Brazilian Health Regulatory Agency Research Articles

Bioequivalence of lisdexamfetamine dimesylate hard capsules formulations

Lisdexamfetamine (LDX), an inactive prodrug of dexamphetamine, is used as a second-line treatment for attention deficit hyperactivity disorder (ADHD) and for moderate to severe binge eating disorder (BED). The objective of this study is to evaluate the bioequivalence of two LDX formulations, including the reference product manufactured by Patheon Pharmaceuticals (Venvanse® 70 mg) versus a formulation manufactured by Eurofarma Laboratórios S/A. A randomized, crossover, open-label study was conducted with two treatments, two periods, two sequences, and 48 healthy participants of both sexes who received oral administration of the medications. A total of 24 blood samples were collected from each participant, from T0 (before taking the medication) to 10 hours later. The plasma concentration of LDX was quantified using liquid chromatography coupled with mass spectrometry (LC-MS/MS). Both formulations were well tolerated, and no serious adverse events were reported. Cmax and AUC0-t were compared: the ratio between the test and reference formulations for Cmax was 106.22% with a 95% confidence interval (CI) of 97.72% - 116.66% and a power of 98.75%. The ratio between the test and reference formulations for AUC0-t was 106.28%, CI (100.68% - 112.19%), with a power of 100.00%. The ratio between the test and reference formulations for AUC0-inf was 106.29%, CI (100.71% - 112.17%), with a power of 100.00%. The formulations were shown to be statistically bioequivalent in terms of their rate and extent of absorption, based on criteria established by the Brazilian Health Regulatory Agency (ANVISA).

12580 Factitious Cushing’s Syndrome Secondary To Indiscriminate Use Of Brazilian Herbal Medicine: Case Report

Abstract Disclosure: L. Warszawski: None. K.F. Seidel: None. C. Padilla: None. V.N. de Souza: None. J.R. Calmon: None. Background: Herbal medicines are obtained exclusively from active plant raw materials, which leads people to believe that these medications are safer and free from side effects. Moreira milk is a Brazilian herbal medicine used mainly for its supposed anti-inflammatory properties. This medication is not regulated by The Brazilian Health Regulatory Agency (Anvisa). Herein we report a case of exogenous Cushing's Syndrome (CS) caused by continuous use of Moreira milk. Case report: A 53-year-old female patient was seen in October 2018 at the endocrinology clinic due to progressive weight gain, mood swings, edema and weakness of the lower limbs, violet streaks on the flanks, easy bruising and dorsocervical fat pad. She brought tests to our specialized consultation that showed low basal cortisol (0.4 mcg/dL - RR 5 to 25 mg/dL) and ACTH ( %lt; 5 pg/ml - RR 10 to 60mg/dL), two HbA1c values above 6.5% and a sella turcica MRI revealing normal-sized pituitary gland with a hypo-enhancing contrast area, possibly corresponding to a microadenoma. New tests were carried out which showed the maintenance of low basal cortisol and ACTH. The patient reported background use of losartan and Moreira milk for 2 years - as a phytotherapy to control joint pain after Chikungunya. She denied use of topical, inhalatory or oral corticoids. Exogenous CS was suspected and the use of Moreira milk was interrupted. We proceeded to use prednisone for weaning, which had to be gradual, but the patient progressed with clinical improvement. Conclusion: There are some cases of hypercortisolism associated with herbal medicines, the majority of which are due to contamination with synthetic glucocorticoids, as is believed to occur with Moreira milk. Despite being widely sold in Brazil, because it is not approved by ANVISA, the production cannot be inspected, therefore, can be contaminated. Those cases of exogenous CS are challenging, and misidentifying Cushing's syndrome can result in a series of improper treatments with severe repercussions. Presentation: 6/1/2024

Experiences and Initiatives on Pharmacokinetics Modeling and Simulation Data analyses: Perspectives from the Brazilian Health Regulatory Agency (ANVISA).

The landscape of drug product development and regulatory sciences is evolving, driven by the increasing application of systems thinking and modeling and simulation (M&S) techniques, especially from a biopharmaceutics perspective. Patient-centric quality standards can be achieved within this context through the application of quality by design (QbD) principles and M&S, specifically by defining clinically relevant dissolution specifications (CRDS). To this end, it is essential to bridge in vitro results to drug product in vivo performance, emphasizing the need to explore the translational capacity of biopharmaceutics tools. Physiologically based M&S analyses offer a unique avenue for integrating the drug, drug product, and biological properties of a target organism to study their interactions on the pharmacokinetic response. Accordingly, Physiologically Based Biopharmaceutics Modeling (PBBM) has seen increasing use to support drug development and regulatory applications globally. In Brazil, a Model-Informed Drug Development (MIDD) policy and strategic project are not yet established, limiting applicability of M&S techniques. Drawing from the experience of the ANVISA-Academia PBBM Working Group (WG), this article assesses the opportunities and challenges for pharmacometrics (PMx) in Brazil and proposes strategies to advance the adoption of M&S analyses into regulatory decision-making.

HEMATOPOIETIC CELL TRANSPLANTATION (HCT) FOR ALL: A report from the 2024 Congress of the Brazilian Bone Marrow Transplantation and Cellular Therapy Society (SBTMO)

This article analyzes current data, and the main challenges faced in Hematopoietic cell Transplantation (HCT) in Brazil, as presented at the SBTMO 2024 meeting, with the aim of guiding future actions. Topics discussed included the waiting list for HCT transplants, access to beds for adults and pediatric patients, and the need for a more efficient distribution of resources across the country. Among the identified needs were the creation of a program to expand access to transplants through the Brazilian Unified Health System (SUS), the importance of health registries for data-driven decisions, and the development of the "Mais Saúde Amazônia" project to expand transplant centers in the Amazon region. Additionally, the provision of financial incentives for transplant centers, the implementation of mentorship programs to increase access to HCT, and the formation of a cooperative network between SBTMO (Brazilian Society of Bone Marrow Transplantation and Cellular Therapy), ABHH (Brazilian Association of Hematology, Hemotherapy, and Cellular Therapy), ANVISA (Brazilian Health Regulatory Agency), ABRALE (Brazilian Association of Lymphoma and Leukemia), and INCA (Brazilian National Cancer Institute) to improve the integration of HCT services were discussed

Open Exceptions: Why Does the Brazilian Health Regulatory Agency (ANVISA) Exempts RIA and Ex Post Reviews?

Abstract In this article, we examine the evolving landscape of Regulatory Impact Assessment (RIA) decisions made by the National Health Regulatory Agency (Agência Nacional de Vigilância Sanitária [Anvisa]), a prominent federal agency leading RIA implementation in Brazil. We quantify Anvisa’s RIA usage rates, exploring the influence of emergency and other justifications for RIA exemptions both pre and post the enactment of detailed procedural requirements in a recent Presidential Order No. 10,411/2020. Our quantitative analysis shows a sharp decline in RIA usage after Presidential Order No. 10,411/2020 came into force in April 2021, as well as a diversification of the justifications given in decisions not to use RIA (exception decisions). This effect is present even if we take into consideration a large proportion of exception decisions tied to Anvisa’s regulatory stock review and to urgent measures prompted by the COVID-19 pandemic. Additionally, we conduct a qualitative analysis of exception decisions due to emergency, post-Presidential Order. We find that Anvisa failed to provide compelling justifications for exempting RIA in emergency regulations in several cases and avoids ex post reviews when RIAs are waived due to emergencies. We conclude the article with recommendations to enhance the scrutiny and transparency of Anvisa’s exception decisions to conduct RIA.

New Oncologic Drugs from 2008 to 2023-Differences in Approval and Access between the United States, Europe and Brazil.

Advancements in oncology have revolutionized cancer treatment, with new drugs being approved at different rates worldwide. Our objective was to evaluate the approval of new oncological drugs for solid tumors by the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Brazilian Health Regulatory Agency (ANVISA) since 2008. Data were collected from public and online databases by searching for the date of submission, the date of the procedure, the date of approval, clinical indication, and drug characteristics. The distribution was tested using the Shapiro-Wilk, test and comparisons were made using the Mann-Whitney U test; the data are reported using median days and interquartile range (IQR1-IQR3). In total, 104 new oncologic drugs for the treatment of solid tumors were approved by the three agencies: 98 by the FDA, 90 by the EMA, and 68 by ANVISA. The cancer types with the highest number of first indications were lung cancer (n = 24), breast cancer (n = 15), and melanoma (n = 15). Most approvals were for oral medications (n = 63) and tyrosine-kinase inhibitors or other small-molecule inhibitors (n = 54). Time to approval after submission was as follows: the FDA-224 days (167-285); the EMA-364 days (330-418); and ANVISA-403 days (276-636) (p < 0.00001 for the FDA to the EMA and the FDA to ANVISA). The difference between submission dates among the agencies was as follows: EMA-FDA: 24 days (0-85); ANVISA-FDA: 255 (114-632); and ANVISA-EMA: 260 (109-645). The difference in approval dates between the agencies was as follows: EMA-FDA: 185 days (59-319); ANVISA-FDA: 558 (278-957); and ANVISA-EMA: 435 days (158-918). New oncologic drugs are submitted to the FDA and EMA for approval on similar dates; however, the longer appraisal period by the EMA pushes the approval date for Europe to approximately 6 months later. The same steps at ANVISA delay the approval by 1.5 years. Such procedures cause a significant difference in available medications between these regions.

Consumption of antibiotics in Brazil - an analysis of sales data between 2014 and 2019

BackgroundAntibiotic consumption is a driver for the increase of antimicrobial resistance. The objective of this study is to analyze variations in antibiotic consumption and its appropriate use in Brazil from 2014 to 2019.MethodsWe conducted a time series study using the surveillance information system database (SNGPC) from the Brazilian Health Regulatory Agency. Antimicrobials sold in retail pharmacies were evaluated. All antimicrobials recorded for systemic use identified by the active ingredient were eligible. Compounded products and formulations for topic use (dermatological, gynecological, and eye/ear treatments) were excluded. The number of defined daily doses (DDDs)/1,000 inhabitants/day for each antibiotic was attributed. The number of DDDs per 1,000 inhabitants per day (DDIs) was used as a proxy for consumption. Results were stratified by regions and the average annual percentage change in the whole period studied was estimated. We used the WHO Access, Watch, and Reserve (AWaRe) framework to categorize antimicrobial drugs.ResultsAn overall increase of 30% in consumption from 2014 to 2019 was observed in all Brazilian regions. Amoxicillin, azithromycin and cephalexin were the antimicrobials more consumed, with the Southeast region responsible for more than 50% of the antibiotic utilization. Among all antimicrobials analyzed 45.0% were classified as watch group in all Brazilian regions.ConclusionWe observed a significant increase in antibiotics consumption from 2014 to 2019 in Brazil restricted to the Northeast and Central West regions. Almost half of the antibiotics consumed in Brazil were classified as watch group, highlighting the importance to promote rational use in this country.

Discrepancies in therapeutic indications for the same oncology drugs among FDA, EMA, and Brazilian agency.

e23035 Background: Divergent marketing approvals for oncology drugs among prominent agencies can prompt questions, especially when they are grounded in the same evidence. The aim of this study was to evaluate and compare the assessment and approval processes for novel products and indications by the FDA, EMA, and the Brazilian Health Regulatory Agency (ANVISA). Methods: Therapeutic indications for FDA-approved anticancer drugs from January 2019 to December 2023 were identified. Data, including approval dates, details on authorization procedures and evidence presented, were extracted from the databases of the FDA, EMA, and ANVISA. Only approvals for non-hematologic solid tumors were considered. All data were publicly available, and ethical approval was not required. No patient involvement occurred in this study. Results: Between 2019 and 2023, the FDA granted approval for 154 therapeutic indications for marketing authorization, resulting from 148 pivotal trials. The predominant cancer types during this period were non-small cell lung cancer (31 approvals [20.1%]). Most trials were in phase III (66.8%) and randomized (68.1%). Additionally, 41 (26.6%) received accelerated approvals, with 6 subsequently obtaining regular approvals. Among the therapies, 66 trials (42.8%) involved active comparators, while 53 (34.4%) and 35 (22.7%) were single-arm and placebo-controlled trials, respectively. Approximately half (74 [48%]) of the therapies were approved for metastatic first-line treatment, 54 (35%) for second-line treatment, and the rest for neoadjuvant and/or adjuvant treatment. Regarding endpoint characteristics supporting approval, the most prevalent was a combination of objective response rate (ORR) + duration of response (DoR) (38 [24.6%]), followed by progression-free survival (PFS) + overall survival (OS) (31 [20.1%]). When comparing the 154 FDA-approved indications, 50 (32.4%) were not approved by EMA, and 60 (38.9%) were not approved by ANVISA. Furthermore, in 33 cases (21.4%), there were disparities in clinical indications between the FDA and EMA, primarily related to the target population specification, with 10 cases (6.4%) attributed to programmed death ligand-1 (PD-L1) expression. Notably, in these instances, the FDA approved the drug regardless of PD-L1 expression, while the EMA required a percentage of cells with PD-L1 expression. In all these cases, ANVISA aligned with the FDA's assessment. Conclusions: Significant clinical disparities were identified in the outcomes of the approval process for oncology products among the FDA, EMA, and ANVISA. Additional efforts are needed to standardize decision-making across regulatory systems.

Abstract PO1-17-04: Influence of regulatory agency approval of trastuzumab-deruxtecan on the diagnosis of HER2-low status at a reference cancer center in Brazil

Abstract BACKGROUND HER-2 low status is defined by immunohistochemistry (IHC) expression for human epidermal growth factor receptor 2 (HER-2) 1+ or IHC 2+ without gene ERBB2 amplification. HER2-low breast cancers (BC) accounted for approximately 55% of all cases, and among hormone receptor positive (HR+) tumors it represents up to 60% of patients (pts), while 10-20% in triple negative tumors (TNBC). Trastuzumab-deruxtecan (T-dxd) has been FDA approved for HER-2 low breast cancer after Destiny-Breast 04 trial (DB04) demonstrated a robust overall survival benefit either in HR+ or TNBC heavily pre-treated pts. The Brazilian Health Regulatory Agency (ANVISA) has later approved T-dxd for HER-2 low BC. However, due to its dynamic nature and subjectivity, the definition of HER-2 low status still lacks better criteria. This study aims to evaluate whether HER-2 low status diagnosis was impacted according to the time of the diagnosis - before DB04 publication and after ANVISA drug approval - in a reference cancer center in Brazil. METHODS This retrospective study was conducted in a single institution in Sao Paulo, Brazil. Pts diagnosed with BC between October 1st 2021 to June 1st 2023 were classified in 2 groups according to the time of diagnosis. Group 1 (g.01) included those who were diagnosed between October 1st 2021 until DB04 publication in July 7th 2022; and Group 2 (g.02) included pts diagnosed after ANVISA T-dxd approval on October 31st, 2022 until June 1st 2023. All pathological analysis of the primary breast tumor was performed by 2 experienced breast pathologists. HER-2 IHQ Score was defined according to ASCO/CAP guideline 2018. The primary endpoint was to evaluate the proportion of patients who were defined as HER-2 low according to the time of diagnosis. Secondary endpoint consists in evaluate change in pathologists practice to distinguish IHC 1+ results from 0 after the definition of HER-2 low. To compare the categorical variables between the groups, the Chi-square test was used. P values below 0.05 were considered statistically significant. Statistical analyses were carried out with the R program (R Foundation, Vienna, Austria). RESULTS A total of 713 pts with diagnosis BC were included in the study, 401 (56%) in g.01 and 312 (44%) in g.02. Overall, before DB04 publication, the diagnosis HER “Negative-NOS” without subdivision in score 0 or 1 was found in 127 (31.7%), but only in 27 (8.7%) reports in g.02 (p=0.007-13). HER-2 low status was observed in 12.2% in g01 and in 33.3% of the pts in g.02 (p &amp;lt; 0.00001). Specifically, negative score 0 was found in 45.6% of pts in g.01 and 44.6% in g.02 (p= 0.014). A significant difference was also observed among pts with negative Score 1+ between groups (6.0% vs 21.2%, p=0.009-3), as shown in Table 1. No significant difference was seen in the frequency of HER2 score 2+ and score 3+ between g.01 and g.02. CONCLUSION The recent impact of a highly effective treatment derived from definition of HER-2 low BC led to a greater relevance in differentiating IHC 1+ from IHC 0, both considered HER negative by ASCO/CAP protocols. Distinguishing between HER2 0 and 1+ is subject to considerable interobserver variability , and the time of regulatory approval demonstrated a direct influence on the HER-low diagnosis. Table 1 Distribution of HER2 IHQ results in Group 1 and Group 2 Citation Format: Paula Martinez Vianna, Venancio Avancini Ferreira Alves, Pedro Exman. Influence of regulatory agency approval of trastuzumab-deruxtecan on the diagnosis of HER2-low status at a reference cancer center in Brazil [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-17-04.

Analysis of COVID-19 diagnostic test implementation in Brazil: strategies in place at the beginning of the pandemic

The World Health Organization considers the mass testing one of the main tools for controlling the COVID-19 pandemic. The aim of this study was to evaluate the strategies adopted by the Brazilian Federal Government to promote population testing and access to in vitro diagnostic products for COVID-19 within the Unified Health System. Thus, we analyzed the information collected in databases from ANVISA (Brazilian Health Regulatory Agency), the Ministry of Health and Our World in Data on regulatory flexibility for in vitro diagnostic products for COVID-19, the impacts of acquisition and distribution for tests and the pandemic indicators, respectively. Around 65% of the tests registered at ANVISA were from China, while only 17% were Brazilian tests. Of the 441 registered tests, 67.8% were rapid antibody tests. Brazil only carried out 20 million of the 46 million tests planned for 2020 by the Diagnosis to Care Program. The reduced mass testing and the use mainly of rapid tests for antibodies detection may contribute to the underreporting of the disease and to Brazil's position among the countries that test the least and with a high number of cases and deaths presented in the early years of the COVID-19 pandemic.

Vaccination against COVID-19: the view of Brazilian federal judges.

The aim was to analyze the perception of Brazilian federal judges on the implications of COVID-19 vaccination. A study was carried out with Brazilian federal judges, who received a survey designed with multiple-choice questions on COVID-19 vaccination, covering topics such as its mandatory aspect, the application of coercive measures, hesitation to vaccinate, priority groups, the duties of Brazilian Health Regulatory Agency (Anvisa, acronym in Portuguese), the role of the Judiciary branch, and immunity passports. A total of 254 out of 1,300 federal judges from all states responded to the survey. Most respondents have a Bachelor's degree or a specialization (59.1%) and have been judges for more than 10 years (63.8%). A great majority of the judges (87.7%) agree with vaccine mandates for adults and for children and adolescents (66.1%). Over 75% of judges believe that all levels of government can impose sanctions on those who refuse to get vaccinated. The judges trust vaccination 93% of the time, 56.1% reject anti-vaccination movements, and 75.2% believe that Anvisa duties should be respected. The Judiciary branch actions concerning the COVID-19 pandemic are approved by 62.6% of judges, and 88.2% support immunity passports. There is a direct connection among mandatory vaccination, trust in the vaccine, and the adoption of immunity passports. Most federal judges agree with vaccine mandates for children and adults, support the application of sanctions for vaccination refusal, disapprove of anti-vaccination movements, agree with Anvisa's duties, and support judicial intervention in relation to the COVID-19 pandemic.

USO DE FILMES DE QUITOSANA PARA EXTRAÇÃO DO CORANTE ALIMENTAR BORDEAUX S COM QUANTIFICAÇÃO POR ANÁLISE DE IMAGENS DIGITAIS

USE OF CHITOSAN FILMS TO REMOVE BORDEAUX S FOOD COLORING WITH QUANTIFICATION BY DIGITAL IMAGE ANALYSIS. Bordeaux S is a food dye still allowed in Brazil, being present in soft drinks, gelatins, chewing gums, candies and many other industrialized foodstuffs. Because of its carcinogenic potential, it is forbidden to be added to food in Japan, in the USA and in most of the European Union. Many studies related to the employment of digital images analysis to food quality control have been published in recent years mainly due to its low costs of implementation. Nevertheless, one of the few drawbacks of applying this technique is its poor sensitivity, which can be significantly improved by employing solid substrates, such as chitosan films. In this work, chitosan sorbent films were synthesized, characterized and used to retain Bordeaux S present in gelatin samples, followed by recording the films’ images and quantifying the analyte by digital images analysis. The proposed method was able to extract the analyte and eliminate interferences present in the matrixes in a single step. LOD of 20 µg L-1 and LOQ of 74 µg L-1 were obtained, allowing adequate quantification when considering the recommendations of the Brazilian Health Regulatory Agency (ANVISA).

PP104 Impact Of New Permbrolizumab Indications After Initial Registration By Brazilian Health Regulatory Agency (ANVISA)

IntroductionMost new drugs have only clinical studies focused on a single population at the time of first registration, hence their indications for use are restricted to this population. For clinical conditions when there are no other treatments available, new drugs have higher costs in Brazil. There is no review of prices when these medications broaden their therapeutic areas, and this can have a significant financial impact. This study’s objective is to assess the financial implications of pembrolizumab’s incremental indication after its initial registration.MethodsWe calculated the annual cost to treat all Brazilian patients with indications for use in the first registration and all incremental indications of pembrolizumb. Populations were estimated by epidemiological data from the pembrolizumab clinical trials called, KEYNOTE studies, and the INCA 2023 cancer estimate for the Brazilian population. Costs were calculated by CMED-ANVISA price value and considering the dosing of 200mg every 3 weeks.ResultsIn 2016, pembrolizumab was granted registration in Brazil was restricted to patients with advanced melanoma. In 2022 the indication was expanded to more than 20 new indications, with several studies in progress that potentially will lead to further inclusions. The estimate of patients eligible for indications increase of 1,796 to 99,544 patients with an increased total cost from BRL625,802,837 to BRL34,685,366,192 (USD121,185,677.4 to USD6,716,763,399.04).ConclusionsThe financial burden of pembrolizumab’s expanded uses after it was first approved could significantly rise, endangering the long-term viability of healthcare systems. In Brazil, where medicine costs are not regularly monitored, the annual inflation adjustment is the only factor that causes prices to change. In order to lower medicine prices in response to the addition of new indications, the expansion of therapeutic options for the same condition, or even obsolescence, regulations are required.

PP30 The Fast Track In Drug Registration By ANVISA – Brazil And Possible Consequences

IntroductionThe fast track in drug registration by the Brazilian Health Regulatory Agency, ANVISA, began in 2017 and is intended to prioritize analysis related to drugs relevant to public health. This process is appropriate in situations where there are no therapeutic alternative available or for technologies show significant improvement in safety, efficacy, or adherence to treatment.MethodsThe Brazilian public administration has a tool for accessing information called Transparency Portal. Thus, data on the number of drugs approved by fast track between 2018 and 2021 were requested through this tool and evaluated.ResultsThe data received by the Brazilian transparency portal shows that the number of requests for fast track had an increase from one in 2018 to 32 in 2021. There is an important increase of registrations, being drugs with phase II trials and with single-arm clinical trials. With registration based on a phase II trial, these patients are in fact receiving drugs in a context similar to clinical trials, but with funding from the healthcare system. Given that phase II studies are conducted in a limited population, there has been an increase in the registration of drugs with suboptimal efficacy and safety concerns. This scenario of uncertainty leads to non-adherence to treatment and a discrepancy in real-world outcomes in comparison to the clinical trial. About 70 percent of phase II trials, show no benefit, and only 30 percent proceed to later phases. It is noteworthy that about 50 percent of the studies that move on to later phases fail to show benefits. Nowadays the number of drugs approved by the fast track has increased, many probably with phase II studies and no comparator group.ConclusionsGiven the uncertainties in the efficacy and safety of a drug registered via fast track, often based on phase II studies, implementing provisional registration with real-world evaluation of outcomes, and coupled with financing based on risk-sharing agreements, may be a sustainable alternative for health systems.

PP27 The Private Healthcare Responses Against COVID-19 Emergencies In Brazil

IntroductionThe Corona Virus Disease 2019 (COVID-19) pandemic is the biggest public health crisis of all time. Private health care plays a major role in health globally. We conducted a study to document the engagement of a Brazilian private health care organization to influence decisions to private and public health emergencies of COVID-19.MethodsThis retrospective study evaluated the outputs of the health technology assessment (HTA) group of Unimed-BH, a private Health Maintenance Organization (HMO) with 1.5 million participants in Belo Horizonte, Minas Gerais state. The study evaluated the impacts on the overview of health local decisions in the municipality and the national supplementary health agency (ANS) during the period from March 2020 to December 2022.ResultsDuring the pandemic, Unimed-BH made all its sanitary decisions based on scientific research, such as the use of masks and appropriate medications. Even though some medicines, such as regdanvimab, were authorized for emergency use by the Brazilian Health Regulatory Agency (ANVISA), Unimed-BH did not recommend their use due to uncertain evidence, and months later, ANVISA withdrew the registration.Unimed-BH also conducted a systematic review of ivermectin for COVID-19 treatment, which showed no effect, and therefore did not recommend its use. Additionally, Unimed-BH provided weekly updates on COVID-19 data, including suspected and confirmed cases, hospitalizations, and deaths in their customer portfolio. The organization also actively supported the decisions made by ANS and municipal managers using evidence and statistics on the pandemic. The Unimed-BH HTA group produced a total of 167 reports from March 2020 to December 2022.ConclusionsBelo Horizonte had the lowest in-hospital mortality rates with COVID-19 in Brazil. Unimed-BH’s HTA reports provided evidence-based assessments for decision-making, proposed partnership with policymakers, fomented information transparency, and strict follow-up on pandemic numbers, which may have contributed to the lower fatality rate in our city. These findings underscore the importance of private healthcare organizations in responding to COVID-19 emergencies, and their potential to support evidence-based decision-making and minimize the impact of the pandemic.

Application of ventilator-associated events (VAE) in ventilator-associated pneumonia (VAP) notified in Brazil (IMPACTO MR-PAV): a protocol for a cohort study

IntroductionCertain criteria for ventilator-associated events (VAE) definition might influence the type of an event, its detection rate and consequently the resource expenditure in intensive care unit. The Impact of Infections...

Are we missing the opioid consumption in low- and middle-income countries?

The rise in opioid prescriptions with a parallel increase in opioid use disorders remains a significant challenge in some developed countries (opioid epidemic). However, little is known about opioid consumption in low- and middle-income countries (LMICs). In this short report, we aim to discuss the increase in opioid consumption in LMICs by providing an update on the opioid perspective in Brazil. We analyzed opioid sales on the publicly available Brazilian Health Regulatory Agency (ANVISA) database from 2015 to 2020. In Brazil, opioid sales increased 34.8 %, from 8,839,029 prescriptions in 2015 to 11,913,823 prescriptions in 2020, this represents an increase from 44 to 56 prescriptions for every 1,000 inhabitants. Codeine phosphate combined with paracetamol and tramadol hydrochloride were the most common opioids prescribed with an increase each year. The results suggest that opioid prescriptions are rising in Brazil in a 5 years period. Brazil may have a unique opportunity to learn from other countries and develop consistent policies and guidelines to better educate patients and prescribers and to prevent an opioid crisis.

Edulcorantes artificiais: regulamentação no Brasil, implicações tecnológicas na produção de alimentos e na saúde

Sweeteners provide a sweet taste to foods and are used to replace sucrose and reduce caloric value. Acesulfame potassium, aspartame, sodium cyclamate, saccharin, sucralose and neotame are the artificial sweeteners regulated in Brazil by the Brazilian Health Regulatory Agency (ANVISA). The consumption of these additives has become controversial due to recent scientific evidence questioning their safety and outcomes regarding weight loss, dysbiosis of the intestinal microbiota, insulin resistance, diabetes and cancer. Even today, little is known about the long-term consequences of their consumption. Therefore, this study aimed to carry out a review of artificial sweeteners regulated in Brazil, contextualizing their regulatory framework, the technological implications regarding their use and the effects on health. Considering the now controversial outcomes regarding the consumption of many artificial sweeteners, and the long period in which levels of acceptable daily intake have been in place, it is suggested their consumption should now not be encouraged, being restricted to population groups that have a risk-based physiological or metabolic need to replace sucrose. Also, for these cases, it would be important to differentiate between foods containing different sweeteners (or tabletop sweeteners), to alleviate possible chronic health effects. New studies with more robust and consistent methodologies are required to support the safety assessment reviews of each artificial sweetener.

Análise de situações de trabalho na fiscalização sanitária de medicamentos da agência reguladora federal

Abstract This study analyzes the work situations experienced by professionals in the sanitary fiscalization of medicines at the Brazilian Health Regulatory Agency, during the COVID-19 pandemic. This is a single-case study, qualitative in nature, with an ergological approach. The data were collected from 2020 to 2021. During this period, 18 interviews and 3 online work meetings were conducted. The discursive practices were systematized in ergodialogical maps, resulting in three categories: the works experienced in the sanitary enforcement of medicines; the variabilities of the organizational context and the renormalizations facing the pandemic. The fragilities of the information systems, the outdated regulatory framework, the performance model, the fragmentation of the work, among others, have caused barriers to the professional’s activity. The conformation of a new way of performing the sanitary fiscalization of medicines involves the combination of interventions aimed at prevention, detection, and response to the consumption of medicines that are harmful to health. The necessary transformation goes beyond the restricted function of control and punishment and consolidates itself as a new proactive and dynamic action model, based on health risk management and the implementation of Good Fiscalization Practices.

Analysis of work scenarios in the sanitary enforcement of medicines from the federal regulatory agency.

This study analyzes the work situations experienced by professionals in the sanitary fiscalization of medicines at the Brazilian Health Regulatory Agency, during the COVID-19 pandemic. This is a single-case study, qualitative in nature, with an ergological approach. The data were collected from 2020 to 2021. During this period, 18 interviews and 3 online work meetings were conducted. The discursive practices were systematized in ergodialogical maps, resulting in three categories: the works experienced in the sanitary enforcement of medicines; the variabilities of the organizational context and the renormalizations facing the pandemic. The fragilities of the information systems, the outdated regulatory framework, the performance model, the fragmentation of the work, among others, have caused barriers to the professional's activity. The conformation of a new way of performing the sanitary fiscalization of medicines involves the combination of interventions aimed at prevention, detection, and response to the consumption of medicines that are harmful to health. The necessary transformation goes beyond the restricted function of control and punishment and consolidates itself as a new proactive and dynamic action model, based on health risk management and the implementation of Good Fiscalization Practices.