Seeking to differentiate itself from competitive wholesale pharmaceutical distributors, and to stay ahead of e-Pedigree legislation, Golden State Medical Supply, Inc. (GSMS™) has employed the software-based Pharmaceutical Track and Trace system from IBM.
The system is built on IBM WebSphere® RFID Information Center and IBM WebSphere Premises Server platforms. The RFID Information Center software's IBM e-Pedigree feature integrates serialization into existing packing lines and distribution-center workflows. It also shares data between GSMS, its suppliers and customers to let them know when packages are shipped and received.
Established in 1986, Camarillo, CA-based GSMS focuses on specialty solid-dose pharmaceutical packaging for government mail-order agencies and functions as a contract manufacturer and packaging company that serves public and private pharmacies and their suppliers. It does not manufacture pills at this time; but rather, packages pills produced by a tablet or capsule manufacturer into bottle sizes that accommodate the customers' needs.
GSMS operates in a two-story, 95,500-sq-ft facility that houses four packaging rooms, or lines, two of which are dedicated to antibiotics, while two fill other solid-dose products. The lines have been running for just over a year. Before that, GSMS outsourced packaging functions. Bringing packaging functions in-house last year gave the company more control of product distribution and provided better product security.
This year the company is starting up four new lines/rooms within the plant to add solid-dose manufacturing and packaging capacity.
Staying ahead of the e-Pedigree curve with RFID
Each of the lines provides GSMS with the flexibility to handle any product, according to Jim Stroud, company president and CEO. And while the rooms are not officially clean rooms, they all utilize HEPA filters.
“The four rooms initially were running five days a week, eight hours a day,” says Stroud. “We are at a point where we're running 16 hours a day, so we need those additional four rooms, which will employ all new equipment.”
Asked about the company's packaging equipment philosophy, Stroud says, “We try to work with one reputable supplier [for each type of machine] that provides good service and well-known equipment. We don't necessarily go for the cheapest equipment because we've found that if it breaks down, it's more trouble than its worth.”
Stroud's list of preferred packaging machinery suppliers includes the following:
The California Board of Pharmacy drives e-Pedigree regulation in the state and will require each prescription drug to have a unique identification and pedigree that tracks its source, transaction ownership, and authentication information. Doing business in California, GSMS stays on top of e-Pedigree matters.
“In the last four years there have been a lot of state regulations going into effect,” says Stroud. “In California, e-Pedigree law was actually going to be required as of January 1, 2010, with every product that enters the market in the state serialized. Then the deadline was moved back to 2015. Things keep getting changed, and sometimes it's hard to know what's going on, but we are all hoping for a federal regulation to be passed to make e-Pedigree law uniform across the whole country.”
Stroud says e-Pedigree lets you know where the product came from, tracking the product from the point of manufacture, by lot number and expiration date. “We've been RFID-tagging since early 2009, so we were ahead of everybody else,” he says. “We use RFID tagging at the case level right now, but we're looking at and trying to apply RFID tags at the bottle level as well. Our goal is to get that done by the end of 2010 or maybe 2011.”
RFID tags are embedded into rollstock supplied by Zebra Technologies . A Zebra printer is used to print the labels and the labels are hand-applied to the case.
Once product is packaged within one of GSMS's rooms or lines, cases are either conveyed to warehousing or to a shipping area. As pallets are conveyed through portals, RFID case-tag reading is executed on four portals from Alien Technology. “The Alien portals are located at our shipping and receiving locations,” says Stroud. “Entire pallets are moved through the portals, which read all the tags on that pallet.”
Stroud admits, “RFID is a little bit more expensive [than other track-and-trace methods], but we feel that's where technology eventually is going. There are a lot of big retail organizations, not necessarily the pharmaceutical companies, that are driving this.”
He acknowledges, “Walmart is interested in that technology. They RFID-tag almost everything in their stores. So just to be able to count and track product to find out where it is going, and to monitor the movement of the product would help to prevent counterfeiting and prevent diversion in the pharmaceutical industry.”
Connecting with IBM
Looking back at the company's wish to stay abreast of e-Pedigree law and a step ahead of competitive businesses, Stroud explains that GSMS learned about IBM as the company was developing this software.
“Originally I thought of IBM as a huge company that could be hard to work with, as big companies have a tendency to move pretty slowly. But right off the bat they had a unique team that was impressive. They knew how to deal with small businesses. We were pretty much on the same wavelength as them and we began sharing information, eventually employing the technology that we now use here. They provided all the software that we need to gather the data, and to track and trace product.”
According to John Krachenfels, solutions executive, pharmaceutical track and trace at IBM, the system utilized by GSMS is based on the Electronic Product Code Information System (EPCIS) global standard. That Web site explains, “EPCglobal is leading the development of industry-driven standards for the Electronic Product Code™ (EPC) to support the use of Radio Frequency Identification in today's fast-moving, information-rich trading networks.”
Krachenfels adds, “It has importance for both GSMS as well as their customers in that the standard ensures interoperability so that when you are exchanging information across the supply chain, through different systems that are specific to another distributor, or a contract packager, or a manufacturer or a pharmacy, it all works together.”
“The ideal scenario that we are shooting for this year is for a patient to be able to take our bottle and scan it within a store or pharmacy and get all the data they need off of that bottle, such as where it was manufactured and the lot number/expiration date,” says Stroud. “As consumers become more educated as to what's going on and where they are getting their drugs from they may realize they shouldn't be buying a drug off the Internet if they don't know where it came from. I think people are curious to know what they're taking and putting into their body.”
Beyond RFID technology for individual bottle tracking and tracing, Stroud says GSMS “is working on developing a label that allows us to create what we call a 'smarter bottle' because it tells the pharmacist and the consumer a wealth of information that you wouldn't normally see on a bottle.”
For example, he cites color-coded labels. “They go from cold to hot colors. Part of our market research showed that the pharmacist wanted some kind of color-coding system to better identify products to help stop dispensing errors. We came up with a system that goes from cold to hot colors, with the coldest being the lowest strength of that drug, and colors becoming hotter the more potent they are in strength.” GSMS employs Pantone Matching System colors that it prints onto labels. “We provide a color map on our Web site to help identify color meanings,” says Stroud. The printed color labels are provided by Steven Label.
How does GSMS justify the investment in the additional packaging rooms, equipment, materials, and the new software system? “Being committed to the safety of the consumers using our pharmaceuticals, we were happy to find IBM's proven track-and-trace solution,” says Stroud. “Now we're ahead of the competition in meeting California's serialization regulation and can attract more trading partners because of it.
“Yes,” it is an investment, Stroud admits. “But it's definitely going to be beneficial. The data that we can collect with the IBM system is going to yield monetary [advantages]. It's going to be a very positive thing for us.”