CeBIT 2010: Barcodes pushed for national medicine recalls

The Therapeutic Goods Administration (TGA) may introduce a new barcode-based product recall notification system as early as June next year, according to the company that built it.

The new system will be based on a global product database created by not-for-profit organisation, GS1, which is also used in sectors ranging from grocery and retail to transport and defence supply chain management.

According to GS1 Australia's chief executive officer, Maria Palazzolo, the RecallNet system would ensure compliance among individual healthcare providers for pharmaceutical and medical goods.

GS1 Australia is currently piloting the system for the grocery sector, and working with the Food Standards Australia and New Zealand (FSANZ) board to tweak requirements, with plans to roll out by January. It is also in negotiations with TGA and the National eHealth Transition Authority (NeHTA) to repurpose the system for the healthcare sector for a June 2011 launch.

GS1 Canada has already implemented the system for the grocery sector and, in association with HP, uses cloud-based architecture to ensure potentially harmful food products are removed as quickly as possible.

Once the system is implemented in Australia, a recall notification can be issued directly from the supplier, and will be notified once the healthcare provider reads its. The recall catalogue would work in conjunction with GS1's national product catalogue, also being rolled out as part of its work with NeHTA.

"There's a whole string of processes that follow from there that ensures that the informaiton has been acted on," Palazzolo said.

Product recalls for pharmaceuticals and medical goods are currently initiated and largely carried out by the manufacturer or sponsor of the affected product through a mixture of email, fax and any other notification methods available. The TGA - an agency under that the Department of Health and Ageing - helps to perform a risk assessment and form a recall strategy, but has no direct involvement in notifying providers and ensuring compliance.

Even state government recall coordinators are only really tasked with notifying healthcare providers in high-risk situations which, according to one medical professional, only occurs once or twice a year at most.

Once a recall has been sent out by the pharmaceutical manufacturer, it is the onus of the pharmacy servicing the healthcare provider - whether a hospital or general practitioner - to ensure the affected batch is collected and returned.

"Community pharmacists were concerned about the amount of work they had to do if there was a recall; they would have to check all of their stock, and it's work that they do for nothing," the professional, who requested anonymity, said.

"There were suggestions that there could be other ways of trying to make sure everybody was aware of recalls in a timely way,"

While the current system has no major flaws or increased risks according to those in the industry, it is an ageing system that was last reviewed in 2004, and has no industry-wide method of ensuring compliance.

"What's ideal is to have a means of communication that people check; it's not dependent on someone having to go and look every five minutes for it," the medical professional said.

"It's really about finding a way that is viable and it gets to people quickly and reliably."

The use of dispensary barcode scanners in pharmacies is, to date, only mandatory in Tasmania, New South Wales, South Australia and Victoria. The Pharmacy Board of South Australia, which mandated the use of barcode scanners in 2009, claimed the technology could reduce selection errors within pharmacies by up to 50 per cent.

"The community quite rightly has an expectation that pharmacists will take all possible steps to minimise the occurrence of medication errors," a newsletter from the board reads.

Though GS1's standard could be implemented quickly into pharmacies with existing barcode scanners, apart from existing negotiations with NeHTA there is no guarantee the system will be rolled out across the sector.

"The reality is systems will always do what's best for them and what their customers want," Medical Software Industry Association (MSIA) president, Geoffrey Sayer, said. "If there is a universal standard behind barcoding, it would make sense for scanning, but a lot of places don't have scanning technology."

GS1 proposed the use of its barcode system and numbering standard as part of the e-health identifier program due for implementation in July, but was turned down by the e-health authority in favour of Object Identifiers (OID). While the chosen identifier type is a global ISO standard, the specification and implementation into healthcare providers is largely localised to Australia.

The failure to attain the e-health identifier standard was a disappointment for GS1 Australia, though Palazzolo said it was still looking to build the chosen standard into the GS1 GTIN standard and, subsequently, into barcodes for providers that wish to implement the system. However, treasurer of the MSIA, Dr Vince McCauley, said the identifier should have a standard implementation across the sector.

"The reason to have a national identifier is to make cross-enterprise identification easier," he said in an email. "To realise significant benefits they will have to be rolled out sector/industry wide."

Copyright © 2010 IDG Communications, Inc.

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