Brazilian National Health Surveillance Agency Research Articles

Post-market evaluation of medical electrical equipment

PurposeThe present paper discusses the technical assistance for electrical equipment under sanitary surveillance by analyzing Brazilian regulations and legislation and proposes an improved post-market approach based on international standards.MethodsBrazilian legal and regulatory documentation was the basis of this research. The time span from 2000 to 2020 was used to review the legislation. The actual post-market practice in Brazil was examined in detail, and it was pointed out that there is a clear dichotomy between the legal foundation and the patient protective practice.ResultsThe Brazilian National Health Surveillance Agency regulates and the Brazilian National Institute of Metrology, Quality, and Technology owns the conformity assessment scheme of medical electrical equipment under a sanitary surveillance system. The conformity assessment is based on a certification process using technical standard series IEC 60601. The certification in its present form does not consider any active post-market surveillance, which is a potential risk for the final users because of the varied medical electrical equipment. From the consumer protection perspective, the objective responsibility of service providers includes accountability to the eventual harm caused by the equipment in normal operation. Therefore, a clear regulation or legislation on post-market technical assistance is of interest to the medical industry and technicians.ConclusionThe prospective assurance of the safety and performance of the well-being of citizens would be much more probable to be assured with the renewing of legislation on the post-market evaluation of medical electrical equipment, mainly if international technical standards are used. The dissemination of available medical electrical equipment technology would consequently help public health. Revising the post-market surveillance approach could lead to a better response to deal with medical electrical equipment maintenance issues.

Suplementação combinadas de vitaminas C e E com objetivo de redução do risco de doenças

Esta revisão objetivou compilar os resultados da utilização da suplementação combinada de vitaminas C e E, seus efeitos antioxidantes aplicados em doenças em geral, pesquisados nos últimos anos e comparar com as dosagens recomendadas pela ANVISA, de forma separadamente, publicadas na Instrução Normativa nº28 de Junho/2018. Foi realizado pesquisa bibliográfica em 2 bases de dados sobre a suplementação combinada e a relação sinérgica existente entre as vitaminas C e E. As dosagens utilizadas pelos pesquisadores foram tabuladas para melhor compreensão e os resultados encontrados foram discutidos e comparados com as recomendações estabelecidas por esta instituição. Conclui-se, que ao elaborar uma legislação com os limites máximos e mínimos de ingestão diária de vitaminas C e E, conforme os subgrupos populacionais, a ANVISA definiu os critérios da designação dos compostos bioativos antioxidantes e regularizou a possibilidade de suplementação combinada destes compostos na redução do risco de doenças por meio do estresse oxidativo. Por outro lado, é responsabilidade do pesquisador e/ou profissional de saúde definir previamente o protocolo de suplementação, considerando a relação sinérgica dos constituintes evitando a geração de efeitos pró-oxidantes, o que possivelmente tende a resultar em efeito adverso ao desejado.

Role of different nutrient profiling models in identifying targeted foods for front-of-package food labelling in Brazil.

To compare the degree of strictness and agreement of different nutrient profiling models (NPM) used to identify which foods would be required to show front-of-package (FOP) warning labels. Using data of 11434 packaged foods found in the five largest food retailers in Brazil, we used two published NPM: the Pan American Health Organization (PAHO) model and the NPM used in the Chilean nutritional FOP labelling policy, and compared them with a NPM proposed by the Brazilian National Health Surveillance Agency (Anvisa). The proportion of foods that would be required to show FOP warning labels was calculated overall and by food category. We also tested whether a modified version of the PAHO NPM would behave similarly to the original version. Brazil. Two-thirds of the packaged products (62 %) would receive FOP warning labels under the PAHO NPM, as compared with 45 % of products using the proposed Anvisa NPM and 41 % if the Chilean NPM was applied. The PAHO NPM identified more foods high in critical nutrients such as sweetened dairy and non-dairy beverages, canned vegetables and convenience foods. Overall agreement between models was considered good with kappa coefficient ranging from 0·57 to 0·92 but was lower for some food categories. We found variations in the degree of strictness and agreement between assessed NPM. The PAHO NPM identified more foods and beverages high in sugar which are among the top contributors to sugar and energy intake in Brazil.

Zika virus serological diagnosis: commercial tests and monoclonal antibodies as tools.

Zika virus (ZIKV), an emerging arthropod-borne virus (arbovirus) of the Flaviviridae family, is a current issue worldwide, particularly because of the congenital and neurological syndromes associated with infection by this virus. As the initial clinical symptoms of all diseases caused by this group are very similar, clinical diagnosis is difficult. Furthermore, laboratory diagnostic efforts have failed to identify specific and accurate tests for each virus of the Flaviviridae family due to the cross-reactivity of these viruses in serum samples. This situation has resulted in underreporting of the diseases caused by flaviviruses. However, many companies developed commercial diagnostic tests after the recent ZIKV outbreak. Moreover, health regulatory agencies have approved different commercial tests to extend the monitoring of ZIKV infections. Considering that a specific and sensitive diagnostic method for estimating risk and evaluating ZIKV propagation is still needed, this review aims to provide an update of the main commercially approved serological diagnostics test by the US Food and Drug Administration (FDA) and Brazilian National Health Surveillance Agency (ANVISA). Additionally, we present the technologies used for monoclonal antibody production as a tool for the development of diagnostic tests and applications of these antibodies in detecting ZIKV infections worldwide.

Proposed reduction of the in vivo pyrogen test by the in vitro LAL assay for the quality control of anticrotallic, antiscorpion, antirabies and antitetanus sera

The rationale for a formal study of the LAL (kinetic chromogenic method) assay for anticrotallic (SAC), antirabies (SAR), antitetanus (SAT) and antiscorpion (SAE) sera involved the determination of parameters required by the Brazilian National Health Surveillance Agency (ANVISA), the USA Food and Drug Administration (FDA), USP (United States Pharmacopeia, 39) and ICH (International Conference on Harmonization). The curve correlation coefficients obtained with the standard endotoxin control ranged from −0.980 to −1.000 in all experiments. Endotoxin recovery added to the SAC, SAR, SAT and SAE samples, at the working dilutions (1:10, 1:10, 1:10 and 1, 100 respectively), met the criteria required by the FDA, USP and Brazilian ANVISA for the Inhibition-Potentiation test. The applied methodology for the four analyzed sera fulfilled the required criteria for all performance parameters. Thus, the present study demonstrated that the in vivo pyrogen test can be potentially replaced by the LAL assay for all assessed sera samples displaying higher sensitivity and following the 3 Rs principle, in addition to maintaining quality control in Sanitary Surveillance.

Method development and validation of ursodiol and its major metabolites in human plasma by HPLC-tandem mass spectrometry.

BackgroundUrsodeoxycholic acid (UDCA) and its metabolites tauroursodeoxycholic acid (TUDCA) and glycoursodeoxycholic acid (GUDCA) have been the subject of several pharmacological studies. The objective of this study was to develop an innovative method of quantification by HPL-tandem mass spectrometry (LC-MS/MS), with a lower cost and suitable, for application in bioequivalence studies.MethodsThe procedure involved liquid–liquid extraction for quantification of UDCA/GUDCA and precipitation extraction for TUDCA, using deuterated substances as internal standards (ISs) and Phenomenex Luna 250×4.6 mm 5μ C18 100A column. The mobile phase used was acetonitrile/ammonium acetate 30 mM (420: 580 v/v pH 7) for UDCA, acetonitrile/ammonium acetate 10 mM/ammonium hydroxide (400:600: 0.5 v/v/v pH 9) for GUDCA, and acetonitrile/ammonium acetate 10 mM (570: 430 v/v pH 7) for TUDCA. Ions were monitored by the electrospray ion source (ESI) mass spectrometer, operating in a negative ionization mode. Compound determination was performed by LC-MS/MS system using a calibration curve of 15–10,000 ng/mL for UDCA/GUDCA and 5–500 ng/mL for TUDCA. The method was developed and validated according to the Brazilian National Health Surveillance Agency (ANVISA) of Brazil norms harmonized with the main international guidelines as a prerequisite for conducting in vivo study in human volunteers.ResultsThe method did not present matrix effect and residual effect, showing to be selective for studied molecules, with adequate accuracy and precision. In addition, the method was considered sensitive presenting a coefficient of variation less than 20% for the lower limit of quantification of each compound.ConclusionThis method can be applied in bioequivalence studies to determine ursodiol and its metabolites reproducibly, simply, and effectively with the use of readily accessible analytical materials and instrumentation.

Development of New Formulations of Biologics: Expectations, Immunogenicity, and Safety for Subcutaneous Trastuzumab.

Subcutaneous (SC) trastuzumab has long been approved as a cancer treatment for early and advanced HER2-positive (HER2+) breast cancer by both the European Medicines Agency (EMA) and Agência Nacional de Vigilância Sanitária (ANVISA), the Brazilian National Health Surveillance Agency. A pivotal non-inferiority phase III trial, which aimed to provide a more convenient and cost-effective treatment in the HER2+ breast cancer neoadjuvant setting, showed that the SC group met prespecified efficacy endpoints and the SC formulation was considered as safe as the intravenous (IV) formulation. Considering the recent approval of several biosimilars, new SC formulations are also an interesting manufacturer strategy as these drugs can obtain patent protection. Despite being considered non-inferior to the IV formulation of trastuzumab, in clinical development, the SC formulation elicited higher immunogenicity, mainly related to overall anti-drug antibodies (ADAs); however, this finding was classified as clinically non-significant. In this article, we explore different aspects of the benefits and risks of the SC trastuzumab formulation according to published data.

Does public consultation encourage social participation?

PurposeSocial participation or public participation is a mechanism that aims to enable decision makers to understand the real needs of society and to promote more appropriate and acceptable public policies. The purpose of this paper is to analyze, through Douglasian Cultural Theory, the public-consultation mechanism, and to what extent it encourages the participation of people with different points of view in the formulation of public policies.Design/methodology/approachThis research paper uses theoretical propositions from Douglasian Cultural Theory to investigate the process of public consultation adopted by the Brazilian National Health Surveillance Agency (Anvisa) in the formulation of public policies for Brazil’s health sector.FindingsThe results contribute to the findings of previous studies, i.e., that social participation is unequal, and that some points of view are dominant in policy formulation. This indicates that public managers should seek mechanisms of participation that promote more inclusive and pluralistic public participation.Research limitations/implicationsThe main limitations of this study are the subjectivity inherent in the classification of “voices” in Douglasian Cultural Theory, the small number of contributions analyzed and the absence of some unpublished data.Originality/valueThe analysis contributes to the literature by supporting some and rejecting other propositions of Douglasian Cultural Theory, as well as indicating possible potential from this theory through public administration in the evaluation of mechanisms of social participation.

Detection of Listeria monocytogenes in frescal cheese traded in the northwestern region of the state of Paraná

ABSTRACT Listeria monocytogenes is responsible for listeriosis, a food-borne zoonosis causing food poisoning episodes throughout the world. It lives in the soil, vegetation, silage, nasal discharge and also in the intestinal flora of many animals. Its transmission takes place through material contaminated with feces, urine, aborted fetuses, uterine discharge, milk and its derivatives, mainly frescal cheese, since they are manufactured with non-pasteurized milk, are not cured, present a low percentage of salt and a high humidity, factors that are favorable for the quick microbial growth and consequent food poisoning to its consumers. Frescal cheese is widely consumed due to its low cost, palatability and in-natura state, meeting the growing demand for minimally processed food. This paper had the purpose of detecting the presence of Listeria monocytogenes in frescal cheese traded in the northwestern region of the state of Parana. A total of 21 samples of frescal cheese traded in different establishments were purchased. The samples were stored in thermal boxes and duly identified. They were then forwarded to the Laboratory of Food and Water Quality Control and Inspection (LACOMA) at Universidade Federal do Parana (UFPR), Palotina campus, where the analyses were performed. All of the 21 samples analyzed were absent for Listeria monocytogenes in a 25-gram sample, in compliance with the microbiological standard for high-humidity cheese (55%) as defined by the Brazilian National Health Surveillance Agency (Agencia Nacional de Vigilância Sanitaria - ANVISA).

Occurrence of Aspergillus section Flavi and aflatoxins in Brazilian rice: From field to market

The guarantee of the high quality of rice is of utmost importance because any toxic contaminant may affect consumer health, especially in countries such as Brazil where rice is part of the daily diet. A total of 187 rice samples, from field, processing and market from two different production systems, wetland from the state of Rio Grande do Sul, dryland, from the state of Maranhão and market samples from the state of São Paulo, were analyzed for fungi belonging to Aspergillus section Flavi and the presence of aflatoxins. Twenty-three soil samples from wetland and dryland were also analyzed. A total of 383 Aspergillus section Flavi strains were isolated from rice and soil samples. Using a polyphasic approach, with phenotypic (morphology and extrolite profiles) and molecular data (beta-tubulin gene sequences), five species were identified: A. flavus, A. caelatus, A. novoparasiticus, A. arachidicola and A. pseudocaelatus. This is the first report of these last three species from rice and rice plantation soil. Only seven (17%) of the A. flavus isolates produced type B aflatoxins, but 95% produced kojic acid and 69% cyclopiazonic acid. Less than 14% of the rice samples were contaminated with aflatoxins, but two of the market samples were well above the maximum tolerable limit (5μg/kg), established by the Brazilian National Health Surveillance Agency.

How much does the backlog on drug patents cost for health in Brazil?

The backlog in processing patent applications in Brazil has persisted since the enactment of Law 9,279/1996, when the country resumed granting patents on drugs. The agencies responsible for granting such patents, namely the Brazilian National Patent and Trademark Office (INPI) and the Brazilian National Health Surveillance Agency (Anvisa) cite technical and administrative reasons for the backlog. However, little research has focused on the economic impacts for health due to the inefficiency of the Brazilian patent system. The current study thus proposes a methodology to estimate the extent to which government procurement of medicines is burdened by the backlog in drug patent applications. According to the results, a total of more than BRL 14 million (USD 4.5 million) is spent unnecessarily per year by the Federal Government on just one antiretroviral drug due to the extension of the respective patent's life. Measures to resolve this situation are urgently needed in the three branches of government. These include hiring more staff for the INPI, analysis of bills of law under review in the two houses of the Brazilian Congress to amend the Industrial Property Law, and ruling on direct class action claims of unconstitutionality to suppress the legal mechanisms that allow extending the life of patents.

Economic evaluation of human albumin use in patients with nephrotic syndrome in four Brazilian public hospitals: pharmacoeconomic study.

In 2004, the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) published a resolution establishing guidelines for albumin use. Although the published data do not indicate any definitive conclusions about the benefits of albumin use in patients with nephrotic syndrome (NS), the guidelines recommend this procedure only in cases of edema that is refractory to use of diuretics. The aim here was to analyze albumin use among patients with nephrotic syndrome. Pharmacoeconomic study conducted in four large public referral hospitals for nephrology services in northeastern Brazil. Cost-effectiveness and cost-utility economic evaluations were performed on a concurrent cohort of patients with nephrotic syndrome, who were divided into two groups according to compliance or noncompliance with the guidelines. Quality-of-life data were obtained from the SF36 and CHQ-PF50 questionnaires. This study enrolled 109 patients (60% adults and 56% women); 41.3% were using albumin in accordance with the guidelines. The weight, diuresis and fluid balance parameters were more cost-effective for patients who adhered to the guidelines. Regarding days of hospitalization avoided, the incremental ratio showed a daily cost of R$ 55.33, and guideline-compliant patients were hospitalized for five days or fewer. The quality of life improved by 8%, and savings of R$ 3,458.13/QALY (quality-adjusted life year) for the healthcare system were generated through guideline compliance. The economic analyses of this study demonstrated that there were greater cost benefits for patients whose treatment followed the guidelines.

O JULGAMENTO DO CASO DA FOSFOETANOLAMINA E A JURISPRUDÊNCIA DO SUPREMO TRIBUNAL FEDERAL

Recentemente noticiou-se a difusão do uso da substância fosfoetanolamina sintética, conhecida como a pílula do câncer, entre portadores de neoplasia maligna. Ocorre que a substância, além de não contar com registro na Agência Nacional de Vigilância Sanitária, sequer havia concluído os estudos clínicos necessários à garantia de sua eficácia e segurança. Não obstante, o governo federal editou a Lei n. 13.269/2016, que autorizava o fornecimento pelo Sistema Único de Saúde sob determinadas condições, e diversas liminares foram concedidas obrigando o Estado a fornecê-la. A questão foi apreciada pelo Supremo Tribunal Federal em dois rumorosos julgamentos, em que a Corte suspendeu todas as liminares concedidas e suspendeu a eficácia da referida lei por indícios de inconstitucionalidade. Neste artigo analisamos os fundamentos das citadas decisões no contexto de posicionamentos anteriores da Corte e das orientações estabelecidas no julgamento do Agravo Regimental na Suspensão de Tutela Antecipada 175.

Evaluation of the effectiveness of ozone as a sanitizer for fish experimentally contaminated with Salmonella sp.

Abstract Salmonellosis is a major public health problem related to food contamination and ensuing food poisoning. Brazilian resolution RDC nº 12/2001 of the Brazilian National Health Surveillance Agency (ANVISA) established the absence of Salmonella in 25 g of fish for consumption. However, the significant increase in the occurrence of fish contamination by Salmonella and other pathogenic bacteria shows that the currently applied strategies are not sufficient and that, in addition to the implementation of good health practices, the application of new sanitizer technologies in the fish industry is also necessary. In this context, the present study evaluated the effectiveness of ozone in an aqueous medium as a sanitizer for Salmonella contaminated fish. The experiment was carried out using a completely randomized design with eight treatments and five replicates, giving a total of 40 experimental units. Each sample consisted of three fishes, totalizing 120 fishes. The treatments consisted of different combinations of temperature and water-dissolved ozone (O3) concentrations (21 °C × 0.35 ppm; 20 °C × 0.45 ppm; 21 °C × 0.60 ppm; 20 °C × 0.80 ppm; 19 °C × 1.7 ppm; 6 × 5.1 ppm; 4 °C × 7.2 ppm; and 2 °C × 9.1 ppm). Colossoma macropomum (Tambaqui) samples were experimentally infected with Salmonella typhymurium (ATCC 14028) and immersed in water with the different treatments. After three minutes, the fish samples were collected and subjected to qualitative Salmonella analyses. The ozone tests were not efficient in eradicating Salmonella under the experimental conditions presented here, indicating the need for the identification of effective sanitizers in order to meet the determinations of Brazilian law.

Development and Validation of a Simultaneous RP-HPLCUV/DAD Method for Determination of Polyphenols in Gels Containing S. terebinthifolius Raddi (Anacardiaceae).

Topical gels containing extracts of Schinus terebinthifolius have been used to treat bacterial vaginosis. It has been reported that this species has antimicrobial, anti-inflammatory and anti-ulcerogenic properties, which can be attributed to the presence of phenolic compounds. In this work, a sensitive and selective reversed-phase HPLC-UV/DAD method for the simultaneous assay of six polyphenols that could be present in S. terebinthifolius was developed. The method was shown to be accurate and precise. Peak purity and similarity index both exceeded 0.99. Calibration curves were linear over the concentration range studied, with correlation coefficients between 0.9931 and 0.9974. This method was used to determine the polyphenol content of a hydroalcoholic extract and pharmacy-compounded vaginal gel. Although the method is useful to assess the 6 phenolic compounds, some compounds could not be detected in the products.SUMMARY A sensitive, selective, accurate and precise reversed-phase HPLC-UV/DAD method for the simultaneous assay of six polyphenols in S. terebinthifolius Raddi Abbreviations used: RP-HPLC-UV/DAD: Reverse Phase High Performance Liquid Chromatograph with Ultraviolet and Diode Array Detector, HPLC: High Performance Liquid Chromatograph, HPLC-UV: High Performance Liquid Chromatograph with Ultraviolet Detector, ANVISA: Brazilian National Health Surveillance Agency, LOD: Limit of detection, LOQ: Limit of quantitation

Study of Dabigatran Use in a Brazilian Public Hospital Specialized in Cardiology

Abstract Background: During its commercialization phase, unprecedented effects of new medicaments can be discovered. Dabigatran is an anticoagulant approved by Brazilian National Health Surveillance Agency in 2008. Objectives: To assess safety, effectiveness adverse event profile and adherence to dabigatran (110 mg and 150 mg) prescribed for patients with non-valvular atrial fibrillation. Methods: Patients taking dabigatran were subjected to interviews during the first year of treatment, evaluating the prescription depending on the dose, age, gender and risk factors as well as the prevalence of adverse events and the profile of the patients involved. Results: Between the beginning and the end of the study there was a reduction in the number of subjects using this anticoagulant (10% for the dose of 110 mg and 30% for the dose of 150 mg), without changes in the proportions of individuals regarding to gender (men ≅65%), age (age <75 anos ≅80%), anticoagulation previous history (≅85%) and risk scores for thromboembolic (CHA2DS2≥VASc = 2 ≅80%) and bleeding (HASBLED <3 ≅50% dose 110 mg and ≅85% dose 150 mg) events. The most common adverse event was dyspepsia (≥10%), regardless of gender, but less frequently in patients over 75 years of age (≅20% of cases). Dyspepsia related to dabigatran was mainly associated to its combination with beta-blockers (≅70%), but minoritarily with oral hypoglycemic (≅20%), antiplatelet agents (≅10%), proton pump inhibitors (≅30%) and antagonists H2 (≅3%). Therapeutic adherence was ≅60% regardless of the described adverse events. There were no cases of thromboembolic event and major bleeding. Conclusions: Dabigatran has shown to be safe and effective in the evaluated conditions.

The potential of aqueous extracts of Bellucia dichotoma Cogn. (Melastomataceae) to inhibit the biological activities of Bothrops atrox venom: A comparison of specimens collected in the states of Pará and Amazonas, Brazil

Ethnopharmacological importanceThe effectiveness of aqueous extract of Bellucia dichotoma Cogn. (Melastomataceae) specimems collected in Santarém, PA, against some biological activities of Bothrops atrox venom (BaV) has been scientifically proven. Here, we analyzed the components and assessed the anti-snakebite potential of aqueous extracts of bark of B. dichotoma collected in Manaus, AM, (AEBd-MAO) and Santarém, PA, (AEBd-STM), both in Brazil. Materials and methodsThe phytochemical profiles of the aqueous extracts were identified using thin layer chromatography (TLC), and the concentrations of phenolics were determined by colorimetric assay. The inhibitory potential of the extracts was tested against the phospholipase A2, coagulant and gelatinolytic activities of BaV in vitro and its defibrinating and edema-inducing activities in vivo. Interaction between BaV and the extracts was investigated using SDS-Page electrophoresis and Western blotting. Extract cytotoxicity and antioxidant potential were assessed using the human fibroblast cell line MRC-5 and the DPPH assay in cell culture, respectively. ResultsWhile there was no difference between the phytochemical profiles of the extracts, AEBd-MAO had higher concentrations of total phenolics, total tannins and hydrolysable tannins. The extracts inhibited 100% of the phospholipase and coagulant activity of BaV when pre-incubated. Without pre-incubation, however, there was no reduction in phospholipase activity, although significant inhibition of coagulant activity was observed. In the doses used in folk medicine, without pre-incubation, both extracts inhibited 100% of the coagulant activity of BaV. In vivo, the extracts were unable to inhibit the defibrinating activity of the venom but were effective in inhibiting its edema-inducing activity. In the profiles of the extracts pre-incubated with BaV, not all the protein bands revealed by SDS-PAGE and Western blot were observed. Both extracts had a high antioxidant potential and neither had a cytotoxic effect. ConclusionAlthough the concentrations of phenolics in each extract were different, the anti-snakebite potential was similar for the concentrations of extract tested. Our findings are of importance for the quality control of this raw material, which, once tested in accordance with Brazilian National Health Surveillance Agency recommendations, may be suitable for use as a phytomedicine to complement treatment of the local effects induced by Bothrops venoms.

Avaliação da característica de personalização dos medicamentos magistrais manipulados pelas farmácias comunitárias com Autorização Especial quanto à individualização da dose

The main purpose of compounding medicines is to meet individual needs, such as therapeutic dose, appropriate dosage forms, and absence of pharmaceutical ingredients for patients with a history of intolerance, among other technical reasons. this work analyzes, through documentary research, the compounding formula for dosage individualization of oral capsules/mono drug containing an Active Pharmaceutical Ingredient (API), according to Order No. 344/98, and prepared by community pharmacies located in Nova Friburgo, Rio de Janeiro. Data were recorded in November 2006, from prescription books of pharmacies with Special Authorization issued by ANVISA (Brazilian National Health Surveillance Agency). From the 12253 analyzed formulae, 22% met the inclusion criteria of this study. the results lead us to the conclusion that the prevalence of compounded medication for dosage individualization was low. on average, only 34% of the formulae presented a different dosage from the standard one in the available specialties on the Brazilian pharmaceutical market, which results in a diminution of personalized, compounded medications. this study therefore highlights the need of a more substantial risk assessment to justify the compounding of real compounded prescriptions.

Análise das ações judiciais individuais para fornecimento de medicamentos em São João da Boa Vista

O presente artigo tem por objetivo analisar as ações judiciais individuais realizadas para garantir o acesso a medicamentos no município de São João da Boa Vista (SP). Tratou-se de um estudo longitudinal retrospectivo, de caráter exploratório documental, nos anos de 2009 a 2012, tendo como objeto de análise processo judicial movido individualmente em face do Município com a finalidade de fornecimento de medicamento. Após a análise de 87 ações judiciais, foram encontrados os seguintes resultados: mandado de segurança individual interposto por mulheres beneficiárias da gratuidade de justiça, com patrocínio de advogados particulares, em que a ré é a diretora do Departamento Municipal de Saúde, solicitando, através de receitas privadas, medicamentos pelo nome comercial, não listados pelo Sistema Único de Saúde, todos com registro na Agência Nacional de Vigilância Sanitária. Os resultados obtidos são compatíveis com os encontrados pela literatura. Concluiu-se que, a fim de garantir o direito constitucional à saúde dos indivíduos, será necessária uma melhor organização do Estado quanto à assistência farmacêutica.

Normative evaluation of blood banks in the Brazilian Amazon region in respect to the prevention of transfusion-transmitted malaria.

ObjectiveTo evaluate blood banks in the Brazilian Amazon region with regard to structure and procedures directed toward the prevention of transfusion-transmitted malaria (TTM).MethodsThis was a normative evaluation based on the Brazilian National Health Surveillance Agency (ANVISA) Resolution RDC No. 153/2004. Ten blood banks were included in the study and classified as ‘adequate’ (≥80 points), ‘partially adequate’ (from 50 to 80 points), or ‘inadequate’ (<50 points). The following components were evaluated: ‘donor education’ (5 points), ‘clinical screening’ (40 points), ‘laboratory screening’ (40 points) and ‘hemovigilance’ (15 points).ResultsThe overall median score was 49.8 (minimum = 16; maximum = 78). Five blood banks were classified as ‘inadequate’ and five as ‘partially adequate’. The median clinical screening score was 26 (minimum = 16; maximum = 32). The median laboratory screening score was 20 (minimum = 0; maximum = 32). Eight blood banks performed laboratory tests for malaria; six tested all donations. Seven used thick smears, but only one performed this procedure in accordance with Ministry of Health requirements. One service had a Program of External Quality Evaluation for malaria testing. With regard to hemovigilance, two institutions reported having procedures to detect cases of transfusion-transmitted malaria.ConclusionMalaria is neglected as a blood–borne disease in the blood banks of the Brazilian Amazon region. None of the institutions were classified as ‘adequate’ in the overall classification or with regard to clinical screening and laboratory screening. Blood bank professionals, the Ministry of Health and Health Surveillance service managers need to pay more attention to this matter so that the safety procedures required by law are complied with.