The barcode can be considered one of the great innovations of the 20th century. This automation technology allows for more detailed transaction information and, consequently, greater responsiveness to people’s needs.  In addition to security, operating costs are reduced.

Other advantages of bar coding include

  • Increasing the level of accuracy,
  • Improved traceability,
  • Ease of handling by those who work with the barcode.

Another very important aspect is that the barcode is used by the entire supply chain, from the manufacturer to the end consumer.

In history, the barcode was created and patented by Joseph Woodland in the United States in 1952.

According to Wikipedia, it is a graphical representation of numeric or alphanumeric data. The decoding (reading) of the data is performed by a type of scanner – or barcode reader.

The data captured in this optical reading is understood by the corresponding device, which in turn converts it into human-readable letters or numbers. Its use is very common in various fields: industry, commerce and services, although in the healthcare sector its use is still rare in many countries.

Basic barcode mechanism

The barcode for products works on the EAN-13 standard and serves as identification in the point-of-sale system of retailers.

Any product, e.g., food products, CDs and DVDs, clothing, apparel and shoes, among others, use EAN-13 barcodes.

The only exceptions are books and controlled drugs.

Explanation of the EAN 13 code digits

First of all, EAN-13 means that it necessarily has to have 13 digits the distribution is:

  1. The first 3 digits represent the origin of the organization responsible for controlling and licensing the numbering.
  2. The following digits can vary from 4 to 7 and represent the identification of the company that owns the prefix;
  3. They represent the product identification and are assigned by the manufacturer, when the manufacturer has its own prefix, and vary from 2 to 6 digits;
  4. The last digit 7 is called check digit and mathematically confirms that the previous digits are correct, this serves to avoid erroneous readings;
  5. Only to indicate the end of the code.

It should be noted that the second numbers vary from one company to another, as well as the third, control numbers that identify the item, which must be recalculated whenever necessary. This means that each of the different items in a company has its own specific barcode number, which makes it necessary to have a body to regulate and control this system. This organization, which operates in 150 countries, is known as GS1.

There are numerous forms of barcodes, the most used ones must take into account the following aspects:

  • The information to be printed
  • Substrate to be printed on
  • Place of use
  • Local regulations

Readers installed on the chain

 

CodeShapeFunctionData included
EAN/UPC

 

EAN/UPCDeveloped specifically for reading at the point of sale (POS). Widely used around the world for its agility in capturing information.GTIN
DatabarDataBarComprises a family of codes that can be scanned at the point of sale. It can be much smaller than EAN/UPC codes and can decode additional information such as serial number, lot number and/or expiration date. It is a worldwide trend to use this code in the fruit and vegetable and another perishable products sector.·   GTIN

·   Serial

·   Lot number

·   Expiration date

Code 128

 

Code 128Barcode that can encode all GS1 keys. It is used in logistics management and traceability by encoding additional information such as serial number, batch number, expiration date, quantities, customer order number, net weight, gross weight, etc.·  GTIN

·  Serial

·  Lot number

·  Expiration date

·  Quantity

·  Gross weight

·  Net weight

DatamatrixDatamatrixTwo-dimensional symbol for special applications to encode information in smaller spaces than linear codes and to add additional information such as product code, batch and expiration date. Main code for the hospital segment to enable the identification of very small objects and their traceability.·  GTIN

·  Anvisa Registration Number

·  Serial

·  Lot number

·  Expiration date

ITF-14ITF-14Barcode designed to encode GTINs only, can be printed directly on corrugated substrate (cardboard) offering good read performance. It cannot be used to identify commercial items that will pass through the point of sale.·      GTIN

·      Número de registro Anvisa

·      Serie

·      Número de lote

·      Fecha de caducidad

QR CodeQR CodeQR codes are dense black modules distributed in a standard box format on a white background. It is a more sophisticated form of barcode that can contain 100 times more information.·       GTIN

·       URL

Reader types and application

Connections:

USB: These are state-of-the-art readers that send the information faster. They do not need additional power, because they get it from the connection.

PS/2, Keyboard Interface: When the decoder is required to be keyboard based, or data is entered into the application as if it had a keyboard, what is known as a keyboard wedge is used, which connects to the keyboard input of the computer or terminal.

RS232 (Serial): Scanners that connect to the RS-232 interface (or serial interface) require special software that retrieves the information sent by the barcode scanner and decodes it.

BlueTooth or Wifi: Readers with Bluetooth or Wifi transmit the information in real time to the desktop without the need for cables. Communication occurs via radio frequency.

Mobility:

Handheld readers: There are readers with or without cables. They are light and ergonomic, ideal for actions, among others, they have a wide range of variety and prices.

Fixed readers: Widely used in application processes and sorting systems that require high speed. Allows the operator to work with two hands, usually applied to business automation solutions.

Code types:

Linear readers: These are the cheapest and only read linear barcodes, i.e. they cannot interpret QR or Datamatrix code information.

2D/PDF417 readers: Can read a large number of barcode symbologies, including codes considered 2D and are capable of scanning images such as signature or defective codes. Perfect in environments where you need to be sure of the correct reading.

 

Leitores de códigos de barras

 

THE INTEGRATION OF BARCODES IN COMPUTER SYSTEMS AND THE NEW TRACEABILITY LAW IN BRAZIL

The constant practice of medicine counterfeiting and cargo theft led ANVISA to create specific legislation for the control of medicines throughout the national territory. From 2007 to 2011, data was collected by ANVISA which, together with the Federal Police Department, concluded that 10% of the medicines sold in the country were counterfeit.

In 2009, Law 11.903 was published, which determines the creation of the National System for the Control of Medicines (NSCM), from production to consumption. The tracking of medicines must be carried out by means of technology for the capture, storage and electronic transmission of data, of pharmaceutical products throughout the national territory.

All secondary packaging of medicines must have the GS1 Datamatrix code, making mandatory information such as, UMI (Unique Medicine Identifier) which groups the GTIN (Global Trade Item Number), ANVISA registration number, serial code, batch and expiration date. These data must be directly related to the ANVISA and CNPJ product registration of the company holding the drug registration.

The movement of medicines along the pharmaceutical product chain can occur in aggregate form, for this the code, TPI (Transport Packaging Identifier), was created when one or more IUMs are packed in a transport packaging.

 

 

RDC 157/2017 defined the members of the SNCM drug movement chain and the roles that each must develop:

  • Registrant (industry),
  • Distributor,
  • Transporter,
  • Dispenser (Drugstores, Pharmacies and Hospitals).

The roles may vary depending on the case of the events being reported.

 

Illustration of the drug movement chain (Source: Minuta, version 0.0.49, ANVISA website)

Each member of the drug movement chain is responsible for transmitting to the database all records related to the movement of drugs under its custody.

For the system to correctly accompany the processes of the horizontal chain (industries, distributors, transporters, pharmacies, hospitals) the synchronization and alignment of data between the systems of the companies, will ensure that the updated information will increase the accuracy of the data between the companies and ANVISA, in search of harmony of processes with successful implementations, so that the impacts of the traceability system are lower, in addition to fewer movement errors that can generate anomalies.

For this, the software of the communicators must be able to assemble and disassemble the Transport Packaging Identifiers (TSI), Unique Medicine Identifier (UMI), since the method of communication with ANVISA will be unique.

ANVISA developed a pilot project in which the technological standards and business rules to be used in the SNCM were defined.

The Pilot Project has a testing environment, in which the handling teams of industries, transporters, distributors, suppliers and dispensers such as pharmacies and hospitals must further exercise their processes, so that when the system goes live there are no errors that can be remedied earlier.

The SNCM will be very important to improve drug safety, but we need to go beyond the barcode. More than two systems working together are needed for better control and safety.

The new law does not meet the safety needs of hospital traceability, however, it will be an important advance in the safety of the entire population that uses medicines in pharmacies, drugstores and hospitals.

It is known that every process needs intervention and can suffer some kind of error, whether intentional or unintentional. But when human lives are involved, this error can have serious consequences, so it is not enough to perform the tasks. Mechanisms must protect and preserve drug information, increasingly reducing errors.

Within hospitals, medication traceability is a responsibility of the Hospital Pharmacy, in storage centers and in places where the unit-dose medication process is performed.

Unit-dose is the process of packaging and identifying medications so that they can circulate through the hospital in a personalized and controlled manner and be administered to patients in a safer way.

This can be done manually or by machines. It involves two main processes:

  1. The unit package (or unidosis) that will receive the medication.
  2. The label printing (or direct printing) that the new container will receive.

The unit-dose process of medications, in addition to improving their control throughout the hospital and in stocks, also differentiates their packaging and eliminates possible typing errors, and thus contributes to the reduction of Adverse Events: it translates into more safety in their administration and in communication with the professionals involved, in addition to reducing the waste of materials and medications.

Adding more information is very important for better communication between Pharmacy and Nursing. Since approximately 70% of sentinel effects are due to lack of information.

In the unit-dose process, preserving the information from the primary package to the new package is the biggest challenge, and the unit-dose process team has this goal.

To achieve this, it is necessary to:

  • Create protection mechanisms
  • Best practice procedures
  • Use the highest level of automation possible
  • Keep employees motivated and trained.

Example of unit-dose packaging:

Modelos de embalagem de unitarização (unidose), Frente/Verso

Models of unit packages, front/back

 

The information presented on the package can be called Layout, which are the texts, images, barcodes, among others.

Essential information such as the Active Ingredient and dosage of the drug, expiration date, batch, laboratory, FRC and the name of the Responsible Pharmacist are fixed, and must always be legible on all drug packages.

Variable information on unitarized drug containers changes and should be primarily intended to assist in the safety and administration of the drugs (warnings, alerts, routes of administration).

In addition to the greater safety offered by the unitization through machines, technology has automatic methods of drug stock and more administrative and financial efficiency, avoiding great expenses and loss of time in the control of stock and its inventories.

Thus, the use of bar codes for all possible operations allows greater control and security of the products and systems used.

For medicines, the Datamatrix code will also be fundamental for its greater safety and better control, in addition to reducing errors, which can cost lives.

Pharmacist Daniela Faria