Look-alike sound-alike (LASA) medication errors in Thai hospitals / Errores de medicación por sonido similar (LASA) en hospitales tailandeses

Look-alike sound-alike (LASA) drugs cause a high proportion of medication errors in hospitals. Drug lists available in hospitals are diverse and complicated. Presently, each hospital has its own LASA drug list and unique management strategies to minimize and prevent LASA errors. Objective: This study aimed to explore the prevalence of LASA drug lists, types of LASA drugs, and categories of medication errors in hospitals in Thailand. Methods: For this crosssectional study, questionnaires were developed and distributed along with a letter to 500 government hospitals (selected from a total of 1,309 hospitals) in Thailand via mail from April to June 2021. Data were analyzed using descriptive statistics (frequencies and percentages). Results: A total of 128 hospitals participated in this study (response rate: 25.60%), including 12 tertiary hospitals (9.38%), 33 secondary hospitals (25.78%), 24 large primary hospitals (18.75%), 51 small primary hospitals (39.84%), and eight private hospitals (6.25%). A total of 2,510 pairs of LASA drugs were identified, which included 1,674 (66.69%) tablets/capsules (Simvastatin 10-Simvastatin 20 pair had the highest frequency), 427 injections (17.01%) (Ceftriaxone-Ceftazidime pair had the highest frequency), 85 liquid dosage forms (3.39%) (Milk of magnesia-alum milk pair had the highest frequency), 74 special techniques in medicine (2.95%) (Seretide evohaler®-Seretide accuhaler® pair had the highest frequency), 49 external used drugs (1.95%) (Clotrimazole cream-Clobetasol cream pair had the highest frequency), and 28 powder dosage forms (1.12%) (ORS for pediatrics-ORS for adult pair had the highest frequency). Conclusion: Despite relevant awareness among healthcare professionals, LASA medication errors occur in hospitals. The most frequent similarities among LASA drugs were detected in their names/pronunciations, and the most common errors belonged to Category B.(AU)

Medication related litigation in Ireland: A 6-year review.

AIMS: The primary aims of the study were to identify those medications most frequently associated with clinical litigation in Ireland and to quantify the cost of such litigation. Secondary aims were to identify where in the medication-use process claims were most likely to arise, the medication incident types involved and the primary injury alleged. METHODS: The National Incident Management System (NIMS) for incident and claims management was searched to identify all medication-related claims finalised from 2011 to 2016 (inclusive). The physical case files were obtained and additional data not available on NIMS was extracted in order to build a detailed picture of the incident and subsequent claim. RESULTS: The search identified 79 relevant claims, of which 48 closed with a payment to the plaintiff. These 48 claims involved 54 medications. Medication groups identified included general anaesthetics (n = 7), opioids (n = 6), penicillins, antithrombotics and local anaesthetics (all n = 5). The errors alleged occurred exclusively at the administration (58%) and prescribing (42%) stages of the medication-use process. Medication incident types included wrong dose/strength (n = 17), wrong drug (n = 7) and adverse drug reaction (n = 6). The most commonly pleaded primary injuries were allergic reaction (n = 9), deterioration in clinical status (n = 9) and post-traumatic stress disorder (n = 8). The median total cost of these claims was €60 991, including median damages of €33 858. CONCLUSIONS: This study links data on medication incidents, actual harm to patients and litigation costs. Thus, it presents a comprehensive picture of the consequences of medication error.

Monitorizacion de la calidad del proceso farmacoterapéutico hospitalario mediante el programa paciente centinela / Monitoring the quality of the hospital pharmacoterapeutic process by sentinel patient program

Objetivo: Analizar los resultados del programa paciente centinela para la monitorización de la calidad del proceso farmacoterapéutico en el paciente hospitalizado mediante indicadores basados en errores de medicación. Método: Diseño: Estudio observacional, transversal y prospectivo. Ámbito: Hospital general de 1.000 camas. Periodo: mayo 2011-junio 2016. Muestra: Pacientes con cuatro o más medicamentos. Variables: Error de medicación, medicamentos prescritos, medicamentos y dosis preparadas, medicamentos administrados. Se definieron indicadores de seguridad a partir de los errores de medicación en cada fase del proceso farmacoterapéutico. Resultados: Durante el periodo de estudio, 334 de 746 pacientes presentaron algún error, lo que supuso un 44,8% (IC95%: 41,7 a 47,8). Se detectaron 564 errores de medicación (0,75 errores por paciente; IC95%: 0,7 a 0,8). Los indicadores de seguridad (errores de medicación por fase): omisión de registro de alergia 5,1% (38/746 pacientes); prescripción 2,3% (156/6.724 medicamentos); validación 0,6% (38/6.724 medicamentos), preparación: 2,6% (142/5.465 medicamentos) y administración: 3,7% (190/5.111 administraciones observadas). La evolución temporal de los indicadores, con gráficos de control estadístico, mostró procesos estables, excepto para la fase de administración. Las acciones de mejora propuestas fueron de normalización, formación y organización. Conclusiones: El programa paciente centinela proporciona una visión global de la calidad del proceso farmacoterapéutico y fomenta la cultura de seguridad en el centro. Los gráficos de control estadístico han sido una herramienta útil para monitorizar los errores de medicación. El análisis de los errores de medicación ha servido para plantear acciones de mejora en cada una de las fases del proceso farmacoterapéutico (AU)

Objective: To analyze the results of sentinel patient program to monitoring the quality pharmacoterapeutic process in the hospitalized patient through medication errors. Method: Design: Observational, prospective and transversal study. Ambit: General hospital of 1000 beds. Period: From May 2011 to June 2016. Sample: Patients with treatment prescribe within 24 hours of being admitted with 4 or more medications. Variables: Medication error, drugs prescribed, medications and doses dispensing, drugs administered. Safety indicators were defined based on medication errors at each stage of the pharmacotherapeutic process. Results: Of the 746 patients studied, 334 had at least 1 medication error (44.8%; IC95%: 41.7-47.8). In the 746 treatments, 564 medication errors were detected (0.75 errors by patient; IC95%: 0.7-0.8). The safety indicators (medication error by stage) were: 5.1% (38/746 patients) for omission of allergy record; 2.3% (156/6724 drugs) for prescription; 0.6% (38/6724 drugs) for validation, 2.6% for dispensing (142/5465 drugs) y 3.7% (190/5111 administered drugs observed) for administration. The temporal evolution of the indicators, with graphs of statistical control showed stable processes, except for the administration. The proposed improvement actions were of a training, standardization and organizational type. Conclusions: The sentinel patient program provides an overview of the quality of the pharmacotherapeutic process and promotes the safety culture at the center. Statistical control charts have been a useful tool for monitoring medication errors. The analysis of medication errors has served to propose improvement actions in each stage of the pharmacotherapeutic process (AU)

[Oral drops: unsafe or unwieldy method of administration?] / Druppels: onveilige of onhandige toedieningsvorm?

The Netherlands Medicines Evaluation Board (MEB) was recently informed about a serious pipamperone overdose in a 6-year-old boy, which happened because the boy was given the medication in streams rather than in drops. This article describes the use of drops in pharmaceutical patient care and explains why the MEB has maintained marketing authorization for the product on the basis of currently available information. The MEB urgently requests the healthcare professional groups to report all problems concerning drug use to the Netherlands Pharmacovigilance Centre Lareb, and the Portal for Patient Safety; this is the only way in which it can be verified whether incidental medication errors are actually, and continue to be, incidental.

Thematic Analysis of Obstetric Anesthesia Cases From the AANA Foundation Closed Claims Database.

Maternal morbidity and mortality in the United States continues to be high. Understanding parturient complications and causes of death is critical to determine corrective actions. Analysis of closed malpractice claims evaluates patient care, identifies preventable morbidity and mortality, and offers recommendations for improvement. A review of obstetric anesthesia malpractice claims filed against nurse anesthetists (N = 21), extracted from the American Association of Nurse Anesthetists Foundation Closed Claims database, was completed. The malpractice claims included 18 maternal claims and 3 neonatal claims. The most common adverse maternal outcomes were maternal death (8/18) and nerve injury (4/18). Hemorrhage accounted for the greatest number of maternal deaths (3/8) followed by cardiovascular failure, emboli, and neuraxial opioid overdose. All neonatal claims (3/3) involved hypoxic encephalopathy resulting in 1 neonatal death and 2 cases of neonatal permanent brain injury. The majority of maternal cases were identified as nonemergent (15/18) and involved relatively healthy patients (15 identified as ASA physical status 2). Qualitative analysis of closed claims provides the opportunity to identify patterns of injuries, precipitating events, and interventions to improve care. Themes related to poor outcomes in this study include care delays, failed communication, incomplete documentation, maternal hemorrhage, and lack of provider vigilance.

Cuidados na administração de medicamentos: as responsabilidades dos profissionais de enfermagem / Care in the administration of medicines: the responsibilities of nursing professionals

Objetivo: avaliar o conhecimento de profissionais de enfermagem atuantes em uma instituição hospitalar pública quanto às responsabilidades jurídicas e éticas envolvidas na administração de medicamentos. Método: estudo avaliativo, exploratório, com abordagem quantitativa e qualitativa. Foram aplicados questionários a162 profissionais de enfermagem. Os dados quantitativos formaram um banco de dados, digitados no software Statistical Package for the Social Sciences – SPSS. As informações qualitativas foram submetidas à análise de conteúdo. Resultados: constatou-se que os profissionais de enfermagem necessitam de maior aprofundamento científico acerca do Código de Ética da Profissão e que o conhecimento dos enfermeiros acerca das responsabilidades perante os erros de medicação foi superior ao dos técnicos e auxiliares de enfermagem. A advertência verbal foi a principal conduta adotada para responsabilizar os profissionais envolvidos após a ocorrência dos erros. Conclusão: constata-se que o conhecimento acerca do direito e da deontologia propiciam um fazer com resultados efetivos.

Responsabilidad por pérdida de oportunidad asistencial en patología oncológica maligna en la medicina pública española / Responsibility for the loss of opportunity in malignant cancer care in the Spanish public healthcare system

Objetivo: La pérdida de oportunidad asistencial se ha introducido con mucha fuerza en las resoluciones judiciales dictadas en los últimos años. Nuestro objetivo fue analizar las sentencias condenatorias por responsabilidad derivada de pérdida de oportunidad asistencial, dictadas por la Jurisdicción Contencioso Administrativa (es decir, en la medicina pública), en las que tanto el origen de la patología a tratar como las secuelas fueron procesos oncológicos. Método: Se han analizado las 137 sentencias judiciales, relacionadas con patologías oncológicas, en el ámbito de la Jurisdicción Contencioso Administrativa, que hacían referencia al concepto de pérdida de oportunidad asistencial y que fueron dictadas en España hasta mayo de 2014. Resultados: De las 137 sentencias, 119 (86,9%) fueron dictadas por error diagnóstico y 14 (10,2%) por un tratamiento inadecuado. Desde el año 2010 se han producido 100 (73,0%) sentencias, lo que supone más de un 170% de aumento con respecto a las 37 (27,0%) dictadas en los primeros 6 años del estudio (2004 a 2009). La mayoría de los pacientes (68,6%) fallecieron, siendo las de mama y de órganos genitales femeninos (24,1%), así como las digestivas (21,1%), las neoplasias malignas que con más frecuencia originaron la condena. Conclusiones: La actividad litigante por pérdida de oportunidad asistencial en patologías oncológicas en la medicina pública española ha aumentado de manera significativa estos últimos años. Las sentencias fueron dictadas fundamentalmente por error diagnóstico o tratamiento inadecuado (AU)

Objective: The loss of chance in healthcare has been forcibly introduced in the adjudications pronounced in recent years. Our objective was to analyse the verdicts of guilt resulting from the loss of chance ordered by the Contentious-Administrative Court (i.e., in the public healthcare system), in which both the origin of the disease to be treated and the sequelae were oncological processes. Method: We analysed 137 cancer-related court judgments from the Contentious-Administrative Court, which referred to the concept of loss of chance, issued in Spain up to May 2014. Results: Of the 137 sentences, 119 (86.9%), were pronounced due to diagnostic error and 14 (10.2%) due to inadequate treatment. Since 2010, 100 sentences have been passed (73.0%), representing an increase of more than 170% with respect to the 37 (27.0%) ordered in the first six years of the study (from 2004 to 2009). Most of the patients (68.6%) died, predominantly from breast cancer and gynaecological cancer (24.1%), and gastrointestinal cancers (21.1%). These malignancies were the ones most often involved in the sentences. Conclusions: The litigant activity due to loss of chance in oncological processes in the public health care has significantly increased in the last years. The judgments were mainly given because of diagnostic error or inadequate treatment (AU)

National Rules for Drug-Drug Interactions: Are They Appropriate for Tertiary Hospitals?

The application of appropriate rules for drug-drug interactions (DDIs) could substantially reduce the number of adverse drug events. However, current implementations of such rules in tertiary hospitals are problematic as physicians are receiving too many alerts, causing high override rates and alert fatigue. We investigated the potential impact of Korean national DDI rules in a drug utilization review program in terms of their severity coverage and the clinical efficiency of how physicians respond to them. Using lists of high-priority DDIs developed with the support of the U.S. government, we evaluated 706 contraindicated DDI pairs released in May 2015. We evaluated clinical log data from one tertiary hospital and prescription data from two other tertiary hospitals. The measured parameters were national DDI rule coverage for high-priority DDIs, alert override rate, and number of prescription pairs. The coverage rates of national DDI rules were 80% and 3.0% at the class and drug levels, respectively. The analysis of the system log data showed an overall override rate of 79.6%. Only 0.3% of all of the alerts (n = 66) were high-priority DDI rules. These showed a lower override rate of 51.5%, which was much lower than for the overall DDI rules. We also found 342 and 80 unmatched high-priority DDI pairs which were absent in national rules in inpatient orders from the other two hospitals. The national DDI rules are not complete in terms of their coverage of severe DDIs. They also lack clinical efficiency in tertiary settings, suggesting improved systematic approaches are needed.

Medication errors as malpractice-a qualitative content analysis of 585 medication errors by nurses in Sweden.

BACKGROUND: Many studies address the prevalence of medication errors but few address medication errors serious enough to be regarded as malpractice. Other studies have analyzed the individual and system contributory factor leading to a medication error. Nurses have a key role in medication administration, and there are contradictory reports on the nurses' work experience in relation to the risk and type for medication errors. METHODS: All medication errors where a nurse was held responsible for malpractice (n = 585) during 11 years in Sweden were included. A qualitative content analysis and classification according to the type and the individual and system contributory factors was made. In order to test for possible differences between nurses' work experience and associations within and between the errors and contributory factors, Fisher's exact test was used, and Cohen's kappa (k) was performed to estimate the magnitude and direction of the associations. RESULTS: There were a total of 613 medication errors in the 585 cases, the most common being "Wrong dose" (41 %), "Wrong patient" (13 %) and "Omission of drug" (12 %). In 95 % of the cases, an average of 1.4 individual contributory factors was found; the most common being "Negligence, forgetfulness or lack of attentiveness" (68 %), "Proper protocol not followed" (25 %), "Lack of knowledge" (13 %) and "Practice beyond scope" (12 %). In 78 % of the cases, an average of 1.7 system contributory factors was found; the most common being "Role overload" (36 %), "Unclear communication or orders" (30 %) and "Lack of adequate access to guidelines or unclear organisational routines" (30 %). The errors "Wrong patient due to mix-up of patients" and "Wrong route" and the contributory factors "Lack of knowledge" and "Negligence, forgetfulness or lack of attentiveness" were more common in less experienced nurses. The experienced nurses were more prone to "Practice beyond scope of practice" and to make errors in spite of "Lack of adequate access to guidelines or unclear organisational routines". CONCLUSIONS: Medication errors regarded as malpractice in Sweden were of the same character as medication errors worldwide. A complex interplay between individual and system factors often contributed to the errors.

Análisis y evaluación de resultados tras la implantación de un programa de prescripción electrónica asistida en un hospital de tercer nivel / Analysis and evaluation of results following the implementation of a programme of e-prescribing in a tertiary hospital

Introducción: la Prescripción Electrónica Asistida (PEA), constituye en la actualidad una herramienta útil en el proceso de hospitalización. La supresión de la prescripción y/o transcripción manuscrita, ha conseguido minimizar los errores relacionados con la medicación, mitigando la constante preocupación que supone la seguridad del paciente. Objetivo: analizar los datos de intervención farmacéutica registrados tras la implantación de un software de prescripción electrónica y la seguridad que confiere al usuario. Material y método: estudio retrospectivo de cinco meses de duración, en el que se revisaron las historias clínicas electrónicas de prescripción, describiendo los errores de medicación detectados y el número de intervenciones farmacéuticas realizadas. Resultados: sobre un total de 27.533 validaciones, fueron realizadas 4.917 intervenciones farmacéuticas (IF), lo que supone 32,78 errores de medicación/día y 0,95 errores/paciente

Introduction: the Electronically Assisted Prescription (EAP) is now a useful tool in the process of hospitalization. The removal of the prescription or transcript handwritten, has managed to minimize errors related to medication, mitigating the constant concern involving the safety of the patient. Objective: to analyze data pharmaceutical intervention reported following implementation of a software for e-prescribing and the security that gives the user. Materials and methods: retrospective study of five months duration, which reviewed the electronic medical records of prescription, describing medication errors that are detected and the number of pharmaceutical interventions carried out. Results: out of a total of 27.533 validations, were performed 4.917 pharmaceutical interventions (IF), which represents 32.78 medication errors per day and 0.95 errors per patient

Conciliación de la medicación al ingreso y alta hospitalaria. Una experiencia consolidada / Medication reconciliation at admission and discharge. A consolidated experience

La conciliación de la medicación es actualmente una de las principales estrategias para reducir los errores de medicación relacionados con la transición asistencial. Objetivo. Describir una metodología de trabajo que permita garantizar la continuidad asistencial del paciente en relación con la farmacoterapia, al ingreso y al alta hospitalaria. Material y método. Se describe la metodología implantada en un hospital de tercer nivel y los principales resultados de la conciliación de medicación al ingreso y alta de pacientes mayores de 75 años en el Servicio de Traumatología durante el año 2014. Resultados. Las fases de la metodología fueron: 1. obtención de la historia farmacoterapéutica (al menos 2 fuentes de información); 2. análisis de discrepancias y validación de la medicación al ingreso: se realizó un check list para estandarizar el proceso; 3. comunicación del perfil farmacoterapéutico: se diseñó un formulario en la historia clínica electrónica; y 4. conciliación de la medicación al alta hospitalaria e información al paciente: entrega de esquema posológico y recomendaciones al paciente. Aplicando esta metodología, en 2014 se conciliaron 318 pacientes ingresados en traumatología (294 al ingreso y alta). El 35,5% presentó al menos un error de conciliación. La media de errores por paciente conciliado fue de 0,69. En el 74,1% de los pacientes se entregó información escrita al alta. Conclusiones. Esta metodología ha permitido establecer un flujo de trabajo que facilita la coordinación interprofesionales; disminuir los errores de medicación y dar respuesta a uno de los principales problemas de la continuidad asistencial (AU)

Medication reconciliation is currently one of the main strategies to reduce medication errors related to transitional care. Objective. To describe a method that would ensure continuity of patient care as regards drug therapy from admission to discharge. Methods. A description is presented on the methodology implemented in a tertiary hospital and the main results of medication reconciliation at admission and discharge of patients older than 75 years in the Trauma Unit during 2014. Results. The phases of the methodology were: 1. Obtain medication history (at least two sources of information); 2. Analysis of discrepancies and validation of medication on admission: A checklist was made to standardise the process, 3. Report on the pharmacotherapeutic profile: a form was designed in electronic medical records, and 4. Medication reconciliation at discharge and patient information: presenting the dosing schedule and recommendations to the patient. The medication of 318 patients admitted to Trauma was reconciled (294 at admission and discharge) by applying this methodology during the study period. There was at least one medication reconciliation error in 35% of cases. The mean error per patient reconciled was 0.69. Written discharge information was given to 74.1% of patients. Conclusions. This methodology has allowed a workflow to be established that facilitates coordination between healthcare providers, in order to reduce medication errors and to respond to one of the main problems of continuity of care (AU)

[Preventing interruptions during the administration of medicines]. / Administration du médicament, prévenir les interruptions de tâches.

The medication use pathway is a complex process with a high risk of error, all the more so if it is interspersed with interruptions. Interruptions during care procedures are a real problem which can result in serious adverse events. A legal frame obliges the health institutions to secure the administration of medicines. This priority objective is translated by risks assessments, tools of self-assessment, audits, corrective actions, which allow a raising awareness of the professionals to the risks associated to medicines.

Regulatory incentives to ensure better medicines for older people: From ICH E7 to the EMA reflection paper on quality aspects.

Ageing comes with an increased propensity in the alteration of human organ and body functions, which can e.g. result in multi-morbidity, frailty, polypharmacy, altered medication safety and/or efficacy, and problems with the practical use of medicines in a real world setting. Such problems may e.g. involve difficulties opening containers, swallowing large tablets, breaking tablets by hand, or correctly understanding the user instruction. This review aims to summarize the European regulatory activities towards better medicines for older people, with a main focus on formulation development and the overall drug product design. It addresses the ICH E7 guideline "Studies in support of special populations, geriatrics", the ICH Q8 guideline "Pharmaceutical development", the EMA good practice guide on "Risk minimisation and prevention of medication errors" and the forthcoming EMA CHMP QWP reflection paper on the "Quality aspects (pharmaceutical development) of medicines for older people". In addition, three key aspects to the practical use of medicines by older people are discussed in a wider context: multi-particulates including small tablets (also referred to as mini-tablets), ease of opening and storage conditions. Furthermore, attention is paid to work in progress e.g. incentives by the European national drug regulatory authorities, and patient centric drug product development.

Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.

A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation. These changes included a modification of the 'adverse reaction' definition to include events associated with medication errors, and the requirement for national competent authorities responsible for pharmacovigilance in EU Member States to collaborate and exchange information on medication errors resulting in harm with national patient safety organisations. To facilitate reporting and learning from medication errors, a clear distinction has been made in the guidance between medication errors resulting in adverse reactions, medication errors without harm, intercepted medication errors and potential errors. This distinction is supported by an enhanced MedDRA(®) terminology that allows for coding all stages of the medication use process where the error occurred in addition to any clinical consequences. To better understand the causes and contributing factors, individual case safety reports involving an error should be followed-up with the primary reporter to gather information relevant for the conduct of root cause analysis where this may be appropriate. Such reports should also be summarised in periodic safety update reports and addressed in risk management plans. Any risk minimisation and prevention strategy for medication errors should consider all stages of a medicinal product's life-cycle, particularly the main sources and types of medication errors during product development. This article describes the key concepts of the EU good practice guidance for defining, classifying, coding, reporting, evaluating and preventing medication errors. This guidance should contribute to the safe and effective use of medicines for the benefit of patients and public health.