Patient safety, ethics and whistleblowing : a nursing response to the events at the Campbelltown and Camden Hospitals

In November 2002, in what stands as one of the most significant whistleblowing cases in the history of the Australian health care system, four nurses went public with concerns they had about the management of clinical incidents and patient safety at two hospitals in Sydney, New South Wales. The handling of this case and its aftermath raises important moral questions concerning the nature of whistleblowing in health care domains and the possible implications for the patient safety and quality of care movement in Australia. This paper presents an overview of the case, the moral risks associated with whistleblowing, and some lessons learned.

Clinical risk management and the ethics of open disclosure : part 1 : benefits and risks to patient safety

Patient safety experts and other authorities have strongly postulated the open disclosure of errors and adverse events to patients as an essential component of effective clinical risk management in health care. Commentators also contend that ‘when things go wrong’, openly disclosing such events to the patient and his or her nominated support person is simply ‘the right thing to do’. Despite the obvious importance of the issue of open disclosure and its possible implications for the nursing profession, it has not been comprehensively addressed in the nursing literature. A key aim of this article (the first of a two-part discussion) is to contribute to the positive project of redressing this oversight by providing a brief overview of what open disclosure is and what its intended purpose, aims, and rationale are. Consideration is also given to the risks and benefits of open disclosure as a public policy and whether it will succeed in achieving the anticipated outcomes envisaged. In a second article (to be presented as Part II), the ethics of open disclosure and its possible implications for the nursing profession are explored.

Engaging patients as safety partners : some considerations for ensuring a culturally and linguistically appropriate approach

Engaging patients as ‘safety partners’ with health service providers to help identify and rectify preventable adverse events in health care is being increasingly accepted in the USA, Australia, and elsewhere as a promising strategy to improve patient safety outcomes. The implications of this trend for patients and families of minority cultural and language backgrounds have not, however, been comprehensively considered. In this article, attention is given to briefly exploring the notion of patient participation in health care and the problematic transposition of the concept into patient safety discourse. The importance of recognising and responding to the critical relationship between culture, language and
patient safety outcomes, and the possible benefits and risks of engaging patients of minority ethnic backgrounds in safety partnership programs are explored. It is suggested that if patient safety engagement/partnership programs are to perform well in cross-cultural health care contexts, they need to be supported by research evidence and appropriately informed by the perspectives and experiences of patients and families/nominated carers from minority cultural and language backgrounds. They also need to be appropriately supported by culturally competent policies and practices across the entire health care system. The importance of robust internationally comparative research on this issue is highlighted.

Domestic violence and the exemption from seeking child support : providing safety or legitimizing ongoing poverty and fear

This article examines the experience of low-income women on welfare in Australia and the process of seeking child support from a violent ex-partner, contrasting this with research from the United States and the United Kingdom. Women in Australia who fear ongoing or renewed abuse as a result of seeking child support are eligible for an exemption. However, the exemption policy does not necessarily provide the intended protection of women and children from ongoing abuse and poverty. The exemption policy route also produces an unintended outcome whereby the perpetrators of violence are financially rewarded as they do not have to pay child support. These outcomes are shaped by a complex interaction of personal, cultural and structural forces that make the process of seeking child support for women who have experienced violence extremely problematic. The article demonstrates how in Australia, as in the US and UK policy contexts, the needs of women and their children are compromised by the details of policy specification and the way policies are implemented within the different systems.

A qualitative investigation of the safety culture of two organisations

A qualitative investigation of the safety culture of two contrasting organisations was undertaken. The research sought to identify categories and themes in the data that highlighted similarities and differences in salient safety issues for employees from the two organisations. The participants were 131 employees attending safety training sessions in a large national retail organisation and a heavy manufacturing organisation. Unobtrusive observation was used to collect data during the safety training sessions. Thematic analysis was used to identify emergent categories and themes from the data. Ten broad categories with relevant themes were identified and provided some insight into the safety culture of the two organisations, with both similarities and differences being evident. Participants from both organisations mentioned management issues in relation to safety, discussed the impact of employee risk- taking behaviour on safety, made reference to a blame culture, and raised integrity issues regarding safety. For the manufacturing organisation, a number of themes focused on contractor issues, while in the retail organisation, several themes highlighted differences in safety attitudes between head office and store-level employees.

Perceptions of neighborhood safety and physical activity among youth : the CLAN study

Background: The purpose of this study was to examine associations between perceptions of neighborhood safety and physical activity among youth. Methods: We completed a cross-sectional study of children age 8 to 9 years (n = 188) and adolescents age 13 to 15 years (n = 346) in areas of varying socioeconomic status in Melbourne, Australia. Parents and adolescents completed questionnaires on perceptions of neighborhood safety. Scores were computed for perceptions of road safety, incivilities, and personal safety of the child or adolescent. Moderate-to-vigorous physical activity (MVPA) before or after school, on evenings, and on weekends was recorded using accelerometers. Results: There were no associations between parental perceptions of neighborhood safety and children’s MVPA outside school hours. Parental perception of personal safety was positively associated with adolescent boys’ MVPA after school. Adolescent girls’ concern about road safety was negatively associated with their MVPA during evenings and outside school hours. Conclusion: Perceptions of neighborhood safety might influence physical activity among youth in different ways according to age group and sex.

Playing it safe : the influence of neighbourhood safety on children's physical activity − A review

Compared with previous generations, children spend less time playing outdoors and have lower participation rates in active transport. Many studies have identified lack of neighbourhood safety as a potential barrier to children's physical activity. This review describes concerns regarding ‘stranger danger’ and road safety, and discusses empirical studies that examine associations between neighbourhood safety and physical activity among youth. Variability of perceptions of safety between parents and youth are examined; ‘social traps’ are identified; and physical/social environmental interventions aimed at improving neighbourhood safety are discussed. A research agenda is suggested for further study of perceived and objective measures of neighbourhood safety and their associations with children's physical activity.

Pharmaceutical ecomonics and politics vs. patient safety : Lumiracoxib in Australia

Lumiracoxib (Prexige©) 200 mg was listed in Australia’s Pharmaceutical Benefits Scheme (PBS) schedules on 01 August 2006. The listing was intended as a cost-minimisation strategy, as lumiracoxib 200 mg was deemed equivalent in therapeutic effect to celecoxib (Celebrex©) 200 mg, and was available at a lower cost. By the time of listing on the PBS, a safety re-evaluation of the recommended daily dose of lumiracoxib was being considered in other national regulatory jurisdictions. Within 3 months of listing, the manufacturer revised the recommended dosage to half that of the PBS-listed dosage. However, the PBS listing was neither revoked nor modified. At the time of listing on the PBS, lumiracoxib was known to be 17 times as biochemically selective in inhibiting the COX-2 isoform as celecoxib, and twice as selective as rofecoxib, already withdrawn for safety reasons. Safety concerns had already been raised about adverse hepatic outcomes on daily doses of lumiracoxib 200 mg. Communication of information about the risk potential of lumiracoxib was inadequate. Economic and political considerations were prioritised over patient safety, and lumiracoxib 200 mg remained available via the PBS until 10 August 2007, when it was withdrawn for safety reasons following cases of hepatic morbidity and mortality.

Health care provider and consumer understandings of cultural safety and cultural competency in health care : an Australian study

There is increasing recognition in Australia that racial and ethnic minority groups experience significant disparities in health and health care compared with the average population and that the Australian health care system needs to be more responsive to the health and care needs of these groups. The paper presents the findings of a year long study that explored what providers and recipients of health care know and understand about the nature and implications of providing culturally safe and competent health care to minority racial and ethnic groups in Victoria, Australia. Analysis of the data obtained from interviewing 145 participants recruited from over 17 different organizational sites revealed a paucity of knowledge and understanding of this issue and the need for a new approach to redress the status quo.

Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640]

Background: Vertebroplasty is a promising but as yet unproven treatment for painful osteoporotic vertebral fractures. It involves radiographic-guided injection of various types of bone cement directly into the vertebral fracture site. Uncontrolled studies and two controlled quasi-experimental before-after studies comparing volunteers who were offered treatment to those who refused it, have suggested an early benefit including rapid pain relief and improved function. Conversely, several uncontrolled studies and one of the controlled before-after studies have also suggested that vertebroplasty may increase the risk of subsequent vertebral fractures, particularly in vertebrae adjacent to treated levels or if cement leakage into the adjacent disc has occurred. As yet, there are no completed randomised controlled trials of vertebroplasty for osteoporotic vertebral fractures. The aims of this participant and outcome assessor-blinded randomised placebo-controlled trial are to i) determine the short-term efficacy and safety (3 months) of vertebroplasty for alleviating pain and improving function for painful osteoporotic vertebral fractures; and ii) determine its medium to longer-term efficacy and safety, particularly the risk of further fracture over 2 years.

Design: A double-blind randomised controlled trial of 200 participants with one or two recent painful osteoporotic vertebral fractures. Participants will be stratified by duration of symptoms (< and ≥ 6 weeks), gender and treating radiologist and randomly allocated to either the treatment or placebo. Outcomes will be assessed at baseline, 1 week, 1, 3, 6, 12 and 24 months. Outcome measures include overall, night and rest pain on 10 cm visual analogue scales, quality of life measured by the Assessment of Quality of Life, Osteoporosis Quality of Life and EQ-5D questionnaires; participant perceived recovery on a 7-point ordinal scale ranging from 'a great deal worse' to 'a great deal better'; disability measured by the Roland-Morris Disability Questionnaire; timed 'Up and Go' test; and adverse effects. The presence of new fractures will be assessed by radiographs of the thoracic and lumbar spine performed at 12 and 24 months.

Discussion: The results of this trial will be of major international importance and findings will be immediately translatable into clinical practice.

Trial registration: Australian Clinical Trial Register # [ACTRN012605000079640]

Implementation of a medication guideline to improve medication safety for patients

Although the incidence of medication error remains unknown, in Australian hospitals, they are thought to occur in 5-20 % of drug administrations 1. Not surprisingly, international debate has focused on the mechanisms to improve the safety of patients. Thus a new National Inpatient Medication Chart (NIMC) was endorsed to improve communication and reduce medication errors 2. This study aimed to investigate the documentation practices of clinicians following the implementation of a medication guideline and NIMC.
A pre and post-test design was used to evaluate the adoption of and adherence to the medication guideline at Western Health, an 850 bed healthcare network in Australia. Audits of inpatient medication charts (N=265) were conducted at 3 months prior to and repeated 4 months (N=290) after implementation. The pre-test data was used to formulate an interdisciplinary organizational strategy that included mandatory education for all clinical staff, practice reminders, decision prompts, a telephone hotline for support, an intranet information website and electronically distributed Frequently Asked Questions.
Pre and post implementation audits highlighted areas of potential medication error. The post-test showed an overall trend towards improvement in documentation. There were significant improvements in 4 critical practices: Drug name clear (p=0.0003); Drug dose clear (p=0.0002); Prescribed frequency equals documented frequency (p=0) and; No signature by administrator (p=0).
The majority of documentation errors showed poor attention to detail and would be considered a slip or lapse in skill based judgment 3. Although this study was designed to evaluate documentation practices, future research should include observation methods to increase our understanding of the context behind the judgments such as work place interruptions, skill mix and knowledge levels. While evidence based guidelines enable work, they are not the actual work or substance of patient care. Organisational systems can assist in preventing unconscious aberrations that lead to error.

Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures : a randomised double-blind placebo-controlled trial

Background: Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures despite limited evidence to support its use. The primary aim of this study was to determine its short-term efficacy and safety in this patient population.

Methods: In a multicentre randomized placebo-controlled trial, participants with one or two painful osteoporotic vertebral fractures < 12 months duration confirmed active by MRI were randomly assigned, stratified by center, gender and duration of symptoms (< or ≥ 6 weeks), to receive vertebroplasty or sham treatment. Primary outcome was overall pain (0–10 scale) at 3 months. Participants, investigators (other than the interventional radiologist) and outcome assessors were blinded to treatment assignment.

Results: 78 participants were enrolled and 73 (36/38 active, 37/40 placebo, 94%) completed 3-month follow up. Vertebroplasty did not show any statistically significant advantage in any measured outcome with 95% confidence intervals indicating no plausible practically important benefits of vertebroplasty over placebo. At 1 week, 1 and 3 months, there were significant improvements in overall pain in both treatment groups (mean improvement (SD): 1.5 (2.5), 2.1 (2.8), 2.3 (2.6), and 1.7 (3.3), 2.5 (2.9), 1.9 (3.4) in the active and placebo groups respectively). Similar improvements in both groups were observed for night and rest pain, function, quality of life and perceived improvement. Eight incident clinical vertebral fractures (3 active, 5 placebo) occurred during 3-month follow up.

Conclusion: We found no evidence of a beneficial effect of vertebroplasty over sham treatment for painful osteoporotic vertebral fractures, 1 week, 1 and 3 months following treatment. [Australian Clinical Trial Register number, ACTRN012605000079640]