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

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.

The task of securing the supply chain and the need to adopt a layered approach using overt and covert security features often seems overwhelming; companies don’t know where to start or what technologies to invest in. That was a key message taken from anti-counterfeiting sessions at the 2008 Americas Technology Summit, an event focusing on brand protection and sustainability held in San Juan, Puerto Rico April 16-17. Americas Technology Summit was sponsored by National Label Co. and MWV .

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."

“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.

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.

Healthcare Packaging and Packaging World, producers of the Pharmaceutical Packaging Forum, and Ipack-Ima Spa, organizers of Pharmintech, announce a cooperative agreement in which Healthcare Packaging and Packaging World will offer promotional support to Ipack-Ima Spa, increasing the visibility for their Italian trade event, Pharmintech, to the U.S. pharmaceutical market. Pharmintech, held every three years in Italy, will next take place May 12th -14th, 2010 in Bologna, Italy.

In this question-and-answer interview, Andrew Billington (shown), operations manager at Brecon Pharmaceuticals in Wales, addresses recent trends in packaging. What is he looking for in new packaging machinery? Billington says: "Quicker changeover and anything that facilitates GMPs [Good Manufacturing Practices] are at the top of the list. Both are especially important for a contract packager because our runs can be quite short. Added changeover pressure can also come from the multiple languages we deal with here in Europe. That’s something our counterparts in the United States do not have to face."

A call for RFID pilots was heard from the California Board of Pharmacy at the EPC conference held in early October in Chicago. There's More. Click to continue reading "California ePedigree update"

Related Topics:
Anti-counterfeiting
RFID
Track and trace

A call for RFID pilots was heard from the California Board of Pharmacy during the 4th Annual EPC Connection Conference & Exhibition held in early October in Rosemont, IL. Judi Nurse, supervising inspector of the California Board of Pharmacy, noted that the goal through electronic tagging is to prevent counterfeit drugs from entering the supply chain in California. "The problem has been the inability to track the source of counterfeit drugs," she said.

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.

Packaging Hall of Fame inductee Edward J. Bauer, investigative reporter and award-winning author Katherine Eban, and Joint Equipment Transition Team (JETT) Chairman Jim John are among the speakers scheduled to make presentations at the upcoming Pharmaceutical Packaging Forum (PPF) 2008. Produced by Healthcare Packaging and Packaging World magazines, the event will be held on Wednesday, March 12, 2008 at The Rittenhouse Hotel in Philadelphia, the same venue that hosted the initial PPF March 29, 2007.

The recent rash of news about quality and identity issues involving a broad range of products imported from China has companies and consumers wondering. Counterfeit drugs and other products have recently been the subjects of one or another problem.

The recent rash of news about quality and identity issues involving a broad range of products imported from China has companies and consumers wondering. Counterfeit drugs and other products have recently been the subjects of one or another problem. China has been recognized by companies, the Food & Drug Administration, and other governments as a problematic source of counterfeit drugs for years. So what's the answer, are Chinese products and ingredients immediately suspect?

* 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.”

The results of Cardinal Health’s RFID pilot were presented at the Pharmaceutical Supply Chain Integrity conference, which was held in May and was sponsored by The Institute for International Research . Cardinal’s Pharmaceutical Technologies and Services (PTS) operations were recently divested and acquired by The Blackstone Group. This information was shared by Renard Jackson, formerly VP/GM Global Packaging Services of Cardinal Health, Dublin, OH, and now with PTS.

Healthcare Packaging Contributing Editor Chang-Hong Whitney (shown) reports that rapid economic gain, a weak legal system and lack of enforcement have helped counterfeiting flourish in China, but the global healthcare community can help the country battle counterfeiting. “Fake products are everywhere. We can’t trust anything on the market.” Such comments are common in China by people from all walks of life. Everything from household items to foods to industrial and commercial products, and to drugs are being copied, manufactured illegally, and sold on the open market via various channels and vendors. Living in China requires vigilance even for a trip to the grocery store.

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.

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.

Aylward Enterprises appoints Dana S. Waterman as CEO... Hubert H. Keil, managing director and CEO of Uhlmann Packaging Systems, was appointed vice chairman of the Board of Directors of the Healthcare Compliance Packaging Council... TCP Reliable acquired the assets of Cryopak Industries... International Business Solutions Alliance, LLC signed an agreement with SATO America, Inc., to offer a more secure method of administering patient care and improved patient safety through SATO's Positive Patient Identification solution... Paxonix and Global Vision have formed a drug packaging partnership to help companies reduce packaging blunders and meet compliance and validation demands... Oracle acquired Tolas Healthcare Packaging... Perfecseal will expand several facilities, including those in New London, WI; Derry, Northern Ireland; and Selangor, Malaysia.

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.

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.

At the Pharmaceutical Packaging Forum, Attorney Eric F. Greenberg revealed key Food and Drug Administration issues pertaining to healthcare packaging. Among them were drug safety, inspections, cGMPs, labeling of prescription and OTC drugs, and how a unique coalition came together last year to lobby for more FDA funding.

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.

Spend an educational day with your peers and solution providers at the Pharmaceutical Packaging Forum (PPF) in Philadelphia March 29. The event is produced by Summit Publishing Company, publishers of Healthcare Packaging and Packaging World business publications. Seats are going quickly, so register soon.

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.

Vital issues include validation, FDA regulations, counterfeiting, and the challenges of shipping pharmaceuticals and biologics through the cold chain. (Part I of II)... Surely one of the most interesting developments to unfold lately in the healthcare product manufacturing arena is the formation of the Coalition for a Stronger FDA. The coalition came together officially on Sept. 25 with former government officials, patient group representatives, consumer advocacy organizations, and industry associations bringing it into existence.

Pharmaceutical firms face a different set of realities about whether or not to use RFID than do consumer packaged goods companies.

At an October 31 conference session during Pack Expo in Chicago, investigative reporter Katherine Eban detailed her three-year investigation into how counterfeit drugs are increasingly moving into the legitimate supply chain.

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.”

Packagers share enthusiasm at February’s RFID World event in Grapevine, TX.

Purdue Pharma's 60-day pilot of RFID- enabled OxyContin at the item level was summarized by Mike Celentano, the company’s associate director, supply chain and RFID systems: “We had fantastic reliability—only 10 to 15 bad tags out of 230,000. We concluded that the fundamental building blocks for RFID-based serialized point-to-point e-Pedigree exists today.” He said the company has an interest in case and pallet-level tagging.

Ken Reich, TAGSYS marketing director, revealed that Pfizer's item-level RFID program for bottles of Viagra manufactured in France features Web-based authenticity that permits pharmacies to verify the Viagra it receives.

Meanwhile, Randall Lutter, the U.S. Food and Drug Administration’s associate commissioner, policy and planning, reminded attendees that, unlike overseas, counterfeit drugs in the United States are quite rare. He suggested that the rise in cases in 2004 to 58 versus 30 in 2003 may be due to awareness. Final figures for 2005 will see a decline, he said, thanks to proactive investigations.