Battling Falsified Medicines

A labeling solutions provider can help stakeholders throughout the healthcare supply chain comply with the EU’s Falsified Medication Directive.

Episys, an information technology company working with global pharmaceutical companies and other stakeholders throughout the supply chain, has devised technologies to support EU Directive 2011/62/EU for falsified medicines, which became law earlier this year. “The whole issue of falsified medicines needs to be tackled using a systematic approach that will ensure that these compounds are no longer found in any healthcare supply chain anywhere in the world,” says Derek Buchanan, CEO of Episys, in a statement provided to PMP News. “This may sound like an almost insurmountable task, but a solution that makes perfect sense is tracking and tracing medicines so that pharmacists can quickly see where they come from and what the relevant license numbers are for the product.”

Episys can help automate the track-and-trace process from raw ingredients to processing, from the wholesaler to the pharmacy, using unique serial numbers. Best practices currently are to bar code all packs with a linear 1-D code, which allows the pack to be traced back to the source where it was over-labeled. However, those 1-D codes are now being supplemented or even replaced with a 2-D code, which will give additional information for further traceability and auditing. Serial numbers, for instance, can be encoded into 2-D bar codes and applied to individual products. And each country can add to this unique number to meet requirements within individual regulatory frameworks.

Episys’s solution can produce labeling for patient prescriptions, outer packaging, and clinical trials.

For instance, some U.K. hospitals are already using 2-D bar codes as a means to comply with the EU directive on falsified medicines. Episys’s Enterprise Communication Suite product is being used to produce accurate labeling for patient prescriptions, outer packaging, and clinical trials. The Worksheets Module allows users to create and print worksheets within a validated secure environment complete with audit trail, while the Headers and Footers Module produces separate label batches.

Episys also provides software validation documentation and consultancy as well as a prepackaged database containing the UK BNF Pharmacy Warning phrases.

Pharmaceutical organizations and UK NHS Hospitals, which are licensed to manufacture and repackage drugs, require a validated labeling solution. Episys’s Enterprise Communication Suite was developed according to Good Automated Manufacturing Practice standards and is compliant with UK Medicines and Healthcare Products Regulatory Agency and U.S. FDA 21 CFR Part 11 standards.

An associated challenge for the global pharmaceutical supply chain is the overwhelming amount of data for one producer to keep track of and the massive amount of man-hours associated with keeping data captured, organized, and useable. When coupled with the number of manufacturers who “touch” a single ingredient used to make the final product, the task of gathering this information can be daunting. As a result, careful attention must be paid to the management of information collected and the effective transfer of information along the chain.

Robots can be used for automated label application.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) has called upon all players and stakeholders to maximise their efforts in taking responsibility for ensuring that a secure and safe supply chain is in place to best safeguard public health. Says Buchanan: “At Episys, our solutions and processes are MHRA compliant and our continued commitment to accuracy and quality has provided our NHS clients with mechanisms to help them get the best possible medicines to their patients. Our clients in the UK are being 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. Here it is more about keeping products out rather than having anything in the supply chain that could be a problem.” 

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