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.