RESUMO
WHAT IS KNOWN AND OBJECTIVES: Most antineoplastic drugs are highly toxic and have low therapeutic indexes, which can result in drug-related problems. In this context, pharmacist interventions may play an important role in the success of the treatment. The objective of this study was to examine the effects of pharmacist interventions on adult outpatients with cancer using antineoplastic drugs. METHODS: A literature search was performed using PubMed, ISI Web of Science and LILACS databases from January 1990 to April 2016, using MeSH terms or text words related to pharmacist interventions, cancer and outpatient care. Studies published in English, Portuguese or Spanish on the effects of pharmacist interventions in outcome measures in adult outpatients with cancer were included. Two independent authors performed study selection and data extraction with a consensus process. The articles were analysed according to previously established criteria, such as country, study design, setting, population, type of cancer, description of the intervention and control groups, outcomes, main conclusions and study limitations. RESULTS AND DISCUSSION: A total of 874 records were identified, of which 11 satisfied the inclusion criteria. The studies were conducted mainly in the United States and included patients aged >50 years. Most studies had a before-after design. Pharmacist interventions primarily included educating and counselling patients on the management of adverse events. Rates of nausea and vomiting control, medication adherence and patient satisfaction were the most common outcome measures; a significant benefit in these parameters as a result of pharmacist interventions was noted in most studies. WHAT IS NEW AND CONCLUSION: The findings from this systematic review indicate that pharmacist interventions can improve outcome measures in outpatients with cancer. However, the collective quality of the studies was poor and gaps identified indicate that further research is needed to provide more robust results.
Assuntos
Antineoplásicos/administração & dosagem , Neoplasias/tratamento farmacológico , Farmacêuticos/organização & administração , Adulto , Assistência Ambulatorial/organização & administração , Humanos , Adesão à Medicação , Avaliação de Resultados em Cuidados de Saúde , Pacientes Ambulatoriais , Satisfação do Paciente , Papel ProfissionalRESUMO
WHAT IS KNOWN AND OBJECTIVE: Given the increasing healthcare costs and the recent introduction of novel agents in the treatment for multiple myeloma (MM), an incurable haematologic malignancy, more efficient use of existing resources is fundamental. The objective of this study was to systematically review economic evaluations of the use of novel agents in MM and assess their reporting quality. METHODS: A literature search was performed in PubMed/Medline, Latin American and Caribbean Health Sciences Literature, Cost-Effectiveness Analysis Registry and the National Health Services Economic Evaluation Database for economic evaluations up to June 2015. The search strategy included Medical Subject Headings terms or text words related to MM, economic evaluations and drugs. Full economic evaluations of bortezomib, thalidomide or lenalidomide in patients with MM that were published in English, Portuguese or Spanish were included. Two independent authors performed study selection, data extraction and quality assessment using 24 items from the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. RESULTS AND DISCUSSION: Of the 132 potentially relevant records identified, eight satisfied the inclusion criteria. Most studies were cost-effectiveness analyses combined with cost-utility analyses (n = 6) from the public payer perspective (n = 4) and were performed in Europe (n = 6) on patients with refractory or relapsed MM (n = 5). All studies were based on economic models, with four of them using discrete event simulation. We found bortezomib-based therapies to be one of the more commonly selected treatment strategies for comparison (n = 7). Overall, the intervention was more effective and costlier than the alternative strategy (average of $54 630 per life year; $68 261 per quality-adjusted life year-QALY). The CHEERS' total score was 14·6 (SD = 2·6) with the most frequent problems being the lack of precision measures for all model parameters, no evaluation of heterogeneity of the results by subgroup analyses and no description of the role the funder in the identification, design, conduct and reporting of the analysis. WHAT IS NEW AND CONCLUSION: Most analyses of the novel therapeutic agents determined that they were cost-effective in MM at a threshold of up to $100 000/QALY. Nevertheless, the poor reporting quality of the economic studies requires improvement to ensure greater transparency.
Assuntos
Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Mieloma Múltiplo/economia , Análise Custo-Benefício/economia , Europa (Continente) , Custos de Cuidados de Saúde , Humanos , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND: The concept of pharmaceutical care (PC) specifically refers to the pharmacist being able to identify, prevent and resolve negative outcomes associated with medication (NOM). According to the Third Consensus of Granada, these are patient health-related outcomes not consistent with pharmacotherapy objectives, and are associated with the proper or erroneous use of medicines. In this way, pharmacists might provide the pharmacist to provide the correct use of medicines to patients who are attended at home. OBJECTIVE: This study aimed to detect, classify and quantify NOM, according to the Third Consensus of Granada, in patients treated at home, who were assisted by the Home Assistance Programme of the University Hospital of University of Paulo, Brazil. METHOD: A descriptive, observational and cross-sectional study was conducted. The pharmacotherapy plan was filled during the interview with the patient or caregiver. RESULTS: The study included 87 patients with a mean age of 66 years old, adults (89%), children (11%), female (58%) and retired (62%). A total of 62% patients presented NOM, with an average of 1.13 NOM per patient. The NOM included untreated health problems (20.6%), effects from unnecessary medicines (9.1%), non-quantitative ineffectiveness (34.5%), quantitative ineffectiveness (3.4%), non-quantitative safety problems (11.4%) and quantitative safety problems (3.4%). Patients with the following characteristics were more prevalent than expected in the NOM effectiveness group: those aged between 65 and 74 years (p=0.0199), those with a low education level (p=0.0266), those with increased comorbidity (p=0.0461), those using medicine for the digestive tract and metabolism (p=0.0475) and those using medicine for blood and blood-forming organs (p=0.0466). For the NOM necessity group, patients with endocrine, nutritional and metabolic diseases (p=0.0587) were in greater numbers than expected; and for the NOM safety group, only patients aged over 74 years (p=0.01809) were in greater numbers. CONCLUSION: For this population, it was concluded that there were several factors related to the occurrence of NOM: age, education, number of comorbidities, use of medicines for the digestive tract and the metabolism and medicines for blood and blood-forming organs. The use of the Third Consensus of Granada classification was very important for the recognition and measurement of NOM.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Serviços de Assistência Domiciliar , Assistência Farmacêutica , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Brasil , Criança , Pré-Escolar , Estudos Transversais , Feminino , Hospitais de Ensino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
Fluconazole is an antifungal agent. The purpose of this study was to evaluate bioequivalence of two commercial 150 mg capsule formulations of fluconazole available in the Brazilian market. The study was an open, randomized, two-period, two-group crossover trial with a 2-week washout interval. Blood samples were collected throughout a 96-h period after administration of reference product (R) and test product (T) to 28 fasting volunteers. A simple, accurate, precise and sensitive high-performance liquid chromatographic (HPLC) method with ultraviolet detection was developed and validated for quantification of fluconazole in plasma samples after liquid-liquid extraction. Bioequivalence between the products was determined by calculating 90% confidence intervals (90% C.I.) for the ratio of C(max), AUC(0-t) and AUC(0-infinity) values for the test and reference products, using logarithmic transformed data. The 90% confidence intervals for the ratio of C(max) (101.06-105.45%), AUC(0-t) (97.11-104.69%) and AUC(0-infinity) (97.96-103.36%) values for the test and reference products are within the 80-125% interval, proposed by FDA and EMEA. It was concluded that the two fluconazole formulations are bioequivalent in their rate and extent of absorption.
Assuntos
Fluconazol/administração & dosagem , Fluconazol/farmacocinética , Adulto , Análise de Variância , Cápsulas , Intervalos de Confiança , Estudos Cross-Over , Avaliação de Medicamentos/métodos , Feminino , Fluconazol/sangue , Humanos , Masculino , Pessoa de Meia-Idade , Equivalência TerapêuticaRESUMO
This report describes results of an in vitro study in which capsules containing omeprazole in enteric-coated pellets from different Brazilian manufacturers were evaluated. The original product was the reference in comparison to three similar products (A, B, and C). Samples were submitted to severe conditions (40 degrees C and 75% relative humidity during 120 days), and the tests performed were the omeprazole content, the percentage of omeprazole dissolved from the pellets, and the amount of H 238/85, its main degradation product. The data obtained suggest that these products could not be considered interchangeable. Differences in physical and physicochemical properties of products A, B, and C indicated that they did not maintain the required stability and that bioavailability might be affected by the poor dissolution of omeprazole from the pellets.
Assuntos
Omeprazol/administração & dosagem , Omeprazol/farmacocinética , Disponibilidade Biológica , Biofarmácia , Brasil , Química Farmacêutica , Estabilidade de Medicamentos , Humanos , Técnicas In Vitro , Omeprazol/normas , Controle de Qualidade , Comprimidos com Revestimento Entérico/análise , Comprimidos com Revestimento Entérico/normasRESUMO
1. In a randomized placebo-controlled study, 12 hypertensive patients were treated po for one week with 20 mg nitrendipine once daily plus placebo, twice daily and later with the same dose of nitrendipine plus 300 mg ranitidine (150 mg twice a day). 2. When ranitidine was coadministered, plasma nitrendipine levels (0-24 h) were significantly increased (P < 0.001), although no significant increase in peak plasma nitrendipine level (Cmax) was observed due to the wide range of variation of this parameter (Cmax) in hypertensive patients. 3. Ranitidine coadministration increased the area under the curve for 24-h (AUC0-24) plasma concentration vs time, from 49.07 +/- 6.28 micrograms.h/l to 82.35 +/- 2.57 micrograms.h/l (P < 0.01). This significant increase caused a reduction in total body clearance from 2008.33 +/- 246.33 to 1284.00 +/- 182.16 ml/min (P < 0.002). 4. Nitrendipine bioavailability was increased by 89% when ranitidine was coadministered but the kinetic effect of this drug interaction is unlikely to be of clinical relevance since no adverse effects were observed in patients evaluated after ranitidine association.
Assuntos
Hipertensão/tratamento farmacológico , Nitrendipino/farmacocinética , Nitrendipino/uso terapêutico , Ranitidina/farmacologia , Adulto , Disponibilidade Biológica , Interações Medicamentosas , Quimioterapia Combinada , Humanos , Hipertensão/metabolismo , Pessoa de Meia-IdadeRESUMO
In a randomized placebo-controlled study, 12 hypertensive patients were treated po for one week with 20 mg nitrendipine once daily plus placebo, twice daily and later with the same dose of nitrendipine plus 300 mg ranitidine (150 mg twice a day). When ranitidine was coadministered, plasma nitrendipine levels (0-24 h) were significantly increased (P<0.001),although no significant increase in peak plasma nitrendipine level (C max) was observed due to the wide range of variation of this parameter (C max) in hypertensive patients. Ranitidine coadministration increased the area under the curve for 24-h (AUC 0-24) plasma concentration vs time, from 49.07 ñ 6.28 ug h/l to 82.35 ñ 2.57 ug h/l (P<0.01). This significant increase caused a reduction in total body clearance from 20008.33 ñ 246.33 to 1284.00 ñ 182.16 ml/min (P<0.002). Nitrendipine bioavailability weas increased by 89% when ranitidine was coadministered but the kinetic effect of this drug interaction is unikely to be of clinical relevance since no adverse effects were observed in patients evaluated after ranitidine association