Off-label drug use and the risk of medication errors in critically ill neonates: A conceptual pilot study

2021 ◽  
pp. 1-15
Author(s):  
Kannan Sridharan ◽  
Muna Al Jufairi ◽  
Eman Al Ansari
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Birth Weight ◽  
Drug Use ◽  
Critically Ill ◽  
Medication Errors ◽  
Off Label ◽  
Increased Risk ◽  
Critically Ill Neonates ◽  
Medication Risk

BACKGROUND: Off-label drug (OLD) use is common in neonates. There is a dearth of information associating the OLD use and the risk of medication errors in critically ill neonates. Hence, the present study was carried out. METHODS: Drug prescriptions in neonates admitted to the intensive care unit of a tertiary care hospital between September 2018 and June 2019 were evaluated. Details on their demographics, reason for admission in intensive care unit, drug-related information and serum creatinine were extracted. United States Food and Drug Administration approved drug labels were compared. World Health Organization (WHO) anatomy, therapeutic and chemical (ATC) classification was used for drug categorization. We assessed the risk of medication errors using a validated tool, medication risk score (MERIS). RESULTS: One hundred and seventy-one neonates with 2394 prescriptions were included in this study. Seventy one percent of the neonates in the present study received at least one OLD/unlicensed prescription item. A trend in increased numbers of OLD/unlicensed drug use in more premature and lower birth weight neonates were observed. Medication risk score was significantly higher in neonates receiving OLD/unlicensed drugs compared to those with only labelled drugs. Very and extreme pre-term (along with very low and extremely low birth weight) neonates were at higher risk of medication errors compared to others. Presence of OLD/unlicensed prescribed items is associated with an increased risk of medication errors by an odds ratio of 20.4 compared to labelled drugs. CONCLUSION: Significant proportions of critically ill neonates received at least one OLD/unlicensed drug and such use was associated with potentially increased risk of medication errors.

scholarly journals Low 25-Hydroxyvitamin D Levels on Admission to the Intensive Care Unit May Predispose COVID-19 Pneumonia Patients to a Higher 28-Day Mortality Risk: A Pilot Study on a Greek ICU Cohort

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3773
Author(s):  
Alice G. Vassiliou ◽  
Edison Jahaj ◽  
Maria Pratikaki ◽  
Stylianos E. Orfanos ◽  
Ioanna Dimopoulou ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Vitamin D ◽  
Intensive Care ◽  
Critically Ill ◽  
Mortality Risk ◽  
Rank Test ◽  
Icu Admission ◽  
Hydroxyvitamin D ◽  
Increased Risk ◽  
25 Hydroxyvitamin D

We aimed to examine whether low intensive care unit (ICU) admission 25-hydroxyvitamin D (25(OH)D) levels are associated with worse outcomes of COVID-19 pneumonia. This was a prospective observational study of SARS-CoV2 positive critically ill patients treated in a multidisciplinary ICU. Thirty (30) Greek patients were included, in whom 25(OH)D was measured on ICU admission. Eighty (80%) percent of patients had vitamin D deficiency, and the remaining insufficiency. Based on 25(OH)D levels, patients were stratified in two groups: higher and lower than the median value of the cohort (15.2 ng/mL). The two groups did not differ in their demographic or clinical characteristics. All patients who died within 28 days belonged to the low vitamin D group. Survival analysis showed that the low vitamin D group had a higher 28-day survival absence probability (log-rank test, p = 0.01). Critically ill COVID-19 patients who died in the ICU within 28 days appeared to have lower ICU admission 25(OH)D levels compared to survivors. When the cohort was divided at the median 25(OH)D value, the low vitamin D group had an increased risk of 28-day mortality. It seems plausible, therefore, that low 25(OH)D levels may predispose COVID-19 patients to an increased 28-day mortality risk.

Off-label and unlicensed drug use: Results from a pilot study in a paediatric intensive care unit

2017 ◽  
Vol 86 (1) ◽  
pp. 28-36
Author(s):  
Isabel García-López ◽  
Javier Ezequiel Fuentes-Ríos ◽  
Silvia Manrique-Rodríguez ◽  
Cecilia M. Fernández-Llamazares
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Pilot Study ◽  
Drug Use ◽  
Paediatric Intensive Care Unit ◽  
Paediatric Intensive Care ◽  
Off Label

scholarly journals Association between Malnutrition and Hospital Mortality and Duration of Intensive Care Unit Admission in the Critically Ill: A Prospective Cohort Study

2017 ◽  
Author(s):  
Charles Chin Han Lew ◽  
Gabriel Jun Yung Wong ◽  
Ka Po Cheung ◽  
Ai Ping Chua ◽  
Mary Foong Fong Chong ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Cohort Study ◽  
Intensive Care ◽  
Hospital Mortality ◽  
Critically Ill ◽  
Prospective Cohort Study ◽  
Critically Ill Patients ◽  
Prospective Cohort ◽  
Unit Length ◽  
Increased Risk

There is limited evidence for the association between malnutrition and hospital mortality as well as Intensive Care Unit length-of-stay (ICU-LOS) in critically ill patients. We aimed to examine the aforementioned associations by conducting a prospective cohort study in an ICU of a Singapore tertiary hospital. Between August 2015 and October 2016, all adult patients with ≥24 h of ICU-LOS were included. The 7-point Subjective Global Assessment (7-point SGA) was used to determine patients’ nutritional status within 48 hours of ICU admission. Multivariate analyses were conducted in two ways: 1) presence versus absence of malnutrition, and 2) dose-dependent association for each 1-point decrease in the 7-point SGA. There were 439 patients of which 28.0% were malnourished, and 29.6% died before hospital discharge. Malnutrition was associated with an increased risk of hospital mortality [adjusted-RR 1.39 (95%CI: 1.10–1.76)], and this risk increased with a greater degree of malnutrition [adjusted-RR 1.09 (95%CI: 1.01–1.18) for each 1-point decrease in the 7-point SGA]. No significant association was found between malnutrition and ICU-LOS. Conclusion: There was a clear association between malnutrition and higher hospital mortality in critically ill patients. The association between malnutrition and ICU-LOS could not be replicated and hence requires further evaluation.

Unlicensed and Off-Label Drug Use in an Australian Neonatal Intensive Care Unit

PEDIATRICS ◽  
2002 ◽  
Vol 110 (5) ◽  
pp. e52-e52 ◽  
Author(s):  
C. P. F. O'Donnell ◽  
R. J. Stone ◽  
C. J. Morley
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Drug Use ◽  
Neonatal Intensive Care Unit ◽  
Neonatal Intensive Care ◽  
Off Label

scholarly journals Nucleated Red Blood Cells: Could They Be Indicator Markers of Illness Severity for Neonatal Intensive Care Unit Patients?

Children ◽  
2020 ◽  
Vol 7 (11) ◽  
pp. 197
Author(s):  
Rozeta Sokou ◽  
Georgios Ioakeimidis ◽  
Maria Lampridou ◽  
Abraham Pouliakis ◽  
Andreas G. Tsantes ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Critically Ill ◽  
Roc Curve ◽  
Blood Cells ◽  
Neonatal Intensive Care ◽  
Curve Analysis ◽  
Roc Curve Analysis ◽  
Nucleated Red Blood Cells ◽  
Critically Ill Neonates

Background: We aimed to assess whether nucleated red blood cells (NRBCs) count could serve as a diagnostic and prognostic biomarker for morbidity and mortality in critically ill neonates. Methods: The association between NRBCs count and neonatal morbidity and mortality was evaluated in an observational cohort of critically ill neonates hospitalized in our neonatal intensive care unit over a period of 69 months. The discriminative ability of NRBCs count as diagnostic and prognostic biomarkers was evaluated by performing the Receiver Operating Characteristics (ROC) curve analysis. Results: Among 467 critically ill neonates included in the study, 45 (9.6%) of them experienced in-hospital mortality. No statistically significant difference was found with regards to NRBCs count between survivors and non-survivors, although the median value for NRBCs was sometimes higher for non-survivors. ROC curve analysis showed that NRBCs is a good discriminator marker for the diagnosis of perinatal hypoxia in neonates with area under the curve (AUC) [AUC 0.710; 95% confidence interval (CI), 0.660–0.759] and predominantly in preterm neonates (AUC 0.921 (95% CI, 0.0849–0.0993)) by using a cut-off value of ≥11.2%, with 80% sensitivity and 88.7% specificity. NRBCs also revealed significant prognostic power for mortality in septic neonates (AUC 0.760 (95% CI, 0.631–0.888)) and especially in preterms with sepsis (AUC 0.816 (95% CI, 0.681–0.951)), with cut-off value ≥ 1%, resulting in 81.6% sensitivity and 78.1% specificity. Conclusion: NRBCs count may be included among the early diagnostic and prognostic markers for sick neonates.

scholarly journals Adverse events during the intrahospital transfer of critically ill perioperative patients in a South African tertiary hospital

2020 ◽  
pp. 131-138
Author(s):  
LY Seilbea ◽  
K de Vasconcellos
Keyword(s):  
Intensive Care Unit ◽  
Adverse Event ◽  
Intensive Care ◽  
Adverse Events ◽  
South African ◽  
Critically Ill ◽  
Multivariable Analysis ◽  
Inotropic Support ◽  
Physiological Changes ◽  
Increased Risk

Background: Critically ill patients frequently require intrahospital transfer for diagnostic or therapeutic procedures, or transfer to the intensive care unit. Intrahospital transfer exposes patients to an increased risk of adverse events. The reported rate of adverse events ranges from 4.2% to 79% based on data from high income countries. There is limited data available on intrahospital transfers in the South African context. This study aimed to determine the incidence of adverse events during intrahospital transfer, the physiological effects of intrahospital transfer, identify potential risk factors for adverse events and determine if adverse events were associated with poor clinical outcomes. Methods: The study was a single-centre, prospective, observational study of adult patients undergoing transport between the operating theatre and the intensive care unit (or vice versa) of a tertiary academic hospital in South Africa. Demographic data, transfer data (including adverse events, and the physiological parameters of the patients before and after transfer), and intensive care unit outcome data was collected between September 2018 and May 2019. Results: Data on 94 transfers was collected. Adverse events occurred in 23.4% (95% CI 14.7–32.1%) of transfers. Clinical adverse events, namely hypotension requiring management, made up 55% of the adverse events, while the remaining were technical adverse events (32% monitor failure, 9% ventilator failure and 4% infusion pump failure). The median transfer time was 10 minutes. Patients who developed adverse events during transfer were significantly older (median age 48 years versus 37 years, p = 0.037) and were significantly more likely to be receiving inotropic support (81.8% versus 51.4%, OR 4.26; 95% CI 1.31–13.82, p = 0.011) than those who did not have adverse events. Only the association with inotropic support remained on multivariable analysis. Patients who suffered an adverse event during transfer had a significantly higher mortality than those who did not have an adverse event (63.6% versus 30.6%, OR 3.98; 95% CI 1.46–10.84, p = 0.005) on univariate analysis, however this association was no longer significant on multivariable analysis. Increasing age, inotropic support and transfer by a medical officer as opposed to a registrar remained significant predictors on multivariable analysis. Significant physiological changes were noted in 80.9% of patients, with 64.9% of patients showing deterioration in at least one physiological parameter. Conclusion: Adverse events are common during the transfer of critically ill patients between the operating theatre and the intensive care unit. Even in the absence of adverse events, physiological changes occur in the majority of patients undergoing transfer. Patients receiving inotropic support are at increased risk of adverse events during transfer and enhanced attention to pre-transfer preparation and intratransfer management is warranted in these patients. The potential associations between adverse events during transfer and transferring personnel and ICU mortality needs to be explored in further studies.

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