Serialization: So Close and Yet So Far

Tracelink recently released results of its latest Drug Supply, Safety, and Traceability Report, which looks at how effectively the links within the pharmaceutical supply chain-pharmaceutical manufacturers and contract manufacturing organizations (CMO) and distributors-are implementing serialization and traceability programs (1). Because 2018 is the last year that companies have to meet serialization requirements set by the US Drug Supply Chain Safety Act (DSCSA), the report’s findings were somewhat unsettling. “Despite goodwill efforts by industry and regulators to meet compliance on time, the industry is extremely behind in being ready for serialization,” wrote Tracelink’s CEO Shabbir Dahod in the report’s introduction. 

Analyzing survey responses from 660 pharmaceutical companies, CMOs, wholesale distributors, hospitals, and pharmacies, the study found that only one-third are confident that they are ready to meet serialization requirements set by the DSCSA and the EU Falsified Medicines Directive. 

In addition, none of the respondents had finished all the groundwork required for serialization. Only half of the pharmaceutical manufacturers and CMOs, for example, had prepared their internal packaging lines for serialization or projected the number of units to be serialized annually, wrote Dahod. 

The readiness gap between pharmaceutical manufacturers and CMOs appears to be “staggering,” Dahod noted. “Pharmaceutical companies are troubled about connectivity to their CMO partners, while CMOs appear to be overstating their actual serialization readiness,” he wrote.

Of the 660 respondents to the survey, 174 were from pharmaceutical manufacturers; 155 were from CMOs; 50 from wholesaler distributors; 195 from hospitals; 75 from pharmacies; and 11 from third-party logistics companies.  Of the pharma company respondents, 32% were at director level and 25% at manager level.  

Of the 146 respondents from pharmaceutical companies that must meet DSCSA requirements, only one third said they felt very ready. 90% had prepared for master data management; 80% said they will be shipping serialized product by the deadline, and 72% felt confident that they understand the legal requirements behind the DSCSA and European Union Falsified Medicine Directive regulations.  In addition, 62% say their organizations began preparing for serialization 13 months before the deadline; 55% say they will use the proper electronic forms; and 55% say they have estimated the number of units that will be serialized each year. Another 51% plan to eliminate 81–100% of paper forms by November 2018.

However, at this point, only 8% had integrated serialization processes with their CMOs, and only 11% said their CMOs were ready to ship serialized product, while only 12% said they had ordered and installed the equipment required for serialization on their internal packaging lines.  As a result, the study says, only 25% of respondents whose companies must meet requirements by November 2018 are ready for serialization and have taken the necessary foundational steps. 

The survey found that half of all pharma CMOs felt very ready and have taken the basic steps required for serialization.  For European pharmaceutical companies and CMOs, one third of respondents said they felt very ready for serialization requirements.  13% of respondents said that most CMOs were ready to ship serialized product and 46% said that internal packaging lines had been readied for serialization. In addition, 94% of respondents from this group say they have begun preparing for master data management; 54% have projected the number of units that will need to be serialized, while 48% said they have integrated serialization efforts with their pharmaceutical company clients. However, the research found, only 15% within this group were found to be on the true path to readiness, suggesting that more work and more coordination will be needed this year.

The study found that pharmaceutical companies had hired more staff in 2017 to help with serialization efforts, with 21% of respondents saying that they had hired or were planning to hire more staff. In 2016, only 9% responded that way.

Product aggregation on the rise
Tracelink’s research also found that aggregation efforts were in full swing; nearly 75% of respondents from those pharmaceutical manufacturers and CMOs that must meet DSCSA requirements had already begun to aggregate product or were planning to implement aggregation by the November serialization deadline. Within that group, 20% of pharmaceutical companies and 31% of CMOs reported that they were already aggregating product, while 33% of pharma respondents and 20% of CMO respondents said they would be aggregating by November 2018.  

Tracelink’s study also found a disconnect between the pharmaceutical manufacturing and distributors in the chain. 60% of wholesalers who responded to the survey said they are requesting that their pharma partners aggregate product, yet one third of pharma company respondents said that their trade partners haven’t been asking for aggregation yet.

Reference

• Tracelink, “Drug Supply, Safety, and Traceability Report,” (April 2018).

INTERPHEX session on serialization and blockchain

Pharmaceutical Technology presents the INTERPHEX Keynote Series: Information Technology Trends and Best Practices for blockchain technology and serialization to be held on Wednesday, April 18, 2018. The series includes a 1:30 pm session on the industrial internet of things, blockchain, and smart contracts and a 2:15 pm presentation on serialization. The sessions will be held on the show floor at the Innovation Stage and are open to all show attendees.