Variabilidade de preços de aquisição de medicamentos do grupo 1B do Componente Especializado da Assistência Farmacêutica / Variability in Drug Procurement within Group 1B of the Pharmaceutical Specialized Scheme in Brazil

Resumo No Sistema Único de Saúde os medicamentos do grupo 1 do Componente Especializado da Assistência Farmacêutica (CEAF) são financiados pela União e adquiridos de forma centralizada (grupo 1A) ou por cada Unidade Federativa (UF) (grupo 1B). Diferentemente de outros países onde se negocia um preço fixo a ser praticado no sistema público, no Brasil as aquisições são realizadas por licitação, o que pode levar a diferentes preços. Para permitir a comparação de preços, foi pactuada a obrigatoriedade de registro das aquisições públicas no Banco de Preços em Saúde (BPS). O estudo teve como objetivo analisar a variabilidade dos preços de medicamentos do grupo 1B adquiridos pelas UF do Brasil em 2021. Foram obtidas as aquisições de medicamentos do grupo 1B realizadas pelas Secretarias de Estado das 27 UF por consulta ao BPS excluindo-se os medicamentos sem preço de ressarcimento estabelecido em dezembro/2021. Foi obtido do Sistema de Informações Ambulatoriais o ressarcimento para cada UF. Verificou-se grande variabilidade dos preços de aquisição para cada medicamento entre as UF e dentro da mesma UF. O estudo demonstrou potencial iniquidade de acesso ao CEAF, privilegiando com menores preços UF mais favorecidas (maior população e riqueza).

Abstract In the Brazilian Health System (SUS), drugs covered by the Specialized Pharmaceutical Scheme (CEAF) receive federal funding and can be procured either centrally (Group 1A) or by individual states (Federal Units - UF) (Group 1B). Unlike other countries where national procurement prices are negotiated centrally by the government, public procurement in Brazil follows a public auction procedure, potentially resulting in varying purchase prices. To facilitate price comparisons, it is a legal requirement to register public acquisitions in the Health Prices Registry (BPS). This study aimed to assess the variability in the procurement prices for Group 1B drugs across the 27 Brazilian states during 2021. Data on the acquisitions of Group 1B drugs by the 27 Health Secretariats were obtained from the BPS. Drugs with no reported reimbursement prices as of December 2021 were excluded from the analysis. The total reimbursement amount for each state was sourced from the SUS Ambulatory Information System. The findings revealed significant variability in drug procurement prices both across and within states. The study underscored a potential disparity in CEAF access, favoring wealthier states (those with larger populations and higher economic status) by securing lower drug prices.

Empirical antimicrobial therapy based on active surveillance cultures in ICU patients

Objetivo: Avaliar o valor preditivo da colonização prévia por Acinetobacter baumannii (CRAB) e Pseudomonas aeruginosa (CRPA) resistente a carbapenêmicos estabelecida em culturas de vigilância para infecção subsequente por esses patógenos em pacientes internados em UTI. Métodos: Foi realizado um estudo de coorte com pacientes internados na unidade de terapia intensiva por pelo menos 48 h. Foram medidos os valores preditivos negativos e positivos, sensibilidade e especificidade das culturas de vigilância em CRAB e CRPA. Resultados: Foram incluídos 693 pacientes infectados. Pacientes previamente colonizados por CRAB e CRPA tiveram maior probabilidade de serem infectados por esses patógenos: OR ajustado: 10,34 (6,58 - 16,45; p < 0,001) e 2,30 (3,88 - 10,26; p < 0,001), respectivamente. Encontramos altos valores preditivos negativos de culturas de vigilância para CRAB (87,18%) e CRPA (88,30%) e alta especificidade 91,96% e 90,13%, respectivamente. Conclusões: Pacientes não colonizados por CRAB e CRPA mostraram-se menos propensos à infecção por esses patógenos. Esses achados podem contribuir para a escolha da terapia antimicrobiana empírica e desencorajar a prescrição de antibióticos contra esses patógenos em pacientes sem colonização prévia.

Objective: To assess the predictive value of prior carbapenem-resistant Acinetobacter baumannii (CRAB) and Pseudomonas aeruginosa (CRPA) colonization established in surveillance cultures for subsequent infection by these pathogens in ICU patients. Methods: A cohort study was performed with patients admitted to the intensive care unit for at least 48 h. Negative and positive predictive values, sensitivity, and specificity of surveillance cultures in CRAB and CRPA were measured. Results: 693 infected patients were included. Patients previously colonized by CRAB and CRPA were more likely to be infected by these pathogens: adjusted OR: 10.34 (6.58 - 16.45; p < 0.001) and 2.30 (3.88 - 10.26; p < 0.001), respectively. We found high negative predictive values of surveillance cultures for CRAB (87.18%) and CRPA (88.30%) and high specificity 91.96% and 90.13%, respectively. Conclusions: Patients not colonized by CRAB and CRPA were less prone to infection by these pathogens. These findings may contribute to the choice of empirical antimicrobial therapy and discourage the prescription of antibiotics against these pathogens in patients without previous colonization.

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.

Pharmacovigilance: an evaluation on the practice of pharmacists acting in pharmacies and drugstores

Abstract Pharmacists acting in pharmacies and drugstores stores are some of the most accessible healthcare providers and the last to intervene before the patient takes their medicine. This puts the pharmacist in a position of authority that should be harnessed for the benefit of health. Thus, this professional is strategic for performing pharmacovigilance. Our objective of this study was to interrogate the practice of pharmacists in relation to pharmacovigilance activities, and to identify difficulties and possible stimuli for the improvement these activities in pharmacies and drugstores. The information was collected through an online questionnaire via Survey Monkey®. The data were analyzed statistically using SPSS software. Responses were received from 5174 pharmacists: mostly young women within five years of graduation and experience in pharmaceutical retail. 81% of them reported having identified suspected substandard medicines, but only 16% used the Brazilian notification system Notivisa. More than 85% of pharmacists agreed with the importance of pharmacovigilance and the recognition of reporting services as part of pharmacist duties and pharmaceutical care. The main barriers to making notifications were the lack of access and knowledge about Notivisa. Pharmacists agreed that simplifying the system would be a stimulus for notifications, and requested more feedback from notifications, as well as material and courses to understand the notification process. Pharmacists have important data to feed into pharmacovigilance systems, recognize their responsibilities and are willing to contribute, but still demonstrate low compliance. Simplification of the system and training on it are likely to increase notifications.

Mapping community pharmacy services in Brazil: a scoping review

Abstract The delivery of clinical pharmacy services has been growing in Brazilian community pharmacies, and it is necessary to have a comprehensive understanding of the topic. This scoping review aimed to provide an overview of Brazilian studies about clinical pharmacy services in community pharmacies. Original research articles, with no restriction of time, study design, or patient's health condition, were included. Searches were conducted in PubMed, Scopus, Web of Science, Scielo, and Lilacs. Two reviewers conducted the screening, full-text reading, and data extraction independently. ROB and ROBINS-I were used for the assessment of quality. Charts and tables were built to summarise the data. Seventy-two articles were included. A diversity of study designs, number of participants, terms used, and outcomes was found. São Paulo and Sergipe States had the highest number of studies (n=10). Pharmacists' interventions were not fully reported in 65% of studies, and most studies presented an unclear risk of bias. Studies were very diverse, impairing the comparisons between the results and hindering their reproducibility. This review suggests using guidelines and checklists for better structuration of pharmacists' interventions as well as reporting results and measuring fidelity in future research.

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.

Prevalence of rheumatoid arthritis in South America: a systematic review and meta-analysis / Prevalência da artrite reumatoide na América do Sul: revisão sistemática e meta-análise

Abstract Rheumatoid arthritis (RA) is among the most prevalent chronic autoimmune and inflammatory diseases worldwide. The aim of this study was to establish a pooled estimate of the RA prevalence in South America by means of a meta-analysis of the available epidemiologic studies. Systematic searches in PubMed, Lilacs, SciELO, Scopus, and Web of Science databases (updated May 2019) were done followed by a systematic grey literature search to identify original research articles and reports, published after 2000, providing data of RA prevalence in any South American country. Proportion meta-analysis of weighted pooled was performed, with between-trial heterogeneity assessed by the inconsistency relative index. Sensitivity analyses and sub-group analyses were also done. A total of 25 articles, representing 27 population-based studies were included. Pooled prevalence of RA resulted in 0.48% with 591,981 cases in a population of 114,537,812 individuals (I2=99%). Brazil and Colombia presented the lowest rates of RA prevalence 0.22%, and 0.24%, respectively. RA prevalence in indigenous population was higher 1.45%, and studies using COPCORD method reported also the highest rates 1.07%.

Resumo A artrite reumatóide (AR) está entre as doenças autoimunes e inflamatórias crônicas mais prevalentes no mundo. O objetivo deste estudo foi estabelecer uma estimativa conjunta da prevalência da AR na América do Sul por meio de uma meta-análise dos estudos epidemiológicos disponíveis. Buscas sistemáticas nas bases de dados PubMed, Lilacs, SciELO, Scopus e Web of Science (atualizado em maio de 2019) foram seguidas por uma busca sistemática na literatura cinzenta para identificar artigos e relatórios de pesquisa originais, publicados após 2000, fornecendo dados de prevalência de AR em qualquer país da América do Sul. Foi realizada uma meta-análise da proporção de dados agrupados ponderados, com heterogeneidade entre experimentos avaliada pelo índice relativo de inconsistência. Análises de sensibilidade e de subgrupos também foram realizadas. Foram incluídos um total de 25 artigos, representando 27 estudos de base populacional. A prevalência agrupada de AR resultou em 0,48% com 591.981 casos em uma população de 114.537.812 indivíduos (I2=99%). Brasil e Colômbia apresentaram as menores taxas de prevalência de AR 0,22% e 0,24%, respectivamente. A prevalência da AR na população indígena foi maior 1,45%, e estudos pelo método COPCORD relataram também as maiores taxas 1,07%.

Iodine deficiency in women of childbearing age in Brazil: systematic review and meta-analysis / Deficiencia de yodo en mujeres en edad fabricante en Brasil: revisión sistemática y metanálisis

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

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

Reports of substandard medicines: a lexicographic analysis of the Brazilian Health Surveillance Report System

Regulatory agencies are responsible for collecting and evaluating spontaneous reports of suspected problems related to medications, including those from substandard medicines (SM). Objectives: The aim was to evaluate the profile of SM reports submitted to the Brazilian Health Surveillance Notification System (Notivisa) and classify these reports objectively by means of lexicographic analysis. Methods: Was extracted all SM reports available in Notivisa during the period 1 January 2007 to 31 December 2017. Descriptive statistics were performed and the reasons for SM reporting were standardized (using OpenRefine and Microsoft Excel). The following analyses were performed using IRAMuTeQ 0.7 alpha2: lexicographic analysis to obtain the frequency of active words; descending hierarchical classification (DHC) to categorize the active words into lexical classes; factorial correspondence analysis (FCA) to obtain graphs of the classes. Approved by the Ethics Committee of the Hospital do Trabalhador/SES/PR CAAE 81873417.3.0000.5225 (protocol number: 2.506.594). Results: A total of 61,775 reports were analyzed, most of them reported by hospitals (46%). The DHC of the reasons for SM produced four classes visualized in the FCA: (i) packaging problems (16%) mainly leakages/opening issues; (ii) inadequate drug identification (22%), such as illegible label information; (iii) stability and contamination issues (11%) such as presence of particles; (iv) damaged tablets/blisters (23%) mainly broken tablets. Most SM (52%) were solutions for parenteral use; sodium chloride (9%), glucose and dipyrone (3%) were the products with most complaints. Conclusions: The reasons for SM reporting can be objectively classified into classes that represent the main problems submitted to Notivisa. This classification could guide the standardization of SM reporting and contribute to improving surveillance reporting systems worldwide.

Factor XIII-guided treatment algorithm reduces blood transfusion in burn surgery / Algoritmo de tratamento guiado pelo fator XIII reduz a transfusão sanguínea na cirurgia de queimados

Abstract Background and objectives: Major burn surgery causes large hemorrhage and coagulation dysfunction. Treatment algorithms guided by ROTEM® and factor VIIa reduce the need for blood products, but there is no evidence regarding factor XIII. Factor XIII deficiency changes clot stability and decreases wound healing. This study evaluates the efficacy and safety of factor XIII correction and its repercussion on transfusion requirements in burn surgery. Methods: Randomized retrospective study with 40 patients undergoing surgery at the Burn Unit, allocated into Group A those with factor XIII assessment (n = 20), and Group B, those without assessment (n = 20). Erythrocyte transfusion was guided by a hemoglobin trigger of 10 g.dL-1 and the other blood products by routine coagulation and ROTEM® tests. Analysis of blood product consumption included units of erythrocytes, fresh frozen plasma, platelets, and fibrinogen. The coagulation biomarker analysis compared the pre- and post-operative values. Results and conclusions: Group A (with factor XIII study) and Group B had identical total body surface area burned. All patients in Group A had a preoperative factor XIII deficiency, whose correction significantly reduced units of erythrocyte concentrate transfusion (1.95 vs. 4.05, p = 0.001). Pre- and post-operative coagulation biomarkers were similar between groups, revealing that routine coagulation tests did not identify factor XIII deficiency. There were no recorded thromboembolic events. Correction of factor XIII deficiency in burn surgery proved to be safe and effective for reducing perioperative transfusion of erythrocyte units.

Resumo Justificativa e objetivos: A cirurgia no grande queimado causa hemorragia de grande porte e disfunção da coagulação. Os algoritmos de tratamento guiados por ROTEM® e fator VIIa reduzem as necessidades de hemoderivados, mas falta evidência em relação ao fator XIII. A deficiência do fator XIII altera a estabilidade do coágulo e diminui a cicatrização. Este estudo avalia a eficácia e a segurança da correção do fator XIII e sua repercussão nas necessidades transfusionais na cirurgia do queimado. Métodos: Estudo retrospectivo randomizado de 40 doentes submetidos à cirurgia na Unidade de Queimados alocados em grupo A com estudo do fator XIII (n = 20) e grupo B sem estudo (n = 20). A transfusão eritrocitária foi guiada por gatilho de hemoglobina de 10 g.dL-1 e os outros hemoderivados por testes de coagulação de rotina e ROTEM®. A análise do consumo de hemoderivados incluiu unidades de eritrócitos, plasma fresco congelado, plaquetas e fibrinogênio. A análise dos biomarcadores da coagulação comparou os valores pré e pós-operatórios. Resultados e conclusões: O grupo A (com estudo de fator XIII) e o grupo B apresentaram área de superfície corporal total queimada idêntica. Todos os doentes do grupo A revelaram déficit pré-operatório de fator XIII, cuja correção reduziu significativamente a transfusão de unidades de concentrado eritrocitário (1,95 vs. 4,05, p = 0,001). Os biomarcadores de coagulação pré e pós-operatórios foram semelhantes entre os grupos, revelaram que os testes de coagulação de rotina não identificam o déficit de fator XIII. Sem eventos tromboembólicos registrados. A correção do fator XIII na cirurgia do queimado revelou-se segura e eficaz na redução da transfusão perioperatória de unidades de eritrócitos.

Quality of evidence of anti-obesity pharmacotherapy: an overview of systematic reviews

The safety and effectiveness of main anti-obesity drugs are controversial, and there is no consensus among regulatory agencies regarding anti-obesity drugs. We undertook an overview of systematic reviews (SR) of randomized controlled trials (RCT) to summarize the quality of evidence related to anti-obesity drugs. Data sources included Medline, Scopus, The Cochrane Library and PROSPERO. Twenty-one SR (564 RCT; average of 2,356 participants per review) satisfied the inclusion criteria. Ten SR presented a high level of heterogeneity, and only five SR included sensitivity analyses. The most important limitations reported by the SR were a high level of attrition, a small sample size, and a short follow-up. Eight different outcomes for efficacy were used, 15 different outcomes for biomarkers were used, and nine different outcomes for safety were used. Conclusions: In conclusion, the quality of SR pertaining to anti-obesity drugs is low, and these reviews have a high level of heterogeneity. Future SR should present more detailed population inclusion criteria, larger sample sizes, and focus variables reported in a predefined anti-obesity core outcome set.(AU)

Impact of discharge medication counseling in the cardiology unit of a tertiary hospital in Brazil: A randomized controlled trial

OBJECTIVES: This study aimed to evaluate the impact of pharmacist-provided discharge counseling on mortality rate, hospital readmissions, emergency department visits, and medication adherence at 30 days post discharge. METHODS: This randomized controlled trial was approved by the local ethics committee and included patients aged 18 years or older admitted to the cardiology ward of a Brazilian tertiary hospital. The intervention group received a pharmacist-led medication counseling session at discharge and a telephone follow-up three and 15 days after discharge. The outcomes included the number of deaths, hospital readmissions, emergency department visits, and medication adherence. All outcomes were evaluated during a pharmacist-led ambulatory consultation performed 30 days after discharge. RESULTS: Of 133 patients, 104 were included in the analysis (51 and 53 in the intervention and control groups, respectively). The intervention group had a lower overall readmission rate, number of emergency department visits, and mortality rate, but the differences were not statistically significant (p>0.05). However, the intervention group had a significantly lower readmission rate related to heart disease (0% vs. 11.3%, p=0.027), despite the small sample size. Furthermore, medication counseling contributed significantly to improved medication adherence according to three different tools (p<0.05). CONCLUSIONS: Pharmacist-provided discharge medication counseling resulted in better medication adherence scores and a lower incidence of cardiovascular-associated hospital readmissions, thus representing a useful service for cardiology patients.

Systematic review and meta-analysis of the efficacy and safety of amfepramone and mazindol as a monotherapy for the treatment of obese or overweight patients

The aim of this study was to evaluate efficacy and safety of amfepramone, fenproporex and mazindol as a monotherapy for the treatment of obese or overweight patients. A systematic review of primary studies was conducted, followed by a direct meta-analysis (random effect) and mixed treatment comparison. Medline and other databases were searched. Heterogeneity was explored through I2 associated with a p-value. Of 739 identified publications, 25 were included in the meta-analysis. The global evaluation of Cochrane resulted in 19 studies with a high level of bias and six with unclear risk. Due to the lack of information in primary studies, direct meta-analyses were conducted only for amfepramone and mazindol. Compared to placebo, amfepramone resulted in higher weight loss in the short-term (<180 days; mean difference (MD) -1.281 kg; p<0.05; I2: 0.0%; p=0.379) and long-term (≥180 days; MD -6.518 kg; p<0.05; I2: 0.0%; p=0.719). Only studies with long-term follow up reported efficacy in terms of abdominal circumference and 5-10% weight reduction. These results corroborated the finding that the efficacy of amfepramone is greater than that of placebo. Treatment with mazindol showed greater short-term weight loss than that with placebo (MD -1.721 kg; p<0.05; I2: 0.9%; p=0.388). However, metabolic outcomes were poorly described, preventing a meta-analysis. A mixed treatment comparison corroborated the direct meta-analysis. Considering the high level of risk of bias and the absence of important published outcomes for anti-obesity therapy assessments, this study found that the evaluated drugs showed poor evidence of efficacy in the treatment of overweight and obese patients. Robust safety data were not identified to suggest changes in their regulatory status.

Cross-cultural adaptation of Hypertension Knowledge Test into European Portuguese

ABSTRACT We aim to validate a European-Portuguese version of the Hypertension Knowledge Test (HKT) questionnaire and examine its factorial structure with a confirmatory factor analysis (CFA). A process of translation and back-translation was performed. A cross-sectional study was developed in which all adult patients taking at least one antihypertensive drug were invited to participate. Data on personal and family history were collected, and the HKT, Strelec, and the Batalla questionnaires were administered. We enrolled 304 patients with a mean age of 68.12±10.83 years. The mean score of HKT was 15.33±2.79. CFA indicated that the construct being tested was unidimensional, and Cronbach's alpha (α=0.65) showed that the instrument had an acceptable internal consistency. When evaluating concurrent validity, HKT was significantly correlated with the Batalla and Strelec scores. Thus, the Portuguese version of HKT (HKT-pt-PT) can be used either in research or in clinical practice. With this version, a potential standard exists to evaluate knowledge about hypertension, which could avoid the practice of using non-validated questionnaires in Portugal and allow the cross-sectional and longitudinal comparability of studies.

Morbidade e mortalidade relacionadas a medicamentos no Brasil: revisão sistemática de estudos observacionais / Drug-related morbidity and mortality in Brazil: a systematic review of observational studies

Este estudo avaliou a morbimortalidade relacionada a medicamentos no Brasil, sua prevalência, grupos farmacológicos e fatores de risco, Foi realizada uma revisão sistemática de estudos observacionais publicados até agosto de 2012, sem restrição de data de início, nas bases de dados Medline, Lilacs, Scielo, Embase, IPA, Science Direct, Scopus e Web of Science, Foram selecionados estudos nacionais avaliando a ocorrência de qualquer tipo de dano ocasionado por medicamento, Foram incluídos 45 estudos, A maior prevalência de evento adverso a medicamento foi observada em hospitais, em adultos e idosos, variando de 15,6% a 34,1%, Nas creches, 19,9% das crianças sofreram alguma reação adversa, Em serviços de emergência, 25% dos adultos ou idosos sofreram dano relacionado à falha terapêutica, Medicamentos atuantes no sistema nervoso central foi o principal grupo farmacológico envolvido, Os principais fatores de risco foram idade, presença de comorbidades e uso de > 5 medicamentos, Os resultados encontrados são alarmantes e demonstram a necessidade da avaliação e estratificação de risco populacional, ações preventivas e de intervenção precoce que possam reduzir o impacto da morbimortalidade relacionada a medicamentos no Brasil...

This study evaluated the drug-related morbidity and mortality in Brazil, its prevalence, the pharmacological groups and risk factors associated. We performed a systematic review of observational studies published up to August 2012, without restriction start date, in the databases Medline, Lilacs, SciELO, EMBASE, IPA, Science Direct, Scopus and Web of Science. Were selected national studies evaluating the occurrence of any damage caused by medications. We included 45 studies. The highest prevalence of adverse drug events was observed in hospitals for adults and elderly, ranging from 15.6% to 34.1%. In nurseries, 19.9% of the children suffered some adverse drug reaction. In emergency departments, 25% of adults and elderly suffered harm related to therapeutic failure. Medications acting on the central nervous system were the main pharmacological group involved. The main risk factors were age, comorbidities and use of more than 5 medications. The results are alarming and demonstrate the need for screening and medication risk stratification in the population, and preventive or early interventions that can reduce the impact of drug-related morbidity and mortality in Brazil...

Smoking cessation in a community pharmacy: preliminary results of a pharmaceutical care programme / Cesación tabáquica en farmacia comunitaria: resultados preliminares de un programa de atención farmacéutica

Background: According to the World Health Organisation, tobacco use is one of the most widespread public health threats in the world, making it particularly urgent to promote smoking cessation. The effectiveness of pharmacist interventions in smoking cessation has been documented in the international literature, but not sufficiently in Portugal. Objective: To report the preliminary results of study to assess the effectiveness of a smoking cessation programme delivered in Portuguese community pharmacies using an outsorcing-based regimen. Methods: Within the scope of a pharmaceutical care programme implemented in seven community pharmacies by an outsourced pharmacist, a specific consultation for smoking cessation was developed, in accordance with Portugal's General Directorate of Health's recommendations and instruments. The smokers were identified and invited to join the programme by the pharmacy staff during their daily activities. Patients that accepted signed an informed consent. Through several face-to-face and phone consultations and based on a comprehensive patient approach, personalised plans to quit tobacco were defined with the patients' agreement. The effectiveness of the service was assessed through the evaluation of quit rates at 1, 6 and 12 months. The continuous variables were expressed as mean ± standard error of the mean. Results: During approximately 5 years (between January 2009 and July 2014), 69 smokers joined the programme. Of these, 17 desisted during the first consultation. Of the remaining 52 patients, the mean age was 47.4 ± 2.11 years old and 55.8% were male. A total of 264 pharmaceutical consultations were delivered and, on average, each patient received 7.7 ± 0.81 interventions. Most interventions (60.1%) were pharmacological (e.g. nicotine replacement products), while non-pharmacological measures (e.g. motivational interviewing) represented 39.9%. Five patients were referred to a physician. At 1 month after the quit date, 37 patients were abstinent (53.6%); 6 months later the number reduced to 24 (34.8%) and, 1 year later, 16 patients remained abstinent (23.2%). Conclusions: The implementation of a smoking cessation programme in community pharmacies using an external pharmacist may contribute effectively to tobacco cessation in Portugal.

Antecedentes: Según la Organización Mundial de la Salud, el tabaco es una de las mayores amenazas del mundo, siendo urgente promover el abandono tabáquico. La efectividad de las intervenciones farmacéuticas en cesación tabáquica ha sido documentada en la literatura, pero no en Portugal. Objetivo: Comunicar los resultados preliminares de un estudio para evaluar la efectividad de un programa de cesación tabáquica desarrollado en farmacias comunitarias portuguesas usando un régimen de out-sourcing. Métodos: En el ámbito de un programa de atención farmacéutica implantado en siete farmacias por un farmacéutico externalizado, se desarrolló una consulta de cesación tabáquica siguiendo las recomendaciones e instrumentos de la Dirección General de Salud de Portugal. Se identificó a los fumadores y el personal de la farmacia durante sus actividades rutinarias les invitó a unirse al programa. Los que aceptaban firmaban un consentimiento informado. Mediante consultas presenciales y telefónicas y a través de un abordaje global del paciente, se definieron en acuerdo con el paciente planes personalizados de abandono del tabaquismo. La efectividad del servicio se midió mediante las tasas de cesación a 1, 6 y 12 meses. Las variables continuas se expresaron como media ± error estándar de la media. Resultados: Durante aproximadamente 5 años (entre enero 2009 y julio 2014), 69 fumadores se unieron al programa. De estos, 17 desistieron durante la primera consulta. Entre los restantes 52 pacientes, tenían 47.4 ± 2.11 años y el 55,8% eran hombres. Se realizaron 264 consultas farmacéuticas y, en media cada paciente recibió 7.7 ± 0.81 intervenciones. La mayoría de las intervenciones (60,1%) eran farmacológicas (p.e. productos de substitución de nicotina), y el restante 39,9% fueron medidas no farmacológicas (p.e. entrevista motivacional). Cinco pacientes fueron remitidos al médico. Después de 1 mes de la fecha convenida para el inicio de la cesación, 37 pacientes (53,6%) estaban en abstinencia; 6 meses más tarde el número se reducía a 24 (34,8%) y un año más tarde 16 pacientes (23,2%) permanecían abstinentes. Conclusión: La implantación de un programa de casación tabáquica en farmacias comunitarias, utilizando un farmacéutico externo, puede contribuir efectivamente a la cesación tabáquica en Portugal.

Cross-cultural adaptation of the Beliefs about Medicines Questionnaire into Portuguese / Adaptação transcultural do Beliefs about Medicines Questionnaire para o Português

CONTEXT AND OBJECTIVES The Beliefs about Medicines Questionnaire (BMQ-Specific) has proven useful for measuring patients' beliefs and associating them with non-adherence to treatment in several illness groups. The aim was to cross-culturally adapt the BMQ-Specific into Portuguese for the general population of medicine users. DESIGN AND SETTING Cross-sectional study conducted among users of public hospitals and outpatient clinics in Guarda and Covilhã, Portugal. METHODS The BMQ-Specific was translated using international recommendations for performing cross-cultural adaptation and was administered to 300 patients. An initial principal component analysis (PCA) was conducted with the extraction criterion of eigenvalue > 1.0, followed by a second PCA with restriction to two components. Reliability was assessed by calculating Cronbach's alpha coefficient. RESULTS The mean scores obtained for the Necessity and Concerns subscales of the Portuguese BMQ-Specific were 19.9 (standard deviation, SD = 2.8) (range 10 to 25) and 17.7 (SD = 3.9) (range 6 to 30), respectively. The first PCA produced an unstable three-component structure for the Portuguese BMQ-Specific. The final PCA solution yielded a two-component structure identical to the original English version (a five-item Necessity and a six-item Concerns subscale), and explained 44% of the variance. Cronbach's alpha for the complete Portuguese BMQ-Specific was 0.70, and 0.76 and 0.67 for the Necessity and Concerns subscales, respectively. CONCLUSION A cross-culturally adapted Portuguese version of the BMQ-Specific questionnaire for use among the general population of medicine users was obtained, presenting good internal consistency and component structure identical to the original English version. .

CONTEXTO E OBJETIVO O Beliefs about Medicines Questionnaire (BMQ-Específico) tem se mostrado útil na mensuração sobre as crenças dos pacientes e associando-os à não adesão ao tratamento em vários grupos de doença. O objetivo foi realizar a adaptação transcultural do BMQ-Específico em Português para a população geral de usuários de medicamentos. TIPO DE ESTUDO E LOCAL Estudo transversal conduzido com usuários de hospitais públicos e clínicas ambulatoriais em Guarda e Covilhã, Portugal. MÉTODOS O BMQ-Específico foi traduzido utilizando-se recomendações internacionais para realizar a adaptação transcultural e foi administrado a 300 pacientes. Uma primeira análise de componentes principais (ACP) com critério de extração eigenvalue > 1.0 foi realizada, seguida de uma segunda ACP com restrição para dois componentes. A confiabilidade foi avaliada calculando-se o coeficiente alfa de Cronbach. RESULTADOS Os escores médios obtidos para as subescalas de Necessidade e Preocupação do BMQ-específico em Português foram de 19,9 (desvio padrão, DP = 2,8; intervalo 10 a 25) e 17,7 (DP = 3,9; intervalo 6 a 30), respectivamente. A primeira ACP produziu estrutura instável de três componentes para o BMQ-específico em português. A solução final de ACP produziu estrutura de dois componentes idênticos à versão original em inglês (subescala de Necessidade de 5 itens e subescala de Preocupação de 6 itens), explicando 44% da variância. Alfa de Cronbach para o BMQ-Específico em Português completo foi de 0,70, sendo 0,76 e 0,67 para as subescalas de Necessidade e Preocupação, respectivamente. CONCLUSÃO ...

Avaliação econômica do seguimento farmacoterapêutico em pacientes com diabetes melito tipo 2 em farmácias comunitárias / Economic evaluation of pharmacotherapeutic follow-up in type 2 diabetic mellitus patients in community pharmacies

OBJETIVO: Avaliar os resultados econômicos do seguimento farmacoterapêutico (SFT) em pacientes com diabetes melito tipo 2 em farmácias comunitárias privadas do sistema suplementar de Saúde. MÉTODOS: Foi realizado estudo clínico prospectivo com 161 pacientes separados em dois grupos, dos quais somente um recebeu SFT durante 12 meses. A partir dos resultados, foram calculados os dados de efetividade e os custos. O desfecho primário foi a avaliação econômica do SFT por meio da utilização de um indicador de efetividade (variação de hemoglobina glicada), relacionada aos custos do atendimento farmacêutico. Os desfechos secundários foram os valores de pressão arterial, circunferência abdominal e índice de massa corporal dos pacientes, que foram utilizados e relacionados a custos do atendimento do farmacêutico. RESULTADOS: Foi observada uma redução adicional de 1,3 por cento da HbA1 no grupo que recebeu SFT em comparação ao grupo controle. Os custos anuais por paciente do grupo SFT relacionados à redução de 1 por cento nos valores da HbA1 foram de R$ 78,83. Para melhoria no controle dos pacientes diabéticos tipo 2, esse recurso pode ser implementado com o investimento anual médio de R$ 456,05 por paciente, utilizando SFT e monitorização com testes de glicemia. CONCLUSÕES: É possível obter redução da HbA1 para níveis desejados por meio da utilização do SFT. Este pode ser considerado um recurso adicional para o alcance do controle metabólico, resultando, nesse estudo, em um custo de R$ 76,00 paciente/ano, para redução de 1 por cento nos valores da HbA1.

OBJECTIVE: Assess economics results of Pharmacotherapeutic Follow-up (PF) in patients with diabetes mellitus type 2 in community pharmacies from additional Health system. METHODS: In a prospective clinic study, 161 patients were divided into two groups, of which only one group received PF for 12 months. From the results, we calculated data of effectiveness and costs. The primary endpoint was the economic evaluation PF by using an indicator of effectiveness (changes in glycated hemoglobin), which was related to the costs of pharmaceutical care. Secondary endpoints were values of blood pressure, waist circumference and body mass index of patients, also related to costs of pharmaceutical care. RESULTS: A real reduction of 1.3 percent of HbA1 was observed in the PF group, in comparison to control group. The annual cost of the reduction in 1 percent in HbA1 values in the PF group patients was $45.15. This feature to improve the control of type 2 diabetic patients can be implemented with annual investments of about $225.76 per patient, using PF and monitoring of blood glucose test. CONCLUSIONS: It is possible to reduce the HbA1 values to desired levels by using PF. This can be considered an additional resource for the attainment of metabolic control, resulting in this study a cost of $37.62 per patient, per year, to reduce 1 percent in the HbA1 values.

Satisfação dos usuários com serviços da farmácia: tradução e validação do Pharmacy Services Questionnaire para o Brasil / Patient satisfaction with pharmacy services: translation and validation of the Pharmacy Services Questionnaire for Brazil

Este estudo teve por objetivo traduzir e validar para o português o Pharmacy Services Questionnaire (PSQ). O instrumento possui 20 questões que medem a satisfação dos usuários com serviços da farmácia, organizadas em dois domínios. Utiliza uma escala de respostas Likert de 1 (ruim) a 5 (excelente). O Questionário de Satisfação com os Serviços da Farmácia (QSSF) foi aplicado a 137 diabéticos entre 31 e 89 anos (60,6 por cento mulheres), clientes de farmácias privadas, em sua maioria usuários de serviços públicos de saúde (65,7 por cento), com baixa escolaridade (67,9 por cento até ensino fundamental) e utilizando em média 4,3 medicamentos por pessoa. O escore geral na população estudada foi de 3,6 [DP = 1,1 (IC95 por cento: 3,4-3,8)]. Após análise fatorial, os domínios "exposição agradável" e "manejo da terapia" incluíram 8 e 12 itens, respectivamente, e se correlacionaram significativamente entre si (r = 0,92; p < 0,001) e com o escore geral. O instrumento obteve um a de Cronbach de 0,98 para o escore geral. Os domínios exposição agradável e manejo da terapia mostraram um a de 0,941 e 0,980. O QSSF apresenta aspectos de confiabilidade e validade adequados para sua utilização.

The aim of this study was to translate into Portuguese and validate the Pharmacy Services Questionnaire (PSQ). The instrument includes 20 questions that measure user satisfaction with pharmacy services, and is organized according to two factors. It uses a Likert scale of answers from 1 (poor) to 5 (excellent). The PSQ-Brazil was applied to 137 diabetics from 31 to 89 years of age (60.6 percent women), clients of private pharmacies, mostly users of public health services (65.7 percent), with low education (67.9 percent elementary schooling or less), and who used an average of 4.3 medicines per person. Overall score in the sample was 3.6 (SD = 1.1 [95 percentCI 3.4-3.8]). After factor analysis, "pleasant exposure" and "treatment management" included 8 and 12 items, respectively, and were significantly correlated with each other (r = 0.92, p < 0.001) and with the overall score. The instrument obtained a Cronbach's alpha of 0.98 for the overall score. The pleasant exposure and treatment management variables showed alphas of 0.94 and 0.98. PSQ-Brazil shows adequate reliability and validity for use in the country.

Tradução para o português e validação do instrumento Diabetes Quality of Life Measure (DQOL-Brasil) / Translation to portuguese and validation of the Diabetes Quality Of Life Measure (DQOL-Brazil)

OBJETIVO: Avaliar as propriedades psicométricas da versão brasileira do questionário de medida da qualidade de vida em diabetes (DQOL). MÉTODOS: O DQOL foi traduzido ao português segundo protocolo e aplicado em 121 indivíduos (56,2 por cento mulheres), com tempo diagnóstico médio de diabetes melito tipo 2 de 8,1 ± 7,13 anos e na faixa etária de 32 a 89 anos. RESULTADOS: O instrumento apresentou consistência interna total (alfa de Cronbach = 0,92). Todas as questões apresentaram correlação positiva (p < 0,01) com seus domínios e com o escore geral do questionário, exceto as questões 18 e 35, que requereram exclusão da versão traduzida. O instrumento foi capaz de diferenciar pacientes com HbA1c acima e abaixo de 9 por cento (p = 0,01). CONCLUSÃO: O DQOL-Brasil apresenta aspectos de confiabilidade e validade adequados para sua utilização em pacientes adultos com diabetes tipo 2.

OBJECTIVE: To evaluate the psychometric properties of Brazilian version of Diabetes Quality of Life measure (DQoL-Brazil). METHODS: The DQOL was translate to Portuguese, following a recommended protocol, and applied to 121 subjects (56.2 percent females) with average diagnostic to type 2 diabetes of 8.1 (SD=7.13) years, (range 32-89 years old). RESULTS: The translated measure showed high internal consistency (Cronbach’s alpha = 0.92). A positive correlation (p < 0.01) was found between all the items and their scales and the total score of instrument, except in the items 18 and 35. These items were excluded from the translated version of DQoL. In concurrent validity analysis, patients with HbA1C higher than 9 percent presented a significantly higher (p = 0.01) total score for DQoL. CONCLUSION: DQoL-Brazil presents reliability and validity to be used in type 2 diabetes adult patients.