Bar code: An Overview

In the recent years, bar code technology has gained popularity in the pharmaceutical sector. Accuracy, speed and ability to store great amount of information is responsible for its success in this field. The present article discusses bar codes, their application in different segments of pharmaceutical industry and regulatory aspects affecting the use of bar code in pharmaceuticals.

A bar code may be defined as a series of bars and spaces arranged according to encodation rules of a particular specification in order to represent data, its purpose is to represent information in a form that is machine readable. Symbologies are the systems of encoding data such that a scanner &/or a decoding system may together read and decode the data encoded in the bar code in electronic format. Number of bar code symbologies (data structures) used through out health care business. Uniform Code Council/European Article Number International (EAN.UCC) and Health Industry Business Communications Council (HIBCC) developed most commonly used bar code symbologies. UCC and EAN International’s joint set of internationally accepted standards and guidelines is known collectively as the EAN.UCC system. The foundation of all EAN.UCC systems is the 14-digit Global Trade Item Number (GTIN) data structure, which is used by manufacturers to identify their products down to the packaging level for use anywhere in the world. EAN.UCC is best known for creating and maintaining the Universal Product Code system. EAN.UCC developed and standardized the Reduced Space Symbology (RSS) family of data carriers to meet the needs of its healthcare and pharmaceutical members.

RSS can encode a National Drug Code (NDC) in a fraction of space required for a traditional UPC system. HIBCC maintains the Healthcare Identification Number (HIN) system and Labeler Identification Codes (LIC) used to identify trading partners in electronic transactions, and has undertaken a variety of bar code and e-commerce standards efforts. HIBCC champions the Universal Product Number (UPN) method to identify medical and surgical products similar to the way that NDC is used to identify drugs. UPNs uniquely identify manufacturers and products to the packaging level. Other symbologies and proprietary data structures are also in use. An another very space-efficient two-dimensional (2D) bar code symbology, Data Matrix, is widely used for pharmaceuticals and medical devices. The various bar code symbologies are shown in Table 1.

Bar code technology has gained wide acceptance and has been successfully employed sectors. Benefits of bar code and related e-commerce to the entire supply chain cannot be ignored. Healthcare providers, manufacturers and distributors are taking following advantages of bar coded medication doses.

Use of bar code can be profitable in hospitals and it also offers the ability to perform in-process controls that are not practical to perform manually. Scanning ID badges of doctors and nurses who receive narcotics pharmacies can improve security. It can accurately and automatically update inventory records by scanning medications before dispensing and release, making reordering easier and ensuring that needed medications are always in stock. Robotic automation is one of the new means to guide the pharmacist or corpsman at each step in the prescription filling process to minimize human intervention and reduce errors. The output has nearly doubled under the new system along with significantly reduction in mistakes. Unlike most pharmacies, which print the prescription label first, the system only prints the label after the correct drug and dosage has been verified and is in hand. The prescriptions are input into the Combined Healthcare Computer System (CHCS), and a printout is generated listing the medications and their side effects. Using the bar code of each medication, the robot fills the prescription. Under the automated system, each prescription bottle is scanned for its bar code. The automation shows a picture and description of the medication written by the physician. It displays the image during the filling and refilling, allowing continued validation of the proper medication. The pharmacist then matches the medication bottle with the screen's picture and reads the label on the vial to verify the doctor's written prescription. If correct, a blue screen appears and a prescription label is printed. A red screen indicates the wrong medication was selected and warns the technician of a possible error. When the correct medication is identified by the system, a prescription label is printed. To further ensure patients safety, the pharmacist scans the bar code printed on the prescription label for final verification. The software then retrieves all information necessary for that prescription. Although the robotic system is more efficient and eliminates the potential for human error, it is also emphasized that robots do not replace the thinking ability, judgment or experience of the physician, pharmacist or technician. The system guarantees the patient will receive the proper medication, as ordered by the physician and it will reduce patient waiting time in the future through better utilization of human resources. Errors in medication doses can easily be avoided by benefits of using unit-dose coding when administering medication to patients. Medication scanning systems can also be integrated with bar coded patient wristbands which provide alerts and automatically generate records. Bar-coded wristbands identify patients before drawing blood samples, performing surgery, transferring patients, and taking X-rays or other diagnostic tests, thus also improve accuracy and safety. The wristbands facilitate compliance with Joint Commission on Accreditation of Healthcare Organizations National Patient Safety Goals and Best Practices for patient identification.

Bar coded items meet customer requirements which manufacturers miss out on many efficiency improvements that bar codes can provide Greater batch control and compliance with the FDA’s Good Manufacturing Practices can be provided by reading bar codes during the production process. Quality control and testing data can also be obtained automatically and linked to production records. Production equipment can read codes and route the product automatically to the appropriate packaging and testing stations. Bar codes also verify that items are placed in the right packaging. Scanning lot codes or expiration dates can aid in stock rotation and automatic shipping operation. It enables manufacturers to build a completely accurate, real-time record of inventory, materials management and purchasing operations. The work in process can be accomplished by encoding the lot number and scanning it at different stages throughout the production, storage, and distribution processes.

The use of unit-of-use coding provides cost-saving opportunities for the drug distribution channel. Distributors can improve their own inventory control by applying unit bar codes when items are received and can also offer repackaging services. Scanning expiration dates facilitates automatic first-in, first-out shipping operations and better stock rotation. By taking advantage of the increased data generated by unit-of-use coding, distributors offer new value added services and enhance customer relationship management (CRM) applications. Recently, Searle R&D (Skokie, IL) developed a new drug product that required an efficient mechanism for product tracking between the U.S. manufacturing plant and a labeling location in Europe. Ideally the tracking mechanism should not interfere with the market appearance of the product. As the vials needed to be shipped nude from the United States to Europe for country-specific labeling, a 2D Data Matrix code, which is compact code taking up little space was printed on the bottoms of the nude vials in an invisible ultraviolet ink. The Data Matrix code gives more digits or bits of information encoded in the same space as a traditional bar code, which makes it more helpful in cases of very small vials.

There is little consensus as to how bar codes should be applied to drugs and pharmaceutical products and what information the codes should contain. Manufacturers, distributors, and healthcare providers are reluctant to implement automated medication controls because no unified standard governs the market and future regulations are unclear. Food and Drug Administration (FDA) has taken action to alleviate these concerns and create an environment in which the industry can invest in medication control systems with confidence. The FDA’s primary effort is to improve patient safety by facilitating procedures for automated patient and medication verification. The FDA is likely to create a data structure that defines the information to be included with each medication dose, and to define data carriers that specify how the information is encoded and presented. FDA has issued final rule on bar coding of drugs. The bar-code ruling applies to prescription and OTC drugs as well as to blood and vaccine products commonly used in hospitals and pharmacies. Manufacturers of both over-the-counter and prescription drugs are scrambling to figure out packaging redesigns and packaging line upgradation in the wake of the final rule on bar coding of drugs. The bar code can use RSS, which allows for a greatly reduced bar-code size that would make the bar code small enough to fit on almost all packages, though unit-dose blister cells, which also must be bar coded, could be a problem due to their small size. RSS is typically used to encode the NDC plus lot number and expiration date. An NDC code uniquely identifies the drug, its formulation, strength and dosage, the manufacturer/packager and the packaging type. Although RSS bar codes containing just the NDC may fit on many blister cells, it will not be true in all cases; it depends what other information is currently written on the foil backing and whether the company wants to add a production lot number and expiration date to the RSS bar code. That would mean a second line of “stacked” numeric, leaving even less room for other information. However, the FDA ruled out 2D Data Matrix bar codes, which are even smaller than RSS codes and better suited to the tiniest of packages. The FDA realized these potential difficulties and inserted two different kinds of possible exemptions in the final rule. First, there are blanket exemptions for drug samples, allergenic extracts, intrauterine contraceptive devices that are regulated as drugs, medical gases, radiopharmaceuticals, low-density polyethylene form/fill/seal containers, and prescription drugs sold directly to patients. In addition, the FDA tossed in a general exemption if a company can prove that “compliance with the bar code requirement would adversely affect the drug's safety, effectiveness, purity, or potency or not be technologically feasible.” The request for an exemption must also explain why the problem cannot be reasonably remedied by measures such as package redesign or use of over wraps. Things get a little more complicated, when it turns to even smaller packages such as ampoules and injectables. These labels are currently etched by lasers or printed by ink-jet or hot-stamping equipment applied on packaging lines at speeds up to 600 units/ min. Laser etching and RSS bar codes containing all three data elements—NDC, lot number, and expiration date, again may be a bad match because longer processing speeds are required to etch so large a message. So companies may have to consider alternative options such as an RSS code for just the NDC number and a second, two-dimensional code that would include all three data elements. The RSS would meet the FDA requirement and satisfy some hospital needs, whereas the second, more-inclusive code via data matrix, which measures 1/4-inch-square, would meet the needs of hospitals clamoring for not only the NDC but also lot number and expiration date. FDA anticipates that market forces will lead manufacturers to add lot numbers and expiration dates to bar codes. In the future, radio frequency identification (RFID) tags, which transmit data wirelessly, may be used as data carriers for pharmaceutical identification. Bar codes will provide the rare opportunity to implement a programme that improves quality and saves money.

The potential of bar code technology can be realized by its growing use in different areas of pharmaceutical industry. The cost effectiveness, reliability and upcoming rules and regulations imposed by Food and Drug Administration will further enhance its utility in the pharmaceuticals.

Barthel, H. Code Bar, In: The Wileys Encyclopedia of packaging technology, IInd Edition, Barody &Marsh (Eds.); A Wiley Interscience Publication, John Wiley & Sons, 225-28.

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{mospagebreak title=About Harish Dureja}

Harish Dureja studied Pharmacy at C. C. S. University (India) and obtained Masters Degree in Pharmaceutics from Punjabi University (India). He has authored and/or coauthored over 20 publications. His research areas include Transdermal Drug Delivery Systems, Pharmaceutical Process Development and Chemical Computation. He is currently working as Lecturer at Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak. His current job responsibilities include teaching UG/PG classes as well as guiding research. He is Life Member of Indian Pharmaceutical Association. Harish can be contacted at harishdureja@rediffmail.com