Abstract Objective: To identify and assess the current evidence available about the costs of managing hospitalized pediatric patients diagnosed with Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in upper-middle-income countries. Methods: The authors conducted a systematic review across seven key databases from database inception to July 2022. Costs extracted were converted into 2022 International Dollars using the Purchasing Power Parity-adjusted. PROSPERO identifier: CRD42020225757. Results: No eligible study for PIV3 was recovered. For RSV, cost analysis and COI studies were performed for populations in Colombia, China, Malaysia, and Mexico. Comparing the total economic impact, the lowest cost per patient at the pediatric ward was observed in Malaysia ($ 347.60), while the highest was in Colombia ($ 709.66). On the other hand, at pediatric ICU, the lowest cost was observed in China ($ 1068.26), while the highest was in Mexico ($ 3815.56). Although there is no consensus on the major cost driver, all included studies described that the medications (treatment) consumed over 30% of the total cost. A high rate of inappropriate prescription drugs was observed. Conclusion: The present study highlighted how RSV infection represents a substantial economic burden to health care systems and to society. The findings of the included studies suggest a possible association between baseline risk status and expenditures. Moreover, it was observed that an important amount of the cost is destinated to treatments that have no evidence or support in most clinical practice guidelines.

Resumo Objetivo Estimar a prevalência de níveis inadequados de vitamina D e seus fatores associados para mulheres em idade fértil no Brasil. Métodos Uma revisão sistemática foi realizada (última atualização em maio de 2020). As meta-análises foram realizadas usando o inverso da variância para o modelo fixo com cálculo de proporção sumarizada por transformação arco-seno duplo de Freeman-Tukey. A qualidade metodológica e de reporte foi avaliada usando a ferramenta do Joanna Briggs Institute para estudos de prevalência. Resultados Nossa revisão identificou 31 estudos, compreendendo 4.006 participantes. Todos os estudos apresentaram pelo menos uma limitação, principalmente devido ao uso de amostra de conveniência e tamanho amostral pequeno. As prevalências gerais de deficiência, insuficiência e deficiência de vitamina D foram 35% (intervalo de confiança, IC 95%: 34-37%), 42% (IC 95%: 41-44%) e 72% (IC 95%: 71-74%), respectivamente. Conclusão Embora a magnitude da prevalência de níveis inadequados de vitamina D seja incerta, a evidência sugere que presença de deficiência ou insuficiência de vitamina D em mulheres em idade reprodutiva pode causar problemas moderados a graves.

Abstract Objective To estimate the prevalence of inadequate vitamin D level and its associated factors for women of childbearing age in Brazil. Methods A systematic reviewwas conducted (last updatedMay 2020).Meta-analyses were performed using the inverse-variance for fixed models with summary proportion calculation by Freeman-Tukey double arcsine. Reporting and methodological quality were assessed using the Joanna Briggs Institute tool for prevalence studies. Results Our review identified 31 studies, comprising 4,006 participants. All the studies had at least one weakness, mainly due to the use of convenience sampling and small sample size. The overall prevalence of vitamin D deficiency, insufficiency, and both deficiency and insufficiency were 35% (confidence interval, 95%CI: 34-37%), 42% (95%CI: 41-44%), and 72% (95%CI: 71-74%), respectively. Conclusion Although the magnitude of the prevalence of inadequate levels of vitamin D is uncertain, the evidence suggests that presence of vitamin D deficiency or insufficiency in women of reproductive age can cause moderate to severe problems.

Abstract To assess the therapy relative to indication, effectiveness, safety and adherence in patients with Alzheimer’s disease (AD). An interventional, prospective, non-randomized study was conducted in a single secondary care center in Brazil. The pharmacist-led medication therapy management (MTM) was conducted to detect drug-related problems (DRPs) at baseline and after six months of intervention. The health status outcomes (i.e. cognitive screening tests; levels of glucose; total cholesterol; triglycerides; thyroid stimulating hormone; serum free thyroxine and blood pressure) were measured. 66 patients with AD were included, of whom 55 patients completed the follow-up of six months. 36 patients (36/55) were non-adherent to AD drug therapy. Out of detected 166 DRPs, 116 were solved. Four patients were withdrawn from the AD protocol due to resolution of prodromal symptoms. On the conclusion of the study, the MTM improved and controlled blood pressure, glucose, total cholesterol, triglycerides levels (p<0.05). The pharmacist-led MTM was effective in solving 69.8% of DRPs, improving and controlling the clinical parameters evaluated.

ABSTRACT BACKGROUND: Despite the several options available for supplements containing vitamins C and E, evidence regarding the prevalence of deficiency or insufficiency of these vitamins is weak. OBJECTIVES: To estimate the prevalence of deficiency or insufficiency of vitamins C and E and associated factors among women of childbearing age, in Brazil. DESIGN AND SETTING: Systematic review and meta-analysis conducted at a Brazilian public university. METHODS: A search from index inception until May 2020 was conducted. Meta-analyses were performed using inverse variance for fixed models, with summary proportions calculation using Freeman-Tukey double arcsine (base case). Reporting and methodological quality were assessed using the Joanna Briggs Institute tool for prevalence studies. RESULTS: Our review identified 12 studies, comprising 1,316 participants, especially breastfeeding women. There was at least one quality weakness in all studies, mainly regarding sampling method (i.e. convenience sampling) and small sample size. The prevalence of vitamin C deficiency ranged from 0% to 40%. Only vitamin E deficiency was synthetized in meta-analyses, with mean prevalences of 6% regardless of the alpha-tocopherol cutoff in plasma, and 5% and 16% for cutoffs of < 1.6-12.0 mmol/l and < 16.2 mmol/l, respectively. The cumulative meta-analysis suggested that a trend to lower prevalence of vitamin E deficiency occurred in recent studies. CONCLUSIONS: Although the studies identified in this systematic review had poor methodological and reporting quality, mild-moderate vitamin C and E deficiencies were identified, especially in breastfeeding women. Thus, designing and implementing policies does not seem to be a priority, because the need has not been properly dimensioned among women of childbearing age in Brazil. REGISTRATION NUMBER IN PROSPERO: CRD42020221605.

Resumen Antecedentes: A pesar de las políticas actuales de yodación de la sal, la deficiencia de yodo sigue siendo un problema de salud pública mundial, especialmente en las mujeres. Hasta ahora, se han sugerido pruebas contradictorias sobre la prevalencia de la deficiencia de yodo en Brasil. Objetivo: Estimar la prevalencia de deficiencia de yodo y factores asociados en mujeres en edad fértil, en Brasil. Métodos: Se realizó una revisión sistemática, buscando en PubMed, LILACS, OMS, Scopus y la base de datos de disertaciones y tesis de Capes desde el inicio hasta mayo de 2020. Se realizaron metanálisis de proporciones utilizando la variancia inversa para el modelo fijo. La calidad de información y metodológica se evaluó utilizando la herramienta del Institute Joanna Briggs para estudios de prevalencia. Resultados: Nuestra revisión identificó siete estudios publicados entre 2002 y 2017, incluyendo 1354 participantes, especialmente mujeres embarazadas. Todos los estudios presentaron al menos una limitación de calidad, principalmente con respecto al método de muestreo (es decir, la conveniencia) y el pequeño tamaño de la muestra. La prevalencia de la deficiencia de yodo varió entre los estudios del 16% y el 62%, mientras que el metanálisis identificó una prevalencia media del 40% (intervalo de confianza del 95%, IC 37%-43%) para las mujeres embarazadas y del 13% (IC del 95% 4%-24%) para mujeres no embarazadas. El metanálisis acumulativo sugiere una tendencia a una mayor prevalencia de deficiencia de yodo a partir de 2018 en mujeres embarazadas. Conclusiones: Si bien esta revisión sistemática identificó estudios con mala calidad metodológica y de reporte, se identificó una alta prevalencia de deficiencia de yodo en mujeres embarazadas, lo que refuerza la importancia de las políticas nutricionales nacionales para monitorear el estado de yodo en esta población. Los estudios futuros deben considerar el muestreo probabilístico aleatorio, el tamaño de muestra apropiado y el análisis de subgrupos predefinidos para informar adecuadamente la prevalencia de la deficiencia de yodo y los factores asociados en mujeres en edad fértil y para respaldar las políticas de salud.

Abstract Background: Despite current policies of salt iodination, iodine deficiency is still a global public health problem, especially in women. So far, conflicting evidence has been suggested for the prevalence of iodine deficiency in Brazil. Objective: To estimate the prevalence of iodine deficiency and associated factors in women of childbearing age in Brazil. Methods: A systematic review was conducted using databases (PubMed, LILACS, WHO, Scopus, and Capes’ dissertation and thesis), from inception to May 2020. Meta-analyses of proportions were performed using the variance inverse for the fixed model. Reporting and methodological quality were assessed using the Joanna Briggs Institute tool to prevalence studies. Results: Our review identified seven studies published between 2002 e 2017, including 1354 participants, especially pregnant women. All studies presented at least one quality limitation, mainly regarding the sampling method (i.e., convenience) and small sample size. The prevalence of iodine deficiency ranged among studies from 16% to 62%. In contrast, the meta-analysis identified a mean prevalence of 40% (95% confidence interval, CI 37%-43%) for pregnant women and 13% (95% CI 4%-24%) for non-pregnant women. Cumulative meta-analysis suggests a tendency of higher iodine deficiency prevalence from 2018 in pregnant women. Conclusions: Although this systematic review identified studies with poor methodological and reporting quality, a high prevalence of iodine deficiency was identified in pregnant women, reinforcing the importance of national nutritional policies for monitoring iodine status in this population. Future studies should consider random probabilistic sampling, appropriate sample size, and pre-defined subgroup analysis to adequately inform the prevalence of iodine deficiency and associated factors in women of childbearing age and support health policies.

RESUMO CONTEXTO: A hemorragia digestiva alta não varicosa (HDANV) secundária à úlcera péptica é uma emergência médica digestiva e pode ser uma reação adversa a medicamento severa. OBJETIVO: Estimar a frequência de HDANV secundária à doença péptica. MÉTODOS: Estudo prospectivo e epidemiológico realizado em um hospital brasileiro terciário de referência, no período de julho de 2016 a dezembro de 2019. Os laudos de endoscopia gastrointestinal alta foram avaliados diariamente. O diagnóstico de HDANV secundária para úlcera péptica foi definido por achados endoscópicos de úlcera péptica e lesões gástricas erosivas e sintomas clínicos. A frequência de diagnóstico de HDANV secundária à úlcera péptica foi estimada por meio da razão entre o número de pacientes diagnosticados e o número de pacientes submetidos à endoscopia gastrointestinal alta no mesmo período. RESULTADOS: Um total de 2.779 laudos endoscópicos (2.503 pacientes) foram avaliados e 178 pacientes foram elegíveis. A frequência total de diagnóstico de HDANV secundária à úlcera péptica foi de 7,1%. A frequência anual de diagnósticos entre 2017 e 2019 variou de 9,3% a 5,7%. A maioria dos pacientes era do sexo masculino (72,8%); auto-declarado branco (71,8%); idoso (56,7%); e não possuía histórico familiar ou pessoal de doenças gastrointestinais (60,1%). 90% dos pacientes apresentaram úlcera péptica e melena (62,8%). Os pacientes faziam uso crônico de ácido acetilsalicílico como antiagregante plaquetário (29,3%), outros antiplaquetários (21,9%) e anticoagulantes orais (11,2%); e fizeram uso e uso de anti-inflamatórios não esteroidais na semana anterior ao início dos sintomas clínicos de HDANV (25,8%). CONCLUSÃO: Cerca de sete em cada 100 pacientes admitidos em um hospital terciário e submetidos à endoscopia gastrointestinal alta foram diagnosticados com HDANV secundária à úlcera péptica.

ABSTRACT BACKGROUND: Non-variceal upper gastrointestinal bleeding (NVUGIB) secondary to peptic ulcer disease is a medical digestive emergency and could be one of the most serious adverse drug reactions. OBJECTIVE: To identify the frequency of diagnosis of NVUGIB secondary to peptic ulcer disease. METHODS: Prospective and epidemiological study conducted in a tertiary referral Brazilian hospital, from July 2016 to December 2019. Upper gastrointestinal endoscopies (UGE) reports were evaluated daily. The diagnosis of NVUGIB secondary to peptic ulcer disease was defined through endoscopic findings of peptic ulcer and erosive gastric lesions, and clinical symptoms. The frequency of diagnosis of NVUGIB secondary to peptic ulcer disease was estimated through the ratio between the number of patients diagnosed and the number of patients underwent UGE in the same period. RESULTS: A total of 2,779 endoscopic reports (2,503 patients) were evaluated, and 178 patients were eligible. The total frequency of diagnosis of NVUGIB secondary to peptic ulcer disease was 7.1%. The annual frequency of diagnosis between 2017 and 2019 ranged from 9.3% to 5.7%. Most patients were men (72.8%); self-declared white (71.8%); older people (56.7%); and, had no familiar or personal history of gastrointestinal diseases (60.1%). 90% of the patients had a peptic ulcer and melena (62.8%). Patients made chronic use of low-dose aspirin (29.3%), other antiplatelet agents (21.9%) and, oral anticoagulants (11.2%); and non-steroidal anti-inflammatories use in the week a prior to the onset of clinical symptoms (25.8%). CONCLUSION: Seven in every 100 patients admitted and underwent UGE in a tertiary hospital were diagnosed with NVUGIB secondary to peptic ulcer disease.

ABSTRACT BACKGROUND: Improving knowledge and establishing strategies and policies for better patient safety are worldwide priorities. OBJECTIVE: To evaluate drug safety among elderly people with Alzheimer’s disease (AD). DESIGN AND SETTING: Cross-sectional study among elderly people within the National AD Assistance Protocol (PCDTDA/MS) who were living in the municipality of Araraquara, Brazil, in 2017. METHODS: Through interviews conducted with relatives/caregivers of elderly people with diagnoses of AD, the following variables were evaluated: comorbidities, drug therapy used, use of potentially inappropriate medications for the elderly (PIMs), presence of potentially inappropriate interactions (PIIs) and medication regimen complexity index. Factors associated with AD severity were also evaluated. Multivariate and simple logistic regressions were applied. RESULTS: 143 elderly people enrolled in PCDTDA/MS were analyzed. The majority were women (67.1%); assisted only through the public healthcare system (75.5%); polymedicated (57.4%); using at least one PIM (63.6%); presenting at least one PII (63.6%); and under drug therapy of low to medium complexity (92.2%). No semi-annual monitoring of the effectiveness of PCDTDA/MS drugs was identified. The proportion using AD drug therapy at daily doses differing from those recommended by the World Health Organization was 75.6%. However, these doses were not associated with drug risk. CONCLUSION: The data from this study raise the hypothesis that use of polypharmacy might show a correlation with severity of AD. The drug safety risk may be associated with comorbidities of the metabolic syndrome, anxiety and off-label use of PIMs, such as risperidone and quetiapine, and benzodiazepines (i.e. clonazepam and flunitrazepam).

RESUMO A demência é uma doença crônica e neurodegenerativa, e a doença de Alzheimer (DA) é a mais prevalente. Objetivo: Descrever o monitoramento da farmacoterapia de pacientes inseridos no Protocolo Clínico e Diretrizes Terapêuticas da Doença de Alzheimer (PCDTDA), Brasil. Métodos: Estudo descritivo, conduzido por meio de entrevistas em 2017. Foram incluídos pacientes com diagnóstico da doença de Alzheimer (DA) inseridos no PCDTDA. As variáveis foram idade; sexo; tempo de diagnóstico e farmacoterapia da DA; os parâmetros clínicos Mini-exame do estado mental (MEEM) e Clinical Dementia Rating (CDR); e farmacoterapia em uso. Resultados: O monitoramento de 143 pacientes foi avaliado. Considerando a exigência dos testes de rastreio para a inserção do paciente no PCDTDA, observou-se que todos os pacientes tinham pelo menos um escore no MEEM e no CDR na admissão no protocolo. Nenhum paciente foi submetido à primeira reavaliação da efetividade da farmacoterapia da DA e nem à reavaliação semestral. Conclusão: Apesar do PCDTDA ser a maior evidência do tratamento da DA, dados evidenciam falhas no monitoramento da efetividade da farmacoterapia da DA na dispensação.

ABSTRACT Dementia is a chronic neurodegenerative disease and Alzheimer’s disease (AD) is the most prevalent type. Objective: To describe the drug monitoring of patients enrolled in a Clinical Protocol and Therapeutic Guidelines of Alzheimer’s Disease (PCDTDA) in Brazil. Methods: A descriptive study based on interviews conducted in 2017 was performed. Patients diagnosed with Alzheimer’s disease (AD) enrolled on the PCDTDA were included. The variables assessed were age, sex, time since diagnosis, clinical parameters of Mini-Mental State Exam (MMSE) and Clinical Dementia Rating (CDR), drug therapy used and AD drug collection. Results: The drug monitoring of 143 patients was evaluated. Observing the requirements of the screening tests for patient enrolment on the PCDTDA, all patients had scores for at least one MMSE and CDR assessment at protocol admission. None of the patients underwent the first reassessment of the effectiveness of AD drug therapy or the semiannual reassessment. Conclusion: Although PCDTDA provides the best evidence of AD treatment, the data showed failures in the monitoring of the effectiveness of AD drug therapy at dispensing.

OBJECTIVES: Evaluate adherence to the therapeutic prophylaxis protocol for venous thromboembolism (VTE) as well as the costs of this practice. METHODS: A descriptive and cross-sectional study was conducted at a State General Hospital in Brazil through reports of drug dispensions, prescriptions and risk stratification of patients. Adherence to the VTE prophylaxis protocol was monitored. The tests for VTE diagnosis measured the adherence to therapeutic prophylaxis treatment, and the purchase prices of the drugs went into the calculation of drug therapy costs. The level of adherence to prescriptions for VTE prophylaxis in the hospital was classified as “adherence”, “non-adherence” and “justified non-adherence” when compared with the protocol. RESULTS: Protocol adherence was observed for 50 (30.9%) patients, and non-adherence was observed for 63 (38.9%) patients, generating an additional cost of $180.40/month. Justified non-adherence in 49 (30.2%) patients generated $514.71/month in savings due to a reduction in the number of daily administrations of unfractionated heparin while still providing an effective method for preventing VTE. Twenty-six patients stratified as having medium to high risk of VTE who did not receive prophylaxis were identified, generating $154.41 in savings. However, these data should be evaluated with caution since the risks and outcomes associated with not preventing VTE outweigh the economy achieved from not prescribing a drug when a patient needs it. The only case of VTE identified during the study period was related to justified non-adherence to the protocol. CONCLUSION: The protocol is based on scientific evidence that describes an effective therapy to prevent VTE. However, the protocol should be updated because the justifications for non-adherence are based on scientific evidence, and this justified non-adherence generates savings and yields effective disease prevention.

ABSTRACT BACKGROUND: Risks regarding hospital admission due to adverse drug reactions and drug interactions from use of omeprazole have been reported. The question guiding the present review was “Which adverse events occur in patients using omeprazole in a Food and Drug Administration-approved and/or off-label manner?” It was also proposed to evaluate the safety of use of omeprazole. DESIGN AND SETTING: Qualitative narrative review with critical evaluation, in a public university. METHODS: The PubMed, SCOPUS, LILACS, SciELO, EMBASE and EBSCO databases were searched on July 31, 2018. Studies evaluating adverse events were screened. RESULTS: 72 articles were included, among which 58 reported on adverse drug events (47, adverse drug reactions; 5, drug interactions; and 6, situations of ineffectiveness). 28 adverse drug reactions not described in compendia and drug leaflets were described in these studies: myocardial infarction (6); stroke (2); spontaneous abortion (1); proliferative changes (1); chills (1); heart failure (1); thrombosis (2); and dementia (1), among others. Severe adverse reactions, for instance cardiac problems, Steven-Johnson syndrome and proliferative changes, were identified. The antiplatelet effects of drugs such as clopidogrel, in patients who underwent heart-related surgery, increased the risk of developing cardiac problems, such as cardiovascular death, myocardial infarction and stroke. In newly transplanted patients, decreased absorption of mycophenolate mofetil occurred, thus leading to rejection of transplanted organs. CONCLUSION: Use of omeprazole should be monitored primarily in patients with heart disorders using antiplatelet agents concomitantly, and in newly transplanted patients using mycophenolic acid, in order to avoid serious adverse reactions.

RESUMO Paciente idosa, 76 anos, diagnosticada com disfagia, depressão, hipotireoidismo, doença de Alzheimer e déficit cognitivo leve, foram identificados problemas relacionados com a sertralina e levotiroxina. O Gerenciamento da Terapia Medicamentosa foi usado para ajustar a terapia às necessidades da paciente, macerando comprimidos de sertralina e solubilizando-os em 10-30 mL de suco de laranja. Foi recomendado a paciente tomar levotiroxina após o jejum. Seis meses depois, o seguimento farmacêutico identificou um aumento no score da escala Mini-Mental de 22 para 26 e Avaliação Clínica da Demência (CDR) de 1,0 para 0,5 em conjunto com melhorias físicas e de humor, bem como uma diminuição significativa na agressividade e agitação. O déficit cognitivo pode ser o resultado de procedimentos de administração inadequada de fármacos, levando à ineficácia do fármaco. A otimização da administração de levotiroxina e sertralina, com conhecimento de suas propriedades físico-químicas, melhora sua efetividade clínica, incluindo a cognição do paciente com a doença de Alzheimer e disfagia.

ABSTRACT An elderly patient, aged 76 years, diagnosed with dysphagia, depression, hypothyroidism, Alzheimer's disease and mild cognitive deficit, was identified with sertraline and levothyroxine- drug-related problems. Medication Therapy Management (MTM) was used to adjust therapy to the patient's needs by macerating sertraline tablets and solubilizing them in 10-30 mL of orange juice. The patient was advised to take levothyroxine after fasting. Six months later, pharmaceutical follow-up identified an increase in the Mini-Mental State Exam score from 22 to 26 and a decrease in the Clinical Dementia Rating (CDR) scale score from 1.0 to 0.5 in conjunction with mood and physical improvements, as well as a significant decrease in aggressiveness and agitation. Cognitive deficit may be a result of poor drug administration procedures, leading to drug ineffectiveness. Optimizing levothyroxine and sertraline administration, based on knowledge of their physicochemical properties, improves their clinical effectiveness, including the cognition of patients with Alzheimer's disease and dysphagia.

ABSTRACT Objective The purpose was to identify the barriers of underreporting, the factors that promote motivation of health professionals to report, and strategies to enhance incidents reporting. Method Group conversations were carried out within a hospital multidisciplinary team. A mediator stimulated reflection among the subjects about the theme. Sixty-five health professionals were enrolled. Results Complacency and ambition were barriers exceeded. Lack of responsibility about culture of reporting was the new barrier observed. There is a belief only nurses should report incidents. The strategies related to motivation reported were: feedback; educational intervention with hospital staff; and simplified tools for reporting (electronic or manual), which allow filling critical information and traceability of management risk team to improve the quality of report. Conclusion Ordinary and practical strategies should be developed to optimize incidents reporting, to make people aware about their responsibilities about the culture of reporting and to improve the risk communication and the quality of healthcare and patient safety.

RESUMEN Objetivo Identificar las barreras de la subnotificación, los factores que motivan el relato y las estrategias para promover los registros de incidentes. Método Mediante ruedas de conversación y la presencia de un mediador, el equipo multidisciplinario del hospital, compuesto de 65 profesionales, fue estimulado a hablar acerca del tema. Resultado Complacencia y ambición son barreras superadas. Falta de responsabilidad acerca de la notificación fue la nueva barrera observada. Existe una creencia de que solo la enfermería es responsable de la notificación. Conclusión Las estrategias para motivar los registros fueron retornos de las notificaciones relatadas (feedback), intervenciones educativas en el equipo sanitario, herramientas simplificadas para notificación (manual o electrónica), con informaciones mínimas necesarias para que el equipo sanitario optimice el proceso y el tiempo de notificación. Para la garantía de la calidad del relato, el equipo de gestión de la seguridad podría mejorar o complementar el relato.

RESUMO Objetivo Identificar as barreiras da subnotificação, os fatores que motivam o relato e as estratégias para promover os registros de incidentes. Método Por meio de rodas de conversas e a presença de um mediador, a equipe multidisciplinar do hospital, composta por 65 profissionais, foi estimulada a falar sobre tema. Resultado Complacência e ambição são barreiras superadas. Falta de responsabilidade sobre notificação foi a nova barreira observada. Há uma crença de que apenas a enfermagem é responsável pela notificação. Conclusão As estratégias para motivar os registros foram retornos das notificações relatadas (feedback), intervenções educativas na equipe de saúde, ferramentas simplificadas para notificação (manual ou eletrônica), com informações mínimas necessárias para a equipe de saúde otimizar o processo e o tempo de notificação. Para a garantia da qualidade do relato, a equipe de gerenciamento da segurança poderia melhorar ou complementar o relato.

RESUMO Objetivo Identificar as barreiras da subnotificação, os fatores que motivam o relato e as estratégias para promover os registros de incidentes. Método Por meio de rodas de conversas e a presença de um mediador, a equipe multidisciplinar do hospital, composta por 65 profissionais, foi estimulada a falar sobre tema. Resultado Complacência e ambição são barreiras superadas. Falta de responsabilidade sobre notificação foi a nova barreira observada. Há uma crença de que apenas a enfermagem é responsável pela notificação. Conclusão As estratégias para motivar os registros foram retornos das notificações relatadas (feedback), intervenções educativas na equipe de saúde, ferramentas simplificadas para notificação (manual ou eletrônica), com informações mínimas necessárias para a equipe de saúde otimizar o processo e o tempo de notificação. Para a garantia da qualidade do relato, a equipe de gerenciamento da segurança poderia melhorar ou complementar o relato.

ABSTRACT Objective The purpose was to identify the barriers of underreporting, the factors that promote motivation of health professionals to report, and strategies to enhance incidents reporting. Method Group conversations were carried out within a hospital multidisciplinary team. A mediator stimulated reflection among the subjects about the theme. Sixty-five health professionals were enrolled. Results Complacency and ambition were barriers exceeded. Lack of responsibility about culture of reporting was the new barrier observed. There is a belief only nurses should report incidents. The strategies related to motivation reported were: feedback; educational intervention with hospital staff; and simplified tools for reporting (electronic or manual), which allow filling critical information and traceability of management risk team to improve the quality of report. Conclusion Ordinary and practical strategies should be developed to optimize incidents reporting, to make people aware about their responsibilities about the culture of reporting and to improve the risk communication and the quality of healthcare and patient safety.

RESUMEN Objetivo Identificar las barreras de la subnotificación, los factores que motivan el relato y las estrategias para promover los registros de incidentes. Método Mediante ruedas de conversación y la presencia de un mediador, el equipo multidisciplinario del hospital, compuesto de 65 profesionales, fue estimulado a hablar acerca del tema. Resultado Complacencia y ambición son barreras superadas. Falta de responsabilidad acerca de la notificación fue la nueva barrera observada. Existe una creencia de que solo la enfermería es responsable de la notificación. Conclusión Las estrategias para motivar los registros fueron retornos de las notificaciones relatadas (feedback), intervenciones educativas en el equipo sanitario, herramientas simplificadas para notificación (manual o electrónica), con informaciones mínimas necesarias para que el equipo sanitario optimice el proceso y el tiempo de notificación. Para la garantía de la calidad del relato, el equipo de gestión de la seguridad podría mejorar o complementar el relato.

Resumen: Antecedentes: Hierbas medicinales son utilizadas empíricamente con la base en el conocimiento etnofarmacobotánico, los cuales tienen limitaciones. Los informes de los eventos adversos (EA) pueden contribuir a la seguridad, la calidad y la evaluación de la eficacia de estos productos. Objetivos: El objetivo del estudio fue desarrollar un formulario para permitir la detección y evaluación de la probabilidad causal de EA relacionado al uso de plantas medicinales e fitoterápicos. Métodos: Investigación cuantitativa, de desenvolvimiento se llevó a cabo con los profesionales sanitarios de atención primaria. Dos casos fueran distribuidos, en un intervalo de una semana, con el fin de ser llenado en el formulario propuesto. La fiabilidad inter-observadores del instrumento fue evaluada y los resultados fueran clasificados en satisfactorio, regular e insatisfactorio, según los datos esenciales, necesarios y recomendados que fueran rellenados en el formulario de notificación. Resultados: Cincuenta y siete profesionales fueran elegibles. Se observó alto grado de fiabilidad entre observadores para la mayoría de los campos esenciales, necesarios y recomendados. El formulario contribuyó para la evaluación de la asociación causal definitiva, una vez que los campos de duración de las reacciones; evolución, retirada y re- exposición tuvieran alta fiabilidad. La mayoría de los campos flacamente llenados estaban relacionados con defectos de calidad, tales como: nombre popular y apariencia. Conclusiones: Los datos sugieren que el formulario propuesto es adecuado para reportar EA derivados de hierbas medicinales. Por la información relativa a las características organolépticas, el instrumento es diferente de lo instrumento para notificación de medicamentos. Por lo tanto, se pretende mejorar los informes de EA relacionados con los productos naturales y contribuir para el uso apropiado.

Abstract: Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow detection and evaluation of the causal likelihood of AE related to herbal medicines. Methods: A quantitative methodological development research intervention was performed with primary care health professionals. Two cases were distributed in an interval of one week in order to allow for completion of the proposal form. The within-rater reliability was calculated and classified into satisfactory, regular, and unsatisfactory, according to essential, necessary, and recommended items reported. Results: Fifty-seven professionals were enrolled. A high degree of the within-rater reliability was observed for the most essential, necessary, and recommended fields. The instrument contributed to assessment of definite causal association, once the duration of reactions including evolution, withdrawal, and reposition items showed high reliability. Most fields poor and weak filled were related to quality defects, such as popular name and appearance. Conclusions: Data suggest the instrument is adequate to report AE arising from herbal medicines. Owing to information regarding to organoleptic characteristics, the instrument is different from drug instruments. Therefore, it is intended to improve AE reports related to herbal medicines and contribute for appropriate use.