The Nature, Causes, and Clinical Impact of Errors in the Clinical Laboratory Testing Process Leading to Diagnostic Error:A Voluntary Incident Report Analysis

OBJECTIVES: Diagnostic errors, that is, missed, delayed, or wrong diagnoses, are a common type of medical errors and preventable iatrogenic harm. Errors in the laboratory testing process can lead to diagnostic errors. This retrospective analysis of voluntary incident reports aimed to investigate the nature, causes, and clinical impact of errors, including diagnostic errors, in the clinical laboratory testing process. METHODS: We used a sample of 600 voluntary incident reports concerning diagnostic testing selected from all incident reports filed at the University Medical Center Utrecht in 2017-2018. From these incident reports, we included all reports concerning the clinical laboratory testing process. For these incidents, we determined the following: nature: in which phase of the testing process the error occurred; cause: human, technical, organizational; and clinical impact: the type and severity of the harm to the patient, including diagnostic error. RESULTS: Three hundred twenty-seven reports were included in the analysis. In 77.1%, the error occurred in the preanalytical phase, 13.5% in the analytical phase and 8.0% in the postanalytical phase (1.5% undetermined). Human factors were the most frequent cause (58.7%). Severe clinical impact occurred relatively more often in the analytical and postanalytical phase, 32% and 28%, respectively, compared with the preanalytical phase (40%). In 195 cases (60%), there was a potential diagnostic error as consequence, mainly a potential delay in the diagnostic process (50.5%). CONCLUSIONS: Errors in the laboratory testing process often lead to potential diagnostic errors. Although prone to incomplete information on causes and clinical impact, voluntary incident reports are a valuable source for research on diagnostic error related to errors in the clinical laboratory testing process.</p

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BACKGROUND: Psychotropic drugs are prescribed to approximately 30-40% of adults with intellectual disability (ID) and challenging behaviour, despite the limited evidence of effectiveness and the potential of adverse events. AIMS: To assess the prevalence of adverse events in association with psychotropic drug use in adults with ID and challenging behaviour and to examine the relation of these adverse events with the person's quality of life. METHOD: The presence of adverse events was measured with a questionnaire that had to be filled in by the physicians of the participants. Movement disorders were measured separately with a standardised protocol. The strength of the association between adverse events and Intellectual Disability Quality of Life-16 (IDQOL-16), and daily functioning was investigated using linear regression analyses, taking into account the severity of disease (CGI-S) as potential confounder. RESULTS: Virtually all of 103 adults with ID and challenging behaviour had at least one adverse event (84.4%) and almost half had ≥3 adverse events (45.6%) across different subclasses. Using psychotropic drugs increased the prevalence of adverse events significantly. Respectively 13% of the patients without psychotropic drugs and 61% of the patients with ≥2 psychotropic drugs had ≥3 adverse events. Having adverse events had a significantly negative influence on the quality of life. CONCLUSIONS: A large majority of all patients had at least one adverse event associated with psychotropic drug use. More attention is needed for these adverse events and their negative influence on the quality of life of these patients, taking into account the lack of evidence of effectiveness of psychotropic drugs for challenging behaviour

The association between prescription change frequency, chronic disease score and hospital admissions: a case control study

BACKGROUND: The aim of this study was to assess the association between prescription changes frequency (PCF) and hospital admissions and to compare the PCF to the Chronic Disease Score (CDS). The CDS measures comorbidity on the basis of the 1-year pharmacy dispensing data. In contrast, the PCF is based on prescription changes over a 3-month period. METHODS: A retrospective matched case–control design was conducted. 10.000 patients were selected randomly from the Dutch PHARMO database, who had been hospitalized (index date) between July 1, 1998 and June 30, 2000. The primary study outcome was the number of prescription changes during several three-month time periods starting 18, 12, 9, 6, and 3 months before the index date. For each hospitalized patient, one nonhospitalized patient was matched for age, sex, and geographic area, and was assigned the same index date as the corresponding hospitalized patient. We classified four mutually exclusive types of prescription changes: change in dosage, switch, stop and start. RESULTS: The study population comprised 8,681 hospitalized patients and an equal number of matched nonhospitalized patients. The odds ratio of hospital admission increased with an increase in PCF category. At 3 months before the index date from PCF=1 OR 1.4 [95% CI 1.3-1.5] to PCF= 2–3 OR 2.2 [95% CI 1.9-2.4] and to PCF ≥ 4 OR 4.1 [95% CI 3.1-5.1]. A higher CDS score was also associated with an increased odds ratio of hospitalization: OR 1.3 (95% CI 1.2-1.4) for CDS 3–4, and OR 3.0 (95% CI 2.7-3.3) for CDS 5 or higher. CONCLUSION: The prescription change frequency (PCF) is associated with hospital admission, like the CDS. Pharmacists and other healthcare workers should be alert when the frequency of prescription changes increases. Clinical rules could be helpful to make pharmacists and physicians aware of the risk of the number of prescription changes

Про оцінку напружено-деформованого стану конвеєрної стрічки на дузі ковзання

Работа посвящена расширению сферы применения техники Л. Прандтля на решение задачи о взаимодействии конвейерной ленты и нефутерованного барабана. Получено решение задачи Ламе с соответствующими граничными условиями, что позволило выяснить характер деформаций на дуге скольжения. Приведены графики деформаций и соответствующих им напряжений.The paper is devoted to expand L. Prandtl technique to contact the conveyor belt with rigid drum. The Lamb task solving with corresponding boundary condition allow explaining the deflection nature in slide arch drum. The deflections and corresponding stresses graphics are demonstrated

Less discontinuation of ADHD drug use since the availability of long-acting ADHD medication in children, adolescents and adults under the age of 45 years in the Netherlands

Treatment options for ADHD in the Netherlands have increased with the introduction of the extended-release formulations of methylphenidate (MPH ER, Concerta®) in 2003 and atomoxetine (ATX, Strattera®) in 2005, but data on the effect on drug usage patterns are scarce. The objective of the present study was to describe changes in the patterns of ADHD medication use and determinants thereof among children, adolescents and adults (<45 years) starting ADHD medication since the introduction of MPH ER and ATX. Data were obtained from Dutch community pharmacies as collected by the Foundation for Pharmaceutical Statistics, covering 97% of all dispenses for prescription medicines to outpatients in the Netherlands. Usage patterns (continuation, discontinuation, switching and addition) of ADHD drugs were evaluated at 3, 6 and 12 months after initiation for three separate time cohorts (patients starting ADHD medication in Jan-Dec 2002, Jan 2003–June 2004, respectively July 2004–Dec 2005). It was found that between 2002 and 2006, most ADHD drug users were initiated on methylphenidate IR. Discontinuation of any ADHD drug treatment decreased over time partly in favour of switching and addition. Discontinuation at 3 months decreased from around 33% to around 25%, at 6 months from less than 50% to almost 35%, and at 12 months from just fewer than 60% to less than 45%. Discontinuation was higher among females and in adults >18 years. After the introduction of MPH ER and ATX (time cohort III), 16.5% of the incident ADHD drug users switched their medication and almost 9% added an ADHD drug to the prior ADHD drug. In conclusion, discontinuation of incident ADHD drug use is high after 3, 6 and 12 months. During the study period, the incidence of discontinuation decreased because of the availability of extended-release methylphenidate and atomoxetine

Post-approval quality-related regulatory actions for biopharmaceuticals approved in the European Union and the United States between 1995 and 2019

The quality of biopharmaceuticals is carefully monitored by manufacturers and regulators to ensure safety and efficacy throughout the entire product life cycle. Quality defects can lead to post-approval regulatory actions (RAs) to inform healthcare professionals (HCPs). The present study identified quality-related RAs for biopharmaceuticals approved in the European Union and United States between 1995 and 2019. Quality-related RAs were issued due to various quality defects and required different actions by HCPs. The quality defects were not identified due to a negative impact on efficacy and/or safety, which is reassuring. The findings reflect the capability of the stringent regulatory system and quality control to capture and counter various quality defects before the affected product and batches can harm patients

Association between HTR2C polymorphisms and weight loss in obese patients

OBJECTIVE To investigate whether the HTR2C rsUU334 and 759 C/T polymorphisms are associated with weight loss in an anti- obesity programme. DESIGN AND METHODS A longitudinal observational follow-up study was used to assess the association between HTR2C genotypes and weight loss during a nine month programme in an obesity clinic. Caucasian patients aged 18 years or older were included. Data were extracted from the patients' medical records. In total, 128 patients were included 129 males). RESULTS There was a significant association between the HTR2C 759 T allele and resistance to weight loss in the first month of the programme. For each T allele present, there was 0.78% (95% confidence interval [95%-CI] 0.19-1.38; P = 0.011 less weight loss (as a percentage of the body weight at start). Patients carrying the variant HTR2C 759 T allele were also less likely to reach > 7% weight loss (odds ratio [OR] 0.23; 95%-CI 0.06- 0,85; P = 0.028), and dropped out of the programme sooner [-0.78 months; 95%-CI -1.51- -0.06; P = 0.035; corrected for gender). No associations with the HTR2C rsUU334- genotype and any of the primary endpoints for weight loss or secondary endpoints were found. CONCLUSION Patients carrying the HTR2C 759 T allele were more resistant to weight loss and dropped out of the programme sooner. However, these effects were small and only explained a small part of a very complex puzzle. Genotyping HTR2C to predict a patient's chance of success in an obesity clinic is therefore not warranted

Flow variability and its physical causes in infusion technology: a systematic review of in vitro measurement and modeling studies

Infusion therapy is medically and technically challenging and frequently associated with medical errors. When administering pharmaceuticals by means of infusion, dosing errors can occur due to flow rate variability. These dosing errors may lead to adverse effects. We aimed to systematically review the available biomedical literature for in vitro measurement and modeling studies that investigated the physical causes of flow rate variability. Special focus was given to syringe pump setups, which are typically used if very accurate drug delivery is required. We aimed to extract from literature the component with the highest mechanical compliance in syringe pump setups. We included 53 studies, six of which were theoretical models, two articles were earlier reviews of infusion literature, and 45 were in vitro measurement studies. Mechanical compliance, flow resistance, and dead volume of infusion systems were stated as the most important and frequently identified physical causes of flow rate variability. The syringe was indicated as the most important source of mechanical compliance in syringe pump setups (9.0×10-9 to 2.1×10-8 l/Pa). Mechanical compliance caused longer flow rate start-up times (from several minutes up to approximately 70 min) and delayed occlusion alarm times (up to 117 min)