Security Printing and Imaging : packaging

EFPIA Announcements

StevenSimske — Mon, 26 Oct 2009 17:12:00 GMT

Hi, all

The next few blogs will point you to information on the recent announcement of the EFPIA 2D labelling scheme. The EFPIA is the European Federation of Pharmaceutical and Industries Association.

In-Pharma's article on this announcement is:

http://www.in-pharmatechnologist.com/Packaging/2D-barcodes-make-faking-less-attractive-says-EFPIA/?c=JiBz%2FX6W8967KGa2Liah%2FA%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

Importantly, as our partner Siemens notes,

[Siemens] "will provide connectivity for pharmacies and manufacturers to the EFPIA database, which is hosted by Hewlett Packard (HP). Manufacturers will populate the EFPIA database with the serial numbers of the saleable units shipped, and pharmacies will read those serial numbers at the point of sale (via 2D barcode) and authenticate the unit sold against the EFPIA database."

In other words, the cloud enables the crowd. 2D barcode readers are not just in the hands of the pharmacists. Look for us all--corporations, enterprises, brand owners, shippers, retailers, consumers, environmentalists--to embrace this approach. It helps level the playing field for everyone, except--one hopes--the counterfeiters.

Cheers,

Steve

Conference Time Part I: Extended Packaging

StevenSimske — Thu, 24 Sep 2009 02:12:00 GMT

It's September. The month when most people's gas bills hit rock bottom. Kids are back in school, harvest is still just sweat and fury in the future. Closed are the pools, open are the schools, and life is good. Too good. So, those wonderful conference organizers have nothing better to do than make us travel. Last week and this, I had the pleasure to present at ACM Doc Eng 2009, IS&T NIP25, and IEEE BIdS. I've already posted the ACM DocEng paper and plugged it a few times on this, my blog, but just to complete the trifecta, it's here:

http://www.hpl.hp.com/techreports/2009/HPL-2009-177.html

This blog focuses, however, on one of the NIP25 papers. It's about how to extend the information you add to packaging by using "semi-covert" variable data printing (VDP) driven layout variability, and it's with my long-time friend and colleague Margaret Sturgill. You'll find the PDF here:

http://www.hpl.hp.com/techreports/2009/HPL-2009-316.html

Thanks to Omer Gila for the invitation to present this work,

Steve

HP and Dubai Police seize Dhs70m worth of counterfeit components

StevenSimske — Tue, 07 Jul 2009 02:48:00 GMT

A quick blog today on an HP seizure of a mountain of counterfeit materials. Apologies for the long time between postings...just back from an amazing trip to Ireland for vacation.

http://www.ameinfo.com/202085.html

"HP Middle East's efforts to protect its customers from counterfeits in the region, resulted in one of the largest seizures of counterfeit print cartridges and components in the Middle East, conducted by Dubai Police in 2009. The raid uncovered an illegal counterfeit operation in Dubai at a 600m2 warehouse with two floors filled with packaging materials and security labels as well as finished goods. The counterfeit goods were intended for export to countries in the Middle East, Europe, and Africa. Four people were arrested and Dubai Police have started a criminal investigation."

At current exchange rates, this is approximately $20 million US. A lot of inventory on hand, but an effective just-in-time supply chain nevertheless: remember, counterfeiting is a business. Spanning at least 3 continents in this case.

Cheers, Steve

Simplified Labels do not Improve Compliance...by Themselves

StevenSimske — Wed, 01 Apr 2009 22:55:00 GMT

in-Pharma Technologist reports that Target's 4-year implementation of simplified labels may not increase patient compliance:

http://www.in-pharmatechnologist.com/Packaging/Target-s-packaging-failed-to-increase-compliance-study

The gist of the report is summarized here:

1. Patient compliance is problematic: greater than half of the "patients with chronic illnesses fail to adhere to their medications".

2. "Failure to properly follow a prescription can result in worse health outcomes and more frequent hospitalisations, which has been estimated to cost the US health care system $170bn (€129bn) annually."

3. Target introduced simplified packaging in 2005, "to increase readability and understanding of the product’s label".

4. "A study published in the Journal of General Internal Medicine that compared 23,745 Target users with one of nine chronic diseases and 162,368 matched non-Target pharmacy users found no significant difference in compliance between the groups."

This is not the last word. Other factors (increasing dependence on the internet, primary care provider, pharmacist, etc. for compliance information) may have helped create a situation in which the label is less important for compliance (thus evening the ground between the two pools of users).

However, it also suggests the creation of a hybrid label where the most salient (and dictated by law) information on compliance is printed on the packaging, and the packaging also contains a mark that leads either directly (e.g. barcode to URL such as the Open Mobile Alliance and GS1 efforts) or indirectly (e.g. listing of a URL to go to for more information) to the salient (and updated!) additional product compliance information.

This works well for both the brand owner and the consumer. The consumer has the key information on the product, but can get additional information as needed. The brand owner can update the URL to reflect real-time changes (recalls, new compliance regulations, new instructions, side effects, etc.). This is easier said than done--the regulators will have to carefully consider how to implement this. But it is possible.

Cheers,

Steve

Getting a feel for Label Requirements

StevenSimske — Thu, 19 Mar 2009 14:39:00 GMT

Label and packaging folks, especially, take note--

A Braille standard has been proposed by the IADD for pharma packaging. This was actually a key discussion point at the recent Graphics of the Americas "Brand Protection" conference. Sure, there is an easy joke here--"If I'm reading this, then it doesn't affect me". Think again.

The U.S., as with so many things these days (try mobile barcoding), is not the leader here:

"Since 2005 it has been mandatory in the European Union to include Braille wording on the pack of every newly approved medicine, including uncontracted forms of the drug name and its strength if more than one is made available. By October 30, 2010, the requirement will be applied to all products, regardless of when they were approved. The European Commission published revised guidance on Braille in January. "

The full article is at:

http://www.in-pharmatechnologist.com/Packaging/Braille-standard-drawn-up-for-US-pharma-packaging/?c=JiBz%2FX6W894S79s6QuBFwQ%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

In the absence of US legislation, "The International Association of Diecutting and Diemaking (IADD) has produced a Braille standard for pharma packaging in North America that it plans to publish at the 2009 IADDFSEA Odyssey show in May, according to a report in Packaging News."

Cheers,

Steve

Hide the Supply Chain...Trust the Seller?

StevenSimske — Wed, 12 Nov 2008 06:18:00 GMT

Thanks to my friend Bill Tucker to this link to Amazon's "frustration-free" packaging:

http://www.amazon.com/gp/help/customer/display.html/?nodeId=200285450

It is described as:

"The Frustration-Free Package (on the left) is recyclable and comes without excess packaging materials such as hard plastic clamshell casings, plastic bindings, and wire ties. It's designed to be opened without the use of a box cutter or knife and will protect your product just as well as traditional packaging (on the right). Products with Frustration-Free Packaging can frequently be shipped in their own boxes, without an additional shipping box."

Amazon is (rightly) advertizing this as a sustainability approach--less packaging is used, and less plastic is wasted. By partnering with the brand owner, Amazon states, "we work directly with manufacturers to box products in Frustration-Free Packages right off the assembly lines, which reduces the overall amount of packing materials used".

This is true--when there is no fraud. It will be interesting to see what security devices are placed on the Frustration-Free Packaging as it moves forward. If "none", I'd be looking at this carefully if I were a counterfeiter.

-Steve

Pharmaceutical Commerce Webinar, November 18

StevenSimske — Tue, 04 Nov 2008 04:58:00 GMT

In two weeks, I have the opportunity to participate in Pharmaceutical Commerce's webinar on "How Digital Printing Changes the Game for Packaging, Labeling, and Brand Protection". The link to register for the webinar is:

http://events.newanglemedia.com/pc/digital_printing/

A brief description of the webinar is:

"This webinar will help you create a more agile supply chain network, and reduce capital outlay around serialization projects. You'll learn how to turn your printing process into a business and supply chain solution!"

"We've assembled an expert panel from HP and Nosco who will discuss ways to improve supply chain flexibility and efficiency through use of digital printing technologies. These industry experts will explore solutions for change management, reduced obsolescence and enhanced customer service across the biopharma supply chain."

"Pharmaceutical Commerce Editor Nick Basta will moderate the panel discussion featuring Joe Tenhagen of Nosco, Matt Gindele of HP Indigo Label & Packaging, and Steve Simske of HP Labs."

"Register today to get a glimpse of how current and future technologies are improving supply chain flexibility and efficiency."

Cheers,

Steve

Does Theft Matter?

StevenSimske — Tue, 09 Sep 2008 05:15:00 GMT

One of my colleagues and friends, Puneet Mehta (one of HP’s top RFID/Supply Chain experts), pinged me recently, and mentioned “I found this interesting article about the theft of baby formula. [Is it salient] to Security Printing?” This is an excellent question. Does Theft Matter?

When you consider the logic of a three-part plan for your company against its worst competitors (the counterfeiters), yes, theft really matters. In act, it is logically where you are directing the counterfeiters. As I’ve discussed before, one of the main advantages of security printing is to provide a low-cost means of adding product security. You’re going to print, anyway, so a would-be consumer can see it’s your product, so why not print something that helps you identify authentic, as opposed to counterfeit, product in your supply chain (or in someone else’s supply chain, come to that). Yes, you need security-VDP (variable data printing) to do so, but if you haven’t already gone digital (and thus variable), it’s time you considered it.

This segues directly to Step #1 in forcing the counterfeiters to do you bidding—get them to spend more on counterfeiting than you did in legitimately creating the product. If you spend nothing incrementally using security-VDP, then the counterfeiter will outspend you, if for no other reason than to figure out what you did, while you did it effortlessly. This is one place where reverse-engineering costs more than the original engineering. Use it. Don’t, however, think you can get the counterfeiter to spend more than you by getting an expensive, but restricted-access deterrent. The counterfeiter will either more cheaply spoof it, purchase them from an insidious insider at the very same provider as you purchase it from, or simply buy in greater bulk than you, and thus get a cheaper rate on the deterrent than you do! Remember, a good counterfeit company (“good” meaning successful here—don’t get all judgmental on me!) will have multiple products in the market, and so they can afford a good price for bulk purchasing.

Step #2 is to get the counterfeiter to buy your equipment. As mentioned above, I’m sure plenty of security deterrent companies are already achieving this “success”. How many security deterrents—from holograms to Holy-cruds [this being those Holy-crud-are-these-hard-to-open plastic shells around many toys and electronic items]—are purchased by counterfeiters to make their product seem “legitimate”? Probably more than we care to know. A more successful strategy is to provide packaging/labeling/printing of products—from notebooks and doughnuts to banknotes and documents—using a special printer that the counterfeiters need to replicate the job. I recommend the HP Indigo, but in fairness there are other non-HP presses with signature technologies and capabilities, especially in finishing. Get one of them, and use it for your products. If you use static and/or generic printing, you’re asking for trouble. And, in the case of HP (or any other special print device provider), you’re missing a revenue opportunity. Just because counterfeiters have become our biggest competition, there’s no reason they can’t become our customers, too.

Step #3, however, is the main focus of today’s blog. Puneet pointed out an article (http://www.phillyburbs.com/pb-dyn/news/113-09012008-1584236.html) describing how thieves have begun targeting baby formula. The article reports on thefts of up to or exceeding $1,000 worth of formula at a time. The response? The infant formula was brought behind the counter. A sure way to stop thieves, but for those who like browsing while shopping, a turn off. Sales are lost when wares are locked. The director of CVS Pharmacy stated, “The store will soon display the formula in a locked case.”

Who are these thieves? Not desperate housewives or househusbands, usually that is. The article notes “Many times the culprits are rings of thieves who sweep Similac, Enfamil and similar products from the shelves because they are a valuable commodity in the retail-theft marketplace”. Oh yeah, baby formula is easy to sell. In other words, it has high turnover in the undermarket, or what I call the market underneath the marketplace. And the rest is, sadly, old hat to any long-time readers of this blog. The thieves mislabel the formula, store it at the wrong temperature, and are often members of organized crime rings with big, nasty folks nicknamed “Bubba” and “Hurty”.

But, in Step #3 of any cohesive anti-counterfeiting program, you will drive the thieves to stealing. If they actually can’t economically reproduce your branding and security, they’ll start to hijack your trucks and raid your distributors. Your supply chain’s integrity is only as robust as the weakest deterrent, lock or mind you have working for you. Remember the mantra—security is not as much about prevention as it is about detection and reaction. Using tamper-evident, copy-evident and uniquely identifiable deterrents forces the thieves to steal. And you complete, with success, the three part program to “win” the brand protection battle. Now you must be prepared to “win” the after-branding battle. When you drive your competition—the counterfeiters—to theft, you need to bring the rest of your armaments to the fray. These are education, investigation, evidence and reaction. I’ve talked about how to put a system providing this into PRACTICE (May 12, 2008), but let me recapitulate briefly.

Make the brand identification integral to your security. That way, if a thief uses your label, he can be tracked. If he doesn’t, well, he will still provide clues to his identity by how he tries to mimic your label. If he doesn’t try to mimic your label and uses his own, fewer clues are gained (and less pity felt for the purchaser, who should know better). But, you’re surely getting the drift here—if you routinely inspect your packages, labels and documents as part of track and trace and authentication, then you will also gather intelligence on the rats scurrying around in your supply chain warehouses. I mean the two-legged rats, of course. This intelligence can be used to define—find and fingerprint—the counterfeiters and thieves, and provide evidence to those willing to prosecute them.

So, does theft matter? It sure does. First off, it is a sign of success. Yeah! You’re making it so hard for your counterfeiters, they’re resorting to stealing. They may actually go to jail for that. But, there’s no time to rest on your laurels. Stealing still requires a smart, security-VDP-driven approach. Why not plan for the future, and put into place a practical program that can both help prevent counterfeiting and later help fight theft?

-Steve

Ecosystem Score: Proving It’s Real vs. Proving It’s Fake?

StevenSimske — Sun, 17 Aug 2008 06:43:00 GMT

In the previous blog, I talked about your Deterrent Score, and mentioned you must multiply it by your Ecosystem Score to get your overall effectiveness. As I mentioned in the May 12 blog, it takes PRACTICE to put such an ecosystem together. In today’s blog, let’s talk about how a deterrent might fit into the ecosystem.

Also, for today’s blog, I had a discussion with two of HP’s top experts on anti-counterfeiting. Jim Colby is HP’s Manager for Packaging and Anti-Counterfeiting Technology, and Dave Kellar is a Technical Expert for Package and Product Anti-Counterfeiting. Dave initiated the conversation, sending a link to XStream Systems, Inc.’s XT250 System that provides Authentication Technology with “See –Through” Vision (see http://www.bpcouncil.com/index.php?sid=10&lang=en&act=page&id=716).

The description states that “drugs can be verified while still in their manufacturer's sealed containers – as the system can scan through opaque plastic, cardboard, and even metal packaging to ensure consumer safety”. This is classified as a “forensic” deterrent—meaning a deterrent that can authentic down to the individual item. However, there has to be an ecosystem around this deterrent—starting off with measuring the material property, comparing the property to the correct data for the product, and receiving the real/fake result.

In addition, there are some issues specific to the type of forensic deterrence offered. For one thing, how sensitive is the technology to the active ingredient? Can different concentrations of reagent be readily differentiated? How often are there false positives? How often are there false negatives? Can the “authentic” amount of active ingredient be spoofed with 1%, 10%, 1000% of the normal amount? By including some of it on the packaging?

The ecosystem issues extend well beyond these questions. Who are the intended authenticators? Inspectors? Retailers? Customers? How will these authenticators be educated to understand what to do when the results indicate a failure? And what of cost? How much does the test cost? How much does the education and training cost? How is the data conveyed from the point of testing to the analysis service? How is data integrity maintained? The comment that “Wholesalers acquire conclusive proof of due diligence and of the authenticity of their inventory” could provide a few liability issues if/when there is a mistake (false positive, or especially false negative). In other words, XStream claims to “prove” authenticity, which in my experience is usually more difficult than proving something is non-authentic (or counterfeit).

Take mass serialization data, for instance. A legitimate number suggests but does not prove authenticity, but a non-legitimate number proves something is wrong. Just because the correct active ingredient is present does not prove the product is legitimate. After all, savvy counterfeiters really do want to get away with it as long as possible without having to change to another product.

I ran these concerns past Jim and Dave. Dave’s feedback was: “The main area of interest for me was the process to check the product through the package, eliminating the risk of used packaging or refills. The main problem is still who would check, as I do not see this system as a consumer overt confirmation. As you stated I do not believe the system could check for fake product salted in with the good or the ingredient added to the package material.” Like me, Dave was excited that the device allows you to potentially check the product through the packaging. This is even more powerful than RFID, which allows you to check the mass serialization information through the outer packaging.

Jim backed this up. He noted “I too am enamored with the concept of 'authenticating' actual product through packaging, and this does take the serialization step farther, but with all the same issues with serialization; namely, how to interpret results.” Jim noted that wholesalers would have difficulty arguing for “having conclusive proof of authentic inventory”. Jim also offered the important observation that “the more complex and costly it is to 'authenticate' a product-- the happier a counterfeiter becomes, because they know very few people will have the means to check and so very few products will actually get checked". Indeed, trying to outspend a counterfeiter is never a good idea.

Based on this example of a very good technology being deployed into a rather challenging ecosystem, we see that the Ecosystem Score is really dependent on much more than technology. It depends on simplicity; that is, ease of training and implementation as much as ease of performing the authentication. It depends on an “impedance match” between what you are trying to prove and what you actually can easily prove. In my opinion, this technology will be very useful in screening large lots by (indepthly) analyzing only a sample of the product. It may be less useful at the item level.

-Steve