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The constant practice of counterfeiting medicines and cargo thefts led ANVISA to create specific legislation to control medicines throughout the country. 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, determining the creation of the National Medicines Control System (SNCM), from production to consumption. Medication tracking will be carried out using technology to capture, store and transmit electronic data for pharmaceutical products throughout the country.

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

All secondary packaging of medicines must have the GS1 DataMatrix code, making information such as IUM (unique medicine identifier) ​​that groups the GTIN (Global Trade Item Number), ANVISA registration number, serial code, batch and expiration date mandatory. This data must be directly related to the product registration at ANVISA and the CNPJ of the company holding the medicine registration.

The movement of medicines throughout the pharmaceutical product chain can occur in an aggregated form, for this purpose the code, IET (Transport Packaging Identifier), was created, when one or more IUM are packaged in a transport package.

A RDC 157/2017, defined the members of the SNCM drug movement chain and the roles that each one must play:

• Registration Holder (Industry);
• Distributor,
• Conveyor
• Dispenser (Drugstores, Pharmacies and Hospitals).

Roles may vary depending on the event instance being communicated.

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

To this end, the communicators' software must be able to assemble and disassemble the Transport Packaging Identifiers (IET) and Unique Medication Identifiers (IUM) as the method of communication with ANVISA will be unique.

The companies' software must be ready by May 01, 05, when the Traceability System will begin in Brazil. The synchronization and alignment of data between the companies' systems ensures that updated information increases the accuracy of data between companies, with the aim of creating and consolidating global standards to achieve process harmony with successful implementations, guarantee the efficiency of the health chain and the patient safety.

The Information Technology and logistics areas must be involved in the needs for changes and implementations for the new system.

The major challenge to be overcome in the traceability project for the companies involved is to review the internal processes of each one and to define the correct equipment to help in data collection and service quality, reducing the rate of errors and rework. This will improve the identification of errors and allow for faster changes to structures when necessary.

The traceability movement is global and, according to experts on the subject, Brazil has the best level of traceability system to be implemented. It proposes traceability also in the middle of the chain to ensure safety, since by tracking only the ends, an error could allow an unsuitable medicine to be placed on the market and sold for consumption.

Implementing drug traceability using barcodes is safer and:

• Agility in the dispensing process, with online stock reduction;
• History of the medication batch from receipt to the moment it is used by patients;
• Guarantee of dispensing of medicines in usable condition, with dispensing of banned or expired batches blocked via the system;
• Agility in locating products banned for recall.
• Important tool for obtaining certification of the origin of medicines.

Pilot project

In April 2017, ANVISA and GAESI HCFMUSP (an association of researchers from the Polytechnic School of SP and the Faculty of Medicine of SP, who work with innovation projects and, together with ANVISA, defined technological standards and business rules that will be used in the SNCM) signed an agreement for the development of a Pilot Project for the traceability of SNCM medicines.

According to Vidal Augusto Zaparolli, a member of the GAESI group, it was detected in the Pilot Project and in the test environment, also made available by ANVISA, that the movement teams must exercise their processes more in these environments, so that when the system starts, errors that could be corrected do not occur.

The Pilot Project has an environment where events involving medicines can be declared, which varies according to the companies' registration with ANVISA.

But if something is wrong with the declaration, it may be REVOKED or REPLACED.

The pilot project monitored the production, distribution and dispensing chain of medicines in pre-determined locations for one year. The results were then evaluated and the necessary adjustments were made to the SNCM regulations.. And three years were determined for the implementation of the system, which will be 01/05/2022.

According to ANVISA, companies in the horizontal chain must now carry out more tests in the environment makes available