Résumé
A evolução da biotecnologia somada à ascensão da tecnologia para recombinação do DNA impulsionou a produção de biológicos ao longo de décadas. Com o término das patentes, os biossimilares emergiram com potencial de gerar um grande impacto na acessibilidade e assim estabelecer seu lugar no mercado após comprovação da equivalência com o medicamento biológico. Entretanto, as preocupações sobre as trocas de medicamentos biológicos e biossimilares é um importante debate atual que ressalta a relevância de acompanhamento pós mercado das pessoas em uso de biofármacos. Este estudo teve como objetivo elaborar um protótipo para identificar e validar os dados necessários para a construção de um software específico para o monitoramento dos medicamentos biossimilares para doenças inflamatórias imunomediadas, tendo em vista o processo de trabalho dos profissionais de saúde e da indústria farmacêutica, considerando os aspectos legais e legislativos das agências reguladoras em benefício do doente crônico. Trata-se de uma pesquisa aplicada, com abordagem qualitativa, na modalidade pesquisa-ação. A população amostral foi constituída por profissionais de saúde, profissionais da indústria farmacêutica, agência reguladora, usuários de medicamento biológico e medicamento biossimilar e especialistas de informática que aceitaram participar da pesquisa por meio da assinatura do Termo de Consentimento Livre e Esclarecido. Abordados na primeira etapa do estudo, os apontamentos dos integrantes do Comitê de Especialistas agregaram as diretrizes estabelecidas pelas agências reguladoras e contribuíram com o levantamento de requisitos que, permeado por padrões de terminologia, direcionou o desenvolvimento dos protótipos (estático e de software). O Adobe Illustrator® foi o editor de imagens vetoriais utilizado para desenvolver o protótipo estático e contribuir para consolidar as telas, ao passo que o protótipo de software explorou as potencialidades da tecnologia Angular e favoreceu a interação do usuário com as telas desenvolvidas. Na segunda fase do estudo, os integrantes do Comitê de Avaliadores acessaram o protótipo para avaliação da tecnologia por meio da aplicação de um questionário. Os resultados evidenciam a importância de desenvolver estratégias para identificar os desvios de qualidade e dessa forma minimizar os eventuais danos das novas gerações de medicamentos. Soma-se a relevância de identificar as trocas de medicamentos biológicos e biossimilares e qualificar as informações para favorecer o acompanhamento pós mercado dos biofármacos e, assim, fortalecer a farmacovigilância e contribuir com a segurança do paciente. A aproximação entre o pesquisador e as pessoas implicadas na jornada do paciente em uso de medicamento biológico e biossimilar proporcionou a inserção de perspectivas não previstas pela literatura e, sobretudo, delineou potenciais soluções para os problemas apontados.
The evolution of biotechnology added to the rise of technology for DNA recombination boosted the production of biologicals for decades. With the end of patents, biosimilars emerged with the potential to generate a great impact on accessibility and thus establish their place in the market after proof of equivalence with biological medicine. However, concerns regarding the exchange of biological and biosimilar medicines is an important current debate that highlights the relevance of post-market monitoring of people using biopharmaceuticals. This study aimed to develop a prototype to validate the data necessary for the monitoring of biological and biosimilar medicines for immune-mediated inflammatory diseases. It is an applied research, with a qualitative approach, in the action-research modality. The sample population consisted of health professionals, professionals from the pharmaceutical industry, regulatory agency, users of biological and biosimilar products and IT specialists who agreed to participate in the research by signing the Free and Informed Consent Form. Approached in the first stage of the study, the notes of the members of the Committee of Experts added the guidelines established by the regulatory agencies and contributed to the survey of requirements that, permeated by terminology standards, guided the development of prototypes (static and software). Adobe Illustrator® was the vector image editor used to develop the static prototype and contributed to consolidate the developed screens, while the software prototype explored the potential of Angular technology and favored user interaction with the screens developed. In the second phase of the study, the members of the Committee of Evaluators accessed the prototype for evaluating the technology through the application of a questionnaire. The results show the importance of developing strategies to identify quality deviations and minimize the potential damages of new generations of medicines. biopharmaceuticals and, thus, strengthen pharmacovigilance and contribute to patient safety. The approximation between the researcher and the people involved in the journey of the patient using biological and biosimilar medicines provided the insertion of perspectives not foreseen in the literature and, above all, outlining potential solutions to the problems mentioned.
Sujets)
Technologie , Informatique médicale , Surveillance des médicaments , Systèmes de signalement des effets indésirables des médicaments , PharmacovigilanceRésumé
Background: Adverse drug reactions (ADRs) constitute a major clinical problem in terms of human suffering and increased health-care costs all over the world. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects, or any other drug related problems. Thus, the information generated is useful in educating doctors about ADRS as well in the official regulation of drug use. However, the pharmacovigilance program faces the challenge of under reporting of ADRs and one needs to find the ways to overcome it. Aim and Objectives: The aim of the study was to improve the reporting of ADRs from the hospital and overcome the problem of under-reporting of ADRs. Materials and Methods: A prospective observational study was conducted as part of pharmacovigilance program over 6 months between June 2021 and December 2021. Undergraduate students were trained to collect cases of ADR from hospital during their clinical postings. The details of cases obtained by such active surveillance were filled into suspected ADR–CDSCO forms and submitted to pharmacovigilance unit. Causal relationship was assessed and categorized by Naranjo algorithm and WHO-UMC causality scale. All values were expressed in percentages. Results: A total of 120 cases were reported over 6 months compared to just 20 cases during the past year. Among them, 66% were in males and 55% were in females. The majority of ADRs were due to antimicrobial agents (40.78%) followed by hematinics (12%) and anti-epileptics (10%). The maximum number of patients (30.25%) reported with dermatological manifestations. The highest number of ADRs was reported from the Department of Medicine (45%). As per Naranjos scale, 54% reports were assessed as probable and 46% as possible. Conclusion: This new way of training and involving undergraduates significantly improved the number of ADR cases being reported to the pharmacovigilance center. This helped overcome the problem of under reporting of cases and has strengthened the pharmacovigilance activity in our institute.
Résumé
Introdução: Danos decorrentes de eventos adversos relacionados a medicamentos (EAM) estão entre os mais frequentes no mundo. Logo, seu monitoramento é essencial, especialmente entre os idosos que apresentam maior risco de sofrer tais danos. Adicionalmente, a pandemia da COVID-19, a sua elevada incidência entre idosos e o uso frequente de medicamentos off-label reforçaram a importância do monitoramento de EAM nessa população. Objetivo: Descrever as suspeitas de EAM entre idosos no Brasil antes e após o início da pandemia por COVID-19. Método: Foi realizada a descrição das suspeitas de EAM notificadas no sistema VigiMed da Agência Nacional de Vigilância Sanitária envolvendo idosos (idade ≥ 65 anos) no período pré-pandemia (01/2019 a 03/2020) e pós-início da pandemia (04/2020 a 06/2021). A diferença entre a proporção de EAM graves entre os períodos foi avaliada mediante teste qui-quadrado de Pearson. Resultados: Foram notificadas 57.167 suspeitas de EAM no período global avaliado; 22,2% envolviam idosos. No período pré-pandemia, 2.924 suspeitas de EAM foram notificadas (44,2% eram EAM graves), destacando-se aquelas envolvendo antineoplásicos, antimicrobianos e anticoagulantes. No período pós-início da pandemia, 9.771 suspeitas de EAM foram notificadas (57,5% graves), destacando-se a hidroxicloroquina e as vacinas contra a COVID-19. A diferença na proporção de suspeitas de EAM graves notificadas para idosos entre os períodos avaliados foi estatisticamente significativa (p < 0,001). Conclusões: Notificações de EAM e estudos que avaliem EAM entre idosos são essenciais para gerar informações que possam subsidiar a otimização da farmacoterapia e a priorização de redução de danos entre eles, sobretudo no contexto pandêmico que afeta consideravelmente essa população.
Introduction: Harm resulting from adverse drug events (ADE) is among the most frequent in the world. Therefore, its monitoring is essential, especially among older adults, who are at greater risk of suffering such type of harm. Additionally, the COVID-19 pandemic, its high incidence among older adults and frequent use of off-label medications have reinforced the importance of monitoring ADE in this population. Objective: To describe the suspected ADE among older adults in Brazil before and after the beginning of the COVID-19 pandemic. Method: A description of suspected ADEs reported in the VigiMed system of the National Health Surveillance Agency was carried out, involving older adults (age ≥ 65 years) in the pre- (01/2019 to 03/2020) and post-onset of the pandemic period (04/2020 to 06/2021). The difference between the proportion of severe ADE between the periods was evaluated using Pearson's chi-square test. Results: 57,167 suspected ADE were reported in the global period evaluated; 22.2% involved older adults. In the pre-pandemic period, 2,924 suspected ADEs were reported (44.2% were severe ADEs), especially those involving antineoplastic, antimicrobial, and anticoagulant drugs. In the post-pandemic period, 9,771 suspected ADEs were reported (57.5% severe), especially related to hydroxychloroquine and vaccines against COVID-19. The difference in the proportion of severe suspected ADE reported for the older adults between the periods evaluated was statistically significant (p < 0.001). Conclusions: ADE notifications and studies that evaluate ADE among older adults are essential to generate information that can support drug therapy optimization and prioritization of harm reduction among them, especially in the pandemic context that considerably affects this population.
Résumé
Resumo Avaliou-se os formulários de notificação de suspeitas de reações adversas a medicamentos (RAM) do sistema de farmacovigilância do Brasil e outros doze países latino-americanos. O estudo foi composto por três etapas. Na primeira, os formulários foram pontuados em relação à presença de itens essenciais para compor uma notificação de RAM. Na segunda, as variáveis dos formulários foram quantificadas e classificadas, quanto à razoabilidade em contribuírem para a avaliação de causalidade. Na última etapa, recorreu-se à análise de agrupamento hierárquico para identificar os formulários similares. O formulário da Venezuela obteve a maior pontuação (18 pontos). A mediana das variáveis nos formulários dos países foi de 41 [26 (Guatemala) a 95 (Brasil)]. A maioria das variáveis dos formulários foram classificadas como vitais e a maior parte contribui como fator de explicação alternativo para a avaliação de causalidade. Quatro agrupamentos foram identificados (1, 2, 3 e 4). Os formulários do Brasil e da Bolívia formaram dois grupos distintos, 1 e 3 respectivamente. Há necessidade de modificação dos formulários dos países ou até mesmo exclusão de variáveis, tornando-os mais adequados ao processo de avaliação da causalidade das RAM.
Abstract The scope of this study was to assess the forms used to report suspected adverse drug reactions (ADR) to the pharmacovigilance system in Brazil and twelve other Latin-American countries. The study comprised three stages. In the first stage, the forms were attributed a score relating to the presence of critical items to generate ADR notification. In the second stage, the variables of the forms were quantified and classified regarding feasibility to contribute to an appropriate assessment of causality. In the last stage, hierarchical clustering was used to identify similar forms. The Venezuelan form achieved the highest score (18 points). The median number of variables in the forms of each country was 41 [26 (Guatemala) to 95 (Brazil)]. Most of the variables of the form were classified as life-critical and the majority contribute as an alternative explanation to causality assessment. Four clusters were identified (1, 2, 3 and 4). The forms of Brazil and Bolivia formed two distinct groups, 1 and 3 respectively. The results of this study indicate the need to change the forms of the different countries studied or even delete some variables, making them more appropriate for the process of assessment of ADR causality.
Sujets)
Humains , Effets secondaires indésirables des médicaments/épidémiologie , Pharmacovigilance , États-Unis , Bolivie , Brésil/épidémiologie , Systèmes de signalement des effets indésirables des médicamentsRésumé
Resumen | Introducción. El uso de medicamentos puede conllevar errores de medicación que desemboquen en la hospitalización del paciente, el aumento de los costos relacionados con la atención e, incluso, la muerte. Objetivos. Determinar la prevalencia de errores de medicación notificados en un sistema de información de farmacovigilancia en Colombia entre el 2018 y el 2019. Materiales y métodos. Se hizo un estudio observacional a partir del registro de errores de medicación de un sistema de farmacovigilancia que cubre a 8,5 millones de pacientes ambulatorios afiliados al sistema de salud de Colombia. Los errores se categorizaron en ocho grupos de la A (situaciones potenciales de error) hasta la I (error que pudo llevar a la muerte). Se hizo el análisis descriptivo y se estableció la prevalencia de los errores de medicación. Resultados. Durante los años 2018 y 2019, se reportaron 29.538 errores de medicación en pacientes ambulatorios, con una prevalencia general de 1,93 por cada 10.000 medicamentos dispensados. En el 0,02 % (n=6) de los casos, se presentaron errores que llegaron a afectar a los pacientes y causaron daño (tipos E, F e I). La mayoría de los errores se asoció con la dispensación (n=20.636; 69,9 %) y la posible causa más común fue la falta de concentración en el momento de dispensar los medicamentos (n=9.185; 31,1 %). Los grupos farmacológicos más implicados en errores de medicación fueron los antidiabéticos (8,0 %), los inhibidores del sistema renina-angiotensina (7,6 %) y los analgésicos (6,0 %). Conclusiones. Los errores de medicación son relativamente poco frecuentes y con mayor frecuencia se catalogan como circunstancias o eventos capaces de generar un error de tipo A. Muy pocas veces, pueden causarle daño al paciente, incluso, hasta la muerte.
Abstract | Introduction: The use of drugs may involve medication errors leading to hospitalization, increased costs related to care, and even death. Objective: To determine the prevalence of medication errors reported in a pharmacovigilance information system in Colombia between 2018 and 2019. Materials and methods: We conducted an observational study based on the records of medication errors from a pharmacovigilance system covering 8.5 million outpatients affiliated with the Colombian health system. The errors were categorized from A (potential situations to error) to I (an error that could lead to death). We performed a descriptive analysis and established the prevalence of medication errors. Results: During 2018 and 2019, 29,538 medication errors in outpatients were reported with a general prevalence of 1.93 per 10,000 drugs dispensed. The errors that reached the patient and caused damage (types E, F, and I) occurred in 0.02% (n=6) of the patients. Most of them were related to the dispensation (n=20,636; 69.9%) and the possible most common cause was the lack of concentration at the time of dispensing (n=9185; 31.1%). The pharmacological groups most involved in medication errors were antidiabetics (8.0%), renin-angiotensin system inhibitors (7.6%), and analgesics (6.0%). Conclusions: Medication errors are relatively rare situations, generally classified as circumstances or events capable of generating the error (type A error). In low proportion, they can reach the patient and cause damage or even death.
Sujets)
Erreurs de médication , Systèmes de signalement des effets indésirables des médicaments , Pharmacovigilance , Préjudice au patientRésumé
Objective:To investigate the efficacy of Nicorandil in the treatment of unstable angina pectoris.Methods:Sixty patients with unstable angina pectoris who received treatment in Department of Cardiovascular Disease, Suixi Hospital of Traditional Chinese Medicine, China during January-July 2020 were included in this study. They were randomly assigned to receive either conventional treatment including antiplatelet, increasing coronal blood flow velocity, lipid-lowering treatment and stabilization of atherosclerotic plaque (control group, n = 30) or Nicorandil treatment and conventional treatment (observation group, n = 30). Clinical efficacy was compared between the two groups. Angina attack, electrocardiogram changes and adverse reactions in each group were analyzed before and after treatment. Results:Total effective rate in the observation group was significantly higher than that in the control group [88.67% (26/30) vs. 53.33% (16/30), χ2 = 7.937, P = 0.005]. The frequency and duration of angina pectoris in the observation group were (1.53 ± 0.62) times/week, (1.93 ± 0.78) minutes, which were significantly lower or shorter than those in the control group [(1.97 ± 0.71) times /week, (2.60 ± 1.00) minutes, t = -2.359, -3.162, P = 0.025, 0.004). The total effective rate of electrocardiogram in the observation group was significantly higher than that in the control group [70.00% (22/30) vs. 43.34% (13/30), χ2 = 5.554, P = 0.018]. There was no significant difference in the incidence of adverse drug reactions such as nausea, dizziness and palpitation between the two groups (all P > 0.05). Conclusion:Based on conventional treatment, Nicorandil treatment for unstable angina pectoris can improve the clinical symptoms and electrocardiogram changes, exhibit remarkable efficacy, and therefore deserve clinical promotion.
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Abstract: The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events. The available information on the renal safety profile for remdesivir is limited, thus we analyzed the renal and urinary adverse reactions attributed to remdesivir reported in a large open pharmacovigilance database. We obtained reports of remdesivir and other drugs used to treat COVID-19 (tocilizumab, hydroxychloroquine, lopinavir/ritonavir) registered by September 30 2020, from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed the reporting odds ratios (RORs) for reports of adverse renal and urinary events for remdesivir and other drugs. We found 2,922 reports with remdesivir registered in FAERS for COVID-19. Among these, 493 renal and urinary adverse effects (16.9%) were reported. The most frequent events were acute kidney injury (338; 11.6%), renal impairment (86; 2.9%), and renal failure (53; 1.8%). Versus hydroxychloroquine, lopinavir/ritonavir, or tocilizumab, the use of remdesivir was associated with an increased chance of reporting renal and urinary disorders regardless of gender and age of patients (2.53; 95%CI: 2.10-3.06). The ROR remained significant when we restricted the analysis to hydroxychloroquine (4.31; 95%CI: 3.25-5.71) or tocilizumab (3.92; 95%CI: 2.51-6.12). Our results reinforce this already reported signal, emphasizing that it could be extremely useful for health professionals who prescribe this new antiviral to treat COVID-19, mainly knowing its low efficacy.
Resumo: De acordo com a Agência de Controle de Alimentos e Medicamentos dos Estados Unidos (FDA), a prescrição do remdesivir deve ser feita com cautela em pacientes com taxa de filtração glomerular estimada (TFGe) < 30, sendo que diversos estudos relatam risco de eventos adversos renais. São limitados os dados disponíveis sobre o perfil de segurança renal do remdesivir. Assim, analisamos as reações adversas renais e urinárias atribuídas ao remdesivir e notificadas em um grande base de dados abertos de farmacovigilância. Obtivemos notificações sobre remdesivir e outros medicamentos usados para tratar a COVID-19 (tocilizumabe, hidroxicloroquina, lopinavir/ritonavir) registradas até 30 de setembro de 2020 do Sistema de Notificação de Eventos Adversos da FDA (FAERS). Analisamos as razões de chances de notificação (RORs) para notificações de eventos adversos renais e urinários referentes ao remdesivir e outros medicamentos. Encontramos 2.922 notificações sobre remdesivir registradas no FAERS para COVID-19. Entre esses casos, foram notificados 493 efeitos adversos renais e urinários (16,9%). Os eventos mais frequentes foram lesão renal aguda (338; 11,6%), comprometimento renal (86; 2,9%) e insuficiência renal (53; 1,8%). Comparado com a hidroxicloroquina, lopinavir/ritonavir ou tocilizumabe, o uso do remdesivir esteve associado com um aumento das chances de notificação de transtornos renais e urinários, independentemente do sexo e idade dos pacientes (2,53; IC95%: 2,10-3,06). A ROR permaneceu significativo quando limitamos a análise à hidroxicloroquina (4,31; IC95%: 3,25-5,71) ou ao tocilizumabe (3,92; IC95%: 2,51-6,12). Nossos resultados corroboram outros estudos e destacam a utilidade para profissionais da saúde que usam esse novo antiviral para tratar a COVID-19, sobretudo em função de sua baixa eficácia.
Resumen: La Agencia Americana de Control de Alimentos y Medicamentos (FDA) ha destacado que la prescripción de remdesivir debe ser prudente con pacientes con tasa de filtración glomerular estimada (TGFe) < 30; además, algunos estudios informaron del riesgo de reacciones adversas renales. La información disponible sobre el perfil de seguridad renal, en el caso del remdesivir, es limitada. Por ello, analizamos las reacciones adversas renales y urinarias atribuidas al remdesivir e notificadas en una extensa base de datos abierta de farmacovigilancia. Obtuvimos las notificaciones de remdesivir y otros medicamentos usados para tratar la COVID-19 (tocilizumab, hidroxicloroquina, lopinavir/ritonavir) registrados el 30 de septiembre de 2020 por el Sistema de Notificación de Eventos Adversos de la FDA (FAERS). Analizamos las odds ratios informadas (RORs) en el caso de informes de eventos adversos renales y urinarios adversos relacionados con el remdesivir y otros medicamentos. En el FAERS, encontramos 2.922 notificaciones de remdesivir registradas como medicament sospechoso usado en COVID-19. De estos, habían 493 con efectos renales y urinarios adversos (16,9%). Los efectos adversos más frecuentes fueron lesiones renales agudas (338; 11,6%), insuficiencia renal (86; 2,9%), y fallo renal (53; 1,8%). Frente a hidroxicloroquina, lopinavir/ritonavir, o tocilizumab, el uso de remdesivir se asoció con un riesgo mayor de notificar alteraciones renales y urinarios, independientemente del género y edad de los pacientes (2,53; IC95%: 2,10-3,06). La ROR permaneció significativo al restringir el análisis a la hidroxicloroquina (4,31; IC95%: 3,25-5,71) o tocilizumab (3,92; IC95%: 2,51-6,12). Nuestros resultados corroboran datos previos, algo que podría ser extremadamente útil para los profesionales de la salud que decidan usar este nuevo antiviral para tratar la COVID-19, sobre todo conociendo su baja eficacia.
Sujets)
Humains , Pharmacovigilance , COVID-19/traitement médicamenteux , Brésil , AMP/analogues et dérivés , Systèmes de signalement des effets indésirables des médicaments , Alanine/analogues et dérivés , SARS-CoV-2 , ReinRésumé
In the current review, the relationship between the reporting odds ratio (ROR) and the case-control study is addressed.The proportional mortality ratio (PMR) obtained in the proportional mortality studies in the death registry cannot be regarded as the risk ratio (RR) in the cohort study, but, the mortality odds ratio (MOR) estimated by using deaths unrelated to the exposure as ‘controls’ can be regarded as the RR.In 2004, Rothman et al proposed to estimate the ROR which can be regarded as the RR by using proper ‘control events’ in the spontaneous reports database. However, in the study conducted in Japan where the RORs estimated from 20 ‘control events’ were compared with the RRs obtained from many ‘drug use investigations’, the ROR vs RR plots were so diverse.The author of the current review concludes that the study estimating the ROR in the spontaneous reports cannot be regarded as the case-control study as the case-control study should estimate the RR of the cohort study in the source population as the odds ratio (OR).The ‘disproportionality measures’ like the ROR in the spontaneous reports database should be used primarily to detect the signals of the association between a drug and an adverse outcome. However, spontaneous reports can contribute to the characterization of the adverse drug reactions and to determining the causal relationship as well. The methods of signal detection are evolving and it is hoped that Japanese researchers contribute to their further developments.
Résumé
Resumo Avaliar o desempenho do Sistema Nacional de Notificações para a Vigilância Sanitária no que diz respeito ao registro de informações sobre danos à saúde relacionados com medicamentos (Notivisa-medicamento) a partir de atributos previamente selecionados. Realizou-se um estudo de avaliação em saúde de corte transversal, entre 2008 e 2013, que empregou oito atributos previstos em diretrizes para avaliação de sistemas de vigilância da saúde pública (simplicidade, aceitabilidade, representatividade, completude, validade, consistência, erro preditivo positivo e oportunidade). No período estudado, 63.512 registros foram identificados no Notivisa-medicamento, sendo a maioria classificados como graves (60,5%). O desempenho do Notivisa-medicamento foi considerado satisfatório para dois dos oito atributos (validade e erro preditivo positivo) e deficitário para os demais (simplicidade, aceitabilidade, representatividade, completude, consistência e oportunidade). É necessário discutir e implementar maneiras de como aprimorar o sistema com vistas a fornecer informações completas, oportunas e confiáveis para diferentes segmentos da sociedade brasileira, sobretudo os gestores de vigilância sanitária.
Abstract The scope of this paper is to assess the performance of the Brazilian Notification System for Health Surveillance, with respect to the registration of information on adverse drug-related effects on health (Notivisa/medication) based on previously selected attributes. A cross-sectional health evaluation study was conducted between 2008 and 2013 using eight attributes established by international guidelines to assess public health surveillance systems: simplicity, acceptability, representativeness, completeness, validity, consistency, positive predictive error and timeliness. In the study period, 63,512 registrations were identified in Notivisa/medication, the majority being considered severe (60.5%). The performance of Notivisa/medication was considered satisfactory with respect to two of the eight attributes (validity and positive predictive error) and deficient in six of the remaining attributes (simplicity, acceptability, representativeness, completeness, consistency and timeliness). Quality improvement strategies to remedy the system need to be discussed and implemented in order to provide complete, timely and reliable surveillance information for different segments of Brazilian society, especially health surveillance managers.
Sujets)
Humains , Surveillance de la population , Pharmacovigilance , Facteurs temps , Brésil , Études transversales , Surveillance de la santé publiqueRésumé
Objective To explore and compare the clinical efficacy of levetiracetam tablets and compound sodium valproate sustained release tablets in the treatment of children and adolescents with epilepsy.Methods From April 2017 to April 2018,80 children and adolescents with epilepsy treated in Chaonan Minsheng Hospital of Shantou were selected as study objects,and they were randomly divided into two groups by drawing lots,with 40 cases in each group.The observation group was given levetiracetam tablets,and the control group was treated with valproate.The improvement of EEG after therapy,the total effective rate,and the incidence of adverse reactions were observed and evaluated.Results The EEG improvement rates after treatment for 6 months in the observation group and control group were 41.17%,45.71%,respectively,the difference was not statistically significant(x2 =0.508,P >0.05).The EEG improvement rates after treatment for 9 months in the observation group and control group were 70.58%,74.28%,respectively,the difference was not statistically significant (x2 =0.225,P > 0.05).The total effective rate in the observation group was 92.50%,which was 95.00% in the control group,the difference was not statistically significant between the two groups (x2 =0.354,P > 0.05).However,the incidence rate of adverse reactions of the observation group(22.50%) was significantly lower than that of the control group(45.00%)(x2 =6.864,P < 0.05).Conclusion Both levetiracetam tablets and compound sodium valproate sustained release tablets have appreciable efficacy and safety in the treatment of epilepsy in children and adolescents,but levetiracetam therapy has less adverse reactions,which deserves further promotion in monotherapy of epilepsy in children and adolescents.
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Objective@#To compare the efficacy and adverse reaction of rituximab injection(Rituximab) and splenectomy in the treatment of adult chronic idiopathic thrombocytopenic purpura(ITP).@*Methods@#From March 2013 to June 2015, 105 chronic ITP patients who were treated in the Fifth People's Hospital of Datong were divided into rituximab group(n=43) and splenectomy group(n=62). The clinical efficacy, adverse reaction and survival time of the two groups were compared.@*Results@#There was no statistically significant difference in baseline characteristics between the two groups.After treatment for 3 months, the response rates of the splenectomy group and the rituximab group were 91.9%(57/62), 69.8%(30/43), respectively, the difference was statistically significant between the two groups(χ2=5.04, P=0.005). After treatment for 12 months, the response rates of the splenectomy group and the rituximab group were 88.7%(55/62), 58.1%(25/43), respectively, the difference was statistically significant between the two groups (χ2=6.83, P=0.001), respectively.After treatment for 3, 12 months, the complete response rates of the splenectomy group were 82.2%(51/62), 80.6%(50/62), respectively, which were higher than those of the rituximab group [39.5%(17/43), 34.9%(15/43)] (χ2=7.25, P<0.001). There was no statistically significant difference in adverse reactions after treatment for 1 year between the two groups(P>0.05). The survival time of the splenectomy group was longer, but there was no statistically significant difference(t=4.85, P=0.18).@*Conclusion@#The curative effect of splenectomy in the treatment of adult ITP is better than rituximab, and the adverse reaction is not obvious between two methods.
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Objective To compare the efficacy and adverse reaction of rituximab injection( Rituximab) and splenectomy in the treatment of adult chronic idiopathic thrombocytopenic purpura ( ITP). Methods From March 2013 to June 2015,105 chronic ITP patients who were treated in the Fifth People's Hospital of Datong were divided into rituximab group(n=43) and splenectomy group( n =62).The clinical efficacy,adverse reaction and survival time of the two groups were compared.Results There was no statistically significant difference in baseline character-istics between the two groups. After treatment for 3 months, the response rates of the splenectomy group and the rituximab group were 91. 9%( 57/62 ), 69. 8%( 30/43 ), respectively, the difference was statistically significant between the two groups(χ2 =5.04,P=0.005).After treatment for 12 months,the response rates of the splenectomy group and the rituximab group were 88.7%(55/62),58.1%(25/43),respectively,the difference was statistically significant between the two groups ( χ2 =6. 83, P =0. 001 ), respectively. After treatment for 3,12 months, the complete response rates of the splenectomy group were 82.2%(51/62),80.6%(50/62),respectively,which were higher than those of the rituximab group [39.5%(17/43),34.9%(15/43)] (χ2 =7.25,P<0.001).There was no statistically significant difference in adverse reactions after treatment for 1 year between the two groups(P>0.05). The survival time of the splenectomy group was longer,but there was no statistically significant difference( t=4.85, P=0.18).Conclusion The curative effect of splenectomy in the treatment of adult ITP is better than rituximab,and the adverse reaction is not obvious between two methods.
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There are no drugs without the risk of potential adverse reactions. All pharmacologically active substances can cause adverse drug reactions (ADRs). This paper aims at introducing recent trends in pharmacosurveillance systems for ADRs, which can be broadly classified into type A and B reactions. Since type A reactions are associated with drug pharmacology, they are usually dose-dependent and predictable. Whereas, type B reactions occur in some susceptible individuals, regardless of the pharmacological action of drug. Drug hypersensitivity reactions are typical examples of type B reactions and are subclassified according to the underlying pathomechanism. Recent advancements in pharmacogenomics have enlightened the understanding of individual differences in drug efficacy and susceptibility to ADRs. Therefore, expectations for safe personalized medicines are higher than ever before. However, premarketing clinical trials are too small and too short to uncover rare but serious ADRs and detect long-standing ADRs. In the past, post-marketing surveillance systems mainly focused on passive ADR monitoring systems, based on spontaneous reports. Recently, the importance of active pharmacovigilance systems, which use big data, is growing with recent advancements in medical informatics. Thus, regarding ADRs, suspecting and detecting the causative drug using causality assessment based on data science may contribute to decrease suffering induced by ADRs.
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Humains , Systèmes de signalement des effets indésirables des médicaments , Hypersensibilité médicamenteuse , Effets secondaires indésirables des médicaments , Individualité , Informatique médicale , Pharmacogénétique , Pharmacologie , PharmacovigilanceRésumé
Esta revisão de escopo objetiva descrever e caracterizar o sistema de farmacovigilância do Brasil (SINAF) e averiguar o atendimento aos requisitos mínimos propostos pela Organização Mundial da Saúde para um desempenho funcional de sistemas nacionais dessa natureza. A estratégia de pesquisa bibliográfica utilizou recomendações do STARLITE e termos de busca nas bases de dados MEDLINE/PubMed, Google, Imprensa Nacional da República do Brasil e website da Agência Nacional de Vigilância Sanitária (Anvisa), compreendendo o período entre 1999, ano de criação da Anvisa, e março de 2016. Foram incluídas 47 (4,4%) publicações, de um total de 1.068 identificadas, prevalecendo, nesta ordem: 14 normas jurídicas (29,8%), 13 (27,6%) documentos técnicos e 10 (21,3%) artigos científicos. Os estudos e documentos técnicos analisados compreenderam a criação, em âmbito federal, da primeira unidade técnica de farmacovigilância do sistema de notificação de eventos adversos, o Centro Nacional de Monitorização e a Câmara Técnica de Medicamentos. A taxa de notificação de eventos adversos a medicamentos no Brasil correspondeu, em 2013, a 36 notificações/1 milhão de habitantes, bastante inferior à meta proposta na literatura internacional, que sugere 300 notificações/1 milhão de habitantes. Este estudo identificou aspectos estruturais e funcionais que podem comprometer o desempenho do SINAF, como a falta de legislação que institua oficialmente o próprio sistema e suas finalidades.
Esta revisión de alcance tiene como objetivo describir y caracterizar el sistema de farmacovigilancia de Brasil (SINAF) y constatar su adscripción a los requisitos mínimos propuestos por la Organización Mundial de la Salud, respecto al desempeño funcional de los sistemas nacionales de esta naturaleza. La estrategia de investigación bibliográfica utilizó recomendaciones del STARLITE y términos de búsqueda en las bases de datos MEDLINE/PubMed, Google, Imprenta Nacional de la República de Brasil y de la página web de la Agencia Nacional de Vigilancia Sanitaria (Anvisa), comprendiendo el período entre 1999, año de creación de la Anvisa, y marzo de 2016. Se incluyeron 47 (4,4%) publicaciones, de un total de 1.068 identificadas, predominando por este orden: 14 normas jurídicas (29,8%), 13 (27,6%) documentos técnicos y 10 (21,3%) artículos científicos. Los estudios y documentos técnicos analizados incluyeron la creación, en el ámbito federal, de la primera unidad técnica de farmacovigilancia del sistema de notificación de eventos adversos, el Centro Nacional de Monitoreo y la Cámara Técnica de Medicamentos. La tasa de notificación de eventos adversos en medicamentos dentro de Brasil correspondió, en 2013, a 36 notificaciones/1 millón de habitantes, bastante inferior a la meta propuesta en la literatura internacional, que sugiere 300 notificaciones/1 millón de habitantes. Este estudio identificó aspectos estructurales y funcionales que pueden comprometer el desempeño del SINAF, como la falta de legislación que instituya oficialmente al propio sistema y sus finalidades.
This scoping review aims to describe and characterize the Brazilian pharmacovigilance system Brazil (SINAF) and verify to what extent it meets the minimum requirements proposed by the World Health Organization for the functional performance of this type of national system. The literature search strategy used STARLITE recommendations and search terms in MEDLINE/PubMed, Google, the Brazilian National Press, and the website of the Brazilian Health Regulatory Agency (Anvisa), from 1999, when Anvisa was created, to March 2016. The review included 47 publications (4.4%), out of a total of 1,068 identified, in the following order: 14 legal provisions (29.8%), 13 (27.6%) technical documents, and 10 (21.3%) scientific articles. The studies and technical documents covered the creation of the first pharmacovigilance technical unit at the federal level, the reporting system for adverse events, the National Monitoring Center, and the Technical Chambers on Medications. The reporting rate for adverse drug events in Brazil in 2013 was 36 reports per million inhabitants, considerably lower than the target proposed in the international literature, which suggests 300 reports per million inhabitants. This study identified structural and functional aspects that can compromise the performance of SINAF, such as lack of legislation officially establishing the system itself and its objectives.
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Humains , Surveillance des médicaments/normes , Systèmes de signalement des effets indésirables des médicaments/législation et jurisprudence , Pharmacovigilance , Organisation mondiale de la santé , Brésil , Réglementation gouvernementale , Agences gouvernementalesRésumé
SUMMARY The Yellow Fever virus was isolated in 1927 and the disease is considered endemic and epidemic in tropical regions of South America and Africa, with thousands of new cases reported annually. Several side effects of the vaccine have already been reported. Although reports of skin rash secondary to the vaccine range from 0 to 15%, no image or detailed description of the lesions were found in the literature. Here we describe a rash on a toddler vaccinated to travel.
RESUMO O vírus da febre amarela foi isolado em 1927, e a doença é considerada endêmica e epidêmica em regiões tropicais da América do Sul e África, com milhares de novos casos relatados anualmente. Vários efeitos colaterais da vacina já foram relatados. Embora os relatos de erupções cutâneas secundárias à vacina variem de 0% a 15%, nenhuma imagem ou descrição detalhada das lesões foi encontrada na literatura. Aqui descrevemos a erupção de uma criança vacinada para viajar.
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Humains , Mâle , Nourrisson , Vaccin antiamaril/effets indésirables , Érythème/étiologie , Photographie (méthode) , Membres , Tronc , Maladie liée aux voyagesRésumé
INTRODUÇÃO: Reações adversas e os incidentes associados com medicamentos ocasionam a morte e ameaçam a segurança do paciente. No Brasil, persiste-se uma escassez de dados epidemiológicos e uma abordagem ainda insuficiente. OBJETIVO: Descrever a frequência e as características das notificações de queixas técnicas e reações adversas a medicamentos (RAM) em um hospital regional. MÉTODOS: Estudo transversal, realizado em um hospital de ensino referência para o noroeste do Estado de São Paulo. Por meio do sistema Notivisa da Anvisa, foram contabilizadas as notificações de RAM e queixas técnicas do período de junho de 2012 a julho de 2014. Excluíram-se as não finalizadas e com dados incompletos. Os casos de RAM foram classificados de acordo com o critério de gravidade, sistema de órgãos afetado e caracterização da classe do fármaco suspeito. Ademais, as características do sexo e da idade dos pacientes envolvidos também foram investigadas. Os dados foram descritos como frequência simples e proporções. RESULTADOS: No total, contabilizaram-se 151 (84,8%) notificações de potenciais RAM e 27 (15,2%) de queixas técnicas. Mulheres (62,9%) com idades entre 26-59 anos (42,4%) foram predominantes entre os pacientes notificados com RAM. A maioria das reações foram distúrbios da pele (33,1%), de gravidade moderada (70,2%), provindas de fármacos que atuam no sistema nervoso (35,8%). Sobre as queixas técnicas, o extravasamento de líquido do material de acondicionamento foi a ocorrência mais descrita (40,7%). CONCLUSÃO: As notificações associadas com medicamentos são recorrentes no âmbito hospitalar e as características relatadas embasam conhecimentos sobre o perfil clínico dos episódios adversos apresentados.
INTRODUCTION: Adverse reactions and incidents associated with drugs cause death and threaten patient safety. In Brazil, there is still a shortage of epidemiological data on these episodes and an approach still insufficient. OBJECTIVE: To describe the frequency and characteristics of reports of technical complaints and adverse drug reactions (ADRs) in a regional hospital. METHODS: A cross-sectional study was carried out in a Hospital School in the northwest of the São Paulo State. Through the Anvisa's Notivisa system, it was computed the notifications characterized as ADRs and technical complaints from June 2012 to July 2014. The notifications that were not finalized, with status pending completion or with incomplete data, were excluded. The cases of ADRs were classified according to the criterion of severity, organ system affected and characterization of the suspected drug class. The characteristics of the sex and age of the patients involved were also investigated. Data were described as single frequency and proportions. RESULTS: A total of 151 (84.8%) notifications of possible ADRs and 27 (15.2%) of technical complaints was recorded. Women (62.9%) aged 26-59 years (42.4%) were predominant among patients reported with ADRs. The majority of the reactions were skin disorders (33.1%), of moderate severity (70.2%), coming from drugs that act on the nervous system (35.8%). Regarding the technical complaints, the extravasation of liquid from the packaging material was the most described occurrence (40.7%). CONCLUSION: The reports associated with drugs are recurrent in the hospital setting and the characteristics reported base knowledge on the clinical profile of the adverse events presented. (AU)
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Humains , Mâle , Femelle , Adulte , Adulte d'âge moyen , Gestion du risque , Épidémiologie Descriptive , Systèmes de signalement des effets indésirables des médicaments , Effets secondaires indésirables des médicaments , Pharmacovigilance , Sécurité des patients , Études transversales , Hôpitaux d'enseignementRésumé
BACKGROUND: Adverse cutaneous drug reactions (ACDRs) are common and are responsible for increased morbidity, mortality, and socioeconomic costs. OBJECTIVE: The purpose of our study was to investigate the common drugs and clinical patterns related to ACDRs using an electronic drug adverse reaction reporting system at a single secondary referral center. METHODS: We conducted a retrospective analysis of the ACDR database between January 2014 and April 2016 at the Ilsan Paik Hospital. RESULTS: The study analyzed 320 patients with ACDRs (male:female ratio=93:227; mean age 50.8±17.8 years). Using a Korean causality evaluation algorithm, the percentage of drugs with a possible relationship with ACDRs was calculated to be 50.6%, while the percentage with a probable relationship was 44.7%. Antibiotics (44.0%), radiocontrast media (15.1%), and non-steroidal anti-inflammatory drugs (NSAIDs) (14.3%) were the most commonly implicated drugs. Antibiotics, including cephalosporins (30.6%) and quinolones (10.2%), were responsible for the majority of the ACDRs. Acetic acid (5.9%) and propionic acid (5.9%) derivatives of NSAIDs were also common causative agents. The most common clinical presentations were maculopapular exanthema (33.4%), pruritus (30.9%), and urticaria (25.7%). Severe ACDRs were significantly associated with older age, eosinophilia, and underlying heart and renal diseases (p<0.05). CONCLUSION: Antibiotics, radiocontrast media, and NSAIDs were identified as common causes of ACDRs. Older age, eosinophilia, heart disease, and renal disease were associated with severe ACDRs.
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Humains , Acide acétique , Systèmes de signalement des effets indésirables des médicaments , Antibactériens , Anti-inflammatoires non stéroïdiens , Céphalosporines , Produits de contraste , Amfépramone , Effets secondaires indésirables des médicaments , Éosinophilie , Exanthème , Coeur , Cardiopathies , Mortalité , Prurit , Quinolinone , Études rétrospectives , Centres de soins secondaires , UrticaireRésumé
Objective@#To analyze characteristics of serious adverse drug reaction from Qingdao and provide reference for clinical applications.@*Methods@#1 130 reports collected by Qingdao Center for ADR Monitoring in 2016 were analyzed using retrospective study method.@*Results@#The antibiotics, traditional Chinese medicine injection and antitumor drug caused the higher proportion of serious adverse drug reaction.Injection was the main way for administration, which induced 73.45% of serious adverse drug reaction.65.00% cases with allergic shock occurred within 10min.Levofloxacin lactate injection caused the highest proportion of serious adverse drug reaction, Danhong injection caused the highest proportion of allergic shock reaction, Reduning injection caused the highest proportion of serious adverse drug reaction in children.@*Conclusion@#Safety monitoring for antibiotics, traditional Chinese medicine injection and antitumor drug should be further strengthened, including children adverse reactions.
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Objective The adverse drug reaction (ADR) reports of compound Kushen injection in Qingdao Central Hospital were analyzed to improve the level of safe and rational use of drugs.Methods We investigated 35 cases of severe ADR reports induced by compound Kushen injection in Qingdao Central Hospital from 2016.09 to 2018.03 retrospectively.Then the type of report,relevance evaluation and prognosis,ADR occurrence and recovered time,involved system/organs and main clinical manifestations were analyzed.Results The new moderate and new severe ADR incident were 51.4% of 35 ADR reports.Twenty-nine cases of the ADR were occurred 30 minutes after injection.Twenty-three cases of ADR clinical symptoms can be recovered after 30 minutes.The main ADR was the digestive system reaction,followed by the neural system,respiratory system and cardiovascular system.Conclusions It is important to pay attention to the occurrence of compound Kushen injection ADR and strengthen its monitoring.
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Objective To observe the effect of propofol infusion on the side effects of carboplatin and trometamol at different plasma target concentrations in cesarean section.Methods From January 2016 to October 2017,a total of 184 cases of cesarean section pregnant women in the People's Hospital of Quzhou were selected for prospective study.They were divided into A group ,B group,C group and control group (N group) according to random number table method,with 46 cases in each group.The A,B,C three groups were target -controlled infusion of propofol,the concentrations were 0.8μg/mL,1.2μg/mL,1.6μg/mL,respectively,while N group was infused 0.9%sodium chloride injection at the rate of 0.5mL· kg-1· h-1.The operative time,intraoperative blood loss,fluid replacement,elevated blood pressure,decreased blood pressure ,the incidence of tachycardia and adverse reactions were compared among the four groups.Results The operation time of the four groups were (46.65 ±5.32) min, (49.21 ±4.75)min,(48.74 ±4.28) min,(49.76 ±5.25) min,respectively,the differences were not statistically significant(F=1.501,P >0.05).The volume of intraoperative blood loss in the four groups were (425.66 ± 39.54)mL,(428.71 ±41.03)mL,(427.96 ±41.55)mL,(431.56 ±42.35)mL,respectively,the differences were not statistically significant(F=1.882,P>0.05).The fluid replacement in the four groups were (884.59 ±51.22)mL, (879.20 ±47.63)mL,(883.59 ±50.14)mL,(896.33 ±50.23)mL,respectively,the differences were not statistically significant(F=1.634,P>0.05).The satisfaction rate of sedation in B group was 91.30%,which was significantly higher than 58.70%in A group and 30.43%in C group(Z=91.428,P<0.05).The incidence rates of cardiovascular events in B group and C group were significantly lower than those in A group (all P<0.05),which in B group were lower than those in C group(all P<0.05).There were no statistically significant differences in chest tightness ,head-ache,facial flushing incidence in the three groups (χ2=3.450,4.816,5.396,all P>0.05).The incidence rates of nausea and vomiting in B group were 8.70%and 4.35%,respectively.The incidence rates of nausea and vomiting in C group were 8.70%and 2.17%,respectively,which were significantly lower than those in A group (26.09% and 19.57%)(χ2=7.485,10.405,all P<0.05).Conclusion Targeted infusion of propofol at 1.2 μg/mL can effec-tively prevent the side effects of cesarean section carduvastatin trometamol with good sedative effect .