Your source for news, trends and analysis of pharmaceuticals, biologics, medical devices, and nutraceuticals.

Watson Laboratories’ Glipizide Key.In package won the 2007 Compliance Package of the Year award from the Healthcare Compliance Packaging Council . The package, a unique carded wallet, is manufactured by Nosco for Watson Laboratories. The pack functions with a removable key card that must be inserted into a lock in order to access the blisters within.

The holographic industry is working hard to destroy the myth that sophisticated holograms cannot be counterfeited; anything can be counterfeited. The question is how well, and this is where the real value of holograms can be appreciated. The evolving anti-counterfeiting role of holograms lies in their ability to combine authentication with detection--and this is why enlightened pharmaceuticals companies and enforcement agencies continue to make them an integral part of their anti-counterfeiting strategies.

Could illicit trade—involving everything from handbags to humans to counterfeit pharmaceuticals to weapons-grade uranium—be an even greater threat to our way of life than terrorism? Dr. Moisés Naím, editor of Foreign Policy magazine, believes that could be the case. A new National Geographic Special, Illicit: The Dark Trade, which aired April 16 on PBS television stations, estimated the global value of this trade to be as high as $3 trillion, with some assessments believing it represents 10 percent of the world’s trade. As the accompanying photo of counterfeit drugs seized in Bogota, Columbia, shows, counterfeit packaging is part of this illicit trade. (Photo by Richard Numeroff/©2008 National Geographic Television.)

David Howard (shown), director product protection global brand integrity at Johnson & Johnson, spoke about how to implement a brand-protection program. “The first step in any organization is to know thyself,” Howard advised. “Where are your products made? How do you distribute? Where do you market? Are you local? Regional? Global? Who touches your products?” Without detailed answers to such questions, solutions being considered or the ones already being implemented may be misguided, Howard told the audience at the first Brand-Protection Packaging Forum.

More is going on in RFID apart from news of the decision by the California Board of Pharmacy to delay requirement for e-pedigree tracking of drugs until 2011. RFID analysts from ABI Research commented about RFID developments and drivers in pharmaceutical markets. Analyst Peter Poorman (shown here) says the current state of affairs in RFID is typical to that of many technologies. "After a period of excitement and then a period of disappointment, there follows a period of adoption on an upward ramp. I think we’re at the beginning of that ramp with RFID."

Three major healthcare stakeholders are among the speakers who will deliver presentations April 8 in Chicago at the Brand-Protection Packaging Forum, which is produced by Packaging World magazine. Global marketing director Akan Oton (shown in photo) of Catalent Pharma Services will share details of an ambitious implementation of a track-and-trace solution based on 2D bar codes that is designed to meet California's e-pedigree requirements.

“It really is about time we got some form of e-pedigree system in place” for drug products, states Bryan Liang, law professor, medical professor, and Vice President of the Partnership for Safe Medicine.
He describes the Partnership for Safe Medicine as “a group of organizations and individuals dedicated to ensuring the safety of the drug supply,” including physician, pharmacist, university, industry, and other professional organizations. The partnership has been heavily involved in advocating for a pedigree system to thwart counterfeiting and diversion, but it wants a workable system.

A two-year-old boy is rushed to a Kwale hospital in Kenya’s Coast Province. The clinical officer at the health facility diagnoses febrile convulsions and quickly rushes to the hospital’s pharmacy for a dose of medicine that will ease the boy’s suffering. But nothing happens, so the boy is given additional doses but still the boy does not respond. Finally, he dies. Only later, upon investigation, is it discovered that the drug had no active ingredients. The drug was a fake. Read how health officials and drug manufacturers are developing ways to battle counterfeiting in an effort to keep this African nation from becoming what some would call “a healthcare catastrophe.”

New Brand Protection Packaging Forum presents strategies for brand owners to protect their products from counterfeiting, diversion, and gray-market distribution, using the latest packaging-related technologies. Summit Publishing Company, publisher of Healthcare Packaging magazine, announces the launch of a new conference for brand owners looking to enhance the security of their products using the latest packaging technologies. Produced by Summit Publishing Company’s flagship magazine, Packaging World, the Brand-Protection Packaging Forum will take place on April 8, 2008 at the Chicago Marriott Schaumburg.

Synchronized lines, rather than individual pieces of equipment, will be a focus of pharmaceutical manufacturers, predicts PMMI’s Ben Miyares. In this exclusive Q&A interview with Healthcare Packaging, Miyares addresses multiple healthcare packaging-related issues, including mechatronics and robotics, which, he says, "have the potential to transform the development of packaging equipment." He also looks at sustainability, packaging equipment purchase considerations, E-machinery, and counterfeiting topics.

Arguably, one of the most promising areas in the healthcare sector is biologics. Biologics-based products and combination products appeal to some pharmaceutical firms not just for their treatment potential, but for their financial prospects, and for their ability to extend patent protection. “There is a lot more patent protection around these [biologics] molecules,” says Robert Smith, a director at Genzyme in the U.K. “Proteins and biologics are larger molecules than typical drugs."

In the next decade, counterfeit drugs will double, according to Alistair Dand, marketing manager for LGR Emballages, a supplier of folding cartons in France. Currently, one out of every two drugs bought on the internet is a fake. “Counterfeiters are benefiting in developed countries from our desire for lifestyle drugs," said Dand, "and in developing countries from the need for life-saving drugs." Dand offered these remarks February 7, 2008, at Pharmapack in Paris.

Pharmaceutical firms seek packaging line improvements to cut costs, biologics present packaging challenges, and medical device growth is driven by aging baby boomers. These treatment advances bode well for the healthcare/life sciences packaging community. Packaging materials need to offer protection from point of manufacture to the “last mile” where healthcare products reach a patient. Packaging materials must provide barriers for moisture, oxygen, light and heat, and they may include overt and/or covert security measures to combat counterfeiting and diversion. Equipment will need to package products more efficiently, be validatable and versatile.

Panelists from McKesson Corp., Pfizer Pharmaceuticals, Amerisource Bergen Corp., and Ahold USA recognize that while radio-frequency identification (RFID) offers promise in the pharmaceutical sector, its adoption raises questions. That message came through loud and clear at a recent gathering at the EPC Connection event, held in Chicago in October.

A new law that was widely described as strengthening Food and Drug Administration powers over approved drugs contains a spotlight on packaging that, among other things, will soon require unique numbering of individual packages of prescription drug products. In the FDA Amendments Act of 2007, little-noticed section 913 adds a new section to the law called "Pharmaceutical Security" that calls for federal government officials to "develop standards and validate effective technologies" to secure the drug supply chain against "counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs."

Although the use of radio-frequency identification is in its early stage, “RFID holds great potential for the healthcare industry, and the adoption of the technology is expected to increase significantly owing to the benefits it offers.” That’s according to RFID Opportunities in Healthcare in the U.S., a new $3,900 market-research report from Kalorama . This year, the RFID market in the U.S. healthcare industry is estimated to be about $297 million, says the report. By 2012, the market’s value is forecast to be $3.1 billion.

* made from polymers such as nylon, polypropylene, and polyester, these covert materials may be placed on medicines such as capsules and tablets

Using varying technologies makes it more challenging for counterfeiters to keep pace with your packaged pharmaceuticals, suggests Bryan A. Liang of the Institute of Health Law Studies. When it comes to employing anti-counterfeiting technologies, “don’t put your eggs in one basket,” Liang advises. Radio-frequency identification, which he says “the FDA is pushing so hard, has some role, but it is not perfect. If you package two million units a day, which is typical for a wholesaler, even a one-percent error rate or non-read rate is too high. Even the best RFID technology is getting to the 95-percent level, according to some of the studies that just came out last year.”

A New York federal court’s invalidation of some aspects of the U. S. Food and Drug Administration’s drug pedigree requirement has not dampened the push being made by many pharmaceutical manufacturers to quickly get a handle on the complexities of item-level RFID tagging. Both manufacturers and wholesalers are motivated as much by California’s January, 2009, ePedigree requirement as the FDA Pedigree dictate, which would have required many smaller wholesalers without formal, manufacturer contracts to get detailed product information from manufacturers and pass it down the supply chain, step-by-step.

Tumi, Inc. is selling a kit for airline passengers that offers spill-proof bottles in a zippered bag. New York City-based Tumi uses O.Berk Co. PET bottles for its newest product, the Carry-On Essentials Kit. It is a response to the Transportation and Security Administration’s (TSA) latest restrictions on what passengers can take with them aboard airplanes.

Attention packagers in the healthcare business: Healthcare has entered a time of profound change. That’s according to TRAX: Pharmaceutical Supply Chain Integrity, a conference held May 3-4 in Baltimore and produced by the Institute for International Research. The conference brought the following ideas to its audience:

Several anti-counterfeiting initiatives are underway in the pharmaceutical sector, where it isn’t just brand protection that’s at stake but rather the very lives of people who take packaged drugs assuming the contents are genuine.

Merix Pharmaceutical Corp. switched its retail packaging for Releev 1 Day Cold Sore Symptom Treatment to BlisterGuard security package from Colbert Packaging to thwart tampering and pilferage and meet retailer demands.

Beware drug abusers and diverters: Attempts to tamper with this pill container will result in the disintegration of its contents in a puff of smoke... It may sound like a far-fetched idea, but prototypes of the PillSafe, a drug container that causes pills to disintegrate if the unit is tampered with, are being tested at the University of Kentucky Center for Manufacturing. Anthony McEldowney, M.D., and Robert Muncy, D.M.D, formed R.A.M.M. LLC and collaborated with the university to develop a device that would reduce the abuse and diversion of highly addictive Schedule II narcotics.

Merix Pharmaceutical Corp. switched its retail packaging for Releev 1 Day Cold Sore Symptom Treatment to the BlisterGuard security package from Colbert Packaging to thwart tampering and pilferage and meet retailer demands. This new format introduced last September is now used nationwide at Walgreens and Kmart stores, with expanded retail distribution planned throughout 2007.

Electronic compliance monitoring packaging has been around for years, yet many pharmaceutical companies are unable to quantify the return on investment of smart packaging. Pundits who predict the future of packaging often talk bout the rise of smart packaging. What exactly is a smart package? One U.K. Web site cites examples such as time-temperature food quality labels, self-heating or self-cooling containers—any package enhanced to deliver additional consumer convenience.

In conducting research for his presentation at the recent HealthPack 2006 conference in Dallas, Joe Kornick “found a real and growing need for medical and pharmaceutical companies to give special consideration to their Internet packaging.”

ArjoWiggins

• synthetic substrate is suitable for most self-adhesive label applications requiring authentication and tamper evidence
• base is made from biaxially oriented expanded HDPE film that receives a special security coating
• damaged or missing label indicates contents may be altered or counterfeit

International attendance at U.S. expositions and conferences has taken a hit the last few years due to Homeland Security stemming from 9-11-01. Typically, international visitors decide to attend a show three to four months preceding the event. Visa applications to travel to the U.S. from countries such as China or India can take as long as nine months.

So, a packaging machinery or materials company in the U.S. that markets to global prospects has to find new ways to reach these international customers. That heightens the importance of your Web site, and the use of new technology such as Webcasts (see next article).

Pharma top growth market for flexibles
• Flexible packaging converters ranked pharmaceuticals as the top growth market, with aging baby boomers cited as a key reason for the growth. Medical device packaging was ranked as the ninth-highest flexible packaging growth market.
• The medical and pharmaceutical end-use market accounted for $1.5 billion of the $20.5 billion U.S. flexible packaging pie in 2003.

Source: Flexible Packaging Assn., 2004 State of the Industry Report

Portola subsidiary introduces brand security measure

Portola Packaging Inc. has launched a new subsidiary, YottaMark, to provide anti-counterfeiting solutions for packaged goods.