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There are pharmacies that perform the new rapid antigen tests without complying with the technical requirements demanded by the General Directorate of Health, Infarction and the National Institute of Health Dr. Ricardo Jorge to all entities already authorized to carry out the examination or others that come. to be so.
Last Friday a joint informative circular was signed that determines that, at this stage, the performance of these rapid tests for the detection of the new coronavirus is limited to “establishments that provide health care, with valid registration before the Health Regulatory Authority, since duly qualified for the collection and laboratory diagnosis ”. Such, considers the professor of Health Law, Paula Lobato de Faria, from the National School of Public Health, excludes pharmacies, which according to the Basic Health Law, are not entities that provide health care.
The public health authorities admit in the circular that, in a second phase, “other entities will be defined at later times, due to the evaluation of the implementation of this circular, the epidemiological situation in the country and the needs identified at the regional and regional level. local”.
In any case, the joint circular makes it clear that “all entities that perform rapid antigen tests must meet” certain requirements. Among these requirements is the obligation to have a space dedicated to crops; the sample is collected by an experienced healthcare professional with specific training to collect samples from the upper respiratory tract – which is done with a swab (a kind of long swab) that is inserted into the nose or mouth up to the pharynx; the need for this professional to use personal protective equipment and comply with biosecurity standards, since we are faced with possible pathogens that cannot go to normal trash.
In addition to these requirements, it is necessary for whoever performs the analysis to guarantee that “the results are inserted into the National Epidemiological Surveillance System – SINAVE within 12 hours after the test is performed.” The circular warns that it is mandatory to notify “all the results obtained (positive, negative and inconclusive)” derived from a regulation of the General Directorate of Health on antigen testing, which came into effect on the 9th of this month.
And here lies the main problem. Pharmacies do not have, at least until now, access to this computer platform, and they are not communicating the results of these tests to the General Directorate of Health, as is mandatory. This requirement, explains Paulo Lobato de Faria, is justified because the pandemic is something that goes beyond the private dimension due to the need to know who is infected, to avoid the spread of the new coronavirus. “Making a swab at this time is something that has a public dimension”, underlines the specialist in Health Law.
The National Association of Pharmacies, which, unlike the Ordem dos Farmacêuticos, is categorical in saying that pharmacies are authorized to perform rapid antigen tests, sees no problem in the absence of notification. “In compliance with current legislation, positive results are communicated by the user to the health authorities through the SNS24 line, or by the pharmacist if duly authorized by the same,” he says in response sent to the PUBLIC.
Paula Lobato de Faria has another vision. “If pharmacies want to carry out these tests, they have to be equipped with the system to notify the results of the tests and comply with the rest of the conditions,” defends the specialist from the National School of Public Health. The teacher considers it a “danger” that tests are carried out without at least the health authority knowing the positive ones. “We cannot have people who take the test, test positive and then stay with the god-god,” he emphasizes.
Notifications and recipes
The Order of Pharmacists also says that it is analyzing the joint circular and Infarmed did not want to clarify whether, at this stage, pharmacies are or cannot carry out, at this stage, rapid antigen tests, which detect proteins on the surface of the virus in the Our organism. This despite the fact that the PUBLIC asked for more than two weeks to clarify the matter and this week insisted on the need to clarify the situation. In the first response, given at the end of October, Infarmed referred to only two circulars that experts do not consider enlightening. And this Wednesday he added the circular from last Friday and the rule that came into force on the 9th, promising a response for later, which did not arrive.
Among the pharmacies that PUBLIC found to carry out these tests is Aliança, in Porto, which charges 25 euros for the exam carried out by a nurse. Interested users are informed that this “is not an official result” and is not used, for example, to obtain medical discharge. Sofarma, the group that owns seven pharmacies in the northern region of the country, only performs the test at home, charging 50 euros for the service, which they assure has to be subsequently validated through a molecular test.
Pedro Veiga, one of the owners of Farmácia Frielas and a parapharmacy located in the Ikea de Loures car park, has a different opinion and experience, who does these tests for 30 euros. The pharmacist admits that we are currently “in a gray area” and recalls that the tests are certified and authorized by Infarmed. “They are like the Red Cross does it,” he argues. He says that this Wednesday he detected a positive case in an asymptomatic patient and learned that people had contacted the SNS 24, having at the end of the day the health delegate validated the positive diagnosis.
Pedro Veiga guarantees that he is not doing these tests for money, but only to help break the chains of transmission. “There is no margin. The 30 euros pay 23% VAT and are used to pay for the test, the disposable gown, the gloves and the work of those who perform it ”, he assures. None of the other pharmacies responded in time to the PUBLIC’s requests for clarification.
Pedro Veiga’s allusion to the Red Cross is pertinent. Until recently, the body only reported positive results, since it does not have access to the SINAVE Lab, a platform used by analysis laboratories, but only the Med, intended for doctors. It is a question that Gonçalo Órfão, the national coordinator of this project, guarantees to be out of date: “Until now, we have always communicated the positive results. At this time, we have a direct communication to the SINAVE Lab and all the results are recorded [positivos e negativos]”.
But there is a condition in the circular that very few meet, including some of the largest networks of private laboratories, such as Unilabs (even for molecular tests, known as PCR), or others, such as the Red Cross. This is the prescription necessary to perform antigen tests. “We have to realize that all tests are complementary diagnostic tests. It is recommended that there is a medical prescription and medical monitoring. We have reinforced that the medical prescription is something that must exist and that is what the guide says ”, says Gonçalo Órfão, admitting that they do the test even without this prescription. With Miguel Dantas
