PurposeThe study aims to assess the clinical evidence, outcome and cost of off-label use of medicines in the hospital setting.MethodsA multicentric prospective cohort study of patients treated with off-label medicines was carried out in five tertiary hospitals from May 2011 to May 2012. Information on clinical characteristics of patients, drugs, outcomes and costs was collected. Patients were followed up to 6 months, and information was assessed by reviewing clinical records and interviewing physicians.ResultsA total of 226 patients were included. The median (interquartile range (IQR)) age of patients was 46 (33–62) years; 59 % were women. Patients had received a median of three previous treatments, and a lack of response (or suboptimal) was the main reason for off-label use (72.1 %). A total of 232 off-label medicines were administered for 102 different indications. The most frequent medicines were rituximab (49; 21.1 %), botulinum toxin (25; 10.7 %) and omalizumab (14; 6.0 %). In 117 (51.8 %) cases, the level of clinical evidence for their use was low. A partial clinical response was observed in 82 patients (36.3 %), complete response in 71 (31.4 %) and stabilization in 11 (4.9 %). A total of 58 (26.5 %) patients had adverse effects, which in 11 (4.9 %) were severe. The median (IQR) cost per patient was €2,943.07 (541.9–5,872.54).ConclusionsThere was a high variability of off-label medicines and indications. Although the clinical evidence of off-label medicines was often low, clinical response was observed in many patients with previous multiple treatment failure, but at the expense of some adverse effects and a high cost. Registers of patients would be helpful for clinical decisions, although clinical trials are needed.Electronic supplementary materialThe online version of this article (doi:10.1007/s00228-014-1746-2) contains supplementary material, which is available to authorized users.
A total of 191 patients (17.8 patients per 1000 inhabitants) sought medical attention because of vertigo over the year of the study. Of these, 82 patients (7.6 per 1000 inhabitants) experienced vertigo for the first time, a de novo crisis. Women were more often affected and the crises occurred more frequently in individuals between 50 and 60 years of age. The work status had influence on the results obtained.
BackgroundThe literature reveals that approximately 20% of healthcare professionals fail to document drug allergies (DA) in the electronic records. Breakdowns in the documentation of allergies can lead to medicines errors (MEs).PurposeThe aims of this study were to examine patient DA profiles documented in the electronic records and to determine MEs associated with DAs.Material and methodsRetrospective observational study including all adult patients admitted to our hospital on February 24, 2014. Discharge prescriptions and patient DA profiles entered into the different (non-integrated) electronic records were reviewed.Results258 patients were included in the study. In all patients, a history of an allergic reaction to drugs or not was reported in at least one electronic record: 55% in the patient’s admission prescriptions, 60% in the nursing consumption form and 46.4% in the electronic prescription system. Nevertheless, only in 3% of the cases was it reported in all of the records. In 13.2% of the cases, there were discrepancies between different electronic records. DAs were recorded in 60 patients. The drugs most frequently involved were penicillin (50%) and metamizole (25%). 11 MEs were identified in which a drug was prescribed for a patient with a documented DA. In 6 cases the medicine didn’t reach the patient and was prevented by a pharmacist in four cases. In the other 5, the medicine reached the patients. Fortunately, there was no evidence of any reactions following the administration of the drugs.ConclusionThe existence of different non-integrated electronic records favours inadequately recorded DAs, discrepancies and MEs related to DA. Pharmacists can play an active role in getting adequate DA recording systems into hospitals and improving inpatient safety.References and/or acknowledgementsI thank Dra. Ana Pérez for helpful comments.No conflict of interest.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.