Heidi Cozart

Reevaluating the Safety Profile of Pediatrics: A Comparison of Computerized Adverse Drug Event Surveillance and Voluntary Reporting in the Pediatric Environment

OBJECTIVES. Children are at exceptionally high risk for adverse drug events. At Duke University Hospital, computerized adverse drug event surveillance and voluntary safety reporting systems work synergistically to identify adverse drug events. Here we identify the most deleterious drug classes to pediatric inpatients and determine which detection methodology provides the greatest opportunity to reduce harm. PATIENTS AND METHODS. We evaluated all of the medication-related events detected by our computerized surveillance and safety reporting systems over a 1-year period for Duke University Hospital pediatric inpatients. Events from both systems were scored for severity and assigned a drug event category. Surveillance events were additionally scored for causality. RESULTS. A total of 849 medication-related reports were entered into the safety reporting system, and 93 caused patient harm, resulting in an adverse drug event rate of 1.8 events per 1000 pediatric patient-days. Seventy eight of the 1537 medication-related events detected by surveillance resulted in patient harm, giving a rate of 1.6 events per 1000 patient-days. The most common events identified by the safety reporting system were failures in the medication use process (26.9%), drug omissions (16.1%), and dose- or rate-related events (12.9%). The most frequent adverse drug event surveillance categories were nephrotoxins (20.7%), narcotics and benzodiazepines (19.3%), and hypoglycemia (11.5%). Most voluntarily reported events originated in ICUs (72.0%), whereas surveillance events were split evenly across intensive and general care. There was little overlap between methodologies. CONCLUSIONS. The epidemiology of pediatric adverse drug events is best addressed by using voluntary reporting in tandem with other strategies, such as computerized surveillance and targeted chart review. Although voluntary reporting excels at identifying administration errors, surveillance excels at detecting adverse drug events caused by high-risk medications and identifies evolving conditions that may provoke imminent patient harm. Surveillance underperformed in pediatrics when compared with adult detection rates, suggesting that tailored rules may be necessary for a robust pediatric adverse drug event surveillance system.

Automated Surveillance for Adverse Drug Events at a Community Hospital and an Academic Medical Center

OBJECTIVES To compare the rates and nature of ADEs at an academic medical center and a community hospital using a single computerized ADE surveillance system. DESIGN Prospective cohort study of patients admitted to two tertiary care hospitals. Outcome Measure Adverse drug events identified by automated surveillance and voluntary reporting. METHODS We implemented an automated surveillance system across an academic medical center and a community hospital. Potential events identified by the computer were reviewed in detail by medication safety pharmacists and scored for causality and severity. Findings were compared between the two hospitals, and with voluntary reports from nurses and pharmacists. RESULTS Over the 8 month study period, 25,177 patients were admitted to the university hospital and 8,029 to the community hospital. There were 1,116 ADEs in 900 patients at the university hospital for an overall rate of 4.4 ADEs per 100 admissions. At the community hospital, 399 patients experienced 501 ADEs for a rate of 6.2 events per 100 admissions. Rates of antibiotic-associated colitis, drug-induced hypoglycemia, and anticoagulation-related ADEs were significantly higher at the community hospital compared with the university hospital. Computerized surveillance detected ADEs at a rate 3.6 times that of voluntary reporting at the university hospital and 12.3 times that at the community hospital. CONCLUSIONS Operation of a common automated ADE surveillance system across hospitals permits meaningful comparison of ADE rates in different inpatient settings. Automated surveillance detects ADEs at rates far higher than voluntary reporting, and the difference may be greater in the community hospital setting. Community hospitals may experience higher rates of certain types of ADEs compared with academic medical centers.

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

BackgroundGiven 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.MethodsComputerized 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.ResultsWe 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.ConclusionA 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.

Preoperative low molecular weight heparin reduces heparin responsiveness during cardiac surgery

PurposeCardiac surgery with cardiopulmonary bypass requires systemic anticoagulation, defined by an activated clotting time (ACT) of 400–480 sec. Patients with altered heparin responsiveness require disproportionately higher doses of heparin to achieve this target ACT. A common risk factor for heparin resistance is preoperative heparin therapy. Recently, therapy with low molecular weight heparin (LMWH) has become an acceptable substitute for prolonged heparin therapy. The current study examines the effect of preoperative LMWH therapy on subsequent heparin responsiveness during cardiac surgery.MethodsRecords of patients undergoing cardiac surgery with cardiopulmonary bypass over a period of four months were reviewed. We identified patients who, during the week preceding surgery, had received prolonged (> 24 hr) therapy with eithersc LMWH (LMWH group) or continuousiv unfractionated heparin (Heparin group). A Control group consisted of patients who received neither heparin nor LMWH preoperatively. The heparin sensitivity index (calculated as the first change in ACT from baseline divided by the first intraoperative heparin dose, normalized to body weight), was compared among groups using ANOVA.ResultsOne hundred and thirty-nine patients were included in the analysis. The heparin sensitivity index was 33–45% higher in the Control group (1.6 ± 0.7 sec·IU−1·kg−1;P < 0. 0001) compared to the LMWH (1.2 ± 0.4 sec·IU−1·kg−1) and Heparin (1.1 ± 0.5 sec·IU−1·kg−1) groups. In a multivariable model, the use of preoperative LMWH remained a significant predictor of reduced intraoperative heparin responsiveness (P = 0.002).ConclusionProlonged preoperative LMWH therapy, similar to the known effect of prolonged unfractionated heparin infusion, reduces subsequent intraoperative response to heparin.RésuméObjectifLa chirurgie cardiaque sous circulation extra-corporelle nécessite une anti-coagulation systémique, définie par un temps de coagulation activé (TCA) de 400–480 sec. Les patients présentant une réponse modifiée á l’héparine nécessitent des doses nettement plus importantes d’héparine pour atteindre le TCA cible. Un facteur de risque commun de la résistance á l’héparine est la thérapie préopératoire à l’héparine. L’héparine à bas poids moléculaire (HBPM) est récemment devenue un substitut approprié des thérapies prolongées à l’héparine. Cette étude porte sur l’effet de thérapies préopératoires HBPM sur la réaction à l’héparine durant la chirurgie cardiaque.MéthodeLes dossiers de patients subissant une chirurgie cardiaque sous circulation extra-corporelle sur une période de quatre mois ont été étudiés. Les patients ayant suivi une thérapie prolongée (<24 h) d’HBPMsc (groupe HBPM) ou d’héparine non fractionnée iv en continu (groupe Héparine) la semaine précédant la chirurgie ont été identifiés. Le groupe témoin était composé de patients n’ayant reçu ni héparine non fractionnée ni HBPM avant l’opération. L’indice de sensibilité à l’héparine (calculé comme l’augmentation du TCA depuis la ligne de base divisé par la première dose d’héparine intra-opératoire, normalisé à la masse corporelle), a été comparé entre les groupes à l’aide d’une ANOVA.RésultatsCent-trente-neuf patients ont été analysés. L’indice de sensibilité à l’héparine fut de 33–45 % plus élevé dans le groupe témoin (1,6 ± 0,7 sec·IU−1·kg−1; P > 0,0001) que dans les groupes HBPM (1,2 ± 0,4 sec·IU−1·kg−1) et Héparine (1,1 ± 0,5 sec·IU−1·kg−1). Dans un modèle multivarié, l’utilisation de HBPM préopératoire demeure un indice prédicteur significatif de réponse diminuée à l’héparine intra-opératoire (P=0,002).ConclusionUne thérapie préopératoire prolongée à l’HBPM, comme l’effet connu d’une perfusion prolongée d’héparine non-fractionnée, réduit la réponse intra-opératoire à l’héparine.

Sharing Adverse Drug Event Data Using Business Intelligence Technology

Introduction: Duke University Health System uses computerized adverse drug event surveillance as an integral part of medication safety at 2 community hospitals and an academic medical center. This information must be swiftly communicated to organizational patient safety stakeholders to find opportunities to improve patient care; however, this process is encumbered by highly manual methods of preparing the data. Description of Case: Following the examples of other industries, we deployed a business intelligence tool to provide dynamic safety reports on adverse drug events. Once data were migrated into the health system data warehouse, we developed census-adjusted reports with user-driven prompts. Drill down functionality enables navigation from aggregate trends to event details by clicking report graphics. Reports can be accessed by patient safety leadership either through an existing safety reporting portal or the health system performance improvement Web site. Discussion: Elaborate prompt screens allow many varieties of reports to be created quickly by patient safety personnel without consultation with the research analyst. The reduction in research analyst workload because of business intelligence implementation made this individual available to additional patient safety projects thereby leveraging their talents more effectively. Conclusions: Dedicated liaisons are essential to ensure clear communication between clinical and technical staff throughout the development life cycle. Design and development of the business intelligence model for adverse drug event data must reflect the eccentricities of the operational system, especially as new areas of emphasis evolve. Future usability studies examining the data presentation and access model are needed.

Implementing and integrating a clinically driven electronic medical record for radiation oncology in a large medical enterprise

Purpose/Objective: While our department is heavily invested in computer-based treatment planning, we historically relied on paper-based charts for management of Radiation Oncology patients. In early 2009, we initiated the process of conversion to an electronic medical record (EMR) eliminating the need for paper charts. Key goals included the ability to readily access information wherever and whenever needed, without compromising safety, treatment quality, confidentiality, or productivity. Methodology: In February, 2009, we formed a multi-disciplinary team of Radiation Oncology physicians, nurses, therapists, administrators, physicists/dosimetrists, and information technology (IT) specialists, along with staff from the Duke Health System IT department. The team identified all existing processes and associated information/reports, established the framework for the EMR system and generated, tested and implemented specific EMR processes. Results: Two broad classes of information were identified: information which must be readily accessed by anyone in the health system versus that used solely within the Radiation Oncology department. Examples of the former are consultation reports, weekly treatment check notes, and treatment summaries; the latter includes treatment plans, daily therapy records, and quality assurance reports. To manage the former, we utilized the enterprise-wide system, which required an intensive effort to design and implement procedures to export information from Radiation Oncology into that system. To manage “Radiation Oncology” data, we used our existing system (ARIA, Varian Medical Systems.) The ability to access both systems simultaneously from a single workstation (WS) was essential, requiring new WS and modified software. As of January, 2010, all new treatments were managed solely with an EMR. We find that an EMR makes information more widely accessible and does not compromise patient safety, treatment quality, or confidentiality. However, compared to paper charts, time required by clinicians to access/enter patient information has substantially increased. While productivity is improving with experience, substantial growth will require better integration of the system components, decreased access times, and improved user interfaces.

Characteristics of ambulatory anticoagulant adverse drug events: a descriptive study

127K was spent on new hardware and software; elimination of paper yields projected savings of

Tailoring adverse drug event surveillance to the paediatric inpatient

21K/year. One year after conversion to an EMR, more than 90% of department staff favored the EMR over the previous paper charts. Conclusion: Successful implementation of a Radiation Oncology EMR required not only the effort and commitment of all functions of the department, but support from senior health system management, corporate IT, and vendors. Realization of the full benefits of an EMR will require experience, faster/better integrated software, and continual improvement in underlying clinical processes.

Towards the creation of a flexible classification scheme for voluntarily reported transfusion and laboratory safety events

BackgroundDespite 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).MethodsA 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.ResultsA 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.ConclusionsAmbulatory 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.

Culture counts--sustainable inpatient computerized surveillance across Duke University Health System.

Introduction Although paediatric patients have an increased risk for adverse drug events, few detection methodologies target this population. To utilise computerised adverse event surveillance, specialised trigger rules are required to accommodate the unique needs of children. The aim was to develop new, tailored rules sustainable for review and robust enough to support aggregate event rate monitoring. Methods The authors utilised a voluntary staff incident-reporting system, lab values and physician insight to design trigger rules. During Phase 1, problem areas were identified by reviewing 5 years of paediatric voluntary incident reports. Based on these findings, historical lab electrolyte values were analysed to devise critical value thresholds. This evidence informed Phase 2 rule development. For 3 months, surveillance alerts were evaluated for occurrence of adverse drug events. Results In Phase 1, replacement preparations and total parenteral nutrition comprised the majority (36.6%) of adverse drug events in 353 paediatric patients. During Phase 2, nine new trigger rules produced 225 alerts in 103 paediatric inpatients. Of these, 14 adverse drug events were found by the paediatric hypoglycaemia rule, but all other electrolyte trigger rules were ineffective. Compared with the adult-focused hypoglycaemia rule, the new, tailored version increased the paediatric event detection rate from 0.43 to 1.51 events per 1000 patient days. Conclusions Relying solely on absolute lab values to detect electrolyte-related adverse drug events did not meet our goals. Use of compound rule logic improved detection of hypoglycaemia. More success may be found in designing real-time rules that leverage lab trends and additional clinical information.