Patient safety ethics and human error management in ED contexts part I : development of the global patient safety movement

In recent years there has been increasing recognition internationally that health care is not as safe as it ought to be and that patient safety outcomes need to be improved. To this end patient safety has become the focus of a world-wide endeavour aimed at reducing the incidence and impact of preventable human errors and related adverse events in health care domains. The emergency department has been identified as a significant site of preventable human errors and adverse events in the health care system, raising important questions about the nature of human error management and patient safety ethics in rapidly changing environments. In this article (the first of a two-part discussion on the subject) an overview of the incidence and impact of preventable adverse events in ED contexts is explored. The development of a ‘culture of safety’ in other hazardous industries and the ‘lessons learned’ and applied to the health care industry are also briefly examined. In a second article (to be presented as Part II), some of the ethical tensions that have arisen in the context of implementing patient safety processes and their possible implications for ED contexts are explored.

Patient safety ethics and human error management in ED contexts Part II : Accountability and the challenge to change

In recent years there has been increasing recognition internationally that health care is not as safe as it ought to be and that patient safety outcomes need to be improved. To this end, patient safety has become the focus of a world-wide endeavour – endorsed by the World Health Organisation – to reduce the incidence and impact of preventable human errors and related adverse events in health care domains. The emergency department has been identified as a significant site of preventable human errors and adverse events in the health care system, raising important questions about the nature of human error management and patient safety ethics in rapidly changing environments, of which the Emergency Department is a prime example. In Part I of this article series, an overview of the incidence and impact of preventable adverse events in Emergency Department contexts and the development of the global patient safety movement was presented. In this second article brief attention is given to examining some of the ethical tensions that have arisen in response to the patient safety movement and their possible implications for Emergency Department contexts and staff.

Getting your life back on track after stroke : a phase II multi-centered, single-blind, randomized, controlled trial of the Stroke Self-Management Program vs. the Stanford Chronic Condition Self-Management Program or standard care in stroke survivors

Background Self-management is seen as a primary mechanism to support the optimization of care for people with chronic diseases such as symptomatic vascular disease. There are no established and evidence-based stroke-specific chronic disease self-management programs. Our aim is to evaluate whether a stroke-specific program is safe and feasible as part of a Phase II randomized-controlled clinical trial.
Methods Stroke survivors are recruited from a variety of sources including: hospital stroke services, local paper advertisements, Stroke South Australia newsletter (volunteer peer support organization), Divisions of General Practice, and community service providers across Adelaide, South Australia. Subjects are invited to participate in a multi-center, single-blind, randomized, controlled trial. Eligible participants are randomized to either;
• standard care,
• standard care plus a six week generic chronic condition self-management group education program, or,
• standard care plus an eight week stroke specific self-management education group program.
Interventions are conducted after discharge from hospital. Participants are assessed at baseline, immediate post intervention and six months.
Study Outcomes The primary outcome measures determine study feasibility and safety, measuring, recruitment, participation, compliance and adverse events.
Secondary outcomes include:
• positive and active engagement in life measured by the Health Education Impact Questionnaire,
• improvements in quality of life measured by the Assessment of Quality of Life instrument,
• improvements in mood measured by the Irritability, Depression and Anxiety Scale,
• health resource utilization measured by a participant held diary and safety.

Conclusion The results of this study will determine whether a definitive Phase III efficacy trial is justified.

Baseline comorbidities in a population-bases cohort of rheumatoid arthritis patients receiving biological therapy: data from the Australian Rheumatology Association database

Aims: To describe the baseline characteristics of an Australian population-based cohort of rheumatoid arthritis (RA) patients commencing biological therapy.

Methods: Descriptive analysis from the Australian Rheumatology Association Database (ARAD).

Results: Up to October 2006, there were 681 RA patients taking biologics enrolled in ARAD. Baseline data were available for 624 (72% female, mean (SD) age 57.0 (12.5) years). Of these, 59.5% reported at least one comorbid condition, most commonly hypertension (35.7%) and osteoporosis (30.4%); 61 (9.8%) had a history of malignancy (35 nonmelanoma skin, 5 breast, 4 bowel, 5 cervix, 3 melanoma, 3 prostate and 1 each of lip, lung, myeloma, testis, uterus, vagina). Self-reported infections within the previous 6 months were common (71.5%).

Conclusions: History of comorbidities, including recent infections, is common among Australian RA patients commencing biologics, and 10% have a history of malignancy. This may impact future evaluations of health outcomes among this population, including attribution of adverse events of biologic therapy.

Pain relief for the removal of femoral sheath in interventional cardiology adult patients (Review)

Pain relief for removal of femoral sheath after cardiac procedures
Procedures for the non-surgical management of coronary heart disease include balloon angioplasty and intracoronary stenting. At the start of each procedure an introducer sheath is inserted through the skin (percutaneously) into an artery, frequently a femoral artery in the groin. This allows the different catheters used for the procedure to be exchanged easily without causing trauma to the skin. At the end of the procedure the sheath is removed and, if the puncture site isn't "sealed" using a device closure, firm pressure is required over the site for 30 minutes or more to control any bleeding and reduce vascular complications. Removing the sheath and the firm pressure required to control bleeding can cause pain, although this is generally mild. Some centres routinely give pain relief before removal such as intravenous morphine, or an injection of a local anaesthetic in the soft tissue around the sheath (called a subcutaneous injection). Adequate pain control during sheath removal is also associated with a reduced incidence of a vasovagal reaction, a potentially serious complication involving a sudden drop of blood pressure and a slowed heart rate. Four studies were reviewed in total. Three trials involving 498 participants compared subcutaneous lignocaine, a short acting local anaesthetic, with a control group (participants received either no pain relief or an inactive substance known as a placebo). Two trials involving 399 people compared intravenous opioids (fentanyl or morphine) and an anxiolytic (midazolam) with a control group. One trial involving 60 people compared subcutaneous levobupivacaine, a long acting local anaesthetic, with a control group. Intravenous pain regimens and subcutaneous levobupivacaine appear to reduce the pain experienced during femoral sheath removal. However, the size of the reduction was small. A significant reduction in pain was not experienced by participants who received subcutaneous lignocaine or who were in the control group. There was insufficient data to determine a correlation between pain relief administration and either adverse events or complications. Some patients may benefit from routine pain relief using levobupivacaine or intravenous pain regimens. Identifying who may potentially benefit from pain relief requires clinical judgement and consideration of patient preference. The mild level of pain generally experienced during this procedure should not influence the decision as some people can experience moderate levels of pain.

Medical error and decision making : learning from the past and present in intensive care

Background : Human error occurs in every occupation. Medical errors may result in a near miss or an actual injury to a patient that has nothing to do with the underlying medical condition. Intensive care has one of the highest incidences of medical error and patient injury in any specialty medical area; thought to be related to the rapidly changing patient status and complex diagnoses and treatments.

Purpose : The aims of this paper are to: (1) outline the definition, classifications and aetiology of medical error; (2) summarise key findings from the literature with a specific focus on errors arising from intensive care areas; and (3) conclude with an outline of approaches for analysing clinical information to determine adverse events and inform practice change in intensive care.

Data source : Database searches of articles and textbooks using keywords: medical error, patient safety, decision making and intensive care. Sociology and psychology literature cited therein.

Findings : Critically ill patients require numerous medications, multiple infusions and procedures. Although medical errors are often detected by clinicians at the bedside, organisational processes and systems may contribute to the problem. A systems approach is thought to provide greater insight into the contributory factors and potential solutions to avoid preventable adverse events.

Conclusion : It is recommended that a variety of clinical information and research techniques are used as a priority to prevent hospital acquired injuries and address patient safety concerns in intensive care.

Do high-risk medicines alerts influence practice?

Background: Medicine-related adverse events are prevalent, costly and mostly preventable. The High Risk Medicines Working Party (Victoria) developed and distributed three highrisk medicines alerts – wrong route of administration of oral medicines, subcutaneous insulin and unfractionated heparin – and accompanying audit tools in 2008 and 2009.
Aims: To determine the impact of the three high-risk medicines alerts on Victorian health services; to assess the clinical relevance and utility of the audit tools; to identify barriers to implementing recommendations; and to obtain feedback and suggestions for future alert topics.
Method: A cross-sectional survey was undertaken from 6 to 31 July 2009 using an online questionnaire. The questionnaire was distributed to 90 metropolitan, regional and rural public health services in Victoria and approximately 200 members of the Quality Use of Medicines Network (Victoria).
Results: Most of the 90 respondents were pharmacists (53%) and nurses (31%). 53 (59%) respondents reported making changes as a result of receiving the high-risk medicines alerts – 21 (40%) concerned the wrong route of administration, 12 (23%) subcutaneous insulin and 7 (13%) unfractionated heparin. Barriers to implementation included time constraints, inadequate staff and resources, excessive paperwork and competing priorities. A minority of respondents indicated some alerts were not relevant to small rural services. Suggestions for
improving the audit tools included making them less labour intensive, enabling electronic responses and ensuring their distribution is coordinated with other medicine-related tools.
Conclusion: High-risk medicines alerts and the accompanying audit tools facilitated change but there were some barriers to their implementation, such as time and resource constraints. Not all alerts and audit tools were relevant to all health services.

Nurses' role in medication safety

Aim To explore the nurses role in the process of medication management and identify the challenges associated with safe medication management in contemporary clinical practice.
Background Medication errors have been a long-standing factor affecting consumer safety. The nursing profession has been identified as essential to the promotion of patient safety.
Evaluation A review of literature on medication errors and the use of electronic prescribing in medication errors.
Key issues Medication management requires a multidisciplinary approach and interdisciplinary communication is essential to reduce medication errors. Information technologies can help to reduce some medication errors through eradication of transcription and dosing errors. Nurses must play a major role in the design of computerized medication systems to ensure a smooth transition to such as system.
Conclusion The nurses roles in medication management cannot be over-emphasized. This is particularly true when designing a computerized medication system.
Implication for nursing management The adoption of safety measures during decision making that parallel those of the aviation industry safety procedures can provide some strategies to prevent medication error. Innovations in information technology offer potential mechanisms to avert adverse events in medication management for nurses.

Monitoring the safe use of Clozapine : a consensus view from Victoria, Australia

Clozapine is an important antipsychotic agent that has a unique profile of clinical benefits, but that has also been associated with several serious and potentially life-threatening safety concerns. In order to minimise the impact of haematological adverse events, health professionals treating patients with clozapine are currently required to register their patients on a centrally administered data network and to conform to strict protocols. The consensus statement documented in this article extends existing protocols by recommending monitoring of patients treated with clozapine for additional adverse effects during treatment. This consensus statement reflects the current practice at five major public psychiatric hospitals in Victoria, Australia, for the monitoring and management of clozapine-related adverse events, and has been implemented at these sites because of emerging safety concerns associating clozapine with cardiovascular and metabolic adverse effects.

A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program

Background and Purpose—The benefits of chronic disease self-management programs for stroke survivors are uncertain because individuals with severe impairments have been excluded from previous research. We undertook a phase II randomized controlled trial to determine whether a self-management program designed for survivors (SSMP; 8 weeks) was safe and feasible compared to standard care (control) or a generic self-management program (generic; 6 weeks).
Methods—Stroke survivors were recruited from 7 South Australian hospitals via a letter or indirectly (eg, newspapers). Eligible participants were randomized at a 1:1:1 ratio of 50 per group. Primary outcomes were recruitment, participation, and participant safety. Secondary outcomes were positive and active engagement in life using the Health Education Impact Questionnaire and characteristics of quality of life and mood at 6 months from program completion.
Results—Of 315 people screened, 149 were eligible and 143 were randomized (48 SSMP, 47 generic, 48 control); mean age was 69 years (SD, 11) and 59% were female. Demographic features were similar between groups and 41% had severe cognitive impairment; 57% accessed the interventions, with 52% SSMP and 38% generic completing >50% of sessions (P=0.18). Thirty-two participants reported adverse events (7 control, 12 generic, 13 SSMP; P=0.3; 34% severe); however, none was attributable to the interventions. Potential benefits for improved mood were found.
Conclusions—SSMP was safe and feasible. Benefits of the stroke-specific program over the generic program included greater participation and completion rates. An efficacy trial is warranted given the forecast growth in the stroke population and improved survival trends.

Multifactorial influences on and deviations from medication administration safety and quality in the acute medical/surgical context

Background and Aims: Although numerous factors influence medication administration, our understanding of the interplay of these factors on medication quality and safety is limited. The aim of this study was to explore the multifactorial influences on medication quality and safety in the context of a single checking policy for medication administration in acute care.

Approach: An exploratory/descriptive study using non-participant observation and follow-up interview was used to identify factors influencing medication quality and safety in medication administration episodes (n = 30). Observations focused on nurses’ interactions with patients during medication administration, and the characteristics of the environment in which these took place. Confirmation of observed data occurred on completion of the observation period during short semi-structured interviews with participant nurses.

Findings: Findings showed nurses developed therapeutic relationships with patients in terms of assessing patients before administering medications and educating patients about drugs during medication administration. Nurses experienced more frequent distractions when medications were stored and prepared in a communal drug room according to ward design. Nurses deviated from best-practice guidelines during medication administration.

Implications: Nurses’ abilities and readiness to develop therapeutic relationships with patients increased medication quality and safety, thereby protecting patients from potential adverse events. Deviations from best-practice medication administration had the potential to decrease medication safety. System factors such as ward design determining medication storage areas can be readily addressed to minimise potential error.

Conclusions: Nurses displayed behaviours that increased medication administration quality and safety; however, violations of practice standards were observed. These findings will inform future intervention studies to improve medication quality and safety.

Early intervention with erythropoietin does not affect the outcome of acute kidney injury (the EARLYARF trial)

We performed a double-blind placebo-controlled trial to study whether early treatment with erythropoietin could prevent the development of acute kidney injury in patients in two general intensive care units. As a guide for choosing the patients for treatment we measured urinary levels of two biomarkers, the proximal tubular brush border enzymes γ-glutamyl transpeptidase and alkaline phosphatase. Randomization to either placebo or two doses of erythropoietin was triggered by an increase in the biomarker concentration product to levels above 46.3, with a primary outcome of relative average plasma creatinine increase from baseline over 4 to 7 days. Of 529 patients, 162 were randomized within an average of 3.5 h of a positive sample. There was no difference in the incidence of erythropoietin-specific adverse events or in the primary outcome between the placebo and treatment groups. The triggering biomarker concentration product selected patients with more severe illness and at greater risk of acute kidney injury, dialysis, or death; however, the marker elevations were transient. Early intervention with high-dose erythropoietin was safe but did not alter the outcome. Although these two urine biomarkers facilitated our early intervention, their transient increase compromised effective triaging. Further, our study showed that a composite of these two biomarkers was insufficient for risk stratification in a patient population with a heterogeneous onset of injury.

Underlying neurobiology and clinical correlates of mania status after subthalamic nucleus deep brain stimulation in Parkinson's Disease : a review of the literature

Deep brain stimulation (DBS) is a novel and effective surgical intervention for refractory Parkinson's disease (PD). The authors review the current literature to identify the clinical correlates associated with subthalamic nucleus (STN) DBS-induced hypomania/mania in PD patients. Ventromedial electrode placement has been most consistently implicated in the induction of STN DBS-induced mania. There is some evidence of symptom amelioration when electrode placement is switched to a more dorsolateral contact. Additional clinical correlates may include unipolar stimulation, higher voltage (>3 V), male sex, and/or early-onset PD. STN DBS-induced psychiatric adverse events emphasize the need for comprehensive psychiatric presurgical evaluation and follow-up in PD patients. Animal studies and prospective clinical research, combined with advanced neuroimaging techniques, are needed to identify clinical correlates and underlying neurobiological mechanisms of STN DBS-induced mania. Such working models would serve to further our understanding of the neurobiological underpinnings of mania and contribute valuable new insight toward development of future DBS mood-stabilization therapies.

A comparative study of the constant observation model of care

This study investigated two different nursing models of care for ‘at-risk’ patients requiring constant observation. One patient group was managed with a specialised nursing team and the other with a traditional custodial model utilising attendants and agency nurses. Patients cared for with the specialist team had fewer adverse events and a shorter period under constant observation.