HEALTH: Brazil will have two leaflets at the end of the year
This article was translated by an automatic translation system, and was therefore not reviewed by people.
SAO PAULO, By the end of the year, Brazil will have two leaflets for medicines: one with technical language, aimed at doctors, and another dedicated to patients, with more didactic information.
The will of the patient leaflet inside the box of medicine, while the other is electronic, available on the site of Anvisa (National Health Surveillance Agency). Patients also can access it. The letters and the spacing between paragraphs in the text of the leaflet should be larger, to facilitate the reading of texts. These and other proposals in a public consultation of Anvisa ending on 24.
Some studies suggest that the leaflets of medicines sold in the country are incomplete, too technical for the lay public and surface and out to the doctors.
In 2008, the Idec (Brazilian Institute for Consumer Protection) evaluated 19 drug leaflets (antidepressants, tranquilizers, anti-inflammatory, vasodilatory, antirreumáticos and drugs against high blood pressure and to lower cholesterol) and found several problems.
Among them, found significant differences between the information of the reference drugs and their generic or similar, although the effect should be the same.
The institute also compared with the U.S. national leaflets. In the U.S., the anti-inflammatory stressed the risk of death from cardiovascular problems. In Brazil, two anti-inflammatory (diclofenac Voltaren and generic) has not brought this alert.
According to general manager of the drugs Anvisa, Nur Shuqair, with new leaflets, these problems will be solved.
"All have the same technical information, the same model of leaflet. This will help both the supervision and the professionals who prescribe and dispense medicines, which can be confused with the differences," says Shuqair.
Another case of entities of consumer protection and monitoring of medicines is the lack of periodic updating of leaflets. The doctor sanitarista José Ruben de Alcântara Bonfim, coordinator of Sobravime (Sociedade Brasileira de Vigilância de Medicamentos), with the current format of the leaflet, or doctors or patients to have a complete and updated information.
"There was much more flexibility in publishing, for example, new adverse effects that were not foreseen," says Bonfim. Shuqair of Anvisa, reports that, with the bulário email, the update of the information gain agility.
Bonfim also supports a comprehensive review of the technical terms of the bull, which in its evaluation, only to ease understanding. "Who knows what xerodermia? It is easier to write dry skin?" Questions.
Source: Folha de São Paulo
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