The nature, severity and causes of medication incidents from an Australian community pharmacy incident reporting system: The QUMwatch study.

AIMS: Most research into medication safety has been conducted in hospital settings with less known about primary care. The aim of this study was to characterise the nature and causes of medication incidents (MIs) in the community using a pharmacy incident reporting programme. METHODS: Thirty community pharmacies participated in an anonymous or confidential MI spontaneous reporting programme in Sydney, Australia. The Advanced Incident Management System was used to record and classify incident characteristics, contributing factors, severity and frequency ratings. RESULTS: In total, 1013 incidents were reported over 30 months, 831 of which were near misses while 165 reports involved patient harm. The largest proportion of cases pertained to patients aged >65 years (35.7%). Most incidents involved errors during the prescribing stage (61.1%), followed by dispensing (25.7%) and administration (23.5%), while some errors occurred at multiple stages (17.9%). Systemic antibacterials (12.2%), analgesics (11.8%) and renin-angiotensin medicines (11.7%) formed the majority of implicated classes. Participants identified diverse and interrelating contributing factors: those concerning healthcare providers included violations to procedures/guidelines (75.6%), rule-based mistakes (55.6%) and communication (50.6%); those concerning patients included cognitive factors (31.9%), communication (25.5%) and behaviour (6.1%). Organisational safety culture and inadequate risk management processes were rated as suboptimal. CONCLUSION: An MI reporting programme can capture and characterise medication safety problems in the community and identify the human and system factors that contribute to errors. Since medicine use is ubiquitous in the community, morbidity and mortality from MIs may be reduced by addressing the prioritised risks and contributing factors identified in this study.

Medication incident recovery and prevention utilising an Australian community pharmacy incident reporting system: the QUMwatch study.

PURPOSE: To identify factors in community pharmacy that facilitate error recovery from medication incidents (MIs) and explore medication safety prevention strategies from the pharmacist perspective. METHODS: Thirty community pharmacies in Sydney, Australia, participated in a 30-month prospective incident reporting program of MIs classified in the Advanced Incident Management System (AIMS) and the analysis triangulated with case studies. The main outcome measures were the relative frequencies and patterns in MI detection, minimisation, restorative actions and prevention recommendations of community pharmacists. RESULTS: Participants reported 1013 incidents with 831 recovered near misses and 165 purported patient harm. MIs were mainly initiated at the prescribing (68.2%) and dispensing (22.6%) stages, and most were resolved at the pharmacy (76.9%). Detection was efficient within the first 24 h in 54.6% of MIs, but 26.1% required one month or longer; 37.2% occurred after the patient consumed the medicine. The combination of specific actions/attributes (85.5%), appropriate interventions (81.6%) and effective communication (77.7%) minimised MIs. An array of remedial actions were conducted by participants including notification, referral, advice, modification of medication regimen, risk management and documentation corrections. Recommended prevention strategies involved espousal of medication safety culture (97.8%), better application of policies/procedures (84.6%) and improvements in healthcare providers' education (79.9%). CONCLUSION: Incident reporting provided insights on the human and organisational factors involved in the recovery of MIs in community pharmacy. Optimising existing safeguards and redesigning certain structures and processes may enhance the resilience of the medication use system in primary care.

Evaluating the Effectiveness of an Educational Intervention to Improve the Patient Safety Attitudes of Intern Pharmacists.

Objective. To evaluate the effectiveness of a face-to-face educational intervention in improving the patient safety attitudes of intern pharmacists. Methods. A patient safety education program was delivered to intern pharmacists undertaking The University of Sydney Intern Training Program in 2014. Their patient safety attitudes were evaluated immediately prior to, immediately after, and three-months post-intervention. Underlying attitudinal factors were identified using exploratory factor analysis. Changes in factor scores were examined using analysis of variance. Results. Of the 120 interns enrolled, 95 (78.7%) completed all three surveys. Four underlying attitudinal factors were identified: attitudes towards addressing errors, questioning behaviors, blaming individuals, and reporting errors. Improvements in all attitudinal factors were evident immediately after the intervention. However, only improvements in attitudes towards blaming individuals involved in errors were sustained at three months post-intervention. Conclusion. The educational intervention was associated with short-term improvements in pharmacist interns' patient safety attitudes. However, other factors likely influenced their attitudes in the longer term.

Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003-2012.

STUDY OBJECTIVES: Stimulated reporting occurs when patients and healthcare professionals are influenced or "stimulated" by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006-2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored. METHODS: Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012. RESULTS: Odds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster. CONCLUSIONS: Although our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies.

Evaluation of a survey tool to measure safety climate in Australian hospital pharmacy staff.

BACKGROUND: Safety climate evaluation is increasingly used by hospitals as part of quality improvement initiatives. Consequently, it is necessary to have validated tools to measure changes. OBJECTIVE: To evaluate the construct validity and internal consistency of a survey tool to measure Australian hospital pharmacy patient safety climate. METHODS: A 42 item cross-sectional survey was used to evaluate the patient safety climate of 607 Australian hospital pharmacy staff. Survey responses were initially mapped to the factor structure previously identified in European community pharmacy. However, as the data did not adequately fit the community pharmacy model, participants were randomly split into two groups with exploratory factor analysis performed on the first group (n = 302) and confirmatory factor analyses performed on the second group (n = 305). RESULTS: Following exploratory factor analysis (59.3% variance explained) and confirmatory factor analysis, a 6-factor model containing 28 items was obtained with satisfactory model fit (χ2 (335) = 664.61 p < 0.001, RMSEA = 0.06, CFI = 0.93, TLI = 0.92), internal reliability (α > 0.643) and model nesting between the groups (Δχ2 (22) = 30.87, p = 0.10). Three factors (blame culture, organisational learning and working conditions) were similar to those identified in European community pharmacy and labelled identically. Three additional factors (preoccupation with improvement; comfort to question authority; and safety issues being swept under the carpet) highlight hierarchical issues present in hospital settings. CONCLUSIONS: This study has demonstrated the validity of a survey to evaluate patient safety climate of Australian hospital pharmacy staff. Importantly, this validated factor structure may be used to evaluate changes in safety climate over time.

Exploring the link between organizational climate and the use of psychotropic medicines in nursing homes: A qualitative study.

BACKGROUND: Research concerning the overprescribing of psychotropic medicines in nursing homes suggests that organizational climate plays a significant role in the use of psychotropic medicines. Organizational climate refers to how members of the organization perceive their work environment as well as interactions with each other or outsiders. OBJECTIVES: This study aimed to explore the key dimensions of organizational climate and their subsequent influence on the use of psychotropic medicines. METHODS: Semi-structured interviews were conducted with 40 on-site and visiting staff from eight nursing homes in Sydney, Australia. Purposive sampling was used to recruit participants representing a broad range of health disciplines and roles. Transcripts were content coded for participants' perceptions related to the work environment and descriptions of psychotropic medicines use. Thematic analysis was used to derive key concepts. RESULTS: Three salient dimensions of organizational climate were linked to the use of psychotropic medicines in nursing homes: staffing, managerial expectations and teamwork among visiting and on-site staff. Inadequate staffing levels were perceived to influence on-site staff requests for initiation of psychotropic medicines to cope with high workload. Participants reported managers that prioritized the non-pharmacological management of behavioral disturbances led other on-site staff to have a reduced preference for psychotropic medicines. In addition, trust and open communication among on-site and visiting staff facilitated the cessation of psychotropic medicines. CONCLUSION: This study illustrates that organizational climate is an important factor influencing the use of psychotropic medicines. Furthermore, the study highlights what aspects of organizational climate need to be addressed to reduce the inappropriate prescribing of psychotropic medicines.

Enhancing generational change in patient safety attitudes through peer leadership.

Background: Despite peer-led teaching demonstrating benefits in patient safety education, few studies have evaluated these programmes from the perspective of peer leaders. Objective: To evaluate the impact of peer leader participation in a patient safety education workshop in improving their patient safety attitudes. Participants: 34 final year pharmacy student peer leaders. Methods: An interactive peer-led patient safety workshop was delivered to 249 first year pharmacy students. Peer leaders' attitudes were assessed 2 months prior to and immediately after peer leader training; and immediately after and 1 month following the workshop. Using a validated patient safety attitudinal survey, repeated measures analysis of variance and pairwise comparisons were used to evaluate changes in four key attitudes over time: being quality improvement focused; internalising errors; questioning more senior healthcare professionals' behaviours; and attitudes towards the open disclosure of errors. Results: Compared to baseline, peer leaders' attitudes towards open disclosure significantly improved immediately following the workshop (p=0.010) and were sustained after 1 month (p=0.028). Attitudes towards being quality improvement focused also improved significantly 1 month after the workshop (p=0.003). Conclusions: Participation in a peer-led patient safety education programme benefits both students and peer leaders, enabling further mastery of concepts and enhancing generational change in patient safety practices.

Evaluating the effectiveness of a peer-led education intervention to improve the patient safety attitudes of junior pharmacy students: a cross-sectional study using a latent growth curve modelling approach.

OBJECTIVE: Despite the recognition that educating healthcare students in patient safety is essential, changing already full curricula can be challenging. Furthermore, institutions may lack the capacity and capability to deliver patient safety education, particularly from the start of professional practice studies. Using senior students as peer educators to deliver practice-based education can potentially overcome some of the contextual barriers in training junior students. Therefore, this study aimed to evaluate the effectiveness of a peer-led patient safety education programme for junior pharmacy students. DESIGN: A repeat cross-sectional design utilising a previously validated patient safety attitudinal survey was used to evaluate attitudes prior to, immediately after and 1 month after the delivery of a patient safety education programme. Latent growth curve (LGC) modelling was used to evaluate the change in attitudes of first-year students using second-year students as a comparator group. SETTING: Undergraduate university students in Sydney, Australia. PARTICIPANTS: 175 first-year and 140 second-year students enrolled in the Bachelor of Pharmacy programme at the University of Sydney. INTERVENTION: An introductory patient safety programme was implemented into the first-year Bachelor of Pharmacy curriculum at the University of Sydney. The programme covered introductory patient safety topics including teamwork, communication skills, systems thinking and open disclosure. The programme consisted of 2 lectures, delivered by a senior academic, and a workshop delivered by trained final-year pharmacy students. RESULTS: A full LGC model was constructed including the intervention as a non-time-dependent predictor of change (χ(2) (51)=164.070, root mean square error of approximation=0.084, comparative fit index=0.913, standardised root mean square=0.056). First-year students' attitudes significantly improved as a result of the intervention, particularly in relation to internalising errors (p=0.010), questioning behaviours (p<0.001) and open disclosure (p=0.008). CONCLUSIONS: Peer-led education is an effective method that can be adopted to improve junior pharmacy students' attitudes towards patient safety.

Validation of a survey tool to assess the patient safety attitudes of pharmacy students.

OBJECTIVE: Patient safety education is a key strategy to minimise harm, and is increasingly being introduced into junior pharmacy curricula. However, currently there is no valid and reliable survey tool to measure the patient safety attitudes of pharmacy students. This study aimed to validate a modified survey tool, originally developed by Madigosky et al, to evaluate patient safety attitudes of junior pharmacy students. DESIGN: A 23-item cross-sectional patient safety survey tool was utilised to evaluate first and second year pharmacy students' attitudes during May 2013 with both exploratory and confirmatory factor analyses performed to understand the psychometric properties of the survey tool and to establish construct validity. SETTING: Undergraduate university students in Sydney, Australia PARTICIPANTS: 245 first year and 201 second year students enrolled in the Bachelor of Pharmacy Programme at The University of Sydney, Australia in May 2013. RESULTS: After exploratory factor analysis on first year student responses (55.76% variance explained) and confirmatory factor analysis on second year responses, a 5-factor model consisting of 14 items was obtained with satisfactory model fit (χ(2) (66)=112.83, p<0.001, RMSEA=0.06, CFI=0.91) and nesting between year groups (Δχ(2)(7)=3.079, p=0.878). The five factors measured students' attitudes towards: (1) being quality improvement focused, (2) internalising errors regardless of harm, (3) value of contextual learning, (4) acceptability of questioning more senior healthcare professionals' behaviour and (5) attitude towards open disclosure. CONCLUSIONS: This study has established the reliability and validity of a modified survey tool to evaluate patient safety attitudes of pharmacy students, with the potential for use in course development and evaluation.

Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants.

PURPOSE: The US Food and Drug Administration Adverse Event Reporting System (FAERS), one of the world's largest spontaneous reporting systems, is difficult to use because of report duplication and a lack of standardisation in the recording of drug names. Unresolved data quality issues may distort statistical analyses, rendering the results difficult to interpret when detecting and monitoring adverse effects of pharmaceutical products. The aim of this study was to develop and implement a data cleaning protocol to identify and resolve drug nomenclature issues. The key 'data treatment' plan involved standardising drug names held in the FAERS database. METHODS: Four million five hundred and six thousand five hundred and seventy-seven. Individual Safety Reports submitted to the FAERS between 1 January 2003 and 31 August 2012 were included for this study. OpenRefine was used to standardise drug name variants in the database such that they were consistent with international non-proprietary nomenclature defined by the World Health Organisation Anatomical Therapeutic Chemical classification. Drug variants where generic constituents could not be confidently determined, undecipherable drug names and non-medicinal products were retained verbatim. RESULTS: After the standardisation process, more than 16 611 916 drug entries were cleaned to their relevant international non-proprietary name. The cleaned drug table comprised 71 858 drug name variants and includes both standardised and original terms. Ninety-nine per cent of drug names was standardised using this method. CONCLUSIONS: The millions of reports enclosed in the FAERS contain valuable information that is of interest to pharmacovigilance, toxicology and post-marketing surveillance researchers. With the standardisation of the drug nomenclature, the database can be better utilised by research groups around the world.

An exploration of Australian hospital pharmacists' attitudes to patient safety.

OBJECTIVES: To explore the attitudes of Australian hospital pharmacists towards patient safety in their work settings. METHODS: A safety climate questionnaire was administered to all 2347 active members of the Society of Hospital Pharmacists of Australia in 2010. Part of the survey elicited free-text comments about patient safety, error and incident reporting. The comments were subjected to thematic analysis to determine the attitudes held by respondents in relation to patient safety and its quality management in their work settings. KEY FINDINGS: Two hundred and ten (210) of 643 survey respondents provided comments on safety and quality issues related to their work settings. The responses contained a number of dominant themes including issues of workforce and working conditions, incident reporting systems, the response when errors occur, the presence or absence of a blame culture, hospital management support for safety initiatives, openness about errors and the value of teamwork. A number of pharmacists described the development of a mature patient-safety culture - one that is open about reporting errors and active in reducing their occurrence. Others described work settings in which a culture of blame persists, stifling error reporting and ultimately compromising patient safety. CONCLUSION: Australian hospital pharmacists hold a variety of attitudes that reflect diverse workplace cultures towards patient safety, error and incident reporting. This study has provided an insight into these attitudes and the actions that are needed to improve the patient-safety culture within Australian hospital pharmacy work settings.

Primary health care practitioner perspectives on the management of insomnia: a pilot study.

This paper reports a qualitative pilot study exploring primary care health practitioners' perspectives on the management of insomnia following the extensive media coverage on the adverse effects of zolpidem in 2007-08. General practitioners and community pharmacists were recruited throughout metropolitan Sydney, New South Wales using a convenience sampling and snowballing technique. Demographic information was collected from each participant followed by a semistructured interview. In total 22 participants were interviewed, including eight general practitioners and 14 community pharmacists. Interview transcripts were analysed using 'framework analysis'. Participants' responses illuminated some of the key issues facing primary care practitioners in the management of insomnia. Practitioners perceived there to be an overreliance on pharmacotherapy among insomnia patients and inadequate support for directing patients to alternative treatment pathways if they require or prefer non-pharmacological management. Current prescribing trends appear to favour older benzodiazepines in new cases of insomnia whereas some successful sporadic users of zolpidem have continued to use zolpidem after the media coverage in 2007-08. The findings of this pilot study suggest the need to address the limitations in the management of insomnia within the current health care system, to revise and disseminate updated insomnia guidelines and to provide educational opportunities and resources to primary care practitioners concerning management options.

Spontaneous adverse event reports associated with zolpidem in Australia 2001-2008.

A prominent media publicity cluster during 2007-2008 in Australia linked the common hypnotic zolpidem to adverse drug reaction reports of parasomnias, amnesia, hallucinations and suicidality. The collection of adverse drug reaction data through spontaneous reporting systems is a mainstay of drug safety monitoring, but a stimulated reporting event such as this often renders such data uninterpretable. As such, we aimed to investigate whether these associations were present before the media cluster and then to quantify the effect of stimulated reporting on those four specific outcomes. Using disproportionality analyses we compared zolpidem to all other drugs in the database, and then separately to each of all hypnotics, then all benzodiazepines, and then temazepam alone, and did so in every year from 2001 to 2008. Year-by-year analyses of Reporting odds ratios for zolpidem exposure and adverse events of interest, adjusted for a number of covariates, revealed an association between zolpidem exposure and parasomnias, amnesia and hallucination both before and after the cluster of media publicity beginning in early 2007. The odds ratios increased significantly after the media publicity for only parasomnias and amnesia. Suicidality was increased in some analyses, but limited data make this outcome difficult to interpret. We conclude that zolpidem adverse drug reaction reports have higher odds for parasomnia, amnesia, hallucination and perhaps suicidality compared to either all other drugs or hypnotics, even before the media publicity cluster. However, the extant literature and the limitations of these spontaneously reported adverse drug reaction data do not allow us to conclude that these events are related causally to zolpidem.

Anticholinergic activity of commonly prescribed medications and neuropsychiatric adverse events in older people.

This study sought to determine whether the presence of in vitro anticholinergic activity (AA) among different drugs is associated with reporting of neuropsychiatric adverse events (NPAEs) and whether age affects this relationship. Retrospective case/noncase analyses using Australia's spontaneous Adverse Drug Reaction System (ADRS) database containing 150 475 reports determined crude and adjusted reporting odds ratios (RORs) for NPAEs for 23 drugs with various reported in vitro AA. Covariates were age (treated as a dichotomous variable [> or =65 years]), gender, and concomitant use of antipsychotics, benzodiazepines, tricyclic antidepressants, and drugs with recognized inherent anticholinergic properties (anticholinergic drugs). The interaction effect between these covariates and each drug exposure category was examined. Age (> or =65 years) has a significant association with greater odds relative to younger age for reporting NPAEs. Drugs with reported significant AA in vitro were not always associated with RORs greater than 1 for reporting NPAEs, highlighting a dissonance between the in vitro AA index and ADRS observations. Significant interactions were observed between age (> or =65 years) and exposure to cimetidine, anticholinergic drugs, antipsychotics, and tricyclic antidepressants in modifying odds for reporting NPAEs, reinforcing the need for cautious use and monitoring of drugs with AA in older people.

Compounded medicines and 'off label' prescribing - a case for more guidance.

BACKGROUND: Interest by prescribers and pharmacists in the provision of individualised pharmaceutical therapy in the form of compounded medicines has grown in recent times. However, there have also been a number of case reports of patient harm associated with these medicines. OBJECTIVE: To highlight areas for clinicians and pharmacists to consider when prescribing or dispensing compounded medicines, which are consistent with quality use of medicines principles. DISCUSSION: Regulators of pharmaceutical products have expressed concerns with the production, marketing and use of compounded medicines dispensed by pharmacists. This has prompted debate over the need for more regulation of these products. We propose an expansion of off label prescribing guidelines to include a risk based assessment of pharmaceutical quality, a consumer information/education strategy and the development of a code of practice for pharmacists engaging in compounding. These strategies recognise a shared responsibility among prescribers, dispensers and regulators to achieve contemporary quality, safety, and efficacy standards and support the quality use of compounded medicines.