Off-label use of inhaled bronchodilators in hospitalised patients in Spain: a multicentre observational study.

BACKGROUND: Off-label prescription of inhaled bronchodilators (IB) is frequent, despite the fact that they can be ineffective and increase avoidable healthcare costs. OBJECTIVE: To analyse the frequency of off-label prescription of IB in hospitalised patients. Indications and level of evidence, involved drugs, medical specialties prescribing off-label IB and patients' adherence to IBs were also evaluated. METHOD: A descriptive, observational, cross-sectional study was performed in four tertiary hospitals in Spain. The main outcome measure was the number of patients prescribed off-label IBs. Prescriptions were checked against the European Medicines Agency-approved indications. The level of evidence supporting off-label prescription of IBs (according to MICROMEDEX 2.0) was also analysed. Patients were interviewed to test differences (off-label vs on-label) in adherence and knowledge about their inhaled therapy. RESULTS: 217 patients were prescribed IBs, 92 of whom were givend off-label IBs (54.7% men, mean age 73.9±12.9 years). The most common off-label prescriptions for IBs were: unspecified dyspnoea (not related to COPD or asthma) (27.2%), respiratory infections (23.9%) and heart failure (22.8%). 76.8% of patients did not have evidence supporting them. Beta2-agonist+corticosteroids and anticholinergics were most commonly prescribed off-label. Internal Medicine was the main medical specialty involved. There were no differences between off-label and on-label users in terms of patients' knowledge about treatment and adherence. CONCLUSION: Off-label indications for IBs are common in hospitalised patients and are generally indicated without scientific support. Dyspnoea not related to COPD or asthma, respiratory infections and heart failure were the main off-label indications, most frequently treated with anticholinergics and beta2-agonists+corticosteroids, for which their efficacy and safety has not been proved. Our results show that prescribing needs to be improved to follow the evidence that exists. Moreover, further research focused on off-label indications is needed to clarify whether they are effective, safe and cost-effective.

Effect of intravenous iron on functional outcomes in hip fracture: a randomised controlled trial.

OBJECTIVES: to determine the safety and effect of intravenous iron sucrose on functional outcomes, delirium, nosocomial infections and transfusion requirements in older patients with hip fracture. DESIGN: single-centre randomised, double-blind, placebo-controlled clinical trial. SETTING AND PARTICIPANTS: orthogeriatric share care service at an academic tertiary care hospital. A total of 253 patients were recruited: 126 patients were assigned to intravenous iron and 127 to placebo. METHODS: on days 1, 3 and 5 after admission, the iron group received 200 mg Venofer® (iron sucrose) in 100 ml saline and the placebo group 100 ml saline. The primary outcome was absolute functional gain, considered as Barthel index (BI) at discharge minus BI on admission. Secondary outcomes included incidence of postoperative delirium according to the confusion assessment method, proportion of patients recovering prior functional status at 3 months, postoperative transfusion requirements, haemoglobin at 3 months, incidence of nosocomial infections and safety. RESULTS: the median participant age was 87 (interquartile range, 82.5-91.5) years. Most patients were female (72.7%), and the median previous BI was 81(59-95). No significant effect of intravenous iron was observed for the primary outcome: the median AFG score was 17.1 points (4.8-23.3) in the intravenous iron group and 16 points (6-26) in the placebo group (P = 0.369). No significant treatment effects were observed for other functional outcomes or secondary end points. CONCLUSION: while we found no impact of intravenous iron sucrose on functional recovery, incidence of postoperative delirium, transfusion requirements, haemoglobin at 3 months, mortality and nosocomial infections rates in older patients with hip fracture, we did find that the intervention was safe.

Análisis del número y diseño de ensayos clínicos y de la prescripción de medicamentos para indicaciones no incluidas en su ficha técnica en pacientes hospitalizados pediátricos / Analysis of clinical trials and off-label drug use in hospitalized pediatric patients

Introducción. La falta de ensayos clínicos en pediatría (ECP) conduce a la prescripción off-label de medicamentos en niños (POMN). Nuestro objetivo fue analizar el número y diseño de ECP y de POMN en los últimos años. Población, material y métodos. Estudio observacional, retrospectivo de ECP y POMN desde 2007 hasta 2012 realizados en un hospital infantil con 252 camas. Se analizó el número y diseño de ECP y de POMN por año y sus características. Resultados. Se evaluaron 87 ECP y 449 principios activos correspondientes a 1049 medicamentos prescritos a niños hospitalizados. De ellos, 117 (26%) se utilizaron fuera de prospecto. Los ECP fueron en aumento desde 2008 hasta 2011. Ese año, el 52,2% de los ECP fueron no aleatorizados ni controlados y solo 39,1% fueron aleatorizados controlados. Un 77% de los fármacos investigados eran prescritos fuera de prospecto. La POMN se mantuvo estable durante el estudio. Conclusiones. En nuestro hospital, ha aumentado la investigación en pediatría en los últimos años; los estudios no aleatorizados ni controlados fueron los más frecuentes. La POMN no se ha modificado.

Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed children's hospital. The number and design of PCTs and OLDU in children were analyzed by year and by characteristics. Results. Eighty-seven PCTs and 449 active ingredients corresponding to 1049 drugs prescribed to hospitalized children were evaluated.Of these, 117 (26%) were used off-label. The number of PCTs increased from 2008 to 2011. In 2011, 52.2% of PCTs were non-randomized and uncontrolled studies, and only 39.1% were randomized, controlled trials. Of all studied drugs, 77% corresponded to off-label use. OLDU in children remained steady throughout the study period. Conclusions. In our hospital, the number of pediatric research studies has increased in the past years, being non-randomized and uncontrolled studies the most frequent. OLDU in children has not changed

Analysis of clinical trials and off-label drug use in hospitalized pediatric patients.

Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed children's hospital. The number and design of PCTs and OLDU in children were analyzed by year and by characteristics. Results. Eighty-seven PCTs and 449 active ingredients corresponding to 1049 drugs prescribed to hospitalized children were evaluated.Of these, 117 (26%) were used off-label. The number of PCTs increased from 2008 to 2011. In 2011, 52.2% of PCTs were non-randomized and uncontrolled studies, and only 39.1% were randomized, controlled trials. Of all studied drugs, 77% corresponded to off-label use. OLDU in children remained steady throughout the study period. Conclusions. In our hospital, the number of pediatric research studies has increased in the past years, being non-randomized and uncontrolled studies the most frequent. OLDU in children has not changed.

Analysis of clinical trials and off-label drug use in hospitalized pediatric patients. / Analysis of clinical trials and off-label drug use in hospitalized pediatric patients.

Introduction. The lack of pediatric clinical trials (PCTs) leads to an off-label drug use (OLDU) in children. Our objective was to analyze the number and design of PCTs and OLDU in children in the past years. Population, material and methods. Observational and retrospective study on PCTs and OLDU in children, conducted from 2007 to 2012 in a 252-bed childrens hospital. The number and design of PCTs and OLDU in children were analyzed by year and by characteristics. Results. Eighty-seven PCTs and 449 active ingredients corresponding to 1049 drugs prescribed to hospitalized children were evaluated.Of these, 117 (26

) were used off-label. The number of PCTs increased from 2008 to 2011. In 2011, 52.2

of PCTs were non-randomized and uncontrolled studies, and only 39.1

were randomized, controlled trials. Of all studied drugs, 77

corresponded to off-label use. OLDU in children remained steady throughout the study period. Conclusions. In our hospital, the number of pediatric research studies has increased in the past years, being non-randomized and uncontrolled studies the most frequent. OLDU in children has not changed.

Potential medication errors associated with computer prescriber order entry.

INTRODUCTION: To assess the frequency of medication errors (ME) induced or enhanced by computerized physician order entry (CPOE). Error type, drug classes involved, specialty, patient outcome and system failures were also evaluated. METHODS: Observational quantitative study in a large tertiary care medical center over March 2012 3 years after CPOE implementation. Pharmacists detected ME associated with CPOE (those that wouldn't have occurred if the clinician had prescribed manually) and unassociated in pharmacological treatments in inpatients of 13 specialties (421 beds). Main outcome measured were ME associated and unassociated with CPOE. RESULTS: We found 714 ME with 85.857 drug prescriptions (a 0.8 % error rate, 95 % CI 0.6-0.7). Percentage of error associated with CPOE was 77.7 %. The main types of error related to CPOE were wrong medication selection (20.9 %) and improper data placement (20.3 %). Failures with medications prescribed in primary care, unavailable in the hospital pharmacy, were involved in 21.6 % of all ME. Errors involving surgical specialties were double those involving medical specialties (1.2 vs. 0.6 %). Most ME associated with CPOE were potential errors (90 %). During the study system failures occurred four times. CONCLUSIONS: The use of CPOE minimises the occurrence of medication errors, however, they still occur. Most errors are associated with the CPOE technology. We therefore face a new challenge in the prevention of ME that require a change in strategy for patient safety. Continued training of prescribers, standardization of the electronic prescription programs and integration between computer applications in hospitals and with primary care should be a priority.

Colquicina: ¿qué hay de nuevo, viejo? / Colchicine: what's up, doc?

En los últimos años se ha incrementando notablemente el uso de colquicina fuera de sus indicaciones autorizadas (off-label), fundamentalmente en la enfermedad cardiovascular y, en concreto, en la prevención de recurrencias tras pericarditis aguda o recurrente y de pericarditis tras cirugía cardíaca. Sin embargo, no es un fármaco exento de riesgos debido a su estrecho margen terapéutico, interacciones farmacológicas potencialmente graves y toxicidad asociada a una elevada morbimortalidad. En esta revisión analizamos los beneficios aportados por la colquicina en la enfermedad cardiovascular, los riesgos derivados de su utilización y las últimas recomendaciones para un uso seguro de este antiguo fármaco (AU)

Over de past years use off-label of colchicine has notably increased, mainly as a result of the latest studies published about its efficacy in the prevention of recurrence after acute or recurrent pericarditis and pericarditis after cardiac surgery. Nevertheless, colchicine use has been associated with serious drug interactions and toxicity with high morbimortality.Taking into account the recent results about the efficacy of colchicine in pericarditis management, we envisage an increase in the use of this drug by clinicians. In this review we analyse the risks and current recommendations for a safety use of this ancient drug (AU)

[Colchicine: what's up, doc?]. / Colquicina: ¿qué hay de nuevo, viejo?

Over de past years use off-label of colchicine has notably increased, mainly as a result of the latest studies published about its efficacy in the prevention of recurrence after acute or recurrent pericarditis and pericarditis after cardiac surgery. Nevertheless, colchicine use has been associated with serious drug interactions and toxicity with high morbimortality. Taking into account the recent results about the efficacy of colchicine in pericarditis management, we envisage an increase in the use of this drug by clinicians. In this review we analyse the risks and current recommendations for a safety use of this ancient drug.

Strategies for improving documentation and reducing medication errors related to drug allergy.

New technologies like computerized physician order entry systems, that includes a support alert for drug allergies, can be an effective tool to prevent medical errors related to drug hypersensitivity most of them caused by lack of documentation and information.