Rx-360 eyeing drug traceability pilot later this year

Pharma group Rx-360 is hoping a new white paper will facilitate the start of a medicine traceability pilot before the end of 2015.

The White Paper on Traceability Data Exchange and Architecture - published last month - comes as more than 20 markets around the world have present or ending requirements to identify pharmaceutical products through the use of serial numbers.

It provides a series of possible data storage and 'choreography' models that look at where data from traceability systems resides, how it moves, who owns it and who has access.

It is hoped that the work could form a starting point to - eventually - arrive at a harmonised architecture for tracking medicines through the supply chain in major world markets, according to the Rx-360's Traceability Data Exchange and Architecture workgroup, which started work on the white paper last August.

Peggy Staver - one of the TDEA workgroup's tri-chairs - said on a recent Rx-360 webinar that a lot more work still needs to be done on issues such as aggregation/inference, errors and exception handling and the overall impact of serialisation on existing business processes.

The Pharmaceutical Distribution Security Alliance (PDSA) - a consortium set up in 2012 that includes drugmakers, wholesalers, industry associations and other stakeholders - is working to assess the various models covered in the white paper.

Depending on the outcome - PDSA member the Healthcare Distribution Management Association (HDMA) has agreed to provide a forum to start working towards pilot studies that it is hoped will get underway in the second half of the year.

Staver said Rx-360 is keen to get the pilots underway a soon as possible concerned that some people may think that there is a lack of urgency for the initiative, given that in the US item-level traceability is not due to kick in until 2023.

"The amount of time it takes to gain consensus and go from concept and design to full implementation can be many years," she said.

The US FDA is also responsible for providing some oversight on pilots that will be used to develop the requirements for item-level traceability, the hope is that by carrying out this work quickly the PDSA and HDMA can play a role in the development of emerging standards.

The work could also help inform developments beyond the USA's border. Last year for example the Asia Pacific Economic Cooperation (APEC) Business Advisory Council started a project looking at developing and implementing processes and procedures directed at regulatory convergence to efficiently enhance global medical product quality and supply chain integrity.

"This is an industry call to action … to help drive the harmonisation we are all looking for," she said.