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

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 .

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."

To no one’s great surprise, the California Board of Pharmacy voted March 25 to postpone until 2011 a law requiring that prescription drugs be electronically tracked from the time they leave the manufacturer to the time they reach the pharmacy. First enacted in 2004, the law’s original deadline was January 2007. That deadline was pushed back to January 2009, and now it’s been pushed back again. Included among the reasons for the decision was the concern that implementation might be done poorly.

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.

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.

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.

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."

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.

* pressure-sensitive labels with 100%-readable RFID tags delivered ready to use for item-level products, as well as case and pallet lots

* RFID labels are part of the company's RxTrackNSecure protective product line to combat diversion and counterfeiting

Cortegra

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.

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.

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.

The golden state's ePedigree requirement may force the Food and Drug Administration's hand on the use of radio frequency identification.

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.

So-called smart packaging has been around for years, but what about "smart shelves"?

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

A macrolide azithromycin chronic obstructive pulmonary disease (COPD) Phase III study is using Med-ic RFID smart sensors embedded in blister packs. Sponsored by the National Institute of Health, the multiyear, double-blind study will enroll more than 1,100 patients at 10 clinical centers across the country.

Crucial decisions need to be made by drug companies now, insists the CEO of a silicon chip maker.

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.

Nosco

• RFID Package Integration brand initiative helps pharmaceutical, biotech, and medical device manufacturers, and distributors meet federal guidelines and state legislation to protect the U.S. drug supply through the development of an electronic pedigree to track and trace products

Might the FDA set a mandatory RFID standard? Comments from a February 8 and 9 meeting make it likely.

On February 8 and 9, the Food and Drug Administration sent a signal on RFID to the pharmaceutical industry, which companies clearly received. “I am disappointed at the apparent slowdown in RFID implementation,” stated acting FDA commissioner Andrew von Eschenbach at a meeting of the FDA Counterfeit Drug Task Force in Bethesda, MD. Eschenbach asked the task force to figure out what was slowing down drug companies on RFID and to make recommendations to him by May. Based on the comments of the members of the task force, who are all FDA legal, regulatory, and enforcement officials, it seems very likely the FDA will develop a mandatory standard requiring pharmaceutical companies to adopt RFID tagging in a phased manner, with the highest-risk drugs going first.

Third in a series of reports from last November’s RFID Healthcare Industry Adoption Summit in Arlington, VA.

Pfizer is one of five pharmaceutical pilot implementations of an item-level serialized RFID solution with "parent-child" association software.

How can pharmaceutical companies protect their drugs and consumers against the growing blight of counterfeiting and product diversion? One option is the Total Integrated Packaging Solution (TIPS). TIPS works in conjunction with serialized item-level RFID to protect products throughout the supply chain via a parent-child approach to the electronic-pedigree chain of custody.

As someone who takes prescription drugs on an ongoing basis, I found Katherine Eban’s book, Dangerous Doses—How Counterfeiters Are Contaminating America’s Drug Supply, to be an eye-opener.

Second in a series of reports from last November's RFID Healthcare Industry Adoption Summit in Arlington, VA.

Bruce Cohen, director of packaging technology for GlaxoSmithKline (GSK), said that his company was ready to start tagging one of its drugs, which he declined to identify. Cohen made it clear that GSK was honoring its commitment to the Food and Drug Administration, which in February 2004 agreed to give pharmaceutical manufacturers some breathing room to implement RFID tagging voluntarily. At that time GSK pledged that it would tag at least one product within 12 to 18 months.

But Randall Lutter, associate commissioner of the FDA, told attendees at the conference sponsored by the National Assn. of Chain Drug Stores and the Healthcare Distribution Management Assn., “From our vantage point today, it appears a voluntary approach may not be enough. At this point we have become concerned about the slow or inadequate progress [being made in] implementing an electronic pedigree.”

Lutter’s impatience aside, the conference featured evidence that the pharmaceutical industry is not exactly mired in RFID mud. Even generic drug manufacturers, who have been lagging behind on RFID for the most part, are expanding their implementations.

After a successful pilot program, your RFID system is ready for production, the final deployment step.

First in a series of reports from the RFID Healthcare Industry Adoption Summit in Arlington, VA.

Last month, RFID authority Patrick J. Sweeney pointed out that the first step is creating the metrics to measure the change created by RFID. Here, he discusses creating an RFID team and planning your solution.

Last month, RFID authority Patrick J. Sweeney described the primary benefits RFID can deliver for healthcare packaging applications. Here, Sweeney begins a multi-part series on RFID deployment.

A Q&A with Patrick J. Sweeney II explores benefits and compares healthcare use of RFID with food and beverage firms.

This month, Cesar Castillo Inc. (CCI) will begin testing an RFID system that marries item identification with storage location to address inventory errors and inefficiencies.

Pfizer and Purdue Pharma are already testing RFID. This year, the Senate will likely pass legislation making it legal for wholesalers to import pharma packaging using RFID tags.

If the use of RFID technology makes sense anywhere in the field of packaging, the one place where it should be recognized as an obvious problem solver is in drug packaging. So why has the use of RFID in pharma become so bogged down in unnecessary complexity? Let’s first consider the nature of the pharmaceutical industry. Making and packaging drugs is both complex and capital-intensive. It’s also heavily regulated and policed by many. On the drug manufacturing side, batch and quality control have long benefited from the use of bar codes that bring order to what otherwise might be chaos. And when it comes to packaging and distribution—to either consumers in the store or professionals at a healthcare facility—we’ve found ways of promoting brand identity without jeopardizing our ability to comply with labeling regulations. That’s the good news. The bad news is that the pharmaceutical industry has had to contend with a grey market for both branded and generic drugs and a black market for diverted drugs. It’s also in a quandary over the efficacy of some drugs. Throw in the fact that in some countries the drug supply is fraught with local circumstances involving theft and diversion, and you get a feel for what the drug industry is like.

Mike Wallace of Abbott Laboratories’ Ross Laboratories Division offered multiple RFID insights, including his company’s work with Wal-Mart.

Shahram Moradpour, CEO of RFID consultancy Cleritec, notes, “There are a lot of pharmaceutical companies leaning toward high frequency (HF),” referring to 13.56 MHz radio waves. "HF can often be a better solution than current UHF technology for item-level tagging. A drug manufacturer isn't as concerned about a $1 RFID tag on bottled medicine that costs dozens of dollars. It's more important for them to track the pedigree of the product.”

Speaking of frequencies, ultra-high frequency (868 MHz to 915 MHz) shortcomings (such as low read rates) were uncovered during the Project Jumpstart pilot, conducted by pharmaceutical stalwarts such as Pfizer, Abbott Laboratories, and Cardinal Health.

Item-level RFID tagging of pharmaceuticals potentially could dwarf RFID use for Wal-Mart.

• TAD-RF Series applicators feature in-line verification system that directs a radio signal to each label on the roll before applying to package
• discard defective labels, applying only working labels
• available with one or two labeling heads and may be configured for horizontal, vertical, or inside-the-carton label placement

Logotech Machines

Is RFID the only answer?

The pharmaceutical industry has quickly embraced the use of Radio Frequency Identification Devices (RFID) as a way to protect consumers. Yet, preventing counterfeit drug products from reaching consumers is not a simple task and the implementation of RFID is only part of the solution. Another part is the development and utilization of pedigrees. A pedigree is a tracking mechanism, either paper or electronic, that identifies the path a drug product has taken from the manufacturer. Pedigrees were required by the Prescription Drug Marketing Act enacted in 1988. However, the pedigree requirements have yet to be fully defined by the Food and Drug Administration.

Another method to protect consumers is to increase the number of inspections for imported drug substances and products. Both consumers and businesses are purchasing drug substances and products from firms outside of the United States. More inspectors must be available from the Department of Homeland Security and the FDA, in order to increase the inspections.

Report describes ‘smart’ weapons to battle counterfeiting
In its just-published study Low-Cost Smart Packaging in Pharmaceuticals and Cosmetics, Pira International reports that smart or intelligent packaging technologies offer designers, producers, and users of pharmaceuticals or cosmetics a broad and diverse range of functions to address counterfeiting and theft. These include the following:

• Electronic compliance monitoring of medications in blister packs and bottles
• Battery-powered patches for applying cosmetics and medications
• “Talking” packaging to communicate with visually impaired patients
• Visual displays to indicate “freshness” of vaccines or high-value healthcare products
• Enhanced levels of brand security and authentication
• Tamper-evident seals and sterilization indicators

Pira’s study, based on the results of interviews with converters, technology suppliers, brand owners, and retailers, serves to:

RFID technology can provide some specific benefits for clinical trial packaging, but there's a downside as well. Both were spelled out by Charles Gettis, senior VP, operations, AccuLogix, at a presentation at the recent ISPE conference in October 2004.

Benefits:

• Positive identification for dispensing the right medications to the right patient, reducing dispensing errors
• Works with validated systems
• Scans supplies as they come in
• Reduces quality assurance staff tasks with 100% accuracy
• Identifies errors before a packaging run starts
• Good for injectable units

An induction-sealing head helps eliminate interference between an induction sealer and RFID antenna-readers that track pill bottles on a packaging line at Prescription Solutions.

Packager: Prescription Solutions is the Costa Mesa, CA, pharmacy division of Pacific Care, Cypress, CA. Prescription Solutions serves “insurance companies and employer groups who want to provide prescription coverage to their employees as part of their healthcare package,” explains Dave Booher, pharmacy manager. “We are primarily involved in filling prescription orders.” About 80% of the prescriptions are shipped via U.S. mail.

Problem: As a point of differentiation in the mail-order pharmacy business, Prescription Solutions induction seals bottles for tamper evidence. But the sealing energy emitted during induction sealing interfered with the radio-frequency identification (RFID) antennas used to track bottles along a packaging line at the company’s Carlsbad, CA, facility. The antennas read RFID tags on pucks. Each puck contains one tag that corresponds to the prescription in the pill bottle contained by that puck. The antenna reads a number from the passive tag and downloads it to a computer. In turn, the computer triggers pneumatic devices on the conveyor that move the puck downstream on the line. The interference between the similar frequencies interrupted those communications and slowed down the line.

Looks like there’s some steak to go with radio-frequency identification’s sizzle.

In mid-November, Walgreen Co. and Purdue Pharma LP announced plans to test RFID in their respective packaging operations. Walgreens, the Deerfield, IL-based drugstore chain, received prescription products from several manufacturers and a distributor with RFID tags placed on bottles and cases as part of Project Jumpstart.

“Today’s announcement by the FDA to encourage manufacturer use of RFID and EPC tags will allow us to gain more practical experience using these technologies,” said Trent Taylor, Walgreens’ CIO. “The potential to electronically track and trace product at the bottle level through the entire drug supply chain offers great promise toward eliminating counterfeit medications.

In November, the U.S. Food and Drug Administration released Compliance Policy Guide (Sec. 400.210) Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs.

Its goal, says the FDA, “is to facilitate the performance of RFID studies and allow industry to gain experience with the use of RFID.” The agency noted, “we believe that use of RFID technology is critical to ensuring the long-term safety and integrity of the U.S. drug supply.” (Download a copy of the guidance.)

The FDA is accepting written public comments. For questions on the interpretation of this guidance, contact the Office of Policy, Paul Rudolf (301/827-3360).

In mid-November, Stamford, CT-based Purdue Pharma LP announced a pilot program to apply radio-frequency identification (RFID) labels to 100-ct bottles of its OxyContin tablets shipped to Wal-Mart and wholesaler H.D. Smith, two of its largest customers.