via Securing Industry
Commissioned by consultancy firm KPMG, the report involved a survey of leading organisations within the pharmaceutical industry – including branded pharma, generics, distributors and virtual manufacturers – looking at their degree of readiness to meet the new US anti-counterfeiting serialisation requirements introduced later this year.
Using serialisation data for process improvement
The survey found that 73% of respondents agreed that serialisation data has the potential to transform existing business processes, with the greatest value, as a result of the new compliance measures, coming from returns credit calculation and diversion monitoring (52% each). The report also cited order fulfilment accuracy (38%), patient information and engagement (24%), wholesaler performance (19%), and 3PL performance (15%) as areas where improvement will occur through the implementation of the serialisation requirements.
"Serialisation-enabled processes and transactional data can lead to companies deriving value from their investments, increasing productivity, and enhancing brand and revenue protection," the report says.
The new serialisation requirements in the US under the US Drug Supply Chain Security Act (DSCSA) come into force in November, and stipulates that all medicine packs sold in the US must be marked with a product identifier, serial number, lot number and expiration date using a 2D datamatrix barcode.
Other measures and compliance deadlines, including a full unit-level requirement to electronically track packs through the supply chain, will come into effect in the following years with full implementation by 2023.
Impact of serialisation throughout the supply chain
KPMG says the new requirements over the next five years will not only impact pharmaceutical companies but also the downstream supply chain partners, including distributors and dispensers. It adds that capabilities will mature, however, and companies will increasingly focus on how to derive value from the solutions they have implemented.
"A compliance programme of this magnitude creates significant implementation challenges and disruptions across various functions within and across organisations," KPMG says. "However, it also provides opportunities to seek and achieve value through business process improvements and more effective revenue lifecycle management."
Progress on implementation of serialisation solutions
According to the report, 45% of survey respondents have already invested more than $50 million in building the necessary capabilities for compliance.
Other results from the survey show that 100% of respondents plan to implement enterprise-level IT infrastructures to manage serialisation, with 76% already complete, while 86% said they have extended capabilities for serialization, commissioning data capture beyond their own enterprise to include internal and external suppliers, and 72% plan to capture serial number shipping events to establish the relationship between outbound sales order/delivery and product serial numbers shipped to customers.
Meanwhile, although not an explicit DSCSA requirement, 48% have completed aggregation projects, which sees the complex linking of individually coded packs with the codes used on cartons, cases and pallets used in shipping.
The report also found that only 29% say they have no future plans to use serialisation data with existing business practices.
The KPMG report follows several other reports looking at the readiness of the industry to meet serialisation requirements. In November last year, a poll by the Healthcare Distribution Alliance (HAD) found it was unlikely companies will meet the target of providing 100% serialized medicine packs by the November deadline, with just two-thirds of manufacturers saying they will meet the deadline and 90% saying that at least half of their products will be compliant.
Meanwhile, 4 in 10 were worried contract manufacturing organisations would not be prepared in time.
And in October last year, a Pharma IQ report also noted concerns that companies would not be ready with the sufficient capabilities by serialisation deadlines in both the US and EU. That report found that only 13.5% had fully implemented their approach, while 20.3% were only in the early planning phases and 5.4% had not yet started thinking about serialization.
More than 30% didn't know how many packaging lines they would need to upgrade and almost a quarter didn't know what sort of budget they would need to become fully compliant.
Source: Securing Industry