Traceability of medicines. Technology that guarantees more security and optimization

Traceability of medicines is already a reality in Brazil. For many years, players in the pharmaceutical sector have been debating the need to create mechanisms to optimize logistics, guarantee greater transparency and security for consumers and prevent counterfeiting. 

New regulatory standards, such as RDC nº 157/2017, helped to accelerate this trend. Until April 2022, all Brazilian medicines will have to meet Anvisa standards that provide for the traceability of medicines.

How does drug traceability work?

We can understand traceability as a set of processes, systems, procedures and mechanisms that map the position of the medicine, from its origin until it reaches the final consumer. Furthermore, this concept arose due to the need to know where a product is in the logistics chain and also as a resource that contributes to quality control and the fight against counterfeits. 

In this system, each box of medicine receives a unique identification number printed in a two-dimensional code that brings together all the information relating to it. This data includes the batch, validity, serial number and registration with Anvisa, in addition to the history and trajectory of the product in the different logistical stages. This way, the patient will know the exact origin of what they are purchasing and will know the entire path taken by the product in the supply chain.

Advantages of drug traceability

Traceability is an important tool for reducing the sale of fake medicines. This system thus makes it possible to reduce the financial losses of the pharmaceutical industry and ensure that the patient has access to a highly reliable medicine.

For patients, the main advantage is linked to the safety and quality of the medicines. After all, with traceability, the origin of the medicines is guaranteed. Furthermore, it is possible to avoid the trade and consumption of unsuitable items or those with manufacturing problems.

Another advantage is the ease of recalls. Therefore, if there is a need to reevaluate a batch of a medicine, the manufacturing company will know exactly where to source the product and how to remove it from the market quickly, reducing harm to the population.

Learn about the legislation that regulates traceability

On May 15, 2017, Anvisa published new guidelines for the traceability of medicines. With the resolution RDC no. 157/2017, the organization seeks to ensure the adoption of new standards to certify the origin of medicines. This new standard serves to reinforce Law 11,903/09, which created the National Medicines Control System (SNCM). 

A Law nº 13,410, responsible for the creation and regulation of the National Medicines Control System, was created in 2002, but since then has undergone a series of changes to reach this model.

This new regulation is an important mechanism to prevent counterfeiting and loss. In the National Medicines Control System, all elements involved in the medicine production and distribution chain are part of the tracking. 

The serialization and traceability of medicines are solutions that seek to minimize this type of risk for the population, generating more restrictions on the sale of fake products. This way, the consumer has more security regarding the information on the origin and authenticity of the product.
The new ANVISA standards determine that both the primary packaging (in direct contact with the product) and the secondary packaging (which houses the primary packaging) must contain all data relating to manufacturing. This data includes the serial number, expiration date and batch, now known as the Unique Medicine Identifier (IUM).

Technologies involved in traceability

Unique Medicine Identifier (IUM): As the name suggests, this identifier is unique, which makes it easier to track throughout the chain. The IUM is made up of a series of numeric, special or alphanumeric characters, created through identification and coding standards. In this way, it allows the exclusive, individualized and unambiguous identification of each commercial package.

Serial code: This individual barcode, contained in the IUM, is composed of 20 alphanumeric characters. It provides varied information about the product.

Serialization: Process of generating and including the DataMatrix, a type of QR Code that allows you to store more information in smaller spaces. It also includes the inscription of the serial code on the drug’s commercial packaging.

GS1 DataMatrix: This is a two-dimensional code standardized by GS1 Brasil and is part of Anvisa’s RDC for drug traceability. It may be small enough to be printed on packaging, but it still encodes a lot of distinct information.

RFID: Radio Frequency Identification is a device that has the function of individually identifying each product, allowing tracking each unit and recording their technical information. Companies use this technology a lot in logistics, as it helps to speed up and make inventory control and the shipping process more accurate.

The labels attached to inputs, products and packaging contain electronic components that record the serial number, model and manufacturer’s data. Therefore, RFID allows the industry to have information on when its product returns via consumer to a collection point and prove that it was disposed of properly.

Learn how plastic pallets help traceability

To prevent medicines from suffering damage during transport, it is necessary to carry out strict monitoring of the products from the moment they leave the industry to their final destination.

RFID technology allows the individual identification of the product, its location throughout the entire logistics chain and the monitoring of storage characteristics. This way, it is possible to simplify processes, reduce costs and enhance results.

The Super Roto® rotomolded plastic pallet favors compliance with standards, as it has expressive ownership identification. This feature allows the management of pallets with freight forwarders, exporting companies or with inter-company material flow. Furthermore, it also enables traceability using, for example, Radio Frequency Identification or RFID.

Did you like this article? Want to know more about how to increase efficiency in the pharmaceutical industry? See this article about essential care to increase safety in the sector.