Methods to reduce medication errors in a clinical trial of an investigational parenteral medication

Abstract

There are few evidence-based guidelines to inform optimal design of complex clinical trials, such as those assessing the safety and efficacy of intravenous drugs administered daily with infusion times over many hours per day and treatment durations that may span years. This study is a retrospective review of inpatient administration deviation reports for an investigational drug that is administered daily with infusion times of 8-24 hours, and variable treatment durations for each patient. We report study design modifications made in 2007-2008 aimed at minimizing deviations from an investigational drug infusion protocol approved by an institutional review board and the United States Food and Drug Administration. Modifications were specifically aimed at minimizing errors of infusion rate, incorrect dose, incorrect patient, or wrong drug administered. We found that the rate of these types of administration errors of the study drug was significantly decreased following adoption of the specific study design changes. This report provides guidance in the design of clinical trials testing the safety and efficacy of study drugs administered via intravenous infusion in an inpatient setting so as to minimize drug administration protocol deviations and optimize patient safety.

Effects of pharmacist interventions on reducing prescribing errors of investigational drugs in oncology clinical trials

“…A more stringent standard of error rates, close to zero, is needed. 20 The overall prescribing error rate in this study was 5.36%, which was higher than that in general anticancer drug studies. Prescribing error rates in general anticancer studies were reported to be 1.1-3%.…”

Evolution of Intravenous Medication Errors and Preventive Systemic Defenses in Hospital Settings—A Narrative Review of Recent Evidence

“…The systematic search on Medline (Ovid) found 47 articles describing systemic defenses to prevent IV MEs published between June 2016 and October 2021 (Supplementary file 3, http://links.lww.com/JPS/A612). The studies were conducted in the United States (n = 16), 47–62 the United Kingdom (n = 7), 63–69 Australia (n = 3), 70–72 Brazil (n = 3), 73–75 Spain (n = 3), 76–78 Mexico (n = 2), 79,80 Saudi Arabia (n = 2), 81,82 Singapore (n = 2), 83,84 Canada (n = 1), 85 China (n = 1), 86 France (n = 1), 87 Germany (n = 1), 88 Italy (n = 1), 89 Netherlands (n = 1), 90 and Switzerland (n = 1) 91 . Some studies (n = 2) were carried out in multiple countries 92,93 .…”

“…lww.com/JPS/A612). The studies were conducted in the United States (n = 16), [47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62] the United Kingdom (n = 7), [63][64][65][66][67][68][69] Australia (n = 3), [70][71][72] Brazil (n = 3), [73][74][75] Spain (n = 3), [76][77][78] Mexico (n = 2), 79,80 Saudi Arabia (n = 2), 81,82 Singapore (n = 2), 83,84 Canada (n = 1), 85 China (n = 1), 86 France (n = 1), 87 Germany (n = 1), 88 Italy (n = 1), 89 Netherlands (n = 1), 90 and Switzerland FIGURE 2. Outline of the narrative review process, analysis of the included articles (n = 63), and comparison to our previous systematic reviews.…”

“…91 Some studies (n = 2) were carried out in multiple countries. 92,93 The studies were conducted in hospital settings without a specification of a specialty area (n = 10), 55,56,[61][62][63]66,73,76,82,90 adult ICU (n = 9), 49,50,52,69,75,[78][79][80]92 hospital pharmacy (n = 7), 47,51,[57][58][59][60]93 pediatric intensive care unit (n = 5), 65,68,72,74,77 pediatric hospital (n = 3), 54,64,71 emergency department (n = 2), 70,84 anesthesia department (n = 1), 87 cancer hospital (n = 1), 86 and pediatric emergency department (n = 1). 81 Some studies (n = 8) were carried out in simulated environments comprising an anesthesia setting (n = 2), 83,88 hospital setting (n = 2), 48,67 ICU (n = 1), 85 NICU (n = 1), ...…”

“…retrospective analysis of smart infusion pump alert log data (n = 5), 55,62,77,80,82 studies measuring costs or cost effectiveness of the studied defense (n = 4), 66,74,87,90 observational intervention studies (n = 3), 61,71,73 retrospective or observational studies measuring drug consumption (n = 2), 52,79 chart reviews (n = 2), 70,72 and studies to design and develop systemic defenses (n = 2). 65,92 Other methods included an analysis of administration error reports (n = 1), 54 a survey study (n = 1), 84 healthcare failure mode and effects analysis (HFMEA) (n = 1), 86 a systematic review (n = 1), 78 and a systematic review with a meta-analysis (n = 1). 75 The evolution of systemic defenses to prevent IV MEs between our previous systematic review 20 and the present narrative review (n = 47 articles) is presented in Figure 4.…”