Serialisation survey highlights large gap in industry readiness, says TraceLink

The industry’s largest survey on serialisation readiness, including data from 660 respondents in the pharma supply chain, has been published by TraceLink.

This second annual Global Drug Supply, Safety and Traceability report highlights a large gap in industry readiness for drug serialisation, with only one third of respondents reporting they are ‘very prepared’ to comply with forthcoming serialisation deadlines in the US and EU. Furthermore, the report has revealed that not a single respondent has completed all of the fundamental steps for serialisation compliance.

“This year, serialisation becomes a true reality for many pharmaceutical companies. As the leader in the market, we feel that TraceLink has a responsibility to provide insight into the state of serialisation as it stands today, by leveraging our unique ability to reach the entire supply chain, from end-to-end, through our 266,000+ trade partner network,” said Shabbir Dahod, president and CEO of TraceLink. “These survey results are startling. Despite goodwill efforts by industry and regulators to meet compliance on time, the industry is extremely behind in being ready for serialisation. In 2018, as we reach the final hours of serialisation in both the US and EU, the industry-wide lag in full serialisation implementations remains a concern and emphasizes the criticality of trade partner connectivity within the supply chain.”

Key findings include:

• Only one-third of the 146 respondents from pharmaceutical companies with US Drug Supply Chain Security Act (DSCSA) requirements believe they are ‘very ready’ for serialisation, a regulation that went into effect in November 2017, which requires pharmaceutical companies to place unique identifiers, or serial numbers, on each saleable unit of product sold into the US;

• Compared to their pharma counterparts, half of the 88 respondents from contract manufacturing organizations (CMOs) serving customers with DSCSA requirements believe they are ‘very ready’ for serialisation;

• In both the DSCSA pharmaceutical company and CMO groups that feel ‘very ready’, not one respondent has completed all of the necessary basic steps for serialisation;

• For pharmaceutical companies and CMOs with EU Falsified Medicine Directive (FMD) requirements, only one-third of respondents believe they are ‘very ready’ for their serialisation deadline in February 2019;

• After applying the basic steps to serialization in the analysis, the report found that only 15% of the EU FMD respondents are truly ready for serialisation;

• The report also found that one-quarter of wholesale distributor respondents and 11% of hospital and pharmacy respondents are ‘early movers’ in serialisation, due to their progressive serialisation preparations and ability to be ready ahead of their respective DSCSA deadlines.

TraceLink partnered with independent research firm, Penn Schoen Berland, to conduct the survey and produce the report analysis.