The understanding of the mesorectal spread in rectal cancer has lead to wide acceptance of total mesorectal excision (TME) as the surgical technique of choice for carcinoma in the lower and mid rectum. While oncological results and survival have improved with TME-surgery, morbidity and mortality remain important issues. The most feared complication is symptomatic anastomotic leakage. The aim of this thesis was to focus on the role of the defunctioning stoma, risk factors, and postoperative monitoring in regard to anastomotic leakage in sphincter saving resection of the rectum. Intraoperative adverse events were analysed in a retrospective population based case-control study in which all patients who underwent elective anterior resection in Sweden between 1987 and 1995, and who died within 30 days or during the initial hospital stay (n=140), were compared with patients chosen at random (n=423) who underwent the same operation during the same period, but survived the operation. Intraoperative adverse events were more frequent in those who died, and reconstruction of an anastomosis judged unsatisfactory by the surgeon improved the outcome. In a population based retrospective case-control study, risk factors for symptomatic anastomotic leakage were investigated in randomly chosen sample of patients who underwent anterior resection in Sweden between 1987 and 1995 (n=432). Twelve per cent of the patients developed symptomatic leakage, and 25% of the patients with leakage ended up with a permanent stoma. In multivariate regression analysis, low anastomosis, preoperative radiotherapy, male gender and intraoperative adverse events were independent riskfactors for anastomotic leakage. In a randomised multicentre trial patients operated with sphincter saving TME¨surgery for rectal cancer were randomised to a defunctioning stoma (n=116) or not (n=118). The overall rate symptomatic leakage was 19%. Patienst without a defunctioning stoma leaked in 28% and patients with a defunctioing stoma in 10%, a statistically significant difference (p<0.001) not previously demonstrated in any randomised trial of adequate size. Postoperative monitoring with computed tomography scan (CT-scan) on postoperative day 2 and 7, and C-reactive protein (CRP) daily in 33 patients operated on with anterior resection of the rectum, demonstrated larger pelvic fluid collections in patients with leakage before the leakage was clinically diagnosed. CRP was increased from postoperative day 2 and onwards in patients in whom clinical leakage was diagnosed on median postoperative day 8. In 23 patients who underwent anterior resection of the rectum, intraperitoneal metabolism was investigated using microdialysis technique measuring the carbohydrate metabolites lactate, pyruvate and glucose. Intraperitoneal cytokines IL-6, IL-10 and TNF-α were collected through a pelvic drain and analysed. In patients who developed leakage, the latate/pyruvate ratio was increased near the anastomosis on postoperative day 5 and 6, as well as IL-6 and IL-10 which were increased postoperatively day 1 and 2, while TNF-α was higher on day 1.

The dualistic South African health system is divided into a private and public health care sector. The core difference between these two sectors is that private hospitals are based on a business model with a profit motive, while public hospitals offer a free service, accessible to all citizens of South Africa and is nurse-driven. The increased need towards higher quality health care is evident in the launching of the National Health Insurance system. The pilot of this system was activated in ten sub-districts in South Africa and will become the mechanism to enhance quality and safety of patient care in the private and public sectors. Registered nurses’ reporting of quality and safety of patient care is an important factor in quality-related research and has been linked with international studies on quality of care. As the registered nurses are directly involved in all the facets of patient care, this population serves as a valuable contribution in the assessment of quality care. In this research quality of care refers to quality, patient safety and adverse events. Quality of care refers to the extent to which actual care is in conformity with the present criteria for good care. Patient safety is a parameter used to monitor and enhance quality. Through enhanced patient safety, adverse events can be prevented. Adverse events refer to all the incidents that can affect a patient during hospitalisation that is not due to the patient’s illness, such as hospital acquired infections, medication safety and patient falls with injury. This research aimed to explore and describe the nurse reported differences in quality of care, patient safety and adverse events in the adult medical and surgical units of private and public hospitals in the Free State and North West Provinces. This study was conducted within the RN4CAST research programme, an international consortium of fifteen countries working together towards the formulation of nurse workforce forecasting models. A quantitative, correlational, explorative, descriptive and contextual design was followed. The population consisted of registered nurses employed for at least one year in the selected private and public hospitals in the two participating provinces. Private hospitals with more than 100 beds were included. The public hospitals had a level three status. An all-inclusive sampling was conducted (n=332) after participants gave informed consent. Data was collected through the completion of the National Nurse Survey that covered four sections of which quality of care, patient safety and adverse events was one. Field workers were utilised during data collection. Data capturing was conducted by means of EpiData 3.1. Secondary data analysis was utilised by means of SPSS 16.0. Descriptive statistics were extracted with regard to the demographic status of the participants. The descriptive statistics were congruent with the demographic profile of nursing in South Africa. The inferential statistics included the difference in quality of care, patient safety and adverse events between the private and public hospitals in the selected provinces. Both the t-test based on the quality of care and patient safety as well as the Mann-Whitney test on adverse events indicated an insignificant difference between nurse reported quality of care, patient safety and adverse events between the private and public hospitals. Reliability and validity were assured and recommendations were formulated for nursing education, practice and research. / MCur, North-West University, Potchefstroom Campus, 2013

The dualistic South African health system is divided into a private and public health care sector. The core difference between these two sectors is that private hospitals are based on a business model with a profit motive, while public hospitals offer a free service, accessible to all citizens of South Africa and is nurse-driven. The increased need towards higher quality health care is evident in the launching of the National Health Insurance system. The pilot of this system was activated in ten sub-districts in South Africa and will become the mechanism to enhance quality and safety of patient care in the private and public sectors. Registered nurses’ reporting of quality and safety of patient care is an important factor in quality-related research and has been linked with international studies on quality of care. As the registered nurses are directly involved in all the facets of patient care, this population serves as a valuable contribution in the assessment of quality care. In this research quality of care refers to quality, patient safety and adverse events. Quality of care refers to the extent to which actual care is in conformity with the present criteria for good care. Patient safety is a parameter used to monitor and enhance quality. Through enhanced patient safety, adverse events can be prevented. Adverse events refer to all the incidents that can affect a patient during hospitalisation that is not due to the patient’s illness, such as hospital acquired infections, medication safety and patient falls with injury. This research aimed to explore and describe the nurse reported differences in quality of care, patient safety and adverse events in the adult medical and surgical units of private and public hospitals in the Free State and North West Provinces. This study was conducted within the RN4CAST research programme, an international consortium of fifteen countries working together towards the formulation of nurse workforce forecasting models. A quantitative, correlational, explorative, descriptive and contextual design was followed. The population consisted of registered nurses employed for at least one year in the selected private and public hospitals in the two participating provinces. Private hospitals with more than 100 beds were included. The public hospitals had a level three status. An all-inclusive sampling was conducted (n=332) after participants gave informed consent. Data was collected through the completion of the National Nurse Survey that covered four sections of which quality of care, patient safety and adverse events was one. Field workers were utilised during data collection. Data capturing was conducted by means of EpiData 3.1. Secondary data analysis was utilised by means of SPSS 16.0. Descriptive statistics were extracted with regard to the demographic status of the participants. The descriptive statistics were congruent with the demographic profile of nursing in South Africa. The inferential statistics included the difference in quality of care, patient safety and adverse events between the private and public hospitals in the selected provinces. Both the t-test based on the quality of care and patient safety as well as the Mann-Whitney test on adverse events indicated an insignificant difference between nurse reported quality of care, patient safety and adverse events between the private and public hospitals. Reliability and validity were assured and recommendations were formulated for nursing education, practice and research. / MCur, North-West University, Potchefstroom Campus, 2013

Aggressive hospital discharge policies adopted in the 1990s led to an influx of patients recovering from acute illness accessing post-acute home care services. Performance of the post-acute home care program in the Saskatoon Health Region was examined using formative program evaluation methods. Brief surveys of clients and nurse providers captured: care objectives and service outcomes; patient-centeredness; trust in providers; health improvement/decline; emotional/social functioning; functional status; injury avoidance; and overall quality. For clients, perceptions of quality were significantly affected by patient centeredness and experiencing unexpected health complications, which accounted for 83.0% of the variation. For nurse providers, overall quality of care was significantly related to patient centeredness, service outcomes, team communication and injury avoidance. Analysis revealed for clients with complex needs, the service period could be extended from 60 to 97 days which would cover 50.0% of clients. The research examining administrative data predicted the dependent variable Log of Total Care Hours (TCH) to enable analysis using General Linear Modelling. The results showed post-acute home care clients referred from Emergency Departments received approximately 84.2 % more TCH; post-acute home care clients referred from Surgical wards received approximately 42.1% more TCH; and post-acute home care clients referred from Cardiology received approximately 66.3% more TCH than clients referred from the community. Furthermore, single clients received more TCH than married clients. Nursing chart reviews of post-acute home care clients with wound care also predicted the Log of TCH to enable analysis using General Linear Modelling. Post-admission, 11.3% of post-acute home care clients receiving wound care displayed clinical signs and symptoms of emerging infection, while 19.7% displayed clinical signs and symptoms of acquired infection. Post-acute home care clients receiving wound care experiencing injury, trauma or harm while admitted to home care received approximately 53.3% TCH; and post-acute home care clients who acquired an infection after admission received approximately 70.2% TCH. The implications of this research suggest there is room to improve post-acute home care services to address client re-hospitalisation, unexpected health symptoms/complications, and wound care.

Current state: The goal of nursing is a quality of nursing healthcare. Each department has its own specific features and therefore has its own quality indicator. This work focuses on two quality indicators related to healthcare, specifically on patients with MRSA infection and their falls. Methodology: In the research were applied three methods of data collection: 1) statistical data from the hospital system; 2) intentional structured observation; 3) structured interviews. Research file: In order to evaluate the incidence of falls and cause of falls, were examined a total of 85 patients and a total of 98 patients for evaluation of decolonized patients with MRSA infection. The investigated group of people for observation and in-depth interviews were ONP nurses from the 6th floor of České Budějovice Hospital, plc. Results: The hypothesis that the most common cause of the fall is leaving the bed without any accompaniment has not been confirmed and the incidence of falls at the patients throughtout the observation period of the year 2015 dropped down significantly in comparison with the year 2014. The most common source of MRSA infection was a wound. Also, has not been confirmed the hypothesis that the number of decolonized patients with MRSA infection who were observing in the year 2015 will be statistically higher than in the year 2014. Most nurses know the cause of MRSA infection, but the problems they have are the precise definitions. By observing the practical activities and skills of nurses during the treatment of patients with MRSA infection were revealed certain shortages, especially the improper use of protective equipment and the improper disinfection of aids after their use. Conclusion: The results of the research show the need for more nursing education in this subject. Adverse events are a serious complication of the nursing process. The number of falls as well as the number of decolonized patients with MRSA infection is not successful significantly decrease in comparison year-on-year. The research also found inadequate theoretical preparedness of the nurses in the area of infectious diseases and a certain discrepancy between verbally presented experiences and the results of observation real activities.

Introdução: Na fase pré-comercialização, os ensaios clínicos randomizados (ECRs) constituem-se em ferramenta primordial no acúmulo de informação sobre a segurança de um medicamento. Recomendações têm sido publicadas no sentido de que a informação sobre eventos adversos seja adequadamente descrita nesses estudos. Na fase pós-comercialização, vigilância ativa e passiva complementam-se e relatos de caso de reações adversas a medicamentos (RAMs) publicados em revistas médicas deveriam contribuir no processo de geração de sinal, alertando o meio científico e auxiliando na adoção de medidas pelas agências regulatórias de medicamentos. Seu impacto, no entanto, é incerto, seja na geração de estudos confirmatórios ou incorporação das RAMs em fontes de informação sobre medicamentos utilizadas na prática médica. Objetivo: avaliar, em revistas de alto impacto da área médica: 1) a adoção das recomendações da versão do CONSORT “Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement” e das recomendações propostas por outros autores em ECRs envolvendo medicamentos publicados em 2009; 2) o impacto de relatos de caso de RAMs novas publicados em 1998, através da geração de estudos controlados confirmatórios e inclusão na base de dados MICROMEDEX e no British National Formulary (BNF). Metodologia: Através de buscas no Medline, foram selecionados todos os ECRs envolvendo medicamentos publicados em 2009 nas revistas British Medical Journal, The Journal of The American Medical Association, The Lancet e The New England Journal of Medicine e os relatos de caso publicados em 1998 nas revistas Annals of Internal Medicine, Archives of Internal Medicine, The Journal of the American Medical Association e New England Journal of Medicine. Baseando-se nas recomendações propostas por Ioannidis e Lau e na versão ampliada do CONSORT, as informações sobre eventos adversos foram extraídas dos ECRs. O impacto dos relatos de caso foi avaliado através da geração de estudos controlados confirmatórios publicados em revistas indexadas no Medline e/ou EMBASE e da incorporação da informação na base de dados MICROMEDEX e no BNF. Resultados: Dos 122 ECRs analisados, 32,8% objetivaram avaliar desfechos de segurança do medicamento em questão (posicionando-se a este respeito na introdução), 72,1% mencionaram riscos no título ou resumo; 10,7% esclareceram como a informação sobre riscos foi coletada; 46,7% apresentaram as frequências dos eventos adversos, separando-os por tipo e braço do estudo e especificando se algum tipo de evento adverso não ocorreu; e 18,0% apresentaram discussão balanceada sobre riscos e benefícios. Dos 32 relatos de caso de RAMs novas avaliados, verificou-se a inclusão da RAM em questão no MICROMEDEX em 16 (50%) relatos de caso e, no BNF, em 10 (32,1%). Observou-se geração de estudos controlados confirmatórios para 4 (12,5%) relatos. Conclusões: Informações importantes sobre eventos adversos permanecem insuficientemente atendidas em ECRs. Relatos de caso publicados em revistas médicas desempenham papel importante no processo de geração de sinal, impactando relativamente na geração de estudos confirmatórios e em fontes de informação da prática médica. / Introduction: In pre-commercialization phase, randomized clinical trials (RCTs) represent an essential tool for obtaining information on drug safety. Recommendations have been published so that the information about adverse events is properly described in these studies. In the pre-commercialization phase, active and passive vigilance complement one another, and case reports of adverse reactions to drugs (ADRs) published in medical journals should contribute for the process of sign generation, making the scientific world alert and supporting the adoption of measures by the regulatory drug agencies. Its impact, nonetheless, remains uncertain, both regarding the generation of confirmation studies and the ADR acceptance in the drug information sources used in the medical practice. This study aims at assessing, in highly-impacting medical journals: the compliance with the recommendations from the CONSORT version ‘Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement’ , as well as with the ones proposed by other authors in RCTs involving drugs, published in 2009; the impact of new ADR case reports published in 1998, through carrying out controlled confirmation studies and including them in the MICROMEDEX databank and in the British National Formulary (BNF). Methodology: Through Medline search, all the RCTs involving drugs published in 2009 in the journals British Medical Journal, The Journal of The American Medical Association, The Lancet and The New England Journal of Medicine were chosen. The same was done for the case reports published in 1998 in the Annals of Internal Medicine, Archives of Internal Medicine, The Journal of the American Medical Association and New England Journal of Medicine. Based on the recommendations proposed by Ioannidis and Lau and in the CONSORT comprehensive version, the information on adverse events was extracted from the RCTs. The impact of the case reports was assessed through carrying out controlled confirmation studies published in journals indexed in the Medline and/or EMBASE and the inclusion of this information in the MICROMEDEX databank and the BNF. Outcomes: Among the 122 RCTs analyzed, 72.1% mentioned risks in the title or abstract; 10.7% explained how information on risks had been collected; 46.7% presented adverse event frequency, sorting them by kind and study ramification, and also specifying whether some kind of adverse event had not occurred; and 18.0% presented a balanced discussion on risks and benefits. Among the 32 new ADR case reports analyzed, it was verified that these ADRs were included in the MICROMEDEX in 16 (50%) of the case reports, and in the BNF in 10 (32.1%). It was observed that controlled confirmation studies were designed for 4 (12.5%) of these studies. Conclusions: Relevant information on adverse events remains insufficient in RCTs. Case reports published in medical journals play an important part in the sign generating process, and they also relatively impact the carrying out of confirmation studies and the information sources of the medical practice.

The thesis contains a summary of issues relating the quality and safety of services and healthcare environment. The theoretical part is a cross section of the whole topic of quality and safety from a culture of quality and safety, ensuring and creating safe care at European and global level, through causes and prevention of adverse events, the influence of the European Union on this issue, the national legislation, the accreditation investigation and evaluation of the quality and safety. The research is focused towards deeper investigation the issue, clarification of concepts, causes and contexts. The pur-pose is not to draw conclusions directly, but to explore how some facilities are in comparison with the theory and in comparison with each other. The purpose and goal of this work is to determine whether the currently implemented measures and changes lead to improving of services and greater safety. The main goal of the thesis is: To determine whether the introduction of DSO (Departmental security objectives) has a positive effect on patient safety in health facilities in Pilsen and South Bohemia regions and compare the differences. As a tool to clarify the quality and safety I chose a descriptive qualitative research and quantitative analysis of adverse events in observed group. Quality was assessed by using questionnaire consisting of the main and most important parts of the theoretical concept. From data obtained by questionnaire was subsequently compiled a description of the culture of quality and safety of each facility and then compared. A numeric data was used to compare the incidence of adverse events before and after the implementation of a program of continuous improving quality and safety as well as between members of the research group.

ABSTRACT/SUMMARY Background: The clinical efficacy of tamoxifen therapy may be modified by the drug-metabolizing enzymes and transporting molecules involved into the pharmacokinetics of tamoxifen. The aim of this study was to evaluate the association of CYP2D6, ABCB1 polymorhisms and comedication with efficacy and safety of tamoxifen treatment. Methods: Totally 258 women with hormonal positive breast carcinoma were retrospectively evaluated in relation to CYP2D6, ABCB1 polymorphisms and comedication. Results: CYP2D6 polymorphisms or co-medication affecting CYP2D6 activity demonstrated no statistically significant effect on the efficacy of tamoxifen therapy or adverse event incidence; there was only a trend towards shortening the time to event (TTE) in CYP2D6 poor metabolizers. ABCB1 polymorphism rs2032582 was not associated with clinical outcomes, while a trend towards an increase of TTE in variant allele carriers was noted. The ABCB1 polymorphism rs1045642 demonstrated statistical significance in premenopausal patients (p = 0.0012, HR 0.69 (95% CI 0.21 to 2.31), and its significant association was noted with gynaecological /vasomotor adverse events (p = 0.0221, HR = 1.0588), with no evidence of the influence on the incidence and onset of venous complications. Conclusions: Although this work did not show...

Introdução: Na fase pré-comercialização, os ensaios clínicos randomizados (ECRs) constituem-se em ferramenta primordial no acúmulo de informação sobre a segurança de um medicamento. Recomendações têm sido publicadas no sentido de que a informação sobre eventos adversos seja adequadamente descrita nesses estudos. Na fase pós-comercialização, vigilância ativa e passiva complementam-se e relatos de caso de reações adversas a medicamentos (RAMs) publicados em revistas médicas deveriam contribuir no processo de geração de sinal, alertando o meio científico e auxiliando na adoção de medidas pelas agências regulatórias de medicamentos. Seu impacto, no entanto, é incerto, seja na geração de estudos confirmatórios ou incorporação das RAMs em fontes de informação sobre medicamentos utilizadas na prática médica. Objetivo: avaliar, em revistas de alto impacto da área médica: 1) a adoção das recomendações da versão do CONSORT “Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement” e das recomendações propostas por outros autores em ECRs envolvendo medicamentos publicados em 2009; 2) o impacto de relatos de caso de RAMs novas publicados em 1998, através da geração de estudos controlados confirmatórios e inclusão na base de dados MICROMEDEX e no British National Formulary (BNF). Metodologia: Através de buscas no Medline, foram selecionados todos os ECRs envolvendo medicamentos publicados em 2009 nas revistas British Medical Journal, The Journal of The American Medical Association, The Lancet e The New England Journal of Medicine e os relatos de caso publicados em 1998 nas revistas Annals of Internal Medicine, Archives of Internal Medicine, The Journal of the American Medical Association e New England Journal of Medicine. Baseando-se nas recomendações propostas por Ioannidis e Lau e na versão ampliada do CONSORT, as informações sobre eventos adversos foram extraídas dos ECRs. O impacto dos relatos de caso foi avaliado através da geração de estudos controlados confirmatórios publicados em revistas indexadas no Medline e/ou EMBASE e da incorporação da informação na base de dados MICROMEDEX e no BNF. Resultados: Dos 122 ECRs analisados, 32,8% objetivaram avaliar desfechos de segurança do medicamento em questão (posicionando-se a este respeito na introdução), 72,1% mencionaram riscos no título ou resumo; 10,7% esclareceram como a informação sobre riscos foi coletada; 46,7% apresentaram as frequências dos eventos adversos, separando-os por tipo e braço do estudo e especificando se algum tipo de evento adverso não ocorreu; e 18,0% apresentaram discussão balanceada sobre riscos e benefícios. Dos 32 relatos de caso de RAMs novas avaliados, verificou-se a inclusão da RAM em questão no MICROMEDEX em 16 (50%) relatos de caso e, no BNF, em 10 (32,1%). Observou-se geração de estudos controlados confirmatórios para 4 (12,5%) relatos. Conclusões: Informações importantes sobre eventos adversos permanecem insuficientemente atendidas em ECRs. Relatos de caso publicados em revistas médicas desempenham papel importante no processo de geração de sinal, impactando relativamente na geração de estudos confirmatórios e em fontes de informação da prática médica. / Introduction: In pre-commercialization phase, randomized clinical trials (RCTs) represent an essential tool for obtaining information on drug safety. Recommendations have been published so that the information about adverse events is properly described in these studies. In the pre-commercialization phase, active and passive vigilance complement one another, and case reports of adverse reactions to drugs (ADRs) published in medical journals should contribute for the process of sign generation, making the scientific world alert and supporting the adoption of measures by the regulatory drug agencies. Its impact, nonetheless, remains uncertain, both regarding the generation of confirmation studies and the ADR acceptance in the drug information sources used in the medical practice. This study aims at assessing, in highly-impacting medical journals: the compliance with the recommendations from the CONSORT version ‘Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement’ , as well as with the ones proposed by other authors in RCTs involving drugs, published in 2009; the impact of new ADR case reports published in 1998, through carrying out controlled confirmation studies and including them in the MICROMEDEX databank and in the British National Formulary (BNF). Methodology: Through Medline search, all the RCTs involving drugs published in 2009 in the journals British Medical Journal, The Journal of The American Medical Association, The Lancet and The New England Journal of Medicine were chosen. The same was done for the case reports published in 1998 in the Annals of Internal Medicine, Archives of Internal Medicine, The Journal of the American Medical Association and New England Journal of Medicine. Based on the recommendations proposed by Ioannidis and Lau and in the CONSORT comprehensive version, the information on adverse events was extracted from the RCTs. The impact of the case reports was assessed through carrying out controlled confirmation studies published in journals indexed in the Medline and/or EMBASE and the inclusion of this information in the MICROMEDEX databank and the BNF. Outcomes: Among the 122 RCTs analyzed, 72.1% mentioned risks in the title or abstract; 10.7% explained how information on risks had been collected; 46.7% presented adverse event frequency, sorting them by kind and study ramification, and also specifying whether some kind of adverse event had not occurred; and 18.0% presented a balanced discussion on risks and benefits. Among the 32 new ADR case reports analyzed, it was verified that these ADRs were included in the MICROMEDEX in 16 (50%) of the case reports, and in the BNF in 10 (32.1%). It was observed that controlled confirmation studies were designed for 4 (12.5%) of these studies. Conclusions: Relevant information on adverse events remains insufficient in RCTs. Case reports published in medical journals play an important part in the sign generating process, and they also relatively impact the carrying out of confirmation studies and the information sources of the medical practice.

Submitted by Biblioteca da Faculdade de Farmácia (bff@ndc.uff.br) on 2018-03-12T16:30:47Z No. of bitstreams: 1 PAULA AMARAL MARCOLINO - MESTRADO.pdf: 1108247 bytes, checksum: d4876accb5b7867b72fdcbecf1ee77e7 (MD5) / Made available in DSpace on 2018-03-12T16:30:47Z (GMT). No. of bitstreams: 1 PAULA AMARAL MARCOLINO - MESTRADO.pdf: 1108247 bytes, checksum: d4876accb5b7867b72fdcbecf1ee77e7 (MD5) / A vigilância pós-comercialização realizada através da notificação de eventos adversos (EA) e de queixas técnicas (QT) por profissionais de saúde e pela população, possibilita a proteção à saúde na medida em que origina o aperfeiçoamento do conhecimento sobre os efeitos de um determinado produto, proporcionando maior garantia da segurança e da qualidade dos mesmos. O objetivo deste estudo transversal com caráter descritivo foi investigar a prática da vigilância pós-comercialização de medicamentos entre farmacêuticos que atuam em farmácias comunitárias do município de Niterói pela utilização do sistema NOTIVISA. O projeto foi aprovado pelo comitê de ética em pesquisa do Hospital Universitário Antônio Pedro da UFF. A metodologia utilizada foi a aplicação de um questionário estruturado para farmacêuticos do município e de outro questionário em usuários de medicamentos. O estudo teve duração de 1 mês e contou com a participação de 181 pessoas, dentre elas 61 farmacêuticos e 120 usuários. O resultado demonstrou que os farmacêuticos têm conhecimento sobre a ferramenta NOTIVISA, mas têm dúvidas na sua utilização devido à ausência de treinamento para tal. Além de receberem poucos casos suspeitos de eventos adversos a medicamentos, raros são notificados. Há ainda muitas barreiras para a efetivação do profissional no mercado, principalmente o reconhecimento no trabalho do farmacêutico por parte da população, a falta de tempo para prática da atenção farmacêutica e a melhor capacitação do profissional. O baixo percentual de notificação no NOTIVISA demonstra que, são necessárias intervenções educativas como forma de aumentar as notificações e colaborar desta forma, para uma saúde de melhor qualidade / Post-marketing surveillance through the reporting of adverse events (AE) and product complaints (PC) by health professionals and the population, enables health protection as it leads to improved knowledge about the effects of a product, providing greater assurance of the safety and quality of the same. The purpose of this descriptive cross-sectional study was to investigate the knowledge and practice of post-marketing surveillance of medications among pharmacists working in community pharmacies in the city of Niterói, using the NOTIVISA system. The project was approved by the research ethics committee of the University Hospital Antônio Pedro da UFF .The methodology used was the application of a structured questionnaire for pharmacists in the municipality and another questionnaire in drug users. The study lasted 2 months and had the participation of 181 people, among them 61 pharmacists and 120 users. The result showed that pharmacists are aware of the NOTIVISA tool, but have doubts about its use due to the lack of training. In addition to receiving few suspected adverse medications events, rare are reported. There are still many barriers to the effectiveness of the professional in the market, especially the recognition in the work of the pharmacist by the population, the lack of time to practice pharmaceutical care and the better qualification of the professional. The low percentage of notification in NOTIVISA demonstrates that it is necessary that educational interventions must be adopted in order to stimulate and enhance the notifications, and thus collaborate for better health