Validation of a method to assess the severity of medication administration errors in Brazil.

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.

Assessing the severity of medication administration errors identified in an observational study using a valid and reliable method.

BACKGROUND: Epidemiological data on medication errors severity are scarce. The assessment of the prevalence and severity of medication errors may be limited because of several reasons, including a lack of standardization in the method of identifying medication administration errors and little knowledge about the appropriate assessment tools to measure severity. Thus, in this study, we aim to assess the potential severity of errors identified by direct observation in a teaching hospital. METHODS: We used a validated method for assessing the potential severity of medication administration errors. Responses are scored on a 10-point scale. The 203 errors identified in a previous study were organized per similarity, resulting in 67 errors. This list was assessed by a panel of a physician, a nurse, and two pharmacists. The average score for each of the 67 errors was estimated considering the scores given by the 4 judges. Errors with a severity index < 3, between 3 and 7, and > 7 were considered minor, moderate, and severe, respectively. RESULTS: Professionals classified the potential clinical significance of the errors as minor, moderate, and severe in 8.8% (18/203), 82.8% (168/203), and 8.4% (17/203) of the cases, respectively. Most errors considered potentially serious (41%, 7/17) were technical errors. Most potentially serious errors involved insulin. Regarding the administration route, nine (53%) potentially serious errors involved medications administered intravenously. CONCLUSIONS: Most of the errors were considered as potentially moderated by the expert panel; however, the frequency of potentially serious errors was higher than that in previous studies using the same methodology, which highlights the need for strategies to reduce their occurrence.

Observational study on medication administration errors at a University Hospital in Brazil: incidence, nature and associated factors.

BACKGROUND: Medication administration errors are frequent and cause significant harm globally. However, only a few data are available on their prevalence, nature, and severity in developing countries, particularly in Brazil. This study attempts to determine the incidence, nature, and factors associated with medication administration errors observed in a university hospital. METHODS: This was a prospective observational study, conducted in a clinical and surgical unit of a University Hospital in Brazil. Two previously trained professionals directly observed medication preparation and administration for 15 days, 24 h a day, in February 2020. The type of error, the category of the medication involved, according to the anatomical therapeutic chemical classification system, and associated risk factors were analyzed. Multivariate logistic regression was adopted to identify factors associated with errors. RESULTS: The administration of 561 drug doses was observed. The mean total medication administration error rate was 36.2% (95% confidence interval 32.3-40.2). The main factors associated with time errors were interruptions. Regarding technique errors, the primary factors observed were the route of administration, interruptions, and workload. CONCLUSIONS: Here, we identified a high total medication administration error rate, the most frequent being technique, wrong time, dose, and omission errors. The factors associated with errors were interruptions, route of administration and workload, which agrees well with the results of other national and international studies.

Drug administration errors in Latin America: A systematic review.

PURPOSE: This study systematically reviewed studies to determine the frequency and nature of medication administration errors in Latin American hospitals. SUMMARY: We systematically searched the medical literature of seven electronic databases to identify studies on medication administration errors in Latin American hospitals using the direct observation method. Studies published in English, Spanish, or Portuguese between 1946 and March 2021 were included. A total of 10 studies conducted at 22 hospitals were included in the review. Nursing professionals were the most frequently observed during medication administration and were observers in four of the ten included studies. Total number of error opportunities was used as a parameter to calculate error rates. The administration error rate had a median of 32% (interquartile range 16%-35.8%) with high variability in the described frequencies (9%-64%). Excluding time errors, the median error rate was 9.7% (interquartile range 7.4%-29.5%). Four different definitions of medication errors were used in these studies. The most frequently observed errors were time, dose, and omission. Only four studies described the therapeutic classes or groups involved in the errors, with systemic anti-infectives being the most reported. None of the studies assessed the severity or outcome of the errors. The assessment of the overall risk bias revealed that one study had low risk, three had moderate risk, and three had high risk. In the assessment of the exploratory, observational, and before-after studies, two were classified as having fair quality and one as having poor quality. CONCLUSION: The administration error rate in Latin America was high, even when time errors were excluded. The variation observed in the frequencies can be explained by the different contexts in which the study was conducted. Future research using direct observation techniques is necessary to more accurately estimate the nature and severity of medication administration errors.

Validation of a method to assess the severity of medication administration errors in Brazil: a study protocol.

BACKGROUND: Medication errors are frequent and have a high economic and social impact and is critical to know their severity. A variety of tools exist to measure and classify the harms associated with medication errors, but few are internationally validated. DESIGN AND METHODS: It was decided to validate a method proposed by Dean and Barber for assessment of the potential severity of medication administration errors. A number of thirty health care professionals (doctors, nurses and pharmacists) from Brazil will receive an invitation to take part by scoring 50 cases of medication errors gathered from an original UK study regarding their potential harm to the patient on scale 0 to 10. Sixteen cases with known actual harm outcomes will be used to assess the validity of their scoring. By looking at 10 errors (out of the 50 cases) scored twice, reliability shall be assessed; and potential sources of variability in scoring will be evaluated depending on the severity of each of error case, the occasion when the scores were given, the scorer, their profession, and interactions among these variables. Generalizability theory will be used for analysing data. Expected impact of the study for public health: This study was submitted to the evaluation of the Research Ethics Committee of the Complexo Hospitalar Universitário Professor Edgard Santos and approved under no. 3.102.570/2019. This is the first validation of this method for use in Brazil, and will allow researchers to conduct more standardised evaluations of interventions to reduce the impact of medication errors.

Evidence of the association between adherence to treatment and mortality among patients with COPD monitored at a public disease management program in Brazil.

OBJECTIVE: To evaluate the association between adherence to treatment and mortality among Chronic Obstructive Pulmonary Disease (COPD) patients treated in the Brazilian public health system. METHODS: This is cohort study of moderate-to-severe COPD patients monitored in a public pharmaceutical care-based Disease Management Program (DMP). All subjects who died one year after the beginning of the cohort were age-matched with those who remained alive at the end of the cohort period. Treatment adherence was measured through pharmacy records. Patients who received at least 90% of the prescribed doses were considered adherent to treatment. RESULTS: Of the 333 patients (52.8% age ≥ 65 years, 67.9% male), 67.3% were adherent to treatment (adherence rate, 87.2%). Mortality was associated with lack of adherence (p = 0.04), presence of symptoms (mMRC ≥ 2) and COPD treatment use. The death was associated with non-adherence, presence of symptoms and previous hospitalization. After adjustment, non-adherent patients to treatment were almost twice times likely to die compared to those adherents (Hazard Ratio (HR) 1.86; CI 1.16-2.98, p = 0.01). CONCLUSION: Non-adherence to treatment was associated with higher mortality among moderate-to-severe COPD patients treated in the Brazilian public health system. Strategies to monitor and optimize adherence should be strengthened to reduce COPD-related mortality.

Management of COPD within the Brazilian Unified Health Care System in the state of Bahia: an analysis of real-life medication use patterns.

OBJECTIVE: To describe COPD pharmacological treatment patterns in the state of Bahia, Brazil, and to evaluate the extent to which these patterns conform to clinical guidelines for the management of COPD. METHODS: This was a cross-sectional study of 441 patients referred from the Public Health Care Network of the state of Bahia to a public referral outpatient clinic of a COPD management program of the Brazilian Unified Health Care System. Individuals with a spirometry-confirmed diagnosis of moderate to very severe COPD were included in the study. Patients were evaluated as to whether they had used any COPD medications in the last seven days. The appropriateness or inappropriateness (undertreatment or overtreatment) of the patient's pharmacological treatment was evaluated by comparing the patient's current treatment with that recommended by national and international guidelines. RESULTS: A total of 383 individuals were included in the analysis. Approximately half of the patients (49.1%) used long-acting bronchodilators. These patients were older and had had the disease longer. Of the sample as a whole, 63.7% and 83.0% did not receive pharmacological treatment in accordance with international and national recommendations, respectively. Inappropriateness due to undertreatment was indentified in more than half of the patients. CONCLUSIONS: Long-acting bronchodilators are frequently underused in individuals with moderate to very severe COPD within the Brazilian Unified Health Care System in the state of Bahia. Most patients in our sample were treated inappropriately, and undertreatment predominated. Strategies to improve access to long-acting bronchodilators and the quality of COPD pharmacological management are required.

Management of COPD within the Brazilian Unified Health Care System in the state of Bahia: an analysis of real-life medication use patterns / Gerenciamento da DPOC no Sistema Único de Saúde do estado da Bahia: uma análise do padrão de utilização de medicamentos na vida real

ABSTRACT Objective: To describe COPD pharmacological treatment patterns in the state of Bahia, Brazil, and to evaluate the extent to which these patterns conform to clinical guidelines for the management of COPD. Methods: This was a cross-sectional study of 441 patients referred from the Public Health Care Network of the state of Bahia to a public referral outpatient clinic of a COPD management program of the Brazilian Unified Health Care System. Individuals with a spirometry-confirmed diagnosis of moderate to very severe COPD were included in the study. Patients were evaluated as to whether they had used any COPD medications in the last seven days. The appropriateness or inappropriateness (undertreatment or overtreatment) of the patient's pharmacological treatment was evaluated by comparing the patient's current treatment with that recommended by national and international guidelines. Results: A total of 383 individuals were included in the analysis. Approximately half of the patients (49.1%) used long-acting bronchodilators. These patients were older and had had the disease longer. Of the sample as a whole, 63.7% and 83.0% did not receive pharmacological treatment in accordance with international and national recommendations, respectively. Inappropriateness due to undertreatment was indentified in more than half of the patients. Conclusions: Long-acting bronchodilators are frequently underused in individuals with moderate to very severe COPD within the Brazilian Unified Health Care System in the state of Bahia. Most patients in our sample were treated inappropriately, and undertreatment predominated. Strategies to improve access to long-acting bronchodilators and the quality of COPD pharmacological management are required.

RESUMO Objetivo: Descrever o padrão de tratamento farmacológico da DPOC no estado da Bahia e avaliar a conformidade desse padrão com diretrizes clínicas de manejo da doença. Métodos: Estudo de corte transversal envolvendo 441 pacientes referenciados da Rede de Atenção à Saúde do Estado da Bahia para um ambulatório de referência público de um programa do Sistema Único de Saúde de gerenciamento da DPOC. Foram incluídos no estudo indivíduos com diagnóstico de DPOC moderada a muito grave, confirmado por espirometria. Os pacientes foram avaliados com relação ao uso de algum medicamento para o tratamento da doença nos últimos sete dias. A avaliação da adequação ou da inadequação (sub ou sobretratamento) do tratamento farmacológico dos pacientes foi realizada comparando-se o tratamento atual desses pacientes ao preconizado por diretrizes nacionais e internacionais. Resultados: Um total de 383 indivíduos foi incluído na análise. Aproximadamente metade dos pacientes (49,1%) utilizava algum broncodilatador de longa duração. Esses pacientes eram mais idosos e possuíam maior tempo de duração da doença. Da amostra, 63,7% e 83,0% não recebiam tratamento farmacológico em concordância com as recomendações internacionais e nacionais, respectivamente. A inadequação por subtratamento foi identificada em mais da metade dos pacientes. Conclusões: Os broncodilatadores de longa duração são frequentemente subutilizados em indivíduos com DPOC moderada a muito grave no Sistema Único de Saúde da Bahia. Nesta amostra, a maioria dos pacientes era tratada de forma inadequada, com predominância de subtratamento. Estratégias que melhorem o acesso a broncodilatadores de longa duração e a qualidade do manejo farmacológico da doença são necessárias.