Episys calls for co-operation on labelling and traceability
Careful attention must be paid to managing information and to its effective transfer along the chain
Following the implementation of EU Directive 2011/62/EU for falsified medicines into EU law in January this year, IT solutions company Episys is calling for greater international co-operation on traceability systems.
Derek Buchanan, CEO of Episys, says that key to tracking and traceability is the unique serial number created when the medication is produced and registered within a specific country. This can be encoded into a 2D barcode and applied to individual products. Each country will add to this unique number to fit in with its individual regulatory framework.
A major challenge for the global pharma supply chain is that years of paper trail detail produces an overwhelming amount of data for each producer to keep track of, and the man-hours associated with keeping data captured, organised and useable is mammoth. When coupled with the number of manufacturers who ‘touch’ a single ingredient used to make the final product, the task of gathering this information is daunting. Careful attention must be paid to managing such information and to its effective transfer of information along the chain.
In a recent analysis1 published in the British Medical Journal, experts suggested that because this is a worldwide problem, countries should consider a global treaty that will stimulate political energy across the globe. This should include tracking and traceability, as many countries mandate that medicines carry unique serial numbers that can be verified electronically. This analysis also indicates that the lack of agreement on an internationally accepted technology or data standards risks making country-by-country compliance difficult and costly.
Some experts also believe that falsified medicines have not been helped by the lack of regulations in some countries, especially in developing nations2 where they are not able to put in place rigorous monitoring procedures using international standards.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has called upon all players to maximise their efforts in taking responsibility for ensuring that a secure and safe supply chain is in place to best safeguard public health.
‘Episys’ solutions and processes are MHRA-compliant and a continued commitment to accuracy and quality has provided our NHS clients with mechanisms to help them get the best possible medicines to their patients,’ says Buchanan.
‘Our UK clients are as proactive as possible to ensure that they have robust procedures in place that will allow them to provide the best possible array of tracking and traceability mechanisms to comply with MHRA guidelines.’
References
1. BMJ 2012;345:e7381 doi: 10.1136/bmj.e7381
2. East Afr J Public Health, 2008 Dec; 5(3):205-10