Off-label prescription of drugs at hospital

Objectives: To develop a procedure for management of off-label medications, and to analyze the treatments, indications, and hospital units which will request them more frequently, as well as which variables will have an impact on the authorization decision, and its economic impact. Methods: A procedure was designed where clinicians would complete request forms and the Hospital Unit would prepare reports assessing their efficacy, safety, convenience, and cost. The request forms for the past five years were analyzed. Results: A total of 834 applications were received, and 88.1% of these were accepted. The authorization rates were higher for Paediatric Units (95.7% vs. 86.6%; p<0.05). The reasons for considering prescriptions as off-label were: different indication (73.2%), different combination (10.2%), different line of treatment (8.6%) and different age (8%). A 73.4% of requests were for antineoplastic drugs, and the most frequently prescribed were rituximab (120) and bevacizumab (103). The quality of evidence supporting the prescriptions was moderate-low, though no direct relationship with the likelihood of approval was demonstrated (p = 0.413). The cost of the approved medications was 8,567,537 €, and the theoretical savings for those drugs rejected was of 2,268,642 €. There was a statistically significant decrease in the authorization rate (p < 0.05, Student's t test) when spending increased. Conclusions: The responsibility for assessing off-label prescriptions has fallen on the Pharmacy Unit. It has not been demonstrated that the quality of evidence represents a decisive variable for approval of treatment; on the other hand, age and cost have demonstrated a significant impact.

Comparison of two field methods for estimating body fat in different Spanish Dance disciplines

The purpose of the present study was to investigate percentage body fat (%BF) differences in three Spanish dance disciplines and to compare skinfold and bioelectrical impedance predictions of body fat percentage in the same sample. Seventy-six female dancers, divided into three groups, Classical (n=23), Spanish (n=29) and Flamenco (n=24), were measured using skinfold measurements at four sites: triceps, subscapular, biceps and iliac crest, and whole body multi-frequency bioelectrical impedance (BIA). The skin-fold measures were used to predict body fat percentage via Durnin and Womersley's and Segal, Sun and Yannakoulia equations by BIA. Differences in percent fat mass between groups (Classical, Spanish and Flamenco) were tested by using repeated measures analysis (ANOVA). Also, Pearson's product-moment correlations were performed on the body fat percentage values obtained using both methods. In addition, Bland-Altman plots were used to assess agreement, between anthropometric and BIA methods. Repeated measures analysis of variance did not found differences in %BF between modalities (p<0.05). Fat percentage correlations ranged from r= 0.57 to r=0.97 (all, p<0.001). Bland-Altman analysis revealed differences between BIA Yannakoulia as a reference method with BIA Segal (-0.35 ± 2.32%, 95%CI: -0.89to 0.18, p=0.38), with BIA Sun (-0.73 ± 2.3%, 95%CI: -1.27 to -0.20, p=0.014) and Durnin-Womersley (-2.65 ± 2,48%, 95%CI: -3.22 to -2.07, p<0.0001). It was concluded that body fat percentage estimates by BIA compared with skinfold method were systematically different in young adult female ballet dancers, having a tendency to produce underestimations as %BF increased with Segal and Durnin-Womersley equations compared to Yannakoulia, concluding that these methods are not interchangeable.