With only a month to go, it really is too late to start trying to develop an in-house solution.
From 27 November 2018, the Drug Supply Chain Security Act (DSCSA) will be actively enforced by regulators in the US. Here, leaders from across the pharmaceutical sector discuss the industry’s readiness and what companies should be thinking about in the final month before and beyond deadline.
Brian Daleiden, vice president of industry marketing at TraceLink
"In TraceLink’s 'Global Drug Supply, Safety and Traceability Survey', a major disparity between perceptions of readiness and actual progress was found among business leaders preparing for DSCSA. Not one of the respondents who felt ‘very ready’ for serialization had taken all the fundamental steps towards serialization readiness.
"Since then, we believe the gap between perception of readiness and real progress has been significantly tightened, as organizations across the pharmaceutical supply chain have been implementing solutions.
"The sense is that most of the market will be ready for the upcoming DSCSA deadline although there is a chance that some organizations, most notably pharmaceutical companies working with CMOs that are not fully prepared, will struggle to meet the deadline.
"The challenges associated with being ‘serialization-ready’ have prevented many businesses from looking ahead and preparing for what is next. Since many companies have been laser-focused on becoming serialization ready by deadline, many have deferred preparing for the next phase of DSCSA, which is when pharmaceutical manufacturers need to have systems in place to meet the impending saleable returns verification requirements imposed on wholesale distributors.
"Beyond this, DSCSA regulations will continue to impact all segments of the pharmaceutical supply chain through the year 2023 when fully electronic, interoperable systems for unit-level traceability become a requirement.
"Importantly, the November deadline is just the first step toward a digital transformation of the pharmaceutical supply chain. It is vital that businesses begin preparing to leverage the new information created by serialization to achieve business value.
"The digitalization of the industry will be driven by new technologies generated by pharmaceutical traceability needs, the utilization of serialization data and the accessibility to derive value from this data within one platform. Through TraceLink’s digital information-sharing network, fundamental processes that will be transformed through digitalization include the issuance of supply chain-wide digital recall notifications, the enablement of secure, distributed product verification for supply chain partners, and the launch of patient-centric programs that enable the ultimate consumers of medicines to interact with real-time product information based on the uniquely identifiable products."
Rick Seibert, senior vice president of innovation & technology services at Sharp
"We experienced a large surge of conversion requests for our serialization packaging services at the beginning of 2017, which was fairly persistent up until the announcement by the FDA that they would delay active enforcement of the DSCSA until November 2018. At that point, our conversion workload was still very high but was steady and we were able to convert a large percentage of existing clients.
"In recent months, running up to next month’s deadline, there’s been another surge in current client demand, as well as a high number of new clients wanting to convert as soon as possible. There has been a clear recognition that the deadline is closing in.
"Based on customer feedback and discussions we've had with industry partners, I would say there remain providers that are not ready to be compliant and it is likely that a proportion of pharma companies are not ready as a result. There is most definitely risk to the industry.
"At this late stage, non-compliant manufacturers must make every effort to either convert or find providers that are ready, have experience in the process, and follow their guidance.
"For those that are ready, they should turn their attention to realizing the opportunities...
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