The mandates to serialize all pharmaceutical products are as challenging for pharmaceutical manufacturers as the Y2K situation was to computer software engineers in 1999. Unlike the computer situation, however, the pharmaceutical industry has no defined protocols or solutions. ulations while working with partners throughout the supply chain to devise interoperable data management solutions that accurately record, track, and manage data as it moves from manufacturer to distributor to dispensing point. The opportunity for error is great.
Serializing individual items, cases, and cartons isn’t as simple as adding a bar code to a label. Often the label must be redesigned to accommodate the bar code, and regulators must approve the new label. The packaging line must be revalidated as equipment is added to generate each bar code, link each bar code to product data, apply the bar code to packages, and track that code throughout the supply chain. That data also must be managed, transforming it from data to actionable information. Employees must be trained to use the new equipment. And, sometimes, the package itself must be changed. “For example, small round bottles aren’t read as easily as small square bottles, because the equipment has to read the bar code straight on,” says Greg Cathcart, CEO, Excellis Health.
Learning details like that now, before the implementation deadline, is the goal of the many serialization pilot projects under way at pharmaceutical manufacturing facilities throughout the United States. Big Pharma is leading the way. “Small companies, in contrast, often have done little to prepare for serialization because they need to serialize only a few packaging lines. Their efforts will be minimal compared with Big Pharma, which sometimes has more than 50 lines,” Cathcart says. Rather than prepare, many in industry are working to delay the implementation date or change the current regulations. “An industry consortium is appealing to both state and federal regulators for a single, national standard,” Cathcart adds.
Regardless of the outcome of such lobbying, companies should prepare now for serialization implementation. “Start now. Companies can’t wait until they are close to the implementation date to begin,” advises Peggy Staver, director of product integrity, Pfizer. “There is so much to learn and do, and it all needs to be tested extensively with all of the trading partners.”
Strategy Development
Pfizer has been planning for serialization for much of the past decade. The first objective was to develop a strategy. Despite the many serialization regulations throughout the world, Pfizer has succeeded in developing a single, standards-based strategy that can be applied locally, with any necessary variations.
Regardless where, geographically, serialization is being applied, or whether it is at the pallet, case, or individual item level, the planning and implementation process is virtually the same. The key is to form a global serialization strategy team. It provides internal governance and insights into global serialization regulations, relying on the expertise of internal and external resources to implement standards-based solutions.
In devising Pfizer’s strategy, the global serialization strategy team considers local drivers. “Although the approach to serialization may be the same, local implementations may vary, based upon local business needs,” Staver says. For example, the California requirement focuses on track-and-trace methodology to thwart counterfeiting. In Europe, the business drivers include provider reimbursement, so a point-of-dispense authentication model is used. “We can use the same coding in both regions, but the business process implications are very different.
“It’s also important to consider the way product is distributed,” Staver continues. In regions where the original manufacturer’s packaging reaches the patient — Nigeria, for example — a process relying upon consumers to authenticate a serial number via cell phone text-messaging may make sense. Using a similar process in the United States is not very practical because, in many instances, the original manufacturer’s packaging does not reach the consumer.
“The biggest issue in defining a global strategy is the need for clarity,” Staver says. “Globally, there are many emerging requirements. As soon as we hear of them, we immediately mobilize our global serialization strategy team to get as much information as possible.” Oftentimes the timelines for implementation are quite short — sometimes only a few months from passage of the law — and the requirements may be unrealistic. Therefore, pharma engages with regulatory authorities globally to understand their requirements and, sometimes, to educate them about the constraints of the pharmaceutical industry.
“Defining the implementation team and resources is a dedicated effort,” emphasizes Natalie Lotier, VP of strategic supply chain operations and planning, Bristol-Myers Squibb (BMS). The planning also must consider vendors who are or may become partners in the future, so the implementation plan should include critical questions and milestones that will be important as implementation is expanded.
Serialization Requires Packaging Line Changes
In designing a serialization plan, Lotier advises manufacturers to consider starting with their desired outcomes and design the process backward. For manufacturers, introducing serialization involves changes to the packaging lines and the distribution systems that cascade throughout the organization. Making those changes requires input from product managers as well as specialists from engineering, packaging, finance, commercial operations, government relations, supply chain, logistics, and master data departments.
To effectively plan the changeover, companies also must determine their business priorities and consider upcoming launch plans, Lotier says. “That can be a very challenging process for industry. It’s a balance of line capacity, line criticality, inventory, and regulatory requirements. You must be well-prepared for everything to go well.”
Although companies usually aren’t changing the boxes or cartons, they are changing the labeling. Nonetheless, manufacturers still must install new hardware, as well as the business technology to manage the serial numbers that are provisioned to the packaging line and the data that is transmitted to customers. “Business process changes are required to enable data capture and exchange, and the new processes must be tested and validated,” Staver says.
Big pharmas, including BMS and Pfizer, are piloting changes to their own lines now and are working with their CMOs to identify changes to the lines they have outsourced. Pfizer, for example, expects to change approximately 60 lines internally for its U.S. operations and is working with its CMOs to change over some 60 additional lines. Manufacturers must expect to also change their international packaging lines because of the growing body of global serialization requirements.
Companies say changing over their packaging lines to accommodate the new bar codes takes four to eight weeks. For a company with 120 lines, that’s between 480 and 960 weeks of cumulative downtime. To minimize downtime, savvy companies are modeling the changeover offline to minimize unforeseen issues. Then, they coordinate the upgrades with other work that is required for the line to minimize overall downtime.
“Some products have a very short shelf life, which further complicates the issue,” Cathcart points out. “Building a stockpile for the interim could reduce the effective shelf life of some products by 20%.” Therefore, companies must work even more closely with their sales representatives to help their customers plan ahead.
Data Exchange Is Big Challenge
As BMS and Pfizer gain experience with serialization, they each stress the importance of integrated, interoperable IT systems. BMS created a new position — the director of enterprise data operations — specifically to deal with this business need. “Data exchange is the most difficult of the serialization challenges facing pharma companies. It’s costly and complex,” Staver emphasizes. Throughout the entire supply chain, from manufacturer to pharmacy, items must be identified using standard data carriers and identifiers and exchanged in a standard way so products may be tracked accurately and efficiently. Establishing and enforcing that system and then installing the proper hardware and software to enable track-and-trace and data mining are only part of the solution, however. The IT systems used by each link in the supply chain also must be interoperable. The individual systems must pass information seamlessly, despite the use of potentially different platforms, applications, and configurations.
To ensure interoperability and seamless, error-free data transmission, Pfizer has conducted multiple pilot projects with its distributors and pharmacies during the past several years. Recently, the company scaled up those smaller pilot projects to include some of its larger distributors and a high-volume product to identify any additional data exchange challenges.
Now Is The Time To Start
“Serialization projects need a strong commitment from the top down. Management must be invested in the outcome and must designate leaders for the business and IT aspects of the projects,” Lotier insists. Making the necessary commitment is difficult for companies because serialization requires a significant financial outlay of finite resources in a globally constrained economic environment.
Half-hearted commitments to serialization will inevitably fail. “Jumping in with fully integrated teams makes sure everyone is aware of each of the issues. Diversity of opinion is vital to move forward holistically,” says Terry Young, director of enterprise data operations, BMS. “This is an evolving space, and as with any new technology or process, you must account for variability and manage expectations.”
It may take as long as one year from the time planning begins to the time products are shipped, in Pfizer’s experience. Although the process becomes more efficient over time, unforeseen issues — often involving legacy equipment and applications — can easily slow serialization programs. “Few implementations are identical, and each is a learning experience,” Staver observes.
As pharmaceutical manufacturers gain experience, their insights are being shared informally, as well as through serialization working groups. GS1, for example, is compiling the learnings of its committee members into what will become serialization best practices. But some things are evident now — serialization is an expensive, time-consuming process.
When pharmaceutical manufacturers began their pilot programs, most knew only a fraction of what was necessary to fully implement a serialization program. And, they still are learning. The message is clear. If you aren’t already planning for serialization, start now.
Editor’s Note: This is the second of a four-part series examining serialization strategies in the United States.