Drug traceability: Are we closer to a solution?
Author: Luiz Fernando Buainain
Source: Medicina e Saúde Online (Grupo Cimed), 25/06/2008
Today, there are discussions, both inside and outside the pharmaceutical sector, of ways to inhibit
development of the illegal drug market in Brazil. Big two
elements can be identified in this scenario: counterfeiting / importing
clandestine remedies and cargo theft. Both have the final consequence
the risk to the patient's health, the ineffectiveness of these medications, the
or repetition of treatment and exposure of the population to risks
unnecessary.
In parallel, incompatible and not serious practices, according to research
of the Brazilian Institute of Competitive Ethics (Etco), point out that taxes
due evasions and informal labor represent a real risk. Compared to
these data, the search for technologies that enable traceability and
validating the authenticity of medicines is extremely necessary.
Controlling the circulation and marketing of these products would facilitate actions
punctual against each of the problems mentioned, as it would be possible to identify
the origin, destination and exact location of medications. Also in situations
simpler, such as the need to collect a batch of medicines, a
tracking system would be of great use.
In effect since January, the National Product Management System
Controllers computerized the entire manual registration of controlled drugs
done in pharmacies and drugstores. However, this measure is still subject to error
human, since the information printed on the packages must be typed in the
computer. In addition, an ideal tracking system should include all
the types of remedies, not just the controlled ones.
The barcode system adopted by the Brazilian government is also a
obstacle, for not storing all the information necessary for
medicines are fully traceable. For better identification, it would be
for example, data such as the batch number,
expiration date, manufacturer, pharmacy of origin, doctor who prescribed it and the buyer.
Working in this direction, Anvisa looks for a system that allows the
tracking all medications from leaving the lab to the patient's hand
patient. To this end, in March this year it held a public consultation, through
57 suggestions for control mechanisms were received.
Now, there is a public consultation already finalized that seeks proposals for the
implementation of a technological solution, be it new bar codes,
stamps or chips. After the evaluation of the proposals, Anvisa will hold a hearing
for discussion with segments and society and intends to place the
system in place in 2009. Tracking technology already exists in the country,
used by Hospital Santa Catarina for the internal control of
medicines.
In the United States and Europe, the biggest problem has to do with drugs
counterfeit goods, while cargo theft is of more concern here. THE
drug traceability is not only welcome, but it can also mean
a change in the image of Brazil, making it one of the pioneers in this type
initiative. It remains to wait for the next steps of Anvisa.
Luiz Fernando Buainain is president of Abafarma - Brazilian Association of
Pharmaceutical Wholesale
Posted by Rede Lajeado
RELATED
Drug traceability: are we closer to a solution?
Author: Luiz Fernando Buainai *
Source: Communicate, 24/06/2008
Today, there are discussions, inside and outside the pharmaceutical sector, of ways to inhibit the development of the illegal drug market in Brazil. Two major elements can be identified in this scenario: the counterfeiting / illegal importation of medicines and cargo theft. Both have the ultimate consequence of the risk to the patient's health, the ineffectiveness of these medications, the increase or repetition of treatment and the exposure of the population to unnecessary risks.
At the same time, incompatible and non-serious practices, according to research by the Brazilian Institute of Ethics in Competition (Etco), point out that the taxes due evaded and informal labor represent a real risk. In view of these data, 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 identified, 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, the National Controlled Products Management System has computerized the entire manual registration of controlled medications done in pharmacies and drugstores. However, this 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 Brazilian government is also an obstacle, as it does not store all the information necessary for medicines to be fully traceable. For better identification, it would be necessary, for example, to store data such as the lot number, validity, manufacturer, pharmacy of origin, doctor who prescribed and the buyer.
Working in this direction, Anvisa looks for a system that allows the tracking 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 which 57 suggestions for control mechanisms were received.
Now, there is a public consultation already finalized that seeks proposals for the implementation of a technological solution, be it new bar codes, stamps or chips. 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. There is already a tracking technology in the country, used by Hospital Santa Catarina for the internal control of medicines .
In the United States and Europe, the biggest problem has to do with counterfeit drugs, while cargo theft is more worrying here. The traceability of medicines is not only welcome, but it can also mean a change in the image of Brazil, making it one of the pioneers in this type of initiative. It remains to wait for the next steps of Anvisa.
* Luiz Fernando Buainain is President of Abafarma - Brazilian Association of Pharmaceutical Wholesale
