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OBJECTIVES: to identify and analyze the factors that contribute to safety incident occurrence in the processes of prescribing, preparing and dispensing antineoplastic medications in pediatric oncology patients. METHODS: a quality improvement study focused on oncopediatric pharmaceutical care processes that identified and analyzed incidents between 2019-2020. A multidisciplinary group performed root cause analysis (RCA), identifying main contributing factors. RESULTS: in 2019, seven incidents were recorded, 57% of which were prescription-related. In 2020, through active search, 34 incidents were identified, 65% relating to prescription, 29% to preparation and 6% to dispensing. The main contributing factors were interruptions, lack of electronic alert, work overload, training and staff shortages. CONCLUSIONS: the results showed that adequate recording and application of RCA to identified incidents can provide improvements in the quality of pediatric oncology care, mapping contributing factors and enabling managers to develop an effective action plan to mitigate risks associated with the process.

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Primary studies have demonstrated that despite being useful, most of the drug-drug interaction (DDI) alerts generated by clinical decision support systems are overridden by prescribers. To provide more information about this issue, we conducted a systematic review and meta-analysis on the prevalence of DDI alerts generated by CDSS and alert overrides by physicians. The search strategy was implemented by applying the terms and MeSH headings and conducted in the MEDLINE/PubMed, EMBASE, Web of Science, Scopus, LILACS, and Google Scholar databases. Blinded reviewers screened 1873 records and 86 full studies, and 16 articles were included for analysis. The overall prevalence of alert generated by CDSS was 13% (CI95% 5-24%, p-value <0.0001, I^2 = 100%), and the overall prevalence of alert override by physicians was 90% (CI95% 85-95%, p-value <0.0001, I^2 = 100%). This systematic review and meta-analysis presents a high rate of alert overrides, even after CDSS adjustments that significantly reduced the number of alerts. After analyzing the articles included in this review, it was clear that the CDSS alerts physicians about potential DDI should be developed with a focus on the user experience, thus increasing their confidence and satisfaction, which may increase patient clinical safety.

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INTRODUCTION: Prescription is the node of medication management and use that most frequently presents medication errors, according to various studies. This study aims to analyze prescriptions before and after the incorporation of a multidisciplinary round in the pediatric intensive care area and its implication in the occurrence of adverse drug events. METHODS: This is an uncontrolled before and after study. RESULTS: 100 patients were studied before and 100 after, range 1-17 years, mean age: 6.4 SD: 8.7. 55.5% (n = 111) were men. A prescription error was detected before the intervention of 12% (n = 12) and after 0% of the intervention, 0%, p = 0.001. A total of 45 adverse events were detected, that is, 45 adverse events per 100 admissions and 38, that is, 38 events per 100 admissions, before and after the intervention respectively (p > 0.05). CONCLUSION: The intervention was useful to reduce prescription error in this sample of patients.

Introducción: La prescripción es el nodo del manejo y uso de medicamentos que con mayor frecuencia presenta errores de medicación, según diversos estudios. Este estudio tiene como objetivo analizar las prescripciones antes y después de la incorporación de una ronda multidisciplinar en el área de cuidados intensivos pediátricos y su implicación en la ocurrencia de eventos adversos por medicamentos. Métodos: Se trata de un estudio antes y después, no controlado. Resultados: Se estudiaron 100 pacientes antes y 100 después, rango 1-17 años, edad media: 6.4 DE: 8.7. El 55.5% (n = 111) eran varones. Se detectó un error de prescripción antes de la intervención del 12% (n = 12) y después de intervención, del 0%, p = 0.001. Se detectó un total de 45 eventos adversos por 100 ingresos y 38 eventos por 100 ingresos, antes y después de la intervención respectivamente (p > 0.05). Conclusión: La intervención fue útil para disminuir el error de prescripción en esta muestra de pacientes.

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OBJECTIVE: The objective of this study was to examine associations between patient age and medication errors among pediatric inpatients. STUDY DESIGN: Secondary analysis of data sets generated from 2 tertiary pediatric hospitals: (1) prescribing errors identified from chart reviews for patients on 9 general wards at hospital A during April 22 to July 10, 2016, June 20 to September 20, 2017, and June 20 to September 30, 2020; prescribing errors from 5 wards at hospital B in the same periods and (2) medication administration errors assessed by direct prospective observation of 5137 administrations on 9 wards at hospital A. Multilevel models examined the association between patient age and medication errors. Age was modeled using restricted cubic splines to allow for nonlinearity. RESULTS: Prescribing errors increased nonlinearly with patient age (P = .01), showing little association from ages 0 to 3 years and then increasing with age until around 10 years and remaining constant through the teenage years. Administration errors increased with patient age, with no association from 0 to around 8 years and then a steady rise with increasing age (P = .03). The association differed by route: linear for oral, no association for intravenous infusions, and U-shaped for intravenous injections. CONCLUSIONS: Older age is an unrecognized risk factor for medication error on general wards in pediatric hospitals. Contributors to risk may be the clinical profiles of these older children or the general level of attention paid to medication practices for this group. Further investigation may allow the design of more targeted interventions to reduce errors.

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Medication errors are one of the biggest problems in healthcare. The medicines' poor labelling design (i.e. look-alike labels) is a well-recognised risk for potential confusion, wrong administration, and patient damage. Human factors and ergonomics (HFE) encourages the human-centred design of system elements, which might reduce medication errors and improve people's well-being and system performance. OBJECTIVE: The aim of the present study is twofold: (i) to use a human reliability analysis technique to evaluate a medication administration task within a simulated scenario of a neonatal intensive care unit (NICU) and (ii) to estimate the impact of a human-centred design (HCD) label in medication administration compared to a look-alike (LA) label. METHOD: This paper used a modified version of the human error assessment and reduction technique (HEART) to analyse a medication administration task in a simulated NICU scenario. The modified technique involved expert nurses quantifying the likelihood of unreliability of a task and rating the conditions, including medicine labels, which most affect the successful completion of the task. RESULTS: Findings suggest that error producing conditions (EPCs), such as a shortage of time available for error detection and correction, no independent checking of output, and distractions, might increase human error probability (HEP) in administering medications. Results also showed that the assessed HEP and the relative percentage of contribution to unreliability reduced by more than 40% when the HCD label was evaluated compared to the LA label. CONCLUSION: Including labelling design based on HFE might help increase human reliability when administering medications under critical conditions.

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Drug information tools help avoid medication errors, a common cause of avoidable harm in health care systems. We sought to describe the design, development process and architecture of an electronic drug information tool, as well as its overall use by health professionals. We developed a tool that can be accessed by all health professionals in a tertiary level university hospital. The functionalities of eDrugs are organized into two main parts: Drug Summary sheet, and Prescription Simulator. Most users accessed eDrugs to use the Drug summary sheet. Clinical information and antimicrobial drugs were the most accessed drug information and drug group. The analysis of log data provides insights into the information priorities of health professionals.

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Este estudo teve por objetivo analisar o processo de administração de medicamentos em um hospital público estadual antes e após uma intervenção educativa sobre a temática, aplicada a profissionais de enfermagem. Trata-se de um estudo quase-experimental, com delineamento tempo-série, com abordagem quantitativa. Foi desenvolvida e aplicada uma intervenção educativa baseada na metodologia da problematização com o Arco de Maguerez, e utilizada a observação direta não participante para a comparação do processo de administração de medicamentos antes e após a intervenção. A amostra foi constituída por observações de 266 doses de medicamentos preparadas e administradas por 19 técnicos de enfermagem. Para a coleta de dados foi utilizado um formulário para obter informações socio-demográficas e de caracterização dos profissionais, além de um roteiro de observação com 41 itens para avaliar o processo de administração de medicamentos, de acordo com os nove certos, preconizados pelo Protocolo de Segurança na Prescrição, Uso e Administração de Medicamentos (BRASIL, 2013). Os dados foram codificados e processados no software IBM® SPSS® versão 22, por meio de análise descritiva de frequência, porcentagem, Teste do Qui-Quadrado de Pearson e Teste Exato de Fisher. Dos participantes, a maioria (94,7%) era do gênero feminino, 73,6% tinham mais de seis anos de formação profissional, 52,6% participaram de alguma espécie de curso ou capacitação desde a conclusão do curso de formação profissional e 26,3% tinham conhecimento do Protocolo de Segurança na Prescrição, Uso e Administração de Medicamentos da ANVISA. Entre os 41 itens analisados 11 (27%) não ocorreram durante as observações, 14 (34%) apresentaram melhora estatisticamente significativa nos seus índices na fase pós intervenção (p<0,001), 9 (22%) mantiveram-se semelhantes antes e após a intervenção, 6 (15%) não apresentaram alterações nos índices entre as fases de observação e 1 (2%) apresentou melhora entre as fases. Conclui-se que uma intervenção educativa pode contribuir de maneira positiva no processo de administração de medicamentos na perspectiva da segurança do paciente, agregando conhecimento, competências e melhoria nas ações.

This study aimed to analyze the medication administration process in a state public hospital before and after an educational intervention on the subject, applied to nursing professionals. This is a quasi-experimental study, with a time-series design, with a quantitative approach. An educational intervention was developed and applied based on the problematization methodology with the Arch of Maguerez, and non-participant direct observation was used to compare the medication administration process before and after the intervention. The sample consisted of observations of 266 doses of medication prepared and administered by 19 nursing technicians. For data collection, a form was used to obtain socio-demographic information and characterization of professionals, in addition to an observation script of 41 items to evaluate the medication administration process, according to the nine rights, recommended by the Protocol of Safety in the Prescription, Use and Administration of Medicines (BRASIL, 2013). Data were coded and processed using IBM® SPSS® software, version 22, through descriptive analysis of frequency, percentage, Pearson's Chi-Square Test and Fisher's Exact Test. Of the participants, the majority (94.7%) were female, 73.6% had more than six years of professional training, 52.6% participated in some kind of course or training since completing the professional training course, and 26.3% were aware of ANVISA's Protocol for Safety in the Prescription, Use and Administration of Medications. Among the 41 items analyzed, 11 (27%) did not occur during the observations, 14 (34%) had an statistically significant improvement in their indices in the post-intervention phase (p<0.001), 9 (22%) remained similar before and after the intervention, 6 (15%) presented no differences in the indices between the observation phases and 1 (2%) resulted in the improvement of the process When comparing pre and post observation phases. It is concluded that an educational intervention can positively contribute to the medication administration process from the perspective of patient safety, adding knowledge, skills and improvement in actions.

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INTRODUCTION: Medication errors are frequent and have high economic and social impacts; however, some medication errors are more likely to result in harm than others. Therefore, it is critical to determine their severity. Various tools exist to measure and classify the harm associated with medication errors; although, few have been validated internationally. METHODS: We validated an existing method for assessing the potential severity of medication administration errors (MAEs) in Brazil. Thirty healthcare professionals (doctors, nurses and pharmacists) from Brazil were invited to score 50 cases of MAEs as in the original UK study, regarding their potential harm to the patient, on a scale from 0 to 10. Sixteen cases with known harmful outcomes were included to assess the validity of the scoring. To assess test-retest reliability, 10 cases (of the 50) were scored twice. Potential sources of variability in scoring were evaluated, including the occasion on which the scores were given, the scorers, their profession and the interactions among these variables. Data were analysed using generalisability theory. A G coefficient of 0.8 or more was considered reliable, and a Bland-Altman analysis was used to assess test-retest reliability. RESULTS: To obtain a generalisability coefficient of 0.8, a minimum of three judges would need to score each case with their mean score used as an indicator of severity. The method also appeared to be valid, as the judges' assessments were largely in line with the outcomes of the 16 cases with known outcomes. The Bland-Altman analysis showed that the distribution was homogeneous above and below the mean difference for doctors, pharmacists and nurses. CONCLUSION: The results of this study demonstrate the reliability and validity of an existing method of scoring the severity of MAEs for use in the Brazilian health system.

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La Atención farmacéutica (AF) ayuda a los pacientes a alcanzar objetivos terapéuticos reduciendo los problemas relacionados al medicamento (PRM). Objetivos: analizar los PRM en la práctica de la AF a pacientes con inmunodeficiencia adquirida (IDA) y/o tuberculosis (TBC) y evaluar su impacto. Método: estudio, descriptivo, observacional, en el área ambulatoria de Farmacia. Se incluyeron pacientes con IDA y/o TBC con: inicio de tratamiento, polifarmacia, reinternaciones frecuentes, regular/mala adherencia, reacciones adversas a medicamentos (RAM) previas y/o comorbilidades. Se entrevistaron pacientes o cuidadores y se registraron PRM, errores, grados de adherencia y conocimiento farmacoterapéutico, retiro oportuno de medicamentos y parámetros clínicos. Se registró la intervención farmacéutica y entregó material educativo. Se repitieron las mediciones en una segunda entrevista. Resultados: Se estudiaron 54 pacientes (28 con IDA y 26 con TBC). Se realizaron 93 intervenciones (29.9% dirigidas al prescriptor, 27.8% a otros profesionales) y se detectaron 8 RAM y 53 errores (28 IDA y 25 TBC), el principal PRM fue la mala/regular adherencia con bajo porcentaje de conocimiento farmacoterapéutico completo. Después de la AF, en IDA el grado de adherencia tuvo una mejora estadísticamente significativa (p= 0.012), también fue significativa la mejora en el retiro oportuno de la medicación (28.6% a 71.4% p=0.005 IDA). Se obtuvieron resultados favorables de carga viral (CV) en 72% pacientes con IDA y aumento de peso en 92% pacientes con TBC, aunque no fueron estadísticamente significativos. Conclusiones: mediante AF se mejoró la adherencia y la comunicación en pacientes pediátricos con IDA y/o TBC (AU)

Pharmacovigilance (PV) helps patients achieve therapeutic goals by reducing drug-related problems (DRP). Objectives: to analyze DRPs in the practice of PV in patients with acquired immunodeficiency (AIDS) and/or tuberculosis (TB) and to evaluate its impact. Methods: A descriptive, observational study was conducted in the outpatient pharmacy area. Patients with AIDS and/or TB with: treatment initiation, polypharmacy, frequent readmissions, regular/poor adherence, previous adverse drug reactions (ADR) and/or comorbidities were included. Patients or caregivers were interviewed, and DRP, errors, adherence and pharmacotherapeutic knowledge, timely drug withdrawal, and clinical parameters were recorded. The pharmaceutical intervention was recorded and educational material was delivered. Measurements were repeated in a second interview. Results: We studied 54 patients (28 with AIDS and 26 with TB). Ninety-three interventions were performed (29.9% addressed to the drug prescriber, 27.8% to other professionals) and 8 ADRs and 53 errors were detected (28 AIDS and 25 TB). The main DRP was poor/regular adherence together with a low level of complete pharmacotherapeutic knowledge. After PV, in patients with AIDS the degree of adherence statistically significantly improved (p= 0.012). The improvement in timely medication withdrawal was also significant (28.6% vs. 71.4% p=0.005 AID). Favorable viral load results were obtained in 72% of patients with AIDS and weight gain in 92% of patients with TB, although they were not statistically significant. Conclusions: PV improved adherence and communication in pediatric patients with AIDS and/or TB (AU)

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OBJECTIVE: To evaluate the quality of prescription writing in the context of public primary health care. BACKGROUND: Prescription errors are one of the leading patient safety problems in primary care and can be caused by errors in therapeutic decisions or in the quality of prescription writing. METHODS: Cross-sectional observational study conducted in a municipality in Northeastern Brazil. The assessment instrument (including 13 indicators and one composite indicator) was applied to a representative sample of drug prescriptions from the 24 Family Health Teams providing Primary Health Care in the municipality, dispensed in January 2021. Estimates of compliance and their 95% confidence intervals and graphical analysis of frequencies are assessed globally and stratified by dispensing units and prescribers. FINDINGS: The average composite prescription writing quality on a 0-100 scale was 60.2 (95% CI 57.8-62.6). No quality criteria had 100% compliance. The highest compliance rates were found for 'frequency of administration' (98.9%) and 'identification of the prescriber' (98.9%). On the other hand, 'recorded information on allergy' (0.0%), 'patient's date of birth' (1.7%), 'nonpharmacological recommendations' (1.7%), and 'guidance on the use of the drug' (25%) were the indicators with lower compliance, contributing to 69% of the noncompliances found. The type and frequency of the errors in the quality of prescription writing uncovered in this study confirm the continuing need to tackle this problem to improve patient safety. The results identify priority aspects for interventions and further studies on the quality of prescription writing in the context of Primary Health Care in Brazil.

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