Track-And-Trace: With Deadline A Year Away, Some Lessons From Early Adopters

EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.

The pharma industry’s to-do list for 2014 includes creating pedigrees for tracking shipments of drug lots – a federal requirement that firms actually welcomed since it overrode what would have been more onerous mandates from California.

But even though industry now has more time to ramp up to an eventual unit-level track-and-trace system, getting there isn’t necessarily going to be easy, as firms that have made early efforts – and even had early successes – can attest.

The first major question firms usually face when developing a track-and-trace system is actually how many systems to develop.

Regulators across the world are moving toward a global standard for track-and-trace, but there are still some slight variations that must be accommodated on a manufacturing line that produces drugs for worldwide distribution, according to Kimberley Fleming, associate director for product security at EMD Serono Inc. “It has been a challenge, but we’ve been fortunate enough to find a vendor that’s been able to help us through this process.”

The company, which declined to name the vendor, has utilized a unit-level track-and-trace system for Serostim (somatropin) since 2002. Based on that experience, it has concluded that centralization, rather than customization, is a preferable approach to implementing the various serialization and tracking requirements now on the books in multiple countries.

In the United States, a federal track-and-trace program was part of the Drug Quality and Security Act (H.R. 3204) signed by President Obama Nov. 27, 2013 (Also see "Early Thanksgiving Present: Obama Signs Compounding/Track And Trace Bill" - Pink Sheet, 27 Nov, 2013.).

The program initially calls for manufacturers to provide transaction information and history in paper or electronic format for drug lots beginning Jan. 1, 2015. The components of a package-level track-and-trace system will be put into place over a 10-year period, with manufacturers required to implement package serialization beginning Nov. 27, 2017. That will enable tracking of drug packages from the manufacturer to the pharmacy (Also see "Track-and-Trace Law: Push Begins For 2015 Exchange Standards" - Pink Sheet, 19 Nov, 2013.).

“The Pink Sheet” spoke with Fleming and Mike Rose, vice president of supply chain visibility at Johnson & Johnson, to glean some lessons learned from their efforts in this area.

EMD installed its Secure Distribution Program, which now also covers Egrifta (tesamorelin), to combat Serostim counterfeiting and fraudulent Medicaid claims (Also see "Rx Counterfeits: FDA Says Serono Serostim Tracking Is Effective Solution" - Pink Sheet, 1 Sep, 2003.). Both drugs are serialized at the package level and their distribution is limited to a network of about 300 pharmacies.

The serial numbers allow the company to find out when a product was manufactured, when it was shipped to, and received by, the pharmacy. The pharmacy in turn, provides the company with the serial number of each unit dispensed, a prescription number and the date of dispensing. This information has helped several law enforcement agencies with investigations of found product, Fleming said.

EMD Serono provides its pharmacies with several options for interaction, including a password-protected website, electronic exchanges of information, a mobile app and use of adjudication vendors.

Pharmacy groups have opposed requirements for keeping track of dispensing the broad range of drugs because of logistics and the cost of installing new systems to implement such a program at small pharmacies, and H.R. 3204 does not require such tracking.

In preparation for California pedigree requirements that now are pre-empted by the federal law, J&J began a serialization effort with one drug, Prezista (darunavir) 600 mg, as a test case (Also see "J&J Building Electronic Drug-Tracking System In Anticipation of California’s E-Pedigree" - Pink Sheet, 25 Apr, 2013.).

That serialization is continuing and the company is expanding the process to other products. J&J started its effort with the HIV therapy because its production is similar to many other J&J products, Rose said, noting that the knowledge gained with Prezista is “very transferable and leveragable.”

Three-Step Serialization Process

With the Secure Distribution Program under its belt, EMD Serono began to extend serialization and track-and-trace to all its products in 2007 in anticipation of the California law. But because the company operates globally, it also must contend with serialization worldwide, in countries such as China, France, Turkey, Brazil and Argentina, as well as the U.S. Their programs all include serialization and track-and-trace and the requirements are similar, but “they’re not exactly the same,” Fleming noted.

Initially, the only option for handling the various national requirements was country-by-country customization, she said in discussing the evolution of her company’s track-and-trace system.

“We found that the custom solutions are not scalable and it’s a lot more challenging to manage,” she explained. With customized programs, a single manufacturing site that produces drugs for multiple countries would have to switch between systems, depending on where the product is sent. The company tried this with the U.S. and China. “We had two separate systems, and that means two separate systems for the same manufacturing guy to manage,” she pointed out. “If you can manage one system, it’s a lot easier.”

The technology designed for the task has three components. The enterprise system contains the serialization database and country requirements. “That’s where all the management of serialization occurs and where the generation of serial numbers is, and where any unique country requirements would be specified,” Fleming said.

The enterprise system feeds into a site-level system at each manufacturing facility, specifying what needs to be done for each particular product and for each country. This then directs the system on the manufacturing line, which is “where all the printing and the unit case aggregation occurs.”

The company is putting serialization in place on “probably somewhere between 65 and 70 manufacturing lines” globally, Fleming said.

To implement the process at the global level, EMD Serono has invested “somewhere between 18 and 25 million U.S. dollars,” she estimated. For the U.S. market, which involves the shipment of about 1.7 million units per year, the cost is “somewhere in the $1.7 to $3 million” range.

Bridging The Physical And Electronic Worlds

Fleming said that “starting early” is her number one suggestion for instituting serialization and track-and-trace. “I say that all the time because we still find things that need to be tweaked or changed or modified and it’s just important to make sure that you start early.”

For EMD Serono the downside of starting early was the need to make alterations in the system. “It’s been a bit frustrating because we started so early, but I wouldn’t change that. l think that was a good thing, a positive thing,” Fleming said.

Case aggregation, ensuring that the units in a case match the records, is a key component of track-and-trace. EMD Serono began to work on aggregation in 2007 when the California Board of Pharmacy began pushing hard for track-and-trace (Also see "California E-Pedigree Law Pushes Final Implementation Back To 2016" - Pink Sheet, 13 Oct, 2008.).

The company put together a cross-functional team. It took about a year and a half to get “everything up and running,” Fleming said, and since then it’s been a constant upgrade and change.”

Putting aggregation “in place in your packaging lines and maintaining that integrity through the supply chain is very, very important,” Rose said. We found that the process of aggregation is doable, but it’s very complicated and it requires a lot of planning, a lot of effort on our side to make sure it’s accurate and works well.” Every factory line is “a little bit different, so the software has to be adapted accordingly,” he noted.

Good engineering staff is a key, he explained, noting that successful aggregation is achieved by “a combination of the actual technology on the packaging line, to make sure that’s working correctly, and then also making sure the software is monitoring and capturing the information from the bottle, making sure that we’ve got a good integration of the physical movement of the product along with the electronic data that goes along with that. … It’s that piece that’s required.”

To do that, you need the staff “to work through this bridge of the physical world to the electronic world. It’s making sure that you’ve got the time allocated on the packaging line to be able to integrate this. And the other element is making sure that the necessary investments are made on the software and the change of management that’s required.”

Implementing serialization is not a piecemeal process, he added. “It is important to have everything in place before putting the new system in. …. Make sure you get the necessary resources” on the line “when you bring it up and take it live. I think that’s the most important thing.”

Managing Each Bottle Uniquely

Both Fleming and Rose noted that serialization and track-and-trace is a company-wide enterprise. “Make sure that you have commitment from the top, from your senior management within the organization. In doing that you can then define your budget, have a well-defined plan,” Fleming said.

Cross-functional engagement also is important to success, she noted. “We found that supply chain, regulatory, legal, quality assurance, manufacturing, all those people need to be involved in developing a concrete solution.”

Rose also stressed that all parts of the company need to be on board. Serialization results in a fundamental change in how a company manages its products, he noted. “We’re still batch processing, but now everything has this unique number on it, so all your processes have to change to be able to manage each bottle uniquely. … It’s an investment in change management and process development and process engineering. That’s very important here. That fact cannot be minimized.”

He said it probably took about nine months from the start of the project to going live with serialization of Prezista. “It was important for us to do it so we gained an understanding of how to do it.” While serialization of Prezista provided a learning opportunity, it was not just a test. “We’re in what we call production mode, where every time this product is produced … it’s serialized,” he noted.

As J&J moves the process to other products, there is some improvement in the timeline because of what has been learned, he said. The company is moving to serialize everything for the U.S. market, more than 200 products, by the 2017 deadline in the law, and is getting ready for the requirements of other countries, as well.

Early Track-And-Trace Tests

Commitment from wholesalers and distributers is also necessary, Fleming said. “We can implement and we can put things in place, but without commitment from our downstream partners, it’s really challenging to test and to move forward.”

EMD Serono has worked with two major wholesalers to pilot the shipment of serialized product with a pedigree. “They’ve physically received it at the case level, been able to scan the case and receive that product with a pedigree,” Fleming said. “Our commitment is to have everything completed by the end of this year,” so all products are serialized by Jan. 1, 2015. The company is discussing tests of the pedigree system with other wholesalers.

J&J has worked with two wholesalers in California and “it’s actually helped both us and them to prepare our systems and our processes” for track-and-trace, and already has been helpful in validating shipments, Rose reported.

There have been one or two examples in which a wholesaler “believed they didn’t receive a case but we were actually able to go back to our record and be able to look at the serial number of that particular case of product and match it up with what records they had, and lo and behold, it was in their inventory. So it’s actually helped us with discrepancies.”

Fleming noted that California “did a tremendous job laying the foundation” for federal track-and-trace requirements. But, she said, “I do think that there will be some modifications as FDA and industry partner together and start developing standards and moving forward with implementing the new law.”