DSCSA one-month countdown!

With only a month to go, it really is too late to start trying to develop an in-house solution.

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 of a serialization-enabled supply chain. Sharp is already developing programs and services that will allow our clients to use the systems already deployed to create value beyond compliance.

"One of our focus areas is around enabling patients to better engage with their treatment and care by providing access to resources and enhanced services via the unique data points on the package created by serialization."

Staffan Widengran, director corporate projects, Recipharm

"In light of the year-long transition period from the initial deadline in November 2017, there is no reason to believe the market will not be compliant in time for the deadline. Some pharmaceutical companies maintained their serialization programme schedule and treated the original 2017 deadline as the final one, and so have been fully compliant for a year already.

"There will be some pharmaceutical companies that struggle to implement a compliant solution in time. A fully serialized supply chain is a financially and logistically demanding task; companies that did not begin their preparations early will find it difficult to reach compliance with only one month to go. Those in this position should prepare for the worst-case scenario; for example, create a bridging stock to pack and deliver before 27 November, as this can cover the period until they are ready.

"It should be noted that this is only a solution for those that are close to completing their preparations; for those who have barely begun, a halt in production will be very difficult to avoid. In these cases, on option could be to outsource to a fully serialized CMO.

"Recipharm has introduced a new standalone serialization service in advance of the deadline, which will allow pharmaceutical companies to benefit from its serialization capabilities - Recipharm has serialized around 1.4 million packs for the US market to date. The service includes adding 2D codes and human readable text to pre-packaged medicines. This will ensure that companies that are currently not ready for the deadline have a way to achieve compliance in time, and avoid a gap in production."

Dexter Tjoa, director corporate strategy, Tjoapack

"As of 27 November 2018, the US DSCSA will be actively enforced by FDA. Although a yearlong grace period was granted to allow underprepared businesses to develop and implement a suitable solution, there remain organizations across the supply chain that are not ready.

"A widespread failure to understand the complexities of serialization will mean that even some of the companies which extended their programmes into the grace period year will not be ready to continue business as usual come next month.

"With only a month to go, it really is too late to start trying to develop an in-house solution, as the implementation process cannot be rushed. A solution needs to be properly scoped out, integrated across lines and fully tried-and-tested to minimize the risk of disruption to supply.

"Outsourcing is an attractive solution for companies that need to ensure compliance, but it is vital that they begin conversations with potential partners as soon as possible. Contract packaging organizations (CPOs) have become a popular alternative to implementing an internal solution over the last year, but — albeit shorter — this solution does present a minimum lead time. The sooner CPOs know about your requirements, the more likely you are to be ready.

"And, of course, it doesn’t end there. Companies that are ready for the November deadline, should start turning their attention to ensuring they are well-prepared for aggregation requirements, come the 2023 deadline."

Daniel Tedham, managing director of Wasdell Manufacturing, a division of the Wasdell Group

"A significant number of businesses have failed to react adequately to the serialization challenge. Inadequate resources and/or limited access to the expertise required to deliver a compliant solution led to many companies delaying their preparations. Now, companies that should have developed and implemented a clear strategy for compliance with the DSCSA are at great risk of missing the November deadline.

"At such a late stage, any company that is not close to validating their solution will have to look for third-party contract providers to outsource their serialization requirements to. Some manufacturers that do not count packaging as one of their core competencies opted for this approach at a much earlier stage to offset some of the cost implications of buying and installing new hardware and IT infrastructure. This approach negated the costs associated with training staff and the production downtime required to equip lines. When you combine these factors, it is easy to see why the outsourcing approach is appealing and as the deadlines loom, this is likely to become more prevalent.

"Ultimately, it is to the benefit of the entire pharmaceutical industry that every business is compliant — the supply chain is simply too vast and intertwined for there to be any missing links. Once businesses have implemented and validated a solution, they should be working with their partners and collaborating with other members of the supply chain and sharing knowledge to ensure every business they interact with is compliant.

"Better prepared companies should be looking look to make the most of their serialization investment by exploring the additional opportunities presented by this increased level of supply chain visibility. Aggregation capabilities should be prioritized as they will be phased in as three-tier parent-child relationships between barcodes become a requirement of DSCSA in 2023. Wasdell has invested in aggregation as part of its serialization service to ensure it could meet this requirement and any future regulations."