Eastpack/Pharmapack 2013

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The choices Impressions Inc. makes on which trade shows to exhibit at are based on an expected amount of traffic that will provide the most likely opportunity for future sales. Location is a secondary consideration, but still important because having multiple transportation options along with affordable prices go along way towards justifying our attendance at the show. There are many shows that meet both these criteria, but outside of the event itself, the experience may be somewhat unpleasant because of the lack of things to do in and around the convention center in which the show is being held. Attending East Pack in Philadelphia, PA was a treat because Philadelphia is a great place to visit. I love Philadelphia!

The Pennsylvania Convention Center is located in the heart of Center City, at approximately an equal distance between the Schuylkill River to the west, and the Delaware River to the east. The convention center itself is clean and modern, built in 1993, and easily within walking distance to most hotels. The Liberty Bell, Reading Market, Independence Hall, and the City Hall adorned with the omnipresent statue of William Penn, and so much more all in close proximity to the center. The service at our hotel was about the best I have ever experienced, and the food was great wherever we went. Philadelphia lived up to our expectations as a great place to attend a show.

Unlike its West Coast cousin, West Pack, which is always held at the Anaheim Convention Center, East Pack moves to a different eastern location each year. Having not displayed at the show before, I have no basis in which to compare this show to previous years and ultimately have to rely on the opinion of fellow exhibiters who have been at previous events. Although the traffic could be brisk at times, the attendance didn’t seem to be at the level we were hoping for. It will be some time before the impact of the show can be evaluated.

The show actually is the combination of several events being run concurrently: East Pack, MD & M, Pharmapack and more. The event bills itself as the largest packaging design and manufacturing event on the East Coast. I would estimate that the total number of companies exhibiting at the show was somewhere around 1200. Exhibitors came from all over the US, as well as from Europe and Asia.

The Pharmapack conference consisted of 18 speakers over two days covering topics such as counterfeiting, serialization, consumer safety and compliance, sustainability, security, and general industry packaging trends. Because of the vast amount of information covered at the conference, I will just touch on serialization in this blog and plan on covering other topics in future entries.

Six of the presentations focused on different aspects on the topic of prescription drug product serialization. The purpose for the serialization initiative is to create a uniform global system for the identification and traceability of all prescription drugs all the way down to the single unit level. The ultimate goal, though, is to protect the end-user from counterfeit drugs that may contain no active ingredient and not be effective, or even worse, a danger to their health. It is estimated that 10% of the world’s total supply of prescription drugs are counterfeit. Although this percentage is based on global estimates, at four billion drugs dispensed per year in the US alone, this would mean that the total number of counterfeit prescription drugs in circulation is in the millions. Frightening numbers to keep you awake at night.

The five components of the serialization standards initiative are: unique identification; product information notification; authentication; Track & Trace; and E-Pedigree. Unique identification includes unique numbers issued by a government agency, product codes and serial numbers, batch and lot numbers and expiration dates, and some machine readable code or carrier. Product information notification captures when the information gets passed along to a national regulatory agency. Authentication is taking the recorded information along with tamper evidence that can be checked for accuracy when dispensed. Track & Trace identifies every product owner our unique location. E-Pedigree is the complete electronic form that maintains the entire item’s history as it relates to location and ownership; all the way from product manufacturing to dispensing at the final sale. The last component, E-Pedigree, implies a central database of almost unimaginable size and scope.

All of this can not come about without the drug manufacturers having to change the bar codes printed on the package from printing linear to serialized 2D DataMatrix. Given the enormous cost of this change, and the massive amount of data that will have to be collected and disseminated, companies are proceeding cautiously and waiting for standards and some mandate before completely moving down this path. At this point and time there are no global standards for serialization, and there doesn’t appear to be any chance of developing them in the foreseeable future. Every country with standards in place has different requirements from other countries, and many have not yet developed a database that will be able to handle all of the data.

The state of California has taken the lead in the United States with their E-Pedigree initiative that has a goal of getting half of the prescription drugs sold in the state serialized by January 1 of 2015, and the remaining by January 1 of 2016. Repackagers and wholesalers must be compliant by July 1, 2016, and distribution centers and pharmacies must be compliant by July 1, 2017. Being compliant consists of the following requirements: unit level serialization; certification of sales and purchases; tracking of product information including lot level and expiration date; upon taking possession, owners must append; and the data must be nonproprietary and interoperable. There will be a penalty of $5000 for each violation per transaction.

The European Union has a similar initiative called the EU Falsified Medicines Directive which they are hoping to have in place by early 2017. Many of the requirements are similar to California. The most distinguishing difference being a specified bar code –GSI Dta Matrix ECC 200- and a requirement for tamper evidence which is not the case with California.

All of the Conference speakers, representing both the industry and regulatory sides of the aisle, agreed that the primary goal of serialization is patient safety, and that is paramount for the initiative. The debate comes down to how you go about that goal, universal agreement of standards, and how to develop and manage this expected giant database.


Author: Nicole Hannover

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