Robert Celeste

The pharmaceutical industry faces complex issues in its effort to meet the requirements of the US Drug Supply Chain Security Act (DSCSA) (1). Pilot programs are needed to determine the feasibility of solutions, but the number of pilots required will be costly, in terms of money, time, and human resources.  Virtual pilots, which use computer software to project or simulate physical pilots, can reduce this burden by providing some measure of learning or proof that a particular set of solutions would be scalable and workable.

	Traditionally, databases, spreadsheets, dashboards, and test systems are used to understand systems, processes, and information and to predict the expected outcome of a physical pilot.  Simulation software, however, is a more efficient technique that can be used to create and execute a virtual pilot for any process, including implementing the DSCSA in the pharmaceutical supply chain.  

	Simulation software has traditionally been used in manufacturing environments to replicate complex processes and provide a way to compare variations on specific scenarios to gain insights beyond algorithmic calculations found in spreadsheets. Due to the increase in computing power, simulation software has become easier to use and is increasingly seen in many industries. Simulation software is used to study processes within and between systems, departments, companies, and industries, including flow of products, people, cash, and information. Simulations can also address human behavior, time considerations, and the physical environment.

	The software has matured to the point that it can be used during the information collection phase of a process study; it can provide meaningful results, both at a summary level and in the details and nuances of a process. Simulations can be used to create multiple scenarios to examine alternatives before large amounts of resources are expended to plan, develop, and execute a physical pilot. In fact, the virtual pilot can become the blueprint for the physical pilot. 

Certain trading partners have physical space or time constraints that must be considered while implementing DSCSA requirements. Production lines, for example, vary in terms of space available to include serialization equipment. Simulation can provide insight into how best to use existing space, such as whether to serialize on the production line or serialize label-stock prior to the production run. Because case and pallet packing may be accomplished elsewhere in the facility, a simulation of the environment could help address product and staff flow.

	Likewise, wholesalers may have time constraints in their window of operations for picking and packing orders to be delivered the next day.  Timing and positioning of product and staff can be simulated to give projections of what to expect upon scale-up

	In addition to product and staff flow, information flow is crucial to meeting DSCSA requirements. Creating, supplying, and archiving DSCSA data can be simulated in order to gain experience with the latency, scalability, and feasibility of making data available from other systems within the organization.  All of these flows can be studied in one simulation, to gain better insight on how they interact with each other and depend on each other. For example, the DSCSA law sets requirements for the timing of transaction information. A virtual pilot may be created to examine the process flow of information, product, and staff, should if the product arrives prior to the required Transaction Information, Transaction History, and Transaction Statement.  

	Another potential problem is that during the transition to 100% serialized products, companies in the supply chain may receive some serialized product and some non-serialized product. To better understand the transition, simulation techniques could examine varying numbers of products received, the mix or percentage of serialized vs non-serialized products on hand, and daily variability of serialized product and associated traceability data. Simulations can also examine the latency of delivery and number of suppliers.   


	For complex systems or processes, it’s often difficult to assess the impact of individual tasks or even understand these tasks and their variation throughout the workweek with enough clarity to confidently declare that a pilot and ensuing implementation will be successful. Operations under the various stages of DSCSA will require supplier, customer, and internal process changes as new steps are added to existing processes, such as receiving, picking, packing, and shipping. A virtual pilot could demonstrate how these new processes will affect daily tasks as well as identify what changes to support systems must be made. Simulations could also provide insight as to the activity balance needed to keep up with throughput of product and information.

	A study of process and information will include interviewing or speaking to the people that perform the process. It is imperative that they are actively engaged in the information collection and analysis process.  There are often nuances of why a particular step occurs and opportunities to explore with the process expert how newly accessible information, equipment, or adjacent processes might improve their process. Some of this information may be difficult to analyze. Using a virtual pilot, however, allows inclusion of behaviors, preferences, and other information points that can directly affect the outcome of the study or pilot. Also, the process expert often is drawn into the simulation process because it is interactive and easily understood. The end result is a more robust picture of the process under study that can be viewed at many levels and replicated with different scenarios (e.g., five people performing a task instead of four). Lastly, simulations can take into consideration the physical environment itself, such as the layout of equipment and materials, size of rooms, and distance between process points.


	Businesses are incorporating DSCSA-triggered changes into established operations that are constantly changing due to changes in business practices and economic conditions (e.g., new customers, the loss of existing customers, or acquisitions and divestitures). Virtual pilots based on simulations are an economic way of re-running DSCSA scenarios, given an ever-changing business environment. Adding a newly acquired warehouse or system to the simulation, for example, offers an opportunity to take advantage of existing work and test it against the new reality.


	Unlike a static diagram, a simulated environment actually runs; processes require certain input, and if that input is not there, the process simulation stops until that problem is fixed. Each glitch that is fixed in the simulated environment is a glitch that won’t have to be fixed in the final physical pilot, during implementation, or in production.

	Not every pilot requires an enormous investment in time, staff, or funds. A pilot may merely demonstrate proof-of-concept or experiment with connecting systems to those of trading partners in a test environment. A company may be interested in piloting what to do with all the new traceability data made possible due to the DSCSA law. A simulation or virtual pilot is capable of generating a lot of data and regenerating it based on changes in input parameters.

	Implementing the DSCSA, with its serialized traceability system that is interoperable with thousands of trading partners, is a complex challenge.  There are many issues yet to be understood and many details that need to be incorporated into a company’s plans and investment. There are also many benefits and opportunities to be gained by early adopters who realize the value that a more connected and visible supply chain brings. Virtual pilots, with simulation at their core, allow for better contingency planning, “what if” analysis, and even training of staff in developing an awareness of new departmental dependencies and contributions toward the new reality that serialization brings.  

Global Serialization: Could Virtual Pilots Be in Our Future?


	Robert Celeste is a founding partner of RC Partners healthcare consultancy and a former senior director at GS1 US, 

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	When referring to this article, please cite it as R. Celeste, "Piloting Track-and-Trace Implementation," 

Articles

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.

Piloting Track-and-Trace Implementation

	On November 27, 2013, US President Obama signed the Drug Quality Security Act (DQSA) law into effect. Article II of that law, named the Drug Supply Chain Security Act (DSCSA), requires members of the US drug supply chain to make a series of changes over a 10-year period in order to better secure the US supply chain from counterfeit, diverted, stolen, or mishandled drugs. The changes also seek to address the drug recall process.

	This new federal law preempted all related state laws and was significant in that it created one federal law that took under consideration aspects of four different concerns:

		California's pending Pedigree law (requiring serialization and traceability by 2015)

		Certain established business practices of the supply chain, such as inference (e.g., inferring what is in a sealed case based on the manufacturer's information)

		FDA’s desire to remove bad product and bad actors from the supply chain

		Patient-safety advocates' desire to protect the patient.

	To allow supply-chain partners to budget and prepare for serialization and traceability, the law also sought to spread implementation over a 10-year period. No one party got all of what they wanted, but in the end, everyone got something that could build momentum toward the ultimate goal of removing illegitimate medications and criminals from the supply chain. As with any undertaking of this magnitude, many questions and issues arose and will continue to arise as actual phased implementations take place.

	Most phase dates in the DSCSA are based on a certain period of time measured from when the law was enacted. An exception was the initial implementation phase of sharing transaction statements (TS), transaction information (TI), and transaction history (TH) at the lot/batch level, which was set for implementation on Jan. 1, 2015. Because of delays in Congress, by the time the law was officially enacted on Nov. 27, 2013, the supply-chain participants had little time to think as they switched from preparing for California’s requirements to the first implementation phase of DSCSA. Manufacturers and wholesalers scrambled to cobble together a solution using the systems they had already in place to meet the TS, TI, and TH sharing requirements. The result was that their systems worked with a lot of manual effort and a certain amount of errors-errors that also needed a lot of manual effort to address. It is well recognized by these manufacturers and wholesalers that these manual efforts are unscalable and unsustainable over time as the more demanding requirements of individual item serialization (in 2017) and traceability (in 2023) come into effect. Challenges for implementing serialization are even more magnified considering the growing number of global laws and regulations for serialization, authentication, and traceability.

	This challenge doesn’t mean that the task at hand is impossible. We are, after all, talking about a country that put a man on the moon and an industry that daily discovers and invents new ways of extending life in terms of quality and longevity. It is doable, and this industry is up to the task.

	So what now? Continue to implement as we go? Some hope not. The law provides enough time for the industry to move from the somewhat rushed implementations of 2015 to a well thought-out, globally integrated system for 2023. The problem is that there are still questions to be addressed to achieve new efficiencies that can help fund serialization and provide real benefits, such as more effective and efficient recalls.

	Today, industry trading partners are actively planning and executing traditional, physical pilots, which involve sending trial packages through the system, to ensure that their systems for handling serialization information function in production. To prepare for mass serialization and traceability, however, pilot programs must be conducted on a broader, more industry-wide scale. Issues such as aggregation, inference, scalability, and the core issues related to supply-chain security and patient safety cannot be solved through traditional pilots.

	So, how can these broader issues be addressed? In parallel with the necessary traditional pilots, supply-chain members could undertake a series of “virtual pilots” that would touch on the more difficult, core issues that have yet to be completely resolved. Loosely defined, a virtual pilot is a series of scenarios executed in a simulated environment where alternative courses of action can be experienced, measured, and compared. This concept is easy to understand in terms of extracting TS, TI, TH, or traceability data from one system and devising a method of comparison with other systems. Issues, such as aggregation, however, must consider behavior (resulting in possible changes to standard operating procedures) and measure the seemingly unmeasurable. For example, will this course of action enhance the security of the supply chain and enhance patient safety? To accomplish these tasks, the industry needs to consider the behaviors of its systems and staff; new business rules, laws, and regulations; and the effects of these factors throughout the global supply chain. This complex task requires the cooperation of all participants in the supply chain and an efficient means to track alternative scenarios and their impact on day-to-day events as well as on each other.

	An early example of using simulation software and techniques is found in the international commercial banking industry. In 1992, a commercial bank was developing an international funds transfer system to move and reconcile cash between international banks. The bank had over 50 designers/developers, fell six months behind schedule, and was $15MM over budget. The bank followed the latest systems and process technique of the time, creating hundreds of data-flow diagrams, data-model diagrams, and structure charts, but the bank wasn't confident that implementation of the transfer system would actually work if put into practice between the various banks around the world. The bank finally decided to use simulation software, which was typically used by manufacturing companies to study and measure internal processes and simulate hundreds of diagrams. The software revealed that the funds-transfer system didn’t work. One-hundred six major functional flaws were found in the design, and the bank was able to make corrections and implement the entire system within weeks.

	Like the bank pilot program, the pharmaceutical industry could also conduct a simulation for the proposed changes to the global supply chain, adding to the simulation the various worldwide requirements, business processes (local and global), and predicted solutions for the functional flaws that could potentially arise in implementation design. Then, having witnessed how scale and alternative methods impact the safe flow of medication (positively and negatively), key issues such as aggregation, inference, global commerce, local needs, scalability, necessary standards, guidelines, and supply-chain vulnerabilities could be resolved prior to mass implementation-resulting in measurable changes that would positively affect patient safety.

	Consider how supply chain industry players might tackle a “big issue” using a virtual pilot. Take the case of determining the impact of “lot/batch aggregation” (i.e., associating each serialized item to only the lot/batch) versus “packaging aggregation” (i.e., associating each serialized item to each case, pallet, or tote they’ve been in) on identifying a counterfeit. It is assumed that packaging aggregation allows for full supply-chain traceability of each item, but lot/batch aggregation alone could possibly miss a transaction where the outer layer (case) remains intact through a number of trading partner movements. A virtual pilot can be used to compare the two types of aggregation.

	Using simulation software, rules of behavior could be expressed for a series of simulated trading partners, and a counterfeiter could be added to the simulation. Then, two versions of the simulation-one where serialized items are aggregated at the lot/batch level and one where they are also aggregated at the case level and at all subsequent outer containers- could be developed.

	Each simulation would be analyzed to determine whether any party in the legitimate simulated supply chain had the potential to detect a counterfeit product. A virtual pilot could determine, for example:

		Whether there is a threshold of counterfeit products that needs to be reached for the proper detection of falsified medications in each scenario

		Whether there is a time difference in detection and alerts between the scenarios.

	Virtual pilots allow deeper analysis of key questions more cost effectively than physical pilots, which could be expensive and could lead the industry to choose an implementation path that may not necessarily lead to the best outcome. Virtual pilots can make good use of the industry’s time between now and 2023 by ferreting out the best and most efficient ways to secure the supply chain while producing a quality blueprint for physical pilots and implementations.

	Robert Celeste is a founding partner of 

 healthcare consultancy and a former senior director at GS1 US, 

Virtual pilot programs that simulate scenarios can help the pharmaceutical industry address core issues in the implementation of serialization systems that comply with the US Drug Supply Chain Security Act.