West Pharmaceutical Services has long been a leader in drug and supply chain security. Its expertise in parenteral packaging and distribution has led to advances such as West Spectra, a technology that incorporates RFID tags into vial seals for improved product authentication.
Don McMillan has led these efforts at West for many years. McMillan, who was recently promoted to President, North America, Pharmaceutical Systems Division, spoke with Pharmaceutical Manufacturing about whats working, and not working, in todays anticounterfeiting efforts.
P.M.: Give us a sense of the anticounterfeiting landscape. How good are the solutions that drug manufacturers are employing these days?
D.M.: The anticounterfeiting landscape is a race. Counterfeiters are becoming smarter and more confident; security solutions must be continually adapted to surpass the capabilities of counterfeiters. Pharmaceutical companies that previously ignored the problem no longer have that option. Counterfeit drugs have become a serious problem around the world and the issue is rapidly spreading to the United States.
P.M.: Do most manufacturers understand that a holistic approach is needed? What is preventing drug makers from developing comprehensive anti-counterfeiting approaches?
D.M.: The pharmaceutical industry is conservative. While the industry sees the need to implement anti-counterfeiting technologies, each organization is waiting for another to make the first to move forward. Some pharmaceutical companies have been discussing security for years; it is a matter of prioritizing and truly understanding the costs of what could happen if a drugs authenticity were to be compromised.
Despite this lack of aggressive forward motion, most of industry, including FDA, recognizes the need for a holistic approach. One solution alone will not be all encompassing and fool-proof. Ensuring the authenticity of a drug product requires a multi-technology, multi-platform approach. West Spectra permits manufacturers to layer and periodically change security features on their drug packaging. Layers of security include overt high-resolution, full-color graphics, sophisticated covert inks and RFID.
P.M.: What security measures are being underutilized, and why is this?
D.M.: RFID remains an underutilized security measure due to cost and infrastructure issues. RFID can be utilized to its full potential once these issues are resolved.
P.M.: Are there some measures that are, for lack of a better term, overrated in terms of their effectiveness?
D.M.: Any security measure that a counterfeiter can overcome immediately becomes obsolete and overrated. Holograms are an example of a security feature that counterfeiters have overcome. Holograms that stand alone without additional layers of security can easily be replicated. In fact, there have been instances of counterfeiters adding holograms to counterfeit drug products that dont have holograms, in an effort to make the product look more authentic.
P.M.: What are your customers' greatest needs at this point? What are they asking of you?
D.M.: West, alongside our customers, is most concerned with protecting patients from counterfeit drugs. Patients often need medications to maintain everyday lifeauthenticity and effectiveness is crucial. This need surmounts all others. Our customers are also mindful of protecting the expensive biotechnology drug supply.
From a technical perspective, customers require comprehensive security solutions that extend beyond overt and covert technologies. Infrastructure for data capture, data management and item-level tracking is a critical component of security solutions. To meet this need, we have partnered with a technology provider, Tagsys, to integrate this element with our product.
P.M.: Spectra seals employ several anti-counterfeiting technologies, including RFID tags from Tagsys. Are you doing this at a cost that customers are comfortable with?
D.M.: The use of RFID in the pharmaceutical industry for item-level identification is a relatively new phenomenon and, therefore, is very expensive at the unit level. Every single dose needs to be verified. Regardless, safety is a priority and volume will continue to increase, driving prices down.
P.M.: What's the advantage of incorporating RFID tags into, say, a vial closure, as opposed to a label? What are some of the challenges from a manufacturing perspective?
D.M.: Vial closures provide many advantages over labels when incorporating RFID technology. RFID tags are comprised of a chip and antenna. If either component is damaged, the system cannot operate accurately. Incorporating the tag into the plastic Flip-Off seal provides a protected placement. The process of reading tags placed on vial closures is uniform, ensures tags are not touching each other, and minimizes the risk of damaged chip and antenna.
The manufacturing challenge is to maintain the security of the seals. We must take multiple measures to ensure the authenticity of our products by limiting access to products and transporting them to customers without identifying markings.
P.M.: With RFID comes a lot of data. How are you helping manufacturers to handle and leverage that data?
D.M.: Understanding the customers specific needs is the first step to managing data.
We work closely with our customers, from a very early stage, to help identify the data that needs to be captured, included on a tag, entered into a database and/or linked to other databases. West is working with customers on the front end and our partners, including Tagsys and other data management integration providers, work with the same customers for back end data management.
P.M.: What will the year ahead bring? Will there be regulatory or technology shifts that will alter the anti-counterfeiting landscape?
D.M.: Currently, we are working with multiple companies to integrate anti-counterfeiting technologies to ensure product authenticity. RFID is one of the many technologies our customers are considering.
In 2006, we expect that many of the pilot programs will be completed, further encouraging other companies to take the issue seriously and implement security measures. For the RFID solution, increased volume will drive costs down dramatically. Counterfeiters are getting more creative and disastrous potential looms; we are pleased to see that the industry is beginning to respond.