ANVISA Research Articles

Application of a multivariate optimization strategy to validate an RP-HPLC analytical method for determining hydroxychloroquine sulphate in pharmaceutical products and in forced degradation studies

AbstractIn this study, a multivariate optimization strategy was used to develop and validate a simple, rapid, accurate, cost-effective, and stability-indicative RP-HPLC analytical method for quantifying hydroxychloroquine sulphate (HCQ) in coated tablets. The validation conditions involved isocratic elution mode, using a mixture of buffer solution at pH 2.2 and methanol (74:26, v/v) as the mobile phase, an Agilent® reverse phase column, model Zorbax Eclipse Plus C18 (250 cm × 4.6 mm × 5 μm), a flow rate of 1.3 mL min−1, column temperature 40 °C and detection at 343 nm. The method showed linearity in the range of 4–44 μg mL−1, with a correlation coefficient (R) of 0.9998. Recovery obtained average values of between 99.71 and 100.84% and precision with average RSD values of <2%. The robustness demonstrated by assessing the effect of seven variables (pH of the mobile phase buffer; percentage of methanol; filter brand; mobile phase flow rate; wavelength; column temperature and sample agitation time), with effect values for each variable lower than the calculated value of s√2 (1.43), showed that none of these factors had a significant influence on the analytical response. The method was applied to samples of the reference medicine Plaquinol® 400 mg and similar Reuquinol 400 mg, nomenclature established by the National Health Surveillance Agency (Anvisa), law no. 978 of 10 February 1999, purchased from local pharmacies. Results showed advantages and benefits in relation to the official method and those reported in the literature. The application of the multivariate strategy, the choice of methanol, in a lower proportion in the organic phase, due to its low toxicity, economy and easier availability compared to acetonitrile, and the other organic solvents used was a promising and important alternative for the analytical method. Furthermore, the use of reversed stationary phase, common in quality control laboratories, provided an analyte retention time of 4.595 min, demonstrating good performance and speed in routine analyses.

Profile of patients in private home care who developed ventilator-associated pneumonia.

to analyze the profile and clinical outcomes of patients who developed Ventilator-Associated Pneumonia (VAP) in private home care and to compare the incidence with national data. this was a retrospective study with data collected from July 2021 to June 2022 from patient records at a private clinic. Patients using intermittent ventilation or without ventilatory support were excluded. the utilization rate of mechanical ventilation was 15.9%. The incidence density of pneumonia in pediatrics was 2.2 cases per 1000 ventilation-days and in adults was 1.7 cases per 1000 ventilation-days, figures lower than those reported by the National Health Surveillance Agency. There were 101 episodes of pneumonia in 73 patients, predominantly male (65.8%), adults (53.4%), and those with neurological diseases (57.5%). The treatment regimen predominantly took place at home (80.2%), and there was one death. patients in home care showed a low incidence and mortality rate from ventilator-associated pneumonia.

A emergência do Zika vírus no Brasil e a resposta federal dos Sistemas Nacionais de Vigilância em Saúde e de Vigilância Sanitária

Abstract The article analyzes the federal response of the National Public Health Surveillance and Brazilian Health Regulatory Systems to the Zika virus epidemic in Brazil, from 2015 to 2018, focusing on the political-institutional contexts and the content of government measures developed during the period. The study was anchored in the historical institutionalist approach, comprising documentary analysis and interviews with key actors. The response was characterized by the initial prioritization of the health emergency on the federal government's political agenda, which was reduced over the period, influenced by the financial and political crises. There was a multiplicity of actors and instances focused on contingency, with a certain articulation between the two systems, based on their own pre-emergency experiences. Vector control had centrality, valuing intersectoral and community actions, induced mainly by the Health Surveillance Secretariat of the Ministry of Health and additionally by the National Health Surveillance Agency. Significant allocation limitations of new financial resources and changes in the organizational response apparatus were observed, with effects on the continuity of post-emergency policies, including the development of medicines, vaccines and tests. The Zika Virus Public Health Emergency in Brazil was marked by limited institutionalization of learning and structuring strategies, reducing opportunities for the (re)organization of surveillance in the Unified Health System.

A HISTÓRIA DA PRODUÇÃO DAS VACINAS DA COVID-19 NO BRASIL: UMA REVISÃO SISTEMÁTICA

Brazil began the search for vaccines against COVID-19 through agreements with different vaccine manufacturers at an international level, such as AstraZeneca, Pfizer, Coronavac (produced by the Butantan Institute in partnership with Sinovac) and the Covax Facility, an initiative global initiative to ensure equitable access to vaccines. In January 2021, the National Health Surveillance Agency (Anvisa) granted emergency use authorizations for the Coronavac and AstraZeneca/Oxford vaccines. Later, other vaccines, such as Pfizer, also received approval for emergency use. Through a bibliographical review, it can be concluded that the process of producing and distributing vaccines in Brazil involved logistical and political challenges, including debates about the effectiveness and safety of vaccines, acquisition of inputs for production, distribution to states and delays in the.

Metal and metalloid content, bioavailability and sorption processes in glitter and raw glitter materials and associations with human and ecological risk concerns

BackgroundMicroplastics comprise a significant group of emerging environmental contaminants with the capacity to adsorb several contaminants. These, in turn, undergo bioaccumulation and biomagnification processes throughout aquatic trophic chains. MethodsGlitter, a microplastic powder composed of a combination of polymers, and raw glitter materials were investigated herein concerning metal and metalloid content, bioavailability, and sorption processes by inductively coupled plasma mass spectrometry (ICP-MS). ResultsMetal and metalloid concentrations were higher in glitter than in raw glitter materials, but all were below the limits established by the Brazilian National Health Surveillance Agency. Elements present in glitter originate mainly from pigments and, thus, depend on glitter color. The bioavailability of the determined elements concerning human skin was assessed. Low desorbed concentrations in solution indicate that glitter does not represent a health risk through dermal contact concerning metal and metalloid contamination. However, several elements were shown to undergo significant desorption and adsorption processes. ConclusionThe findings reported herein indicate seemingly low human health risks from dermal glitter contact but reinforce glitter risks as aquatic environment metal and metalloid transport vectors.

OP167 An Analysis Of Medication Exclusion Reports In The Health Technology Assessment Process For The Brazilian Unified Health System

IntroductionThe National Committee for Health Technology Incorporation of the Brazilian Public Health System (Conitec), which was created in 2011 by federal law, defines the criteria for incorporating and excluding health technologies in the Brazilian health system. For technology evaluation proposals a recommendation report is carried out, which finds the best scientific evidence about the efficacy, accuracy, effectiveness, and safety of the technology being analyzed. The report also provides a comparative economic evaluation of the technologies already in the health system to promote and protect public health, achieve the best allocation of resources, and reduce regional inequalities.MethodsThis exploratory, descriptive, and retrospective study aimed to identify the criteria considered for the exclusion of medicines within the Brazilian health system from 2012 to November 2022. Data were extracted from Conitec’s website into a specific extraction form and analyzed using descriptive statistics.ResultsDuring the evaluation period, 763 technology recommendations by Conitec were identified, of which 75 (10%) related to the exclusion of medicines. Several criteria were identified among the exclusion recommendations, including protocol updates, expiry or lack of registration in the National Health Surveillance Agency, and drugs whose clinical indication was not included in the list of drugs registered for treatments in the health system.ConclusionsAlthough there is no standardization of criteria in Conitec for recommendations on the exclusion of health technologies, this study contributes to a better understanding of these technologies. Disinvestment of technologies positively impacted the population because it resulted in better allocation of resources in the health system, and some of the excluded technologies presented a greater risk of interactions and undesirable adverse reactions.

How Did COVID-19 Impact the Antimicrobial Consumption and Bacterial Resistance Profiles in Brazil?

The indiscriminate use of antibiotics has favored the selective pressure of multidrug resistance among microorganisms. This research evaluated the pattern of antibiotic prescriptions among the Brazilian population between January 2018 and December 2021. Additionally, the study sought to analyze the incidence rates of central line-associated bloodstream infection (CLABSI) and examine the profiles of antibiotic resistance. We assessed the hospital and community antimicrobial consumption from the National Health Surveillance Agency Database and correlated it to microorganisms. The consumption of antimicrobials in the hospital environment increased by 26% in 2021, highlighting polymyxin B, which increased by 204%. In 2021, 244,266 cases of CLABSI were reported, indicating a nosocomial infection rate of 7.9%. The rate of resistance to polymyxin B was higher in Pseudomonas aeruginosa (1400%) and Klebsiella pneumoniae (514%). Azithromycin emerged as the predominant antibiotic utilized within the community setting, accounting for 24% of the overall consumption. Pearson's correlation analysis revealed a significant and positive correlation (r = 0.71) between the elevated usage of azithromycin and the incidence of COVID-19. Our results indicate an increase in antimicrobial consumption during the COVID-19 pandemic and reinforce the fact that the misuse of antimicrobials may lead to an expansion in antimicrobial resistance.

Cannabis sativa L. from Seized Drug Material: In Vitro Germination and Establishment.

Background: With the expansion of the cannabis-derived product market, there is a growing need for seedling development to produce raw material for pharmaceutical applications and medicinal research. However, cannabis cultivation is illegal in many countries, and legal producers do not sell cannabis seeds in these countries. In Brazil, cannabis is still illegal, and the only way to obtain access to cannabis plants for research or as medicine is through importation, which is costly and requires authorization from the National Health Surveillance Agency (ANVISA), or from material seized by the police from drug trafficking. Methods: Therefore, since cannabis seeds obtained from drug trafficking have never been tested regarding their viability and use in in vitro cultivation, the aim of this study was to analyze the in vitro establishment of cannabis from seeds derived from Brazilian drug trafficking seizures that were provided by the police to investigate seed disinfestation procedures and further multiplication of nodal segments, with the purpose of obtaining material for medicinal research in the country. Seeds were subjected to four disinfestation treatments. Results: The best disinfestation treatment consisted in submerging the seeds in a 2 g·L-1 Captan® solution for 30 min before following the standard procedure with 70% ethanol for 30 sec and then 20 min in 2.5% sodium hypochlorite. The in vitro establishment of cannabis from seeds originating from Brazilian drug trafficking seizures was successful. The germination rate ranged from 10% to 90% according to the sample material. Non-brick weed, which consisted of dry leaves, stalks, and flowers, was more suitable for seed extraction and germination. Clones originating from BW4b showed the best development results compared with others. Conclusions: This is the first report of in vitro cannabis use in Brazil and opens great prospects for future work on its cultivation and research for medicinal applications in the country without relying on seed importation.

Assessing the impact of fast-track drug registration by Anvisa in Brazil: A descriptive study of new drug registrations from 2017 to 2022

Prompt release of novel pharmaceuticals is very much sought after during critical circumstances to aid patients and society in need. Nonetheless, the expeditious availability of these medications may jeopardize the well-structured investigations and observations. To tackle this concern, regulatory agencies globally have implemented expedited registration procedures. In Brazil, the National Health Surveillance Agency (Anvisa) has likewise implemented an expedited registration process to cater to patients who cannot afford to wait. The objective of this study is to evaluate the impact of Anvisa’s accelerated drug registration on the challenging regulatory environment in Brazil. Data pertaining to medications registered by Anvisa from 2017 to 2022 through the expedited process were procured from the Federal Government’s transparency portal and the medication consultation portal. The registration of novel drugs by Anvisa through both standard and expedited processes during this timeframe was analyzed. The introduction of the accelerated registration regulation by Anvisa in 2017 led to a substantial rise in registration requests utilizing this regulatory modality. Furthermore, the data concerning drug registration through all channels unveiled a noteworthy reduction in average response time. Despite concerns pertaining to the effectiveness and safety of drugs registered through the expedited process, often reliant on Phase II studies, the utilization of this process is on the rise worldwide, including in Brazil. To ensure the sustainability of health-care systems, it may be advantageous to implement provisional registration in conjunction with subsequent evaluation through real-world studies and financing based on risk-sharing agreements. In conclusion, the accelerated drug registration process implemented by Anvisa in Brazil has exhibited promising results in terms of reduced response times. Nevertheless, the effectiveness and safety of drugs registered through this process necessitate meticulous evaluation. The implementation of provisional registration and the integration of real-world studies, alongside managed entry agreements, could offer a sustainable alternative for health-care systems.

Analytical and chromatographic parameters used to quantify flavonols and chlorogenic acid in Solidago raw extracts

Species in the Solidago genus are used worldwide due to the therapeutic activities of their flavonoids and terpenoids. Its anti-inflammatory, vulnerary, antirheumatic, analgesic, diuretic, aquaretic, wound-healing properties, as well as its ability to relieve the burn and insect bites, allow use in a variety of therapeutic applications. This study was carried out to determine the comparative chemical profile, the content of flavonoids (FLV) and chlorogenic acid (CA) in the inflorescence extracts of Solidago chilensis and Solidago canadensis, as well as the biological potential of these species, regarding other Solidago species used in North America and Europe. S. chilensis was cultivated in Itaipava, Tapera Quilombo’s (Rio de Janeiro/Itaboraí Forum - FIT/Fiocruz) and in the Agroecological Platform of Phytomedicines (PAF/Farmanguinhos/Fiocruz). S. canadensis was acquired in Rio de Janeiro, in a popular market. The inflorescences polar extracts were evaluated and standardized by HPLC analytical methodology about the levels of the flavonoids reference standards and CA content and expressed in µg/mL for quantification, using the selectivity analytical parameters, linearity, limit of detection, accuracy, precision, and robustness as defined by national health surveillance agency in Brazil. The HPLC-UV-PDA revealed mainly flavonols (FLV) such as quercetin, glycosides as well as CA. S. canadensis presented the highest concentrations of quercetin (114.46 ± 0.114 µg/mL) and quercitrin (54.40 ± 2.014 µg/mL) but did not present isoquercitrin. However, the S. chilensis (TT0116 extract) presented the highest amount of CA (96.06 ± 2.365 µg/mL) and isoquercitrin (143.88 ± 4.219 µg/mL), and the samples of TB0116 extract presented the highest amount of hyperoside (227.79 ± 3.333 µg/mL and 153.49 ± 4.200 µg/mL). The presented data in this study indicate qualitative similarities and quantitative differences in the CA and FLV contents in the crude extracts of the two Solidago species. These differences are essential to assess the biological activity of each species, confirm its antioxidant and anti-inflammatory actions, and perform quality control of species occurring in Brazil.

Surveillance of ochratoxin A in cocoa beans from cocoa-growing regions of Ghana

Cocoa is one of the agricultural commodities which is highly susceptible to mycotoxin contamination. During two crop/harvest seasons, the occurrence and distribution of ochratoxin A (OTA) in viable commercial cocoa beans were investigated. The cocoa bean samples were collected randomly from farmers across cocoa-growing regions of Ghana. OTA concentrations in the samples were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods following purification on immunoaffinity solid phase column. The result showed that 21.7% of all samples analyzed were contaminated with OTA at concentrations ranging from 0.01 μg/kg to 12.36 μg/kg. The Western South region had the highest occurrence of OTA-positive samples at 32.5%, followed by the Western North region at 28.75%, the Eastern and Volta regions at 25% each, Brong Ahafo (16.25%), Central (15%) and the Ashanti region at 11.25%. However, 0.9% and 3.5% of the total OTA-positive samples exceeded the OTA maximum limits of 10 μg/kg for cocoa beans and 3 μg/kg for cocoa powder, set by the Brazilian National Health Surveillance Agency and the European Commission, respectively. During the Main and Light crop seasons, the highest concentrations of OTA were detected in the Western North region, reaching up to 12.36 μg/kg and 3.45 μg/kg, respectively. OTA concentrations between the cocoa-growing regions in the Main crop season were not significantly different (p > 0.05), however, the Light crop season indicated a significant difference (p < 0.05). There was a significant difference (p < 0.05) between the two crop seasons. The need for regular monitoring and careful adherence to agronomic strategies such as good agricultural practices (GAPs), recommended code of practices (COPs) and good manufacturing practices (GMPs) for the prevention and reduction of OTA throughout the cocoa value chain cannot be overemphasized.

Quality control in blood irradiation

Irradiation is a technique used in hemotherapy to functionally inactivateviable lymphocytes, in cellular blood components, to reduce the risk of Transfusion-associated Graft-versus-Host Disease (AT-GVHD), is rare but letal. One way to avoid it is to irradiate blood componentes in situations such as: intrauterine transfusion, newborns, patients receiving immunosuppressive therapy in bone marrow transplantation. Thus, it is extremely important that blood component is irradiated and, above all, ensure that the minimum dose is 25 Gy.The blood policy in Brazil is implemented through laws and normative decrees, giving rise to a legal system that underpins the actions of hemotherapy services. In order to correct verify absorbed doses and the quality assurance process as well as the safety for the irradiator operators we describe in this paper a several of physical measurements that is mandatory to support a physicist to evaluate the quality assurance during and after the irradiation process. The results obtained from this physical measurements provided a guarantee of proper radiation dose used in hemotherapy as well as methods and procedures applied to protect the patient, employees and general public due to procedure of blood irradiation accordling the Technical Regulation of Hemotherapy Procedures of the National Health Surveillance Agency (ANVISA) and safety regulations by National Nuclear Energy Commission (CNEN).

Innovation management in biotechnology: from the lab to the market: the entrepreneur's challenges

The objective of this investigation is to identify the barriers faced by biotechnology startups in Brazil, related to lifespan, legislation, maturity stage, among others, by literature review, analyzing the obstacles faced by these companies to take the research from the laboratory to the market from the point of view of innovation management. As a method of confirming the barriers to the entrepreneur identified by the theory, an online non-parametric survey was conducted between October and December 2022, through electronic forms, considering a non-probabilistic sampling. The results obtained reinforce the literature. It was realized that entrepreneurship plays an important role, requires discipline and training, partnerships and cooperation are also necessary throughout the process. The benefits of the Legal Framework for Innovation bring researchers closer to institutions, providing the use of laboratories, as provided by law. The regulatory processes with the agencies: National Health Surveillance Agency, Ministry of Agriculture, Livestock and Supply and National Technical Commission on Biosafety need to reduce bureaucracy, facilitation, and clarification.

Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.

Project Orbis was initiated in May 2019 by the Oncology Center of Excellence to facilitate faster patient access to innovative cancer therapies by providing a framework for concurrent submissions and review of oncology products among international partners. Since its inception, Australia's Therapeutic Goods Administration (TGA), Canada's Health Canada (HC), Singapore's Health Sciences Authority (HSA), Switzerland's Swissmedic (SMC), Brazil's National Health Surveillance Agency (ANVISA), United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), and most recently Israel's Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, have joined Project Orbis. While each country has its own expedited review pathways to bring promising therapies to patients, there are some similarities and differences in pathways and timelines.FDA's fast-track designation and MHRA's marketing authorization under exceptional circumstances (MAEC) allow non-clinical and limited clinical evidence to support approval under these programs. HC's Extraordinary Use New Drug (EUND) pathway allows granting exceptional use authorization with limited clinical evidence. ANVISA, HSA, MTIIR, and TGA do not have standard pathways that allow non-clinical evidence and limited clinical evidence. While there is no definite regulatory pathway for HSA, the current framework for approval does allow flexibility in the type of data (non-clinical or clinical) required to demonstrate the benefit-risk profile of a product. HSA may register a product if the agency is satisfied that the overall benefit outweighs the risk. All Project Orbis Partner (POP) countries have similar programs to the FDA accelerated approval program except ANVISA. Although HSA and MTIIR do not have defined pathways for accelerated approval programs, there are opportunities to request accelerated approval per these agencies. All POP countries have pathways like the FDA priority review except MHRA. Priority review timelines for new drugs range from 120 to 264 calendar days (cd). Standard review timelines for new drugs range from 180 to 365cd.

DESENVOLVIMENTO E VALIDAÇÃO DE MÉTODO ANALÍTICO PARA DETERMINAR O DOSEAMENTO DE CINARIZINA EM CÁPSULAS MAGISTRAIS

Background: Cinnarizine is a brain vasodilator used in labyrinth diseases, a disorder characterized by dizziness, gait deviations, or falling. The quality control of compounded capsules containing cinnarizine is limited. Because of the difficulty accessing official pharmacopeia monographs of this drug, there is a need to describe an analytical method that is reliable and safe to perform the quantitative determination of cinnarizine in capsules. Aim: This work aims to develop and validate an analytical method to determine cinnarizine assay in capsules by spectrophotometry in the UV region that is easy to perform, low cost, and offers reliability in the dosage results. Methods: The RDC nº. 166, of 24 July 2017, of the National Health Surveillance Agency, was used as the guide for validating analytical methods. Results and Discussion: The proposed method was linear in the range of 5.833 to 10.833 μg mL-1 and presented similar results of linear and Person correlation coefficient (0.999), selectivity/specificity (0.14 %), detection limits (130, 20 ng/mL), and quantification (260, 40 ng/mL) at 251 nm. The accuracy results (DPR Rep. accuracy: 2.89 %; DPR Inter. accuracy: 1.07 %) and precision (CQB= 99.96 %, CQM= 100.02 %, and CQA= 100.06 %) complied with the validation parameters. The robustness has been proven, and the analytical method does not vary significantly from small deliberations. After validation, the assay of cinnarizine in capsules of pharmacies of the retail trade of Barra do Garças - MT was determined. The results were found to comply with Farmacopéia Brasileira 6th Edition requirements. Conclusions: The validated analytical method proved to be linear, specific, accurate, and robust and allows the determination of the dosage of cinnarizine in compounded capsules in a simple way, with low cost, and provides reliable results.

PREVENTION OF SEPSIS IN CRITICAL ENVIRONMENTS TO HEALTH

The first step to prevent SEPSE is to follow the vaccination schedule for children and adults is to avoid the exaggerated use of antibiotics and self-medication, not forgetting proper hand hygiene. Sepsis can develop through exposure to etiological agents present in the environment in which the individual lives on a daily basis, which settle down and trigger a reaction in the body, according to the person’s physiological particularities. ANVISA (National Health Surveillance Agency) has created programs for the implementation, monitoring and provision of technical materials so that HAIs are reduced at all levels of assistance in the health network.

Recall of substandard medicines in Brazil during the period 2010–2018

BackgroundEven with all the care taken during the production process, the pharmaceutical industries are still subject to manufacturing medicines with quality deviations, generating commercialized products without the required quality and necessitating their subsequent recall from the market. The objective of this study was to evaluate the reasons that led to the recall of medicines in Brazil in the period evaluated.MethodsThis is a descriptive study (using document analysis), on the recall of substandard medicines registered on the website of the National Health Surveillance Agency (ANVISA), from 2010 to 2018. The variables studied were the type of medicine (reference, generic, similar, specific, biological, herbal, simplified notification, new and radiopharmaceutical), type of pharmaceutical dosage form (solid, liquid, semi-solid and parenteral preparation), and reason for recall (Good manufacturing practices, quality and quality/good manufacturing practices).ResultsA total of n = 3,056 recalls of substandard medicine were recorded. Similar medicines had a higher recall index (30.1%), followed by generics (21.3%), simplified notification (20.7%) and reference (12.2%). Different dosage forms had similar recalls: solids (35.2%), liquids (31.2%) and parenteral preparations (30.0%), with the exception of semi-solids (3.4%). The reasons for the highest occurrences were related to good manufacturing practices (58.4%) and quality (40.4%).ConclusionThe probable cause for this high number of recalls is the fact that, even with all the quality controls and processes in accordance with good manufacturing practices, errors can occur, both human and in automated processes, thus causing the release of batches that should not have been approved. In summary, it is necessary for manufacturers to implement a robust and well structured quality system in order to avoid such deviations, and it is up to ANVISA to apply greater oversight in the post marketing of these products.

Avanços da aplicação de bactérias ácido láticas com funções probióticas na produção de fermentados láticos: uma revisão

Os alimentos com alegações funcionais têm ganhado destaque em virtude dos benefícios à saúde associados ao seu consumo. Produtos lácteos em sua maioria, são oriundos de fermentação por bactérias ácido-láticas (BAL). Esse grupo de microrganismos possui um grande papel no que diz respeito à fermentação de produtos alimentícios. Existem no mercado várias cepas, que são utilizadas na fabricação de produtos lácteos. Além da caracterização sensorial, é conhecido que algumas cepas de BAL apresentam funções probióticas. Frente a isso, este trabalho objetivou verificar os principais gêneros de BAL utilizados na produção de fermentados lácteos e sua funcionalidade probiótica. A partir da revisão bibliográfica no presente trabalho, foi possível evidenciar as contribuições que a inserção de BAL probióticas na alimentação humana pode agregar à saúde, assim como as espécies já autorizadas pela Agência Nacional de Vigilância Sanitária (ANVISA) na produção de alimentos e as que estão em processo de autorização/avaliação.

Phantom comparison for MRI quality control tests according to manufacturers and national standards

Quality control tests are mandatory and essential to monitor Magnetic Resonance Imaging equipment. These assist in determining improper functioning or parameters below established reference levels. The objective of this study was to perform quality control tests in magnetic resonance imaging equipment and to compare their methodology with both FLUKE and KONEX phantoms. Different protocols were used for their evaluation, including the American Association of Physics in Medicine, the American College of Radiologists, and the Brazilian National Health Surveillance Agency. In this study, we demonstrated the results for the most critical tests: slice thickness accuracy, slice position accuracy, high-contrast spatial resolution, low-contrast resolution, magnetic field, and slice thickness uniformity. The results are that, although both phantom objects are efficient for carrying out the tests required in Brazilian regulations, the KONEX phantom consumes less time, as it requires less to image all its structures. The FLUKE phantoms need a longer acquisition time to obtain all test structures and object images. Nevertheless, the results obtained in both are within limits required by Brazilian regulations and limits suggested by the manufacturers' manuals. This work is expected to be a basis for other physicians and services using similar phantoms.

Medications Adverse Effects on Voice: Comparison Between Different Sources of Information

The analysis of drugs with adverse effects on voice provides relevant data for the vocal clinic. It is essential that professionals involved in voice care are aligned on the topic of voice pharmacovigilance in order to understand adverse effects from safe and reliable sources. To compare the voice adverse effects of self-reported medications by dysphonic individuals in different sources of information. Descriptive and analytical study based on self-reported active ingredients by dysphonic individuals and their adverse effects on voice listed in Electronic Database of the National Health Surveillance Agency of Brazil (Anvisa). Adverse effects were comparatively analyzed between the Anvisa's Electronic Database and information from the Micromedex and UpToDate databases. Data were analyzed using descriptive and inferential statistics that compared the three sources researched in relation to the number of adverse effects and in relation to the occurrence of adverse effects to the voice. There was a statistically significant difference between the databases regarding the occurrence of adverse effects of cough, dyspnea, xerostomia, vomiting and hoarseness, with a higher occurrence in the UpToDate database. The UpToDate database showed a statistically significant difference in the amount of drug effects compared to the Anvisa database (P < 0.001, d=0.744) and compared to the Micromedex database (P < 0.001, d=0.598), and in the two cases the mean number of drug effects was higher for the UpToDate database. UpToDate proved to be the most suitable source to complement the data from the medication package inserts at the time of the speech-language pathology assessment. It is recommended that professionals from all countries involved in voice care seek additional evidence-based sources of information to gain access to accurate and up-to-date data on adverse effects of drugs on voice.