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Objective: To evaluate effectiveness and safety profile of pemetrexed in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) when it´s used on real clinical practice in Andalusia (a Spanish region with 8.5 million inhabitants, 2014 census data)., Methods: An observational multicentre retrospective study was conducted. Adult patients with locally advanced/metastatic NSCLC who received pemetrexed in any hospital in the Andalusian Public Health System during the last term of 2011 were included. We collected patients´ baseline characteristics, diagnostic and treatment data, effectiveness variables (response to treatment with pemetrexed and overallsurvival) and main adverse reactions detected., Results: 172 patients from 17 hospitals were included (77.33% were men), median age 63 years old (between 34 and 83). The predominant histology was adenocarcinoma (84.30%) and 85.20% were diagnosed of lung cancer with IV-stage. 78.49% had been smokers at some point in their lives. Median overall survival from the start of pemetrexed was 9 months (95%CI, 4.1-13.9). Progression of the disease was the most frequent response (33.14%), only one patient had complete response. Stable disease was associated with a higher probability of survival. Main adverse reactions detected were asthenia, haematological reactions, gastrointestinal reactions and dermal o mucous toxicity. No patients discontinued treatment for serious toxicity., Conclusions: Pemetrexed resulted quite effective in NSCLC when it was used on real clinical practice, with higher survival in non-squamous histology and patients with the best score of Eastern Cooperative Oncology Group scale. The toxicity profile was well tolerated. Prospective studies would be needed to confirm the effect of prognostic factors observed., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

Background: There is lack of information on the efficacy and safety of piperacillin–tazobactam administered by continuous infusion., Objective: The aim of this study was to investigate whether continuous infusion of piperacillin–tazobactam is superior in terms of efficacy to a 30 % higher dose administered by intermittent infusion to treat suspected or confirmed infection due to Pseudomonas aeruginosa. Setting Multicenter clinical trial with 11 third level Spanish hospitals., Method: Randomized, double-blind parallel-group clinical trial, controlled by conventional administration of the drug. Patients randomly assigned in a 1:1 ratio to receive piperacillin–tazobactam as continuous infusion (CI) or intermittent (II)., Main Outcome Measure: Primary efficacy endpoint was percentage of patients having a satisfactory clinical response at completion of treatment, defined as clinical cure or clinical improvement. Adverse events were reported. Results 78 patients were included, 40 in the CI group and 38 in the II group. Mean (standard deviation) duration of treatment was 7 (±4.44) days. 58 patients (74.4 %) experienced cure or improvement at the end of the treatment. There were no statistical differences in cure rates between the two treatment arms and no adverse events were reported., Conclusion: Continuous infusion of piperacillin–tazobactam is an alternative administration drug method at least similar in efficacy and safety to conventional intermittent infusion. Multivariate analysis is needed to determine whether continuous administration might be more beneficial than intermittent in certain patient subgroups.

Purpose: The successful use of nadolol as an alternative to propranolol therapy in three cases of infantile hemangioma is reported., Summary: Infantile hemangioma is a benign vascular neoplastic disorder that affects up to 10% of newborns and can lead to deformity or local complications in severe cases. Propranolol, administered alone or in combination with corticosteroids, is increasingly used to treat infantile hemangioma, but its ability to cross the blood-brain barrier and potentially cause central nervous system adverse effects has prompted research on alternative β-blocker therapies for the disorder that have more favorable safety profiles, including nadolol. This article describes the use of nadolol to treat three pediatric patients with a buccal or genital hemangioma who developed adverse reactions (mainly, irritability and sleep disturbances) or resistance to initial treatment with propranolol. The patients were 10 months, 12 months, and 4 years of age, respectively, when hemangioma treatment was initiated. The results of nadolol therapy were favorable, with involution of lesions and gradual disappearance of propranolol-associated adverse effects occurring in all three cases. As with any use of β-blocker therapy in a pediatric patient, a cardiac workup is advised before the start of nadolol therapy; blood pressure and heart rate monitoring should be performed at one and two hours after the first dose and continued during dose escalation., Conclusion: Nadolol was an effective alternative to propranolol in three pediatric patients with hemangiomas., (Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

The aim of this study is to determine the profile of the use of pemetrexed in metastatic or locally advanced NSCLC in Andalusia and its variation over 2 years (2010-2011). A prescription-indication observational retrospective multicenter study was conducted. Adult patients with locally advanced/metastatic NSCLC who received pemetrexed in any hospital in the Andalusian Public Health System during the first term of 2010 or the last term of 2011 were included. We collected patients' baseline characteristics, tumour histology and stage, pemetrexed indication and performance status at the start of treatment. In all, 107 and 170 patients (62 ± 11 years old) from 17 hospitals were included in 2010 and 2011, respectively. The predominant histology was adenocarcinoma (85%), 88% of patients had stage IV tumours and 52% Eastern Cooperative Oncology Group stage (ECOG) 1. Pemetrexed indications in 2010 and 2011 were: First line combined with platinum (28.97-37.64%); first line combined with platinum and maintenance with pemetrexed (24.30-28.82%); second line mono-therapy (12.15-7.65%) and maintenance (2.15-7.05%). Off-label use was detected in 22.43% (2010) and 18.84% (2011). In conclusion, pemetrexed combined with platinum is mainly used as first-line treatment in NSCLC patients with stage IV, adenocarcinoma histologic subtype and good performance status. Off-label use is high (especially in 2010). An adequate therapeutic positioning for pemetrexed based on effectiveness and safety analysis should be defined, so that NSCLC patients could be beneficiated with the most cost-effective chemotherapy treatment.

Introduction: Lung cancer accounts for 20 % of cancer deaths in Spain. The most frequent subtype (87 %) is non-small cell lung cancer (NSCLC). Pemetrexed is a recently marketed drug added to NSCLC therapeutic arsenal. It seems to have become one of the most used options for the treatment of this condition over the last 3 years., Aim of the Review: To evaluate the efficacy and safety of pemetrexed in NSCLC, in the different therapy lines. Method A systematic search of published literature was conducted using the main databases (MEDLINE, EMBASE, the Cochrane Library and the Center for Reviews and Dissemination) and subsequently a search of referenced literature was performed. We included clinical trials, meta-analyses and systematic reviews. The evaluation of the quality of the articles was performed by pairs using specific assessment scales, Critical Appraisal Skills Program (CASP) adapted for CASP Spain. Then we extracted data on efficacy and safety according to the treatment line assessed., Results: We identified 277 references. Finally, nine clinical trials and a meta-analysis complied with inclusion criteria. In first-line induction, treatment with pemetrexed associated with a platinum was similar in terms of efficacy to other alternative chemotherapy regimens, except in patients with non-squamous histology, in whom survival was higher in the experimental group. In maintenance treatment, greater efficacy was seen with pemetrexed in patients with non-squamous histology. In second-line treatment, there were no significant differences in terms of efficacy and safety for pemetrexed treatment versus other chemotherapy options. The most frequent adverse reactions were: hematological, gastrointestinal and neurological. All were significantly less frequent with pemetrexed versus other alternative therapies, except for liver toxicity., Conclusions: Due to the high degree of uncertainty as to its efficacy in certain subgroups of patients, including conflicting data; to its recent incorporation, and therefore lack of safety data in the medium and long term, and the high budgetary impact of its incorporation into health systems, it seems reasonable to optimize its use, identifying those patients who may benefit most.

Since allogeneic blood transfusion (ABT) is not harmless, multiple alternatives to ABT (AABT) have emerged, though there is great variability in their indications and appropriate use. This variability results from the interaction of a number of factors, including the specialty of the physician, knowledge and preferences, the degree of anemia, transfusion policy, and AABT availability. Since AABTs are not harmless and may not meet cost-effectiveness criteria, such variability is unacceptable. The Spanish Societies of Anesthesiology (SEDAR), Hematology and Hemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Hemostasis (SETH) and Blood Transfusion (SETS) have developed a Consensus Document for the proper use of AABTs. A panel of experts convened by these 6 Societies have conducted a systematic review of the medical literature and have developed the 2013 Seville Consensus Document on Alternatives to Allogeneic Blood Transfusion, which only considers those AABT aimed at decreasing the transfusion of packed red cells. AABTs are defined as any pharmacological or non-pharmacological measure aimed at decreasing the transfusion of red blood cell concentrates, while preserving patient safety. For each AABT, the main question formulated, positively or negatively, is: "Does this particular AABT reduce the transfusion rate or not?" All the recommendations on the use of AABTs were formulated according to the Grades of Recommendation Assessment, Development and Evaluation (GRADE) methodology., (Copyright © 2012 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.)

What Is Known and Objective: Psoriasis is a chronic skin disease for which there is an increasing range of treatment options. Biological agents (ustekinumab, adalimumab, infliximab and etanercept) are indicated for moderate-to-severe plaque-type psoriasis in adults who fail to respond to, have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA Unfortunately, with new drugs, the pivotal trials leading to their licensing are often placebo-controlled trials rather than comparative trials vs. established therapies. Therefore, inference on comparative effectiveness of the newer agents must be derived indirectly, through estimation of effects of the new agents vs. a common comparator. The objective of this study is to compare the relative efficacy of the biological agents through a systematic review of the indirect clinical trial evidence., Methods: A systematic literature search was performed for clinical trials of biological agents in psoriasis. Pivotal, randomized, double-blind, controlled (placebo) trials using intention-to-treat analysis were selected for detailed analysis. Trials must include PASI 75 as a primary end point. The indirect comparison was performed using the method of Bucher adjusted with the ITC calculator (Indirect Treatment Comparisons of the Canadian Agency for Drugs and Technologies in Health), etanercept being the reference drug. We defined delta value for therapeutic equivalence as a difference in the efficacy of 25% among the different treatment options., Results and Discussion: Fourteen studies (four for ustekinumab, three for adalimumab, three for infliximab and four for etanercept) were included. The indirect comparison results reveal that ustekinumab, adalimumab and infliximab were statistically superior to etanercept with an absolute risk difference for PASI 75 of 12% (95% CI = 5·9-18%), 11% (95% CI = 5·3-16·7%) and 24% (29·7-18·3%) respectively. However, in all situations, the 95% confidence interval does not achieve clinical relevance as no delta exceeds the previously set value (25%)., What Is New and Conclusion: Ustekinumab, adalimumab, infliximab and etanercept can be regarded as clinical equivalents for the treatment of psoriasis. Choice between these agents therefore depends on their relative safety profiles, individual contra-indications and cost effectiveness., (© 2013 Blackwell Publishing Ltd.)

Background and Objective: The Pharmacy and Therapeutics Committee (PTC) evaluates the requests for off-label uses with an abbreviated report format. The aim of this study is to perform a descriptive analysis of this activity and to study the rate of approvals., Material and Methods: A descriptive study was performed on the PTC reports in a tertiary hospital between September 2009 and April 2011. The type of drug by treatment group and by type of dispensing, indication and requesting department was analysed. The final decision adopted was studied as the primary outcome, and the percentage of requests approved according to the characteristics of the drug evaluated, indication requested, alternatives used, evidence and cost, as secondary outcomes., Results: A total of 51 applications were analysed, of which 60.8% were drugs for hospital use and 54.9% cytostatic. The most requested indications were the onco-haematological (43.2%) and autoimmune (35.3%). Haematology was the department that made most requests (11 requests with 72.7% approved), Oncology and Paediatrics (both with 10 requests, with 50% approved). Almost two-thirds (60.8%) of the requests were approved. Of those that were not approved, 11 had not used up the therapeutic alternatives, and 8 had no evidence. Just under half (47.1%) of the drugs requested had a cost/patient between 10,000-100,000 euros,of which 58.3% were approved (cost per course of treatment if it had a defined period, or cost of treatment per year for chronic treatment)., Conclusion: There is an increase in the activity of the PTC that is growing over the years. Most applications focus on drugs for hospital use and cytostatic drugs by Onco-haematology. There is a high rate of approval by the PTC, and high variability in the percentage of approval depending on the department and the evidence of use. The difference between approved and unapproved requests followed a logic of cost-effectiveness., (Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.)

Objective: The purpose of this study is to describe the structure of the CFyT, the Pharmacy and Therapeutics Committee, and a tertiary hospital's selection process for new drugs., Material and Methods: All annals of the P&TC and the New Drug Incorporation Guides (GINF) to incorporate new drugs received at Hospital Virgen del Rocío between 2004 and 2007 were reviewed. We carried out a descriptive study which collected variables having to do with the drug (drug type, type of register, route of administration and legal category), the petitioner (responsible division, professional category and request type) and the result of the evaluation (final decision, elapsed time between the request and the decision)., Results: Of the 72 requested drugs, 45 (62.5%) were approved: six as equivalent treatments, 36 (80%) with specific recommendations, and three (4.2%) with no restrictions. Twelve drugs (81.1%) were not included due to insufficient evidence of their effectiveness compared with the current treatment. The most frequently-requested drug type was the antineoplastics, most commonly requested by Oncology and Haematology divisions. We highlight the fact that many of the petitioners included clinical trials (97.2%) and data referring to costs (84.7%)., Conclusions: There is a high level of compliance with the GINF guide in our centre, which guarantees that the P&TC's final decision is based on scientific evidence., (Copyright © 2009 SEFH. Published by Elsevier Espana. All rights reserved.)

Background: The management of patients with acute myocardial infarction (AMI) has changed over the last decade. The aim of this study was to evaluate the pharmacologic treatment of AMI in the clinical practice, with special emphasis in thrombolytic therapy., Material and Methods: Prospective drug utilization survey, collecting data from 26 hospitals belonging to the Andalusian Health Service, Spain, during one month period. Pharmacologic treatment in the first 24 h was obtained., Results: Out of 379 patients recruited, 52.8% received thrombolytic therapy, although another 19% could have obtained some benefit from that therapy. Alteplase was the most frequently used thrombolytic (65.5%). The regimen prescribed was mainly that followed in GUSTO Study (45.8%) or double bolus (43.5%). In a high percentage of patients the thrombolytic selection was not made according to the results of the literature. Women and patients older than 75 years were less likely to receive thrombolytic therapy. There was a high utilization of aspirin (89.7%), nitrates (84.4%) and heparin (83.6%)., Conclusions: Thrombolytic therapy was prescribed in a higher percentage of patients than is reported in other trials. In spite of that, thrombolytics should have been used in more patients. As alteplase does not have a definitive benefit over streptokinase, protocol is needed when selecting a thrombolytic agent.