National Health Surveillance Agency ANVISA

Brasília, Brazil

National Health Surveillance Agency ANVISA

Brasília, Brazil

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Santana H.T.,National Health Surveillance Agency ANVISA | de Freitas M.R.,Federal University of Rio Grande do Norte | Ferraz E.M.,Federal University of Pernambuco | Evangelista M.D.S.N.,University of Brasilia
Journal of Infection and Public Health | Year: 2016

The World Health Organization (WHO) created the WHO Surgical Safety Checklist to prevent adverse events in operating rooms. The aim of this study was to analyze WHO checklist implementation in three operating rooms of public hospitals in the Brazilian Federal District. A prospective cross-sectional study was performed with pre- (Period I) and post (Period II)-checklist intervention evaluations. A total of 1141 patients and 1052 patients were studied in Periods I and II for a total of 2193 patients. Period I took place from December 2012 to March 2013, and Period II took place from April 2013 to August 2014. Regarding the pre-operatory items, most surgeries were classified as clean-contaminated in both phases, and team attire improved from 19.2% to 71.0% in Period II. Regarding checklist adherence in Period II, "Patient identification" significantly improved in the stage "Before induction of anesthesia". "Allergy verification", "Airway obstruction verification", and "Risk of blood loss assessment" had low adherence in all three hospitals. The items in the stage "Before surgical incision" showed greater than 90.0% adherence with the exception of "Anticipated critical events: Anesthesia team review" (86.7%) and "Essential imaging display" (80.0%). Low adherence was noted in "Instrument counts" and "Equipment problems" in the stage "Before patient leaves operating room". Complications and deaths were low in both periods. Despite the variability in checklist item compliance in the surveyed hospitals, WHO checklist implementation as an intervention tool showed good adherence to the majority of the items on the list. Nevertheless, motivation to use the instrument by the surgical team with the intent of improving surgical patient safety continues to be crucial. © 2016.


PubMed | National Health Surveillance Agency ANVISA, University of Brasilia, Federal University of Rio Grande do Norte and Federal University of Pernambuco
Type: Journal Article | Journal: Journal of infection and public health | Year: 2016

The World Health Organization (WHO) created the WHO Surgical Safety Checklist to prevent adverse events in operating rooms. The aim of this study was to analyze WHO checklist implementation in three operating rooms of public hospitals in the Brazilian Federal District. A prospective cross-sectional study was performed with pre- (Period I) and post (Period II)-checklist intervention evaluations. A total of 1141 patients and 1052 patients were studied in Periods I and II for a total of 2193 patients. Period I took place from December 2012 to March 2013, and Period II took place from April 2013 to August 2014. Regarding the pre-operatory items, most surgeries were classified as clean-contaminated in both phases, and team attire improved from 19.2% to 71.0% in Period II. Regarding checklist adherence in Period II, Patient identification significantly improved in the stage Before induction of anesthesia. Allergy verification, Airway obstruction verification, and Risk of blood loss assessment had low adherence in all three hospitals. The items in the stage Before surgical incision showed greater than 90.0% adherence with the exception of Anticipated critical events: Anesthesia team review (86.7%) and Essential imaging display (80.0%). Low adherence was noted in Instrument counts and Equipment problems in the stage Before patient leaves operating room. Complications and deaths were low in both periods. Despite the variability in checklist item compliance in the surveyed hospitals, WHO checklist implementation as an intervention tool showed good adherence to the majority of the items on the list. Nevertheless, motivation to use the instrument by the surgical team with the intent of improving surgical patient safety continues to be crucial.


The accelerating consumer acceptance and expanding legalization of legal marijuana as well as cannabis infused products and its medicinal applications has resulted in many new opportunities for cannabis based companies and operators. Consumers can now obtain the benefits of legal marijuana without have to smoke the substance as popularity grows for CBD infused products from skin care to medicinal therapies to infused consumer goods and water products. Cannabis, medicinal marijuana, CBD infused product companies include: Puration, Inc. (OTC: PURA), OWC Pharmaceutical Research Corp. (OTC: OWCP), Cannabis Science, Inc. (OTC: CBIS), Medical Marijuana, Inc. (OTC: MJNA) and GrowBlox Sciences, Inc. (OTC: GBLX). Puration, Inc. (OTC: PURA) and Alkame Holdings, Inc. (ALKM) today announced that the two Companies will partner to introduce a second EVERx Bottled Water product at the upcoming Annual Arnold Sports Festival (formerly the 'Arnold Classic' named for Arnold Schwarzenegger) in Columbus, Ohio this week, starting March 2nd, 2017. PURA previously announced the launch of its EVERx CBD Infused Bottled Water to take place at the Arnold. Today, the two companies are announcing that PURA will private label ALKM's patented Alkaline Water under the EVERx brand name. Both EVERx CBD Infused Bottled Water and EVERx Alkaline Bottled Water will be launched at the Arnold. Title contender, number three ranked UFC MMA women's bantamweight fighter, Julianna Peña will be the EVERx Brand Spokesperson at the Arnold for both EVERx CBD Infused Bottled Water and EVERx Alkaline Water. Read this and more news for PURA at: http://marketnewsupdates.com/news/pura.html To learn more about the EVERx Brand Product Launch at the Arnold Sports Festival, follow this link EVERx BRAND LAUNCH AT THE ARNOLD SPORTS FESTIVAL ALKM's patented technology alters the structure of water, producing a combination of characteristics that are unprecedented in the beverage industry. The ALKM technology breaks down the hydrogen bonds, reducing water's cluster size, providing a more efficient delivery system for the CBD in the EVERx CBD Infused Bottled Water, and the ALKM technology includes an optimal alkaline pH level formulated with antioxidants and electrolytes so that the EVERx Alkaline Bottled water can deliver most effective hydration available in the alkaline water market. In other cannabis developments of note: OWC Pharmaceutical Research Corp. (OTCQB: OWCP), an Israeli-based developer of cannabinoid-based therapies targeting a variety of different medical conditions and disorders, yesterday announced it has received Institutional Review Board (IRB) approval to conduct safety testing on its proprietary topical crème compound for the treatment of psoriasis and related skin conditions. The approval follows the Company's February 1, 2017 8K filing announcing an extension to the size and scope of its efficacy study on the same compound, which began in November 2106. Cannabis Science, Inc. (OTC: CBIS), a U.S. company specializing in the development of cannabis-based medicines, announced late last week updates on the proposed self-medicating DPI Inhalation Device for Asthma/COPD and our Cannabinoid infused pain patch. The Company is working on the final packaging for the Cannabinoid-based Pain Patches and will roll out to partner dispensaries in the Los Angeles area very soon, joining the existing Cannabis Science product line. Medical Marijuana, Inc. (OTC: MJNA), the first publicly traded cannabis company in the United States, subsidiary, HempMeds® Brasil announced last week that the Brazilian government has authorized a doctor's prescription for the Company's hemp cannabidiol (CBD) oil product Real Scientific Hemp Oil™ (RSHO™) to treat patients in the country suffering from Multiple Sclerosis. This marks the first time that Brazil's National Health Surveillance Agency ANVISA has granted the filling of a prescription for RSHO™ to specifically help patients combat the effects of Multiple Sclerosis. Per the Multiple Sclerosis International Federation (MSIF), more than 2.5million people worldwide are affected by MS, a progressive disease of the central nervous system, for which there is currently no cure. In Brazil, MS prevalence is estimated to range from 1.36-20 per 100,000 inhabitants. GrowBlox Sciences, Inc. (OTCQB: GBLX) announced earlier this month, filing the second in a series of patent applications for life science inventions by its wholly-owned subsidiary, Growblox Life Sciences, LLC. Inflammatory disorders represent a serious health and economic burden in the US with over $200 billion spent annually. GB Sciences' novel cannabis-based therapies could significantly help both patients and society. According to the CDC, arthritis affects 22.7% (52.5 million) of adults in the US (2010-2012), and the prevalence is projected to increase to an estimated 26% (78 million of the projected total adult population) by 2040. DISCLAIMER: MarketNewsUpdates.com (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. MNU is NOT affiliated in any manner with any company mentioned herein. 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Fagundes S.D.,Catholic University of Brasília | Silva M.T.,Ministry of Health | Thees M.F.R.S.,National Health Surveillance Agency Anvisa | Pereira M.G.,University of Brasilia
Sao Paulo Medical Journal | Year: 2011

CONTEXT AND OBJECTIVE: The rapid growth of the elderly population in Brazil has implied a significant rise in the number of individuals with dementia. The real prevalence of this disease needs to be ascertained in order to establish appropriate measures for improving the quality of life of those affected. The aim of this study was to estimate the prevalence of dementia among elderly Brazilians (≥ 60 years) through a systematic review of high-quality, population-based, double-blind studies published between 1990 and 2010. DESIGN AND SETTING: Systematic review of prevalence studies. The manuscript was produced in the School of Medicine, Universidade de Brasília. METHODS: Database searches for articles were conducted in Medline (Medical Literature Analysis and Retrieval System Online), Embase (Excerpta Medica database), Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde), SciELO (Scientific Electronic Library Online) and theses and dissertations, using specific keywords. Quality was assessed according to eight criteria for sampling and measurement of findings. RESULTS: Out of 112 articles identified, eleven were included in the qualitative synthesis. In five higher-quality studies from São Paulo, the prevalence rates ranged from 5.1 to 19.0%. No meta-analysis was presented because of heterogeneity among the studies. Poor, illiterate, female and very elderly individuals were the groups most affected. CONCLUSION: The findings from this review did not reflect the reality of the whole country. Although the results brought some information on the prevalence and distribution of dementia in Brazil, cross-sectional studies with consistent methodology are needed.


Guerra C.M.,Federal University of São Paulo | Ramos M.P.,Federal University of São Paulo | Penna V.Z.,Federal University of São Paulo | Goto J.M.,Federal University of São Paulo | And 4 more authors.
American Journal of Infection Control | Year: 2010

Background: Several countries have conducted studies to assess the status of their infection control programs (ICP) with the objective of improving quality of infection control practices. Methods: To assess the perceptions and attitudes of the health care workers (HCW) concerning ICP in Brazilian hospitals, we conducted a cross-sectional survey using a self-administered online questionnaire during a Web-based course (WBC) on infection control (IC) and antimicrobial resistance (AR). Results: Of 6256 Brazilian HCW registered for the WBC, 1998 were members of infection control committees (ICC) and answered the survey. Eight hundred six (40.4%) respondents said that an ICP was established for more than 10 years in their institutions. Most professionals reported that their hospitals perform microbiologic surveillance targeted at epidemiologically important multidrug-resistant organisms, but the majority underestimated the prevalence of AR. Conclusion: Our survey highlights important information about the perceptions and attitudes of ICC members that may be used to tailor key interventions for implementing effective ICP. It suggests, additionally, that, to achieve countrywide standardized IC mechanisms in a developing country, authorities should consider the social, cultural, and economical disparities between regions and identify specific regional needs to make available the resources required to minimize such disparities. © 2010 Association for Professionals in Infection Control and Epidemiology, Inc.


PubMed | National Health Surveillance Agency ANVISA, University of Sao Paulo and University of Brasilia
Type: | Journal: JIMD reports | Year: 2016

Knowing the phenylalanine (Phe) content of foods is essential for managing the diet of patients with phenylketonuria. Data on the Phe content of foods are scarce and sometimes vary between different Food Composition Tables (FCT). Brazil created its own table of the Phe contents of fruits and vegetables based exclusively on the chemical analysis of protein content, considering that proteins contain 3-4% Phe (TCFA/ANVISA). This study compared the protein and Phe contents of vegetables and fruits provided by the TCFA/ANVISA with those listed in international food composition tables.The Phe content of 71 fruits and vegetables listed in TCFA/ANVISA was classified into four subgroups, and the Wilcoxon nonparametric test compared the Phe and mean protein contents provided by the FCTs. All tests considered the bilateral hypothesis, and the level of significance was set at 5%. The Spearmans correlation coefficient measured the statistical dependence between Phe and protein contents.The mean Phe content was <50mg Phe/100g for 15 fruits; >50mg/100g for 11 type-A vegetables; <50mg/100g for 8 type-B vegetables; 50mg/100g for 7 type-C vegetables. The percentage of Phe in protein varied from 3.131.03% to 3.742.55% in fruits; 3.331.41 to 4.821.17 in type-A vegetables; 3.461.25% to 4.832.46 in type-B vegetables; and 3.14%1.49 to 4.62%2.26 in type-C vegetables.The Phe and protein contents provided by most FCTs were positively correlated, suggesting that it is possible to estimate the Phe content of fruits by multiplying its protein content by 3%. For type-A, -B, and -C vegetables, 4% may be used.


De Souza J.H.C.,National Health Surveillance Agency ANVISA | Ferreira J.L.,University of Brasilia
IEEE Transactions on Plasma Science | Year: 2012

In this paper, we present some results of a plasma source developed at the Plasma Laboratory of the University of Brasilia for sterilization studies at atmospheric pressure. This source was primarily conceived to produce a corona-type discharge to be used on pollutant control experiments. We used ordinary air as the precursor gas. Our apparatus consists of two coaxial cylindrical tubes with different radii connected to a high-voltage power source. We used G. stearothermophilus spores as the biological indicators. We counted the viable spores after the exposure to the plasma with the pour plate technique. Finally, we studied the biocide mechanisms of the plasma and related the inactivation of the microorganisms to plasma-induced chemical and physical processes. © 2012 IEEE.


Castanheira L.G.,National Health Surveillance Agency ANVISA | Barbano D.B.A.,National Health Surveillance Agency ANVISA | Rech N.,National Health Surveillance Agency ANVISA
Biologicals | Year: 2011

Because of the recent expiry of a large number of patents on the originator biological products, interest in the production and marketing of similar biotherapeutic products in Brazil has been increasing. The national producers have significant interest in this market and have been making a large amount of investments in these kinds of products.Since biotherapeutic products consume a large amount of the government health budget, the Brazilian government also has a big interest in the possibility that more affordable biotherapeutic products could be introduced into the market to improve access, but always is concerned with the quality, safety and efficacy of these products Accordingly, it was necessary to review the biological product regulations in Brazil and to establish specific pathways to license similar biotherapeutic products.The new Brazilian regulations, Resolution n° 55/2010, are based on different regulations and guidelines from around the world, including the WHO SBP Guidelines. They follow the same scientific principles as the WHO Guidelines but also have some differences which are due to specific country needs. © 2011.


Castanheira L.G.,National Health Surveillance Agency ANVISA
Biologicals | Year: 2011

Non clinical studies are one of the requirements for the Brazilian National Regulatory Authority, ANVISA, for licensing a similar biotherapeutic product. During the WHO/KFDA workshop on implementing WHO guidelines on evaluating similar biotherapeutic products (SBP) in Seoul, Republic of Korea, the Brazilian experience with the non clinical studies of a Granulocyte Colony Stimulatory Factor (G-CSF), filgrastim, was presented. The applicant presented a reduced non clinical data package, but the key studies with relevant species were conducted and the non-clinical studies were considered sufficient for approval. Using the comparability exercise, these studies were taken together with the appropriate quality and clinical packages presented. © 2011.


Peres B.S.,National Health Surveillance Agency ANVISA | Padilha G.,Oswaldo Cruz Foundation | Quental C.,Oswaldo Cruz Foundation
Revista Brasileira de Epidemiologia | Year: 2012

When the patent of a drug expires, low cost generics may be introduced in market. Trial results that demonstrate the safety and efficacy of the reference product can be extrapolated to the generic, simplifying the approval process. This paradigm cannot be applied to biopharmaceutical products, large molecules difficult to be characterized. Minor changes in the production process can influence the biological and clinical properties of the product and result in differences in efficacy and safety profiles. It is not possible to demonstrate the identical nature of biopharmaceuticals arising from different manufacturing sources, so they cannot be approved as simple generics and need specific regulation. A bibliographical survey of the main issues involved in the approval of similar versions of biopharmaceuticals was performed as well as a comparative analysis of the regulatory situation in the largests pharmaceutical markets - U.S. and European Union - based on legislation, draft laws, guidelines and technical references issued by their regulatory agencies - FDA (Food and Drug Administration) and EMEA (European Medicines Agency), respectively, in order enlight the discussion now taking place in Brazil. Based on the laws and guidelines studied, it is concluded that, although Brazil, Europe and the United States are at different stages of setting their regulatory framework for biossimilars, it is possible to identify some similarities in approach, such as the need for different treatment for each product class (or a case by case focus) and a step by step comparison exercise, the results of which will define the amount of data and non-clinical and clinical studies required. However, issues such as interchangeability and automatic substitution of biossimilars for reference products are not yet clearly defined. From the sanitary point of view, Europe has a more conservative posture, while the U.S. and Brazil seem to be building a more flexible framework. Besides the health issues, however, we highlight the economic issues, of great importance in Europe and U.S. legislation, and not addressed in the Brazilian regulation - which can bring insecurity to producers interested in this market.

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