Adverse events caused by potential drug-drug interactions in an intensive care unit of a teaching hospital.
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ABSTRACT:
SUBMITTER: Alvim MM
PROVIDER: S-EPMC4738821 | biostudies-other | 2015 Oct-Dec
REPOSITORIES: biostudies-other
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Project description:ObjectivesTo describe adverse drug events (ADEs) in children under intensive care, identify risk factors and tools that can detect ADEs early, and the impact on length of stay (LOS).DesignA prospective observational study.SettingPaediatric intensive care unit of a tertiary care teaching hospital.Patients239 patients with a mean age of 67.5 months representing 1818 days of hospitalisation in intensive care unit.InterventionsActive search of charts and electronic patient records using triggers. The statistical analysis involved linear and logistic regression.Measurements and main resultsThe average LOS was 7.6 days. There were 110 proven, probable and possible ADEs in 84 patients (35.1%). We observed 138 instances of triggers. The major classes of drugs associated with events were: antibiotics (n=41), diuretics (n=24), antiseizures (n=23), sedatives and analgesics (n=17) and steroids (n=18). The number of drugs administered was most related to the occurrence of ADEs and also to the LOS (p<0.001). The occurrence of an ADE may result in an increase in the LOS by 1.5 days per event, but this was not statistically significant in this sample. Patients aged less than 48 months also proved to be at a significant risk for ADEs, with an OR of 1.84 (95% CI 1.07 to 3.15, p=0.025). The number of drugs administered also correlated with the number of ADEs (p<0.0001). The chance of having at least one ADE increased linearly as the patient was administered more drugs.ConclusionsThe use of multiple drugs as well as lower patient age favours the occurrence of ADEs. The active search described here provides a systematic approach to this problem.
| S-EPMC3586175 | biostudies-literature
Project description:BackgroundAdverse events (AEs) are patient injuries caused by medical care. Previous studies have reported increased mortality rates and prolonged hospital length of stay in patients having an AE. However, these studies have not adequately accounted for potential biases which might influence these associations. We performed this study to measure the independent influence of intensive care unit (ICU) based AEs on in-hospital mortality and hospital length of stay.MethodsProspective cohort study in an academic tertiary-care ICU. Patients were monitored daily for adverse clinical occurrences. Data about adverse clinical occurrences were reviewed by a multidisciplinary team who rated whether they were AEs and whether they were preventable. We determined the association of AEs in the ICU with time to death and time to hospital discharge using multivariable survival analysis models.ResultsWe evaluated 207 critically ill patients (81% required mechanical ventilation, median Glasgow Coma Scale = 8, median predicted mortality = 31%). Observed mortality rate and hospital length of stay were 25% (95% CI 19%-31%) and 15 days (IQR 8-34 days), respectively. ICU-based AEs and preventable AEs occurred in 40 patients (19%, 95% CI 15%-25%) and 21 patients (10%, 95% CI 7%-15%), respectively. ICU-based AEs and preventable AEs were not significantly associated with time to in-hospital death (HR = 0.93, 95% CI 0.44-1.98 and HR = 0.72 95% CI 0.25-2.04, respectively). ICU-based AEs and preventable AEs were independently associated with time to hospital discharge ((HR = 0.50, 95% CI 0.31-0.81 and HR = 0.46 95% CI 0.23-0.91, respectively)). ICU-based AEs were associated with an average increase in hospital length of stay of 31 days.ConclusionThe impact of AEs on hospital length of stay was clinically relevant. Larger studies are needed to conclusively measure the association between preventable AEs and patient outcomes.
| S-EPMC2621200 | biostudies-literature
Project description:Background:The potential adverse effects of empiric broad-spectrum antimicrobial use among patients with suspected but subsequently excluded infection have not been fully characterized. We sought novel methods to quantify the risk of adverse effects of broad-spectrum antimicrobial exposure among patients admitted to an intensive care unit (ICU). Methods:Among all adult patients admitted to ICUs at a single institution, we selected patients with negative blood cultures who also received ?1 broad-spectrum antimicrobials. Broad-spectrum antimicrobials were categorized in ?1 of 5 categories based on their spectrum of activity against potential pathogens. We performed, in serial, 5 cohort studies to measure the effect of each broad-spectrum category on patient outcomes. Exposed patients were defined as those receiving a specific category of broad-spectrum antimicrobial; nonexposed were all other patients in the cohort. The primary outcome was 30-day mortality. Secondary outcomes included length of hospital and ICU stay and nosocomial acquisition of antimicrobial-resistant bacteria (ARB) or Clostridium difficile within 30 days of admission. Results:Among the study cohort of 1918 patients, 316 (16.5%) died within 30 days, 821 (42.8%) had either a length of hospital stay >7 days or an ICU length of stay >3 days, and 106 (5.5%) acquired either a nosocomial ARB or C. difficile. The short-term use of broad-spectrum antimicrobials in any of the defined broad-spectrum categories was not significantly associated with either primary or secondary outcomes. Conclusions:The prompt and brief empiric use of defined categories of broad-spectrum antimicrobials could not be associated with additional patient harm.
| S-EPMC5804637 | biostudies-literature
Project description:Patients admitted to the intensive care unit (ICU) are frequently exposed to potential drug-drug interactions (pDDIs). However, reported frequencies of pDDIs in the ICU vary widely between studies. This can be partly explained by significant variation in their methodological approach. Insight into methodological choices affecting pDDI frequency would allow for improved comparison and synthesis of reported pDDI frequencies. This study aimed to evaluate the association between methodological choices and pDDI frequency and formulate reporting recommendations for pDDI frequency studies in the ICU. The MEDLINE database was searched to identify papers reporting pDDI frequency in ICU patients. For each paper, the pDDI frequency and methodological choices such as pDDI definition and pDDI knowledge base were extracted, and the risk of bias was assessed. Each paper was categorized as reporting a low, medium, or high pDDI frequency. We sought associations between methodological choices and pDDI frequency group. Based on this comparison, reporting recommendations were formulated. Analysis of methodological choices showed significant heterogeneity between studies, and 65% of the studies had a medium to high risk of bias. High risk of bias, small sample size, and use of drug prescriptions instead of administrations were related to a higher pDDI frequency. The findings of this review may support researchers in designing a reliable methodology assessing pDDI frequency in ICU patients. The reporting recommendations may contribute to standardization, comparison, and synthesis of pDDI frequency studies, ultimately improving knowledge about pDDIs in and outside the ICU setting.
| S-EPMC9303874 | biostudies-literature
Project description:BackgroundAdverse drug events (ADEs) are an important public health problem with considerable clinical and economic costs. However there are limited studies of ADE incidence in adult inpatients in low-income countries, particularly in Ethiopia. Hence, this study aimed to assess the incidence of adverse drug events and associated factors in patients hospitalized in the medical wards of Wolaita Sodo University teaching referral hospital (WSUTRH).MethodsA prospective observational study was conducted involving 240 patients admitted to the medical wards of WSUTRH. A checklist was used for data collection, while standard tools were employed for assessing the probability and characterization of ADEs. A multifaceted approach involving daily chart review, patient interview, attendance at ward rounds and/or meetings, and staff reports were employed to collect the data. To identify factors independently associated with ADEs, logistic regression analysis was conducted using Stata version 15.ResultsPatients were followed from ward admission to discharge, accounting for 2200 patient-days of hospital stay. Overall, 976 medications were ordered during the hospital stay. Sixty-four ADEs were identified with an incidence of approximately 27 per 100 admissions and 29 per 1000 patient days. Of the total ADEs, 59% were preventable. Regarding the severity, 2% of the ADEs were severe, while 54% were moderate. The risk of ADEs increased with longer hospital stay (LOHS) (p = 0.021), in patients with blood and immune disease diagnosis (p = 0.001), use of cardiovascular medicines (p = 0.028), and an increase in the number of medications prescribed (p = 0.021).ConclusionsIn this study, ADEs were identified in about one-quarter of the participants. Longer hospital stays, blood and immune diseases, cardiovascular medicines use, and multiple medication use had increased the likelihood of ADE occurrences. The majority of the ADEs were preventable, indicating the existence of a window of opportunity to ensure patient safety.
| S-EPMC9115930 | biostudies-literature
Project description:The incidence of candidemia by the Candida parapsilosis complex has increased considerably in recent decades, frequently related to use of indwelling intravascular catheters. The ability of this pathogen to colonize healthcare workers (HCW)' hands, and to form biofilm on medical devices has been associated with the occurrence of nosocomial outbreaks and high mortality rates. Fluconazole has been the leading antifungal drug for the treatment of invasive candidiasis in developing countries. However, azole-resistant C. parapsilosis isolates are emerging worldwide, including in Brazil. Few studies have correlated outbreak infections due to C. parapsilosis with virulence factors, such as biofilm production. We thus conducted a microbiological investigation of C. parapsilosis complex isolates from a Brazilian teaching hospital. Additionally, we identified a previously unrecognized outbreak caused by a persistent azole-resistant C. parapsilosis (sensu stricto) clone in the intensive care unit (ICU), correlating it with the main clinical data from the patients with invasive candidiasis. The molecular identification of the isolates was carried out by PCR-RFLP assay; antifungal susceptibility and biofilm formation were also evaluated. The genotyping of all C. parapsilosis (sensu stricto) was performed by microsatellite analysis and the presence of ERG11 mutations was assessed in the azole non-susceptible isolates. Fourteen C. parapsilosis (sensu stricto) isolates were recovered from patients with invasive candidiasis, eight being fluconazole and voriconazole-resistant, and two intermediate only to fluconazole (FLC). All non-susceptible isolates showed a similar pattern of biofilm formation with low biomass and metabolic activity. The A395T mutation in ERG11 was detected exclusively among the azole-resistant isolates. According to the microsatellite analysis, all azole non-susceptible isolates from the adult ICU were clustered together indicating the occurrence of an outbreak. Regarding clinical data, all patients infected by the clonal non-susceptible isolates and none of the patients infected by the susceptible isolates had been previously exposed to corticosteroids (p = 0.001), while the remaining characteristics showed no statistical significance. The current study revealed the persistence of an azole non-susceptible C. parapsilosis clone with low capacity to form biofilm over two years in the adult ICU. These results reinforce the need of epidemiological surveillance and monitoring antifungal susceptibility of C. parapsilosis isolates in hospital wards.
| S-EPMC6290035 | biostudies-literature
Project description:BackgroundImmune checkpoint inhibitors have reshaped the standard of care in oncology. However, they have been associated with potentially life-threatening immune-related adverse events. With the growing indications of immune checkpoint inhibitors and their position as a pillar of cancer treatment, intensive care physicians will be increasingly confronted with their side effects. The outcome of patients with severe immune-related adverse events in the intensive care unit remains unknown. This retrospective multicentric study aims to describe the characteristics of patients admitted to the intensive care units of 4 academic hospitals in Paris area while receiving immune checkpoint inhibitor treatment between January 2013 and October 2019.ResultsOver the study period, 112 cancer patients who received immune checkpoint inhibitors were admitted to the intensive care unit within 60 days after the last dose. ICU admission was related to immune-related adverse events (n = 29, 26%), other intercurrent events (n = 39, 35%), or complications related to tumor progression (n = 44, 39%). Immune-related adverse events were pneumonitis (n = 8), colitis (n = 4), myocarditis (n = 3), metabolic disorders related to diabetes (n = 3), hypophysitis (n = 2), nephritis (n = 2), meningitis or encephalitis (n = 2), hepatitis (n = 2), anaphylaxis (n = 2) and pericarditis (n = 1). Primary tumors were mostly melanomas (n = 14, 48%), non-small-cell lung cancers (n = 7, 24%), and urothelial carcinomas (n = 5, 17%). Diagnosis of melanoma and a neutrophil/lymphocyte ratio < 10 were associated with immune-related diagnosis versus other reasons for ICU admission. During their ICU stay, immune-related adverse events patients needed vasopressors (n = 7), mechanical ventilation (n = 6), and extra-corporeal membrane oxygenation (n = 2). One-year survival was significantly higher for patients admitted for irAE compared to patients admitted for other reasons (p = 0.004).ConclusionsAdmission to the intensive care unit related to immune-related adverse event was associated with better outcome in cancer patients treated with immune checkpoint inhibitors. Our results support the admission for an intensive care unit trial for patients with suspected immune-related adverse events.
| S-EPMC7567777 | biostudies-literature
Project description:One of the most important concerns of health care systems in the world is the patient safety issues. Root Cause Analysis is a systematic process for identifying root causes and contributory factors of problems or events. The objective of this study is to review RCA reports to determine the effect size of contributory factors on adverse events through an organizational perspective.This study was conducted in a tertiary care teaching hospital in 2014. The process of root cause analysis was taken from National Patient Safety Agency framework. We calculated descriptive statistics to determine the frequency distribution of contributory factors on each adverse event.Having the process of 16 adverse events reviewed, 38 care or service delivery problems were identified which showed that 317 contributory factors and underlying causes had led to these problems. Accordingly, the most important contributory factors included the following: Task factors (20 %), education and training factors (16 %), communication factors (14 %), and team and social factors (13 %).RCA is an effective method of problem solving used for identifying the root causes of initial errors and finding ways to prevent the recurrences. In this study, lack of effective communication skills of nurses and other clinical staff when interacting with colleague and communicating with patients, failure to comply with health care provision standards, lack of adequate supervision on implementation of clinical guidelines and issues related to the organizational culture were the main determining factors which have been considered for implementing preventive measures with regard to the hospital specifications.
| S-EPMC4964171 | biostudies-other
Project description:BackgroundSpontaneous adverse drug reaction (ADR) reporting is the cornerstone of pharmacovigilance. ADR reporting with Yellow Cards has tremendously improved pharmacovigilance of drugs in many developed countries and its use is advocated by the World Health Organization (WHO). This study was aimed at investigating the knowledge and attitude of doctors in a teaching hospital in Lagos, Nigeria on spontaneous ADR reporting and to suggest possible ways of improving this method of reporting.MethodsA total of 120 doctors working at the Lagos State University Teaching Hospital (LASUTH), in Nigeria were evaluated with a questionnaire for their knowledge and attitudes to ADR reporting. The questionnaire sought the demographics of the doctors, their knowledge and attitudes to ADR reporting, the factors that they perceived may influence ADR reporting, and their levels of education and training on ADR reporting. Provision was also made for suggestions on the possible ways to improve ADR reporting.ResultsThe response rate was 82.5%. A majority of the respondents (89, 89.9%) considered doctors as the most qualified health professionals to report ADRs. Forty (40.4%) of the respondents knew about the existence of National Pharmacovigilance Centre (NPC) in Nigeria. Thirty-two (32.3%) respondents were aware of the Yellow Card reporting scheme but only two had ever reported ADRs to the NPC. About half (48.5%) of the respondents felt that all serious ADRs could be identified after drug marketing. There was a significant difference between the proportion of respondents who felt that ADR reporting should be either compulsory or voluntary (chi2 = 38.9, P < 0.001). ADR reporting was encouraged if the reaction was serious (77, 77.8%) and unusual (70, 70.7%). Education and training was the most recognised means of improving ADR reporting.ConclusionThe knowledge of ADRs and how to report them are inadequate among doctors working in a teaching hospital in Lagos, Nigeria. More awareness should be created on the Yellow Card reporting scheme. Continuous medical education, training and integration of ADR reporting into the clinical activities of the doctors would likely improve reporting.
| S-EPMC2731723 | biostudies-literature