Brazil to track 5 billion boxes of medicines by 2016

drug trackingThe Brazilian pharmaceutical industry is preparing to implement one of the largest drug traceability programs in the world, created in 2005 with the help of ETCO. With a final implementation deadline defined by the National Health Surveillance Agency (Anvisa) for 2016, this program should track 5 billion boxes of medicines across the country, according to Sindusfarma, the union that represents the sector.

Established by Law 11.903 / 09, the program determines that each package of medicine receives the printing of a two-dimensional (2D) code, whose technology has already been chosen by the agency (GS1 Data Matrix). This seal, known as the Unique Medicines Identifier (IUM), will store data on the route of each bottle, from the factory to pharmacies (estimated between 60 and 90 in Brazil), in addition to hospitals. The IUM will also store lot numbers, series and expiration date.

For the consumer, the greatest benefit of the new system is the security it adds to medicines. “The industry will be able to know exactly where its product is and act more quickly and in advance in case of problems”, explains the executive president of Sindusfarma, Nelson Mussolini. He adds that traceability can also further reduce drug theft, which has already been greatly minimized by the Electronic Invoice and Tax Substitution, which practically extinguished the figure of the recipient.

Currently, drug logistics information is fragmented across the various agents in the pharmaceutical chain. The industry controls the process from the factory to the distributor. Thereafter, batches of different groups of drugs are fractioned and grouped into smaller shipments, which make up five or six logistical steps to the final destination.

With the new system, the data will be centralized in a database whose administration is the responsibility of the drug registration holder. Anvisa determined that each link in the chain feeds this bank with the information it knows. The bank may be freely consulted by the agency for monitoring and inspection purposes.

Anvisa also defined that by December 2015 all laboratories have at least three lines incorporated into the system. Pharmaceutical Libbs announced in September that it had adapted to that determination. "It is a system that brings benefits to the consumer, from the point of view of security, and for the sector, helping to combat fraud, smuggling and counterfeiting," said the Minister of Health, Arthur Chioro.

Until December 2016, each bottle of medicine that leaves the factories must be traceable. But there are still issues to resolve regarding the confidentiality of the information.

Since the regulation states that data must be provided to the industry, which is also responsible for the costs of the system, it is likely that retail and wholesale will question this requirement, arguing that it violates competition laws. The industry, on the other hand, claims that full access could anticipate and minimize problems. “If the system tells us that there are complaints about drugs that have no effect, for example, I will go there and investigate. Until we are notified to make a recall, the problem may become bigger ”, says Mussolini.

The executive president of Sindusfarma says that the issue of confidentiality can effectively delay the implementation of the system and is working with entities involved to find a solution. “There is probably a technological path that resolves, instituting access controls in the system. But if that is the solution, we will have to adjust the current regulations. ”

(With advice from Libbs Farmacêutica and the Brazilian Automation Association)

Medication will be tracked from production

Anvisa's resolution establishes new rules for manufacturers and importers. In three years, identification on packaging will be standardized

Published on December 11, Resolution 54 of the National Health Surveillance Agency (Anvisa) established new rules for drug tracking in Brazil. The standard presents mechanisms and procedures for identifying the trajectory of drugs from their production to their sale, using technology for the capture, storage and electronic transmission of data throughout the production chain.

For controlled drugs, the system will bring information from the producer to the buyer. The drug packaging will adopt the Unique Drug Identifier (IUM), a type of two-dimensional code similar to the QR Code that will allow the user to know if the product is original.

The formation, generation and implantation of the IUM in the packaging of all drugs sold and distributed in the country will be the responsibility of the companies that have registered with Anvisa. The resolution also establishes the adoption of the two-dimensional bar code (Datamatrix) as a technology for the capture, storage and electronic transmission of data necessary for tracking. According to Anvisa, this technology ensures support, automation and visibility to drug tracking, in addition to allowing integration between information systems.

The code must be formed by the drug registration number with Anvisa and contain 13 digits, in addition to the expiration date, batch number and serial number, which cannot be repeated in the units of other products manufactured by the registration holder. The same rules also apply to fractionated drug packaging and hospital packaging.

The resolution also determines that the data for each drug must be maintained and made available in Anvisa's systems for at least one year after the expiration date of the product. Registration companies, manufacturers or importers will have the responsibility to guarantee and ensure the maintenance of the quality, safety and efficacy of the products to the final consumer, in order to avoid health risks.

In three years, the system will be fully implemented. Anvisa has set a deadline of two years for each pharmaceutical company to submit a full traceability report for at least three batches. To monitor the application of the standard, the regulatory agency will form a technical committee to monitor the implementation of traceability.

Discussion on drug tracking advances

Public Hearing (Anvisa)

On May 29, another important step was taken towards the implementation of the expected National Medicines Control System, with a public hearing at the National Health Surveillance Agency (Anvisa) to discuss the traceability model to be adopted in the country.

Among representatives of drug laboratories, sector entities and members of security and technology companies, the audience was attended by 150 participants, who were able to discuss and opine on the traceability model proposed by the working group formed by various government sectors . Issues such as the database model to be used and the time for companies to adapt to the rules, which are yet to be published, were widely discussed.

As informed by the Chief Executive Officer of Anvisa, Dirceu Barbano, entities in the medication sector should be called for further talks to align proposals. The ideas will be analyzed with the perspective that traceability will achieve the objective of providing more security to the population. After the closing of the final text, it will be discussed in a public meeting of the agency's directors. "Anvisa's commitment is that the system will be available in the shortest possible time for the entire Brazilian population," said Barbano.

In the period when it was available for public consultation, the proposal received around 600 contributions sent by 90 institutions and individuals. Traceability assumes that all drug packaging in Brazil has a unique identification, capable of allowing the user to know if the product is original and if it has legal origin. The measure, among other advantages, will help in combating cargo theft and will allow identifying who manufactured the product, who sold it, who dispatched it and when it arrived at the distributor and pharmacies.

“Undoubtedly, the honest and legal drug industry is affected, and the government loses revenue that could be used to improve services for the population. But the case of medicines brings up a bigger problem, a problem of public health, of life, of citizenship. Brazil cannot and should not continue to run this risk ”, says ETCO's Executive President, Roberto Abdenur, who was in Brasília to accompany the public hearing. Abdenur and the CEO of Anvisa also mentioned the relevant role that ETCO had, years ago, in launching the traceability initiative.

(with information from Press / Anvisa)


Anvisa determines suspension of irregular and fake medicines

Source: Estadão - São Paulo / SP - HEALTH - 22/10/2010

BRASILIA - The National Health Surveillance Agency (Anvisa) published on Friday, 22, in the Federal Official Gazette, measures that establish the suspension of products in an irregular situation, valid for the whole country.

It is forbidden to manufacture, distribute, market and use all batches of Muconat 30 mg / 5ml syrup in plastic bottles, produced by the company Nativita Indústria e Comércio Ltda. These lots are at odds with the model approved by Anvisa and will be collected.

The agency also suspended the manufacture, distribution, trade and use of all cleaning products by Raro Indústria e Comércio Ltda. The company is not authorized to operate or registered with Anvisa.

The 948 batch of the anabolic Hemogenin will also be withdrawn from the market, with an expiration date of 12/12, as it has been subject to forgery. The measure also applies to lots 33099 of the anabolic Deca-Durabolin 25mg; 11873 of Deca-Durabolin 50mg; 233314 of Deca-Durabolin 50mg; and 12658, 18874, 18341 and 03985 of the anabolic Durateston, with date of manufacture in 06/2008 and valid until 06/2012, whose holder of the records is the company Schering-Plogh Indústria Farmacêutica Ltda.

André Franco Montoro Filho: Drug tracking system

Source: Agência Senado - Brasília / DF - 19/10/2010

The illegal sale of medicines not properly registered has posed a serious threat to public health. It is alarming the volume of products without registration and, therefore, without the necessary phytosanitary guarantees, which are traded in the country, putting users' lives at risk.

To face this serious problem, on January 14, 2009, after approval by the National Congress, Law 11.903 was enacted, which created the National Drug Control System. This control would be carried out by means of a unique product identification system and with the use of technologies for the capture, storage and electronic transmission of data.

To collaborate with the National Health Surveillance Agency (Anvisa), the sector's regulatory agency, the Brazilian Institute of Ethical Competition (ETCO) signed a protocol of technical cooperation with that entity, to conduct a pilot test of a drug tracking system . With the collaboration of companies and entities in the sector and monitoring by Anvisa, the test was carried out during 2009 with total success.

The pilot test consisted of the printing of a two-dimensional unit code, internationally accepted, on the cartridges (packaging) of medicines and monitoring the movement of these products throughout the distribution chain, from laboratories to pharmacies and drugstores, through an electronic data capture, storage and transmission system.

The test involved 75 thousand cartridges, which is an adequate volume of drugs for the evaluation of processes and systems. In order to simplify and facilitate the implementation of the system and for companies not to be tied to a single equipment or technology supplier, open and public domain technologies were adopted, with characteristics and flexibility to be implemented by laboratories of any size or sophistication. technological.

The main conclusions of this test were that performing drug tracking by printing a code on the drug packaging is feasible with the technologies available on the market and that direct and indirect costs (possible impacts on production lines) are reduced and proportionate the sophistication or speed of the production lines.

It is reported, however, that Anvisa decided to adopt a different procedure to carry out drug screening. This would be done through the use of adhesive labels (stamps) to be provided by the Casa da Moeda, with a security technology owned by a multinational company. The stamp would cost R $ 0,07 per unit. In Brazil, approximately 4 billion units are sold, which would result in a total cost of R $ 280 million per year.

This procedure is, in our view, wrong for a basic reason. The use of this seal is not provided for in Law No. 11.903 / 2009, which established the mandatory systems for drug tracking as of January 2010, as it provides for the “use of technologies for the capture, storage and economic transmission of data”. This seal in no way contributes to the tracking system.

In view of these considerations, it is necessary for Anvisa to review its position so that it is possible to start with the utmost urgency, as we are already behind schedule in the law, the implementation of an authentic drug tracking system in Brazil.

André Franco Montoro Filho

Ph.D in economics (Yale University), he is a professor at USP and executive president of the Brazilian Institute of Ethics in Competition (ETCO)