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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. 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.

This scoping review aimed to map the evidence of pharmacist-led medication reconciliation in hospital emergency services in Brazil.We performed a scoping review by searching electronic databases LILACS, Pubmed, Embase, CINAHL, Scopus, Web of Science, Clinical trials, REBEC e Cochrane and conducting a manual search to identify studies published up to 20 October 2021. Studies that addressed pharmacist-led medication reconciliation in hospital emergency services in Brazil, regardless of clinical conditions, and outcomes evaluated, were included.A total of 168 studies were retrieved, with three matching the inclusion criteria. Most studies performed pharmacist-led medication reconciliation at emergency department admissions, but it was not the primary pharmaceutical attribution in this setting. Medication errors were identified during the medication reconciliation process, being drug omission the most reported. Studies did not describe the concerns in collecting the best medication history from patients and the humanistic, economic, and clinical outcomes of pharmacist-led medication reconciliation. Conclusions: This scoping review revealed the lack of evidence about the pharmacist-led medication reconciliation process in the emergency setting in Brazil. The findings suggest the need for future studies in this context.Documentar la evidencia de la conciliación de medicamentos dirigida por farmacéuticos en los servicios de emergencia hospitalarios en Brasil.Método: Se realizó una revisión sistemática exploratoria de bases de datos electrónicas LILACS, Pubmed, Embase, CINAHL, Scopus, Web of Science, Clinical Trials, REBEC y Cochrane para identificar estudios publicados hasta el 20 de octubre de 2021. Los estudios incluidos abordaban la conciliación de medicamentos dirigida por farmacéuticos en los servicios de emergencia hospitalarios en Brasil, independientemente de las condiciones clínicas y los resultados evaluados.Se recuperaron un total de 168 estudios, tres de los cuales cumplieron los criterios de inclusión. La mayoría de los estudios realizaban la conciliación de la medicación dirigida por el farmacéutico en las admisiones al servicio de urgencias, pero ésta no era la principal atribución farmacéutica en ese contexto. Los errores de medicación fueron identificados durante el proceso de conciliación de medicamentos, siendo la omisión de medicamentos el error más reportado. Los estudios no hacían referencia a la importancia de recabar un historial farmacológico lo más completo posible ni a los resultados humanísticos, económicos y clínicos de la conciliación de medicamentos dirigida por farmacéuticos.Esta revisión sistemática exploratoria reveló la falta de evidencia sobre el proceso de conciliación de medicamentos dirigido por farmacéuticos en los servicios de urgencias de Brasil. Los hallazgos sugieren la necesidad de seguir investigando sobre este asunto.

Made available in DSpace on 2022-05-01T11:23:34Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-01-01 Ministério da Ciência, Tecnologia, Inovações e Comunicações Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) 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 dou-ble 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 wom-en. There was at least one quality weakness in all studies, mainly regarding sampling method (i.e. conve-nience 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

Objective Tracheal sleeve pneumonectomy is a challenge in lung cancer management and in achieving long-term oncological results. In November 2018, we started a prospective study on the role of extracorporeal membrane oxygenation (ECMO) in tracheal sleeve pneumonectomy. We aim to present our preliminary results. Methods From November 2018 to November 2019, six patients (three men and three women; median age: 61 years) were eligible for tracheal sleeve pneumonectomy for lung cancer employing the veno-venous ECMO during tracheobronchial anastomosis. Results Only in one patient, an intrapericardial pneumonectomy without ECMO support was performed, but cannulas were maintained during surgery. The median length of surgery was 201 minutes (range: 162–292 minutes), and the average duration of the apneic phase was 38 minutes (range: 31–45 minutes). No complications correlated to the positioning of the cannulas were recorded. There was only one major postoperative complication (hemothorax). At the time of follow-up, all patients were alive; one patient alive with bone metastasis was being treated with radiotherapy. Conclusion ECMO-assisted oncological surgery was rarely described, and its advantages include hemodynamic stability with low bleeding complications and a clean operating field. As suggested by our preliminary data, ECMO-assisted could be a useful alternative strategy in select lung cancer patients.

OBJECTIVES CrossFit comprises a set of high-intensity, high-impact exercises that includes movements that may increase intra-abdominal pressure and cause involuntary loss of urine. There is scant literature about the prevalence of urinary incontinence (UI) in female crossfitters, as well as its associated factors. METHODS A population-based Internet survey stored in a website created with information on the benefits and risks of CrossFit for women's health (https://crosscontinencebr.wixsite.com/crosscontinencebr) invited female crossfitters. In total, 551 women answered an online questionnaire, and the demographic variables (age, marital status, and parity), anthropometric data (weight, height, and body mass index), and the presence of UI during exercises were also investigated. The prevalence of UI and its associated factors were calculated using a logistic regression model. The significance level was set at 5%. RESULTS The overall prevalence of UI during CrossFit exercises was 29.95%, and most women with UI reported loss of urine during at least one exercise (16.70%). Women with UI were older (33.77 ± 8.03 years) than those without UI (30.63 ± 6.93 years; P < 0.001). Double under (20.15%) and single under (7.99%) were the exercises that were most frequently associated with UI and also the only variables that remained in the final model that caused UI. The duration of CrossFit practice, number of days per week practicing CrossFit, daily time practice, previous vaginal delivery, and mean birth weight were not statistically associated with UI. CONCLUSIONS One-third of female crossfitters presented with UI during exercise. Double under was the exercise that was the most associated with UI.

Background Although delirium is one of the most common adverse drug reactions observed in hospitalized older people, it remains underdiagnosed. Aim To estimate the prevalence of hospitalization of older people with potential medication-induced hyperactive delirium in the emergency department (ED); to identify the risk factors and the medicines frequently associated with the occurrence of the syndrome. Method A cross-sectional, retrospective study was performed with older people (age ≥ 60) admitted in 2018 to a Brazilian ED. The hospitalizations with suspected hyperactive delirium were screened with the aid of trigger-tools: International Code of Diseases-10th Revision, intra-hospital prescriptions of antipsychotics, and trigger-words related to the syndrome. A chart-review and medication review were developed to establish the causality assessment between adverse event and medicine. Logistic regression was used to determine risk factors for occurrence. Results Among the hospitalizations included, 67.5% (193/286) were screened by at least one trigger-tool. Of these, potential medication-induced hyperactive delirium was observed in 26.0% (50/193). The prevalence estimated in the ward was 17.5% (50/286). Opioids (31.9%), benzodiazepines (18.8%) and corticosteroids (10.6%) were the commonest medicines associated with delirium. Long-lived patients (p = 0.005), potentially inappropriate medicines (PIMs) (p = 0.025), and high weighted deliriogenic load (p = 0.014) were associated with potential medication-induced hyperactive delirium. Conclusion Approximately one in six hospitalizations of older people in the ED showed potential medication-induced hyperactive delirium. Data suggest PIMs and high weighted deliriogenic load, rather than polypharmacy or anticholinergic burden, are considered the most important characteristics of pharmacotherapy associated with avoidable hyperactive delirium among long-lived patients.

Background Nowadays, transvenous lead extraction (TLE) is considered an essential technique in lead management strategy. Since 2011, a multidisciplinary approach was undertaken in our centre involving electrophysiologists, cardiac surgeons and anaesthesiologists to improve cross- unit cooperation and minimize complications and mortality. The present paper reports procedural outcomes and complications of our lead extraction experience. Methods We retrospectively collected and analysed data from all consecutive patients undergoing cardiac implantable electronic device leads TLE at the IRCCS Centro Cardiologico Monzino between January 2011 and November 2017. Results One-hundred fifty patients (111 males, 68 ± 13 years) underwent extraction procedures. The most common extraction indication were infections (86.7%) and TLE was carried out by laser-based approach in 88 (58.6%) patients, by mechanical dilating sheaths in 58 (38.7%) patients and by a combined approach (TLE + open surgical intervention) in 4 (2.7%) patients. Procedural success was obtained in 146 (97.3%) cases with only 3 (2.0%) major complications with 2 cases of structural injury with tamponade requiring emergent median sternotomy. Open surgery extraction was required in 4 patients, after an attempt to TLE, due to leads strict adhesion to cardiac or vascular structures, whereas in 5 (3.3%) cases, the treatment of choice was a combined approach consisting in transvenous leads extraction followed by planned surgery. Conclusions TLE is a complex procedure that sometimes leads to fatal complications. In our single center experience, a multidisciplinary approach involving electrophysiologist, cardiac surgeon, anaesthesiologist in an operating room allows a safer approach and major complications treatment.

Background: Extemporaneous compounding (EC) involves the preparation of a therapeutic product for specific patient need. However, there is a potential relationship between this procedure and the occurrence of health incidents (HI). The use of trigger tools increases HI identification. Objective: This study assessed the performance of EC as a trigger to detect potential health incidents arising from this procedure. Method: A one-month observational and cross-sectional study was performed in internal medicine ward and intensive care unit of medium-sized hospital. Data collection was carried out in 5 stages: all triggered patients with dysphagia or enteral feeding tube with prescription of EC were included; EC executed in prescribed standardized drugs was observed; the procedure was compared with the hospital guide and scientific literature; HI monitoring and their evaluation using WHO and NCC MERP algorithms; a search for pharmaceutical alternatives (PA) that would avoid the observed EC. Results: 197 patients were recruited. Almost half of them were triggered by EC from 84 standardized drugs. 48 patients met the inclusion criteria. 28 adverse drug reactions, 01 therapeutic ineffectiveness, and 29 medication errors were identified. EC as a trigger tool showed a PPV value of 0.38. Only 24 drugs have PA available in the market, which could avoid one third of all observed EC. Conclusion: It was possible to detect potentially HI in one of two patients with enteral feeding tubes using EC as a trigger tool. The use of EC as a trigger tool contributes to identifying potential HI arising from drugs, which have not gotten pharmaceutical alternatives to be administered via enteral feeding tube.

INTRODUCTION This systematic review aimed to assess antibiotic use in Brazilian hospitals in the 21st century, as well as to understand the different drug utilization metrics adopted to assess the consumption of these drugs. METHODS We systematically reviewed five databases (MEDLINE [Medical Literature Analysis and Retrieval System Online], CENTRAL [The Cochrane Central Register of Controlled Trials], EMBASE® [Excerpta Medica Database], Scopus [Elsevier’s abstract and citation database], and LILACS [Literatura Latino-Americana e do Caribe em Ciências da Saúde]) for observational or experimental studies that assessed antibiotic utilization in Brazilian hospitals. The main outcomes were the drug utilization metrics and the consumption of antibiotics. RESULTS We included 23 studies, of which 43.5% were carried out in adult and pediatric care units, 39.1% in adult units, and 17.4% in pediatric units. Regarding the complexity of healthcare, 26.1% of the studies were performed in intensive care units. Two drug utilization metrics were used in these studies: the defined daily dose (DDD) and the percentage of antibiotic prescriptions. The most commonly used antibiotic classes were third-generation cephalosporins, carbapenems, fluoroquinolones, and combinations of penicillins when the DDD was the adopted drug utilization metric. CONCLUSIONS Although few studies have been conducted, existing data indicate a high use of broad-spectrum antibiotics. We found that the lack of standardized antibiotic utilization metrics impaired the mapping of drug consumption at the national level.

Adiponectin exerts relevant actions in immunity and is modulated in several disorders, such as multiple sclerosis (MS). In this study, we characterized adiponectin expression and profiles in cerebrospinal fluid (CSF) from MS patients to investigate its potential relationship with the severity and progression of the disease. Total adiponectin in CSF was measured by ELISA in 66 unrelated CSF MS patients and compared with 24 age- and sex-matched controls. Adiponectin oligomer profiles were analysed by Western blotting and FPLC chromatography. Total CSF adiponectin was significantly increased in MS patients compared with controls (9.91 ng/mL vs 6.02 ng/mL) (p 0.001). Interestingly, CSF adiponectin positively correlated with CSF IgG, and CSF/serum albumin directly correlated with CSF/serum adiponectin. Our data demonstrated that CSF adiponectin predicts a worse prognosis: patients with the progressive form of MS had higher levels compared with the relapsing remitting form; patients with higher EDSS at baseline and a higher MS severity score at 4.5-year follow-up had significantly elevated adiponectin levels with respect to patients with a less severe phenotype. Finally, the adiponectin oligomerization profile was altered in CSF from MS patients, with a significant increase in HMW and MMW. The correlation of CSF adiponectin with the severity and prognosis of MS disease confirmed the role of this adipokine in the inflammatory/immune processes of MS and suggested its use as a complementary tool to assess the severity, progression and prognosis of the disease. Further studies on larger MS cohorts are needed to clarify the contribution of adiponectin to the etiopathogenesis of MS.

Rituximab (RTX), a chimeric anti-CD20 monoclonal antibody, has demonstrated good efficacy as treatment in patients with resistant chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), but it is highly immunogenic due to its structure. Ocrelizumab (OCR) is a humanized anti-CD20 antibody, with higher tolerability and a lower immunogenic profile compared to RTX. We present a case of refractory CIDP effectively treated with OCR, switched from RTX after the development of anti-drug antibodies. A 25-year-old man was admitted to our clinic for the onset of distal upper and lower limb weakness and numbness, with electrodiagnostic criteria of CIDP. After several attempted standard CIDP treatments, RTX was introduced due to poor control of clinical relapses. Unfortunately, the patient developed a high anti-drug antibody titer after RTX infusion, with no control of disease. OCR was started as an off-label treatment, resulting in partial recovery from the last recurrence and achieving good prevention of new relapses with no adverse events. We suggest that OCR should be considered as another therapeutic option in refractory CIDP. In the literature, this is the first case of CIDP treated with OCR, demonstrating good efficacy for its anti-CD20 effect and better tolerability because of its lower immunogenicity.

The consumption of psychotropic drugs is considered a public health problem, due to the potential for addiction and the occurrence of adverse events. In this context, the current study aimed to characterize the consumption of psychotropic medications dispensed in primary healthcare units in Ribeirão Preto, São Paulo State, Brazil. This ecological study consulted the Hygia database from 2008 to 2012. The following variables were extracted: psychotropic drugs dispensed, amount dispensed per year, and patients' sex and age bracket. For each psychotropic drug, we calculated the defined daily dose per 1,000 inhabitants/day (DDD/1,000PD), defined daily dose per 1,000 inhabitants/day considering 75% of the population (DDD75%/1,000PD) who withdrew medicines through the Brazilian Unified National Health System (SUS), and the prescribed daily dose (PDD). The study compared the population growth rate to the growth in the medicines' consumption. A total of 1,577,241 patients were identified who withdrew medications during the study period, of whom 287,373 (18.2%) used at least one drug subject to special control. There was an increase in the total consumption of psychotropic drugs (DDD/1,000PD), but comparison to the population growth rate showed that only sertraline (p = 0.021), risperidone (p = 0.034), and clonazepam (p = 0.043) presented higher growth rates. The PDD for seven drugs were higher than the World Health Organization (WHO) DDD. Identifying discrepancies between DDD and PDD can be useful as a strategy for screening patients eligible for pharmaceutical care, since they can contribute to the prevention of morbidity and mortality related to medications.O consumo de psicofármacos é considerado um problema de saúde pública devido ao potencial de dependência e ocorrência de eventos adversos. Nesse contexto, o presente estudo teve como objetivo caracterizar o consumo de psicofármacos dispensados em unidades básicas de saúde de Ribeirão Preto, São Paulo, Brasil. Conduziu-se um estudo ecológico, com consulta à base de dados Hygia de 2008 a 2012. Foram extraídas as variáveis: psicofármaco dispensado, quantidade dispensada no ano, sexo e faixa etária dos pacientes. Para cada psicofármaco foi calculada a dose diária definida por 1.000 habitantes/dia (DDD/1.000PD), a dose diária definida por 1.000 habitantes/dia considerando-se 75% da população (DDD75%/1.000PD) que retiraram medicamento pelo Sistema Único de Saúde (SUS) e a dose diária prescrita (DDP). Comparou-se a taxa de crescimento populacional com a de crescimento do consumo dos medicamentos. Foram identificados 1.577.241 pacientes que retiraram medicamentos no período avaliado, dos quais 287.373 (18,2%) utilizaram pelo menos um sujeito a controle especial. Houve aumento do consumo total dos psicofármacos (DDD/1.000PD), porém, após a comparação com a taxa de crescimento populacional, apenas a da sertralina (p = 0,021), risperidona (p = 0,034) e do clonazepam (p = 0,043) foram superiores. As DDP de sete fármacos estavam maiores que a DDD da Organização Mundial da Saúde (OMS). As discrepâncias entre DDD e DDP podem ser úteis como estratégia para triar pacientes elegíveis ao cuidado farmacêutico, pois podem contribuir na prevenção de morbimortalidade relacionada ao uso de medicamentos.El consumo de psicofármacos está considerado un problema de salud pública, debido al potencial de dependencia y ocurrencia de eventos adversos. En este contexto, el presente estudio tuvo como objetivo caracterizar el consumo de psicofármacos dispensados en unidades básicas de salud de Ribeirão Preto, São Paulo, Brasil. Se realizó un estudio ecológico, con consulta a la base de datos Hygia de 2008 a 2012. Se extrajeron las variables: psicofármaco dispensado, cantidad dispensada al año, sexo y franja de edad de los pacientes. Para cada psicofármaco se calculó la dosis diaria definida por 1.000 habitantes/día (DDD/1.000PD), la dosis diaria definida por 1.000 habitantes/día, considerándose un 75% de la población (DDD75%/1.000PD) que consiguieron el medicamento por el Sistema Único de Salud (SUS) y la dosis diaria prescrita (DDP). Se comparó la tasa de crecimiento poblacional con la de crecimiento por consumo de medicamentos. Se identificaron a 1.577.241 pacientes que obtuvieron medicamentos durante el período evaluado, entre los cuales 287.373 (18,2%) utilizaron por lo menos uno sujeto a un control especial. Hubo un aumento en el consumo total de los psicofármacos (DDD/1000PD), no obstante, tras la comparación con la tasa de crecimiento poblacional, solamente la de consumo de sertralina (p = 0,021), risperidona (p = 0,034) y del clonazepam (p = 0,043) fueron superiores. Las DDP de siete fármacos eran mayores a la DDD de la Organización Mundial de la Salud. Las discrepancias entre DDD y DDP pueden ser útiles como estrategia para triar pacientes elegibles para el cuidado farmacéutico, puesto que pueden contribuir a la prevención de morbimortalidad relacionada con el uso de medicamentos.

Patient: Female, 65 Final Diagnosis: Clavicle Kirschner wire migration into left lung Symptoms: No symptoms Medication: — Clinical Procedure: Thoracotomy Specialty: Surgery Objective: Diagnostic/therapeutic accidents Background: Kirschner wires are often used to perform osteosynthesis. Migration through tissue of these wires is a rare but well-known occurrence. Case Report: A 65-year-old female presented with light intensity pain complaints in the upper left chest area; personal history included left clavicle fracture 20 years ago that was treated surgically with fixation using a K-wire. Chest radiography showed the presence of metallic foreign body in the left pulmonary apex. An exploratory axillary thoracotomy was performed, and the foreign body was extracted by a pneumotomy. Conclusions: To obtain satisfactory results with a K-wire, some peculiarities in their application should be respected. The time from orthopedic surgery of the collarbone to migration into the chest of the metal rod used can vary from one day to nearly 20 years. Although the migration mechanism remains unclear, it is likely that it involves shoulder movements, breathing movements, negative intrathoracic pressure, gravitational force, or local bone resorption. Caution should be exercised when orthopedic pins and wires are used for the fixation of fractures and dislocations of the shoulder girdle. If there is migration of the wire, it should be removed immediately to avoid sudden and fatal complications.

Made available in DSpace on 2019-10-03T17:32:00Z (GMT). No. of bitstreams: 0 Previous issue date: 2019. Added 1 bitstream(s) on 2019-10-04T16:21:01Z : No. of bitstreams: 1 S1516-31802019005006101.pdf: 91945 bytes, checksum: 5ac2217f6db07c64824a5fde384ec8c5 (MD5) Universidade de São Paulo Faculdade de Ciências Farmacêuticas de Ribeirão Preto Universidade Federal do Paraná Department of Pharmacy Universidade Estadual Paulista School of Pharmaceutical Sciences Department of Drugs and Medicines Universidade Estadual Paulista School of Pharmaceutical Sciences Department of Drugs and Medicines

Made available in DSpace on 2019-10-04T12:36:56Z (GMT). No. of bitstreams: 0 Previous issue date: 2019-03-01 Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) Brazilian pharmacovigilance regulations involve 3 spheres: health services, Marketing Authorization Holders (MAHs), and sanitary agency. Drug tolerability began to be effectively assessed in Brazil after the founding of the National Agency of Sanitary Surveillance, which developed the Sentinel Network Project, The objective of the Sentinel Network Project is to increase the adverse drug reaction (ADR) reporting rate by health care professionals in the hospital setting. Pharmacovigilance practices became mandatory for MAHs, and patient tolerability issues were considered in drug policy in Brazil only as recently as 2000. However, despite recent events, the regulatory advancements in pharmacovigilance in Brazil are only equivalent to international practices (ie, those of the European Union). The pharmacovigilance system in the European Union integrates the national authorities, the European Commission, and the European Medicines Agency, which is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the European Union. Furthermore, ADR patient reporting is included in the new EU pharmacovigilance regulations. Numerous possible ways are available to improve the Brazilian pharmacovigilance system, mainly through regulations of biosimilar, nanotechnology, and veterinary medicines or by training health care professionals and patients to report nonserious cases and quality deviations. It is necessary to encourage and develop strategies for decentralizing pharmacovigilance actions in the whole country, as is common practice in several EU countries. Motivating and considering ADR reports by patients and improving feedback and audit practices in health care services and MAHs are also necessary measures. With the inclusion of Brazil as a member of the International Conference of Harmonization, significant changes in pharmacovigilance regulation are expected; these updates, which will consider international standards, will improve signal detection and risk communication. (C) 2019 Elsevier Inc. All rights reserved. Amer Brasiliense State Hosp, Amer Brasiliense, Brazil Sao Paulo State Univ, Sch Pharmaceut Sci, Dept Drugs & Med, Araraquara, Brazil Univ Aveiro, Dept Med Sci, Inst Biomed iBiMED, Aveiro, Portugal Sao Paulo State Univ, Sch Pharmaceut Sci, Dept Drugs & Med, Araraquara, Brazil FAPESP: 2013/12681-2 FAPESP: 2018/07501-9 CNPq: 131206/2017-6 CAPES: 001

Made available in DSpace on 2019-10-06T16:45:21Z (GMT). No. of bitstreams: 0 Previous issue date: 2019-01-01. Added 1 bitstream(s) on 2021-07-15T15:23:51Z : No. of bitstreams: 1 S1807-59322019000100259.pdf: 945018 bytes, checksum: 6ce7697fd18323909d5b3b7fa5cb64f8 (MD5) 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. Departamento de Farmacos e Medicamentos Faculdade de Ciencias Farmaceuticas Universidade Estadual de Sao Paulo (UNESP) BR Departamento de Ciencias Farmaceuticas Faculdade de Ciencias Farmaceuticas de Ribeirao Preto Universidade de Sao Paulo BR Departamento de Cirurgia e Anatomia Faculdade de Medicina de Ribeirao Preto Universidade de Sao Paulo BR Departamento de Farmacos e Medicamentos Faculdade de Ciencias Farmaceuticas Universidade Estadual de Sao Paulo (UNESP) BR

Made available in DSpace on 2019-10-04T23:10:30Z (GMT). No. of bitstreams: 0 Previous issue date: 2018-01-01. Added 1 bitstream(s) on 2019-10-09T18:34:33Z : No. of bitstreams: 1 S0080-62342018000100443.pdf: 208660 bytes, checksum: 7756403076320153806d10dcf11c92f0 (MD5) Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Programa de Apoio ao Desenvolvimento Cientifico, Faculty of Pharmaceutical Sciences, Universidade Estadual Paulista 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. Univ Estadual Paulista, Fac Ciencias Farmaceut, Campus Araraquara Rodovia Araraquara Jau,Km 1 S-N, BR-14800903 Araraquara, SP, Brazil Univ Sao Paulo, Fac Med Ribeirao Preto, Dept Cirurgia & Anat, Hosp Estadual Amer Brasiliense, Ribeirao Preto, SP, Brazil Univ Estadual Paulista, Fac Ciencias Farmaceut, Campus Araraquara Rodovia Araraquara Jau,Km 1 S-N, BR-14800903 Araraquara, SP, Brazil CAPES: 014301/2013-00 FAPESP: 2013/10263-9

Made available in DSpace on 2018-12-11T17:37:04Z (GMT). No. of bitstreams: 0 Previous issue date: 2018-06-01 Purpose: The purpose of this study was to assess whether prophylaxis for digestive disorders with omeprazole is a risk factor for adverse drug events (ADEs) and kidney impairment. Methods: This was a 9-month, prospective, double-blinded cohort study performed in a Brazilian public hospital. All inpatients 18 years or older admitted during the period of data collection were divided into 2 cohorts. The first group comprised 200 patients receiving prophylaxis for digestive disorders with omeprazole. A total of 54 inpatients who received treatment with omeprazole and whose indication was not approved by the Brazilian Sanitary Agency and the US Food and Drug Administration were excluded. The second group comprised 219 inpatients without a prescription for omeprazole. Follow-up was performed until discharge and included assessment of medical records, medical prescriptions, laboratory data, and pharmaceutical anamnesis. The primary end point was kidney impairment. The variables monitored were kidney function (serum creatinine and urea levels as well as glomerular filtration rate), hepatic function (alanine aminotransferase and aspartate aminotransferase levels), pharmacotherapy, magnesium levels, and imputation of ADEs. With the aid of algorithms of World Health Organization and the National Coordinating Council for Medication Error Reporting and Prevention, we assessed the causality of adverse drug reactions (ADRs) and the seriousness of medication errors (ADEs), respectively. Findings: Prophylaxis for digestive disorders with omeprazole (P = 0.019) and sex (P = 0.010) were considered risk factors for increased serum creatinine level via multivariate logistic regression even with concomitant use of nephrotoxic drugs (P = 0.252). Six ADEs related to omeprazole were identified: 2 ADRs (1 possible and 1 definite), 2 medication errors (nonserious), 1 therapeutic failure, and 1 drug-drug interaction. Implications: Prophylaxis for digestive disorders with omeprazole and male sex may contribute to the development of kidney impairment because both result in increased serum creatinine levels. Therefore, pharmacotherapeutic follow-up of male patients diagnosed with kidney disorders should be considered to identify potential drug-drug interactions early. This follow-up can prevent worsening clinical conditions and/or contraindicate prophylactic use of omeprazole. ClinicalTrials.gov identifier: NCT02278432. Americo Brasiliense State Hospital Americo Brasiliense São Paulo State University (UNESP) School of Pharmaceutical Sciences Araraquara Department of Surgery and Anatomy Ribeirão Preto School of Medicine University of São Paulo São Paulo State University (UNESP) School of Pharmaceutical Sciences Araraquara

Made available in DSpace on 2018-12-11T16:45:52Z (GMT). No. of bitstreams: 0 Previous issue date: 2017-02-01 Fundação para a Ciência e a Tecnologia Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) Background & objectives Different algorithms have been developed to standardize the causality assessment of adverse drug reactions (ADR). Although most share common characteristics, the results of the causality assessment are variable depending on the algorithm used. Therefore, using 10 different algorithms, the study aimed to compare inter-rater and multi-rater agreement for ADR causality assessment and identify the most consistent to hospitals. Methods Using ten causality algorithms, four judges independently assessed the first 44 cases of ADRs reported during the first year of implementation of a risk management service in a medium complexity hospital in the state of Sao Paulo (Brazil). Owing to variations in the terminology used for causality, the equivalent imputation terms were grouped into four categories: definite, probable, possible and unlikely. Inter-rater and multi-rater agreement analysis was performed by calculating the Cohen?s and Light?s kappa coefficients, respectively. Results None of the algorithms showed 100% reproducibility in the causal imputation. Fair interrater and multi-rater agreement was found. Emanuele (1984) and WHO-UMC (2010) algorithms showed a fair rate of agreement between the judges (k = 0.36). Interpretation & conclusions Although the ADR causality assessment algorithms were poorly reproducible, our data suggest that WHO-UMC algorithm is the most consistent for imputation in hospitals, since it allows evaluating the quality of the report. However, to improve the ability of assessing the causality using algorithms, it is necessary to include criteria for the evaluation of drug-related problems, which may be related to confounding variables that underestimate the causal association. São Paulo State University (UNESP) School of Pharmaceutical Sciences CAPES Foundation Ministry of Education of Brazil Departamento de Ciências Médicas Universidade de Aveiro São Paulo State University (UNESP) School of Pharmaceutical Sciences Fundação para a Ciência e a Tecnologia: UID/BIM/04501/2013

Made available in DSpace on 2018-12-11T17:10:02Z (GMT). No. of bitstreams: 0 Previous issue date: 2017-01-01. Added 1 bitstream(s) on 2019-10-09T18:30:52Z : No. of bitstreams: 1 S1807-59322017000100051.pdf: 595694 bytes, checksum: 29334e0b8b1d762e07eb5c1f5650070a (MD5) Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) OBJECTIVES: Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drugrelated problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals. METHOD: This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil. The intervention involved four activities: 1) an interactive lecture, 2) a practical class, 3) a pre-post questionnaire administered to professionals on a multidisciplinary team, and 4) educational material. The intervention’s impact on the professionals’ knowledge and skills was assessed using the World Health Organization’s definitions. The intervention’s effect on the professionals’ attitudes was analysed by the prevalence of adverse drug event reports (adverse drug reactions, medication errors, therapeutic failure and drug quality deviations) and the relevance (seriousness and expectancy) of the events. RESULTS: One hundred seventy-three professionals were enrolled. A 70-fold increase in the number of adverse drug event reports was observed during the 12 months post-intervention. The intervention improved the professionals’ form-completion skills (p

Made available in DSpace on 2015-11-03T15:29:47Z (GMT). No. of bitstreams: 0 Previous issue date: 2014-08-01. Added 1 bitstream(s) on 2015-11-04T10:16:05Z : No. of bitstreams: 1 S0080-62342014000400739-es.pdf: 606509 bytes, checksum: a2984383251f1b97b54111a5cd8c3dcd (MD5). Added 1 bitstream(s) on 2015-11-04T10:16:05Z : No. of bitstreams: 2 S0080-62342014000400739-es.pdf: 606509 bytes, checksum: a2984383251f1b97b54111a5cd8c3dcd (MD5) S0080-62342014000400739-en.pdf: 401093 bytes, checksum: 2fd87469f2c421fe0f35b28ef9b2e7c7 (MD5) Item merged in doublecheck by Felipe Augusto Arakaki (arakaki@reitoria.unesp.br) on 2016-01-28T17:46:01Z Item was identical to item(s): 129243, 132863 at handle(s): http://hdl.handle.net/11449/130163, http://hdl.handle.net/11449/133734 Made available in DSpace on 2016-07-19T13:51:11Z (GMT). No. of bitstreams: 0 Previous issue date: 2014-08-01 Item merged in doublecheck by Luana Priscila Costa (luana@reitoria.unesp.br) on 2019-04-23T18:16:44Z Item was identical to item(s): 133065, 141496 at handle(s): http://hdl.handle.net/11449/133938, http://hdl.handle.net/11449/141862 Objetivo: Identificar as causas de subnotificação de Reação Adversa a Medicamento (RAM) por profissionais da saúde. Método: Revisão sistemática realizada nas bases de dados LILACS, PAHO, SciELO, EMBASE e PubMed, cujo período de abrangência foi de 1992 a 2012. Foram utilizados descritores para buscar os artigos. As causas de subnotificação de RAM identificadas foram analisadas de acordo com a classificação de Inman. Resultados: Identificaram-se 149 artigos, dos quais 29 foram considerados elegíveis. A maioria dos estudos foi conduzida em hospitais (24/29), para médicos (22/29) e farmacêuticos (10/29). As principais causas relacionadas à subnotificação observadas foram: a ignorância (24/29), a insegurança (24/29) e a indiferença (23/29). Conclusão: Os dados evidenciam o oitavo pecado da subnotificação, que é a falta de formação em farmacovigilância. Assim, a educação permanente pode aumentar a adesão dos profissionais ao serviço e melhorar o conhecimento e a comunicação dos riscos associados ao uso de medicamentos. Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29) for physicians (22/29), and pharmacists (10/29). The main causes related to underreporting were ignorance (24/29), insecurity (24/29) and indifference (23/29). Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use. Objetivo: Identificar as causas de subnotificação de Reação Adversa a Medicamento (RAM) por profissionais da saúde. Método: Revisão sistemática realizada nas bases de dados LILACS, PAHO, SciELO, EMBASE e PubMed, cujo período de abrangência foi de 1992 a 2012. Foram utilizados descritores para buscar os artigos. As causas de subnotificação de RAM identificadas foram analisadas de acordo com a classificação de Inman. Resultados: Identificaram-se 149 artigos, dos quais 29 foram considerados elegíveis. A maioria dos estudos foi conduzida em hospitais (24/29), para mé- dicos (22/29) e farmacêuticos (10/29). As principais causas relacionadas à subnotificação observadas foram: a ignorância (24/29), a insegurança (24/29) e a indiferença (23/29). Conclusão: Os dados evidenciam o oitavo pecado da subnotifica- ção, que é a falta de formação em farmacovigilância. Assim, a educação permanente pode aumentar a adesão dos profissionais ao serviço e melhorar o conhecimento e a comunicação dos riscos associados ao uso de medicamentos Universidade Estadual Paulista, Departamento de Fármacos e Medicamentos, Faculdade de Ciências Farmacêuticas de Araraquara

Made available in DSpace on 2014-10-01T13:08:56Z (GMT). No. of bitstreams: 0 Previous issue date: 2014-03-01Bitstream added on 2014-10-01T14:02:53Z : No. of bitstreams: 1 S1807-59322014000300163.pdf: 249036 bytes, checksum: e5bb0870eda76fe58ebdc4c763328016 (MD5) OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%), fatigue (12.3%), and chest pain (9.0%). Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases. Universidade Estadual Paulista Julio de Mesquita Filho School of Pharmaceutical Sciences Department of Drugs and Medications Ministerio da Saude Comissao Nacional de Incorporacao de Tecnologias Universidade Estadual Paulista Julio de Mesquita Filho School of Pharmaceutical Sciences Department of Natural Active Principles and Toxicology Universidade Estadual Paulista Julio de Mesquita Filho School of Pharmaceutical Sciences Department of Drugs and Medications Universidade Estadual Paulista Julio de Mesquita Filho School of Pharmaceutical Sciences Department of Natural Active Principles and Toxicology

Objective: Despite cognitive tests have been validated in multiple sclerosis (MS), a neuropsychological evaluation is not implemented in the Expanded Disability Status Scale (EDSS) scoring. Methods: We used the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) and orientation tests (OTs) to measure the cerebral functional system (CFS) score and to evaluate its impact on the EDSS. We compared EDSS calculated as usual (Native-EDSS) and after the use of the BICAMS and OT (NPS-EDSS). Results: We tested 604 MS patients with BICAMS, OTs, and EDSS. In all, 384 patients (63.6%) had at least one altered test at the BICAMS. Older age, lower education, higher Native-EDSS, and male gender were independently associated with at least one impaired BICAMS test. Native-EDSS was different from NPS-EDSS (−0.112; p Conclusion: The use of brief neuropsychological tests leads to a more accurate CFS assessment in two-thirds of MS patients, and a more accurate EDSS calculation in 25% of patients with a score ⩽4.0. This may help clinicians to better recognize cognitive impairment in everyday clinical practice, especially in the case of isolated cognitive worsening.

Made available in DSpace on 2018-12-11T17:08:39Z (GMT). No. of bitstreams: 0 Previous issue date: 2017-04-01 Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) Purpose This study explored the performance of trigger in detecting adverse drug reactions (ADRs), the confounding variables impairing the causal association of the ADRs, and the underreporting rate by hospital health professionals. Methods A 6-month cross-sectional study was conducted in a public general hospital. Data collection was conducted in 2 stages: (1) screening of patient hospitalizations to identify suspected ADRs with 9 triggers developed by the Institute of Healthcare Improvement; and (2) chart review to perform the causality assessment of the suspected ADRs identified, to describe the confounding variables associated with detection of suspected ADRs that were not drug induced, and to analyze the positive predictive value of triggers in recognizing ADRs. To estimate the underreporting rate, ADRs detected by using the tool were compared with ADRs reported by health professionals during the same period. Findings During the study period, 3318 hospitalizations were analyzed. A total of 837 suspected ADRs were identified. However, after causality assessment, 356 were definite ADRs. Confounding variables associated with the detection-suspected ADRs were related to the clinical conditions of inpatients. The use of triggers contributed to increased ADR detection by 10.5%. The performance ranged from 0.00 to 0.75, with an overall positive predictive value of 0.43. Six ADRs were spontaneously reported, of which just 1 was also detected by using the trigger tool. Only 1 of 356 potential ADRs was reported by health professionals. Implications Findings show that the use of triggers contributes to detecting ADRs underreported by health professionals. However, confounding variables impaired the performance of the tool because they underestimated the causal association. Furthermore, both methods are complementary to early recognition of drug-induced harm and should be applied together in health institutions to contribute to policies of risk management, drug safety, and optimization of pharmacotherapy. School of Pharmaceutical Sciences UNESP-Univ Estadual Paulista Department of Drugs and Medicines School of Pharmaceutical Sciences USP–University of São Paulo Americo Brasiliense State Hospital Department of Surgery and Anatomy Ribeirão Preto School of Medicine University of São Paulo University of Aveiro Department of Medical Sciences & Institute for Biomedicine–iBiMED CAPES Foundation Ministry of Education of Brazil Brasília – DF 70040-020 School of Pharmaceutical Sciences UNESP-Univ Estadual Paulista Department of Drugs and Medicines

Background:The primary aim of the present study was to determine the survival rates and identify predictors of disease duration in a cohort of Huntington's disease (HD) patients from Southern Italy.Methods:All medical records of HD patients followed between 1977 and 2008 at the Department of Neurological Sciences of Federico II University in Naples were retrospectively reviewed and 135 patients were enrolled in the analysis. At the time of data collection, 41 patients were deceased (19 males and 22 females) with a mean ± SD age at death of 56.6 ± 14.9 years (range 18-83).Results:The median survival time was 20 years (95% CI: 18.3-21.7). Cox regression analysis showed that the number of CAG in the expanded allele (HR 1.09 for 1 point triplet increase, p=0.002) and age of onset (HR 1.05 for 1 point year increase, p=0.022) were independent and significant predictors of lower survival rates.Conclusions:We believe that these findings are important for a better understanding of the natural history of the disease and may be relevant in designing future therapeutic trials.

The objectives of this study were to evaluate the efficacy of percutaneous cardiopulmonary support (CPS) for circulatory assistance during electrophysiological endocavitary procedures for ventricular tachycardia (VT) in high-risk patients. From January to June 1999, eight patients with VT not haemodynamically tolerated, underwent an electrophysiological mapping and ablation while supported with percutaneous CPS in the cardiac surgery service of the University of Milan. The CPS system allowed for the maintenance of an arterial pressure of 60-70 mmHg during the tachycardia episodes. CPS was used for 10-20 min periods to restore haemodynamic stability. With the haemodynamic support of CPS, it was possible to target and induce 21 VTs, with a mean cycle of 325 ms. The mean support time was 140 min (120 - 160 min). Stabilization of the arterial pressure at a mean value of 65 mmHg (55 - 85 mHg) was achieved over a mean period of 26 seconds. Oxygen saturation remained over 90% throughout the support for all patients, with no blood gas or electrolyte abnormalities. No CPB-related complications were observed. In conclusion, percutaneous CPS guarantees effective haemodynamic support during mapping and ablation of VTs not haemodynamically tolerated, with no complications related to the extracorporeal circulation or the cannulation.

Introduction: Spontaneous adverse drug events (ADE) reporting is the main source of data for assessing the risk/benefit of drugs available in the pharmaceutical market. However, its major limitation is underreporting, which hinders and delays the signal detection by Pharmacovigilance (PhV).Objectives: To identify the techniques of educational intervention (EI) for promotion of PhV by health professionals and to assess their impact.Methods: A systematic review was performed in the PUBMED, PAHO, LILACS and EMBASE databases, from November/2011 to January/2012, updated in March/2013. The strategy search included the use of health descriptors and a manual search in the references cited by selected papers.Results: 101 articles were identified, of which 16 met the inclusion criteria. Most of these studies (10) were conducted in European hospitals and physicians were the health professionals subjected to most EI (12), these studies lasted from one month to two years. EI with multifaceted techniques raised the absolute number, the rate of reporting related to adverse drug reactions (ADR), technical defects of health technologies, and also promoted an improvement in the quality of reports, since there was increased reporting of ADR classified as serious, unexpected, related to new drugs and with high degree of causality.Conclusion: Multifaceted educational interventions for multidisciplinary health teams working at all healthcare levels, with sufficient duration to reach all professionals who act in the institution, including issues related to medication errors and therapeutic ineffectiveness, must be validated, with the aim of standardizing the Good Practice of PhV and improve drug safety indicators.

Made available in DSpace on 2015-08-21T17:53:17Z (GMT). No. of bitstreams: 0 Previous issue date: 2013 Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Light is the major synchronizer of circadian rhythms. In the absence of light, as for totally blind people, some variables, such as body temperature, have an endogenous period that is longer than 24 h and tend to be free running. However, the circadian rhythm of muscle strength and reaction time in totally blind people has not been defined in the literature. The objective of this study was to determine the period of the endogenous circadian rhythm of the isometric and isokinetic contraction strength and simple reaction time of totally blind people. The study included six totally blind people with free-running circadian rhythms and four sighted people (control group). Although the control group required only a single session to determine the circadian rhythm, the blind people required three sessions to determine the endogenous period. In each session, isometric strength, isokinetic strength, reaction time, and body temperature were collected six different times a day with an interval of at least 8 h. The control group had better performance for strength and reaction time in the afternoon. For the blind, this performance became delayed throughout the day. Therefore, we conclude that the circadian rhythms of strength and simple reaction time of totally blind people are within their free-running periods. For some professionals, like the blind paralympic athletes, activities that require large physiological capacities in which the maximum stimulus should match the ideal time of competition may result in the blind athletes falling short of their expected performance under this free-running condition. Universidade Estadual Paulista Júlio de Mesquita Filho, Departamento de Psicologia Experimental e do Trabalho, Faculdade de Ciências e Letras de Assis, Assis, Avenida Dom Antônio 2100, Parque Universitário, CEP 19806-900, SP, Brasil Universidade Estadual Paulista Júlio de Mesquita Filho, Departamento de Psicologia Experimental e do Trabalho, Faculdade de Ciências e Letras de Assis, Assis, Avenida Dom Antônio 2100, Parque Universitário, CEP 19806-900, SP, Brasil FAPESP: 1998/14303-3 FAPESP: 2004/11913-8

Background: The development of acute kidney injury (AKI) after adult cardiac surgery is associated with increased morbidity and mortality. Our aim was to assess the risk factors for postoperative AKI and whether the addition of perioperative management variables can improve AKI prediction. Methods: We studied 3,219 patients operated from January 2006 to December 2009. The AKI was defined as proposed by the Acute Kidney Injury Network. Patient preoperative characteristics, as well as intraoperative, cardiopulmonary bypass (CPB), and postoperative management variables, were evaluated for association with AKI with logistic regression analysis. The model including all variables was assessed first, then separate models including only preoperative variables followed by the sequential addition of intraoperative, CPB, and postoperative management variables were tested; receiver operating characteristic analysis was used to evaluate and compare models' discriminatory power. Results: The AKI occurred in 288 of 3,219 patients (8.9%). Logistic regression analysis identified 15 predictors of AKI; 4 were preoperative (age, diabetes, smoking, and serum creatinine), 4 intraoperative (inotropes, erythrocytes transfusion, cross-clamp time, and need of a new pump run), 2 CPB-related (urine output and furosemide administration during CPB), and 5 postoperative (erythrocytes transfusion, administration of vasoconstrictors, inotropes, diuretics, and antiarrhythmics). Model-discrimination performance improved from an area under the curve of 0.830 (95% confidence interval 0.807 to 0.854) for the model including only preoperative variables to an area under the curve of 0.904 (95% confidence interval 0.886 to 0.921) for the model including all variables (p < 0.001). Conclusions: Several factors influence AKI development after cardiac surgery and perioperative patient management significantly affects AKI occurrence. Predictive models can be sensibly improved by the addition of these variables. © 2012 The Society of Thoracic Surgeons.

Submitted by Vitor Silverio Rodrigues (vitorsrodrigues@reitoria.unesp.br) on 2014-05-27T11:25:30Z No. of bitstreams: 0Bitstream added on 2014-05-27T14:41:42Z : No. of bitstreams: 1 2-s2.0-84856084328.pdf: 84111 bytes, checksum: ae106103cdcbb3700fcf9a699a368961 (MD5) Made available in DSpace on 2014-05-27T11:25:30Z (GMT). No. of bitstreams: 0 Previous issue date: 2011-03-01 Objectives: The maintenance and stability of peri-implantar soft tissue seem to be related to the crestal bone around the implant platform and different implant designs connections might affect this phenomenon. The aim of this study was to evaluate by photoelastic analysis the stress distribution in the cervical and apical site of implant-abutment interface of conventional implant joints (external hex, internal hex and cone morse) and compare to the novel platform switching design. Materials and methods: It was fabricated photoelastic models using five different implant-abutment connection, one set of external hex (Alvim Ti, Neodent, Curitiba, Brazil), one set of internal hex (Full Osseotite, Biomet 3i, Florida, USA), one cone morse set (Alvim CM, Neodent, Curitiba, Brazil), and two sets of internal hex plus platform switching concept (Alvim II Plus, Neodent, Curitiba, Brazil) (Certain Prevail, Biomet 3i, Florida, USA). These models were submitted to two compressive loads, axial from 20 kgf (load I) and another (load II), inclined 45° from 10 kgf. During the qualitative analysis, digital pictures were taken from a polariscope, for each load situation. For the quantitative analyses in both situations of load, the medium, minimum and maximum in MPa values of shear strain were determined in the cervical and apical site. The Kruskal-Wallis test was used to compare the results between the different systems and between cervical and apical site were compared using Mann-Whitney U test. Results: The results from qualitative analysis showed less concentration of strain in the cervical area to the internal hex plus platform switching (Certain Prevail), in both situation of load. The same results were get in the quantitative analysis, showing less stress concentrations around the implant Certain Prevail with internal hex plus the novel design (17.9 MPa to load I and 29.5 MPa to load II), however, without statistical significant difference between the systems. Conclusion: The minor stress concentration strongly suggest the use of platform switching design as a manner to prevent bone loss around the implant-abutment platform. Clinical Significance: From the result of this study its possible to make clinical decision for implant system which provides implant components with platform switching characteristics. Department of Prevention and Oral Rehabilitation FO-UFG, Goiás Department of Dental Materials and Prosthodontics FOA-UNESP, São Paulo Department of Prevention and Oral Rehabilitation, Avenida Dep. Jamel Cecilio, 2496, Jardim Goiás 74810-100, Goiânia-Goiás Department of Dental Materials and Prosthodontics FOA-UNESP, São Paulo

Low levels of vitamin B12 cause decreased activity of the methinine synthase and methylation cycle impairment, resulting in bnormalities of DNA biosynthesis and cell division. The methyation cycle dysfunction leads to a reduction of various methylated roducts, such as myelin basic protein. Vitamin B12 deficiency may cause anaemia and neurological isorders, including subacute combined degeneration of the spinal ord, peripheral neuropathy, optic atrophy, dementia, and psychitric diseases. Carnivores, including humans, derive vitamin B12 equirement by consumption of meats and food of animal origin, ilk, butter, cheese and eggs. Vitamin B12 absorption needs an dequate HCl concentration in the stomach and the presence of ntrinsic factor, a glycoprotein produced by parietal cells necessary o absorb vitamin B12. The most frequent causes of vitamin B12 deficiency are perniious anaemia, an autoimmune disease caused by autoantibodies gainst parietal cells, achlorhydria, affecting one-quarter of elderly ubjects, and reduced intake with food (e.g. vegetarianism). The itrous oxide exposure during anaesthesia is a rare cause of acute itamin B12 inactivation [1].

Made available in DSpace on 2013-08-28T14:14:09Z (GMT). No. of bitstreams: 1 WOS000295160000012.pdf: 299307 bytes, checksum: 084efbe0beccad55801f2e04e48bb2b6 (MD5) Made available in DSpace on 2013-09-30T18:08:00Z (GMT). No. of bitstreams: 2 WOS000295160000012.pdf: 299307 bytes, checksum: 084efbe0beccad55801f2e04e48bb2b6 (MD5) WOS000295160000012.pdf.txt: 35562 bytes, checksum: f522fd2aa8c9d3e4981650fa6178bf7a (MD5) Previous issue date: 2011-01-01 Submitted by Vitor Silverio Rodrigues (vitorsrodrigues@reitoria.unesp.br) on 2014-05-20T13:25:35Z No. of bitstreams: 2 WOS000295160000012.pdf: 299307 bytes, checksum: 084efbe0beccad55801f2e04e48bb2b6 (MD5) WOS000295160000012.pdf.txt: 35562 bytes, checksum: f522fd2aa8c9d3e4981650fa6178bf7a (MD5) Made available in DSpace on 2014-05-20T13:25:35Z (GMT). No. of bitstreams: 2 WOS000295160000012.pdf: 299307 bytes, checksum: 084efbe0beccad55801f2e04e48bb2b6 (MD5) WOS000295160000012.pdf.txt: 35562 bytes, checksum: f522fd2aa8c9d3e4981650fa6178bf7a (MD5) Previous issue date: 2011-01-01 Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) Purpose: Potentially Inappropriate Medications (PIM) use in elderly people may be responsible for the development of Adverse Drug Reaction (ADR) which, when severe, leads to hospital admissions. Objectives: to estimate the prevalence of elderly who had used PIM before being admitted to hospital and to identify the risk factors and the hospitalizations related to ADR arising from PIM. Methods: A descriptive and cross-sectional study was performed in the internal medicine ward of a teaching hospital (Brazil), in 2008. With the aid of a validated form, patients aged >= 60 years, with length of hospital stay >= 24 hours, were interviewed about drugs taken prior to the hospital admission and the complaints/reasons for hospitalization. Results: 19.1% (59/308) of older patients had taken PIM before hospital admission and in 4.9%; there were a causal relation between the PIM taken and the complaint reported. PIM responsible for admissions were: amiodarone, amitriptyline, cimetidine, clonidine, diazepam, digoxin, estrogen, fluoxetine, lorazepam, short-acting nifedipine and propranolol. 47.0% of the clinical manifestations of PIM-related ADR were: dizziness, fatigue, digoxin toxicity and erythema. Only polypharmacy was detected as a risk factor for the occurrence of ADR of PIM (p = 0.02). Conclusion: PIM use in elderly people is not a risk factor for ADR-related hospital admission. Probably, severe ADR, which lead to hospitalizations of older people, can be explained by idiosyncratic response or the predisposition of these patients to develop adverse drug events, whether or not drugs are classed as PIM. Univ Estadual Paulista, Sch Pharmaceut Sci, Araraquara, SP, Brazil Univ São Paulo Ribeirao Preto, Risk Management Clin Hosp Ribeirao Preto, São Paulo, Brazil Univ Estadual Paulista, Sch Pharmaceut Sci, Araraquara, SP, Brazil

Background: Huntington's disease (HD) is an autosomal dominant neurodegenerative disorder caused by an expanded CAG repeat in exon 1 of the HTT gene. There is increasing evidence pointing towards an involvement of the endocrine system in HD. Recent studies, investigating the increased risk of diabetes mellitus and impaired insulin sensitivity and secretion in HD patients, led to contradictory results. Objective: To investigate glucose homeostasis in HD. Methods: Twenty-eight consecutive patients with HD and 28 healthy controls were matched for age, sex, and BMI. Diagnosis of HD was confirmed genetically. Clinical tools for assessment were the Unified Huntington's Disease Rating Scale (UHDRS) motor section and the Total Function Capacity (TFC). Basal metabolic and endocrine investigations and a 2-hour 75-g oGTT were performed. We used the homeostasis model assessment of insulin resistance (HOMA-IR) as index of insulin sensitivity and the insulinogenic index to assess insulin secretion. Results: HD patients did not differ from the controls with respect to fasting plasma glucose, insulin sensitivity and secretion. CAG expansion size, disease stage and duration, or BMI did not influence HOMA-IR and insulinogenic index. Patients showed lower serum glucose (−19%) and insulin levels (−48%) at 30 min and higher serum insulin levels at 90 (+132%) and 120 min (+380%). Conclusions: Our data do not support an increased risk of diabetes among HD patients although they show glucose regulation abnormalities with a flat glucose curve and delayed insulin peak after oral glucose load.