Preventable adverse drug events in hospitalized patients

Cullen, David J.; Sweitzer, Bobbie Jean; Bates, David W.; Burdick, Elisabeth; Edmondson, Amy C.; Leape, Lucian L.

doi:10.1097/00003246-199708000-00014

Cited by 526 publications

(123 citation statements)

References 13 publications

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“…3,62 We also found a strong correlation between the day of ADR occurrence in the total patient’s length of stay and the total length of stay and a moderate correlation between the number of total medications received and the number of ADRs a patient develop. These results are consistent with known patient- and medication-related risk factors associated with the development of ADRs.…”

Section: Discussionmentioning

confidence: 52%

A Multicenter Evaluation of Off-Label Medication Use and Associated Adverse Drug Reactions in Adult Medical ICUs

Smithburger

Buckley

Culver

et al. 2015

Critical Care Medicine

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Objective Prior research indicates off-label use is common in the intensive care unit (ICU); however the safety of off-label use has not been assessed. The study objective was to determine the incidence of adverse drug reactions (ADRs) associated with off-label use and evaluate off-label use as a risk factor for the development of ADRs in an adult ICU population. Setting Medical ICUs at three academic medical centers Patients Adult patients (age ≥ 18 years old) receiving medication therapy Interventions All administered medications were evaluated for Food and Drug Administration (FDA) approved or off-label use. Patients were assessed daily for the development of an ADR through active surveillance. Three ADR assessment instruments were used to determine the probability of an ADR resulting from drug therapy. Severity and harm of the ADR were also assessed. Cox proportional hazard regression was used to identify a set of covariates that influenced the rate of ADRs. Measurements and Main Results Overall, 1654 patient days (327 patients) and 16,391 medications were evaluated, with 43% of medications being used off-label. One hundred and sixteen ADRs were categorized dichotomously (FDA or off-label), with 56% and 44% being associated with FDA approved and off-label use, respectively. The number of ADRs for medications administered and number of harmful and severe ADRs did not differ for medications used for FDA approved or off-label use (0.74% vs 0.67%, p = 0.336; 33 vs. 31 events, p=0.567; 24 vs. 24 events, p = 0.276). Age, sex, number of high-risk medications, number of off-label medications, and severity of illness score were included in the Cox proportional hazard regression. It was found that the rate of ADRs increases by 8% for every one additional off-label medication (HR = 1.08; 95 % CI: 1.018–1.154). Conclusion While ADRs do not occur more frequently with off-label use, ADR risk increases with each additional off-label medication used.

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Section: Discussionmentioning

confidence: 52%

A Multicenter Evaluation of Off-Label Medication Use and Associated Adverse Drug Reactions in Adult Medical ICUs

Smithburger

Buckley

Culver

et al. 2015

Critical Care Medicine

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“…Table 1 provides definitions of drug related events[2-6]. Approximately one-third of ME result in ADEs[7,8]. Examples of ME resulting in ADEs include missed doses, wrong administration technique, duplicate therapies, drug interactions, equipment failure, inadequate monitoring and preparation errors[9].…”

Section: Introductionmentioning

confidence: 99%

“…Critically ill patients are at greater risk for MEs and ADEs compared to non-ICU patients because of the complexity of their drug regimens, sheer volume of medications that they receive, in particular, the volume of intravenous drugs received and acute changes in organ function that can alter the pharmacokinetics[8,10,11]. Prevention of ME and ADEs is important and the significance can resonate to a greater degree in critically ill patients because the severity of ADEs and related outcomes are worse compared to patients in other settings[8,12-14].…”

Section: Introductionmentioning

confidence: 99%

Clinical decision support for drug related events: Moving towards better prevention

Kane‐Gill

Achanta

Kellum

et al. 2016

WJCCM

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Clinical decision support (CDS) systems with automated alerts integrated into electronic medical records demonstrate efficacy for detecting medication errors (ME) and adverse drug events (ADEs). Critically ill patients are at increased risk for ME, ADEs and serious negative outcomes related to these events. Capitalizing on CDS to detect ME and prevent adverse drug related events has the potential to improve patient outcomes. The key to an effective medication safety surveillance system incorporating CDS is advancing the signals for alerts by using trajectory analyses to predict clinical events, instead of waiting for these events to occur. Additionally, incorporating cutting-edge biomarkers into alert knowledge in an effort to identify the need to adjust medication therapy portending harm will advance the current state of CDS. CDS can be taken a step further to identify drug related physiological events, which are less commonly included in surveillance systems. Predictive models for adverse events that combine patient factors with laboratory values and biomarkers are being established and these models can be the foundation for individualized CDS alerts to prevent impending ADEs.

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“…Critical care areas present a particular challenge with regard to medication errors 9. They are a dynamic environment with critically ill patients who often require rapid adaptation of on-going management.…”

Section: Challenges Encountered In the Intensive Care Unitmentioning

confidence: 99%

Reducing medication errors in critical care: a multimodal approach

Kruer¹,

Jarrell²,

Latif³

2014

CPAA

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The Institute of Medicine has reported that medication errors are the single most common type of error in health care, representing 19% of all adverse events, while accounting for over 7,000 deaths annually. The frequency of medication errors in adult intensive care units can be as high as 947 per 1,000 patient-days, with a median of 105.9 per 1,000 patient-days. The formulation of drugs is a potential contributor to medication errors. Challenges related to drug formulation are specific to the various routes of medication administration, though errors associated with medication appearance and labeling occur among all drug formulations and routes of administration. Addressing these multifaceted challenges requires a multimodal approach. Changes in technology, training, systems, and safety culture are all strategies to potentially reduce medication errors related to drug formulation in the intensive care unit.

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Preventable adverse drug events in hospitalized patients

Cited by 526 publications

References 13 publications

A Multicenter Evaluation of Off-Label Medication Use and Associated Adverse Drug Reactions in Adult Medical ICUs

A Multicenter Evaluation of Off-Label Medication Use and Associated Adverse Drug Reactions in Adult Medical ICUs

Clinical decision support for drug related events: Moving towards better prevention

Reducing medication errors in critical care: a multimodal approach

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