Aegate adds traceability to its portfolio

Aegate, which remains the only company in Europe to have deployed an ‘in/out’ authentication system for pharmaceuticals in the real world, has added to its capabilities with the launch of a full traceability service.

So-called in/out systems generally involve the pharmaceutical manufacturer placing a unique, serialised code on a medicine’s packaging at the time of manufacture, which can then be authenticated by the pharmacy at the time of dispensing to the patient.

What these systems do not do is allow each pack to be tracked as it changes hands through the supply chain, from pharmaceutical manufacturer via distributors, transport companies and wholesalers to the pharmacy and ultimately the patient.

Aegate’s authentication system applies a machine readable code on each pack, which can be read in real-time by the pharmacist using a simple barcode reader at the time of dispensing. The system not only guards against counterfeit medicines, but also helps pick up expired or recalled medicines.

Aegate has already rolled out its authentication technology in Belgium and Greece, and earlier this month reported it had passed a major landmark of checking 2 million packs of medicines. The company also started a pilot of its authentication technology in Italy recently, involving 320 pharmacies in the Brescia region.

Now it has extended the technology to allow the different players in the supply chain to scan the codes, logging the medicine's location at a specific date and time and providing an audit trail en route. This traceability function will also allow authorities to identify when and where a counterfeit drug enters the distribution network.

The critical change in adding a traceability element to Aegate’s system comes in the way the code is handled on scanning, according to Alison Williams, vice president of the company.

In the authentication system, scanning effectively ‘switches off’ the code to indicate that a particular product had been dispensed and the number is no longer valid. The traceability system demands more sophistication, as the code needs to be kept live through a series of verifications before being rendered defunct at the pharmacy on dispensing.

The traceability solution is ready for deployment, subject to integrating the software with systems used by wholesalers or other partners in the supply chain. This is not expected to be a difficult process, said Williams, as Aegate has already integrated its software with around 25 software platforms used in pharmacies.

“A growing number of European Countries are starting to bring in legislation for medicines traceability, including Italy, Turkey, Spain, France and Greece,” said Williams.

“The big question is, how many players in the supply chain do you need to include?” she told SecuringPharma.com.

A system of traceability differs from a full track-and-trace system as it allows selected players to be part of the process, rather than demanding a record every time a medicine changes hands.

“Track-and-trace or electronic pedigree systems mean that pharmacists have to authenticate not only the product, but also the pedigree itself,” according to Williams, who noted that - as pedigrees themselves can be falsified - this adds further complexity to the system.

“Our approach may be more pragmatic. It provides authentication at the point of dispensing, but still allows audit back up the supply chain,” she said.