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.

To eat or not to eat meat: that is the question

Meat is a well accepted food with appreciable appealing. Due to its high nutritional value it plays a central role in human development. Meat/meat derivates are important sources of proteins, minerals and vitamins. Their nutritional importance is paralleled to their economic impact. Paying attention to the social alarm originated by a recent publication of WHO about the relationship between red and/or processed meat consumption and cancer, this paper reviews the following aspects: a) the present consumption of meat/meat products in Spain; b) the contribution of their macro/micronutrients to the recommended dietary allowances; c) the obliged use of additives (e.g. nitrites and nitrates) to warrant the food safety, and their daily intake. In addition health risks derived from a high consumption, as well as the most appropriate culinary uses in order to reduce the formation of toxic products (e.g. N-nitrosocompounds) are commented. Due to the huge variety of available meat products, this paper concludes that any generalization should be avoided. We also emphasize about the advantages of consuming meat/meat products in the frame of a Mediterranean diet, rich in vegetables, fruits, and bioactive compounds.