Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published PMPN June 2005
Roundtable
Securing Pharmaceuticals
Security packaging technologies are needed, but so are open standards that involve everyone in the supply chain.
 |
| “A major help in fighting counterfeiting would be to get tougher legislation and tougher criminal penalties enacted that provide more of a barrier to counterfeiters.” — Steve Hess, senior director of packaging technology, Merck |
FDA’s strong-worded recommendations for combating counterfeits have catapulted security packaging and RFID into the forefront of every drug packager’s mind. In this roundtable, PMP News editor Daphne Allen speaks to pharmaceutical packaging professionals about how far they have come in their technology studies and how security packaging will most certainly change the drug supply chain. This year’s participants are D. Bruce Cohen, director of U.S. packaging services for GlaxoSmithKline for U.S. products; Steve Hess, senior director of packaging technology for Merck; Rich Hollander, senior director of packaging services for Pfizer; and Angela Mooradian, packaging development manager for TAP Pharmaceutical Products.
Should packaging professionals be charged with securing products to fight counterfeiting and diversion?
Hollander: Yes, it is a packaging responsibility. And it is everybody’s responsibility. There are a variety of strategies, policies, and technology-based solutions that the entire industry is working on to help mitigate counterfeiting and diversion. Some of the technology-based solutions are targeted at packaging. These solutions naturally are largely the responsibility of the packaging professional. As an organization, we work with our partners in the supply chain. With their cooperation, we look to institute practices and policies that raise awareness about some supply chain risks. We are always looking for ways to mitigate the potential for counterfeit or diverted goods entering the supply chain.
Hess: Here in the United States, in many cases the packaging that manufacturers provide does not always make it through the whole supply chain. Packaging can include features that are useful, but sometimes those features will get discarded at some point in the supply chain. So the customer does not always get the full benefit of those features.
A major help in fighting counterfeiting would be to get tougher legislation and criminal penalties enacted that provide more of a barrier to counterfeiters. Right now the penalties for counterfeiting are not a significant deterrant.
Cohen: I agree. A while ago a number of us prepared a list of the penalties and what should be increased and gave that list to PhRMA. PhRMA then passed it on to FDA. If you look at what somebody gets for selling illegal drugs versus somebody who diverts or steals or counterfeits legal drugs, it is a night-and-day difference in sentencing. Most people can do great harm to the supply chain of legal pharmaceuticals with little chance of ever seeing the inside of a jail cell.
Mooradian: The penalties for producing a counterfeit logo are actually greater than those for producing counterfeit drug product. If a person were to counterfeit a drug product, he or she would most likely need to produce counterfeit packaging in order to ship the product within the supply chain. It makes a lot of sense to add security features directly to the corporate logo to ensure that the penalties will be increased for counterfeiters if they were to duplicate that logo.
Cohen: Several years ago we were able to force an arrest and prosecute under the copyright laws and trademark infringement before we were able to do anything for counterfeits.
Do you find any particular steps that make the most sense?
Mooradian: In order to minimize risk as much as possible, I believe that we should all work toward securing the supply chain. To do so, we need to eliminate the products that are entering the supply chain through the secondary market. By formally asking wholesalers to keep this in mind as a security measure, we believe that it is possible to eliminate many of the points in which counterfeit product may enter the supply chain.
What about RFID?
Hollander: Each of us has our own internal initiatives going on right now with RFID or Electronic Product Codes (EPC). At Pfizer, RFID/EPC aligns well with our overall patient-safety strategy, which is focused on developing policies, practices and technologies to help ensure that only genuine product is received by our ultimate customers, our patients. We are working to ship Viagra with RFID tags on bottles, cases, and pallets by year end. This is aligned well with FDA’s expectations for adoption of RFID/EPC technology as outlined in its task force report of February 2004. We are approaching this as a pilot aimed at providing a means to authenticate our products by using the EPC, which can be confirmed to be authentic over the Worldwide Web. While we are confident we will be able to accomplish this, we realize that as a company, as well as an industry, we have a lot to learn and develop as we progress, as many questions are being asked for the first time. While authentication is a key aspect of this project, we do believe that with widespread adoption of this technology, the supply chain will eventually be well positioned to meet the needs of state epedigree laws for tracking packages throughout the supply chain.
Technologically, is that now possible?
 |
| “We have always approached anticounterfeiting with multiple technologies for identifying each individual component.” — D. Bruce Cohen, director of packaging services, GlaxoSmithKline |
Hollander: Sure, that is very possible. How robust it is, is yet to be determined. Another issue is cost. I’m not necessarily speaking about the cost of the tags or the packaging line and logistics operations within Pfizer, but the cost to the supply chain. The rate of adoption for our trading partners may well be a function of the costs of hardware and software required to support this new technology. For purposes of our Viagra pilot, they will need to be equipped either to read the EPC RFID tag or to read our redundant code, which is a two-dimensional bar code that contains the same information as the RFID tag, to authenticate our packages.
Hess: The reliability and the robustness of RFID are still to be determined. The pilots that many of us have participated in during the last year were successful. But they did point out some of the current shortcomings of RFID. Time is needed to really let that technology mature. As a packager of biologicals and vaccines in very small vials, I am not sure that the right technology exists that I could implement today.
Cohen: GSK is doing a pilot for one product similar to Pfizer’s pilot, only on a little smaller scale. We are doing it across the board on a particular product. Then we have to line up partners in the supply chain that will accept the products and read and authenticate them. If we limit this to one type of technology, we may limit the number of partners that are ready and available. If we can use more than one technology for getting the serialized EPC number across, then we stand a better chance of getting more partners to take this product and authenticate it and allow us to track all that through the system.
Do you feel that layering the use of RFID with other anticounterfeiting technologies or security packaging elements is a smart approach?
Hollander: We utilize layering as a key component of our technology- based strategies.
Cohen: We have always approached anticounterfeiting with multiple technologies for identifying each individual component. We are certainly looking at driving the addition of a serial number for each unit and in some cases the actual case of product that we send through the supply chain. We may wind up doing redundant type of information on those items for the start until we get a good idea on how the systems are going to work. As with the adoption of bar codes on a large scale, even today there are some wholesalers that do not read all of the bar coded information that is provided. So we know that the uptake on serialization will be a little longer than we probably anticipated.
Hess: The conventional wisdom is that overt, covert, and forensic will be layered nicely on packaging. This approach has been used with some success to at least create additional barriers for the counterfeiter. Bruce’s point about serialization is perhaps the next step. If we can come up with a way to mass serialize the item-level packages, then you have something that is even more powerful.
Should that be sequential or random serialization?
Cohen: I think it definitely ought to be random. This will make it harder for someone to anticipate what the next numbers will be. There are two schools of thought on this right now. One is to make the serialized number an object number to only identify the manufacturer and leave the rest of the information in a database that this number points to. Or use the recommended EPC global format that would basically put the global trade identification number (GTIN) or the National Drug Code (NDC) number in each of these serialized numbers. There are some issues obviously that we have to discuss about privatization and what happens at the retail level and beyond. We need a standard and we all can work towards that standard.
Steve brought up the fact that some packaging that manufacturers create does not make it all the way to the patient. Would unit-of-use packaging for the consumer provide reassurance that the package was never tampered with?
Hollander: A very bad assumption. The rest of the world is in blister packs, and the rest of the world has the same counterfeit issues as we have in the United States.
Cohen: Imitrex tablets are packed only in a blister of nine tablets and the blister is sealed in a card. There is no bottle pack. This package has been a unit of dispense from the pharmacy to the customer. There had been a little resistance in the beginning to some of these types of packs because the customer base is not used to it as they are in Europe. Regardless of what we do to our packs, it does not stop dispensing sites from making tablets fit into a pharmacy vial or making them fit into something that a mail order house might send out.
Unit-of-use packages could carry elements that patients could use to authenticate products. Is that of interest to you?
Hollander: As a patient, I would not feel too good about needing to authenticate my packaging or my prescription. I would rather not have to think about it.
So authentication should take place at the professional level?
Hollander: It should never have to go farther than the dispensing level.
Hess: That really is the role of the pharmacist, the person who is the last line of defense before it is handed to the patient.
Hollander: Patients should realize that if they can buy Viagra over the Internet at price too good to be true, it probably is too good to be true. Asking every patient to authenticate our products sends a signal that we do not have faith in the supply chain. Yet the supply chain in the United States is a closed a system and one of the safest in the world.
Mooradian: In some cases, patients buy product from Internet pharmacies, and they receive bottles with labels that state, “Product or package may differ from previous orders.” The product may or may not be authentic in that case. I think that the patient would read the label on the package received from the Internet pharmacy and assume that their pharmacist had authenticated the product prior to dispensing. In my opinion, consumer education is very important.
Hollander: Our strategy in Europe is different from our strategy in the United States. In Europe for our high-risk products, we do target the patient because we have concerns about the security of that supply chain. There we are afforded the ability to maintain the original package throughout the supply chain all the way to the consumer. So we are putting overt anticounterfeiting features onto our packages, and we are actually encouraging patients to ask for the Pfizer packages that contain these features so that they can be better assured that they are receiving authentic Pfizer products.
But you find that that is not necessary to do here in the United States?
 |
| “We like solutions that are aligned with open standards such that everybody in the supply chain can participate in them.” — Rich Hollander, senior director of packaging services, Pfizer |
Hollander: Right. The United States has a closed drug product supply chain whereas we do not have that luxury in Europe due to parallel trade within Europe.
Could that system change here in the United States through the efforts of legislators trying to facilitate drug reimportation?
Hollander: We will always need to adjust our packaging-targeted strategies as business practices and intelligence gained from the field warrant.
Are there specific technologies that you are interested in?
Hollander: Mass serialization via the EPC will help address anticounterfeiting and diversion. However, it alone will not stop all.
Cohen: The system can also be used for the electronic placement of a package insert for paperless labeling as well as any number of other add-ons. You can do that via the serial number, the RFID tag, the NDC number, the UPC format; any of those things can get you into the system almost instantaneously. You can pull up all kinds of information about that particular product. If the system was fully functional, you could use it certainly as a means to authenticate the pack you have in your hand. It could also give you insight into other things that might be on a company’s Web site that could help you authenticate. There are a lot of add-ons that this paperless labeling system could afford the dispensing site as well as the doctors for that matter. It would cut down on a lot of the things that happen both in the dispensing pharmacy as well as the doctor’s office. You could do your “Dear Doctor” letters or your “Dear Pharmacy” letters. You could send messages about recall of products or alerts on large thefts of product. An amazing amount of information could be at your fingertips at all the dispensing sites.
Hess: So that in itself could be a barrier. If criminals go to all the trouble to try to divert some product, and we have a way to communicate with the pharmacists immediately, that ends up being a barrier.
What sort of security packaging technologies do you want to see from suppliers?
Cohen: Technology has to have some value at some point. You need to weigh that value versus what it takes you as a company to produce that product in quantities reliably. Some of the technologies tie you into a single source of material, whether it is a label or a carton or paper or something that only that one source can provide to you. That can constrain you when obtaining raw materials for your packaging. We have gone down that road in the past with just a simple watermark that we put on our leaflet paper. We had this set up globally so we could identify for which region of the globe we produced that leaflet paper. The problem was they became single source entities, and you had to buy all your paper from them. As soon as we had a problem with a paper mill, we would run out of paper. Then we did not have that watermark. Product was not deemed authentic, which presented lots of problems. So technologies in and of themselves may be very good, but you have to look at them in the context of how you produce product on a global basis.
Hollander: Often suppliers come to show us their products as if they are the “silver bullet.” Often they are trying to sell us a solution but do not understand our business needs and how we approach this topic. Most of the technologies’ features are either covert or forensic, and they are giving us more and more ability each year to uniquely identify a package via various technologies including DNA. That is great technology, but it only supports a narrow use for us, such as by our own field auditors. That is likely to do less for me than an EPC might, where it is developed with open standards and where everybody in the supply chain will be participating.
Mooradian: The package is often not returned with the product, so it is difficult to determine whether or not the packaging has the drug manufacturer’s specific security feature on it. The technology that we are adding to our packaging needs to serve the purpose of authentication at the pharmacist level, due to the fact that the packaging is not always available for authentication at the drug manufacturer. Asking pharmacists to have a stack of pens and readers available for each of the drug manufacturers’ products is not realistic. The technologies need to be impossible to duplicate, yet easy to authenticate before the product ever gets to a patient.
Hess: We are all interested in new technology. We like to hear about it. We are all looking for that silver bullet. So I do not want to discourage people from sharing technology. But we would get better value in the short-term if we were to focus on setting some standards for mass serialization.
Hollander: We like solutions that are aligned with open standards such that everybody in the supply chain can participate in them. That is why when we talk about mass serialization, we talk about the EPC and do not focus too much discussion on RFID tags or 2-D bar codes, as they are just data carriers. We are interested in establishing standards that support the use of the EPC. With these standards established, software developers and tag manufacturers can begin to address the variety of technical challenges unique to our industry.
Cohen: Part of what concerns a number of us is that the general public in the United States wants to reimport products from outside the United States or to order everything off the Internet, unsupervised. We really see that as a concern for the healthcare of the U.S. patient. We have seen a lot of reports that show that products that are purchased off the Internet sites have nothing to do with real pharmaceuticals. They come from many different markets that do not have any control over ingredients or packaging or anything else. At some point they are going to cause real harm to patients in the United States and it is going to be very difficult to stop that product.
Copyright ©2005 Pharmaceutical & Medical Packaging News
