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Brazil faces a crisis in the supply of penicillin for the treatment of syphilis »Pharmaceutical review



Of the 2.5 million bottles ordered for the public network, the laboratory delivered less than half

Margarida Corda

The antibiotic penicillin benzatine has its endangered stock in Brazil. Known for the benzethacil brand, the drug is used to prevent both congenital syphilis in newborns and to treat syphilis in adults and is part of the basic package of pharmaceutical care.

The letter of suspension of penicillin reached the Ministry of Health last year, during the transition of governments. In the document, the Furp, a state-owned laboratory linked to the government of Sao Paulo, wants the termination of the R 10 million contract signed in 2017 for the supply of benzathine penicillin.

Of the 2.5 million vials / ampoules ordered to supply the public health network, the laboratory delivered less than half, 1.15 million. Rationale of the request for suspension? According to a note from the Ministry of Health, "Quality Issues of Active Pharmaceutical Imports (IFA) for Drug Production".

"One part of penicillin had a problem with the thinner that caused clogging of the needles and it was never possible to give the full dose of the medicine," said a technician from the Ministry of Health who prefers not to identify.

Despite the suspension of supplies, the ministry ensures that the public network has enough drugs to meet the country's demand by the second half of 2020 and that a new electronic auction to buy the drug has been opened. According to the dossier, this year 2.7 million bottles of benzathine penicillin have been allocated to treat cases of syphilis during pregnancy and acquired syphilis and a new 913,000 ampoule delivery is scheduled to begin in June.

dependence

State executives confirm that penicillin stocks are up to date, but the climate of normality hides a chronic problem in Brazil's drug production and helps to ignite the boiler that feeds the syphilis outbreak.

Only four labs produce the active substance benzathine penicillin in the world. Three of them in China. There are no such in Brazil. As a person who has to make a chocolate cake but no chocolate, the country makes the writhing to provide the raw material of penicillin. Including exempting suppliers of inspections that were banned from other countries precisely because of the product quality issues they deliver, as is the case with the Semisyntech Chinese laboratory.

It was this laboratory, at Furp's request, exempted from registration by the National Agency for Health Surveillance (Anvisa) to provide the active principle. Resolution 1963 was published in the Official Journal on July 22, 2016. But, questioned about the suspension of the contract of the Ministry of Health, Furp is silent and does not confirm the name of the raw material supplier lab of poor quality.

Not for the first time Brazil faces problems with penicillin, condemns the experts in the article "Exhaustion of Penicillin and Impact of the Population on Health". In 2014, the drug is beginning to be lacking and in 2016 at least 16 Brazilian countries are without benzathine penicillin. The shortage of crystalline penicillin used in the treatment of neurosyphilism has now reached 100% over the same period.

But why does Brazil not produce the raw material of an antibiotic discovered almost 100 years ago? Physicist and researcher Phiocruz Claudio Majierovic says dependence is the result of economic policies.

There has been a change in Brazilian industrial policy, which has practically destroyed the national park of the fine chemical industry. The largest icon of this destruction is the government of Kolor. With the large-scale internationalization of the economy, this industry, which began to produce in the 1950s, lost space, and Brazil became the sole importer of raw materials. "

According to National Development Bank (BNDES) data from 2005, drug use imported by Brazilian industries has increased by 90%.

According to Mayerovic's estimation, the industry will not start spontaneously producing the active ingredient of penicillin, "just because it is cheap, it becomes a problem." For the researcher, the decision involves strong government intervention that creates incentives for the industry, ensuring a stable market and sales in a sufficient amount, but does not think we are that way.

"My impression is that this policy, which appreciated the role of the ministry [da Saúde] as an intermediary and promoter of production chains was discontinued. That was part of an economic project. This was the hand of the health field in a Brazilian industrial policy project that included BNDES and [Financiadora de Inovação e Pesquisa] Finep as important industry financiers. It seems to me she has retreated that she has stopped completely. "

The partnership between Fiocruz and the Federal University of Rio de Janeiro (UFRJ) for the construction of the National Reference Center for Pharmaceutical Chemistry, the pole of Active Pharmaceutical Supplies, is an example of a park policy. Last year there was no budget to make the project. Not this year. Researchers still hope to persuade the government to allocate funds to the center, which promises to reduce Brazil's dependence on imports of pharmaceutical raw materials.

The Furp contract for the supply of penicillin was one of the weapons of the Syphilis No program, which the government began to try to limit the spread of the disease. One of the promises made at that time was that measures would be taken to stimulate the production of penicillin raw materials in Brazil. As to what has been done since then, the Ministry of Health has not responded.

Catalyzing the epidemic

Suspension in the supply of penicillin is another component of a problem that seems to be far from circumvention: the progress of syphilis in Brazil.

In the second half of May, the Pan American Health Organization (PAHO) published a report stating that nearly 29,000 cases of congenital syphilis have been reported in 37 countries in North and South America. 85% of them are in Brazil.

Some epidemiologists start discussing whether it is possible to categorize case growth as an epidemic or re-emergence, a revival of an old known disease.

The AIDS epidemologist and deputy coordinator of the São Paulo AIDS / AIDS Program, Arthur Kalichman, is a little more pragmatic about the increase in Brazilian cases.

"You can call it an epidemic, an endemic disease, a revival, whatever you want." It also improves the quality of information. Part of this increase is related to reporting [mais]but part of it is because it happens anyway. "

According to the latest epidemiological bulletin issued by the Ministry of Health between 2010 and 2017, the incidence of congenital syphilis increased by 3.6 times, from 2.4 to 8.6 cases per thousand births. Syphilis detection rates in pregnant women increased by 4.9 times, from 3.5 to 17.2 per 1000 live births. Acquired syphilis, which became mandatory only in 2010, jumped from 2 cases per 100,000 inhabitants in 2010 to 58 cases per 100,000 inhabitants in 2017

The state of Sao Paulo has the highest number of absolute cases of syphilis. In case of acquired syphilis, there are 36,000 cases and fifth place in percent: 80.5 cases per 100,000 inhabitants.

Here, in São Paulo, some municipalities, some regions, are beginning to register some stabilization and even a reduction in congenital syphilis. Acquired syphilis, not yet; continues to grow. In the state as a whole [de São Paulo] also continues to grow but slows down. There are no discounts in Brazil as a whole: [sífilis] pregnant women as well as congenital. Where it does not rise, you may suspect that even the information does not work, "explains Kalicman.

Veriano Terto Júnior, vice president of the Brazilian Interdisciplinary AIDS Association (Abia), believes that the growth of syphilis in Brazil shows exhaustion of the preventative discourse. "Prevention of HIV itself was based on" always use a condom ".

For him, policies that provide health resources such as access to condoms, testing, and treatment are important, but concentrating on prevention efforts rather than discussing sexual practices create a kind of mist that prevents prevention.

"We have to save the idea of ​​safer sex and long-term education. Preventive pedagogy that looks at the life, the sexual trajectory of this person. Where condoms are an important factor, but also how people negotiate more or less risky behavior with agreed security, all this implies a broader approach.

Restructuring the department

Days after talking to the report on the emphasis on sexual practices, the Ministry of Health underwent a restructuring. The department responsible for coordinating the response to sexually transmitted epidemics such as AIDS and syphilis has been renamed to the Department of Chronic Diseases and Sexually Transmitted Diseases. The change does not materialize simply as a kind of slavery nomenclature. The area begins to respond to various types of chronic diseases, from AIDS to leprosy to spinal cord.

This move was criticized by representatives of civil society and class units such as the Federal Medical Board (CFM). – I do not think that helps. I do not think this change is a solution to anything, "says CFM Secretary Pediatrician Sidney Ferreira.

Kalichman is trying to understand the change. – I think that's a set of things. Perhaps the attempt to eradicate the leading role of AIDS in this sense is not good.

In a note, the Ministry of Health explained that "the new regimental structure encourages greater integration between the areas of the Ministry of Health, which seeks to rearrange the activities and decision-making of public policies for the benefit of the population and better governance of the Single health system ) ".

Among the institutions criticizing Abia, who also published a note, refuted the arguments of the federal government, at risk of the measure, fragmenting the department, spurred the resource dispute and compromised the effectiveness of public health policy.

For Veriano, more than the lack of penicillin, the Ministry of Health may put "a fire boiler on the epidemic of syphilis and other sexually transmitted diseases."

Source: Portal Brasil de Fato


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