Source: ETCO Magazine, No. 13, August 2009

Over the past few months, as provided for in the Technical Cooperation Protocol of December 18, 2008 - which aims to carry out a pilot project for the Medicines Tracking and Authenticity System -, members of the ETCO Medicines Chamber, with monitoring Anvisa technicians, have been working intensively in the search for viable and efficient solutions. The objective is to prepare the private sector and provide subsidies to the regulatory agency to meet the requirements of Law 11.903 / 2009, sanctioned by President Luiz Inácio Lula da Silva, on 14/1/2009, which created the National Drug Control System. The law foresees, as of 14/1/2010, the tracking of all types of drugs existing in the country, from production to sale to the final consumer, including dispensing and medical, dental and veterinary prescription. The control will be done through technologies of capture, storage and electronic transmission of data. For this, each product must present a unique identification code.

The first stage of the pilot project consisted of an immersion program by the ETCO Medicines Chamber, whose objective was to raise and map the needs and expectations of its partners, including industries, distributors and retail. In the second phase, a pilot test was carried out in seven industries associated with the Institute (Aché, Bayer Shering, Eurofarma, Mantecorp, Nycomed, Pfizer and Sanofi Aventis), in distributors and retailers. The main objective of the pilot test was to verify the printing process of the identification code on the secondary packaging and the reading and transmission of the data generated by all the links in the pharmaceutical sector chain. For operational reasons, a small volume of drugs was used, but sufficient for the evaluation of the process, for suggestions for changes and improvement. The data collected by information provided by industries, distributors and points of sale were allocated in a data center in order to reflect as closely as possible what will happen in the real model.

The new system, which aims to inhibit and supervise unethical competition practices, will allow inspection agents to verify the origin and authenticity of each medication. Thus, cargo theft, diversion of products, accidents or incidents during transport can be detected. With the total implantation of the system, in any part of the pharmaceutical chain it will be possible to verify if the medicine is genuine or not. The consumer will also benefit, since he will be able to verify the authenticity of the purchased medicine. Law 11.903 / 2009 also provides that the system will have to be fully implemented within three years. At the end of this period, drug control in Brazil should reach levels of excellence, ensuring, in addition to traceability, effective monitoring of drug use and prescription.

THE SYSTEM OPERATION

See the responsibilities of each link in the productive chair

Light industry

The industry will be responsible for printing the Unique Medicines Identifier (IUM) both on the secondary packaging of its medicines (cartridges) as well as on shipping boxes and / or pallets (parent-child codes). The code will contain the following information, first sent to a private database and then to a central database:

• product code
(EAN / GTIN 13);
• lot number;
• expiration date.
• random number

DEPOSIT

If the industry has its own deposit, but registered with a different CNPJ, we will have a movement of the product prior to billing, whose registration should be included in the database. A similar situation occurs when the company has an outsourced logistics operator. In this case, additional information must be sent to the central database. Are they:

• date of receipt of
boarding boxes or pallets,
duly identified with
IUM code;
• carrier.

DISTRIBUTOR

Upon receipt of the goods, the distributor will be in charge of transmitting other information, relating to commercial transactions, to the central database:

• arrival date of
medicines;
• pharmacy name
or recipient drugstore.

POINT OF SALE

Retailers will have to forward the following information to the central database:

• purchase details
goods;
• sales data for the
final consumer

SUPERVISION

The Medicines Tracking and Authenticity System will guarantee inspection agents access to the route of all medications, from production to arrival at points of sale.

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THE 10 STEPS

Follow the steps of the pilot test of the tracking system

Step 1- APPLICATION

Application in the secondary packaging of the product (cartridge), from a company database, but with specifications required by the regulatory agency, of a Unique Medicines Identifier (IUM). This application will be made in the form of a two-dimensional bar code (data matrix ECC 200). The action should represent the last industrial operation in the packaging line, in order to minimize losses of cartridges already identified. Specific printing equipment management software should ensure the transfer reliability of the IUMs to be printed. The procedure aims to prevent the same MUI from being printed more than once.

Step 2- READING

After applying the IUM, the printed code on the secondary packaging will be read. If the print is not of good quality, the cartridge should be separated from the batch. It is important that there is a reconciliation of readings between the selected IUM in the company's database, the printed and the read.

Step 3- PACKAGING

After reading the code, the cartridges must be packed in shipping boxes and identified with “parent-child” labels. The information encoded in the cartridges, in addition to being included in the company's own database, will be stored in a public database.

Step 4- STORAGE AND RELEASE

During the test, each cartridge will be considered a single unit, and no longer an indistinct unit within a batch, which aims to facilitate the location of products - from industry to retail, through distribution channels. As a guarantee of quality control, the product can only be released for commercialization after the reconciliation of the involved IUMs. That is, the IUM selected in the database, the printed and the read. From then on, the medicine will become traceable.

Step 5- BILLING

Distributors and retailers will issue special purchase orders to the industry. The latter, within the normal billing process, will execute the sale operation. During the process of separating the product to be sold, the IUMs involved will be electronically captured.

After activating the IUMs in the private and public databases, the location of the cartridge in the stock will be recognized. For the industry that has logistics operators, there will be a movement of CNPJ prior to billing. Necessary information about industry customers, sales notes issued and contracted carriers will also be included in the system.

Step 6 - TRANSPORT

The industry will have to register changes in the carrier or cargo consolidation in the private and public databases.

Step 7- RECEIPT

The system will allow distributors and retailers to read the IUMs printed on the cartridges and on the “parent-child” labels on the shipping boxes. Distributors and retailers will have to inform industries about the IUMs received. The department responsible for billing will receive a specific file and make the reconciliation between the data contained in the billing (sent-received).

Step 8 - CUSTODY

Distributors and retailers must update their database information and then pass it on to the public database. Once the custody of the product is confirmed by these companies, the industry will be responsible for the traceability of their product. If, within a certain period, distributors or retailers do not update the public database, the system will issue a non-compliance alert for all links in the pharmaceutical chain.

Step 9 - SIMULATIONS

In the pilot test, simulations will be carried out, providing, for example, the return of products, in order to show “reverse logistics”, among others. In these exceptional situations, information in the public database may be changed, and the system will also allow industries to receive an alert regarding irregularities.

Step 10 - FINAL REPORT

Based on the results of the pilot test - which aims to assist Anvisa in choosing the best and most efficient model for the Medicines Tracking and Authenticity System -, ETCO will send a final report to the regulatory agency, with the conviction that this work will benefit to everyone involved in the process: government, businessmen and the final consumer.