Medical Device Link.

Originally Published PMPN April 2005

TRACK AND TRACE

Coding and marking technologies can help pharmaceutical companies comply with FDA regulations, combat counterfeiting, and enhance patient safety.

Richard Jushchyshyn, Director, Eastern Central Operations, JM Hyde Consulting Inc.; Rich Holzchuh, Sales Engineer, Videojet Technologies Inc.; and Xavier Chaveton, Director, Europe Pharmaceutical Market, Videojet Technologies Inc.

Permanent high-resolution marks made by laser coding systems are invaluable for identification on medical packaging. (click to enlarge)

Driven by regulatory changes and counterfeiting threats, drug companies are looking for better methods of product identification. Many are finding that the key to better identification is better product coding and marking. Bar codes, alphanumeric codes, serial codes, and others can provide accurate, reliable product identification, which in turn can combat counterfeiting and prevent errors in drug administration.

Patient safety doesn't have to come at a high price. The latest coding and marking technologies are flexible, helping to streamline production, improve productivity, and reduce costs.

Coding and marking technologies and their application are constantly evolving. The latest advances include:

• Improvements in ink-jet and laser printing that make coding easier, faster, more reliable, and more efficient than ever before.
• Scannable coding that is applied directly to oral dosage forms.
• The development of unique code formats that comply with federal regulations and are readable on standard equipment, including Reduced Space Symbology (RSS) coding and invisible fluorescent inks. These allow for the addition of more information in less space.
• Radio-frequency identification (RFID) is poised to become the ultimate solution as a secure, robust, and highly functional drug-product package coding technology, with instantaneous information updating and tracking.

Companies that adopt the latest coding and marking technologies can improve the way their products are identified, easing product authentication and making it harder for counterfeiters to disrupt the supply chain.

PREVENTING ERRORS

Patient safety is the primary goal of new drug-coding regulations. FDA's final bar coding rule, issued in February 2004, stipulates that a bar code must be printed on most drug products. A scannable bar code in linear format that identifies the National Drug Code (NDC) number for the product in the package must be on each hospital-destined package. The regulation requires that most previously approved drugs must comply within two years; new drugs must comply within 60 days of their approval.

The National Coordinating Council for Medication Error Reporting and Prevention recommends that bar codes be included on all immediate unit-of-use packaging. This includes single-use, single-dose, unit-dose, unit-of-use, multiple-unit, and multiple-dose containers.

While the FDA rule requires each bar code to contain at least the drug's NDC number, many companies are considering including other data, such as lot numbers and expiration dates.

COUNTERFEIT PREVENTION

Another major concern in the pharmaceutical industry is counterfeiting. Counterfeiting can cause serious harm or death to patients. And it can potentially damage a company's reputation.

The World Health Organization reports that counterfeiting occurs when any branded or generic product is deliberately and fraudulently mislabeled for its identity and origin. Counterfeits may include products with the correct ingredients but fake packaging, with wrong ingredients, with insufficient or too much active ingredient, or with no active ingredients at all.

In its 2004 report, "Combating Counterfeit Drugs," FDA cited evidence that counterfeiters are backed by sophisticated technologies. The number of FDA counterfeit drug investigations conducted per year increased by 400% between the late 1990s and 2000.

The application of a well-selected drug-product coding scheme can combat counterfeiting by providing unique serial numbers for marking and tracking. Along the supply chain, if a serial number is identified as not coming from a legitimate source, then its progress to the end-user is halted.

For example, when a drug bar code is scanned at a distribution center, unique information (such as lot number) is compared to records within the manufacturer's system. If the destination is incorrect or if a lot code is invalid, the system is notified that the product is counterfeit. The more information included within a code, the more difficult it is to counterfeit.

Drug coding also helps with electronic pedigree compliance, outlined in 21 CFR Part 211, Section 211.150, "Distribution Procedures," and Section 211.196, "Distribution Records." As drug manufacturers and distributors move away from paper pedigrees and move to electronic pedigrees, coding and data-capturing technologies will eliminate manual recordkeeping and human error and make it harder for criminals to alter pedigrees.

MAXIMIZING INVESTMENT

Using updated coding technologies can reduce costs and increase efficiency and productivity. These technologies include the latest advancements in ink-jet printing, laser coding, and thermal-transfer overprinting. Also applicable is the use of RSS, invisible fluorescent inks, and RFID. By updating their lines, companies can see returns on investment almost instantly.

Ink-jet technology. Ink-jet coding machines today are more efficient and print at higher resolutions than those from only a couple of years ago. Small-character, continuous ink-jet printers use less fluid and require less maintenance than their predecessors. For example, some newer ink-jet printers feature automated nozzle cleaning for maintenance-free start-ups. In addition, autoflushing printheads eliminate the need for manual cleaning.

Modifications in printhead designs have improved print quality. And ink-jet machines have significantly increased their speed, often achieving 1200 ft/min or faster.

Binary-array technology further enhances coding by providing a high-resolution image at fast drying times with no smearing. This technology also allows users to employ a wider variety of fonts and typestyles.

Ink options. A variety of inks are available to simplify coding needs. For example, invisible fluorescent inks that are visible only under ultraviolet light (also known as black light) can allow for more coding on a package. Such inks allow manufacturers to add manufacturing codes to packages with space limitations.

Because the codes are invisible to consumers, they do not interfere with customer-oriented codes and information. Printing detailed manufacturing data (e.g., production line, ingredient batch code, etc.) in invisible ultraviolet ink eliminates the chance that multiple codes on a package could confuse or alarm a consumer.

Invisible codes also improve the security of tracking and tracing shipments from point of origin, through the supply chain, and to the point of sale. If counterfeiters cannot find an invisible code, they cannot copy it.

Laser coding. Compared with ink-jet printing, laser coding increases productivity because it requires virtually no maintenance. Laser coding requires no ink, eliminating the mess, cost, and downtime needed to replace ink. Lasers can produce permanent nonsmearing marks and can print smaller characters, which is important when printing linear and two-dimensional bar codes such as RSS.

For applications that require higher resolution, a steered-beam laser coder is recommended over a dot-matrix laser coder.

Thermal-transfer printing. Instead of printing and applying labels to flexible packaging, such as foil or medical-grade paper, thermal-transfer technology can print directly onto substrates in rollstock form. Direct thermal- transfer systems increase productivity while reducing downtime costs because ribbon changes take less than 30 seconds. This system also requires little maintenance and eliminates the need for and cost of fluids.

RSS. The use of RSS instead of standard bar codes allows more information to fit in 1/15 of the space of a traditional bar code. Instead of just including an NDC number, manufacturers can include proprietary, possibly encrypted, SKU identifiers; lot and date codes; time stamps; drug interaction or other precautionary information; storage requirements; or other data important for the control and tracking of the drug through distribution, storage, and use.

RFID. FDA has stated that RFID is a more reliable solution for ensuring drug legitimacy than current paper recordkeeping (pedigree) requirements. FDA concluded that RFID tagging is the most promising technology for marking and tracing drugs and that RFID is feasible for use by 2007.

RFID will further increase coding and marking efficiency because it eliminates manual scanning. When an RFID tag is within the vicinity of an RFID scanner, the information will be automatically transferred.

Manufacturers shouldn't just "slap and ship" RFID tags to cartons, however. They should investigate the use of sophisticated RFID label application systems, which can increase throughput and reduce labor costs.

MOVING FORWARD

Critical challenges face pharmaceutical companies. Product coding and marking strategies and technologies form an important part of the solutions. Significant emphasis is already placed on designing difficult-to- duplicate, unique drug-dose shapes and colors. Manufacturers should place similar emphasis on using secure, robust drug-product package coding and marking technologies.

Richard Jushchyshyn, BS/MBA, manages JM Hyde Consulting Inc. (North Wales, PA), which provides compliance, engineering, and validation services to pharmaceutical and biopharmaceutical manufacturers. Rich Holzchuh specializes in sales and service of Videojet Technologies' marking and coding solutions for pharmaceutical companies. Based in France, Xavier Chaveton provides market-specific support and direction for Videojet's pharmaceutical customers in Europe, the Middle East, and Asia.

Copyright ©2005 Pharmaceutical & Medical Packaging News