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Medeiros M.A.N.,Agencia Nacional de Vigilancia Sanitaria | De Oliveira D.C.N.,Agencia Nacional de Vigilancia Sanitaria | Dos Prazeres Rodrigues D.,Laboratorio Of Referencia | De Freitas D.R.C.,University of Brasilia
Revista Panamericana de Salud Publica/Pan American Journal of Public Health | Year: 2011

Objective. To describe the prevalence and antimicrobial resistance of Salmonella spp. in frozen chicken carcasses at retail from 15 Brazilian cities. Methods. A descriptive study of data from the Brazilian National Program for Monitoring the Prevalence of Bacterial Resistance in Chicken (PREBAF) was conducted from September 2004 to July 2006. The program collected chicken carcasses in 15 state capitals of Brazil in the five geographic regions of the country. Standardized methodologies were used to isolate Salmonella spp. and identify serotypes. The minimal inhibitory concentration method was used to test resistance to 18 antimicrobials. Results. In 2 679 carcasses examined, the prevalence of Salmonella spp. was 2.7% (range 0.0%-8.9%). São Paulo State produced 50.6% of positive samples. Eighteen serotypes were identified. The most frequently occurring were Salmonella Enteritidis (48.8%), Salmonella Infantis (7.6%), Salmonella Typhimurium (7.2%), and Salmonella Heidelberg (6.4%). All 250 strains tested were resistant to one or more antibiotics, and 133 (53.2%) were multidrug resistant (≥ 3 classes). S. Heidelberg was resistant to ceftriaxone (75.0%) and to ceftiofur (43.8%). Conclusions. The prevalence of Salmonella spp. found in this study was relatively low. However, there were a high proportion of multidrug-resistant strains, including thirdgeneration cephalosporins used to treat invasive salmonellosis. The results confirm the relevance of the PREBAF program. It is recommended that PREBAF be improved, including a timely data analysis. A review of permitted limits for Salmonella spp. in retail chicken in Brazil is also needed.


LONDON, UK / ACCESSWIRE / December 15, 2016 / Active Wall St. blog coverage looks at the headline from Protalix BioTherapeutics, Inc. (NYSE: PLX) as the Company announced on December 14, 2016, that it has received a letter from Fundação Oswaldo Cruz (Fiocruz), a segment of the Brazilian Ministry of Health, which expressed the intended purchase of Alfataliglicerase to treat Gaucher patients in Brazil. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/. One of Protalix BioTherapeutics' competitors within the Biotechnology space, Forward Pharma A/S (NASDAQ: FWP), reported on November 29, 2016, its financial results for the third quarter ended September 30, 2016. AWS will be initiating a research report on Forward Pharma in the coming days. Today, AWS is promoting its blog coverage on PLX; touching on FWP. Get all of our free blog coverage and more by clicking on the links below: Gaucher disease is also known as glucocerebrosidase deficiency and is a type of autosomal disorder while being the most dominating Lysosomal Storage Disorder (LSD) across the world. Typically, the symptoms include a group of disorders which affect special enzymes that break down waste materials to reuse them in a cell. However, at times, when the enzymes are absent or malfunctioning, they may accumulate and turn toxic over a period. This disease occurs when a lipid named glucosylceramide accumulates in the bone marrow, spleen, lungs, liver, and at times, the brain takes a hit. With a presence rate of 1 in about 20,000 childbirths, the symptoms of the disease include fatigue, anemia, bleeding, and easy bruising. The primary solution offered is enzyme replacement therapy (ERT), where recombinant enzymes are injected into the bloodstream of the patient. On November 22, 2016, Protalix announced that the Brazilian National Health Surveillance Agency had granted regulatory approvals for the use of Alfataliglicerase as a long-term ERT to treat children aged four years and above with a confirmed diagnosis stating they are under Type 1 Gaucher disease. In March 2013, ANVISA (Agencia Nacional de Vigilancia Sanitaria) (or, Brazilian National Health Surveillance Agency) approved Alfataliglicerase for long-term ERT treatment of adults with a confirmed Type 1 Gaucher disease diagnosis. Prior to the approval by the Brazilian Ministry of Health, and the placement of this order, Protalix sold relatively small quantities of Alfataliglicerase to the ANVISA. Obviously, it was an attempt to allow the physicians and patients to experience the safety and efficacy, the drug offers. Brazil is reportedly the third in the world in terms of a number of Gaucher patients, after the USA and Israel. With approximately 700 Gaucher patients being treated in Brazil, the firm negotiated the prospects of establishing Alfataliglicerase as the primary ERT. Protalix holds exclusive rights to Alfataliglicerase in Brazil. The letter forwarded from ANVISA requests three shipments of Alfataliglicerase, where the shipments would be made from the middle of 2017 to the end of 2017. With these shipments being executed, Protalix speculated revenue generation of $24 million approximately. The revenues would help reduce the cash consumption rate of the firm by a third in 2017. With an elevation in the demand from ANVISA, the Company's revenues are set to rally and bring in additional benefits for the firm to reap. At the close of trading session on December 14, 2016, Protalix's stock price surged 11.67% to end the day at $0.34. A total volume of 11.68 million shares were exchanged during the session, which was above the 3-month average volume of 868.15 thousand shares. The stock currently has a market cap of $33.39 million. Shares of the company have a PE ratio of 0.72. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. AWS has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute. LONDON, UK / ACCESSWIRE / December 15, 2016 / Active Wall St. blog coverage looks at the headline from Protalix BioTherapeutics, Inc. (NYSE: PLX) as the Company announced on December 14, 2016, that it has received a letter from Fundação Oswaldo Cruz (Fiocruz), a segment of the Brazilian Ministry of Health, which expressed the intended purchase of Alfataliglicerase to treat Gaucher patients in Brazil. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/. One of Protalix BioTherapeutics' competitors within the Biotechnology space, Forward Pharma A/S (NASDAQ: FWP), reported on November 29, 2016, its financial results for the third quarter ended September 30, 2016. AWS will be initiating a research report on Forward Pharma in the coming days. Today, AWS is promoting its blog coverage on PLX; touching on FWP. Get all of our free blog coverage and more by clicking on the links below: Gaucher disease is also known as glucocerebrosidase deficiency and is a type of autosomal disorder while being the most dominating Lysosomal Storage Disorder (LSD) across the world. Typically, the symptoms include a group of disorders which affect special enzymes that break down waste materials to reuse them in a cell. However, at times, when the enzymes are absent or malfunctioning, they may accumulate and turn toxic over a period. This disease occurs when a lipid named glucosylceramide accumulates in the bone marrow, spleen, lungs, liver, and at times, the brain takes a hit. With a presence rate of 1 in about 20,000 childbirths, the symptoms of the disease include fatigue, anemia, bleeding, and easy bruising. The primary solution offered is enzyme replacement therapy (ERT), where recombinant enzymes are injected into the bloodstream of the patient. On November 22, 2016, Protalix announced that the Brazilian National Health Surveillance Agency had granted regulatory approvals for the use of Alfataliglicerase as a long-term ERT to treat children aged four years and above with a confirmed diagnosis stating they are under Type 1 Gaucher disease. In March 2013, ANVISA (Agencia Nacional de Vigilancia Sanitaria) (or, Brazilian National Health Surveillance Agency) approved Alfataliglicerase for long-term ERT treatment of adults with a confirmed Type 1 Gaucher disease diagnosis. Prior to the approval by the Brazilian Ministry of Health, and the placement of this order, Protalix sold relatively small quantities of Alfataliglicerase to the ANVISA. Obviously, it was an attempt to allow the physicians and patients to experience the safety and efficacy, the drug offers. Brazil is reportedly the third in the world in terms of a number of Gaucher patients, after the USA and Israel. With approximately 700 Gaucher patients being treated in Brazil, the firm negotiated the prospects of establishing Alfataliglicerase as the primary ERT. Protalix holds exclusive rights to Alfataliglicerase in Brazil. The letter forwarded from ANVISA requests three shipments of Alfataliglicerase, where the shipments would be made from the middle of 2017 to the end of 2017. With these shipments being executed, Protalix speculated revenue generation of $24 million approximately. The revenues would help reduce the cash consumption rate of the firm by a third in 2017. With an elevation in the demand from ANVISA, the Company's revenues are set to rally and bring in additional benefits for the firm to reap. At the close of trading session on December 14, 2016, Protalix's stock price surged 11.67% to end the day at $0.34. A total volume of 11.68 million shares were exchanged during the session, which was above the 3-month average volume of 868.15 thousand shares. The stock currently has a market cap of $33.39 million. Shares of the company have a PE ratio of 0.72. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. AWS has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.


Minnaert A.C.S.T.,Agencia Nacional de Vigilancia Sanitaria | Freitas M.C.S.,Federal University of Bahia
Ciencia e Saude Coletiva | Year: 2010

The main objective of this research is to understand the meaning of the practices concerning food hygiene in a street market in Salvador, the capital of Bahia State in Brazil. The ethnographic study presents two main categories for symbolic production related to hygiene practices: cleanliness as order and dirtiness as disorder. These cultural codes make correspondence with the studies of Mary Douglas and Nobert Elias. The codes present particularities to decode everyday life, in which concept and hygiene practices are aspects normalized, in daily activity, for persons who share the space of street market: vendors, consumers, street cleaners and official inspectors. The techno-scientific knowledge and sanitary legislation are strange to the symbolic system of street market vendors. The laws are ineffective and their influence is of little importance in the creation of hygiene practices. Official inspectors' attitudes are coercive and punitive and do not take into account any cultural values when enforcing new hygiene practices.


Nilson E.A.F.,Ministerio da Saude | Jaime P.C.,Ministerio da Saude | De Oliveira Resende D.,Agencia Nacional de Vigilancia Sanitaria
Revista Panamericana de Salud Publica/Pan American Journal of Public Health | Year: 2012

The construction of strategies for reducing the sodium content of processed foods is part of a set of actions to decrease the intake of this nutrient in Brazil-from the current 12 g of salt per person per day to less than 5 g per person per day (2 000 mg sodium) by 2020. In this process, a central action is the pact between the government and the food industry to establish voluntary, gradual, and sustainable targets to reduce the maximum sodium content of industrial foods. This article describes the Brazilian experience in building and implementing strategies for the reduction of these maximum limits in processed foods and the social actors involved in this effort. © 2013 Organización Panamericana de la Salud.


PubMed | Agencia Nacional de Vigilancia Sanitaria, Ministerio da Saude, Federal University of Minas Gerais, University of Brasilia and Federal University of Rio Grande do Sul
Type: Journal Article | Journal: Epidemiologia e servicos de saude : revista do Sistema Unico de Saude do Brasil | Year: 2016

to describe the proportion of hypertensive and diabetic patients who reported getting medicines to control these diseases via the Brazilian Peoples Pharmacy Program, according to sociodemographic factors.this was a population-based descriptive study using 2013 National Health Survey data on individuals aged over 18 years.around one third of hypertensive individuals (35.9%; 95%CI 34.1-37.7) and more than half of those with diabetes (57.4%; 95%CI 54.2-60.2%) had got at least one kind of medication via the Program, there being some differences between the countrys regions. Among patients with diabetes, higher rates of getting medication were found in black people (69.4%; 95%CI 60.8-77.9) and those with less schooling (0-8 years) (63.9%; 95%CI 60.2-67.7), with no significant differences between age groups or sex.obtaining at least one kind of medication to treat hypertension and diabetes via the Program was high, especially among the underprivileged.


Alves F.N.R.,Agencia Nacional de Vigilancia Sanitaria | Peci A.,Escola Brasileira de Administracao Publica e de Empresas
Revista de Saude Publica | Year: 2011

Regulatory Impact Analysis, which is recommended to regulatory departments, aims to improve regulatory quality by providing information about the costs and benefits of regulation as well as solutions to current issues to enhance the decision-making process. This article discusses the importance of Regulatory Impact Analysis in the context of the National Agency for Sanitary Surveillance performance as well as the agency's current phase of regulation improvement and strengthening. Also, the main definitions related to the regulatory field as well as some international case experiences are presented.


Hurtado R.L.,Agencia Nacional de Vigilancia Sanitaria | Lasmar M.C.,Federal University of São Paulo
Cadernos de Saude Publica | Year: 2014

The problem of counterfeit medicines is increasing rapidly, aggravated by globalization and the lure of profit from this illegal activity. Various types of drugs have been counterfeited, posing a serious public health and safety problem. The current article provides an overview of the issue in Brazil and the resulting measures taken by the National Health Surveillance Agency (ANVISA) in collaboration with the Federal Police from 2007 to March 2011. The study analyzed seizures of counterfeit drugs, arrests, and other factors. No professional pharmacist was present in 90% of the establishments were some type of crime occurred (sale of counterfeit drugs and lack of control of narcotics and other drugs). Among the products seized, most were drugs for erectile dysfunction. The study showed the importance of inter-agency collaboration for combatting this type of irregular drug sales.


Mota D.M.,Agencia Nacional de Vigilancia Sanitaria | Silva Jr. G.G.,Catholic University of Brasília
Revista da Associacao Medica Brasileira | Year: 2012

Objective: Analyze the use of appetite suppressants in Brazil in 2009, according to the characteristics of users, healthcare system, and other drugs. Methods: Pharmaconeconometric study of cross-sectional data to analyze the relationship between the use of appetite suppressants (mg/per capita) and the independent variables selected (gender, race/color, age, schooling, income, health insurance coverage, and use of fluoxetine and chlordiazepoxide) using multiple linear regression analysis. This study used these variables in level of aggregation by states for 2009. The analyses were performed using the Gretl software. Results: We highlight that São Paulo showed the highest use of appetite suppressants with 97.3 mg/ per capita, followed by Goiás with 94.8 mg/per capita. The lowest use of appetite suppressants was seen in Ceará (3.8 mg/per capita). The biggest fluoxetine users were in Rio Grande do Sul, with 58.0 mg/ per capita, and in Goiás, with 51.5 mg/per capita. Ceará showed the lowest fluoxetine use (2.3 mg/per capita). For chlordiazepoxide, the highest values were seen in Minas Gerais (7.5 mg/per capita) and in Rio de Janeiro (4.8 mg/per capita), while Amazonas (0.08 mg/per capita) showed the lowest use. Based on regression analysis, we can highlight: 1) the use of appetite suppressants is related to income, education, and fluoxetine use; and 2) race/color, gender, age, health insurance coverage, and use of chlordiazepoxide showed no relation to the use of appetite suppressants. Conclusion: These evidences may contribute to the improvement of regulatory actions, sanitary surveillance, and ethical conduct, particularly with regard to the concomitant use of appetite suppressants and fluoxetine, which is prohibited by the Federal Council of Medicine (Conselho Federal de Medicina) and also by Anvisa (Agência Nacional de Vigilância Sanitária - National Health Surveillance Agency). © 2012 Elsevier Editora Ltda.


Dias Sousa V.,University of Brasilia | Ramalho P.I.,Agencia Nacional de Vigilancia Sanitaria | Silveira D.,University of Brasilia
Revista Panamericana de Salud Publica/Pan American Journal of Public Health | Year: 2016

Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs) and Regional Reference Authorities (RRAs). This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report) as tools for strengthening health systems. Based on a narrative (nonsystematic) review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data) and data- and work-sharing (inter-agency data). The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1) the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics) and 2) the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.


The present article aims to propose and to describe the investigation in field pharmacoepidemiology as having a major role in pharmacovigilance by municipal, state and federal governments to manage drug-related repor ts, communication and information in the media. First, pharmacovigilance is put into context, by including its concepts, events of interest and main functions. Subsequently, field pharmacoepidemiology investigation oriented to the twelve steps is described. Then, we present a general picture of the investigation in field pharmacoepidemiology conducted in Brazil. Finally, we argue that investigation in field pharmacoepidemiology is an important tool to improve measures in pharmacovigilance and to improve patient safety in the country.

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