MGIS 301- Management Information Systems

2D Matrix Barcodes in Pharmaceutical Industry

Group Project Abstract

Team members:
Begüm Ekinil, Ezgi Tuğçe Demir, Gözde Şener, Lukas Hrban, Nurgül Karataş,
Tolga Akgündüz, Zeynep Hazal Özuslu

In general; barcodes are used for data transfer in various industries. As the years go by barcode technology developed and it is still improving itself. One of the major and the most beneficial improvements in barcode technology is 2D matrix barcodes. These items contain much more informational characters than the line barcodes do. There are several applications of this improved system. Tax returns, packing list, driver’s licenses and patient record are the major areas in which 2D matrix barcodes are implemented. Since data matrix codes contain details of component such as manufacturer ID, part number, unique serial number and expiration date, in pharmaceutical industry using such barcodes would increase productivity by reducing time spent in pharmacy and prohibiting fake drugs. 2D matrix barcodes are one of the informational technology masterpieces that make the life easy. The wideness of subject and its improvement trend are the two main reasons behind our choice.
Also we specified the project for pharmaceutical industry because 2D labeling technology has remarkable benefits for pharmaceutical purposes. First of all 2D labeling provides additional information coded in the label to allow for supply chain control. Second, pharmacy can reveal drug related information to patient by easily scanning the label. So that 2D matrix coding prevents any possible sale of expired drugs or incorrect prescription of medicine. Since we found the benefits of 2D labeling in pharmacy an appealing subject, we specified the topic as 2D matrix barcodes in pharmaceutical industry”. Besides, in 2010, Turkish Ministry of Health tried to adopt 2D labeling technology for pharmaceutical purposes, yet the system failed. Turkey was one of the first countries that tired to apply this system. We will also analyze the dimensions of this trial.
Mainly, we will discuss the following titles; * History of barcodes * Why are we using barcodes? * The technological background of 2D matrix barcodes , 2D matrix barcode printers and scanners * Advantages and Disadvantages of 2D labeling * 2D labeling in pharmaceutical industry in Turkey * 2D labeling in pharmaceutical industry in Other Countries * 2D matrix barcodes in other industries

HISTORY OF BARCODE:
Firstly, Wallace Flint suggested that an automated retail checkout system might be feasible for systemization in 1932. While his concept was deemed unworkable, Flint continued to support the idea of automated checkout throughout his career since he believed in importance of such a system. In 1948, Woodland first proposed using ultraviolet light sensitive ink. That prototype was working but rejected as being too unstable and expensive. On October 20, 1949, Woodland and Silver succeeded in building a working prototype describing their invention as “article classification…through the medium of identifying patterns”. On October 7, 1952, they were granted a patent for their “Classifying Apparatus and Method”.
During the 40’s, 50’s and 60’s several code formats were developed including a bull’s-eye code, numeral codes, and various other formats. Retail applications drove the early technological developments of bar coding, but industrial applications soon followed. Bar coding was first used commercially in 1966. Barcodes didn’t really make an impact until the 1970’s. It wasn’t until 1974 that the first barcode scanner was employed and the first product barcoded. In June of 1974, the first U.P.C. scanner was installed at a Marsh’s supermarket in Troy, Ohio. The first product to have a barcode was Wrigley’s Gum.

WHY ARE WE USING BARCODE?
As we all know, everything that is meant to be sold in a store is typically expected to have a barcode. Each item is meant to have a unique series of numbers. But, why do we need these tiny little items in our daily lives? In practice, at least one time in a day, we all leave our lives for the need of purchasing at least one piece of product. When we complete our shopping and arrived at checkout in the market, all price-related information of the product is reflected in the system rapidly, by saving our times, through the barcode of the product. Bar codes simplify thousands of data entries. They are used to increase the speed and accuracy of reading and entering data. It is primarily intended as a machine-readable data management system. Bar codes are acceptable all over the world because of their high accuracy for eliminating the any possibilities of errors in data input. The error rate in human reading of hand written data is 7-14%. The error rate in human reading of preprinted data is 1/300 characters. There is a one in two million error rate for scanner read bar codes. It is considered the most effective data entry method. Credited with accuracy, speed, control, reliability and portability, bar code technology is the most popular method of tracking and transmitting data and is replacing other methods of tracking and transmitting data. Because barcodes are not language dependent, it also provides convenience for the industrial relations and business-to-business settings.

TECHNOLOGICAL BACKGROUND OF 2D MATRIX BARCODE:
There are different alternatives to make 2D barcode. You can make barcode by your own or software program by computer, and also you can make it by your cell phone which must include software program to make barcode. In order to make it, you need some data to code in your barcode, also scanner and printer to use it. 2D barcode’s step same as 1D barcode, but you can put more data on 2D barcode. We should specify what information we want to store in the barcode. However, there are some types of 2D barcode, so we should choose one of them. After, we specify all of these, the next step will be generating the barcode by putting information that we want. Then you enter the data that you want to encode into your barcode in the space provided. For instance, it can be coded producer name, code number, serial number, control number, and for which purposes it can be used especially for medicine whereby which information we want to put into it can be specified in this section. The important thing is that there are some limits while coding the data. Then, we should also decide where we want to use the barcode, and for this section there are some instructions belonging to kinds of usage. You should choose your barcode images among different types of images. Then, the code should be read by barcode scanner which is one of the most important components to make barcode. There are some kinds of barcode scanner or barcode reader which is another name for barcode scanner. Data Matrix symbols require a 2-D scanner, so information coded into barcode cannot be read by using an ordinary barcode scanner. The powerful scanning is crucial for health care industry, because it reduces human mistakes and saves time. Therefore, you plug a barcode scanner into its corresponding part of your computer, and hold the paper containing the printed barcode image and scan the image using the barcode scanner. After scanning the required codes, you should print easily with barcode printer which is another one of the most important components of making 2D barcode. Lastly, you should check the data uploaded into your computer program for accuracy. This check can be done by printing whereby you can print whether it is coded correctly or not. The materials used to make 2D barcode especially for health care industry should be powerful, reliable, and qualitative.

ADVANTAGES AND DISADVANTAGES OF 2D LABELLING:
Benefits of 2D Barcode Technology:
2D barcode technology provides high security for applications in retail, production and manufacturing and helps business owners to run their companies without any difficulty. As 2D barcode technologies are useful for asset tracking and theft prevention security systems, it increases profits. Owners and managers can easily track their products leading to very less losses and less prone to human error. * Speed and capacity
The 2D barcodes are better than 1D barcodes that have limited storage. The information can be stored across width and height of the barcode and can be easily accessed accurately by the corresponding reader. Beyond this, the 2D barcodes carry entire information and does not require any linkage to the central storage to gain access to it. The large storage feature has prompted the development of many new applications using the 2D barcodes these days. To be precise on the storage capacity part, the 2D barcodes can store up to 7089 characters as compared to 20 character storage capacity of 1D barcodes. The data access is also very fast owing to the quick response characteristics. * Security
The durability of 2D barcodes is another reason for their preference over linear barcode that are more sensitive to vandalism and counterfeiting. The 2d barcodes are secure and readable even if subjected to repeated exposure to unfavorable working conditions. This is due to the inbuilt redundancy at various levels. This technical feature results in bigger size of a 2D barcode but that can be compromised keeping in view the security and other usability feature. * Flexibility
One of the major advantages of two-dimensional barcodes is in their ability to get scanned irrespective of their orientation. These barcodes occupy very less space and can be easily fit into the small parts such as electronic component, devices, etc. So the dual benefit of storing more information with the less space consumption is achieved with the help of two-dimensional barcodes.
Disadvantages:
* The first disadvantage of 2D barcode is their price of the scanners. These scanners deploy the latest technology and are continuously being modified according to modern technology. Image sensors with increased number of pixels are being installed. As a huge amount of investment goes into the 2D barcode scanners, their prices are a higher than 1d barcode scanners. However, with time, the gap between the prices of the two types of scanners is decreasing.

* The second drawback of 2D barcodes is the working range of the scanners. “Working range'' means the point farthest from which a scanner can read a barcode minus the closest point from which the scanner can read a barcode. For example, if a scanner can read a barcode, from the closest distance of 5 centimeters, and it can read the barcode at the farthest distance of 25 centimeters. Then the working range of this particular scanner would then be 25 - 5 = 20 cm. On the other hand, a 1d barcode scanner would be capable of reading the same barcode from the farthest distance of 45 cm and the closest distance of 2.5 cm. The decreased working range of a 2d barcode scanner might prove to be a barrier in certain applications.

2D LABELING IN PHARMACEUTICAL INDUSTRY IN TURKEY: When we look at the 2D labeling history in Turkey, the picture is not pleasant. On May 16 a new system of drug tracking introduced which was an obligatory application for all pharmaceuticals. The idea behind switching to 2D barcodes instead of linear barcodes was to prevent the duplicated sale of pharmaceuticals while also helping to fight against counterfeit drugs. However system crushed the day after it launched. The crash occurred after 24,000 pharmacies tried to access the system, some companies failed to submit drugs to the Health Ministry and consequently the system was unable to recognise all products. Since the system failed many patients could not obtain their medicine. Yet pharmacies gave medicines as they did before the new system. Another problem occurred when the system overload companies did not submit some drugs to the Turkish Health Ministry in order to the system recognize the drugs.

WHAT ABOUT THE WORLD?
The following are few clips from news related to Data Matrix 2D Barcode regulations around the world. To summarize; France is the leading country in the world that successfully implemented 2D Barcode system in it’s pharmaceutical sector. Because of various reasons it won’t happen overnight for other countries to implement this system however it is likely to happen eventually. It is said to be the first time there has been such a strict regulation on the marking of drugs in case of France. And many countries will likely to follow France throughout the next couple of years. However it should be of notice that costs of implementation are high and pharmaceutical manufacturers are unlikely to begin using 2D barcode until a law is enforced in their country. Recently the UK is discussing the adoption of GS1 Data Matrix with the pharmaceutical industry. 1) The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced its support for a pan-European and industry-wide solution to protect patient safety through a more transparent medicine supply chain, thereby attempting to tackle the rise in counterfeit medicines entering the European legitimate supply chain.
“EFPIA proposes introducing unique bar-coding on every medicine pack in Europe before it leaves its manufacturer” said Cueni “Thereafter, at every stage of its distribution, up to the point at which it reaches the patient, the medicine can be authenticated to make sure it is genuine.” http://www.adcnordic.com/news/efpia-backs-2d-bar-code.php 2) Data Matrix 2D Barcode Regulation Enforced in France — Will UK Follow Suit? (Feb. 2011)
With the new traceability regulation now enforced in France, the rest of the world is expected to adopt a similar law, ensuring all medical products are labelled with a GS1 Data Matrix 2D barcode.
[...] the new regulation will greatly benefit the French pharmaceutical industry, as manufacturers will posses a thorough knowledge of the products they have supplied. France is the first country to adopt this ruling for medicine, with Italy, Spain and Germany likely to be the next to follow suit. [...] The decision to implement this regulation depends entirely on each country’s budget, and from this how they can successfully migrate an international code into their own system.” http://www.epmmagazine.com/x/guideArchiveArticle.html?gname=&id=11565 3) Global Compliance Issues Influence Pharmaceutical Traceability (Feb. 2011)
[...]Pressure on patents, massive growth in the incidence of counterfeit products, a spotlight on manufacturing efficiency, and the increased complexity of developing and releasing new medicines are all causing major upheaval within the industry. [...]Any company supplying to the market in question needs to demonstrate compliance, so that in effect, it’s an issue for virtually the entire global pharmaceutical community.
Global legislation and its ensuing challenges: A growing area of interest is mass serialization and a number of countries are changing their packaging requirements through increased traceability legislation. [...]
Other countries also have similar proposals in place to adopt the same legislation, which will mean that manufacturing companies will be obliged to add new print and verify capabilities to their existing lines. Indeed, from a general technology point of view, it is estimated that up to 80% of installed coding devices within the pharmaceutical and healthcare sector required to print this information will be redundant at the speed and quality levels required.
Implementation issues: It should not be forgotten that, even upon successful application of the appropriate data carrier, problems can still arise further down the supply chain. Like France’s CIP13, Turkey’s ITS (Ilac Takip Sistemi) scheme aims to incorporate the compulsory use of the same 2D code in order to allow full tracking of healthcare products.
In addition to the EFPIA pan-European proposal and defined implementations in Turkey and France, other countries that are proposing increased product identification and authentication within the healthcare sector include Brazil, China, Serbia, South Korea, Spain, and Greece. http://www.healthcarepackaging.com/archives/2011/02/global_compliance_issues_influ.php 2D MATRIX BARCODES IN OTHER INDUSTRIES:
2D barcodes have great importance in pharmaceutical industry. In addition to that, 2 dimensional technology is used in other applications like tax returning, packing list, driver’s license. All of these applications are following; * Tax Return: There comes a time of the year when tax returns must be filed and taxes must be paid. The taxpayer could use some tax software, enter the relevant data, and allow the program to perform all needed calculations. When the task is completed, the tax form can be printed out the data and the 2D barcode symbol using any ink jet or laser printer for mailing to the tax authority. The benefit of using 2D barcodes in tax return is that the data can be captured from the symbol in seconds using a scanner when the form arrives at the tax authority. * Packing List: Trading partners agree on a standard methodology for encoding shipping information in a 2D symbol which is attached to a shipped order. Order data including PO number, shipping date, product codes, quantities, etc. can automatically be entered into the receiver’s receiving computer terminal in a couple of seconds. * Driver’s Licence: The driver’s name, address, licence number, expiry date and driving restriction codes are encoded in a 2D symbol that is printed on the operator’s licence. Police officers, car rental agencies, hotels can easily enter in information regarding the licence holder, with the possibility of adding any mis-keyed data. * Additional areas of 2D technology usage: This application has clear potential outside these areas. When companies or individuals are supplying information to a government in paper form, they could benefit from this idea. This includes company sales tax returns, the submission of company employment information, and the collection of government economic statistics from business enterprises among others.

Just by adding a 2D barcode symbol to a form, it is created an "intelligent document" that can be read by human beings, but that can also be automatically and accurately entered into a computer whenever is required.

REFERENCES:
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“How to Create a 2d Barcode” ehow.com. ehow.com, n.d. Web. 18 Apr. 2011. <http://www.ehow.com/how_5792414_create-2d-barcode.html>

“Turkey’s 2D barcode system crashes day after launch” in-pharmatechnologist.com, n.p., 18 Apr. 2010. Web. 24 Apr. 2011. <http://www.in-pharmatechnologist.com/Packaging/Turkey-s-2D-barcode-system-crashes-day-after-launch>

“2D barcode system for pharmaceutical to begin on May 16” todayszaman.com, TODAY’S ZAMAN, 11 May. 2010. Web. 18 Apr. 2010. <http://www.todayszaman.com/news-209858-2d-barcode-system-for-pharmaceuticals-to-begin-on-may-16.html>