First, Do No Harm

Regulations have drug and device manufacturers looking for a best labeling prescription.

By John Conroy

Multiple-page documents can be fed using the LC-In-Feeder 3000 from PSI Engineering.

It’s a prescription for trouble and a scenario that’s all too common in many hospitals. The lack of a centralized database means that nurses struggle to determine whether a patient received a particular medication. Doctors’ handwritten notes and other patient information are hard to track down. Searching for paperwork wastes nurses’ time. And inaccurate billing makes it difficult to even verify medical care. Error rates rise.

That’s the situation that Beijing Union College Hospital in China faced before Motorola Enterprise Mobility was hired to craft a solution in which bar codes played an integral role. The business unit says that bar code ID wristbands store a patient’s name, gender, and allergies. Its MC50 digital assistant gives doctors and nurses access to medical records from the bedside.

The recent Beijing case study highlights the growing role that bar codes, related symbologies, RFID tags, and other high-tech solutions play in the push to improve patient safety. The trend is driven by FDA safety and anticounterfeiting regulations, with states such as Florida, California, and Texas passing their own pedigree laws. California’s mandate—which requires manufacturers to ensure traceable electronic tracking of a prescription drug’s path from product line to patient—goes into effect January 1, 2009.

The safety trend has traveled beyond U.S. shores. Jeff Schou, senior director for Motorola Healthcare Industry Solutions Group (Holtsville, NY), notes that there are patient safety initiatives in almost every country. In the past few years, 34 countries have instituted safety regulations that “almost always involve medication safety,” he says.

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Schou says there are two related reasons for the uptick in regulations outside the United States: FDA’s influence beyond American shores and the pull of the American drug market. Nearly half of worldwide drug sales are in the United States, he says. “Every pharmaceutical maker has to sell into our market, because it’s just too big.” As a result, FDA regulations influence the business practices of overseas drug manufacturers. That state of affairs has proved a boon for Motorola, which has customers in Asia, Europe, the Middle East, and Africa, Schou points out.

Europe has proved particularly welcoming for a few suppliers stepping up efforts to offer a range of coding and marking solutions. Tom Pugh, vice president of sales for Bell-Mark Sales Corp. (Pine Brook, NJ), believes European manufacturers are “more advanced” than their counterparts in the United States and more likely to consider programmable solutions such as Bell-Mark’s in-line programmable thermal-transfer printing process. “To put it very candidly, when we sell our print equipment in Europe, usually it’s all programmable,” says Pugh, whose company focuses on medical devices.

“A lot of the thermal-transfer technology and ink-jet technologies have all originated in Europe,” Pugh points out. Noting that device manufacturers “are required to print in many languages,” Pugh says that the need for variable bar coding using reduced space symbologies such as data matrix and RSS codes means “there’s not a lot of space left for linear bar codes.” Manufacturers are moving away from common linear codes in favor of GS1 DataBar-14 or Data Matrix symbologies. Thermal-transfer printing can “easily satisfy” the requirements of this new trend, he says.

“The variable bar coding requirements on unit-of-use packaging started in the pharmacy,” Pugh says, “and will eventually be required in the medical device market as well.” Currently, medical device manufacturers have been combining two different printing technologies such as rotary flexographic for “boilerplate” information and programmable printing using ink-jet, laser, or thermal transfer.

Pugh predicts programmable printing will “become a larger part of the in-line print process” over the next three to five years. “Why have two devices? Why not print the whole package with the same device?” he asks. “In-line printing in the long run is going to be completely programmable in my view.” Device manufacturers will want to maximize valuable space on the packaging line by using one versatile programmable printer that reduces costly downtime associated with ink and print plate changes, Pugh mantains.

The LC-In-Feeder system can
perform 100% verification of pharmaceutical package insert dispensing.

Additional regulations demand automation to maintain throughputs, according to John Panunto, president of PSI Engineering (Mississauga, ON, Canada). “Once you put in more regulations, you slow the line down, unless you can automate,” he says. “The biggest hurdle and the last thing that people think about is the automation of the paper.” The company recently sold two printer systems to one manufacturer, with one deployed in the United States and the other in Europe. The systems combine software, mechanical controls, and electrical controls that “automate the whole process,” Panunto says.

In September, a major biopharmaceutical company purchased a PSI printing system for its labeling line. The Laser Mail DPT prints labels with lot numbers, expiration dates, and bar codes at a 500-input capacity. The automated system is designed to operate with minimal operator involvement and uses just one printing pass. Operators needing to scan bar codes slow down a production line, says Tom Napier, automation account manager for PSI, who notes that two systems sold to U.S. manufacturers in 2006 “were able to bring line speeds up from 12 cartons to 25 cartons per minute” at a 100% verification rate.

Panunto says an increase in direct-to-consumer drug sales of 25% to 30% per year “means more and more people are ordering online.” In response to this trend, PSI has developed an automatic prescription packaging system (APPS), which reads a prescription, prepares it in a compact package, and compares the prescription information to the actual prescription. APPS places the prescription and related literature in a bag or carton. Packages are automatically sealed, labeled, and sent directly to the shipping department at up to 1200 orders per hour, says Panunto.

Deciding whether to change to automated printing or different printing technologies can be a hard pill to swallow for some manufacturers. Jack Walsh, director of sales brand protection solutions for Videojet (Wood Dale, IL), says many of the Videojet’s customers are switching from ink-based printing to the company’s laser systems. “The first thing they tell you is they want more reliable coding and marking options and to get away from the mess of ink.” Although print quality is “undeniably a factor,” he believes that the decision to switch is “really more about uptime and reduced maintenance and changeover.”

Medical device manufacturers are adopting the technology more readily than their pharma counterparts, according to Walsh. Drug manufacturers could be reluctant to switch because the companies have had the same production lines for years. Processes such as hot stamping are well integrated, he says. Walsh adds that laser printing will create dust or gases that have to be extracted, a drawback for drug manufacturers that need to maintain clean production environments. As for cost and return on investment (ROI), systems such as Videojet’s 3430 laser-marking system are “low maintenance and have a long mean-time-between-failure rate,” Walsh asserts. Running at full capacity 24 hours a day and 365 days a year, “a laser can pay for itself in two to three months,” he says.

Medical device manufacturers often use two printing technologies on one packaging machine for both static and variable data printing. Shown here are Bell-Mark's FlexPrint Mini and its EasyPrint MLP thermal-transfer printers on a form-fill-seal machine from Multivac.

Walsh says many industries want to develop “a unique ID at the item level. That is a growing trend, and it’s not just because of the FDA mandate.” Tri-Star Technologies (El Segundo, CA) is taking the packaging concept down to the level of packaged pills and medical devices with its Cold Laser marking technology. Alex Kerner, president, says the company is working with major European pharmaceutical manufacturers to test the technology, which uses an Nd:YAG cold laser to chemically alter the titanium dioxide in pharmaceuticals in order to make titanium oxide marks on a pill’s surface.

Kerner says a “very large” drug manufacturer is comparing the Cold Laser system with other methods of marking and is “about a year from implementing this system.” There are several phases of titanium oxide that occur during laser exposure, he says. Lacking specific FDA guidance, Tri-Star is trying to determine which phase of the titanium oxide is acceptable. The company has hired a consultant with FDA experience to help with product approval.

An in-line alternative to lasers offered by CSAT America (Louisville, CO) prints up to four colors with bar codes, alphanumeric codes, and logos, says Joseph Buono, sales manager. The system prints on blister foils using electrophotography, a technology similar to a digital photocopier that employs an LED array instead of a laser. The machine’s photoreceptive print head conducts electricity when exposed to light, he explains. This information is sent digitally to the LED array light source, which writes a latent image onto a photoreceptive drum. That image is developed by a toner and is transferred electrostatically to substrates such as foil, paper, and plastic.

CSAT would like to see the process “adopted wholeheartedly by the industry, because that’s our real specialty,” says Buono. However, he believes the market for blister marking has stalled for several reasons. One major factor, according to Buono, is that Pfizer has adopted the use of RFID tags on a master case “rather than printing specific information on a unit dose. In that regard, Pfizer’s driving the industry away from what we’re providing.”

Buono says that flexographic printing is the “only real competition” for CSAT’s electrophotographic technology. Echoing the comments of Bell-Mark’s Pugh and others, he says, “Newer technologies are slower to be accepted in the United States than in the rest of the world, especially in Europe.” He believes one of the reasons for that reluctance is that European printing line operators are “much more technically savvy” than their U.S. counterparts. In addition, for stateside drug makers, flexographic printing is “a known quantity,” Buono says.

Pfizer is indeed using RFID tags in a well-publicized effort to fight widespread counterfeiting of Viagra. Wolf Bielas, CEO of RSI ID Technologies (Chula Vista, CA), says he expects to see more manufacturers using RFID tags for incorporating tags directly in packaging, authenticating products, and meeting e-pedigree requirements. In October, RSI ID announced a new class of “tamper-evident” tags that come apart when someone attempts to remove them.

Bielas says the pace of RFID adoption by drug and device makers is “set less by cost or regulatory issues and more by companies taking time to research and investigate how the technology can best be used in their processes, building a business case, and calculating ROI.”

Compliance with the new e-pedigree rules and related safety regulations requires compatible software as well as hardware, of course. Tom Thatcher, president of Tharo Systems (Brunswick, OH), says his company began “hearing very loud rumblings” from its device and pharmaceutical customers about five years ago “that FDA was putting pressure on them that all software products within their realm had to comply with 21 CFR Part 11. So we dissected that document. Then we floated what our impressions of what FDA was calling for in the document to many of our customers.”

The collaboration yielded a consensus in the customer base on the key software requirements for use “in this validated environment,” Thatcher says. Tharo’s latest Easylabel 5 Platinum package features updated user sign-on and pass options as well as a new audit trail capability, he notes. Some of the changes include the ability to select a minimum length for IDs and passwords in order to eliminate easily breached single-letter passwords, the capability to save label images as e-mail attachments for faster approval, and an option to save a history of all label changes.

Another soldier in the anticounterfeiting battle is a coding system called CounterFight. Marketed by Griffin-Rutgers (Ronkonkoma, NY), the product is made by Claricom (Nottingham, U.K.). “It allows packagers to use their current digital coding systems and print a unique serialized code on every item,” says Jim Umbdenstock, president of Griffin-Rutgers. The 12-digit alphanumeric code can be placed on labels, individual parts, or pallets, he says. The number of codes generated is virtually endless, he says. “The chance of it being duplicated is fairly nil,” says Umbdenstock. “It doesn’t come from a database. There’s nothing to steal.”

“A hospital could verify that it’s a real code and real product produced by the original company and it’s where it’s supposed to be,” Umbdenstock continues. The other side of that coin, he notes, is that somebody phoning in to verify the number may determine that the drug was diverted to Mexico when it’s “supposed to be in France.”

Umbdenstock believes the “trend of the last half-decade” will be mass serialization as an anti-counterfeit-medication measure. He says anticounterfeiting, track and trace, and mass serialization will be the buzz words for the period.

John Conroy is a freelance writer and editor based in Los Angeles.


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