Since the end of 2021, Brazil has been facing a complete lack of centralized information on the sales of prescription drugs, which require prescription retention and range from antibiotics, antidepressants and anxiolytics, to narcotics such as morphine.
O R7 took the case to the CGU (Comptroller General of the Union) and was informed that after facing “limitations of technological infrastructure” the regulatory agency released all private pharmacies and hospitals from sending medication information. The process has become optional.
The decision was formalized in RDC (Collegiate Board Resolution) 586, of December 17, 2021, signed by the CEO of Anvisa, Antonio Barra Torres.
The document establishes that “the deadlines for transmission of electronic files (XML) are suspended for an indefinite period […] related to stock movements of medicines and pharmaceutical control supplies […] subject to bookkeeping in the National Controlled Products Management System (SNGPC)”.
On the SNGPC data dissemination platform, the agency states that, due to the RDC, “it is not possible to provide accurate information on sales of substances and drugs subject to special control”.
With the decision, Anvisa contradicts one of its competences established in the agency’s creation law (9,782/1992), which includes “regulating, controlling and inspecting products and services that involve risk to public health”.
Sanitary doctor, founder and first CEO of Anvisa, Gonzalo Vecina Neto, understands that inconsistencies in SNGPC information are a serious problem.
“She [Anvisa] has a legal delegation to carry out all this control of all medicines in all stages of production and marketing. The non-functioning of the national system is serious. Until 2014, it was up and down paper, paper that nobody checked. […] The fact is that the absence of the national system prevents us from knowing what is happening”, he says.
For the advisor for the state of Rondônia at the CFF (Federal Council of Pharmacy), Jardel Moura, if there was already a precariousness in the control of medicines and substances by the public power, now the problem is even more serious.
“At this moment, the public power, the health authority, which would be Anvisa, no longer has control. Even so, the rules – ordinance 344 and RDC 471 – remain in force and oblige pharmaceutical professionals and establishments to continue doing this control, especially when dispensing these medications”, he says.
Moura points out that, although most establishments and pharmacists follow the rules when selling medicines, there are those who see the unavailability of the SNGPC as an opportunity for fraud.
“The SNGPC came to complement this situation, so as not to create even more of a gap [à venda sem controle]. It was much more bureaucratic, but it helped a lot. With the suspension, it is possible for pharmacies that do not work seriously to circumvent the system, especially outside of large centers.”
Now all pharmacies only need to keep internal records of purchases and sales that are subject to inspection by the Sanitary Surveillance of each municipality, which comes up against, according to the CFF counselor, the lack of professionals for these actions.
Sensitive medicines without control
Vecina Neto cites as an example a drug that is problematic in the United States, oxycodone, a potent opioid analgesic that is sold here (up to 40 mg) with a double prescription — the same type used to buy antibiotics, for example.
“It has a formulation that prevents you from having blood spikes from the product. That is, you take a pill every 12 hours, take a little dip and keep the amount of analgesic circulating. As there is no spike, in theory, it is not addictive But it turned out that if you take the oxycodone tablet, grind it up and take the powder, it peaks, it breaks the pharmaceutical formulation, and it doesn’t have a slow absorption. That’s what the Americans were doing with this product. lots of people dying there from overdoses.”
Without information, there is no way to identify possible problems, especially indiscriminate use and abuse.
The sanitarista understands that the system is a bureaucracy, but that it aims to “control the inappropriate use of medicines and access in a clinically adequate way to medicines that are vital”.
“The SNGPC was born with this idea. It had been thought about since when Anvisa was created. We knew that all of this could be computerized. You have to have a little system that has a huge volume of data, because every month, all pharmacies, hospitals and clinics have to feed”, he adds.
The lack of data on the sale of antibiotics, for example, is another risk that Brazil runs, since it is not possible to monitor a class of drugs that needs to be consumed with great caution.
The WHO (World Health Organization) has issued repeated warnings about the increase in bacterial resistance to currently used drugs, largely because of overuse, which has increased in recent years, with the Covid-19 pandemic.
System will come back?
The CGU charged Anvisa, but so far there is no prediction of when the supposed technical problem will be solved.
O R7 also got in touch with the inspection agency, which was not even able to say whether it will be possible to have, when the system is restored, data on prescription drugs sold during the blackout period.
The CFF adviser imagines that the agency will launch a new system, capable of meeting control needs.
For the founder of Anvisa, the agency’s board “should be called to account” and present solutions, including an efficient system, to maintain the transparency of information that is fundamental for Brazilian public health.
What does Anvisa say?
In a note sent to R7the agency points out that “pharmacies and drugstores remain obliged to keep records of the sale of controlled drugs” and that “when a specific survey or investigation is necessary, the agency requests, by traditional means, the sending of data”.
It also states that “the inspection of the sale of controlled products and the data generated continues to be carried out on a regular basis, by local health surveillance agencies (municipalities and/or states) considering that in Brazil the inspection takes place in a decentralized and complementary way”.
Regarding the data, Anvisa says it has “auxiliary computerized data”, such as those from the CMED (Chamber of Regulation of the Medicines Market), “which demonstrate sales volumes from manufacturers to resellers”.