Author: Luiz Fernando Buainain *

Source: Correio Brasiliense, 07/07/2008

Two major elements can be identified in this scenario: on the one hand, counterfeiting and illegal imports of medicines; on the other, cargo theft. Both have the final consequence of the risk to the patient's health, the ineffectiveness of these drugs, the increase or repetition of treatment and the exposure of the population to various unnecessary losses.

At the same time, some incompatible and non-serious practices are recurrent, such as tax evasion due, the sale of products without invoices, the informality of the sector's labor force and the sale of medicines in therapeutic classes made through illegal exchange of products. These practices represent real risk, as indicated by research by the Brazilian Institute of Ethics in Competition (Etco).

In the face of this information, the search for technologies that enable traceability and validate the authenticity of medicines is extremely necessary. Controlling the circulation and marketing of these products would facilitate specific actions against each of the problems mentioned, as it would be possible to identify the origin, destination and exact location of the medications. Also in simpler situations, such as the need to collect a batch of drugs, a tracking system would be of great use.

In force since January of this year, the National System of Management of Controlled Products has computerized the entire manual registration of controlled drugs done in pharmacies and drugstores. However, the measure is still subject to human error, since the information printed on the packages must be typed on the computer. In addition, an ideal tracking system should include all types of drugs, not just controlled ones.

The barcode system adopted by the manufacturers is also an obstacle, as it does not store all the information necessary for the drugs to be fully traceable. For better identification, it would be necessary, for example, to store data such as the batch number, validity, manufacturer, among other information.

Working in this direction, Anvisa seeks a system that allows the tracking and identification of all medicines from the laboratory to the patient's hand. To this end, it held a public consultation in March of this year, through a discussion forum on its website. The consultation lasted 60 days and received 57 general suggestions and more than a dozen on control mechanisms.

The suggestions followed some criteria established by Anvisa itself. Among the criteria are the low total cost of implementation, the ability to replace or immediately correct the equipment and the low possibility of fraud in the mechanism of traceability and authenticity of medicines. After evaluating the proposals, Anvisa will hold a public hearing for discussion with the segments and society, and intends to put the system into practice in 2009.

Some parallel initiatives that have already been taken can be highlighted. One of them is that of Hospital Santa Catarina, in the city of São Paulo, which uses a special bar code as a means of internal control of its pharmaceutical articles. The other is a bill that has been pending in the Senate since last year, which deals with the monitoring of some products. The project proposes mandatory electronic identification of medicines, pharmaceutical supplies, cosmetics and other items subject to health surveillance rules.

In the United States and Europe, the biggest problem has to do with counterfeit drugs, while here in Brazil cargo theft and smuggling are the most worrying. A technology that allows the traceability of medicines is not only welcome, but it can also mean a change in the country's image, making it one of the pioneers in this type of initiative. It remains to wait for the next steps of Anvisa.

* President of the Brazilian Pharmaceutical Wholesale Association (Abafarma)