Progress in Pharma Product Identification

As pharmaceutical product coding regulations change, and as the threat of counterfeiting increases, drug companies are looking for better methods of product identification. Coding and marking are keys to accurate, reliable product identification that can combat counterfeiting. The latest coding and marking technologies have the added benefits of helping to provide flexible coding methods, streamline production, improve productivity, reduce costs and increase profits.

Addressing the Challenges

New and updated regulations on drug product coding, driven by security issues and emerging technologies, have left pharmaceutical manufacturers, repackers, relabelers and distributors searching for cost-effective options to comply.

Drug companies, regulators, insurers, caregivers and patients face tremendous challenges due to the growth in drug counterfeiting and need better ways to protect the integrity of the healthcare delivery system, the drug products and patient safeguards.

These are critical challenges to pharmaceutical companies. Product coding and marking strategies and technologies form an important part of the solutions. Control of the drug product begins with the manufacturer. The solutions required to thwart counterfeiting are best applied before the products leave the control of the manufacturer. Significant emphasis is placed on designing difficult-to-duplicate, unique drug dose shapes and colors, and on using secure, robust drug product package coding and marking technologies.

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

• Scannable coding that is applied directly to oral dosage forms.

• Improvements in inkjet printers and lasers that make coding easier, faster, more reliable and more efficient than ever before.

• 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.

Drug companies will inevitably make product line changes to meet regulations, combat counterfeiting, enhance patient safety and address other industry concerns. Companies that adopt the latest coding and marking technologies can improve productivity, reduce costs, comply with the latest regulations and substantially enhance their competitive position.

Counterfeit Prevention

Besides eroding profits, counterfeiting can potentially damage a company’s reputation. Most importantly, it can cause serious harm or death to patients. According to the World Health Organization (WHO), counterfeiting can apply to any branded or generic product that 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 ingredients, or with no active ingredients at all.

According to WHO’s February 2004 report titled, “Combat-ing Counterfeit Drugs: A Report of the FDA,” the FDA has seen growing evidence of well-organized counterfeiters backed by sophisticated technologies and criminal operations set up to profit from drug counterfeiting. Counterfeiting can also be performed by terrorist organizations that intend to cause harm for political or social reasons. In either case, innocent patients are harmed for the gain of others. The report also states FDA counterfeit drug investigations conducted per year have increased by 400% between the late 1990s and 2000.

Counterfeiting is even more prevalent outside the U.S. The FDA estimates that counterfeits make up 10% of the global medicines market. As much as 25% percent of medicines consumed in poor countries are counterfeit or substandard. WHO reports annual earnings from the sale of counterfeit and substandard medicines is estimated at more than $32 billion globally. Additionally, more than one out of every 10 prescription drugs, over-the-counter medicines, vitamins and other pharmaceutical products in Russia could be counterfeit, according to a May 2002 report from the International Federa-tion of Pharmaceutical Manufacturers & Associations.

That same report gives startling examples of the real-life consequences of counterfeit activity:

• In Niger in 1995, more than 50,000 people were inoculated with counterfeit meningitis vaccines, resulting in 2,500 deaths.

• Fake cough syrup containing diethylene glycol (a toxic chemical used in automotive antifreeze) was responsible for 89 deaths in Haiti in 1995 and 30 infant deaths in India in 1998.

• In 1999, at least 30 Cambodians died after taking counterfeit anti-malarials.

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, that 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, it will notify the system that the product is counterfeit. The more information included within a code, the more difficult it is to counterfeit. Because of their capacity for large quantities of information, RSS codes and RFID tagging are ideal for use against counterfeiting.

Other Benefits of Coding

Prevention of counterfeiting is only one benefit of pharmaceutical coding and marking. The technologies also help prevent dispensing errors and reduce costs in inventory control and billing for drug manufacturers, repackers and healthcare providers alike.

Product Dispensing: In February 2004, the FDA issued a final rule amending 21 CFR Part 201, Subpart A, to add Section 201.25, “Bar Code Label Requirements.” This section stipulates that a bar code must be on most drug products, including certain prescription drugs sold into hospitals or intended for hospital use (typically unit-of-use packs), all biologicals and certain over-the-counter drugs commonly used in hospitals. 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 and unit-of-use.

The ruling was made to protect patients from preventable medication errors and to reduce healthcare costs. Bar codes on drugs can help doctors, nurses and other healthcare providers verify that they are giving patients the right drugs at the correct dosages.

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

The setup involves a bar-coding operation at the manufacturer’s plant and a bar code scanning system and computerized database throughout the supply chain and in the hospital. Each package and unit-of-use dose is coded with identifying information by the drug product manufacturer, usually during the packaging operation. This code is scanned during manufacturing, during distribution and upon arrival at the hospital to identify each product.

When admitted to a hospital, a patient would receive a bar-coded identification bracelet that links the patient to his or her electronic medical record. Before administering a medication, the healthcare provider would first scan the patient’s bar code, then scan the bar code on the medication. The computerized system would compare the patient’s record to the drug to confirm a match. In case of an error, the system would indicate a problem – an incorrect medication, a wrong dosage, wrong timing for administering the drug, a patient’s allergy or diet restriction, a drug interaction issue, potentially an outdated or recalled lot (if lot code/expiration date are included in the bar code), or an indication that a patient’s chart has been updated and prescribed medications have changed.

Inventory and Billing: With a simple scan, drug companies and hospitals can determine immediate inventory needs to prevent overstocking or under-stocking a product. In addition, computerized billing systems can invoice in real time— whether it’s a manufacturer billing a hospital, or a hospital billing a patient. This prevents billing errors, reduces paperwork, ensures complete charge capture, and cuts down on accidental over-billing for insurance and Medicare.

Pedigree: Drug coding also helps with electronic pedigree compliance (21 CFR Part 211, Section 211.150, “Distribution Procedures,” and Section 211.196, “Distribution Records”). As drug manufacturing and distributing companies move away from the cumbersome paper pedigree system and move to electronic pedigree, coding and data capturing technologies will eliminate manual record keeping and human error, making the process faster and more accurate.

Maximizing Investment, Increasing Profit

Implementing a new coding system requires a financial and time investment for drug makers, repackers and relabelers. It may involve a redesign of packaging, as well as adjustments to the production line. Such changes often require validation of the system to meet FDA requirements, which can be time-intensive. To better support the industry, some providers of coding systems offer design consultation, custom engineered systems, installation and validation assistance.

During such a changeover, a company can maximize its investment by further investigating updated coding technologies that can reduce costs, increase efficiency and productivity, and improve profits. These technologies include the latest advancements in inkjet printing, laser coding, thermal transfer overprinting, RSS, invisible fluorescent inks and RFID. By making such process improvements to the line, companies can see returns on investment almost instantly.

Updating Inkjet Technology

Inkjet coding machines today are more efficient than those from only a couple of years ago. Small character, continuous inkjet printers use less fluids and require less maintenance than their predecessors. For example, some newer inkjet printers have automated nozzle cleaning for maintenance-free start-ups. Plus, auto-flushing printheads eliminate the need for manual cleaning.

Modifications in printhead designs have increased ink throw distances and improved drop placement for better character generation and print quality. Inkjet machines have significantly increased speeds, often achieving 1,200 feet per minute or faster.

Binary array technology further enhances the coding process by providing a high resolution image at fast drying times with no smearing. This technology also allows for a wider variety of fonts and typestyles to be used.

Inkjet printing process

A variety of inks are available in the industry to simplify coding needs. For example, invisible fluorescent inks that are visible only under ultraviolet lights (also known as blacklight) can allow for more coding on a package without cluttering the customer-targeted graphics on the package. If space limitations are also an issue, manufacturers can add manufacturing codes in invisible fluorescent ink and not interfere with customer-oriented codes and information.

Multiple codes on a package can also confuse or unnecessarily scare a consumer. (Which one is the expiration date? What do all these codes mean?) Printing detailed manufacturing data (production line, ingredient batch code, etc.) in invisible ultraviolet ink reduces such concerns.

In addition, invisible codes improve the security of tracking and tracing shipments from point-of-origin, through the supply chain and to the point of sale.

Laser blister printing

Companies that currently use inkjet technology for coding may want to consider laser coding. Compared to inkjet printing, laser coding significantly increases productivity by up to 5% because it requires virtually no maintenance. Laser coding requires no ink, so there is no mess, no downtime to replace fluids and no fluid costs. Plus, it makes permanent, non-smearing marks and can print smaller characters, which is particularly important when printing 1-D and 2-D linear bar codes such as RSS codes.

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

Switching to Thermal Transfer

Instead of printing and applying labels to flexible packaging— such as foil or medical grade paper—thermal transfer overprinting has the ability to print directly onto substrate in roll-stock form. Direct thermal transfer increases productivity while reducing costs associated with downtime because it requires very little maintenance, and ribbon changes take less than 30 seconds. This system also eliminates the need and cost of fluids.

RSS: A Smaller Coding Option

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

Considering the new regulatory requirements related to bar coding at the single dose level, particularly unit-of-use blister packaging and other small format packages, the space efficient RSS code format may be the only viable option for compliance.

The New Solution: RFID

In the 2004 report, “Combating Counterfeit Drugs,” the FDA stated that track-and-trace technologies and product authentication technologies should provide greater drug security. The FDA also said that this is a more reliable solution for ensuring drug legitimacy than current paper recordkeeping (pedigree) requirements. The FDA also 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 the efficiency of coding and marking systems because it eliminates manual scanning. When an RFID tag is within the vicinity of an RFID scanner, the information will be automatically transferred. For example, when a pallet of a drug leaves or enters a warehouse, the system will scan and log that transaction, making inventory updates instantaneous. With RFID systems installed in hospitals, a healthcare worker entering a patient’s room will instantly know if a prescription is allowed to be administered without having to scan the drug and patient bracelet manually.

As the pharmaceutical industry encounters challenges such as new coding regulations and counterfeits, coding and marking technologies will continuously develop to address those demands. Now is the time for drug companies to take advantage of these opportunities by adopting new technologies to further improve production lines, comply with current regulations, support downstream systems designed to enhance patient safety, and provide for secure distribution of drug products, which will ultimately lead to increased profits.

Richard Jushchyshyn has provided engineering and validation services to the food and pharmaceutical industries for more than 29 years. He currently manages JM Hyde Consulting, Inc.’s office in North Wales, Pa., which provides compliance, engineering and validation services to pharmaceutical and biopharmaceutical manufacturers (www.jmhyde.com). Rich Holzchuh specializes in sales and service of Videojet marking and coding solutions for Pharma companies. Based in France, Xavier Chaveton provides market-specific support and direction for Videojet’s Pharma customers in Europe, the Middle East and Asia. They can be reached at info@videojet.com.