By Megan Brodie 17 May 2019
Local pharma Specialised Therapeutics Australia (STA) has launched a tracking system that will enable real time monitoring of its drug products as they move through the supply chain, while also making the practice of vial sharing more difficult.
The company has adopted a Unique Product Identification (UPI) system that involves printing a 2D barcode on every drug product packaged and distributed, beginning with STA's newest cancer drugs Nerlynx and Aplidin.
While the drugs have been registered by the TGA in the past six months, they are not yet listed on the PBS. Nerlynx was rejected by the PBAC in March and Aplidin is to be considered by the committee in July.
"The UPI system is expected to be rolled out across the company's entire portfolio by 2020," STA CEO Carlo Montagner said, describing his company as "an early pharmaceutical adopter" of the tracking system which is mandated in the US and Europe.
Montagner said the tracking system was designed to improve product integrity by minimising or eliminating dispensing errors and the chance of counterfeit products entering the supply chain, he said it would also prevent the vial sharing practice used in hospital pharmacies to prevent product wastage and save costs.
Montagner said it was common practice for pharmacy compounders to package intravenous cancer drugs for individual patients from multiple supply batches in order to minimise wastage, yet companies were paid per patient not by volume.
With 80 per cent of STA's cancer drugs used in a hospital setting, Montagner told Pharma in Focus this week the practice of vial sharing was a significant threat to both the company's earnings and patient safety because the vial used could not be identified.
"Without tracking technology, there has been poor visibility on the final destination of all batches produced," he said.
"Our new UPI model will ensure that we know exactly which vial any single patient has received from which batch. If there is a recall or any other problem, we can track every unit of product to the patient."
Montagner said it was inevitable a drug tracking system would be implemented industry-wide under federal government mandate in line with Europe and the US.
"I would call on the federal government and indeed, all pharmaceutical manufacturers to introduce similar measures to ensure the highest patient safety standards are adopted," Montagner said.
"We are proud to be Australian innovators but believe these measures must be widely adopted by all pharma companies in this region to mitigate potential patient risks.
"Track and trace technologies enable us and our partners to ensure safe drug distribution chains, and to implement any product recalls as rapidly as possible. In the event of an urgent product recall, we can now quickly and effectively track every unit of product to ensure patient safety remains paramount."