Economic burden of respiratory syncytial and parainfluenza viruses in children of upper-middle-income countries: a systematic review

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.

Análise dos custos diretos e indiretos da COVID-19 em um hospital brasileiro / Analysis of the direct and indirect costs of COVID-19 in a Brazilian hospital

Objetivo: Avaliar os custos diretos na perspectiva hospitalar e do Sistema Único de Saúde (SUS), bem como os custos indiretos de pacientes hospitalizados por COVID-19. Métodos: Estudo observacional com coleta de dados por micro e macrocusteio, realizado com pacientes admitidos por COVID-19 em um hospital paulista (março a setembro de 2020). Custos indiretos foram obtidos pelos métodos de capital humano e de anos de vida ajustados pela incapacidade (DALY). Análises de Mann-Whitney e regressão linear foram realizadas. Resultados: Foram incluídos 158 indivíduos com mediana de idade de 57 anos (IIQ 42-68 anos). A mediana de custo da internação na perspectiva do SUS e hospitalar foi de, respectivamente, R$ 2.009,46 (IIQ: R$ 1.649,11; R$ 4.847,36), principalmente devido à unidade de terapia intensiva (UTI), e R$ 19.055,91 (IIQ: R$ 8.399,47; R$ 38.438,00), principalmente devido a recursos humanos. Tempo total de internação (p < 0,001), óbito (p < 0,001) e ventilação invasiva (p < 0,001) foram preditores de aumento de custo. Foi identificada perda de 381,5 DALY e perda de produtividade de 128 anos, equivalente a US$ 855.307. Conclusão: Os principais direcionadores de custo foram recursos humanos e UTI. Entretanto, na perspectiva da sociedade, foi identificado o maior impacto devido à perda de produtividade e DALY. Tempo de hospitalização foi um dos grandes contribuidores do custo, e esse fator pode estar atrelado a gravidade da doença e protocolos de cuidado ao paciente.

Objective: To evaluate the direct costs from the hospital and Unified Health System (SUS) perspective, as well as the indirect costs of patients hospitalized by COVID-19. Methods: Observational study with data collection by micro- and macro-costing, carried out with patients hospitalized in a hospital in São Paulo (March-September 2020). Indirect costs were obtained using human capital and disability-adjusted life years (DALY) methods. Mann-Whitney and linear regression analyzes were performed. Results: 158 individuals were included, with a median age of 57 years (IQR 42-68 years). The median cost of admission in the SUS and hospital perspective was, respectively, R$ 2,009.46 (IQR: R$ 1,649.11; R$ 4,847.36), mainly due to the intensive care unit (ICU) and R$ 19,055.91 (IQR: R$ 8,399.47; R$ 38,438.00), mainly due to human resources. The total length of stay in hospital (p < 0.001), death (p < 0.001) and invasive ventilation (p < 0.001) were predictors of cost increase.

Deficiency and Insufficiency of Vitamin D in Women of Childbearing Age: A Systematic Review and Meta-analysis / Deficiência e insuficiência de vitamina D em mulheres na idade reprodutiva: Uma revisão sistemática e meta-análise

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.

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.

Impact of pharmacist intervention in patients with Alzheimer's disease

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

Deficiency of vitamins C and E in women of childbearing age in Brazil: a systematic review and meta-analysis

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.

Perfil epidemiológico de pacientes com hemorragia gastrointestinal alta não varicosa decorrente de doença péptica em um hospital brasileiro terciário de referência / Epidemiological profile of patients with non-variceal upper gastrointestinal bleeding secondary to peptic disease in a tertiary referral brazilian hospital

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.

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.

Serum potassium level used as trigger doubled the detection of adverse drug events when compared with calcium polystyrene sulfonate trigger: a cross-sectional study

Background: Prescription of calcium polystyrene sulfonate (CPS) has been considered a trigger with good performance to detect hyperkalemia related to adverse drug events (ADE). However, CPS prescription may underestimate the rate of ADE. Objective: To compare the performance of the serum potassium level (SPL) >5.0mEq/L and CPS triggers in detecting hyperkalemia related to ADE. Design and setting: A six-month cross-sectional study was conducted in a Brazilian medium-complexity public hospital. Methods: SPL Tests with results >5.0mEq/L and the prescriptions of CPS of all patients hospitalized in the internal medicine and infectious diseases wards were used as trigger tools to detect potential ADE. Primary outcome: patients with hyperkalemia related to ADE. Secondary outcomes: effectiveness of treatments and ADE. Variables analyzed were SPL tests, CPS prescriptions, treatments of hyperkalemia and comorbidities. Positive predictive values (PPV) of CPS and SPL triggers were calculated and compared. Results: In total 2,466 SPL tests were assessed, of which 513 were triggered (>5.0mEq/L). The tests triggered 198 patients with hyperkalemia, of whom 121 had hyperkalemia related to ADE (PPV=0.61). In total, 101 CPS prescriptions triggered tests in 35 patients with hyperkalemia, among whom 21 cases were related to ADE (PPV=0.60). SPL detected 204 ADE (PPV=0.40), while CPS prescription detected 22 (PPV=0.21). Seven pharmacological and four non-pharmacological treatments were identified. CPS showed the lowest effectiveness (PPV=0.71). Conclusion: SPL>5.0mEq/L increased the detection of ADE by 9.3-fold, the number of patients tracked with hyperkalemia related to ADE by 5.8-fold, and doubled the performance in detection of ADE in comparison with the prescription of the CPS trigger.

Possíveis desfechos de longo prazo da Covid-19: uma revisão sistemática de escopo / Possible long-term outcomes of Covid-19: a systematic scoping review

Objetivo: mapear os possíveis desfechos de longo prazo da COVID-19 no mundo. Métodos: em acordo com as recomendações do Joanna Briggs Institute, foi realizada uma revisão sistemática de escopo de estudos experimentais e observacionais com busca nas bases de dados PubMed e Scopus, complementada por busca manual. Resultados: de 5.325 registros, 121 atenderam aos critérios de elegibilidade, os quais incluíram 1.638 recuperados da COVID-19. Foram identificados 52 potenciais desfechos de longo prazo da COVID-19, principalmente disfunção olfatória (n=605), disfunção gustativa (n=372), dispneia (n=233) e lesões pulmonares (n=225). Entre os cuidados de longo prazo, destacam-se início de terapia medicamentosa, terapia de substituição renal e amputação. Conclusão: foram mapeados 52 possíveis desfechos de longo prazo da COVID-19 e recomendações de continuação de cuidados, que variaram de manifestações leves a graves com duração menor ou igual a um mês e maior que um mês.

Objective: to map these possible long-term outcomes of COVID-19 worldwide. Methods: In accordance with the recommendations of the Joanna Briggs Institute, a systematic scoping review of experimental and observational studies was carried out with a search in PubMed and Scopus databases, complemented by manual search. Results: Of 5,325 records, 121 met eligibility criteria, which included 1,638 recovered from COVID-19. Fifty-two (52) potential long-term outcomes of COVID-19 were identified, mainly olfactory dysfunction (n=605), taste dysfunction (n=372), dyspnea (n=233) and lung injuries (n=225). Long-term care included initiation of drug therapy, renal replacement therapy and amputation. Conclusion: Fifty-two (52) possible long-term outcomes of COVID-19 and recommendations for continued care were mapped, ranging from mild to severe manifestations lasting less than or equal to one month and greater than one month.

Risk factors associated with drug therapy among elderly people with Alzheimers disease: a cross-sectional study

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).

Monitoring compliance with Clinical Protocol and Therapeutic Guidelines for Alzheimer's disease / Monitoramento do cumprimento do protocolo clínico e diretrizes terapêuticas da doença de alzheimer

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.

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.

Rational use of chloroquine and hydroxychloroquine in times of COVID-19

Considering the COVID-19 pandemic declared, part of the researchers' efforts has been in studies of repurposing chloroquine (CQ) and hydroxychloroquine (HCQ), cheap medicines that have been used for decades with indication for malaria, rheumatoid arthritis and systemic lupus erythematosus. Chinese and South Korean health officials recommended the use of QC and HCQ for prophylaxis and treatment of COVID-19, encouraging researchers around the world to assess the potential of these medicines as antivirals. To date, results of three clinical trials have been released. Two studies show divergent results for virological clearance, while the third suggests a benefit in terms of radiological and clinical improvement. The three studies have methodological limitations and low overall quality of evidence, in view of the absence of randomization, allocation concealment, blinding patients, health care providers, and outcome assessors, missing data and/or selective reporting of results, as well as probable heterogeneity of patients and treatments, imprecision due to the reduced statistical power of the studies, indirect evidence for patients with severe form of the disease or patients with high severity comorbidities. The irresponsible self-medication of these medicines is of concern both for the potential risk of shortages, as well as for the adverse events and potentially fatal intoxications. Thus, in the USA, Europe and Brazil, regulatory agencies have positioned themselves in an emergency, authorizing the use of CQ and HCQ under medical criteria and/or in the context of clinical trials. In Brazil, to restrict irresponsible self-medication and possible shortages, Anvisa included the drugs in a special control list. Evidence on the efficacy and safety of QC and HCQ remains uncertain, so the results of ongoing studies are needed to adequately guide public policy and clinical practice. Evidence-based health assumptions must be maintained even in times of international emergency due to the risk of having to deal with future complications from the irrational use of these medicines.(AU)

Genetic polymorphisms associated with upper gastrointestinal bleeding: a systematic review protocol

Gastrointestinal bleedings (GIB) are one of the most frequent adverse drug reactions. Among the GIB upper gastrointestinal bleeding (UGIB) stands out due to their high mortality. The different idiosyncratic responses related to UGIB ​​in medication users may be due to the presence of genetic variants in the genes that encode enzymes that are targets of pharmacokinetic and pharmacodynamic activity of the metabolism of the drugs, such as cyclooxygenase 1, endothelial nitric oxide synthase, cytochrome P450, among others. Although a review has focused on assessment whether the presence of CYP2C9*2 and CYP2C9*3 could increase UGIB diagnosis, the search is outdated, and more evidence can be identified regarding both CYP polymorphisms and other genes potentially involved with UGIB. The objective of the systematic review is to explore case-control or case-case studies to assess the epidemiological association between genetic polymorphisms and UGIB. This review will consider genetic polymorphisms of case-control and case-case studies and their association with the UGIB, in the presence or absence of drugs exposure. Electronic searches will be performed in PubMed, Scopus and the Cochrane Library with no time limit. Two researchers will select registries and extract data on study and population characteristics, exposure, covariates, and outcomes. Critical appraisal will consider Joanna Briggs tool for case-control studies. Studies will, where possible, be pooled with statistical meta-analysis. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation, where appropriate.(AU)

Assessment of the adherence to and costs of the prophylaxis protocol for venous thromboembolism

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.

Safety assessment of omeprazole use: a review

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.

Drug administration adjustments for elderly patients with dysphagia: A case report / Ajustes da administração de medicamentos para pacientes idosos com disfagia: um relato de caso

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.

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.

Assessment tool for potentially inappropriate medication use in the elderly: a scoping review protocol

Potentially Inappropriate Medication for the elderly (PIM) are drugs in which the safety risks may exceed the benefits, especially when there are safer alternatives. The use of PIM is associated with increased hospitalizations and it is estimated that one every five prescriptions presents at least one PIM. In this context, there are several assessment tools for identification of PIM. The first assessment tool developed was Beers criteria and since its publication, new tools have been developed. The objective of this scoping review is to explore studies presenting assessment tools of PIM to map characteristics, justifications, and therapeutic equivalents. This review will consider studies that developed or validated an assessment tool of PIM. Electronic searches will be performed in PubMed and Scopus with no time limit. Two researchers, independently, will select registries and extract data of studies and tool characteristics, PIM and potentially inappropriate interaction, condition, justification, and therapeutic equivalents. The findings will be presented in narrative form including tables and figures to aid in data presentation, where appropriate.(AU)

Pharmacist-led interventions in Brazil: a scoping review protocol

Drug-related problems consist an important avoidable risk factor to the hospitalization in the general population. The increase of technologies to promote and recovery health and their use makes the design of services aimed at preventing health and drug problems, as well as their adequate management, a priority for public health. Pharmacist-led interventions are capable to optimize the use of medicines. However, it is important to know the characteristics and assessed outcomes of interventions, since, as a complex intervention, the variability between services can explain different performances. The objective of the scoping review is to explore randomized and non-randomized clinical trial, quasi-experimental and cohort studies to explore characteristics and assessed outcome of pharmacist-led interventions conducted in Brazil. This review will consider studies about pharmacist-led interventions, regardless of patient profile or health setting. Electronic searches will be performed in PubMed, Scopus, and LILACS databases with no time limit of publication. Two researchers, independently, will select registries and extract data of study and service characteristics, and outcomes measures. The findings will be presented in a narrative form including tables and figures to aid in data presentation, where appropriate.(AU)

Incidents reporting: barriers and strategies to promote safety culture / Notificação de incidentes: barreiras e estratégias para promover a cultura de segurança / Notificación de incidentes: barreras y estrategias para promover la cultura de seguridad

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.

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.

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.

Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

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 drug-related 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<0.0001) and their knowledge of pharmacovigilance (p<0.0001). The intervention also contributed to detecting serious drug-induced events. The nursing staff reported medication errors, and pharmacists and physiotherapists recognized serious adverse drug reactions. Physicians communicated suspicions of therapeutic failure. CONCLUSIONS: A multidisciplinary approach to drug-safety assessments contributes to identifying new, relevant drug-related problems and improving the rate of adverse drug event reporting. This strategy may therefore be applied to improve risk communication in hospitals.