Computerized surveillance of opioid-related adverse drug events in perioperative care: a cross-sectional study

<p>Abstract</p> <p>Background</p> <p>Given the complexity of surgical care, perioperative patients are at high risk of opioid-related adverse drug events. Existing methods of detection, such as trigger tools and manual chart review, are time-intensive which makes sustainability challenging. Using strategic rule design, computerized surveillance may be an efficient, pharmacist-driven model for event detection that leverages existing staff resources.</p> <p>Methods</p> <p>Computerized adverse drug event surveillance uses a logic-based rules engine to identify potential adverse drug events or evolving unsafe clinical conditions. We extended an inpatient rule (administration of naloxone) to detect opioid-related oversedation and respiratory depression to perioperative care at a large academic medical center. Our primary endpoint was the adverse drug event rate. For all patients with a naloxone alert, manual chart review was performed by a perioperative clinical pharmacist to assess patient harm. In patients with confirmed oversedation, other patient safety event databases were queried to determine if they could detect duplicate, prior, or subsequent opioid-related events.</p> <p>Results</p> <p>We identified 419 cases of perioperative naloxone administration. Of these, 101 were given postoperatively and 69 were confirmed as adverse drug events after chart review yielding a rate of 1.89 adverse drug events/1000 surgical encounters across both the inpatient and ambulatory settings. Our ability to detect inpatient opioid adverse drug events increased 22.7% by expanding surveillance into perioperative care. Analysis of historical surveillance data as well as a voluntary reporting database revealed that 11 of our perioperative patients had prior or subsequent harmful oversedation. Nine of these cases received intraoperative naloxone, and 2 had received naloxone in the post-anesthesia care unit. Pharmacist effort was approximately 3 hours per week to evaluate naloxone alerts and confirm adverse drug events.</p> <p>Conclusion</p> <p>A small investment of resources into a pharmacist-driven surveillance model gave great gains in organizational adverse drug event detection. The patients who experienced multiple events are particularly relevant to future studies seeking risk factors for opioid induced respiratory depression. Computerized surveillance is an efficient, impactful, and sustainable model for ongoing capture and analysis of these rare, but potentially serious events.</p

Master of Science

thesisPatient safety has received unprecedented attention over the past decade. Some of that attention has been focused on the occurrence and prevention of harm from Adverse Drug Events (ADEs). Between 19 and 61 percent of ADEs are preventable. In order to prevent ADEs, they must first be detected. Several methods have been used to detect ADEs, including voluntary reporting, intensified surveillance, and computerized monitoring. Computerized monitoring has been shown to be complimentary to other methods in detecting ADEs. However, very little research has been completed on this method in pediatrics. Pediatric patients pose unique challenges and risks because of physiological immaturity, lack of testing and information on medications, availability of appropriate medication formulations and strengths, and incomplete cognitive and communication development. This study examined the modification and implementation of an adult computerized ADE monitoring tool at one pediatric medical center. It was implemented into the daily practice of pharmacy operations without increasing the pharmacy resources. Pharmacists printed daily reports containing alerts of possible ADEs. They investigated each of the alerts and noted whether an ADE occurred and how much time was needed to investigate. The main objective of this study was to increase the detection of ADEs in the pediatric population. iv Over the 12-week study, 181 ADEs were identified via the computerized monitoring tool. An additional 88 ADEs were voluntarily reported. Overall, this represented a rate of 6.6 ADEs per 100 admissions and 14.8 ADEs per 1,000 patient days. This result represented a significant increase in the detection of ADEs (p<0.0001) as compared to the same timeframe from the previous year. The computerized monitoring tool had a positive predictive value (PPV) of 4.8 percent. It took an average of 6.1 minutes to investigate alerts associated with an ADE, which was significantly higher than the time it took to investigate alerts not associated with an ADE (p<0.0001). Of the ADEs found with this tool, 10.5 percent were considered preventable. The use of a modified computerized ADE monitoring tool in the pediatric environment increased the overall detection of ADEs and warrants continued research

Automated detection of medication administration errors in neonatal intensive care

AbstractObjectiveTo improve neonatal patient safety through automated detection of medication administration errors (MAEs) in high alert medications including narcotics, vasoactive medication, intravenous fluids, parenteral nutrition, and insulin using the electronic health record (EHR); to evaluate rates of MAEs in neonatal care; and to compare the performance of computerized algorithms to traditional incident reporting for error detection.MethodsWe developed novel computerized algorithms to identify MAEs within the EHR of all neonatal patients treated in a level four neonatal intensive care unit (NICU) in 2011 and 2012. We evaluated the rates and types of MAEs identified by the automated algorithms and compared their performance to incident reporting. Performance was evaluated by physician chart review.ResultsIn the combined 2011 and 2012 NICU data sets, the automated algorithms identified MAEs at the following rates: fentanyl, 0.4% (4 errors/1005 fentanyl administration records); morphine, 0.3% (11/4009); dobutamine, 0 (0/10); and milrinone, 0.3% (5/1925). We found higher MAE rates for other vasoactive medications including: dopamine, 11.6% (5/43); epinephrine, 10.0% (289/2890); and vasopressin, 12.8% (54/421). Fluid administration error rates were similar: intravenous fluids, 3.2% (273/8567); parenteral nutrition, 3.2% (649/20124); and lipid administration, 1.3% (203/15227). We also found 13 insulin administration errors with a resulting rate of 2.9% (13/456). MAE rates were higher for medications that were adjusted frequently and fluids administered concurrently. The algorithms identified many previously unidentified errors, demonstrating significantly better sensitivity (82% vs. 5%) and precision (70% vs. 50%) than incident reporting for error recognition.ConclusionsAutomated detection of medication administration errors through the EHR is feasible and performs better than currently used incident reporting systems. Automated algorithms may be useful for real-time error identification and mitigation

Information technology for detecting medication errors and adverse drug events

It is estimated that over three-quarters of a million people are injured or die in hospitals ‎each year from adverse drug events (ADE’s). The majority of medical errors result form ‎poorly designed healthcare systems rather than from negligence on the part of healthcare ‎providers. In general, healthcare systems rely on voluntary reporting, which seriously ‎underestimates the number of medication errors and ADE’s by as much as 90%. This ‎paper reviews the causes and impact of medication errors and ADE\u27s. It also reports ‎studies that have used information technology (IT) to detect and prevent medication ‎errors and ADE’s. Significant reduction of medication errors and ADE’s requires ‎systemic implementation of IT, improvements in the reporting of errors, and integration ‎of the components of the healthcare systems’ information systems. At the present time, ‎most healthcare systems should be able to use IT to detect and prevent ADE’s.

How effective are incident reporting systems for improving patient safety? A systematic literature review

Context: Incident reporting systems (IRSs) are used to gather information on patient safety incidents. However, and despite the financial burden they imply, little is known about their effectiveness. This paper reviews systematically the effectiveness of IRSs as a method of improving patient safety through organizational learning. Method: This systematic literature review identified two groups of studies: a) studies comparing the effectiveness of IRSs relative to other methods of error reporting and b) studies examining the effectiveness of IRSs on settings, structures and outcomes in respect of improvements to patient safety. We used thematic analysis to compare the effectiveness of IRSs with other methods and to synthesize what was effective, where and why. Then, to assess the evidence concerning the ability of IRSs to facilitate organizational learning, we analyzed studies using the concepts of single loop and double loop learning. Findings: In total, 43 studies were identified. Eight studies compared IRSs with other methods, while 35 explored the effectiveness of IRSs on settings, structures and outcomes. We did not find strong evidence that IRSs perform better than other methods. We found some evidence of single loop learning, that is, changes to clinical settings or processes as a consequence of learning from IRSs, but little evidence either of improvements to outcomes or of changes to latent managerial factors involved in error production. In addition, there was insubstantial evidence of IRSs enabling double loop learning that is, cultural change or change of mindset. Conclusions: The results indicate IRSs could be more effective if there were explicit criteria for what counts as an incident; they are owned and led by clinical teams rather than centralized hospital departments; and embedded within organizations as part of wider safety programs

Patient Monitoring Systems

book chapterBiomedical Informatic

Characteristics of ambulatory anticoagulant adverse drug events: a descriptive study

<p>Abstract</p> <p>Background</p> <p>Despite the high frequency with which adverse drug events (ADEs) occur in outpatient settings, detailed information regarding these events remains limited. Anticoagulant drugs are associated with increased safety concerns and are commonly involved in outpatient ADEs. We therefore sought to evaluate ambulatory anticoagulation ADEs and the patient population in which they occurred within the Duke University Health System (Durham, NC, USA).</p> <p>Methods</p> <p>A retrospective chart review of ambulatory warfarin-related ADEs was conducted. An automated trigger surveillance system identified eligible events in ambulatory patients admitted with an International Normalized Ratio (INR) >3 and administration of vitamin K. Event and patient characteristics were evaluated, and quality/process improvement strategies for ambulatory anticoagulation management are described.</p> <p>Results</p> <p>A total of 169 events in 167 patients were identified from December 1, 2006-June 30, 2008 and included in the study. A median supratherapeutic INR of 6.1 was noted, and roughly half of all events (52.1%) were associated with a bleed. Nearly 74% of events resulted in a need for fresh frozen plasma; 64.8% of bleeds were classified as major. A total of 59.2% of events were at least partially responsible for hospital admission. Median patient age was 68 y (range 36-95 y) with 24.9% initiating therapy within 3 months prior to the event. Of events with a prior documented patient visit (n = 157), 73.2% were seen at a Duke clinic or hospital within the previous month. Almost 80% of these patients had anticoagulation therapy addressed, but only 60.0% had a follow-up plan documented in the electronic note.</p> <p>Conclusions</p> <p>Ambulatory warfarin-related ADEs have significant patient and healthcare utilization consequences in the form of bleeding events and associated hospital admissions. Recommendations for improvement in anticoagulation management include use of information technology to assist monitoring and follow-up documentation, avoid drug interactions, and engage patients in their care.</p

PRACTICAL IMPLICATIONS OF SPONTANEOUS ADVERSE DRUG REACTION REPORTING SYSTEM IN HOSPITALS-AN OVERVIEW

Adverse drug reactions (ADRs) are global problems of major concern which leads to morbidity and mortality. It causes 30 of hospitalized patients and lead 2-6 of all medical admissions. Spontaneous reporting of ADRs is the cornerstone of pharmacovigilance and is essential for maintaining patient safety. The necessity of a spontaneous ADR surveillance system is addressed by many authorities like World Health Organization, Food and Drug Administration, Joint Commission International and Uppsala monitoring center. However, existing postmarketing surveillance systems massively rely on spontaneous reports of ADRs which suffer from serious underreporting, latency, and inconsistent reporting. Studies estimated that only 6–10 of all ADRs are reported in hospitals. It is a very low percentage to go in deep and analyze the reason for the same and to resolve that underlying factors. Researchers proved that knowledge, attitude and false perceptions about the ADRs are the major challenges in the spontaneous reporting of ADRs. Which includes personal, professional, system related and organization related conflicts. Majority of them can improve by doing the system and personal targeted implications. Identifying, analyzing and working on these issues can improve the ADR surveillance system in hospitals to attain the patient safety. Understanding the pharmacovigilance, identifying and sorting out the obstacles of spontaneous reporting through an efficient pharmacovigilance department, continuous educational interventions, patient centered surveillance programs, health care team work efforts towards the detection of ADRs and implementation of the computer or personal assisted ADR trigger tool programs can furnish out a successful pharmacovigilance system in the hospitals and thereby we can constitute a good quality health care system.Key words: Spontaneous reporting system, adverse drug reaction, pharmacovigilance, Patient safet