Stephen D. Small

Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group.

OBJECTIVES To assess incidence and preventability of adverse drug events (ADEs) and potential ADEs. To analyze preventable events to develop prevention strategies. DESIGN Prospective cohort study. PARTICIPANTS All 4031 adult admissions to a stratified random sample of 11 medical and surgical units in two tertiary care hospitals over a 6-month period. Units included two medical and three surgical intensive care units and four medical and two surgical general care units. MAIN OUTCOME MEASURES Adverse drug events and potential ADEs. METHODS Incidents were detected by stimulated self-report by nurses and pharmacists and by daily review of all charts by nurse investigators. Incidents were subsequently classified by two independent reviewers as to whether they represented ADEs or potential ADEs and as to severity and preventability. RESULTS Over 6 months, 247 ADEs and 194 potential ADEs were identified. Extrapolated event rates were 6.5 ADEs and 5.5 potential ADEs per 100 nonobstetrical admissions, for mean numbers per hospital per year of approximately 1900 ADEs and 1600 potential ADEs. Of all ADEs, 1% were fatal (none preventable), 12% life-threatening, 30% serious, and 57% significant. Twenty-eight percent were judged preventable. Of the life-threatening and serious ADEs, 42% were preventable, compared with 18% of significant ADEs. Errors resulting in preventable ADEs occurred most often at the stages of ordering (56%) and administration (34%); transcription (6%) and dispensing errors (4%) were less common. Errors were much more likely to be intercepted if the error occurred earlier in the process: 48% at the ordering stage vs 0% at the administration stage. CONCLUSION Adverse drug events were common and often preventable; serious ADEs were more likely to be preventable. Most resulted from errors at the ordering stage, but many also occurred at the administration stage. Prevention strategies should target both stages of the drug delivery process.

Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems

Reducing mishaps from medical management is central to efforts to improve quality and lower costs in health care. Nearly 100 000 patients are estimated to die preventable deaths annually in hospitals in the United States, with many more incurring injuries at an annual cost of

The Incident Reporting System Does Not Detect Adverse Drug Events: A Problem for Quality Improvement

9 billion. Underreporting of adverse events is estimated to range from 50%-96% annually.1–3 This annual toll exceeds the combined number of deaths and injuries from motor and air crashes, suicides, falls, poisonings, and drownings.4 Many stakeholders in health care have begun to work together to resolve the moral, scientific, legal, and practical dilemmas of medical mishaps. To achieve this goal, an environment fostering a rich reporting culture must be created to capture accurate and detailed data about nuances of care. Outcomes in complex work depend on the integration of individual, team, technical, and organisational factors. 5 6 A continuum of cascade effects exists from apparently trivial incidents to near misses and full blown adverse events. 7 8 Consequently, the same patterns of causes of failure and their relations precede both adverse events and near misses. Only the presence or absence of recovery mechanisms determines the actual outcome.9 The National Research Council defines a safety “incident” as an event that, under slightly different circumstances, could have been an accident.10 Focusing on data for near misses may add noticeably more value to quality improvement than a sole focus on adverse events. Schemes for reporting near misses, “close calls,” or sentinel (“warning”) events have been institutionalised in aviation,w1 w2 nuclear power technology,w3 w4 petrochemical processing, steelw5 production,w6 military operations, and air transportation.w7-w11 In health care, efforts are now being made to create incident reporting systems for medical near misses 8 11–15 to supplement the limited …

Simulation based teamwork training for emergency department staff: does it improve clinical team performance when added to an existing didactic teamwork curriculum?

OBJECTIVES The objectives of this study were 1) to determine the frequency with which adverse drug events result in an incident report (IR) in hospitalized patients; and 2) to determine if there were differences between quality assurance administrators, nurse leaders in quality assurance, and staff nurses as to whether an incident report should or would be filed for each adverse drug event. STUDY DESIGN All patients admitted to five patient care units (one medical intensive care unit, two surgical intensive care units, and two medical general care units) in one academic tertiary care hospital were studied between February and July 1993. The main outcome measures used were adverse drug events (ADEs) and IRs. Consensus voting was used by senior hospital administrators, nursing leaders, and staff nurses to determine whether an adverse drug event should have been reported and would have been reported. RESULTS Of 54 adverse drug events identified by the study, only 3 patients (6%) had a corresponding incident report submitted to the hospitals quality assurance program or called into the pharmacy hotline. One additional ADE was identified by an IR, but not by the ADE study. Of the 55 ADEs, 15 were preventable, and 26 were serious or life-threatening, yet only 2 of the 26 led to an incident report. The three voting groups agreed that most ADEs justified an IR, but judged that in actual practice, an IR would infrequently have been filed. CONCLUSIONS Voluntary reporting identified only a small fraction of ADEs. Using IRs for quality assurance/quality improvement will lead to significant bias when assessing quality of care.

Situation Awareness in Anesthesiology

Objective: To determine if high fidelity simulation based team training can improve clinical team performance when added to an existing didactic teamwork curriculum. Setting: Level 1 trauma center and academic emergency medicine training program. Participants: Emergency department (ED) staff including nurses, technicians, emergency medicine residents, and attending physicians. Intervention: : ED staff who had recently received didactic training in the Emergency Team Coordination Course (ETCC®) also received an 8 hour intensive experience in an ED simulator in which three scenarios of graduated difficulty were encountered. A comparison group, also ETCC trained, was assigned to work together in the ED for one 8 hour shift. Experimental and comparison teams were observed in the ED before and after the intervention. Design: Single, crossover, prospective, blinded and controlled observational study. Teamwork ratings using previously validated behaviorally anchored rating scales (BARS) were completed by outside trained observers in the ED. Observers were blinded to the identification of the teams. Results: There were no significant differences between experimental and comparison groups at baseline. The experimental team showed a trend towards improvement in the quality of team behavior (p = 0.07); the comparison group showed no change in team behavior during the two observation periods (p = 0.55). Members of the experimental team rated simulation based training as a useful educational method. Conclusion: High fidelity medical simulation appears to be a promising method for enhancing didactic teamwork training. This approach, using a number of patients, is more representative of clinical care and is therefore the proper paradigm in which to perform teamwork training. It is, however, unclear how much simulator based training must augment didactic teamwork training for clinically meaningful differences to become apparent.

Patient safety and simulation-based medical education

Situation awareness has primarily been confined to the aviation field. We believe that situation awareness is an equally important characteristic in the complex, dynamic, and risky field of anesthesiology. We describe three aspects of situations of which the decision maker must remain aware: subtle cues, evolving situations, and special knowledge elements. We provide examples of real or simulated anesthesia situations in which situation awareness is clearly involved in the provision of optimal patient care, and we map the elements of situation awareness onto a cognitive process model of the anesthesiologist. Finally, we consider how situation awareness can be further investigated and taught in this medical domain using anesthesia simulators and analyses of real cases. The study of situation awareness in anesthesiology may provide a good example of the wider application of the concept of situation awareness to nonaerospace environments.

Ambulatory Patient Safety: What We Know and Need to Know

Continuous quality improvement is an accepted mandate in healthcare services. The delivery of the best, evidence based quality of care ultimately depends on the competences of practitioners as well as the system that supports their work. Medical education has been increasingly called upon to insure providers possess the skills and understanding necessary to fulfill the quality mission. Patient safety has in the past five years rapidly risen to the top of the healthcare policy agenda, and been incorporated into quality initiatives. Demand for curricula in patient safety and transfer of safety lessons learned in other risky industries have created new responsibilities for medical educators. Simulation based medical education will help fill these needs. Simulation offers ethical benefits, increased precision and relevance of training and competency assessment, and new methods of teaching error management and safety culture.Established and successful simulation methods such as standardized patients and task trainers are being joined by newer approaches enabled by improved technology.Continuous quality improvement is an accepted mandate in healthcare services. The delivery of the best, evidence based quality of care ultimately depends on the competences of practitioners as well as the system that supports their work. Medical education has been increasingly called upon to insure providers possess the skills and understanding necessary to fulfill the quality mission. Patient safety has in the past five years rapidly risen to the top of the healthcare policy agenda, and been incorporated into quality initiatives. Demand for curricula in patient safety and transfer of safety lessons learned in other risky industries have created new responsibilities for medical educators. Simulation based medical education will help fill these needs. Simulation offers ethical benefits, increased precision and relevance of training and competency assessment, and new methods of teaching error management and safety culture.Established and successful simulation methods such as standardized patients and task t...

How the NHS can improve safety and learning. By learning free lessons from near misses.

Summary:While safety risks are widespread in ambulatory settings, there has been insufficient attention directed at developing the evidence base that is needed to improve ambulatory safety. In this article, the current state of knowledge about ambulatory safety is reviewed. A research agenda in ambulatory safety is proposed, as well as a series of potential interventions that could be used to improve safety in the ambulatory setting.

Assessing the impact of immersive simulation on clinical performance during actual in-hospital cardiac arrest with CPR-sensing technology: A randomized feasibility study

News p 1689 Reviews p 1738 An Organisation with a Memory , the newly released report from Englands chief medical officer on learning from adverse events in the NHS,1 joins recent high profile policy statements from the United States 2 3 and Australia 4 that acknowledge an epidemic of underreported preventable injuries due to medical management. This report should not, however, be seen as a one off response to preventable patient catastrophes—although recent celebrated cases in Britain, such as the Bristol paediatric cardiac surgery story, have provided a driving force for change. Instead, An Organisation with a Memory should be understood in the larger context of a 10 year modernisation strategy to continuously and measurably improve the quality of health care. If it is understood in this way, and the government is willing to invest in the necessary systems, training, and research, then it will prove a real force for change. Most care in the NHS is of high clinical standard, but the chief medical officers report suggests that as many as 850 000 serious adverse health care events might occur in the NHS hospital sector each year at a cost of over £2bn. Half of these …

Patient safety and health policy: a history and review

AIM Advanced simulation tools are increasingly being incorporated into cardiopulmonary resuscitation (CPR) training. These educational methods have been shown to improve trainee performance in simulated settings, but translation into clinical practice remains unknown for many aspects of CPR quality. This study attempts to measure the impact of simulation-based training for resuscitation team leaders on some measures of CPR quality during actual in-hospital resuscitation attempts. METHODS In this prospective, randomized interventional cluster trial, internal medicine resident physicians (post-graduate year 2) were randomized using a random number generator to participate in a 4-h, immersive simulation course in cardiopulmonary resuscitation leadership using a high-fidelity simulator with video debriefing prior to serving as resuscitation team leaders at an academic medical center. Objective metrics of actual resuscitation performance were obtained from a CPR-sensing monitor/defibrillator. RESULTS Thirty-two residents were randomized to receive simulation training or no additional training between April and July 2007 and data were collected following 98 actual resuscitations between July 2007 and June 2008. CPR quality from resuscitations led by 14 simulation-trained and 16 control group residents was similar in terms of mean compression depth (48 vs 49 mm; p = 0.53); compression rate (107 vs 104 min⁻¹; p = 0.30); ventilation rate (12 vs 12 min⁻¹; p = 0.45) and no-flow fraction (0.08 vs 0.07; p = 0.34). CONCLUSIONS Although we failed to detect any significant differences in objective measures of CPR quality, we have demonstrated that CPR-sensing technology has the potential for use in assessing the impact of a simulation curriculum on some aspects of actual resuscitation performance. A larger study, performed in a setting with lower baseline performance, would be required to assess the specific simulation curriculum.