique serial numbers and tamper-evident features on the secondary packaging.

This programme is based on the use of the GS1 system for traceability and its purpose is to actively limit the use of illegal drugs.

Today, ANMAT has shown that the implementation of the system has delivered more than favourable results.

Approach

The National Traceability System imposes that all drugs be serialised through the application of an unambiguous code, according to the recommendations of the GS1 Standards. Each drug should contain the Commercial Product Code, the Global Trade Item Number (GTIN) and a unique Serial Number placed on the secondary packaging. This information can be integrated into any type of data carrier, provided that it complies with the GS1 standards mentioned above, allowing each owner to choose the most appropriate data carrier for their products (whether it is a linear barcode, GS1 DataMatrix, EPC/RFID tag or any other). Notwithstanding the data carrier of choice, the information must always be placed in human readable format so the patient may read it.

Global Location Numbers (GLNs) are used to identify the various actors in the supply chain.