Reports of substandard medicines: a lexicographic analysis of the Brazilian Health Surveillance Report System

Regulatory agencies are responsible for collecting and evaluating spontaneous reports of suspected problems related to medications, including those from substandard medicines (SM). Objectives: The aim was to evaluate the profile of SM reports submitted to the Brazilian Health Surveillance Notification System (Notivisa) and classify these reports objectively by means of lexicographic analysis. Methods: Was extracted all SM reports available in Notivisa during the period 1 January 2007 to 31 December 2017. Descriptive statistics were performed and the reasons for SM reporting were standardized (using OpenRefine and Microsoft Excel). The following analyses were performed using IRAMuTeQ 0.7 alpha2: lexicographic analysis to obtain the frequency of active words; descending hierarchical classification (DHC) to categorize the active words into lexical classes; factorial correspondence analysis (FCA) to obtain graphs of the classes. Approved by the Ethics Committee of the Hospital do Trabalhador/SES/PR CAAE 81873417.3.0000.5225 (protocol number: 2.506.594). Results: A total of 61,775 reports were analyzed, most of them reported by hospitals (46%). The DHC of the reasons for SM produced four classes visualized in the FCA: (i) packaging problems (16%) mainly leakages/opening issues; (ii) inadequate drug identification (22%), such as illegible label information; (iii) stability and contamination issues (11%) such as presence of particles; (iv) damaged tablets/blisters (23%) mainly broken tablets. Most SM (52%) were solutions for parenteral use; sodium chloride (9%), glucose and dipyrone (3%) were the products with most complaints. Conclusions: The reasons for SM reporting can be objectively classified into classes that represent the main problems submitted to Notivisa. This classification could guide the standardization of SM reporting and contribute to improving surveillance reporting systems worldwide.

Nebivolol for the Treatment of Essential Systemic Arterial Hypertension: A Systematic Review and Meta-Analysis.

INTRODUCTION: Cardiovascular diseases are the main cause of mortality worldwide, and systemic arterial hypertension is associated with a large number of these cases. The objective of health professionals and health policies should be searching for the best therapeutics to control this disease. A recent consensus indicated that ß-blockers have recently lost their place in initial indications for the treatment of systemic arterial hypertension and are now more indicated for the treatment of hypertension in association with other clinical situations such as angina, heart failure and arrhythmia; however, it is known that this approach was based on studies that evaluated older ß-blockers such as atenolol. OBJECTIVE: The main objective of this study was to perform a systematic review with subsequent meta-analysis on the use of nebivolol for hypertensive disease treatment, comparing it with drugs of the main antihypertensive classes. METHODS: This systematic review was based on a search of the MEDLINE (via Pubmed), Scopus, Cochrane, International Pharmaceuticals Abstracts (IPA), and Lilacs databases for randomized and double-blind clinical trials. In addition, we also searched for gray literature studies, to 31 July 2015. Next, a cumulative meta-analysis was performed, with studies being added in a sequential manner, evaluating their impact on the combined effect. For this project, we only meta-analyzed direct comparisons of random effect. RESULTS: Overall, 981 clinical trials were included in this systematic review. After careful analysis, 34 randomized and double-blind clinical trials were included to investigate the efficacy of nebivolol on systolic (SBP) and diastolic blood pressure (DBP) control and adverse effects. The study population comprised 12,465 patients with systemic arterial hypertension (SAH) aged between 18 and 85 years; 17% of subjects were of Black ethnicity, approximately 55% were men, and almost 10% had diabetes. In SBP management, nebivolol was superior to other ß-blockers and diuretics and showed no difference in efficacy when compared with angiotensin receptor blockers or calcium channel blockers. There were insufficient studies on angiotensin-converting enzyme inhibitors for adequate comparison of both SBP and DBP control. For DBP control, nebivolol was more efficient than other ß-blockers, angiotensin receptor blockers, diuretics, and calcium channel blockers. DISCUSSION: Nebivolol is a third-generation ß-blocker with additional capabilities to improve blood pressure levels in patients with arterial hypertension, because it acts by additional mechanisms such as endothelium-dependent vasodilation associated with L-arginine and oxide nitric acid, nitric oxide activity on smooth muscle cells, decreasing platelet aggregation, and leukocyte adhesion in the endothelium, decreasing oxidative stress. Although nebivolol has shown good results in controlling hypertension in this study (with few adverse events when compared with placebo treatment) and has an unquestionable benefit in individuals with heart failure (mainly with reduced ejection fraction), there is a lack of studies proving the benefit of this drug for controlling hypertension and reducing clinical outcomes such as cardiovascular (or general) mortality, acute myocardial infarction, or stroke. CONCLUSIONS: Nebivolol demonstrated at least similar control of blood pressure levels in hypertensive individuals when compared with drugs of the most used classes. In addition, in relation to the control of arterial hypertension, studies with clinical outcomes should be performed to ensure the use of this drug in detriment to others with these well-established results.

Analysis of the discrepancies identified during medication reconciliation on patient admission in cardiology units: a descriptive study.

OBJECTIVES: this observational study aimed to describe the discrepancies identified during medication reconciliation on patient admission to cardiology units in a large hospital. METHODS: the medication history of patients was collected within 48 hours after admission, and intentional and unintentional discrepancies were classified as omission, duplication, dose, frequency, timing, and route of drug administration. RESULTS: most of the patients evaluated were women (58.0%) with a mean age of 59 years, and 75.5% of the patients had a Charlson comorbidity index score between 1 and 3. Of the 117 discrepancies found, 50.4% were unintentional. Of these, 61.0% involved omission, 18.6% involved dosage, 18.6% involved timing, and 1.7% involved the route of drug administration. CONCLUSION: this study revealed a high prevalence of discrepancies, most of which were related to omissions, and 50% were unintentional. These results reveal the number of drugs that are not reincorporated into the treatment of patients, which can have important clinical consequences. OBJETIVOS: este estudo observacional teve como objetivo descrever discrepâncias encontradas na realização de conciliação medicamentosa de pacientes admitidos em unidades de cardiologia de um hospital de grande porte. MÉTODOS: a história de medicação dos pacientes foi coletada dentro de 48h após a admissão, e as discrepâncias, identificadas como intencionais ou não intencionais, foram classificadas como de: omissão, duplicidade, dose, frequência, intervalo e via. RESULTADOS: a maioria dos pacientes incluídos pertençia ao sexo feminino (58,0%), com idade média de 59 anos, e com índice de comorbidades de Charlson entre 1 e 3 (75,5% dos casos). Das 117 discrepâncias encontradas, 50,4% foram não intencionais. Dessas, 61,0% foram de omissão, 18,6% de dose, 18,6% de intervalo e 1,7% de via de administração. CONCLUSÃO: o estudo mostra a alta prevalência de discrepâncias, principalmente de omissão, sendo quase metade não intencionais. Esse dado remete ao número de medicamentos que não são reincorporados ao tratamento dos pacientes, podendo repercutir em consequências clínicas importantes. OBJETIVOS: este estudio observacional tuvo como objetivo describir discrepancias encontradas en la realización de la conciliación medicamentosa de pacientes admitidos en unidades de cardiología de un hospital de gran porte. MÉTODOS: la historia de medicación de los pacientes fue recolectada dentro de 48h después de la admisión, y las discrepancias, identificadas como intencionales o no intencionales, fueron clasificadas como: omisión, duplicidad, dosis, frecuencia, intervalo y vía. RESULTADOS: la mayoría de los pacientes incluidos pertenecía al sexo femenino (58,0%), con edad promedio de 59 años, y con índice de comorbilidad de Charlson entre 1 y 3 (75,5% de los casos). De las 117 discrepancias encontradas, 50,4% fueron no intencionales. De estas, 61,0% fueron de omisión, 18,6% de dosis, 18,6% de intervalo y 1,7% de vía de administración. CONCLUSIÓN: el estudio muestra la alta prevalencia de discrepancias, principalmente de omisión, siendo casi mitad de ellas no intencionales. Ese dato nos indica el número de medicamentos que no son reincorporados al tratamiento de los pacientes, lo que puede repercutir en consecuencias clínicas importantes.

Analysis of the discrepancies identified during medication reconciliation on patient admission in cardiology units: a descriptive study / Análise das discrepâncias encontradas durante a conciliação medicamentosa na admissão de pacientes em unidades de cardiologia: um estudo descritivo / Análisis de las discrepancias encontradas durante la conciliación medicamentosa en la admisión de pacientes en unidades de cardiología: un estudio descriptivo

ABSTRACT Objectives: this observational study aimed to describe the discrepancies identified during medication reconciliation on patient admission to cardiology units in a large hospital. Methods: the medication history of patients was collected within 48 hours after admission, and intentional and unintentional discrepancies were classified as omission, duplication, dose, frequency, timing, and route of drug administration. Results: most of the patients evaluated were women (58.0%) with a mean age of 59 years, and 75.5% of the patients had a Charlson comorbidity index score between 1 and 3. Of the 117 discrepancies found, 50.4% were unintentional. Of these, 61.0% involved omission, 18.6% involved dosage, 18.6% involved timing, and 1.7% involved the route of drug administration. Conclusion: this study revealed a high prevalence of discrepancies, most of which were related to omissions, and 50% were unintentional. These results reveal the number of drugs that are not reincorporated into the treatment of patients, which can have important clinical consequences.

RESUMO Objetivos: este estudo observacional teve como objetivo descrever discrepâncias encontradas na realização de conciliação medicamentosa de pacientes admitidos em unidades de cardiologia de um hospital de grande porte. Métodos: a história de medicação dos pacientes foi coletada dentro de 48h após a admissão, e as discrepâncias, identificadas como intencionais ou não intencionais, foram classificadas como de: omissão, duplicidade, dose, frequência, intervalo e via. Resultados: a maioria dos pacientes incluídos pertençia ao sexo feminino (58,0%), com idade média de 59 anos, e com índice de comorbidades de Charlson entre 1 e 3 (75,5% dos casos). Das 117 discrepâncias encontradas, 50,4% foram não intencionais. Dessas, 61,0% foram de omissão, 18,6% de dose, 18,6% de intervalo e 1,7% de via de administração. Conclusão: o estudo mostra a alta prevalência de discrepâncias, principalmente de omissão, sendo quase metade não intencionais. Esse dado remete ao número de medicamentos que não são reincorporados ao tratamento dos pacientes, podendo repercutir em consequências clínicas importantes.

RESUMEN Objetivos: este estudio observacional tuvo como objetivo describir discrepancias encontradas en la realización de la conciliación medicamentosa de pacientes admitidos en unidades de cardiología de un hospital de gran porte. Métodos: la historia de medicación de los pacientes fue recolectada dentro de 48h después de la admisión, y las discrepancias, identificadas como intencionales o no intencionales, fueron clasificadas como: omisión, duplicidad, dosis, frecuencia, intervalo y vía. Resultados: la mayoría de los pacientes incluidos pertenecía al sexo femenino (58,0%), con edad promedio de 59 años, y con índice de comorbilidad de Charlson entre 1 y 3 (75,5% de los casos). De las 117 discrepancias encontradas, 50,4% fueron no intencionales. De estas, 61,0% fueron de omisión, 18,6% de dosis, 18,6% de intervalo y 1,7% de vía de administración. Conclusión: el estudio muestra la alta prevalencia de discrepancias, principalmente de omisión, siendo casi mitad de ellas no intencionales. Ese dato nos indica el número de medicamentos que no son reincorporados al tratamiento de los pacientes, lo que puede repercutir en consecuencias clínicas importantes.