Exploring the Quality of Systematic Reviews on Pharmacist Interventions in Patients With Diabetes: An Overview.

OBJECTIVE: To assess the reporting and methodological quality of systematic reviews and meta-analysis studies on pharmacist interventions in patients with diabetes. DATA SOURCES: A comprehensive literature search was performed in MEDLINE, Scopus, and LILACS databases for systematic reviews and meta-analysis studies published from January 1990 to June 2013. The standardized search strategy included the use of MeSH terms or text words related to pharmacist interventions, diabetes, and systematic reviews. STUDY SELECTION AND DATA EXTRACTION: The overview included systematic reviews and meta-analysis studies published in English, Portuguese, or Spanish that evaluated the effect of pharmacist intervention on outcomes for diabetic patients. Two independent authors performed study selection, data extraction, and quality assessment with a consensus process to address disagreements. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and Assessment of Multiple Systematic Reviews (AMSTAR) checklists were used to assess reporting characteristics and methodological quality, respectively. DATA SYNTHESIS: The literature search yielded 101 records of potential interest, of which 7 satisfied the inclusion criteria. The total average (SD) for PRISMA and AMSTAR scores were 17.4 (5.6) out of 27 and 6.9 (2.0) out of 11, respectively. The most frequent problems included nonregistration of study protocol, absence of a list of excluded studies, and unclear acknowledgment of conflicts of interests. CONCLUSION: The reporting and methodological quality of systematic reviews and meta-analysis studies were suboptimal, with some areas needing further improvement. It is necessary to ensure better transparency and reproducibility in the literature of clinical pharmacy services for diabetic patients.

A tool to characterize the components of pharmacist interventions in clinical pharmacy services: the DEPICT project.

BACKGROUND: The complexity of clinical pharmacy services usually leads to an inconsistent or even poor description of their interventions in scientific reports. To ensure comparability and reproducibility of the evidence, an in-depth description of pharmacist interventions is required. OBJECTIVE: To validate a new tool called DEPICT (Descriptive Elements of Pharmacist Intervention Characterization Tool) to characterize clinical pharmacy services. METHODS: We developed a 3-phase study. First, to create a theoretical framework, an overview of systematic reviews was performed in PubMed between 2000 and 2010. Then, an in-depth analysis of the included studies was carried out to identify a list of components in order to create the instrument. Finally, 2 independent raters separately applied the tool to a random sample of 28 randomized clinical trials extracted from the systematic reviews. Interrater agreement was evaluated using PABAK (prevalence-adjusted bias-adjusted κ) coefficient or intraclass correlation coefficient (ICC). RESULTS: We included 49 systematic reviews in our overview. Analysis of these studies resulted in 58 intervention components, with 57 dichotomous variables and 1 discrete variable. These items resulted in a preliminary version of the instrument. The reliability analysis showed that 8 binary items of this version had a PABAK less than or equal to 0.60. These items were then excluded or modified, resulting in a final version of the tool, with 54 items organized into 12 domains. DEPICT showed an average PABAK of 0.85 (95% CI 0.81 to 0.88) and an ICC of 1.0. Twenty items presented a PABAK value between 0.61 and 0.80 (substantial agreement) and 33 had a value between 0.81 and 1.0 (almost perfect agreement). CONCLUSIONS: DEPICT is a reproducible instrument for describing the components of pharmacist interventions performed as part of clinical pharmacy services. It allows retrospective analysis of published studies and can be used as a reference guide to report pharmacist interventions in future studies.

A systematic review and meta-analysis of the efficacy and safety of adalimumab for treating rheumatoid arthritis.

Adalimumab (ADA) is a monoclonal antibody. Published studies indicate that its use in patients with rheumatoid arthritis can be efficient in providing long-term benefits. The aim of this study is to evaluate the efficacy and safety of ADA for treating rheumatoid arthritis. A systematic review was performed to search for randomized clinical trials that compare subcutaneous doses of ADA 20 mg weekly or 40 mg every other week with placebo, with or without concomitant methotrexate. Only studies of moderate or high quality were included. A meta-analysis was conducted to assess the efficacy (based in changes of American College of Rheumatology ACR criteria) and the safety (based in serious adverse events, serious infections, malignancy and deaths) of ADA use. Withdrawals due to adverse events or lack of efficacy were also evaluated. Eight studies met the inclusion criteria, comprising 2,692 patients. In the efficacy meta-analysis, a greater number of ADA-treated patients relative to those in placebo group achieved ACR20, ACR50 and ACR70 values from 6 months to 2 years of treatment. For safety results, there were no statistically significant differences between the groups. Withdrawals due to adverse events were higher in ADA group relative to the placebo group, and withdrawals due to the lack of efficacy were higher in placebo group relative to the ADA-treated group. This meta-analysis shows a higher efficacy of ADA relative to placebo, but clinicians should be careful regarding adverse events in ADA-treated patients.

A systematic review and meta-analysis of the efficacy and safety of etanercept for treating rheumatoid arthritis.

The aim of this study was to evaluate the efficacy and safety of etanercept (ETA) for treating rheumatoid arthritis. A systematic review was performed to search for randomized clinical trials comparing subcutaneous doses of ETA at 25 mg twice a week or 50 mg weekly to a placebo group, with or without methotrexate. Studies of low quality (less than 3 points on Jadad's scale) were excluded. The efficacy was assessed by using the criteria of the American College of Rheumatology (ACR). Safety data were evaluated based on serious adverse events, serious infections, malignancy and deaths. Withdrawals as a result of adverse events or lack of efficacy were also evaluated. Eight studies met the inclusion criteria, comprising 2385 patients. In the efficacy meta-analysis, a greater number of ETA-treated patients achieved the efficacy criteria within 6 months of treatment, where the relative risk (RR) was 2.94 [2.27, 3.81] for achieving ACR20, 5.28 [3.12, 8.92] for ACR50 and 4.83 [1.74, 13.47] for ACR70. After 1 year, the RR for achieving ACR20, ACR50 and ACR70 were 1.14 [1.07, 1.23], 1.36 [1.21, 1.53] and 1.56 [1.30, 1.88], respectively. This response rates were higher for ETA-treated patients in comparison with control group patients. For safety, there were no statistically significant differences between treated patients and controls. This was also confirmed by withdrawals as a result of adverse events, which were not statistically different between the two groups. However, more patients withdrew from control groups because of a lack of efficacy as compared with ETA groups (RR = 0.48 [0.30, 0.78]).

Active methodology and blended learning: An experience in pharmaceutical care.

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).

Pharmaceutical care in community pharmacies: practice and research in Brazil.

OBJECTIVE: To discuss the provision of pharmaceutical services and pharmaceutical care in Brazil. FINDINGS: Professional training and pharmaceutical services are undergoing a period of restructuring in Brazil, including the adoption of incentives for pharmaceutical care. Some important national measures include the rational use of medications, evidence-based medicine, and pharmacovigilance. A new and more generalist pharmacy curriculum is being implemented and tailored for the Brazilian Public Health System; recently, the Brazilian government has provided resources for pharmaceutical care research. DISCUSSION: A proposal for national consensus in Brazilian pharmaceutical care was published in 2002. The components of this proposal include drug dispensing, counseling, health education, symptoms advice, and pharmacotherapy follow-up. Pharmacy practice is currently focused on drug dispensing and logistic aspects of drug distribution. Professionals are satisfied with patients' confidence in being counseled by pharmacists and reveal interest in extending their role in patient care. Most pharmacy customers were originally unaware of the term "pharmaceutical care"; however, following an explanation, they showed an interest in this service. Furthermore, over 50% stated that they would pay for this service. Despite these initiatives, numerous barriers to the development of pharmaceutical care remain, the main ones being the commercial objective of most pharmacies that sell medications and the insufficient training of professionals. Although government-owned pharmacies also distribute medications, they do not meet all of the needs of the population and lack sufficient pharmacists. CONCLUSIONS: Several actions are required to stimulate the implementation and development of pharmaceutical care and services in Brazil. Recent research incentives in pharmaceutical care and reorientation of pharmacy education will contribute to this development.

Diethylpropion and mazindol: An end to the discussion?

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.

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.

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.

Quantitative genotoxicity assays for analysis of medicinal plants: A systematic review.

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.

Analysis of the discrepancies identified during medication reconciliation on patient admission in cardiology units: a descriptive study.

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.

Comparing medication adherence tools scores and number of controlled diseases among low literacy patients discharged from a Brazilian cardiology ward.

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.

Proportion of Brazilian diabetes patients that achieve treatment goals: implications for better quality of care.

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.

Development of the Brazilian brief version of the Diabetes Quality of Life Measure (DQOL-Brazil-8).

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.

Clinical correlation between a point-of-care testing system and laboratory automation for lipid profile.

BACKGROUND: We evaluated the clinical correlation between the CardioChek PA analyzer and a clinical laboratory reference method to use for screening program purposes. METHODS: Fasting blood samples were collected on 516 patients (age 20-85 y). One venous sample was collected using a serum tube for the evaluation on a COBAS reference analyzer. A second venous sample was collected in a lithium heparin tube and was evaluated on the CardioChek PA analyzer (CCPA venous). A fingerstick sample (CCPA fingerstick) was evaluated only on the CardioChek PA analyzer. Linear regression analyses were performed for each measured analyte, total cholesterol, HDL-cholesterol and triglycerides. RESULTS: The correlation between the CCPA fingerstick and CCPA venous was extremely high for HDL-C and triglycerides, and good for total cholesterol. Our results demonstrated a good clinical agreement for total cholesterol, HDL-C and triglycerides between 97.7% and 94.6% in the comparison of the CCPA to the reference analyzer. CONCLUSIONS: We identified the pre-analytic phase as an important step to guarantee the quality of results and indicate that the CardioChek PA is a reliable lipid point-of-care testing system that can be used for the application of clinical screening anywhere.

Assessment of pharmacist-led patient counseling in randomized controlled trials: a systematic review.

Background Pharmacists' counseling has improved health-related outcomes in many acute and chronic conditions. Several studies have shown how pharmacists have been contributing to reduce morbidity and mortality related to drug-therapy (MMRDT). However, there still is a lack of reviews that assemble evidence-based clinical pharmacists' counseling. Equally, there is also a need to understand structure characteristics, processes and technical contents of these clinical services. Aim of the review To review the structure, processes and technical contents of pharmacist counseling or education reported in randomized controlled trials (RCT) that had positive health-related outcomes. Methods We performed a systematic search in specialized databases to identify RCT published between 1990 and 2013 that have evaluated pharmacists' counseling or educational interventions to patients. Methodological quality of the trials was assessed using the Jadad scale. Pharmacists' interventions with positive clinical outcomes (p < 0.05) were evaluated according to patients' characteristics, setting and timing of intervention, reported written and verbal counseling. Results 753 studies were found and 101 RCT matched inclusion criteria. Most of the included RCTs showed a Jadad score between two (37 studies) and three (32 studies). Pharmacists were more likely to provide counseling at ambulatories (60 %) and hospital discharge (25 %); on the other hand pharmacists intervention were less likely to happen when dispensing a medication. Teaching back and explanations about the drug therapy purposes and precautions related to its use were often reported in RCT, whereas few studies used reminder charts, diaries, group or electronic counseling. Most of studies reported the provision of a printed material (letter, leaflet or medication record card), regarding accessible contents and cultural-concerned informations about drug therapy and disease. Conclusion Pharmacist counseling is an intervention directed to patients' health-related needs that improve inter-professional and inter-institutional communication, by collaborating to integrate health services. In spite of reducing MMRDT, we found that pharmacists' counseling reported in RCT should be better explored and described in details, hence collaborating to improve medication-counseling practice among other countries and settings.

Cost-Effectiveness of Biologic Agents in the Treatment of Moderate-to-Severe Psoriasis: A Brazilian Public Health Service Perspective.

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.

Efficacy and safety of biologic therapies for systemic lupus erythematosus treatment: systematic review and meta-analysis.

OBJECTIVES: The objectives of this study were to evaluate the efficacy, safety, and tolerability of biologic drugs compared with placebo for systemic lupus erythematosus (SLE) treatment. METHODS: A systematic review evaluating the efficacy and safety of biologic therapies compared with placebo in adult SLE patients treatment was performed. Data from studies performed before September 2013 were collected from several databases (MEDLINE, Cochrane Library, SCIELO, Scopus, and International Pharmaceutical Abstracts). Study eligibility criteria included randomized, double-blind, placebo-controlled trials; regarding treatment with biologic agents in SLE adult patients; and published in English, German, Portuguese, and Spanish. Extracted data were statistically analyzed in a meta-analysis using the Review Manager (RevMan) 5.1 software. Efficacy outcomes included the SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index) score, the SRI (Systemic Lupus Erythematosus Responder Index), normalization of low C3 (<90 mg/dL), anti-double-stranded DNA positive to negative, and no new BILAG (British Isles Lupus Assessment Group index) 1A or 2B flares. Data on safety profile included adverse events, serious and severe adverse events, death, malignancy, infections, and infusion reactions. We also evaluated withdrawals from treatment due to lack of efficacy or adverse events. RESULTS: Thirteen randomized placebo-controlled trials met the criteria for data extraction for systematic review. A meta-analysis regarding the efficacy and safety of belimumab compared with placebo involving four of these trials was undertaken and the remainder contributed to a meta-analysis of the safety of biologic agents. In addition, two trials allowed the performance of a meta-analysis regarding the efficacy and safety of rituximab compared with placebo. Belimumab was more effective than placebo in most evaluated outcomes. No significant differences in the safety and tolerability data were observed between the belimumab and placebo groups. No differences were observed between the rituximab and placebo groups for the efficacy outcomes or safety parameters. Extracted data from the 13 studies were pooled, allowing assessment of the safety of biologic drugs. The meta-analysis revealed a satisfactory safety profile of these agents when used for SLE treatment, as there were no significant differences between the two evaluated groups (biologic agents and placebo) for all outcomes analyzed. CONCLUSION: Belimumab exhibited a satisfactory profile regarding efficacy, safety, and tolerability. Rituximab showed no superiority over placebo in terms of efficacy, despite its suitable safety profile. Biologic agents exhibited a good safety profile for SLE treatment, indicating that these agents are promising therapies and should be further investigated.

Economic evaluation of treatments for chronic hepatitis B.

The aim of this study was to conduct a cost-utility study of adefovir, entecavir, interferon alpha, pegylated interferon alpha, lamivudine and tenofovir for chronic hepatitis B in the context of Brazilian Public Health Care System. A systematic review was carried out for efficacy and safety. Another review was performed to collect utility data and transition probabilities between health states. A Markov model was developed in a time horizon of 40 years with annual cycles for three groups of: HBeAg positive, HBeAg negative, and all patients. These strategies were compared to a fourth group that received no treatment. Discount rates of 5% were applied and sensitivity analyses were performed. Tenofovir offered the best cost-utility ratio for the three evaluated models: U$397, U$385 and U$384 (per QALY, respectively, for HBeAg positive, negative, and all patients). All other strategies were completely dominated because they showed higher costs and lower effectiveness than tenofovir. The sequence of cost-utility in the three models was: tenofovir, entecavir, lamivudine, adefovir, telbivudine, pegylated interferon alpha, and interferon alpha. In the sensitivity analysis, adefovir showed lower cost-utility than telbivudine in some situations. The study has some limitations, primarily related to the creation of scenarios and modeling. In this study, tenofovir presented the best cost-utility ratio. The results obtained in this study will be valuable in decision-making and in the review of the clinical protocol, mainly involving the allocation of available resources for health care.

Analysis of clinical pharmacist interventions in a tertiary teaching hospital in Brazil.

OBJECTIVE: To analyze the clinical pharmacist interventions performed during the review of prescription orders of the Adult Intensive Care, Cardiologic Intensive Care, and Clinical Cardiology Units of a large tertiary teaching hospital in Brazil. METHODS: The analysis took place daily with the following parameters: dose, rate of administration, presentation and/or dosage form, presence of inappropriate/unnecessary drugs, necessity of additional medication, more proper alternative therapies, presence of relevant drug interactions, inconsistencies in prescription orders, physical-chemical incompatibilities/solution stability. From this evaluation, the drug therapy problems were classified, as well as the resulting clinical interventions. RESULTS: During the study, a total of 6,438 drug orders were assessed and 933 interventions were performed. The most prevalent drug therapy problems involved ranitidine (28.44%), enoxaparin (13.76%), and meropenem (8.26%). The acceptability of the interventions was 76.32%. The most common problem found was related to dose, representing 46.73% of the total. CONCLUSION: Our study showed that up to 14.6% of the prescriptions reviewed had some drug therapy problem and the pharmacist interventions have promoted positive changes in seven to ten of these prescriptions.