Get Up To Speed On Track & Trace, Serialization, And The Califorinia e-Pedigree Law

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

By Rob Wright

Dirk Rodgers is a U.S. healthcare supply chain consultant, and co-chair of a number of key technical work groups including GS1, an international not-for-profit association responsible for developing the most widely used global supply chain standards. Rodgers took time out to answer a series of questions regarding the pending California e-Pedigree law, and what pharmaceutical and biotech manufacturing companies should be doing to prepare.

Life Science Leader (LSL): What will be the impact of global serialization on choosing outsourcing partners?
Rodgers: While there are some similarities, the serialization requirements of each country are different.  Outsourcing partners need to keep up-to-date with all of these different regulations around the globe so that they know how to deploy and execute the technology that will allow them to efficiently switch from the requirements of one country to that of another.  It doesn’t make sense for a global manufacturer to retain multiple contract organizations for no reason other than each is only capable of fulfilling the requirements of part of the world.  In fact, the complexity and diversity of these regulations may soon result in larger manufacturers deciding to outsource even more of their packaging and distribution components.  But that will only happen if their executives have confidence in the abilities of the contract organization they would outsource to.

LSL: What should CMOs and packaging companies specifically be doing to prepare for and implement serialization initiatives to meet the California timeline?
Rodgers: Contract organizations who want to stand out should develop in-house expertise about the regulatory requirements so they can make their clients feel comfortable that they know what they are doing.  No one wants to lose sleep wondering if their CMO or CPO will take them down a path that will end up not complying.  This is particularly important for contract packaging and 3PL organizations.  They need to instill confidence that they know what needs to be done on behalf of their clients.

LSL: What should pharma and bio execs be looking for when assessing a CMO’s ability to be compliant with serialization initiatives?
Rodgers: Those executives should fully understand what will be necessary for them to comply and they should use that knowledge to ask probing questions of their contract partners.  Don’t assume you can count on your existing contract partners to know what will keep you compliant.  Look for contract partners who clearly know what they are doing and fully understand what is necessary to ensure compliance with these new regulations.  Remember, it is the manufacturer, distributor and pharmacies that are responsible for compliance.  These are the organizations that are risking loss of business and fines if they fail.  The contract organizations are there to help those primary organizations comply.

LSL: What advice do you have for pharmaceutical manufacturers who have taken a wait-and-see attitude toward implementing serialization initiatives?
Rodgers: In some respects, a wait-and-see approach has paid off up to this point.  Some companies who invested in solutions back in 2008 eventually regretted it because the dates were subsequently pushed out so far.  Could the same thing happen again?  It might.  Congress is considering a nationwide track-and-trace amendment to the Prescription Drug User Fee Act (PDUFA) as I write this and if it passes, we will have a different landscape to consider than we have been looking at — all the more reason to become knowledgeable so you can understand the implications of any change.  At some point it will be time to act and you will need to know what needs to be done in your environment before that point in time.  Only you can decide when and only you can decide what.  If Congress doesn’t enact a national track-and-trace requirement this summer — or if they do but it doesn’t fully pre-empt the California law — be prepared to act soon.  The good consultants and solution providers are going to get booked up fast and you might not be able to get the help you need in the timeframe you need it.

LSL: How much time do you believe necessary to adopt, test, refine, and implement an effective serialization program at a manufacturer?
Rodgers: You will need a lot more time than you might think initially.  All of the pilots that have occurred over the last six years have proved that.  How much time exactly depends entirely on the number of packaging lines a company owns, how much downtime they can tolerate on each one to endure a conversion, and how much automation already exists in their case packing operation.  Manufacturers are often caught off-guard by the fact that the California law isn’t just a serialization law.  It is a pedigree law that includes unit-level serialization, but you will find that neither you nor your downstream trading partners can fulfill the law unless you can make use of inference.  That is, you need to be able to infer the unit serial numbers contained inside of a case by reading only the case serial number.  Inference only works if you have a six-sigma case packing automation system, whether it’s the manufacturer or a contract packager.  The point is, once you start looking at what needs to be done so you will be compliant at the deadline, you will very likely realize that you should have started much earlier.  Some companies won’t be ready on time.  You have to ask yourself how much of a problem that possibility would be for your company.

LSL: What are some reliable sources for finding information and guidance on implementation of a serialization program?
Rodgers: The California Board of Pharmacy website has the main language of the law.  You need a lawyer to help you understand the full legal implications, but you also need technology people to help you understand the technical implications.  I have done a lot of writing about that aspect of the U.S. pedigree laws at www.RxTrace.com so, of course, I recommend that as an initial place to look.  This will help you educate yourself before you talk with contractors and consultants.  But you will quickly need to find a consultant who can help you develop a specific plan for adding the technology necessary to ensure your operation will be compliant.  This goes for both manufacturers and contract organizations.  Most of the big consulting companies have people who are knowledgeable and they are able to staff up very quickly as needed, but there are a number of smaller companies and solo consultants out there who are ideal for smaller manufacturers.  I recommend that people do some targeted internet searches to find a list of companies who are in that market.

LSL: Any companies you see as being ahead of the curve with regard to serialization and why do you think so?
Rodgers: Yes, but I can’t name them.  They are the ones who will be ready on time.  They’ve been quietly working on laying a solid plan and executing it for the last 2 to 4 years already.  They’ll be ready for any eventuality.

LSL: What do you see as being mission-critical initiatives for successful implementation of a serialization program among strategic partners?
Rodgers: I think it starts with the contract organizations acquiring in-house knowledge of the law and the technology that is necessary to ensure their clients are able to comply.  I can’t emphasize that enough, but to be a truly strategic relationship, the manufacturer must also have a solid understanding, too.   From there, the partners will develop a level of trust that will enable them to develop a plan and execute on it together.  They will likely need a lot of outside help from consultants, solution providers, and/or systems integrators, but without that foundation they will likely spend a lot more money than they have to.