Cassyano Januário Correr

Meta‐analysis of the Efficacy and Safety of Adalimumab, Etanercept, and Infliximab for the Treatment of Rheumatoid Arthritis

Study Objective. To evaluate the efficacy and safety of using the anti‐tumor necrosis factor‐α (anti‐TNF‐α) drugs adalimumab, etanercept, and infliximab for the treatment of rheumatoid arthritis.

Translation and validation into portuguese Language of the Medication Regimen Complexity Index

BACKGROUND The complexity of pharmacotherapy is a result of a multiplicity of prescribed regimen factors, including the number of different drugs in the regimen, the number of dosage units per dose, the total number of prescribed doses per day and administration instructions. The Medication Regimen Complexity Index (MRCI) is a specific, reliable and valid tool used to measure the complexity of pharmacotherapy, originally developed in English language. OBJECTIVE Transcultural translation and validation of this tool into Brazilian Portuguese. METHODS A cross-sectional study was developed with 95 type-2 diabetes patients, receiving multiple medications. The validation process included translation into Portuguese, back-translation and pre-test of the tool, creating a new version called the Pharmacotherapy Complexity Index (PCI). The psychometric parameters were assessed, including convergent validity, discriminant validity and reliability (interclass and test-retest correlation). RESULTS The complexity of pharmacotherapy measured by the MRCI-Brazil had an average score of 15.7 points (SD=8.36). MRCI-Brazil showed significant correlation with the number of medications (r=0.86; p<0.001) and age of patients (r=0.28, p=0.005). Interrater reliability analysis found an intra-class correlation (ICC) of 0.99 (p<0.001) and test-retest correlation was of 0.997 (p<0.001). CONCLUSION The results have shown that the Brazilian version of the MRCI presents adequate validity and reliability, and may be useful in clinical practice and research involving the analysis of the drug regimen complexity.

Riscos de problemas relacionados com medicamentos em pacientes de uma instituição geriátrica

Em pacientes geriatricos, o uso de medicamentos leva com frequencia ao surgimento de Problemas Relacionados com Medicamentos (PRM) e exige estrategias de prevencao da morbi-mortalidade relacionada a esses produtos. Este estudo observacional teve por objetivo avaliar prescricoes e a presenca de riscos de PRM em uma instituicao geriatrica. Dois farmaceuticos avaliaram esquemas farmacoterapeuticos de 76 pacientes com relacao a duplicidades terapeuticas, desvios de dose, medicacoes inadequadas e interacoes medicamentosas potenciais. Os pacientes utilizavam em media 3 medicamentos, principalmente do aparelho cardiovascular (36,4%) e sistema nervoso central (47,8%). 13,5% dos medicamentos utilizados (n=230) foram considerados inadequados com riscos de PRM ligados principalmente a seguranca da terapia. Foram identificadas 69 interacoes medicamentosas em 38 pacientes (51,3%), com manifestacoes ligadas principalmente a efetividade da terapeutica. Os resultados reforcam a importância da avaliacao do processo de uso de medicamentos. Os dados apontam, ainda, a necessidade de aprofundamento de estudos de avaliacao de riscos de PRM nessa populacao.

Effectiveness of clinical pharmacy services: an overview of systematic reviews (2000–2010)

Background Multiple reviews have evaluated the impact of pharmacist-delivered patient care on health-related outcomes. However, it is unclear which of the pharmacist-delivered interventions in these services are the most effective. Aim of the review To gather the evidence of the impact of clinical pharmacy services on the medication use process or on patient outcomes using an overview of systematic reviews. Methods PubMed was searched to retrieve systematic reviews published between 2000 and 2010 that assessed the impact of clinical pharmacy services on the medication use process or patient outcomes. Two independent reviewers evaluated the study eligibility and one extracted the description and results of the services. The methodological quality of each review was assessed with the R-AMSTAR tool. Results Of the 343 potentially relevant records identified, 49 systematic reviews, comprising a total of 269 randomized controlled trials, met the selection criteria. Clinical pharmacy services that focused on specific medical conditions, such as hypertension or diabetes mellitus, revealed a positive impact of pharmacists’ interventions on patient outcomes. For other medical conditions, however, the results were inconclusive (e.g., dyslipidemia or thromboprophylaxis). Interventions that targeted medication adherence and assessed the impact of clinical pharmacy services in prescription appropriateness also produced inconclusive results because of the variability of methods used to assess both medication adherence and medication appropriateness. Conclusions Systematic reviews that assessed clinical pharmacy services targeting specific conditions were more conclusive given that the intervention was well defined, and the measured outcomes were unequivocal and tangible. Conversely, the results were inconclusive for interventions with a broader target and with monitoring parameters that were unclearly established or inconsistently assessed across studies. These findings emphasize the need to better define clinical pharmacy services and standardize methods that assess the impact of these services on patient health outcomes.

Efficacy and safety of topical antifungals in the treatment of dermatomycosis: a systematic review

The analysis of comparative efficacy and safety of topical antifungals in the literature is restricted to the treatment of tinea pedis and onychomycosis. Therefore our objective was to evaluate and compare the efficacy and safety of topical antifungals used in the treatment of dermatomycosis, we performed a comprehensive search for randomized controlled trials (RCTs) in the following databases: Medline, Cochrane Central Register of Controlled Trials, EMBASE, Lilacs and International Pharmaceutical Abstracts, we identified studies that compared the use of topical antifungals with other antifungals or with placebo published up to July 2010 in English, Spanish or Portuguese. The quality of reporting was assessed according to the Jadad scale; only studies with a score of 3 or more were included. The outcomes evaluated were mycological cure at the end of treatment, sustained cure, occurrence of adverse events and tolerability, including withdrawals due to adverse events. A total of 104 RCTs satisfied the inclusion criteria, containing a total of 135 comparisons, with 55 out of 120 possible comparisons among the 16 drugs evaluated. Pooled data on efficacy showed that all the antifungals were better than placebo. There were no significant differences among antifungal classes. No differences were found in safety or tolerability in any direct comparison. Sensitivity analysis indicated the robustness of the findings. Our results indicate the clear superiority of topical antifungals over placebo but that there is no consistent difference among classes. Mixed treatment comparisons are necessary to rank antifungals, as direct comparisons among many of them are lacking.

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]).

Efficacy of Topical Antifungals in the Treatment of Dermatophytosis: A Mixed-Treatment Comparison Meta-analysis Involving 14 Treatments

IMPORTANCE Considering that most randomized controlled trials compare antifungals with placebo instead of other antifungals, conventional meta-analysis is insufficient to define superiority between the evaluated strategies. To our knowledge, this is the first mixed-treatment comparison meta-analysis on antifungal treatments in the literature and shows all the evidence available at the time of the study. OBJECTIVE To evaluate and compare the efficacy of topical antifungals used in dermatophytosis treatment, using mixed-treatment comparisons. EVIDENCE ACQUISITION We performed a comprehensive search (up to July 31, 2012) for all entries in MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, Literatura Latino Americana e do Caribe em Ciências da Saúde, and International Pharmaceutical Abstracts. Randomized controlled trials that compared topical antifungals with one another or with placebo in dermatophytosis treatment were selected for analysis. Methodologic quality of the trials was assessed using the Jadad scale. We excluded studies that scored less than 3 points. The outcomes evaluated were mycologic cure at the end of treatment and sustained cure. A random-effects Bayesian mixed-treatment comparisons model was applied to combine placebo-controlled and direct topical antifungals comparison trials. RESULTS Pooled data of the 65 trials identified did not show any statistically significant differences among the antifungals concerning the outcome of mycologic cure at the end of treatment. Regarding the sustained cure outcome, butenafine hydrochloride and terbinafine hydrochloride were significantly more efficacious than were clotrimazole, oxiconazole nitrate, and sertaconazole nitrate. Terbinafine also demonstrated statistical superiority when compared with ciclopirox (ciclopiroxolamine), and naftifine hydrochloride showed better response compared with oxiconazole. No inconsistency was detected in the network of evidence for both outcomes, sustaining the validity of the mixed-treatment comparisons results. CONCLUSIONS AND RELEVANCE With the outcome mycologic cure at the end of treatment, there was no significant difference among the antifungals. Butenafine, naftifine, and terbinafine might be the best strategies for maintaining cured status. Because of the different costs of the antifungals, pharmacoeconomic analysis is required to identify the most efficient strategy for dermatophytosis management.

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.

Comparative efficacy of oral nucleoside or nucleotide analog monotherapy used in chronic hepatitis B: a mixed-treatment comparison meta-analysis.

To compare the efficacy of nucleoside or nucleotide analog monotherapy for the treatment of chronic hepatitis virus B (HBV) with adefovir dipivoxil, entecavir, lamivudine, telbivudine, and tenofovir disoproxil fumarate.

Perfil dos farmacêuticos e farmácias em Santa Catarina: indicadores de estrutura e processo

The present study aimed to assess structure and process quality indicators in community pharmacies in Santa Catarina (Brazil), and also the profile of pharmacists regarding their attitudes and perceptions of pharmaceutical care and professional satisfaction. A cross-sectional study was performed in 10% of Santa Catarina pharmacies randomly chosen. 258 community pharmacies were surveyed. 88.5% pharmacists were in office in the time of the interview. In average, they were 31 years old (SD=8.1) and mainly women (68%). A ratio of 1.4 (SD=0.7) pharmacists per pharmacy and 3.8 (SD=4.5) assistants existed. Only 11.4% pharmacies had an adequate structure for private caring patients. Despite having an average of more than 2 tertiary drug information sources, most of them were low quality. Activities mentioned by the majority of pharmacists were dispensing (98.2%), recording controlled drugs (90.8%), injections administration (85.1%), and helping patients on cash line (84.2%). Most of pharmacies in Santa Catarina (Brazil) do not have the adequate structure for implementing pharmaceutical care services. Barriers identified to implement those services were not different to those communicated in other countries.