Reações adversas a medicamentos do “kit Covid” no Brasil: estudo comparativo entre os períodos antes e durante a pandemia de SARS-CoV-2

Abstract

In December 2019, numerous patients in Wuhan, China, were diagnosed with atypical pneumonia of an unknown origin. This new comorbidity, later named COVID-19 (Coronavirus Disease 2019), caused by the etiological agent, SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2), was classified as a pandemic in March 2020 by the World Health Organization (WHO). Despite the lack of scientific evidence of efficacy or clinical effectiveness for the prevention or treatment of COVID-19, several drugs gained great credibility in Brazil, especially azithromycin, (hydroxy)chloroquine and ivermectin, referred to as the "COVID Kit". This scenario resulted in greater vulnerability of the population to Adverse Drug Reactions (ADRs) and, consequently, a possible increase in morbimortality and encumbrance on the Brazilian Unified Health System (SUS). Hence, this is a descriptive-comparative study of suspected ADRs linked to the "COVID Kit" recorded on VigiMed, a secondary database linked to the pharmacovigilance center of the National Health Surveillance Agency (Anvisa). Thus, the aim was to compare and analyze ADRs, notifier profiles and patient profiles before and during the SARS-CoV-2 pandemic in the country. For this purpose, the chi-square and Fisher's exact tests were used for the qualitative variables, as well as the "t" and "u" tests for the quantitative variables. Subsequently, the variables were then subjected to multivariable logistic regression in order to select those with statistical significance (p<0.05). A total of 426 notifications of suspected ADRs were recorded during both studied periods, with a vertiginous increase during the pandemic, which accounted for 93,19% of the total (n=397). ADRs before the pandemic mostly affected the cutaneous and subcutaneous tissue (34.4%), while during the pandemic they were mainly concentrated in the cardiac system (41.8%). These findings can be explained by the use of the drugs in question in high off-label doses, drug interactions and the patient's own profile, increased by mechanisms of the SARS-CoV-2 infection. In regards to the profile of affected patients: before the pandemic, the average patient was typically 30.3 years and female; during the pandemic, the average was 56.3 years and male. These results could possibly be linked to the higher severity with which ADRs affect men, and the greater sensibility of the elderly population to their adverse effects. In addition, regardless of the period analyzed, pharmacists remained the main notifiers. This reflects the engagement and importance of these healthcare professionals in reporting ADRs in Brazil, as well as the emerging need for greater participation by other professionals. Thus, this study provides data for more assertive prevention planning and combating ADRs, as well as avoiding possible worsening of morbimortality among the population.