[Validation of a method for notifying and monitoring medication errors in pediatrics]. / Validación en pediatría de un método para notificación y seguimiento de errores de medicación.

OBJECTIVE: To analyze the impact of a multidisciplinary and decentralized safety committee in the pediatric management unit, and the joint implementation of a computing network application for reporting medication errors, monitoring the follow-up of the errors, and an analysis of the improvements introduced. MATERIAL AND METHODS: An observational, descriptive, cross-sectional, pre-post intervention study was performed. An analysis was made of medication errors reported to the central safety committee in the twelve months prior to introduction, and those reported to the decentralized safety committee in the management unit in the nine months after implementation, using the computer application, and the strategies generated by the analysis of reported errors. MEASURED VARIABLES: Number of reported errors/10,000 days of stay, number of reported errors with harm per 10,000 days of stay, types of error, categories based on severity, stage of the process, and groups involved in the notification of medication errors. RESULTS: Reported medication errors increased 4.6 -fold, from 7.6 notifications of medication errors per 10,000 days of stay in the pre-intervention period to 36 in the post-intervention, rate ratio 0.21 (95% CI; 0.11-0.39) (P<.001). The medication errors with harm or requiring monitoring reported per 10,000 days of stay, was virtually unchanged from one period to the other ratio rate 0,77 (95% IC; 0,31-1,91) (P>.05). The notification of potential errors or errors without harm per 10,000 days of stay increased 17.4-fold (rate ratio 0.005., 95% CI; 0.001-0.026, P<.001). CONCLUSIONS: The increase in medication errors notified in the post-intervention period is a reflection of an increase in the motivation of health professionals to report errors through this new method.

Lista modelo de medicamentos de alto riesgo / A model list of high risk drugs

Introducción: Los «medicamentos de alto riesgo» son aquellos con un «riesgo» muy elevado de causar daños graves o incluso mortales cuando se produce un error en el curso de su utilización. El Institute for Safe Medication Practices (ISMP) elaboró una relación aplicable a la población general, sin diferenciar población pediátrica y adulta, por lo que existe carencia de información para la población pediátrica. El objetivo de este trabajo es elaborar una lista de medicamentos de alto riesgo adaptada a la población pediátrica y neonatal que sirva de referencia para el personal sanitario de un hospital pediátrico. Material y métodos: Se realizó una búsqueda bibliográfica en mayo del 2012 en las principales bases de datos biomédicas, para identificar posibles listas o referencias publicadas en relación con medicamentos de alto riesgo en población pediátrica y neonatal. Resultados: Se encontraron 15 trabajos, seleccionándose 9 para el objetivo principal del estudio. Se elaboró una lista guía tomando como base la del ISMP, añadiendo fármacos con alta percepción de riesgo para la población pediátrica y eliminando aquellos cuyo uso en pediatría era anecdótico. Conclusiones: No se encontró una lista publicada que se adaptase totalmente a nuestro objetivo. La lista de medicamentos de alto riesgo en población pediátrica y neonatal elaborada puede ser modelo de referencia para hospitales pediátricos. Su conocimiento y utilización, así como actividades derivadas de la misma enmarcadas dentro de la política de seguridad, ayudará a evitar errores de medicación en cada proceso de la cadena terapéutica (prescripción, transcripción, dispensación y administración) (AU)

Introduction: «High-risk drugs» are those that have a very high «risk» of causing death or serious injury if an error occurs during its use. The Institute for Safe Medication Practices (ISMP) has prepared a high-risk drugs list applicable to the general population (with no differences between the pediatric and adult population). Thus, there is a lack of information for the pediatric population. The main objective of this work is to develop a high-risk drug list adapted to the neonatal or pediatric population as a reference model for the pediatric hospital health workforce. Material and methods: We made a literature search in May 2012 to identify any published lists or references in relation to pediatric and/or neonatal high-risk drugs. Results: A total of 15 studies were found, from which 9 were selected. A model list was developed mainly based on the ISMP one, adding strongly perceived pediatric risk drugs and removing those where the pediatric use was anecdotal. Conclusions: There is no published list that suits pediatric risk management. The list of pediatric and neonatal high-risk drugs presented here could be a «reference list of high-risk drugs » for pediatric hospitals. Using this list and training will help to prevent medication errors in each drug supply chain (prescribing, transcribing, dispensing and administration) (AU)

[A model list of high risk drugs]. / Lista modelo de medicamentos de alto riesgo.

INTRODUCTION: «High-risk drugs¼ are those that have a very high «risk¼ of causing death or serious injury if an error occurs during its use. The Institute for Safe Medication Practices (ISMP) has prepared a high-risk drugs list applicable to the general population (with no differences between the pediatric and adult population). Thus, there is a lack of information for the pediatric population. The main objective of this work is to develop a high-risk drug list adapted to the neonatal or pediatric population as a reference model for the pediatric hospital health workforce. MATERIAL AND METHODS: We made a literature search in May 2012 to identify any published lists or references in relation to pediatric and/or neonatal high-risk drugs. RESULTS: A total of 15 studies were found, from which 9 were selected. A model list was developed mainly based on the ISMP one, adding strongly perceived pediatric risk drugs and removing those where the pediatric use was anecdotal. CONCLUSIONS: There is no published list that suits pediatric risk management. The list of pediatric and neonatal high-risk drugs presented here could be a «reference list of high-risk drugs ¼ for pediatric hospitals. Using this list and training will help to prevent medication errors in each drug supply chain (prescribing, transcribing, dispensing and administration).

[Effectiveness and safety of adalimumab and etanercept for rheumatoid arthritis in a third-level hospital]. / Efectividad y seguridad de adalimumab y etanercept en artritis reumatoide en un hospital de tercer nivel.

OBJECTIVE: To assess the effectiveness of adalimumab and etanercept at 6 and 12 months after therapy onset using DAS28, EULAR (European League Against Rheumatism), and ACR (American College of Rheumatology) criteria, and to analyze safety. METHOD: A prospective, 12-month, observational study of a patient cohort diagnosed with rheumatoid arthritis who were started on adalimumab or etanercept at the Rheumatology Department between January 2003 and December 2004. DAS28, EULAR, and ACR criteria were examined at 6 and 12 months. An intention-to-treat analysis was performed, and adverse reactions were quantitized. RESULTS: Ninety-nine patients were included - 50 on adalimumab and 49 on etanercept. Of these, 30 and 20%, respectively, received monotherapy. No differences in effectiveness were seen between both drugs during the studied periods of time according to DAS28. EULAR response to adalimumab at 6 and 12 months was: good 28 and 38%; moderate 40 and 36%; nil 10 and 4%; regarding etanercept at 6 and 12 months: good 29 and 43%; moderate 31 and 24%; nil 18 and 10%. As regards adalimumab at 6 and 12 months: ACR20: 64 and 62%; ACR50: 44 and 46%; ACR70: 22 and 26%; as regards etanercept at 6 and 12 months: ACR20: 61 and 65%; ACR50: 41 and 45%; ACR70: 16 and 24%. Eleven patients discontinued therapy in each group. CONCLUSIONS: Adalimumab and etanercept had a similar effectiveness in our population. Criteria of use may condition results, and thus awareness of other hospitals experience is encouraged.

Efectividad y seguridad de adalimumab y etanercept en artritis reumatoide en un hospital de tercer nivel / Effectiveness and safety of adalimumab and etanercept for rheumatoid arthritis in a third-level hospital

Objetivo: Valorar la efectividad de adalimumab y etanercept alos 6 y 12 meses de tratamiento mediante DAS28, criteriosEULAR (European League Against Rheumatism) y ACR (AmericanCollege of Rheumatology) y analizar la seguridad.Método: Estudio observacional, prospectivo, durante 12meses, de una cohorte de pacientes diagnosticados de artritis reumatoide,que iniciaron tratamiento con adalimumab o etanercepten el servicio de reumatología entre enero de 2003 y diciembrede 2004. Se determinaron criterios DAS28, EULAR y ACR a los6 y 12 meses. Se analizó por intención de tratar y se cuantificaronlas reacciones adversas.Resultados: Se incluyeron 99 pacientes, 50 con adalimumaby 49 con etanercept, de ellos el 30 y 20% en monoterapia. Nohubo diferencia de efectividad según DAS28 entre ambos fármacosen los periodos estudiados. La respuesta EULAR para adalimumaba los 6 y 12 meses fue: buena 28 y 38%, moderada 40 y36%, y ninguna 10 y 4% y para etanercept: buena 29 y 43%,moderada 31 y 24% y ninguna 18 y 10%. Para adalimumab a los6 y 12 meses: ACR20: 64 y 62%; ACR50: 44 y 46%; ACR70:22 y 26% y para etanercept a los 6 y 12 meses: ACR20: 61 y65%; ACR50: 41 y 45%; ACR70: 16 y 24%. Cesaron tratamientoen cada grupo 11 pacientes.Conclusiones: Adalimumab y etanercept presentan similarefectividad en nuestra población. Los criterios de utilización puedencondicionar los resultados, por ello es interesante conocer laexperiencia de otros hospitales

Objective: To assess the effectiveness of adalimumab and etanerceptat 6 and 12 months after therapy onset using DAS28,EULAR (European League Against Rheumatism), and ACR (AmericanCollege of Rheumatology) criteria, and to analyze safety.Method: A prospective, 12-month, observational study of apatient cohort diagnosed with rheumatoid arthritis who were startedon adalimumab or etanercept at the Rheumatology Departmentbetween January 2003 and December 2004. DAS28,EULAR, and ACR criteria were examined at 6 and 12 months.An intention-to-treat analysis was performed, and adverse reactionswere quantitized.Results: Ninety-nine patients were included – 50 on adalimumaband 49 on etanercept. Of these, 30 and 20%, respectively,received monotherapy. No differences in effectiveness were seenbetween both drugs during the studied periods of time according toDAS28. EULAR response to adalimumab at 6 and 12 months was:good 28 and 38%; moderate 40 and 36%; nil 10 and 4%; regardingetanercept at 6 and 12 months: good 29 and 43%; moderate31 and 24%; nil 18 and 10%. As regards adalimumab at 6 and 12months: ACR20: 64 and 62%; ACR50: 44 and 46%; ACR70: 22and 26%; as regards etanercept at 6 and 12 months: ACR20: 61and 65%; ACR50: 41 and 45%; ACR70: 16 and 24%. Elevenpatients discontinued therapy in each group.Conclusions: Adalimumab and etanercept had a similar effectivenessin our population. Criteria of use may condition results, andthus awareness of other hospitals experience is encouraged

[Use of MBDS as a tool for the detection of drug-related adverse events]. / Utilización del CMBD como herramienta para la detección de acontecimientos adversos a medicamentos.

OBJECTIVE: To analyze drug-related adverse events (DRAE) as noted in hospital discharge reports, as well as their severity and drugs involved, and to assess potential avoidability. MATERIAL AND METHODS: A retrospective study for the September-December 2002 period of time in which patients with discharge reports including an ICD-9-CM code E930-E949.9 were selected using the minimum basic data set (MBDS). RESULTS: DRAEs were detected in 2.15% of all discharge reports, and 229 were retrospectively assessed. In all, 62.45% (n = 143) were DRAEs detected at the Emergency Department, and 37.55% (n = 86) were DRAEs detected during hospitalization. Of these, 57.20% are considered potentially avoidable. Drugs most commonly involved in the outpatient DRAE sample studied included: digoxin (24.47%, avoidable 97.14%) and NSAIDs-opioids (13.98%, avoidable 75%). Inpatient DRAEs included: anticoagulants (30.23%, avoidable 57.69%) and antimicrobials (17.44%, avoidable 26.67%). CONCLUSIONS: The study revealed a high proportion of preventable DRAEs around a small number of drugs. Information to prescribing doctors and procedures for treatment follow-up using a unit dose drug dispensing system may be useful to reduce this.

Costs related to inappropriate use of albumin in Spain.

BACKGROUND: Albumin has been used in various treatments for > 50 years, but, recently, its use in clinical practice has become very controversial. OBJECTIVE: To assess the use of albumin in clinical practice in the public hospital setting in Andalucía, Spain, focusing on the economic repercussions of the inappropriate use of albumin. METHODS: Multicentered observational study in 22 public hospitals in which all patients receiving albumin (from start to conclusion of treatment) were assessed during a five-month period on three predetermined, nonconsecutive days. The clinical indications for albumin were evaluated on the basis of Guidelines, a consensus document created by a multidisciplinary team for dissemination by the Governmental Health Authority to all hospitals within its purview. The data were abstracted from the patient case report forms by the pharmacist selected to compile the data in each of the participating hospitals. RESULTS: A total of 242 forms reporting the use of 62,282 g of albumin were evaluated. The most frequent prescribing motives were nutritional intervention (23%), paracentesis in cirrhotic patients (19%), and radical surgery (11%). Only 59 prescriptions (24%), corresponding to 14,539 g of albumin (23%), were considered appropriate. The total cost of albumin therapy for the 242 cases was $183,796 (US$); $42,905 (23%) of this figure was the cost of appropriate use of albumin and $140,891 (77%) was the amount related to inappropriate use. CONCLUSIONS: Evaluated against model guidelines, the use of most of the albumin, deemed clinically necessary by the prescribers, was considered unnecessary or inappropriate. Hence, institutions need to define and implement guidelines that focus on responsible use of such agents in an increasingly cost-conscious healthcare environment.

[Evaluation of drug treatment of myocardial infarction in public hospitals of Andalusia. GAUME (Andalusian Group for performance of Studies on Drug Utilization)]. / Evaluación del tratamiento farmacológico del infarto de miocardio en los hospitales públicos de Andalucía. GAUME (Grupo Andaluz para la realización de Estudios de Utilización de Medicamentos).

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.