Clinical decision support for drug related events: Moving towards better prevention

Clinical decision support (CDS) systems with automated alerts integrated into electronic medical records demonstrate efficacy for detecting medication errors (ME) and adverse drug events (ADEs). Critically ill patients are at increased risk for ME, ADEs and serious negative outcomes related to these events. Capitalizing on CDS to detect ME and prevent adverse drug related events has the potential to improve patient outcomes. The key to an effective medication safety surveillance system incorporating CDS is advancing the signals for alerts by using trajectory analyses to predict clinical events, instead of waiting for these events to occur. Additionally, incorporating cutting-edge biomarkers into alert knowledge in an effort to identify the need to adjust medication therapy portending harm will advance the current state of CDS. CDS can be taken a step further to identify drug related physiological events, which are less commonly included in surveillance systems. Predictive models for adverse events that combine patient factors with laboratory values and biomarkers are being established and these models can be the foundation for individualized CDS alerts to prevent impending ADEs.     

Online reporting system for transfusion-related adverse events to enhance recipient haemovigilance in Japan: A pilot study

BackgroundA surveillance system for transfusion-related adverse reactions and infectious diseases in Japan was started at a national level in 1993, but current reporting of events in recipients is performed on a voluntary basis. A reporting system which can collect information on all transfusion-related events in recipients is required in Japan.MethodsWe have developed an online reporting system for transfusion-related events and performed a pilot study in 12 hospitals from 2007 to 2010.ResultsThe overall incidence of adverse events per transfusion bag was 1.47%. Platelet concentrates gave rise to statistically more adverse events (4.16%) than red blood cells (0.66%) and fresh-frozen plasma (0.93%). In addition, we found that the incidence of adverse events varied between hospitals according to their size and patient characteristics.ConclusionThis online reporting system is useful for collection and analysis of actual adverse events in recipients of blood transfusions and may contribute to enhancement of the existing surveillance system for recipients in Japan.     

ENT Self-Test

Abstract

The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest. The hospital setting, with its clearly defined patient population observed around the clock, is an ideal setting in which to identify potential adverse drug reaction signals and to report them to either the drug manufacturer or the FDA. In this article we describe the present system for addressing adverse events, obstacles to reporting them, and the important role any hospital physician could play in reporting adverse events and potential adverse drug reactions.     

Improving the reporting of adverse drug reactions in the hospital setting

The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest. The hospital setting, with its clearly defined patient population observed around the clock, is an ideal setting in which to identify potential adverse drug reaction signals and to report them to either the drug manufacturer or the FDA. In this article we describe the present system for addressing adverse events, obstacles to reporting them, and the important role any hospital physician could play in reporting adverse events and potential adverse drug reactions.     

Surveillance: A strategy for improving patient safety in acute and critical care units

Surveillance is a nursing intervention that has been identified as an important strategy in preventing and identifying medical errors and adverse events. The definition of surveillance proposed by the Nursing Intervention Classification is the purposeful and ongoing acquisition, interpretation, and synthesis of patient data for clinical decision making. The term surveillance is often used interchangeably with the term monitoring, yet surveillance differs significantly from monitoring both in purpose and scope. Monitoring is a key activity in the surveillance process, but monitoring alone is insufficient for conducting effective surveillance. Much of the attention in the bedside patient safety movement has been focused on efforts to implement processes that ultimately improve the surveillance process. These include checklists, interdisciplinary rounds, clinical information systems, and clinical decision support systems. To identify optimal surveillance patterns and to develop and test technologies that assist critical care nurses in performing effective surveillance, more research is needed, particularly with innovative approaches to describe and evaluate the best surveillance practices of bedside nurses.     

Postmarketing surveillance: accuracy of patient drug attribution judgments

Data from two samples of ambulatory patients participating in a postmarketing surveillance study, one receiving antibiotics and another receiving tricyclic antidepressant agents, are presented, indicating that patients appear to be capable of correctly discriminating probable adverse drug reactions from other adverse clinical events. However, attribution accuracy depended both on the surveillance method and on how reports of the adverse clinical events were obtained. Discrimination was better when patients were reporting adverse clinical events spontaneously than when the interviewer probed for recall in a systematic inquiry. Discrimination was also better when the adverse clinical events were obtained from a staff-initiated surveillance method than from a self-monitoring, patient-initiated telephone-reporting method--probably because the latter method generates an excessively strong tendency to report mainly those adverse clinical events suspected of being drug related.     

Using Medical Emergency Teams to detect preventable adverse events

Introduction  

Medical Emergency Teams (METs), also known as Rapid Response Teams, are recommended as a patient safety measure. A potential benefit of implementing an MET is the capacity to systematically assess preventable adverse events, which are defined as poor outcomes caused by errors or system design flaws. We describe how we used MET calls to systematically identify preventable adverse events in an academic tertiary care hospital, and describe our surveillance results.     

Intrahospital Transport to the Radiology Department: Risk for Adverse Events, Nursing Surveillance, Utilization of a MET and Practice Implications

Nurses providing care in the Radiology Department (RD) are challenged by the broad scope of conditions and varied acuity of patients served by this unit. Nurses must facilitate the required diagnostic testing and simultaneously provide the surveillance necessary to detect physiologic changes signaling the need for rescue interventions. When instability occurs, one method of rescue involves activation of a Medical Emergency Team (MET) to bring an experienced cadre of critical care providers to the unstable patient. Despite recognition that the RD can be a high risk area, there is little in the literature specific to the surveillance of RD patients, risk for and prevention of adverse events, MET activation or the management of patient instability specific to the RD. The purpose of this paper is to examine what is known regarding risk for adverse events during intrahospital transport, utilization of a MET as a rescue intervention, and practice implications.     

Development of the hospital nurse surveillance capacity profile

Better patient outcomes are often achieved through effective surveillance, a primary function of nurses. The purpose of this article is to define, operationalize, measure, and evaluate the nurse surveillance capacity of hospitals. Nurse surveillance capacity is defined as the organizational features that enhance or weaken nurse surveillance. It includes a set of registered nurse (staffing, education, expertise, experience) and nurse practice environment characteristics. Empirical referents were extracted from existing survey data from 9,232 nurses in 174 hospitals. Using a ranking methodology, a Hospital Nurse Surveillance Capacity Profile was created for each hospital. Greater nurse surveillance capacity was significantly associated with better quality of care and fewer adverse events. The profile may assist administrators to improve nurse surveillance and patient outcomes. © 2009 Wiley Periodicals, Inc. Res Nurs Health 32:217–228, 2009     

Best practices in orthopaedic inpatient care

Most patients admitted in the hospital requiring skilled nursing care are at risk for adverse events or complications from their conditions and treatments. They require close observation during their hospital stays, and care providers must be prepared to detect and intervene quickly when complications occur. Orthopaedic patients are a unique surgical patient population in that their underlying physical conditions, operative locations, and comorbidities can place them at higher risk for complications or adverse events than many other surgical patients. Orthopaedic patients are usually admitted to general acute care surgical units where there are no monitoring devices and the staffing ratios are less intense. In the event that a higher level of surveillance is needed, current practice is to transfer the patient to a care area with telemetry or hardwired monitoring capability, which can result in deviation from the orthopaedic care pathway. In this article, we describe the implementation of best care practices that combine lower nurse to patient ratios, innovative and effective patient education, and continuous surveillance using novel technology in an orthopaedic unit. Data demonstrate that this multifaceted approach to high-quality orthopaedic care has contributed to better patient outcomes.     

Toward "pain-free" statin prescribing: clinical algorithm for diagnosis and management of myalgia

Myalgia, which often manifests as pain or soreness in skeletal muscles, is among the most salient adverse events associated with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins). Clinical issues related to statin-associated myotoxicity include (1) incidence in randomized controlled trials and occurrence in postmarketing surveillance databases; (2) potential differences between statins in their associations with such adverse events; and (3) diagnostic and treatment strategies to prevent, recognize, and manage these events. Data from systematic reviews, meta-analyses, clinical and observational trials, and post-marketing surveillance indicate that statin-associated myalgia typically affects approximately 5.0% of patients, as myopathy in 0.1% and as rhabdomyolysis in 0.01%. However, studies also suggest that myalgia is among the leading reasons patients discontinue statins (particularly high-dose statin monotherapy) and that treatment with certain statins (eg, fluvastatin) is unlikely to result in such adverse events. This review presents a clinical algorithm for monitoring and managing statin-associated myotoxicity. The algorithm highlights risk factors for muscle toxicity and provides recommendations for (1) creatine kinase measurements and monitoring; (2) statin dosage reduction, discontinuation, and rechallenge; and (3) treatment alternatives, such as extended-release fluvastatin with or without ezetimibe, low-dose or alternate-day rosuvastatin, or ezetimibe with or without colesevelam. The algorithm should help to inform and enhance patient care and reduce the risk of myalgia and other potentially treatment-limiting muscle effects that might undermine patient adherence and compromise the overall cardioprotective benefits of statins.     

Amiodarone Surveillance in Primary Care

Amiodarone is a drug commonly used in primary care practice to treat serious cardiac arrhythmias. While efficacious, this drug places patients at risk for serious adverse events, and ongoing surveillance is essential. The purpose of this article is 2-fold: summarize pharmacokinetics of amiodarone and potential adverse effects and present current, expert, consensus panel recommendations for surveillance. The methods used are review of relevant literature and creation of quick review tables that may be applied to clinical practice. The intent of this article is to promote improved patient safety and care quality for patients receiving long-term amiodarone therapy.     

Idiosyncratic reactions to drugs: can medicine response profiles provide a dynamic drug surveillance system?

Over the next few years it will be possible to use advances in single nucleotide polymorphism map technology to correlate information from patients' DNA with their response to medicines. This provides significant opportunities to enhance current drug surveillance systems by collecting data that would enable rare serious adverse events to be predicted in subsequent patients before the medicine is prescribed. Reasonable discussion regarding perceived or real barriers to this surveillance concept is required to realize the significant patient benefits which will accrue from this system.     

Early postmarketing drug safety surveillance: data mining points to consider

BACKGROUND: Computer-assisted data mining algorithms (DMAs) are being studied to screen spontaneous reporting databases for signals of novel adverse events. The performance characteristics and optimum deployment of these techniques remain to be established. OBJECTIVE: To explore issues in the practical evaluation and deployment of DMAs by comparing findings from an empirical Bayesian DMA with those from a traditional drug safety surveillance program. METHODS: Published findings from early postmarketing safety surveillance of thalidomide were compared with findings from an empirical Bayesian DMA. Differential results were used to explore practical issues in the evaluation and deployment of DMAs. RESULTS: Most adverse events highlighted by each method were compatible with the product labeling or natural history/complications of reported treatment indications. Traditional surveillance highlighted 4 potentially serious and unexpected adverse events (Stevens-Johnson syndrome, toxic epidermal necrolysis, seizures, skin ulcers) warranting labeling amendments or close monitoring. None of these adverse event terms generated a signal using the DMA. CONCLUSIONS: The DMA would not have enhanced early postmarketing surveillance in this particular setting. While the results cannot be used to draw inferences about the global performance of DMAs, they illustrate the following: (1) DMA performance may be highly situation dependent; (2) over-reliance on these methods may have deleterious consequences, especially with so-called "designated medical events"; and (3) the most appropriate selection of pharmacovigilance tools needs to be tailored to each situation, being mindful of the numerous factors that may influence comparative performance and incremental utility of DMAs.     

Systematic identification and classification of adverse events in human research

Widely accepted standards and safeguards for research participants now include systematic surveillance and recording of adverse events. In the absence of a uniform regulation or structure for such reporting, each institution must now establish suitable yet efficient procedures to accomplish this task. We report herein our single center experience with a customized data collection, storage and review system specifically designed to identify and react appropriately to adverse events. Adverse events are classified by each investigator using three criteria in specific order: seriousness, expectedness and relatedness to the investigational intervention. Once classified, events are entered into an online database that includes collation, retrieval and search capabilities. Events meeting specified criteria are reviewed and adjudicated on a weekly basis by The University of Connecticut Research Adverse Events Committee, which makes advisory recommendations to the hospital's two Institutional Research Boards ranging from modification of informed consent to study suspension. Three hundred and seventy-one serious adverse events from > 900 studies were reviewed in the previous academic year. Our system, which combines timely on-line reporting with regular surveillance, provides a potential model that meets the need for comprehensive yet practical adverse events assessment and reporting.     

浙江省平湖市预防接种不良反应监测

目的掌握预防接种不良反应的发生情况。方法按照浙江省预防接种不良反应监测方案,对全市免疫接种的人群进行监测。结果全市预防接种不良反应发生率为59.25/10万人次,发生率前5位依次为:全细胞百日咳-白喉-破伤风(百白破)联合疫苗(DTwP)320.03/10万、无细胞百白破联合疫苗(DTaP)184.34/10万、白破联合疫苗(DT)178.32/10万、23价肺炎球菌疫苗(PneV23)170.88/10万和A+C群脑膜炎球菌多糖疫苗(MPV-A+C)72.36/10万。结论应设置专人负责预检,提高接种技术,减少预防接种不良反应的发生,并应重视预防接种不良反应的监测。     

Monitoring amiodarone's toxicities: recommendations, evidence, and clinical practice

OBJECTIVES: We sought to develop an explicit evidence-based model of medication monitoring and to evaluate monitoring practices and adverse drug events in patients taking amiodarone at one institution. METHODS: We searched MEDLINE (1966 through 2000) for English-language publications providing specific monitoring recommendations for amiodarone. A cross-sectional retrospective chart review of 99 outpatients receiving amiodarone therapy between Jan 1, 2000, and Jan 1, 2001, at a large tertiary-care hospital was performed to assess monitoring practices. Adverse drug events were identified by use of structured implicit reviews. The main outcome measure was the proportion of patients receiving the monitoring recommended in the literature and having amiodarone-related adverse drug events. RESULTS: Forty-three articles were identified that provided specific monitoring recommendations, although no studies were found that compared the outcomes of patients managed with different monitoring regimens. Overall, 70% of the recommended monitoring criteria were satisfied, although only 9 patients (9%; 95% confidence interval [95% CI], 3%-15%) received all of the recommended monitoring. Variability in monitoring practices was identified at all stages of the monitoring model. Of the patients, 52 (52%; 95% CI, 42%-62%) received minimum baseline evaluations, 22 (22%; 95% CI, 14%-31%) underwent ongoing surveillance, 75 (75%; 95% CI, 61%-89%) had appropriate responses to abnormal surveillance results, and 71 (71%; 95% CI, 62%-80%) had timely follow-up visits. Of the patients, 8 (8%; 95% CI, 3%-13%) had 9 amiodarone-related adverse drug events, of which 3 were judged to be preventable. Interrater agreement for monitoring processes (kappa = 0.83) and adverse drug events (kappa = 0.67) was good. CONCLUSIONS: Current standards for amiodarone toxicity monitoring are based on expert opinion with limited evidence to support most recommendations. Monitoring practices appear to vary significantly, with few patients receiving all of the recommended monitoring. Some amiodarone-related adverse drug events may be preventable and patient safety might be improved with a better understanding of monitoring processes.     

Undesirable effects of spa treatments: apropos of a systematic, prospective spa surveillance study at Bagnères-de-Bigorre

The aim of the study was a systematic prospective survey of adverse events at health resorts using the French method of assessment of imputability of adverse drug reactions. The work was performed over a period of one month in Grands Thermes at Bagnères-de-Bigorre (France, Pyrénées). Seventy-one adverse events were recorded in 1794 patients, i.e. 0.3 pour cent per day of treatment. Only one adverse event was considered as 'serious'. Six adverse events were evaluated as 'possible' and six others 'likely'. Most of the adverse events were general or neurological (such as asthenia, malaise) and were observed during the six first days at health resorts. These data show that health resorts in Bagnères-de-Bigorre are associated with a low number of adverse events. They show that an epidemiological survey of health resorts is possible. This work underlines the necessity of genuine surveillance for a modern evaluation of the benefit/risk ratio of health resorts.     

2007-2009年上海市闵行区预防接种不良反应监测分析

目的 分析上海市闵行区2007-2009年预防接种不良反应监测系统报告的不良反应特征。 方法 利用疑似预防接种异常反应(AEFI)监测系统收集到的所有数据采用描述性方法对相关指标进行流行病学分析。 结果 闵行区2007-2009年AEFI的平均报告率为91.67/10万;病毒类疫苗、细菌类疫苗、非疫苗制品AEFI报告发生率依次为31.75/10万、212.04/10万和73.40/10万;各街道(镇)AEFI报告率存在较大的差异,龙柏街道开始主动监测模式比较早,不良反应报告率明显高于其他地区;AEFI的临床分类以发热和轻微局部反应为主,占总AEFI报告数的63.47%及32.18%,2007-2009年发热及局部红肿、硬结总的发生率分别为58.03/10万及29.42/10万。 结论 闵行区AEFI报告率高于相关文献报告的水平,需进一步探讨AEFI主动监测模式,提高疫苗安全性监测的敏感性,为甄别各产品特性差异提供更全面的信息。