Uso off-label da ivermectina na COVID-19
Off-label medication is one whose indication differs from what is stated in the package insert, being used for a purpose other than that authorized by the country's regulatory body, in relation to age, dose, therapeutic indication, or route of administration. This practice of repositioning medi...
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| Formato: | bachelorThesis |
| Idioma: | pt_BR |
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Universidade Federal do Rio Grande do Norte
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| Endereço do item: | https://repositorio.ufrn.br/handle/123456789/33353 |
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| Resumo: | Off-label medication is one whose indication differs from what is stated in the package insert, being used for a purpose other than that authorized by the country's regulatory body, in relation to age, dose, therapeutic indication, or route of administration. This practice of repositioning medications has been common for the treatment of COVID-19, as it is caused by a new virus, which is still being studied and understood by the scientific community, and there is no specific medication for its treatment, apart from vaccines. The aim of this study is to address the off-label use of Ivermectin in the treatment of COVID-19, its implications for therapy and the role of the pharmacist in relation to repositioned drugs, given the great politicization of its use in the pandemic caused by SarsCov- two. From a brief descriptive literature review, a search was performed in the electronic databases of Science Direct and Scientific Electronic Library Online (SciELO) and Academics Google Search, with the search engine that included “Ivermectin in COVID-19”, whose approaches complemented the discussion. Most studies available in the literature are supported by in vitro therapeutic responses and the recommendation for use in humans has been based on the findings of these studies. In vitro study performed by CALY, L. et al., (2020), Ivermectin showed a 93% reduction of the genetic material of SARS-CoV-2 in 24 hours and a 99.8% reduction after 48 hours. However, in silico studies indicated that plasma concentrations of Ivermectin did not reach the effective concentration (EC 50%). A recent study published in the Journal of the American Medical Association (JAMA) evaluated whether Ivermectin would improve symptoms in people with COVID-19 when used in the first days of infection, and the result was that the drug made no difference when used early. Despite the positive in vitro results, it is not yet possible to know whether the efficacy will be repeated in use in humans, remaining as unproven for COVID-19. Considering that research on the off-label use of Ivermectin in COVID-19 that occurs with medical prescription or by self-medication were mostly ineffective, this study aims to contribute to the importance of the pharmacist in therapy, clarifying to patients who question at all times about the influence of the aforementioned drug in the pathological process of COVID-19, clinical trials are still needed for an unequivocal evaluation of its clinical effectiveness, while respecting the medical autonomy regarding the prescription and consent of the patient. It should also inform that its prior license for other pathologies (off-label use), must be preceded by randomized, controlled and consolidated clinical trials, in accordance with research ethics, so that this drug is eligible for the treatment of COVID-19. |
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