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.

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.

Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding.

One post-marketing surveillance challenge for many regulatory authorities is access to information regarding the safety of over-the-counter (OTC) medicines. National spontaneous adverse drug reaction (ADR) report data represent a rich potential data source for the detection of safety signals associated with OTC medicines, yet little is known regarding the possibility of detecting safety signals for OTC medicines within these datasets. The aim of this study was to evaluate the potential for detecting safety signals for OTC medicines in National ADR spontaneous reporting data, using OTC non-steroidal anti-inflammatory drugs (NSAIDs) and gastrointestinal bleeding as an example.

Is it possible to apply trial outcomes to a real-world population? A novel approach to External Validity Analysis.

Background: Translation of findings from randomised controlled trials (RCT), the foundation of evidence-based medicine, into clinical practice requires an understanding of relationships between patient characteristics, treatment practices and outcomes. We propose a novel technique, External Validity Analysis (EVA), to evaluate applicability of findings from a large RCT, comparing baseline characteristics, interventions and outcomes between the RCT and a large clinical database.

Aim: To perform EVA of the findings of a randomised controlled trial (ESTHER-1) to a population in an Australian clinic setting.

Consumer opinions on adverse events associated with medicines and vaccines.

Introduction: Despite the availability of an Australian consumer adverse event (AE) reporting system for over 50 years, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding AEs is needed to further ascertain factors impacting their engagement in AE reporting.

Aim: The aim of this study was to explore consumer opinions about AEs potentially associated with medicines and vaccines, and their experiences and understanding of managing and reporting AEs.

Consumer opinions on adverse events associated with medical devices.

Introduction: Post-market surveillance of medical devices relies on compulsory and voluntary reports. Although direct consumer reporting of medical device-related adverse events (AEs) is available in Australia, the proportion of consumer reports has remained low. Limited qualitative research has previously explored consumer insights on AEs associated with medical devices and in particular, AE reporting.

Emotional intelligence and perceived stress of Australian pre-registration healthcare students: A multi-disciplinary cross-sectional study.

Background: Healthcare students can experience high levels of stress. Emotional intelligence can moderate stress and increase wellbeing however there has been no prior research on the relationship between emotional intelligence and stress in Australian healthcare students.

Objectives: To measure emotional intelligence (EI) and perceived stress (PS) in final year healthcare students (nursing, pharmacy and dentistry), and to explore the relationships between EI, PS and discipline.

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

To evaluate the effectiveness of a face-to-face educational intervention in improving the patient safety attitudes of intern pharmacists. 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.

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.

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.

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.

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.

A qualitative study exploring visible components of organizational culture: what influences the use of psychotropic medicines in nursing homes?

Background: The influence of organizational culture on how psychotropic medicines are used in nursing homes has not been extensively studied. Schein's theory provides a framework for examining organizational culture which begins with the exploration of visible components of an organization such as behaviors, structures, and processes. This study aimed to identify key visible components related to the use of psychotropic medicines in nursing homes.

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.

Relationships Between Pharmacovigilance, Molecular, Structural, and Pathway Data: Revealing Mechanisms for Immune-Mediated Drug-Induced Liver Injury.

Immune-mediated drug-induced liver injury (IMDILI) can be devastating, irreversible, and fatal in the absence of successful transplantation surgery. We present a novel approach that combines the methods of pharmacoepidemiology with in silico molecular modeling to identify specific features in toxic ligands that are associated with clinical features of IMDILI. Specifically, from pharmacovigilance data multivariate logistic regression identified 18 drugs associated with IMDILI (P < 0.

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.

Course experiences, satisfaction and career intent of final year pre-registration Australian pharmacy students.

Background: In Australia, the profession of pharmacy has undergone many changes to adapt to the needs of the community. In recent years, concerns have been raised with evidence emerging of workforce saturation in traditional pharmacy practice sectors. It is not known how current final year pharmacy students' perceive the different pharmacy career paths in this changing environment.

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.

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.

Factors influencing pharmacy services in opioid substitution treatment.

Introduction And Aim: Heroin dependence is a serious health burden in Australia. Opioid substitution treatment (OST) has been delivered in Australian community pharmacies since 1985. The effectiveness of pharmacy-based OST is evident and the demand is increasing; however, the participation rate of community pharmacies is low, with over 60% non-providers.

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).

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.

[Transfer of a very low birth weight newborn infant to the intensive therapy center at birth. Transfer "in utero" or after delivery?].

During the 1975-1984 period, 93 infants weighing 1500 g or less were transferred to the Magenta Perinatal Center Hospital. The survival rate at discharge was 82.9% for infants transferred in utero and 63.