Clinical Decision Support as a Prevention Tool for Medication Errors in the Operating Room: A Retrospective Cross-Sectional Study.

BACKGROUND: Medication errors in the operating room have high potential for patient harm. While electronic clinical decision support (CDS) software has been effective in preventing medication errors in many nonoperating room patient care areas, it is not yet widely used in operating rooms. The purpose of this study was to determine the percentage of self-reported intraoperative medication errors that could be prevented by CDS algorithms. METHODS: In this retrospective cross-sectional study, we obtained safety reports involving medication errors documented by anesthesia clinicians between August 2020 and August 2022 at a 1046-bed tertiary care academic medical center. Reviewers classified each medication error by its stage in the medication use process, error type, presence of an adverse medication event, and its associated severity and preventability by CDS. Informational gaps were corroborated by retrospective chart review and disagreements between reviewers were resolved by consensus. The primary outcome was the percentage of errors that were preventable by CDS. Secondary outcomes were preventability by CDS stratified by medication error type and severity. RESULTS: We received 127 safety reports involving 80 medication errors, and 76/80 (95%) of the errors were classified as preventable by CDS. Certain error types were more likely to be preventable by CDS than others (P < .001). The most likely error types to be preventable by CDS were wrong medication (N = 36, 100% rated as preventable), wrong dose (N = 30, 100% rated as preventable), and documentation errors (N = 3, 100% rated as preventable). The least likely error type to be preventable by CDS was inadvertent bolus (N = 3, none rated as preventable). CONCLUSIONS: Ninety-five percent of self-reported medication errors in the operating room were classified as preventable by CDS. Future research should include a randomized controlled trial to assess medication error rates and types with and without the use of CDS.

A rose by any other name would smell as sweet: defining patient safety-related terminology.

The definitions of terms related to iatrogenic harm and the potential for iatrogenic harm (e.g. error, medication error, near miss) in the anaesthesia literature are imprecise and variable, resulting in wide discrepancy in conclusions about their rates and potential solutions. Clarification of these terms is both critical and difficult: a concerted effort to achieve expert consensus is warranted.

Ocular Anesthesia-Related Closed Claims from Ophthalmic Mutual Insurance Company 2008-2018.

PURPOSE: To evaluate the types of anesthesia-related closed claims and their contributing factors, using data from the Ophthalmic Mutual Insurance Company (OMIC). DESIGN: Retrospective analysis of preexisting data. PARTICIPANTS: Plaintiffs who filed a professional liability claim or suit (written demand for money) against OMIC-insured ophthalmologists, ophthalmic practices, or surgicenters in which the surgical case occurred. METHODS: Plaintiff claims were collected from the OMIC database from 2008 to 2018 using search queries for terms associated with known complications of ophthalmic anesthesia. MAIN OUTCOME MEASURES: Number and types of anesthesia-related injuries and claims, who administered the anesthesia, the outcomes of the claim or suit, cost to defend, and payments made to plaintiffs. RESULTS: Sixty-three anesthesia-related claims or suits were filed by 50 plaintiffs. Anesthesia-related injuries included globe perforation (n = 17), death (n = 13), retrobulbar hemorrhage (n = 7), optic nerve damage (n = 4), vascular occlusions (n = 2), pain (n = 2), eye or head movement resulting in injury (n = 2), and 1 case each for numbness, diplopia, and tooth loss during intubation. All but 1 patient who died had preexisting, significant comorbidities. Two deaths were related to brainstem anesthesia. Regarding the type of anesthesia in the closed claims, retrobulbar and peribulbar anesthesia were the most common types (n = 16 each), followed by local infiltration around the lids and facial nerve (n = 6), topical anesthesia (n = 5), and general anesthesia (n = 5). In 2 cases, the exact type of anesthesia was unknown but not general. The 5 topical with sedation anesthesia-related claims were due to inadequate pain control (n = 2), ocular movement resulting in capsular rupture (n = 2), or death (n = 1) allegedly related to excessive or inadequate monitoring of sedation. There were 5 claims related to general anesthesia including 4 deaths and 1 tooth loss during intubation. Sedation was alleged to be a factor in 5 cases resulting in death. Anticoagulants were a factor in 3 retrobulbar hemorrhage cases. CONCLUSIONS: Although claims and suits were infrequent given the large number of insured ophthalmologists and the large number of surgical cases requiring various types of anesthesia performed over the 10.5-year study period, severe injuries can occur.

A Systems Theoretic Process Analysis of the Medication Use Process in the Operating Room.

BACKGROUND: While 4 to 10% of medications administered in the operating room may involve an error, few investigations have prospectively modeled how these errors might occur. Systems theoretic process analysis is a prospective risk analysis technique that uses systems theory to identify hazards. The purpose of this study was to demonstrate the use of systems theoretic process analysis in a healthcare organization to prospectively identify causal factors for medication errors in the operating room. METHODS: The authors completed a systems theoretic process analysis for the medication use process in the operating room at their institution. First, the authors defined medication-related accidents (adverse medication events) and hazards and created a hierarchical control structure (a schematic representation of the operating room medication use system). Then the authors analyzed this structure for unsafe control actions and causal scenarios that could lead to medication errors, incorporating input from surgeons, anesthesiologists, and pharmacists. The authors studied the entire medication use process, including requesting medications, dispensing, preparing, administering, documenting, and monitoring patients for the effects. Results were reported using descriptive statistics. RESULTS: The hierarchical control structure involved three tiers of controllers: perioperative leadership; management of patient care by the attending anesthesiologist, surgeon, and pharmacist; and execution of patient care by the anesthesia clinician in the operating room. The authors identified 66 unsafe control actions linked to 342 causal scenarios that could lead to medication errors. Eighty-two (24.0%) scenarios came from perioperative leadership, 103 (30.1%) from management of patient care, and 157 (45.9%) from execution of patient care. CONCLUSIONS: In this study, the authors demonstrated the use of systems theoretic process analysis to describe potential causes of errors in the medication use process in the operating room. Causal scenarios were linked to controllers ranging from the frontline providers up to the highest levels of perioperative management. Systems theoretic process analysis is uniquely able to analyze management and leadership impacts on the system, making it useful for guiding quality improvement initiatives.

Preventing Adverse Events in Cataract Surgery: Recommendations From a Massachusetts Expert Panel.

Massachusetts health care facilities reported a series of cataract surgery-related adverse events (AEs) to the state in recent years, including 5 globe perforations during eye blocks performed by 1 anesthesiologist in a single day. The Betsy Lehman Center for Patient Safety, a nonregulatory Massachusetts state agency, responded by convening an expert panel of frontline providers, patient safety experts, and patients to recommend strategies for mitigating patient harm during cataract surgery. The purpose of this article is to identify contributing factors to the cataract surgery AEs reported in Massachusetts and present the panel's recommended strategies to prevent them. Data from state-mandated serious reportable event reports were supplemented by online surveys of Massachusetts cataract surgery providers and semistructured interviews with key stakeholders and frontline staff. The panel identified 2 principal categories of contributing factors to the state's cataract surgery-related AEs: systems failures and choice of anesthesia technique. Systems failures included inadequate safety protocols (48.7% of contributing factors), communication challenges (18.4%), insufficient provider training (17.1%), and lack of standardization (15.8%). Choice of anesthesia technique involved the increased relative risk of needle-based eye blocks. The panel's surveys of Massachusetts cataract surgery providers show wide variation in anesthesia practices. While 45.5% of surgeons and 69.6% of facilities reported increased use of topical anesthesia compared to 10 years earlier, needle-based blocks were still used in 47.0% of cataract surgeries performed by surgeon respondents and 40.9% of those performed at respondent facilities. Using a modified Delphi approach, the panel recommended several strategies to prevent AEs during cataract surgery, including performing a distinct time-out with at least 2 care-team members before block administration; implementing standardized, facility-wide safety protocols, including a uniform site-marking policy; strengthening the credentialing and orientation of new, contracted and locum tenens anesthesia staff; ensuring adequate and documented training in block administration for any provider who is new to a facility, including at least 10 supervised blocks before practicing independently; using the least invasive form of anesthesia appropriate to the patient; and finally, adjusting anesthesia practices, including preferred techniques, as evidence-based best practices evolve. Future research should focus on evaluating the impact of these recommendations on patient outcomes.

Patient Harm in Cataract Surgery: A Series of Adverse Events in Massachusetts.

Massachusetts state agencies received reports of 37 adverse events (AEs) involving cataract surgery from 2011 to 2015. Fifteen were anesthesia related, including 5 wrong eye blocks, 3 cases of hemodynamic instability, 2 retrobulbar hematoma/hemorrhages, and 5 globe perforations resulting in permanent loss of vision. While Massachusetts' reported AEs likely underrepresent the true number of AEs that occur during cataract surgery, they do offer useful signal data to indicate the types of patient harm occurring during these procedures.

Evaluation of Perioperative Medication Errors and Adverse Drug Events.

BACKGROUND: The purpose of this study is to assess the rates of perioperative medication errors (MEs) and adverse drug events (ADEs) as percentages of medication administrations, to evaluate their root causes, and to formulate targeted solutions to prevent them. METHODS: In this prospective observational study, anesthesia-trained study staff (anesthesiologists/nurse anesthetists) observed randomly selected operations at a 1,046-bed tertiary care academic medical center to identify MEs and ADEs over 8 months. Retrospective chart abstraction was performed to flag events that were missed by observation. All events subsequently underwent review by two independent reviewers. Primary outcomes were the incidence of MEs and ADEs. RESULTS: A total of 277 operations were observed with 3,671 medication administrations of which 193 (5.3%; 95% CI, 4.5 to 6.0) involved a ME and/or ADE. Of these, 153 (79.3%) were preventable and 40 (20.7%) were nonpreventable. The events included 153 (79.3%) errors and 91 (47.2%) ADEs. Although 32 (20.9%) of the errors had little potential for harm, 51 (33.3%) led to an observed ADE and an additional 70 (45.8%) had the potential for patient harm. Of the 153 errors, 99 (64.7%) were serious, 51 (33.3%) were significant, and 3 (2.0%) were life-threatening. CONCLUSIONS: One in 20 perioperative medication administrations included an ME and/or ADE. More than one third of the MEs led to observed ADEs, and the remaining two thirds had the potential for harm. These rates are markedly higher than those reported by retrospective surveys. Specific solutions exist that have the potential to decrease the incidence of perioperative MEs.

The Impact of a Shortage of Pharmacy-Prepared Ephedrine Syringes on Intraoperative Medication Use.

BACKGROUND: Anesthesia-related medication shortages have become increasingly common in the United States. We tested whether a local shortage of pharmacy-prepared ephedrine syringes, replaced by provider-prepared ephedrine, was associated with provider-level changes in ephedrine and phenylephrine use and patient-level changes in intraoperative hemodynamics. METHODS: Consecutive patients undergoing general and orthopedic surgery at a tertiary care center were included 1 month before and 1 month after the start of the pharmacy-prepared ephedrine syringe shortage. Lowest mean arterial blood pressure and slowest heart rate were obtained as measures of hemodynamics. Adjusted associations were tested using mixed-effects regression with repeated measures. RESULTS: Three hundred four patients before the shortage and 298 patients after the shortage began were included. The administration of at least 1 bolus of ephedrine was significantly more common before versus during the shortage (148/304 [48.7]% vs 117/298 [39.3]%; P = 0.0199). After adjusting for age, sex, ASA physical status, surgery type, anesthesia provider, and operative duration, patients were significantly less likely to receive ephedrine during the shortage (relative risk [RR] = 0.78 [95% confidence interval {CI}, 0.61-0.96]; P = 0.0198) and more likely to receive a phenylephrine bolus (RR = 1.27 [95% CI, 1.02-1.51]; P = 0.0357). Patient hemodynamics assessed by slowest heart rate or lowest mean arterial blood pressure did not differ significantly during the shortage. CONCLUSIONS: There was an alteration in medication administration patterns during a shortage of pharmacy-prepared syringes. Changes in ephedrine and phenylephrine use were noted; however, patient hemodynamics remained comparable. Provider use patterns were sensitive even to a relative and not absolute medication shortage as observed in this study.

Understanding physicians' behavior toward alerts about nephrotoxic medications in outpatients: a cross-sectional analysis.

BACKGROUND: Although most outpatients are relatively healthy, many have chronic renal insufficiency, and high override rates for suggestions on renal dosing have been observed. To better understand the override of renal dosing alerts in an outpatient setting, we conducted a study to evaluate which patients were more frequently prescribed contraindicated medications, to assess providers' responses to suggestions, and to examine the drugs involved and the reasons for overrides. METHODS: We obtained data on renal alert overrides and the coded reasons for overrides cited by providers at the time of prescription from outpatient clinics and ambulatory hospital-based practices at a large academic health care center over a period of 3 years, from January 2009 to December 2011. For detailed chart review, a group of 6 trained clinicians developed the appropriateness criteria with excellent inter-rater reliability (κ=0.93). We stratified providers by override frequency and then drew samples from the high- and low-frequency groups. We measured the rate of total overrides, rate of appropriate overrides, medications overridden, and the reason(s) for override. RESULTS: A total of 4120 renal alerts were triggered by 584 prescribers in the study period, among which 78.2% (3,221) were overridden. Almost half of the alerts were triggered by 40 providers and one-third was triggered by high-frequency overriders. The appropriateness rates were fairly similar, at 28.4% and 31.6% for high- and low-frequency overriders, respectively. Metformin, glyburide, hydrochlorothiazide, and nitrofurantoin were the most common drugs overridden. Physicians' appropriateness rates were higher than the rates for nurse practitioners (32.9% vs. 22.1%). Physicians with low frequency override rates had higher levels of appropriateness for metformin than the high frequency overriders (P=0.005). CONCLUSION: A small number of providers accounted for a large fraction of overrides, as was the case with a small number of drugs. These data suggest that a focused intervention targeting primarily these providers and medications has the potential to improve medication safety.

The Additional Cost of Perioperative Medication Errors.

ABSTRACT: The purpose of this report was to estimate the additional annual cost to the U.S. healthcare system attributable to preventable medication errors (MEs) in the operating room. The ME types were iteratively grouped by their associated harm (or potential harm) into 13 categories, and we determined the incidence of operations involving each ME category (number of operations involving each category/total number of operations): (1) delayed or missed required perioperative antibiotic (1.4% of operations); (2) prolonged hemodynamic swings (7.6% of operations); (3) untreated postoperative pain >4/10 (18.9% of operations); (4) residual neuromuscular blockade (2.9% of operations); (5) oxygen saturation <90% due to ME (1.8% of operations); (6) delayed emergence (1.1% of operations); (7) untreated new onset intraoperative cardiac arrhythmia (0.72% of operations); (8) medication documentation errors (7.6% of operations); (9) syringe swaps (5.8% of operations); (10) presumed hypotension with inability to obtain a blood pressure reading (2.2% of operations); (11) potential for bacterial contamination due to expired medication syringes (8.3% of operations); (12) untreated bradycardia <40 beats/min (1.1% of operations); and (13) other (13.0% of operations). Through a PubMed search, we determined the likelihood that the ME category would result in downstream patient harm such as surgical site infection or acute kidney injury, and the additional fully allocated cost of care (in 2021 U.S. dollars) for each potential downstream patient harm event. We then estimated the cost of the MEs across the U.S. healthcare system by scaling the number of MEs to the total number of annual operations in the United States (N = 19,800,000). The total estimated additional fully allocated annual cost of care due to perioperative MEs was $5.33 billion U.S. dollars.

Performance of a Web-Based Reference Database With Natural Language Searching Capabilities: Usability Evaluation of DynaMed and Micromedex With Watson.

BACKGROUND: Evidence-based point-of-care information (POCI) tools can facilitate patient safety and care by helping clinicians to answer disease state and drug information questions in less time and with less effort. However, these tools may also be visually challenging to navigate or lack the comprehensiveness needed to sufficiently address a medical issue. OBJECTIVE: This study aimed to collect clinicians' feedback and directly observe their use of the combined POCI tool DynaMed and Micromedex with Watson, now known as DynaMedex. EBSCO partnered with IBM Watson Health, now known as Merative, to develop the combined tool as a resource for clinicians. We aimed to identify areas for refinement based on participant feedback and examine participant perceptions to inform further development. METHODS: Participants (N=43) within varying clinical roles and specialties were recruited from Brigham and Women's Hospital and Massachusetts General Hospital in Boston, Massachusetts, United States, between August 10, 2021, and December 16, 2021, to take part in usability sessions aimed at evaluating the efficiency and effectiveness of, as well as satisfaction with, the DynaMed and Micromedex with Watson tool. Usability testing methods, including think aloud and observations of user behavior, were used to identify challenges regarding the combined tool. Data collection included measurements of time on task; task ease; satisfaction with the answer; posttest feedback on likes, dislikes, and perceived reliability of the tool; and interest in recommending the tool to a colleague. RESULTS: On a 7-point Likert scale, pharmacists rated ease (mean 5.98, SD 1.38) and satisfaction (mean 6.31, SD 1.34) with the combined POCI tool higher than the physicians, nurse practitioner, and physician's assistants (ease: mean 5.57, SD 1.64, and satisfaction: mean 5.82, SD 1.60). Pharmacists spent longer (mean 2 minutes, 26 seconds, SD 1 minute, 41 seconds) on average finding an answer to their question than the physicians, nurse practitioner, and physician's assistants (mean 1 minute, 40 seconds, SD 1 minute, 23 seconds). CONCLUSIONS: Overall, the tool performed well, but this usability evaluation identified multiple opportunities for improvement that would help inexperienced users.

Correction: Performance of a Web-Based Reference Database With Natural Language Searching Capabilities: Usability Evaluation of DynaMed and Micromedex With Watson.

[This corrects the article DOI: 10.2196/43960.].

Medication safety in the perioperative setting: A comparison of methods for detecting medication errors and adverse medication events.

The purpose of this study was to evaluate perioperative medication-related incidents (medication errors (MEs) and/or adverse medication events (AMEs)) identified by 2 different reporting methods (self-report and direct observation), and to compare the types and severity of incidents identified by each method. We compared perioperative medication-related incidents identified by direct observation in Nanji et al's 2016 study[1] to those identified by self-report via a facilitated incident reporting system at the same 1046-bed tertiary care academic medical center during the same 8-month period. Incidents, including MEs and AMEs were classified by type and severity. In 277 operations involving 3671 medication administrations, 193 MEs and/or AMEs were observed (5.3% incident rate). While none of the observed incidents were self-reported, 10 separate medication-related incidents were self-reported from different (unobserved) operations that occurred during the same time period, which involved a total of 21,576 operations and approximately 280,488 medication administrations (0.004% self-reported incident rate). The distribution of incidents (ME, AME, or both) did not differ by direct observation versus self-report methodology. The types of MEs identified by direct observation differed from those identified by self-report (P = .005). Specifically, the most frequent types of MEs identified by direct observation were labeling errors (N = 37; 24.2%), wrong dose errors (N = 35; 22.9%) and errors of omission (N = 27; 17.6%). The most frequent types of MEs identified by self-report were wrong dose (N = 5; 50%) and wrong medication (N = 4; 40%). The severity of incidents identified by direct observation and self-report differed, with self-reported incidents having a higher average severity (P < .001). The procedure types associated with medication-related incidents did not differ by direct observation versus self-report methodology. Direct observation captured many more perioperative medication-related incidents than self-report. The ME types identified and their severity differed between the 2 methods, with a higher average incident severity in the self-reported data.

Usability of a perioperative medication-related clinical decision support software application: a randomized controlled trial.

OBJECTIVE: We developed a comprehensive, medication-related clinical decision support (CDS) software prototype for use in the operating room. The purpose of this study was to compare the usability of the CDS software to the current standard electronic health record (EHR) medication administration and documentation workflow. MATERIALS AND METHODS: The primary outcome was the time taken to complete all simulation tasks. Secondary outcomes were the total number of mouse clicks and the total distance traveled on the screen in pixels. Forty participants were randomized and assigned to complete 7 simulation tasks in 1 of 2 groups: (1) the CDS group (n = 20), who completed tasks using the CDS and (2) the Control group (n = 20), who completed tasks using the standard medication workflow with retrospective manual documentation in our anesthesia information management system. Blinding was not possible. We video- and audio-recorded the participants to capture quantitative data (time on task, mouse clicks, and pixels traveled on the screen) and qualitative data (think-aloud verbalization). RESULTS: The CDS group mean total task time (402.2 ± 85.9 s) was less than the Control group (509.8 ± 103.6 s), with a mean difference of 107.6 s (95% confidence interval [CI], 60.5-179.5 s, P < .001). The CDS group used fewer mouse clicks (26.4 ± 4.5 clicks) than the Control group (56.0 ± 15.0 clicks) with a mean difference of 29.6 clicks (95% CI, 23.2-37.6, P < .001). The CDS group had fewer pixels traveled on the computer monitor (59.5 ± 20.0 thousand pixels) than the Control group (109.3 ± 40.8 thousand pixels) with a mean difference of 49.8 thousand pixels (95% CI, 33.0-73.7, P < .001). CONCLUSIONS: The perioperative medication-related CDS software prototype substantially outperformed standard EHR workflow by decreasing task time and improving efficiency and quality of care in a simulation setting.

A Monte Carlo Simulation to Estimate the Additional Cost Associated With Adverse Medication Events Leading to Intraoperative Hypotension and/or Hypertension in the United States.

OBJECTIVES: Intraoperative hypertension and hypotension are common and often related to adverse medication events (AMEs). The study objective is to estimate the annual additional fully allocated costs to the U.S. healthcare system related to AMEs associated with clinically significant intraoperative hypertension and hypotension. METHODS: Using anesthesia-trained observers in randomly selected operating rooms, we estimated the rates of clinically significant intraoperative hypotension and hypertension. We conducted systematic literature reviews to estimate incidence and additional costs of acute kidney injury (AKI), acute myocardial injury, and stroke after intraoperative hypotension and hypertension. We used Monte Carlo simulation to estimate annual costs to the U.S. healthcare system. RESULTS: Intraoperative hypotension (mean arterial pressure <55 mm Hg for >6 minutes) occurred in 11 of 277 operations (3.97%), hypotension (>30% drop from baseline mean arterial pressure in patients with coronary artery disease) in 9 operations (3.25%) and hypertension in 14 operations (5.05%). After hypotension, incremental incidence of AKI was 1.46% (additional cost $17,289/case), acute myocardial injury was 0.75% ($21,340/case), and stroke was 0.05% ($19,903/case). After hypertension, incremental stroke incidence was 4.76% ($28,320/case). Annually in the United States, we estimated 11,513 cases of AKI, 5914 of acute myocardial injury, 345 of stroke after intraoperative hypotension, and 47,774 cases of stroke after intraoperative hypertension, costing the U.S. $1.7 billion (90% confidence interval, $1.4-$2.0 billion), of which $923 million (90% confidence interval, $763-$1101 million) is preventable. CONCLUSIONS: Adverse medication events related to blood pressure are frequent, costly, and can cause considerable patient harm. Cost estimates for these events may provide a means of prioritizing safety improvements to reduce cost of care and improve patient outcomes.

Development of a Perioperative Medication-Related Clinical Decision Support Tool to Prevent Medication Errors: An Analysis of User Feedback.

OBJECTIVES: Medication use in the perioperative setting presents many patient safety challenges that may be improved with electronic clinical decision support (CDS). The objective of this paper is to describe the development and analysis of user feedback for a robust, real-time medication-related CDS application designed to provide patient-specific dosing information and alerts to warn of medication errors in the operating room (OR). METHODS: We designed a novel perioperative medication-related CDS application in four phases: (1) identification of need, (2) alert algorithm development, (3) system design, and (4) user interface design. We conducted group and individual design feedback sessions with front-line clinician leaders and subject matter experts to gather feedback about user requirements for alert content and system usability. Participants were clinicians who provide anesthesia (attending anesthesiologists, nurse anesthetists, and house staff), OR pharmacists, and nurses. RESULTS: We performed two group and eight individual design feedback sessions, with a total of 35 participants. We identified 20 feedback themes, corresponding to 19 system changes. Key requirements for user acceptance were: Use hard stops only when necessary; provide as much information as feasible about the rationale behind alerts and patient/clinical context; and allow users to edit fields such as units, time, and baseline values (e.g., baseline blood pressure). CONCLUSION: We incorporated user-centered design principles to build a perioperative medication-related CDS application that uses real-time patient data to provide patient-specific dosing information and alerts. Emphasis on early user involvement to elicit user requirements, workflow considerations, and preferences during application development can result in time and money efficiencies and a safer and more usable system.