Analysis of medication errors during anaesthesia in the first 4000 incidents reported to webAIRS.

Medication error is a well-recognised cause of harm to patients undergoing anaesthesia. From the first 4000 reports in the webAIRS anaesthetic incident reporting system, we identified 462 reports of medication errors. These reports were reviewed iteratively by several reviewers paying particular attention to their narratives. The commonest error category was incorrect dose (29.4%), followed by substitution (28.1%), incorrect route (7.6%), omission (6.5%), inappropriate choice (5.8%), repetition (5.4%), insertion (4.1%), wrong timing (3.5%), wrong patient (1.5%), wrong side (1.5%) and others (6.5%). Most (58.9%) of the errors resulted in at least some harm (20.8% mild, 31.0% moderate and 7.1% severe). Contributing factors to the medication errors included the presence of look-alike medications, storage of medications in the incorrect compartment, inadequate labelling of medications, pressure of time, anaesthetist fatigue, unfamiliarity with the medication, distraction, involvement of multiple people and poor communication. These data add to current evidence suggesting a persistent and concerning failure effectively to address medication safety in anaesthesia. The wide variation in the nature of the errors and contributing factors underline the need for increased systematic and multifaceted efforts underpinned by a strengthening of the current focus on safety culture to improve medication safety in anaesthesia. This will require the concerted and committed engagement of all concerned, from practitioners at the clinical workface, to those who fund and manage healthcare.

A cross-sectional overview of the second 4000 incidents reported to webAIRS, a de-identified web-based anaesthesia incident reporting system in Australia and New Zealand.

This cross-sectional overview of the second 4000 incidents reported to webAIRS has findings that are very similar to the previous overview of the first 4000 incidents. The distribution of patient age, body mass index and American Society of Anesthesiologists physical status was similar, as was anaesthetist gender, grade, location and time of day of incidents. About 35% of incidents occurred during non-elective procedures (vs. 33% in the first 4000 incidents). The proportion of incidents in the various main categories was also similar, with respiratory/airway being most common, followed by cardiovascular, medication-related and medical device or equipment-related incidents. Together these categories made up about 78% of all incidents in both overviews. The immediate outcome was comparable with reports of harm in about a quarter of incidents and a similar rate of deaths (4.7% vs. 4.2%). However, the proportion of patients who had received total intravenous anaesthesia was higher (17.6% vs. 7.7%) and the proportion of patients who received combined intravenous and inhalational anaesthesia was lower (52.3% vs. 58.4%), as was the proportion receiving local anaesthesia alone (1.6% vs. 6.7%). There was a small increase in the number of incidents resulting in unplanned admission to a high dependency or intensive care unit (18.1% vs. 13.5%). It is not clear whether these differences represent trends or random observations. About 48% of incidents were considered preventable by the reporters (vs. 52% in the first 4000). These findings support continued emphasis on human and system factors to promote and improve patient safety in anaesthesia care.

World Health Organization-World Federation of Societies of Anaesthesiologists (WHO-WFSA) International Standards for a Safe Practice of Anesthesia.

The International Standards for a Safe Practice of Anesthesia were developed on behalf of the World Federation of Societies of Anaesthesiologists (WFSA), a non-profit organization representing anesthesiologists in 150 countries, and the World Health Organization (WHO). The recommendations have been approved by WHO and the membership of WFSA. These Standards are applicable to all anesthesia providers throughout the world. They are intended to provide guidance and assistance to anesthesia providers, their professional organizations, hospital and facility administrators, and governments for maintaining and improving the quality and safety of anesthesia care. The Standards cover professional aspects; facilities and equipment; medications and intravenous fluids; monitoring; and the conduct of anesthesia. HIGHLY RECOMMENDED standards, the functional equivalent of mandatory standards, include (amongst other things): the continuous presence of a trained and vigilant anesthesia provider; continuous monitoring of tissue oxygenation and perfusion by clinical observation and a pulse oximeter; intermittent monitoring of blood pressure; confirmation of correct placement of an endotracheal tube (if used) by auscultation and carbon dioxide detection; the use of the WHO Safe Surgery Checklist; and a system for transfer of care at the end of an anesthetic. The International Standards represent minimum standards and the goal should always be to practice to the highest possible standards, preferably exceeding the standards outlined in this document.

Improving Anesthesia Safety in Low-Resource Settings.

The safety of anesthesia characteristic of high-income countries today is not matched in low-resource settings with poor infrastructure, shortages of anesthesia providers, essential drugs, equipment, and supplies. Health care is delivered through complex systems. Achieving sustainable widespread improvement globally will require an understanding of how to influence such systems. Health outcomes depend not only on a country's income, but also on how resources are allocated, and both vary substantially, between and within countries. Safety is particularly important in anesthesia because anesthesia is intrinsically hazardous and not intrinsically therapeutic. Nevertheless, other elements of the quality of health care, notably access, must also be considered. More generally, there are certain prerequisites within society for health, captured in the Jakarta declaration. It is necessary to have adequate infrastructure (notably for transport and primary health care) and hospitals capable of safely carrying out the "Bellwether Procedures" (cesarean delivery, laparotomy, and the treatment of compound fractures). Surgery, supported by safe anesthesia, is critical to the health of populations, but avoidable harm from health care (including very high mortality rates from anesthesia in many parts of the world) is a major global problem. Thus, surgical and anesthesia services must not only be provided, they must be safe. The global anesthesia workforce crisis is a major barrier to achieving this. Many anesthetics today are administered by nonphysicians with limited training and little access to supervision or support, often working in very challenging circumstances. Many organizations, notably the World Health Organization and the World Federation of Societies of Anaesthesiologists, are working to improve access to and safety of anesthesia and surgery around the world. Challenges include collaboration with local stakeholders, coordination of effort between agencies, and the need to influence national health policy makers to achieve sustainable improvement. It is conceivable that safe anesthesia and perioperative care could be provided for essential surgical services today by clinicians with moderate levels of training using relatively simple (but appropriately designed and maintained) equipment and a limited number of inexpensive generic medications. However, there is a minimum standard for these resources, below which reasonable safety cannot be assured. This minimum (at least) should be available to all. Not only more resources, but also more equitable distribution of existing resources is required. Thus, the starting point for global access to safe anesthesia is acceptance that access to health care in general should be a basic human right everywhere.

Refining Target-Controlled Infusion: An Assessment of Pharmacodynamic Target-Controlled Infusion of Propofol and Remifentanil Using a Response Surface Model of Their Combined Effects on Bispectral Index.

BACKGROUND: Propofol and remifentanil are commonly combined for total IV anesthesia. The pharmacokinetics (PK), pharmacodynamics (PD), and drug interactions of the combination are well understood, but the use of a combined PK and PD model to control target-controlled infusion pumps has not been investigated. In this study, we prospectively tested the accuracy of a PD target-controlled infusion algorithm for propofol and remifentanil using a response surface model of their combined effects on Bispectral Index (BIS). METHODS: Effect-site, target-controlled infusions of propofol and remifentanil were given using an algorithm based on standard PK models linked to a PD response surface model of their combined effects on BIS. The combination of a targeted BIS value and adjustable ratio of propofol to remifentanil was used to adjust infusion rates. The standard model performance measures of median performance error (bias) and median absolute performance error (inaccuracy), expressed as percentages, were used to assess accuracy of the infusions in a convenience sample of 50 adult patients undergoing surgery with general anesthesia. The influence of age and weight on the performance of the model was also assessed. RESULTS: Patients had a mean (range) age of 48 (19-73) years, weight of 80 (45-169) kg, and body mass index of 28 (19-45) kg/m. The overall model had a bias of 8% (SD 24%) and inaccuracy of 25% (SD 13%). Performance was least accurate during the early induction phase of anesthesia. There was no significant bias in BIS predictions with increasing age (P = 0.44) or weight (P = 0.56). CONCLUSIONS: The algorithm performed adequately in a clinical setting. The algorithm could be further refined, and assessment of its accuracy and utility in comparison to current clinical practice for giving IV anesthesia is warranted.

The measurement of New Zealand health care.

The effective and economical measurement of the quality and safety of health and disability services in New Zealand is of signal importance. The Health Quality and Safety Commission has overseen the introduction of an architecture of interacting measures. These include quality and safety indicators, or QSIs, which are whole-system measures; quality and safety markers, or QSMs, which are targeted measures of quality and safety interventions comprising process and outcome measures in sets; and the New Zealand Atlas of Healthcare Variation, which illustrates the differences in the health care received in different regions and by different groups of patients within New Zealand.

The Health Quality and Safety Commission: making good health care better.

New Zealand has one of the best value health care systems in the world, but as a proportion of GDP our spending on health care has increased every year since 1999. Further, there are issues of quality and safety in our system we must address, including rates of adverse events. The Health Quality and Safety Commission was formed in 2010 as a crown agent to influence, encourage, guide and support improvement in health care practice in New Zealand. The New Zealand Triple Aim has been defined as: improved quality, safety and experience of care; improved health and equity for all populations; and best value for public health system resources. The Commission is pursuing the Triple Aim via two fundamental objectives: doing the right thing by providing care supported by the best evidence available, focused on what matters to each individual patient, and doing the right thing right, first time, by making sure health care is safe and of the highest quality possible. Improvement efforts must be supported by robust but economical measurements. New Zealand has a strong culture of quality, so the Commission's role is to work with our colleagues to make good health care better.

More for less: best patient outcomes in a time of financial restraint.

In many countries, expenditure on health care has increased dramatically over recent years. There have been parallel improvements in many indicators of population health, but too many patients continue to be harmed by health care or receive care that is supply-sensitive, ineffective, or poorly aligned with their needs and values. In addition to human costs, this translates into substantial waste of resource. The world has recently faced economic challenges unseen since the great depression of the 1930s. The financial situation of a country can, like a business, be expressed in three sets of accounts: statements of financial position, financial performance, and cash flow. A key test of solvency is the ability to pay debts as they become due (whether from current account or further borrowing). In general, this is a function of public debt, which for many countries has become very high. However, private debt and net financial position are also relevant to a country's financial prospects. Ultimately, borrowing is not sustainable indefinitely and given limited prospects for growth in income in the coming years, most countries will likely need to reduce or at least constrain expenditure on health care. This implies obtaining better value from the resources that are available, and we suggest that the key to this lies in improving the quality of care and, in particular, reducing variation in health care. In the United States, new legislation promoting accountable care organizations may help to do this. Cardiac surgery can be particularly effective in extending patients' lives and in improving the quality of their lives. Our ability to continue to provide cardiac surgery in the face of constrained economic times will depend on engaging more actively in ensuring that what we do is the right thing: that our operations are effective and that they truly meet the needs and values of our patients. It will also depend on doing these operations right the first time.

Compliance and quality in administration of a Surgical Safety Checklist in a tertiary New Zealand hospital.

AIM: Recent studies have demonstrated a reduction in perioperative complications if a surgical safety checklist is utilised. In our institution an adaptation of the WHO Surgical Safety Checklist is administered in 3 "domains": on arrival of the patient in the operating room (Sign In); before surgical incision (Time Out) and before the patients leaves the operating room (Sign Out). Since incomplete administration or staff disengagement could diminish any safety benefit we evaluated administration of this checklist. METHOD: 100 adult surgical cases were observed. Compliance with administration of the Sign In, Time Out, and Sign Out domains and their component checklist items was recorded. The timing of the checklist administration, and engagement of operating room teams were also assessed. RESULTS: The rate (per 100 cases) of the checklist domain administration was: 99 for Sign In; 94 for Time Out; and 2 for Sign Out. The mean (range) checklist item compliance was 56% (27-100%) for Sign In, 69% (33-100%) for Time Out, and 40% for Sign Out. Checklist items related to patient identity and surgical procedure were administered in 100% of Sign In administrations. Timing of the checklist administration was appropriate in over 80% of cases. Engagement by theatre teams was frequently incomplete. CONCLUSION: The Sign Out domain was almost always omitted, which may increase the risk of important omissions in postoperative care. Most other aspects of checklist administration could also be improved. This will require strong leadership from senior clinicians in all relevant teams.

Medication errors--new approaches to prevention.

Medication errors in pediatric anesthesia represent an important risk to children. Concerted action to reduce harm from this cause is overdue. An understanding of the genesis of avoidable adverse drug events may facilitate the development of effective countermeasures to the events or their effects. Errors include those involving the automatic system of cognition and those involving the reflective system. Errors and violations are distinct, but violations often predispose to error. The system of medication administration is complex, and many aspects of it are conducive to error. Evidence-based practices to reduce the risk of medication error in general include those encompassed by the following recommendations: systematic countermeasures should be used to decrease the number of drug administration errors in anesthesia; the label on any drug ampoule or syringe should be read carefully before a drug is drawn up or injected; the legibility and contents of labels on ampoules and syringes should be optimized according to agreed standards; syringes should always be labeled; formal organization of drug drawers and workspaces should be used; labels should be checked with a second person or a device before a drug is drawn up or administered. Dosage errors are particularly common in pediatric patients. Causes that should be addressed include a lack of pediatric formulations and/or presentations of medication that necessitates dilution before administration or the use of intravenous formulations for oral administration in children, a frequent failure to obtain accurate weights for patients and a paucity of pharmacokinetic and pharmacodynamic data. Technological innovations, including the use of bar codes and various cognitive aids, may facilitate compliance with these recommendations. Improved medication safety requires a system-wide strategy standardized at least to the level of the institution; it is the responsibility of institutional leadership to introduce such strategies and of individual practitioners to engage in them.

To do or not to do?--How people make decisions.

Outcomes in healthcare depend a great deal on the quality of decisions made by the people who care for patients. In the early days of cardiac surgery decisions were often made on the basis of authority by surgeons with broadly based knowledge and skill, developed through extensive training and very long hours of work. The philosophy of the "captain of the ship" prevailed. The advent of much greater specialization and the emergence of evidence based medicine have led to a shift to a model of decision making in which expertise trumps authority. There has also been a reduction in the length of hours worked by many doctors, and greater emphasis on involving patients in decisions about their own healthcare. The framework for understanding human error has been refined on the basis of empirical and theoretical considerations, and much importance is now placed on the way in which the system as a whole is designed. Unfortunately the complexity of healthcare today is such that some of its properties are best explained through analogies to chaos theory. Furthermore, empirical work suggests that human beings are clearly strong at recognizing patterns, and are less adroit at analyzing complex and unfamiliar situations from first principles in a short time. It follows that the very extensive experience of some of the older practitioners may have been more valuable in decision making than many of the very reasonable and logical advances that have influenced modern practice.

Global operating theatre distribution and pulse oximetry supply: an estimation from reported data.

BACKGROUND: Surgery is an essential part of health care, but resources to ensure the availability of surgical services are often inadequate. We estimated the global distribution of operating theatres and quantified the availability of pulse oximetry, which is an essential monitoring device during surgery and a potential measure of operating theatre resources. METHODS: We calculated ratios of the number of operating theatres to hospital beds in seven geographical regions worldwide on the basis of profiles from 769 hospitals in 92 countries that participated in WHO's safe surgery saves lives initiative. We used hospital bed figures from 190 WHO member states to estimate the number of operating theatres per 100,000 people in 21 subregions throughout the world. To estimate availability of pulse oximetry, we sent surveys to anaesthesia providers in 72 countries selected to ensure a geographically and demographically diverse sample. A predictive regression model was used to estimate the pulse oximetry need for countries that did not provide data. FINDINGS: The estimated number of operating theatres ranged from 1·0 (95% CI 0·9-1·2) per 100,000 people in west sub-Saharan Africa to 25·1 (20·9-30·1) per 100,000 in eastern Europe. High-income subregions all averaged more than 14 per 100,000 people, whereas all low-income subregions, representing 2·2 billion people, had fewer than two theatres per 100,000. Pulse oximetry data from 54 countries suggested that around 77,700 (63,195-95,533) theatres worldwide (19·2% [15·2-23·9]) were not equipped with pulse oximeters. INTERPRETATION: Improvements in public-health strategies and monitoring are needed to reduce disparities for more than 2 billion people without adequate access to surgical care. FUNDING: WHO.

Clinical assessment of a new anaesthetic drug administration system: a prospective, controlled, longitudinal incident monitoring study.

A safety-orientated system of delivering parenteral anaesthetic drugs was assessed in a prospective incident monitoring study at two hospitals. Anaesthetists completed an incident form for every anaesthetic, indicating if an incident occurred. Case mix data were collected and the number of drug administrations made during procedures estimated. From February 1998 at Hospital A and from June 1999 at Hospital B, until November 2003, 74,478 anaesthetics were included, for which 59,273 incident forms were returned (a 79.6% response rate). Fewer parenteral drug errors occurred with the new system than with conventional methods (58 errors in an estimated 183,852 drug administrations (0.032%, 95% CI 0.024-0.041%) vs 268 in 550,105 (0.049%, 95% CI 0.043-0.055%) respectively, p = 0.002), a relative reduction of 35% (difference 0.017%, 95% CI 0.006-0.028%). No major adverse outcomes from these errors were reported with the new system while 11 (0.002%) were reported with conventional methods (p = 0.055). We conclude that targeted system re-design can reduce medical error.

Ethics, industry, and outcomes.

Evidence-based medicine depends on research that is reliable, well conducted, and free of influence from interest groups (which are not confined to industry). There are many ways to influence the outcome of clinical research, and the history of influence in research related to tobacco is illuminating in this regard. Health care depends on industry, and if properly managed, the relationship between industry and medical academia can be symbiotic. Achieving positive outcomes from such relationships depends on ensuring the presence of the elements needed for reasonable independence on the part of investigators, and on understanding the ways in which influence can be exerted over the production and publication of evidence. Regulation cannot substitute for integrity, particularly the integrity of the investigators. Pushing the limits of ethics in research threatens to undermine not only the reputation of those conducting the research but also the standing of science itself.