Neuraxial and peripheral misconnection events leading to wrong-route medication errors: a comprehensive literature review.

We conducted a search of the literature to identify case reports of neuraxial and peripheral nervous system misconnection events leading to wrong-route medication errors. This narrative review covers a 20-year period (1999-2019; English-language publications and abstracts) and included the published medical literature (PubMed and Embase) and public access documents. Seventy-two documents representing 133 case studies and 42 unique drugs were determined relevant. The most commonly reported event involved administering an epidural medication by an intravenous line (29.2% of events); a similar proportion of events (27.7%) involved administering an intravenous medication by an epidural line. Medication intended for intravenous administration, but delivered intrathecally, accounted for 25.4% of events. In the most serious cases, outcomes were directly related to the toxicity of the drug that was unintentionally administered. Patient deaths were reported due to the erroneous administration of chemotherapies (n=16), muscle relaxants (n=4), local anesthetics (n=4), opioids (n=1), and antifibrinolytics (n=1). Severe outcomes, including paraplegia, paraparesis, spinal cord injury, and seizures were reported with the following medications: vincristine, gadolinium, diatrizoate meglumine, doxorubicin, mercurochrome, paracetamol, and potassium chloride. These case reports confirm that misconnection events leading to wrong-route errors can occur and may cause serious injury. This comprehensive characterization of events was conducted to better inform clinicians and policymakers, and to describe an emergent strategy designed to mitigate patient risk.

Daytime intragastric acid control: post hoc analyses of esomeprazole 20 mg and over-the-counter proton-pump inhibitors.

OBJECTIVES: In mild gastroesophageal reflux disease, which accounts for the great majority of cases, the major burden of reflux occurs during daytime hours, after food intake. The aim of these analyses was to evaluate intragastric pH control during the typical 14-hour daytime awake period by proton-pump inhibitors (PPIs) given at over-the-counter (OTC) dosages. METHODS: In one double-blind and three open-label, randomized, crossover studies, intragastric pH was monitored for 24 hours on day 5 of treatment. The 24-hour data have been reported previously. Post hoc analyses reassessed these studies for the 14-hour daytime period, comparing esomeprazole 20 mg with currently available OTC PPIs omeprazole, pantoprazole (not available in the US) and lansoprazole. RESULTS: Subjects maintained intragastric pH >4 for a significantly greater mean percentage of the 14-hour daytime period with esomeprazole 20 mg compared with any of the PPI comparators at OTC dosages. Geometric mean ratios (95% confidence intervals) for esomeprazole 20 mg versus the comparators were: 1.45 (1.14-1.85; p = 0.003) versus omeprazole 20 mg; 2.50 (2.01-3.11; p < 0.0001) versus pantoprazole 20 mg; and 1.69 (1.46-1.97; p < 0.0001) and 1.89 (1.05-3.37; p = 0.03) versus lansoprazole 15 mg. A greater proportion of subjects had better pH control with esomeprazole than with the other PPIs (range: 69-97%). CONCLUSIONS: Across the 14-hour daytime period, esomeprazole 20 mg once daily given 30 minutes before breakfast for 5 days provided acid control for a significantly greater average proportion of time versus the PPI comparators omeprazole, pantoprazole and lansoprazole at currently available OTC dosages.

Rapid resolution of sleep disturbances related to frequent reflux: effect of esomeprazole 20 mg in two randomized, double-blind, controlled trials.

OBJECTIVE: To investigate the resolution of heartburn and gastroesophageal reflux disease (GERD)-related sleep disturbances during the first 14 days of treatment with esomeprazole 20 mg compared to placebo in subjects with frequent nighttime heartburn and GERD-related sleep disturbances. RESEARCH DESIGN AND METHODS: This was a post hoc analysis of 2 week data from two previously published, similarly designed randomized, placebo-controlled trials of 4 weeks' duration comparing esomeprazole 20 mg, 40 mg (one study), and placebo. Inclusion and exclusion criteria for both trials were the same. CLINICAL TRIAL REGISTRATION: NCT00628342; NCT00660660. MAIN OUTCOME MEASURES: The main outcome measures for this analysis were the resolution and/or relief of GERD-related sleep disturbances during 2 weeks of treatment with esomeprazole 20 mg or placebo. Resolution and/or relief of heartburn symptoms were also measured. RESULTS: In trial 1, 455 subjects were randomized, with 225 and 229 receiving esomeprazole 20 mg and placebo, respectively. In trial 2, 276 subjects were randomized, with 142 and 132 receiving esomeprazole and placebo, respectively. After 2 weeks, significantly more subjects who received esomeprazole 20 mg (50.5% [95% confidence interval: 43.8%-57.1%] and 39.4% [31.2%-47.6%] in trials 1 and 2, respectively) had resolution of sleep disturbances compared to placebo (19.9% [14.6%-25.2%] and 16.0% [9.6%-22.4%], respectively; p < 0.0001 for both trials). The median time to resolution of sleep disturbances with esomeprazole 20 mg was 1 day in both trials. After 2 weeks, significantly more subjects receiving esomeprazole 20 mg (32.3% [26.1%-38.5%] and 26.3% [18.9%-33.6%] in trials 1 and 2, respectively) had resolution of nighttime heartburn symptoms compared to placebo (5.4% [2.4%-8.4%] and 4.8% [1.1%-8.5%], respectively; p < 0.0001 for both trials). CONCLUSIONS: Esomeprazole 20 mg significantly and effectively reduced nighttime heartburn and GERD-related sleep disturbances in the first 2 weeks of treatment compared to placebo, with rapid resolution of sleep disturbances in the first days of treatment.