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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.

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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)

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Medication errors extend inpatient stay, increase costs and double the risk of death. Identify patients more likely to present prescription errors would be one manner that could be used to decrease the impact of such events. Thus, the present study identified the prevalence of prescription errors with patients with oncohematologic diseases and the factors associated with these events. Methods: A cross-sectional study was performed in a Brazilian tertiary hospital. Data regarding service, patients and their clinical condition, drug therapy and prescription errors were retrieved and analyzed. Results: Of 344 drug prescriptions identified, 26.2% showed at least one prescription error, mainly involving a wrong drug (48.3%). According to the logistic regression, the factors associated with errors include: presence of neutropenia OR 1.92 (95% CI 1.10­3.35), physicians on holiday or weekend shifts OR 0.40 (95% CI 0.18­0.86) and prescriptions with higher proportion of parenteral administration route OR 1.05 (95% CI 1.03­1.08). Conclusion: In conclusion, identify the factors associated with errors can be useful in developing clinical tools for predicting patients at higher risk for the occurrence of prescribing errors, as well as to contribute to the optimization of health professionals' clinical performance.(AU)

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BACKGROUND AND PURPOSE: The aim of this study was to analyze the implementation of an active methodology in a blended model of education in the teaching-learning processes of students enrolled in two disciplines: Pharmaceutical Care I and Pharmaceutical Care II, both part of the undergraduate Bachelor of Pharmacy program at the Federal University of Paraná. EDUCATIONAL ACTIVITY AND SETTING: The study design was quasi-experimental, prospective, comparative, following a pre/posttest format, where Pharmaceutical Care classes were the intervention. Identical pre- and post-intervention tests were designed based on Anderson and Krathwohl's (2001) revision of Bloom's taxonomy, and according to the three levels of the cognitive domain: remember and understand; apply and analyze; evaluate and create. FINDINGS: Participants were 133 students enrolled in the two Pharmaceutical Care classes. A significant difference between pre- and posttest results was observed, showing an increase in students' performance in the applied tests at all cognitive levels. This is the first study of its kind involving Pharmaceutical Care and Blended Learning. DISCUSSION AND SUMMARY: By comparing the results of the diagnostic and summative assessments based on Bloom's taxonomy at all levels of the cognitive domain, positive results were observed regarding the students' performance in the two disciplines (Pharmaceutical Care I and II).

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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.

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Antiobesity pharmacotherapy remains the main point of disagreement among both scientists and regulators. This is probably due to small sample sizes, high levels of heterogeneity, and low methodological quality. For many years, Brazil was one of the largest consumers of appetite suppressants worldwide, with evidence of irrational use of this drug class. Therefore, the country was the scene of a debate that divided the Brazilian Health Surveillance Agency (Anvisa - Agência Nacional de Vigilância Sanitária) and medical societies over the maintenance record of diethylpropion, mazindol and fenproporex. In this context, this commentary presents new arguments to contribute to the discussion, as well as recommendations for future studies.

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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.

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Objective: Diabetes mellitus (DM) is a serious public health problem in Brazil. The goal of this study was to evaluate the effectiveness of long-acting insulin analogues in controlling glycemia in type 1 DM patients and to analyze the direct costs of the treatment. Methods: A retrospective cohort study was undertaken with data collected from the State Health Secretary's 2nd Regional Health Center from the State of Paraná. After randomization, socio-demographic data, the source of their drug prescriptions, and the pharmacotherapeutic profiles of the drugs were collected, along with clinical outcome information, such as glycated hemoglobin (HbA1c) and fasting plasma glucose levels. The direct costs of treatment with analogue insulin were evaluated based on the drugs and supplies acquisition data from the Center for Drugs, Paraná Cemepar. Results: One hundred and forty-eight type 1 diabetes mellitus patients, older than 18 years of age, were included in the cohort study. The HbA1c reduction after the insulin treatment was 0.36 ± 2.75, and the direct costs to reduce this parameter by 1% over a period of 24 months were U$ 1,806. The estimated costs to reduce HbA1c by 1% are U$ 5,016. Conclusions: In this study, we were able to estimate the public health system costs of using insulin analogues to reduce HbA1c by 1% in patients with type 1 DM. This information will assist clinicians in decision-making regarding insulin treatment.

Objetivo: Diabetes mellitus (DM) é um grave problema de saúde pública no Brasil. O objetivo deste estudo foi avaliar a redução da HbA1c em pacientes usuários de insulinas análogas de longa duração no controle glicêmico de pacientes com DM tipo 1 e avaliar custos diretos do tratamento com insulinas análogas. Métodos: O estudo é uma coorte retrospectiva e análise de custos para o tratamento de DM tipo 1, com pacientes pertencentes a 2a Regional de Saúde do estado do Paraná. Após randomização dos pacientes, foram coletados dados sociodemográficos, origem da prescrição e seu perfil farmacoterapêutico, além dos desfechos clínicos, como hemoglobina glicada (HbA1c) e glicemia em jejum. Foi realizada uma análise dos custos diretos do tratamento com insulinas análogas, e os valores foram obtidos por meio dos dados de compra dos medicamentos e insumos realizados pelo Centro de Medicamentos Básicos do Paraná (Cemepar). Resultados: Foram incluídos 148 pacientes maiores de 18 anos. A variável avaliada foi redução na HbA1c que, entre os pacientes, foi de 0,36 ± 2,75. Os resultados médios dos custos diretos totais do tratamento com DM tipo 1 durante 24 meses foram de R$ 7.224,00, para obter redução em 0,36% dos valores de HbA1c. O custo teórico para a redução em 1% de HbA1c é de R$ 20.064,00. Conclusões: Neste estudo foi possível estimar o custo para o sistema público de saúde, da redução de 1% da HbA1c em pacientes com DM tipo 1 usando insulinas análogas. Essa informação serve de subsídios para gestores e clínicos na tomada de decisão do tratamento com insulinas.

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ABSTRACT Pharmacists and their pharmacies have been evolving in their roles as health promoters in Brazil. Some examples are the recent legislation reaffirming the role of Brazilian pharmacies as health institutions, rather than having only a commercial profile, giving greater clarity to pharmacists about their roles as health care providers. This evolution came with the recognition that is already seen in other developed countries, confirming the need for the pharmacist as a health promoter, and not simply a dispenser of drugs in society. This study has obtained the profile and activities of community pharmacists, as well as the quality indicators of private community pharmacies throughout the State of Paraná through the application of an online survey sent to pharmacists in the state. Out of all pharmacists surveyed, 533 were part of the final analysis, being the pharmacists to complete the survey in full. Participants were mostly female (69.4%) and were, on average, 35.2 ± 9.2 years old. Of these, 60% worked in pharmacy chains and just 37% of all pharmacist respondents were issuing the Declaration of Pharmaceutical Services. The current study showed that many pharmaceutical services are not adopted by pharmacies as these services bring no significant financial reward. Regarding the structure, the Paraná State showed that pharmacies present a good overall structure. The kind of pharmacy (chain or independent) influenced the pharmaceutical services provided and the available structure, where the independent pharmacies provide a wider range of services and have better structure. This study was able to identify the profile and behaviors of pharmacists and also the quality indicators of pharmacies in Paraná State.

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Background Adherence to prescribed drug therapy is associated with lower rates of cardiovascular causes of death. In view of the relevance for public health, it is important to understand the relation between medication adherence tools' scores, especially in low literacy patients discharged from a cardiology ward. Objectives We aimed to assess: (a) the association between number of controlled clinical conditions and adherence tools scores, and (b) the correlation between the scores of three instruments to assess adherence. Methods We conducted a prospective study and included patients discharged from a specialized cardiovascular ward in Brazil. The results of the Beliefs about Medicines questionnaire (BMQ), the Adherence to Refills and Medication Scale (ARMS) and the MedTake test were compared. Results Of 53 included patients, most of them were elderly, and did not complete primary school. On average, there were six health conditions per patient, where two of them were not controlled. ARMS was the only tool that was associated with number of controlled health conditions (r = -0.312, p < 0.05). Moreover, ARMS (average score 15.6 ± 3.4) had significant correlation with MEDTAKE (r = 0.535, p < 0.01) and BMQ (r = 0.38, p < 0.01). BMQ and MEDTAKE were also positively correlated (r = 0.311, p < 0.05). Conclusions Clinically, higher ARMS scores (>12) suggest assumed non-adherence. It is also negatively correlated with the number of controlled clinical conditions in low literacy elderlies with cardiovascular diseases.

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OBJECTIVES: this observational study aimed to describe the discrepancies identified during medication reconciliation on patient admission to cardiology units in a large hospital. METHODS: the medication history of patients was collected within 48 hours after admission, and intentional and unintentional discrepancies were classified as omission, duplication, dose, frequency, timing, and route of drug administration. RESULTS: most of the patients evaluated were women (58.0%) with a mean age of 59 years, and 75.5% of the patients had a Charlson comorbidity index score between 1 and 3. Of the 117 discrepancies found, 50.4% were unintentional. Of these, 61.0% involved omission, 18.6% involved dosage, 18.6% involved timing, and 1.7% involved the route of drug administration. CONCLUSION: this study revealed a high prevalence of discrepancies, most of which were related to omissions, and 50% were unintentional. These results reveal the number of drugs that are not reincorporated into the treatment of patients, which can have important clinical consequences. OBJETIVOS: este estudo observacional teve como objetivo descrever discrepâncias encontradas na realização de conciliação medicamentosa de pacientes admitidos em unidades de cardiologia de um hospital de grande porte. MÉTODOS: a história de medicação dos pacientes foi coletada dentro de 48h após a admissão, e as discrepâncias, identificadas como intencionais ou não intencionais, foram classificadas como de: omissão, duplicidade, dose, frequência, intervalo e via. RESULTADOS: a maioria dos pacientes incluídos pertençia ao sexo feminino (58,0%), com idade média de 59 anos, e com índice de comorbidades de Charlson entre 1 e 3 (75,5% dos casos). Das 117 discrepâncias encontradas, 50,4% foram não intencionais. Dessas, 61,0% foram de omissão, 18,6% de dose, 18,6% de intervalo e 1,7% de via de administração. CONCLUSÃO: o estudo mostra a alta prevalência de discrepâncias, principalmente de omissão, sendo quase metade não intencionais. Esse dado remete ao número de medicamentos que não são reincorporados ao tratamento dos pacientes, podendo repercutir em consequências clínicas importantes. OBJETIVOS: este estudio observacional tuvo como objetivo describir discrepancias encontradas en la realización de la conciliación medicamentosa de pacientes admitidos en unidades de cardiología de un hospital de gran porte. MÉTODOS: la historia de medicación de los pacientes fue recolectada dentro de 48h después de la admisión, y las discrepancias, identificadas como intencionales o no intencionales, fueron clasificadas como: omisión, duplicidad, dosis, frecuencia, intervalo y vía. RESULTADOS: la mayoría de los pacientes incluidos pertenecía al sexo femenino (58,0%), con edad promedio de 59 años, y con índice de comorbilidad de Charlson entre 1 y 3 (75,5% de los casos). De las 117 discrepancias encontradas, 50,4% fueron no intencionales. De estas, 61,0% fueron de omisión, 18,6% de dosis, 18,6% de intervalo y 1,7% de vía de administración. CONCLUSIÓN: el estudio muestra la alta prevalencia de discrepancias, principalmente de omisión, siendo casi mitad de ellas no intencionales. Ese dato nos indica el número de medicamentos que no son reincorporados al tratamiento de los pacientes, lo que puede repercutir en consecuencias clínicas importantes.

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ETHNOPHARMACOLOGICAL RELEVANCE: Medicinal plants are known to contain numerous biologically active compounds, and although they have proven pharmacological properties, they can cause harm, including DNA damage. AIM OF THE STUDY: Review the literature to evaluate the genotoxicity risk of medicinal plants, explore the genotoxicity assays most used and compare these to the current legal requirements. MATERIAL AND METHODS: A quantitative systematic review of the literature, using the keywords "medicinal plants", "genotoxicity" and "mutagenicity", was undertakenQ to identify the types of assays most used to assess genotoxicity, and to evaluate the genotoxicity potential of medicinal plant extracts. RESULTS: The database searches retrieved 2289 records, 458 of which met the inclusion criteria. Evaluation of the selected articles showed a total of 24 different assays used for an assessment of medicinal plant extract genotoxicity. More than a quarter of those studies (28.4%) reported positive results for genotoxicity. CONCLUSIONS: This review demonstrates that a range of genotoxicity assay methods are used to evaluate the genotoxicity potential of medicinal plant extracts. The most used methods are those recommended by regulatory agencies. However, based on the current findings, in order to conduct a thorough study concerning the possible genotoxic effects of a medicinal plant, we indicate that it is important always to include bacterial and mammalian tests, with at least one in vivo assay. Also, these tests should be capable of detecting outcomes that include mutation induction, clastogenic and aneugenic effects, and structural chromosome abnormalities. In addition, the considerable rate of positive results detected in this analysis further supports the relevance of assessing the genotoxicity potential of medicinal plants.

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ABSTRACT Objectives: this observational study aimed to describe the discrepancies identified during medication reconciliation on patient admission to cardiology units in a large hospital. Methods: the medication history of patients was collected within 48 hours after admission, and intentional and unintentional discrepancies were classified as omission, duplication, dose, frequency, timing, and route of drug administration. Results: most of the patients evaluated were women (58.0%) with a mean age of 59 years, and 75.5% of the patients had a Charlson comorbidity index score between 1 and 3. Of the 117 discrepancies found, 50.4% were unintentional. Of these, 61.0% involved omission, 18.6% involved dosage, 18.6% involved timing, and 1.7% involved the route of drug administration. Conclusion: this study revealed a high prevalence of discrepancies, most of which were related to omissions, and 50% were unintentional. These results reveal the number of drugs that are not reincorporated into the treatment of patients, which can have important clinical consequences.

RESUMO Objetivos: este estudo observacional teve como objetivo descrever discrepâncias encontradas na realização de conciliação medicamentosa de pacientes admitidos em unidades de cardiologia de um hospital de grande porte. Métodos: a história de medicação dos pacientes foi coletada dentro de 48h após a admissão, e as discrepâncias, identificadas como intencionais ou não intencionais, foram classificadas como de: omissão, duplicidade, dose, frequência, intervalo e via. Resultados: a maioria dos pacientes incluídos pertençia ao sexo feminino (58,0%), com idade média de 59 anos, e com índice de comorbidades de Charlson entre 1 e 3 (75,5% dos casos). Das 117 discrepâncias encontradas, 50,4% foram não intencionais. Dessas, 61,0% foram de omissão, 18,6% de dose, 18,6% de intervalo e 1,7% de via de administração. Conclusão: o estudo mostra a alta prevalência de discrepâncias, principalmente de omissão, sendo quase metade não intencionais. Esse dado remete ao número de medicamentos que não são reincorporados ao tratamento dos pacientes, podendo repercutir em consequências clínicas importantes.

RESUMEN Objetivos: este estudio observacional tuvo como objetivo describir discrepancias encontradas en la realización de la conciliación medicamentosa de pacientes admitidos en unidades de cardiología de un hospital de gran porte. Métodos: la historia de medicación de los pacientes fue recolectada dentro de 48h después de la admisión, y las discrepancias, identificadas como intencionales o no intencionales, fueron clasificadas como: omisión, duplicidad, dosis, frecuencia, intervalo y vía. Resultados: la mayoría de los pacientes incluidos pertenecía al sexo femenino (58,0%), con edad promedio de 59 años, y con índice de comorbilidad de Charlson entre 1 y 3 (75,5% de los casos). De las 117 discrepancias encontradas, 50,4% fueron no intencionales. De estas, 61,0% fueron de omisión, 18,6% de dosis, 18,6% de intervalo y 1,7% de vía de administración. Conclusión: el estudio muestra la alta prevalencia de discrepancias, principalmente de omisión, siendo casi mitad de ellas no intencionales. Ese dato nos indica el número de medicamentos que no son reincorporados al tratamiento de los pacientes, lo que puede repercutir en consecuencias clínicas importantes.

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BACKGROUND: Diabetes and its complications are substantial causes of morbidity and mortality, and caused approximately 5.1 million deaths worldwide in 2013. Early detection and treatment of diabetes complications can prevent their progression. OBJECT: This study compared the proportions of patients with type 1 and 2 diabetes mellitus (T1DM and T2DM, respectively) who achieved the goals of good clinical control. METHODS: Adults and elderly patients with T1DM and T2DM at a public outpatient endocrinology service in Brazil were retrospectively evaluated between 2012 and 2013. Clinical and socio demographic data were obtained from medical records and evaluated in accordance with the Brazilian Diabetes Society Guidelines. Care process measures, outcomes indicators, and supporting process measures were evaluated. RESULTS: A total of 1031 records were analyzed: 29 and 71 % of patients had T1DM and T2DM, respectively. T2DM patients had significantly higher BMI than T1DM patients (overweight and obesity in 85.1 vs. 47.5 %, p < 0.01). The follow-up periods for diabetes and number of clinical visits to the endocrinology service were significantly greater among T1DM patients than T2DM patients (p < 0.01). However, T2DM patients required significantly more other (i.e., non-endocrinological) healthcare services (p < 0.01). HbA1c was significantly lower in T2DM patients (p < 0.01). Moreover, blood pressure and triglycerides were significantly higher in T2DM patients (p < 0.01), whereas total cholesterol and low-density lipoprotein were significantly lower in T2DM patients (p < 0.01). Only 0.5 % of the patients achieved all targets, and 1.1 % did not achieve any. CONCLUSIONS: The achievement of goals of good clinical practice varies among the parameters evaluated. Almost no patients achieved all targets. Many patients are overweight and do not achieve targets for HbA1c, lipid profile, or blood pressure control.

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RESUMO: Objetivo: Disponibilizar para o Brasil, através da seleção de itens da versão brasileira do Diabetes Quality of Life Measure (DQOL-Brasil), um instrumento resumido. Métodos: Estudo transversal em que o DQOL-Brasil foi administrado a 150 pacientes diabéticos tipo 1 e 146 pacientes diabéticos tipo 2. Os itens do instrumento foram selecionados com base na análise de componentes principais e correlações de Spearman com a satisfação ao tratamento, hemoglobina glicada e Perfil de Saúde de Nottingham. Resultados: De um total de 44 itens, apenas 8 foram selecionados para compor o instrumento resumido (DQOL-Brasil-8). O DQOL-Brasil-8 apresentou correlação de Spearman de 0,873 com o DQOL-Brasil e um coeficiente alfa de Cronbach de 0,702. Conclusão: Os profissionais de saúde brasileiros têm agora um instrumento curto e de aplicação rápida, que preserva as melhores características do DQOL-Brasil completo.

ABSTRACT: Objective: To provide for Brazil, through the selection of items of the Brazilian version of the Diabetes Quality of Life Measure (DQOL-Brazil), a concise instrument. Methods: This is a cross-sectional study in which the DQOL-Brazil was administered to 150 type 1 diabetic patients and 146 type 2 diabetic patients. The items of the instrument were selected according to the analysis of the principal components and Spearman's correlations with treatment satisfaction, glycated hemoglobin level, and Nottingham Health Profile. Results: From a total of 44 items, only 8 were selected to compose the summary instrument (DQOL-Brazil-8). The DQOL-Brazil-8 presented Spearman's correlation of 0.873 with the DQOL-Brazil and a Cronbach's alpha coefficient of 0.702. Conclusion: The Brazilian health professionals now have a brief tool for a fast application that preserves the best features of the full DQOL-Brazil.

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Over-the-counter medicines are available without prescription because of their safety and effectiveness, to treat minor ailments and symptoms. The objective of the study was to analyze the availability and quality of systematic reviews published about nonprescription medicines, identifying the groups for which there are gaps in evidence. We identified published articles through the Cochrane Database of Systematic Review and MEDLINE, from the start of the database until May 2012, using the search terms "nonprescription drugs," "over the counter," and "OTC." We searched for articles that describe systematic reviews addressing the efficacy and safety of drugs dispensed without a prescription, according to the lists published by the Association of the European Self-Medication Industry and in Brazil, in the clinical conditions listed in Groups and Specified Therapeutic Indications. We included 49 articles, 18 articles were of moderate quality and 31 of high quality. Of the studies, 74.5% demonstrated efficacy in favor of the use of drugs evaluated. Of the 24 studies that evaluated safety, 21% showed evidence unfavorable to the drug. Overall, the evidence found in the studies included in the overview is favorable to the use of the drugs evaluated. However, there are gaps in evidence for some therapy groups...

Os medicamentos isentos de prescrição são disponíveis sem prescrição médica devido a sua efetividade e segurança, para tratar sintomas e males menores. O objetivo deste trabalho é revisar a disponibilidade e qualidade das revisões sistemáticas publicadas sobre medicamentos isentos de prescrição, identificando os grupos para os quais há lacunas de evidência. Foram identificados artigos publicados através da Cochrane Database of Systematic Review e MEDLINE (via PubMed) desde o início da base até maio de 2012, utilizando os termos "nonprescription drugs," "over the counter," "OTC". Foram procurados artigos que descrevessem revisão sistemática abordando a eficácia e segurança dos medicamentos dispensados sem prescrição, de acordo com as listas publicadas pela Association of the European Self-Medication Industry e no Brasil, nas condições clínicas constantes na lista de Grupos e Indicações Terapêuticas Especificadas. Foram incluídos 49 artigos, 18 artigos eram de qualidade moderada e 31 de alta qualidade. 74,5% dos estudos demonstraram eficácia favorável ao uso do medicamento avaliado. Dos 24 estudos que avaliaram segurança, 21% mostraram evidência desfavorável ao uso do medicamento. No geral, a evidência encontrada nos estudos incluídos nesta revisão é favorável ao uso dos medicamentos avaliados. Entretanto, há grupos terapêuticos para os quais há lacunas na evidência...

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OBJECTIVE: To provide for Brazil, through the selection of items of the Brazilian version of the Diabetes Quality of Life Measure (DQOL-Brazil), a concise instrument. METHODS: This is a cross-sectional study in which the DQOL-Brazil was administered to 150 type 1 diabetic patients and 146 type 2 diabetic patients. The items of the instrument were selected according to the analysis of the principal components and Spearman's correlations with treatment satisfaction, glycated hemoglobin level, and Nottingham Health Profile. RESULTS: From a total of 44 items, only 8 were selected to compose the summary instrument (DQOL-Brazil-8). The DQOL-Brazil-8 presented Spearman's correlation of 0.873 with the DQOL-Brazil and a Cronbach's alpha coefficient of 0.702. CONCLUSION: The Brazilian health professionals now have a brief tool for a fast application that preserves the best features of the full DQOL-Brazil.

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BACKGROUND: Psoriasis is a chronic disease that affects public health and budget payers. In Brazil, biologic therapy for psoriasis is mostly provided by means of lawsuit with no strategy for efficient allocation of resources. OBJECTIVE: This study aimed to identify which of the available biologic alternatives for psoriasis is the most efficient from the perspective of the Brazilian Public Health Service (SUS). METHODS: Direct costs and efficacy were expressed in Brazilian currency (real [R$]; US $1 = R$1.97) and Psoriasis Area Severity Index 75 (PASI75), respectively. The Markov model process included 12 cycles of 3 months each, comprising 3 years of horizon. Adalimumab (80 mg at week 0 followed by a maintenance dose of 40 mg at week 1 and then every other week), etanercept (50 mg twice weekly for 12 weeks followed by a maintenance dose of 25 mg weekly), infliximab (5 mg/kg at weeks 0, 2, and 6 and then every 8 weeks), and ustekinumab (45 mg at weeks 0 and 4 and then every 12 weeks) were assessed. One-way and horizon sensitivity analyses were performed. Moreover, probabilistic sensitivity analysis was applied to evaluate model robustness. The final result was interpreted as the cost for each patient who achieved and maintained PASI75 for at least 3 years. RESULTS: Adalimumab was the most cost-effective biologic therapy (R$120,981.45/PASI75) for moderate-to-severe psoriasis, followed by ustekinumab (R$126,336.67/PASI75), etanercept (R$225,074.71/PASI75), and infliximab (R$377,656.28/PASI75). One-way sensitivity analysis determined that the acquisition cost of biologics was the most sensitive parameter of the model. Horizon analysis suggests that the result was the same when the horizon was varied from 1 year to a lifetime. Probabilistic sensitivity analysis showed that adalimumab has 80% to 10% probability of being the most cost-effective biologic considering a willingness-to-pay value ranging from R$50,000 to R$500,000, whereas ustekinumab presented a probability of 20% to 90% for the same range. CONCLUSIONS: From the pharmacoeconomics point of view, adalimumab 80 mg at week 0 followed by a maintenance dose of 40 mg at week 1 and then every other week should be the first-line therapy for patients with plaque psoriasis concomitant or not to psoriatic arthritis or nail psoriasis. This study does not have the potential to evaluate the impact of incorporating a specific biologic agent on the final budget. Its goal is to point out which of the technologies is the most efficient, that is, the one that adds more value to the financial resource invested.

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We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible.

Conduziu-se uma revisão sistemática e metaanálise de ensaios clínicos randomizados em pacientes com psoríase moderada a grave, tratados com biológicos ou placebo por 10 a 14 semanas. Foram incluídos 41 estudos, com escore de Jadad médio de 4,4, totalizando 15.586 pacientes. Para os desfechos de eficácia PASI 50, 75 e 90 os resultados não são conclusivos para definir qual é o melhor agente biológico no curto prazo. Não houve diferença estatística entre placebo e biológicos para ocorrência de infecções e eventos ad-versos sérios. Ustequinumabe 45mg foi o biológico com menor ocorrência de descontinuação por conta de eventos adversos. Baseado na evidência até então disponível, não é possível determinar qual agente biológico é o melhor para se atingir resposta PASI 50, 75 e 90 após 10-14 semanas de tratamento. Para o mesmo intervalo, a segurança global parece ser a mesma para todos os biológicos e ustequinumabe 45mg o tratamento melhor tolerado. Para melhor compreender a eficácia e segurança, meta-análise indireta comparando droga-a-droga são necessárias já que ensaios clínicos randomizados podem não ser viáveis.

Se realizó una revisión sistemática y metaanálisis de ensayos controlados aleatorios en pacientes con psoriasis moderada a severa tratados con biológicos o placebo por 10-14 semanas. Se incluyeron 41 estudios con una puntuación de Jadad de 4,4, un total de 15.586 pacientes. Para variables de eficacia PASI 50, 75 y 90, los resultados no son concluyentes para definir cuál es el mejor agente biológico en el corto plazo. No hubo diferencia estadística entre el placebo y la ocurrencia biológica de las infecciones y los eventos adversos graves. Ustequinumabe 45mg fue el biológico con una menor incidencia de la interrupción debido a eventos adversos. Basado en la evidencia disponible hasta el momento, no es posible determinar qué agente biológico es lograr la mejor respuesta PASI 50, 75 y 90 después de 10-14 semanas de tratamiento. Para el mismo período, la seguridad global parece ser el mismo para todos los tratamientos y ustequinumabe 45mg el mejor tolerado. Para comprender mejor la eficacia y seguridad, es necesario un metaanálisis indirecto comparando medicamento a medicamento.

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