Enthusiasm for the tremendous patient safety benefits of unit-of-use bar code pharmaceutical labeling should extend throughout the life sciences supply chain. While unit-of-use labeling will position health services providers to ultimately make improvements in patient safety, pharmaceutical manufacturers and distributors are better positioned to enjoy more immediate benefits. A thoughtful approach to meeting impending FDA unit-of-use labeling requirements, by pharmaceutical manufacturers, relabelers, repackagers and distributors can create new processes that will provide unprecedented control and efficiency for recalls, returns processing and inventory control. By reading unit-of-use codes, instead of just printing them for customers, companies can gain supply chain visibility and improve the quality of their information.
A major benefit to data entry by scanning will be reduced labour and effort required to comply with the myriad regulations covering the transport and storage of controlled substances.
Early adopters in the pharmaceutical industry, including Abbott Laboratories, Baxter Healthcare and Pfizer, have envisioned the benefits and have implemented variable-information unit-of-use labeling programmes that exceed FDA recommendations.
Lot numbers and expiration dates in a bar code makes it easy to record the information accurately and automatically at any point in the supply chain. This capability improves data accuracy, while reducing the effort needed to record and transcribe the information.
The healthcare industry spends $23 billion annually on order management, distribution, transportation and inventory management. Approximately $11 billion of these costs are unnecessary - caused by redundant, non-value-added activities according to a 1997 study on Efficient Healthcare Consumer Response (EHCR). Manufacturers and distributors can help drive these costs out of the supply chain, rather than shifting them to downstream partners, by using automated systems for data capture and communication. The following section describes how encoding lot numbers and expiration dates at the unit-of-use level can enable new processes that improve efficiency.
Applications
For many pharmaceutical manufacturers, the supply chain is the only place where their products are not tracked at the batch or lot level. Production management, enterprise resource planning, environmental health & safety monitoring and other systems frequently provide or require lot-level traceability. To maximize the quality management and safety, it makes sense to extend batch-level traceability to the final product at the unit-of-use level.
In regulated environments where traceability is required, entering data by bar code scanning is highly advantageous because it creates 100 per cent accurate electronic records. Studies have found skilled typists make an error once in every 300 keystrokes, while the error rate for bar code scanning is estimated at one in one million characters. Data can be entered in much less time by scanning than by manual recording, and scanned data can be transferred to any database or software application without further manual data entry. For non-regulatory applications, encoding variable information at the unit-of-use label provides new levels of visibility and control.
Recall Management
Drug recalls are a common and costly occurrence in the pharmaceutical industry. The FDA's Office of Compliance, Center for Drug Evaluation reported 1,230 Type I and II drug recalls from 1997 to 2002, an average of 3.9 per week for the full six-year period.
Recalls create extensive administrative and logistics burdens that have an immediate impact on operations. The long term cost, measured by reduced consumer and physician confidence, lost sales, and impact on share prices, depends in part on how quickly and efficiently the recall is handled. The effectiveness of recall management is a direct result of the level of product visibility in the supply chain. The amount of information included on unit-of-use packaging can make the difference between a general, mass recall with notices going out in newspapers and TV news, and a highly targeted, limited recall where consumers may receive notification by a phone call from their own pharmacist or doctor. By marrying lot codes on unit-of-use labels with electronic records created by production control software systems, manufacturers could conduct a recall like this: "We are recalling 50mg tablets of Ourdrugicol, lot number 0123456789, made on March 19, 2003, between 8 a.m. and 1 p.m. on production line 2 at our Anytown, NJ facility. These products were shipped to Acme Drug Distributors warehouses in Memphis, TN and Columbus OH. No other products are affected."
Encoding lot numbers and expiration dates on the unit-of-use packaging enables manufacturers and distributors to trace specific products to specific customers. Production control systems and auditing procedures enable manufacturers to isolate quality or compliance problems at the batch level. By enabling batch-level traceability throughout the supply chain, specific quantities and shipments can be recalled. This degree of traceability limits the logistics handling costs and administrative burden, so recalls can be resolved more quickly. The audit trail would also limit liability exposure and prevent lawsuits from unaffected individuals. When returned products are received, lot codes can be efficiently checked with a bar code scan, so unaffected products can quickly be redistributed.
Returns Management
Variable information unit-of-use printing could have similar effects on returns management. The pharmaceutical industry handles $2 billion worth of returns annually, according to a study by the Healthcare Distribution Management Association (HDMA). Poor record keeping and the inability to provide audit trails in reverse logistics creates inefficiencies and losses from otherwise acceptable products that can't be redistributed. The scope of the returns management task no doubt is one reason the HDMA's position paper on bar coding includes the following recommendation: "Use bar codes internally wherever possible. Use of bar codes to identify healthcare products has been shown to reduce labor costs in distribution and dispensing while, at the same time, reducing errors."
One of the best ways to collect the information and create the audit trail required to satisfy various regulations is to scan items with bar code readers, which can easily be programmed to attach a date-and-time record to every transaction. Lot-level scanning with the automatic time-and-date stamp creates traceability and produces tremendous time and labor savings for data recording. By setting shipping or database systems to record shipments to customers by specific lot number, manufacturers and distributors can quickly verify that they are receiving authorized returns by scanning an item label.
This practice could also help detect unauthorized or counterfeit products. Scanning expiration dates will enable companies to quickly determine if products are eligible for return and if returned products can be redistributed or require disposal or special handling.
Manufacturing Operations
Enterprise resource planning (ERP), manufacturing execution systems (MES), compliance and reporting systems all need accurate, timely data. Many production facilities already use bar codes to provide the data automatically, accurately and efficiently, track work in process, and provide electronic signatures, batch records and other documentation. However, if lot numbers aren't included on the final product, the link to the electronic record is broken and many of the traceability benefits are gone.
Encoding lot numbers in the unit-of-use packaging and marrying the information with electronic production records can satisfy 21 CRF Part 11 (Electronic Signatures Rule) reporting requirements and provide traceability by raw material batch, manufacturing equipment, time of production, equipment operator and other variables. This data is extremely helpful for recalls but can also be used for process analysis, quality control and other purposes. Manufacturers already track production by lot or batch. By expressing this information in a bar code, they are able to extend their audit trail, realize the full value of their enterprise applications, and enable new applications throughout the supply chain.
Inventory Management
Many pharmaceutical distribution operations are highly automated and make extensive use of bar coding. Meaningful improvements and cost savings are possible by leveraging the scanning infrastructure to process expiration dates in unit-of-use bar codes. Coupled with changes to database and inventory control software applications, automated entry and tracking of expiration dates would lead to improved stock rotation, better compliance with first-in/first-out (FIFO) handling practices, and reduced losses from expired products.
Including expiration dates with sales records could improve customer service and create new sales opportunities. For example, a software application could automatically send notification to customers when products near the expiration date. The message, or a follow-up contact by a salesperson, could also ask if customers need to reorder to cover potential shortfalls caused by expiration. The programme would help customers manage their own inventories, increase sales and reduce the need for special handling rush orders.
The increasing use of break-pack shipments means that manufacturers and distributors can't rely on case or shipping container packaging to provide lot traceability. Scanning the unit-of-use label and entering a product quantity can replace outer-pack scanning to maintain traceability. The process also automates and simplifies billing for less-than-case quantities.
Product Authentication
Unit-level traceability can play an important role in fighting product counterfeiting and diversion. The International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) estimates that 2 per cent of worldwide pharmaceuticals are counterfeit, and the figure is on the rise. Encoding lot numbers at the unit-dose level can aid efforts by pharmaceutical manufacturers and law enforcement agencies to protect legitimate distribution channels and detect diverted or counterfeit products.
Manufacturers and distributors can prevent return fraud and detect diverted products by recording lot numbers that are sold to specific customers. When items are presented for return, they would be scanned to record the lot number. A database lookup would verify whether or not the product was sold to the customer, so the return could be authorized or refused.
A similar application could help detect the source of diverted products. When diverted products are recovered, authorities could check database records and follow the audit trail to see who last had possession of them.
Sample Management
U.S. pharmaceutical companies spent more than $4 billion in 2000 managing sample distribution and related record keeping and administrative tasks, which does not include lost sales time from reps, who spent an average of 5.5 hours per week completing sample-related paperwork, according to a series of studies. Despite the time and money spent on sample management, more than 80 percent of survey respondents said their information was not accurate.
Companies could improve the quality of their data, limit their risk of being out of compliance with the Prescription Drug Marketing Act (PDMA) and reduce data entry administrative requirements by instituting bar code scanning as part of sample distribution procedures. Sales representatives with scanner-equipped PDAs or laptops could automatically record the receipt and disbursement of all samples. The scanning process would save considerable data entry time, and the captured information satisfies PDMA compliance requirements.
The applications described above require changes to business processes, databases and application software to take advantage of lot numbers and expiration dates encoded on unit-of-use packaging. The extent of these changes and the time, money and effort required to implement them is specific to each company based on the desired applications, functionality and existing information system infrastructure. Companies must set their foundation for future applications by selecting a bar code symbology and the most appropriate print technology to support variable data unit-of-use labeling.
Symbology Choices
The FDA's proposed rule did not specify which symbology should be used for unit-of-use labeling, creating the likelihood that multiple symbologies will be used when the rule takes effect. However, the FDA did specifically disallow the use of two-dimensional (2D) symbologies, including Data Matrix and PDF417, which severely limits options for space efficiently encoding lot codes and expiration dates. Fortunately, the reduced space symbology (RSS) family is an outstanding option for encoding variable data at the unit-of-use level, and is also an excellent choice for all unit-of-use labeling applications. Other commonly considered symbologies include Code 128 and Code 39, which are already widely used in the pharmaceutical industry.
Many packaging engineers already have experience using Code 128 and Code 39 symbologies for outer pack labels. Neither Code 128 nor Code 39 scales well, making them unsuitable for small-item identification. For example, encoding an NDC number would require a Code 39 or Code 128 symbol of well more than an inch long and by 0.25 inch tall. Adding the lot number or expiration date would add significantly to symbol size.
Most unit-level packaging doesn't accommodate these minimum symbol sizes, making Code 128 and Code 39 poor choices for the application. The RSS family of symbologies was created specifically to help identify the 10% of pharmaceutical products a UCC/EAN study found are unsuitable for marking with traditional symbologies. RSS Stacked enables an ID code, lot number and expiration date to be encoded in a symbol less than an inch wide. Other symbologies in the RSS family provide options for additional space savings and data capacity. Most legacy, low-cost scanners used throughout the supply chain can easily process RSS symbols, which gives RSS cost and adoption-time advantages over other symbologies.
Print Technology Choices
The limited symbology guidance in the FDA proposal will likely result in multiple symbologies being requested or required by different customers to support their own preferences. Therefore it is extremely important for pharmaceutical manufacturers, packagers and relabelers to develop flexible printing systems that can easily handle all the possible symbology and data encoding options.
The most common technologies currently used for pharmaceutical printing may not be the most effective options for fulfilling emerging labeling challenges. Current print systems are optimized for high-speed, high-volume printing of non-customized packaging without bar codes or variable information. They may lack the adaptability required for shorter print runs that include specific variable data produced for specific customer orders. The high-speed printing capability will be rendered useless if the equipment requires excessive changeover time to accommodate different label formats.
Given these conditions, pharmaceutical labelers should investigate thermal printing technology for unit-of-use labeling. While thermal printers do not have the top-end speed to match web press and ink jet printers, their ability to create variable information bar codes on demand is unsurpassed. Expiration dates and other variable data can be calculated and printed automatically with no operator intervention, providing tight quality control and time savings, especially during changeovers.
Thermal is the dominant technology for producing bar code labels in all industries. Thermal printers excel at producing high-quality, variable-information labels, and are commonly used to create compact bar codes for specimen vials, electronic components, sample containers, and other small items. Even at top speeds, thermal printers maintain the precision needed to produce scannable symbols. High resolution (600dpi) models are especially well suited for producing compact unit-of-use bar codes.
Thermal printers are the smallest and most affordable devices capable of creating unit-dose codes, with models that fit easily on a desktop. Many distributors already use thermal printers for shipping and receiving applications and are familiar with the performance and convenience the technology provides. Manufacturers can use integrated, print-and-apply applicators with thermal printing engines for accurate, automatic label placement on production lines. Their space-efficient design, integrated bar code support, and affordability make thermal printers the only suitable choice for use at all levels in the supply chain.
- (The author is account manager - India, Zebra Technologies Europe Limited)