International Harmonization of Good Pharmacovigilance Practices: Impact on Brazil

Introduction: As in other areas of health management, in Pharmacovigilance it is essential to know the results of interventions carried out and evaluate their impact on decision-making. In this regard, the World Health Organization (WHO) has published references to key performance indicators (KPIs) for Pharmacovigilance systems [1,2]. In Brazil, the Pharmacovigilance Office (GFARM) of the Brazilian Health Regulatory Agency (Anvisa) published, in 2020, a Brazilian standard on good pharmacovigilance practices (GVP) that are in line with the world's leading regulatory agencies. Objective(s): To evaluate the impact of the change in Brazilian Pharmacovigilance regulations on the demand for post-marketing monitoring of drugs at the Anvisa. Method(s): This is a before-and-after descriptive, retrospective, documentary analysis study. In it, the impact of Resolution RDC 406/20, a new standard for GVP published in July 2020, was evaluated using a set of seven KPIs focused on the internal demands of GFARM/ Anvisa. The analyzed period was divided into a before (from July 2019 to June 2020-nb) and an after (from August 2020 to July 2021- na). Result(s): In the comparison, it was possible to observe an increase in all the KPIs analyzed: 10.0% for the number of risk communications made (nb = 20;na = 22), 85.5% for the number of Adverse Drug Reaction (ADR) received (nb = 30035;na = 55723), 38.0% for the number of non-serious ADR (nb = 24257;na = 33476), 285.0% for the number of severe ADR (nb = 5778;na = 22247), 84.1% for the number of notifications of ADR per million inhabitants (nb = 142.4;na = 262.2), 26.0% for the number of technical processes (nb = 998;na = 1257), and 9.5% for the number of technical documents generated (nb = 483;na = 529). Furthermore, when analyzing the number of professionals involved in the demands in each period, a reduction of 10.3% in the average number of GFARM professionals was confirmed (nb = 14.5;na = 13). Conclusion(s): Although there was a reduction in the team, there was an increase in the demand from GFARM/Anvisa with the change in Pharmacovigilance regulations. This may have occurred because of rules in line with the world's leading standards, but also because of the demand of the Covid-19 pandemic. Once implemented, management through KPIs must be ongoing to qualify the management process and the area's decision-making.

International Harmonization of Good Pharmacovigilance Practices: Impact on Brazil: An International Journal of Medical Toxicology and Drug Experience

Introduction: As in other areas of health management, in Pharmacovigilance it is essential to know the results of interventions carried out and evaluate their impact on decision-making. In this regard, the World Health Organization (WHO) has published references to key performance indicators (KPIs) for Pharmacovigilance systems [1,2]. In Brazil, the Pharmacovigilance Office (GFARM) of the Brazilian Health Regulatory Agency (Anvisa) published, in 2020, a Brazilian standard on good pharmacovigilance practices (GVP) that are in line with the world's leading regulatory agencies. Objective: To evaluate the impact of the change in Brazilian Pharmacovigilance regulations on the demand for post-marketing monitoring of drugs at the Anvisa. Methods: This is a before-and-after descriptive, retrospective, documentary analysis study. In it, the impact of Resolution RDC 406/20, a new standard for GVP published in July 2020, was evaluated using a set of seven KPIs focused on the internal demands of GFARM/ Anvisa. The analyzed period was divided into a before (from July 2019 to June 2020-nb) and an after (from August 2020 to July 2021na). Results: In the comparison, it was possible to observe an increase in all the KPIs analyzed: 10.0% for the number of risk communications made (nb = 20;na = 22), 85.5% for the number of Adverse Drug Reaction (ADR) received (nb = 30035;na = 55723), 38.0% for the number of non-serious ADR (nb = 24257;na = 33476), 285.0% for the number of severe ADR (nb = 5778;na = 22247), 84.1% for the number of notifications of ADR per million inhabitants (nb = 142.4;na = 262.2), 26.0% for the number of technical processes (nb = 998;na = 1257), and 9.5% for the number of technical documents generated (nb = 483;na = 529). Furthermore, when analyzing the number of professionals involved in the demands in each period, a reduction of 10.3% in the average number of GFARM professionals was confirmed (nb = 14.5;na = 13). Conclusion: Although there was a reduction in the team, there was an increase in the demand from GFARM/Anvisa with the change in Pharmacovigilance regulations. This may have occurred because of rules in line with the world's leading standards, but also because of the demand of the Covid-19 pandemic. Once implemented, management through KPIs must be ongoing to qualify the management process and the area's decision-making.

Insights for Alzheimer's disease pharmacotherapy and current clinical trials.

Over the years, the scientific community has sought improvements in the life quality of patients diagnosed with Alzheimer's disease (AD). Synaptic loss and neuronal death observed in the regions responsible for cognitive functions represent an irreversible progressive disease that is clinically characterized by impaired cognitive and functional abilities, along with behavioral symptoms. Currently, image and body fluid biomarkers can provide early dementia diagnostic, being it the best way to slow the disease's progression. The first signs of AD development are still complex, the existence of individual genetic and phenotypic characteristics about the disease makes it difficult to standardize studies on the subject. The answer seems to be related between Aß and tau proteins. Aß deposition in the medial parietal cortex appears to be the initial stage of AD, but it does not have a strong correlation with neurodegeneration. The strongest link between symptoms occurs with tau aggregation, which antecede Aß deposits in the medial temporal lobe, however, the protein can be found in cognitively healthy older people. The answer to the question may lie in some catalytic effect between both proteins. Amid so many doubts, Aducanumab was approved, which raised controversies and results intense debate in the scientific field. Abnormal singling of some blood biomarkers produced by adipocytes under high lipogenesis, such as TNFα, leptin, and interleukin-6, demonstrate to be linked to neuroinflammation worsens, diabetes, and also severe cases of COVID-19, howsoever, under higher lipolysis, seem to have therapeutic anti-inflammatory effects in the brain, which has increasingly contributed to the understanding of AD. In addition, the relationship of severe clinical complications caused by Sars-CoV-2 viral infection and AD, go beyond the term "risk group" and may be related to the development of dementia long-term. Thus, this review summarized the current emerging pharmacotherapies, alternative treatments, and nanotechnology applied in clinical trials, discussing relevant points that may contribute to a more accurate look.

Environmental restraint of the elderly in long-term care facilities in times of Covid-19: theoretical reflection

A theoretical and reflexive study addressing the phenomenon of environmental restraint in long-term care facilities for the elderly, presenting the topic under the light of human rights and the legislation in force, which postulate good care practices to institutionalized elderly even in the face of the Covid-19 situation. By considering the negative impacts of environmental restraint on the physical and mental health of the elderly, it is suggested that the technical team of long-term care institutions for the elderly should be better trained, and that the phenomenon needs to be explored to guarantee more dignified conditions that respect the freedom of the elderly.