Considering Full Serialization

The US Drug Supply Chain Security Act (DSCSA), and how pharmaceutical companies can meet its serialization requirements, has been at the top of many agendas since the first phase of the law, which requires change-of-ownership data, came into effect in 2015. A crucial question is whether to implement the requirements in stages (i.e., to meet the machine- and human-readable package-code requirements for November 2017) or to look at the end goal of unit-level track and trace that will be needed in 2023. Implementation-even of today's requirements-has many technical and organizational challenges, and few companies are looking ahead, said speakers at a session on serialization at INTERPHEX 2015 (1). Companies would benefit, however, from a more holistic view, noted Joe Whyte, global serialization lead for Rockwell Automation, in a seminar on May 20, 2015 (2).

"Looking at serialization piece by piece is inefficient and problematic because you need interoperability between all system levels for traceability," said Whyte at the seminar. "Companies shouldn't look only at legislation requirements. Instead, they should look at the business benefits and do the whole traceability project now." Benefits of traceability include real-time visibility into what consumers are buying, which allows businesses to optimize their inventory and production levels. Additional benefits include the opportunity for patients who voluntarily choose to share information with the manufacturers of the products they use to participate in patient support, patient compliance, and patient safety programs (e.g., individual notification of recalls). These benefits are being realized in other industries, such as consumer products and groceries, Whyte pointed out, noting how shoppers today receive targeted coupons at the grocery checkout based on the barcodes of their purchases, for example.

While most countries have serialization laws, most are not yet requiring aggregation and traceability, with the exception of Brazil. "Brazil is the pilot project for the world on aggregation and traceability," said Whyte. Brazil is on the most aggressive timetable, with full traceability required by the end of 2016 and a proof of principle by the end of 2015, for which companies must test traceability of three batches of one product all the way from the manufacturing plant to the consumer. Once Brazil has a completely traceable system with more secure products going to consumers, other countries are likely to implement sooner than legislative deadlines to stay competitive, predicts Whyte.

The equipment needed for a traceability system is available now and is being used in Brazil already, Whyte said. There are, however, some challenges to address when implementing a system. Connecting equipment (e.g., printers and machine vision) is crucial; standard, open network and communication systems, rather than custom systems, facilitate equipment interoperability, which is more flexible and subsequently easier to support, noted Whyte. Storing and accessing data are other challenges that are optimally solved using cloud storage, said Whyte. "The customer standing at the drugstore counter does not want to wait long for data to be checked. Cloud storage allows for secure high speed data movement no matter what the geographic locations."

Choosing a standard for sharing and communicating data is another issue. FDA's draft guidance on data exchange, released in November 2014 (3), allows use of electronic data interchange (EDI); EPCIS, an electronic product code system from GS1; or web portals. Many companies in the US have chosen EDI, but EPCIS, which was built specifically for track and trace, is more flexible and may be a better long-term choice, cautioned Bob Celeste, former senior director at GS1 US and founding partner of consulting company RC Partners, at the seminar (4). For example, EPCIS is a global system that allows queries, while EDI does not, he explained.

Another aspect is testing the traceability system. Virtual systems are a useful tool for testing without the risks of testing a real system, such as a test product accidentally reaching a consumer, said Celeste. Using software, a company can test whether the traceability system works by, for example, introducing a counterfeit drug at some point in the supply chain and testing if and when it is noticed. Scenarios such as recalled product or theft can also be simulated. "Companies are responsible for serialization data and must use it to protect patients, not just collect and store it," noted Celeste.

References

1. A. Shanley, Pharm. Tech. Sourcing and Management enewsletter, Apr. 24, 2015, www.pharmtech.com/serialization-deja-vu-all-over-again.
2. J. Whyte, "Serialization Challenges-Holistic Solution & Support," presentation at the Serialization Seminar (Iselin, NJ, 2015).
3. FDA, Draft Guidance for Industry: DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (Rockville, MD, Nov. 2014).
4. B. Celeste, "Serialization GS1 Standards," presentation at the Serialization Seminar (Iselin, NJ, 2015).