ORCID Profile
0000-0002-6639-7210
Current Organisations
Monash University
,
Alfred Health
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Publisher: Wiley
Date: 27-07-2018
DOI: 10.1002/PDS.4587
Publisher: Wiley
Date: 04-2020
DOI: 10.1002/JPPR.1652
Publisher: Springer Science and Business Media LLC
Date: 16-02-2022
DOI: 10.1007/S00228-022-03287-1
Abstract: Adverse drug reactions (ADRs) contribute significantly to healthcare burden. However, they are largely preventable through appropriate management processes. This narrative review aims to identify the quality indicators that should be considered for routine monitoring of processes within hospital ADR management systems. It also examines the potential reasons behind variation in ADR management practices amongst HCPs, and explores possible solutions, focusing on targeted education programmes, to improve both the quality and quantity indicators of ADR management processes. A comprehensive literature review was conducted to explore relevant themes and topics concerning ADR management, quality indicators and educational interventions. Substantial variability exists in ADR management amongst healthcare professionals (HCPs) with regard to reporting rates, characteristics of ADRs reported, quality of assessment, completeness of reports and, most importantly, risk communication practices. These variable practices not only threaten patient safety but also undermine pharmacovigilance processes. To date, quality indicators to monitor ADR management practices within hospital settings remain ill-defined. Furthermore, evidence behind effective interventions, especially in the form of targeted education strategies, to improve the quality of ADR management remains limited. The focus of ADR management in hospitals should be to promote patient safety through comprehensive assessment, risk communication and safe prescribing. There is a need to develop a system to define, measure and monitor the quality of ADR management. Educational strategies may help improve the quality of ADR management processes.
Publisher: Wiley
Date: 03-06-2023
DOI: 10.1002/JPPR.1867
Abstract: The integrase‐inhibitor bictegravir combination antiretroviral therapy (ART) Biktarvy became available in Australia in October 2018. Neuropsychiatric adverse drug reactions (ADRs) are associated with bictegravir and may affect persistence and adherence to treatment. The aim of this study was to describe the type and frequency of reported neuropsychiatric reactions in people dispensed Biktarvy. Ethics approval was obtained from Alfred Hospital Ethics Committee (Project No. 541/20). Data were collected from records of people dispensed Biktarvy between October 2018 and May 2020 and who subsequently had a new neuropsychiatric reaction reported to the organisation's ADR Review Committee. Data were sourced from ADR reports, medical and dispensing records, and included demographics, medical history, and concurrent medicines with known psychiatric adverse reactions. Data were analysed descriptively. Biktarvy was dispensed to 1265 patients. Twenty‐two (1.7%, 95% confidence interval [CI] 1.0–2.5%) people reported 50 neuropsychiatric ADRs, including abnormal dreams ( n = 13), sleep disorders ( n = 5), and headaches ( n = 5). The median time from initiation to reaction was 13 (interquartile range [IQR] 4–94) days. Eighteen patients discontinued Biktarvy (1.4%, 95% CI 0.85–2.24). There was no statistically significant difference in discontinuation of Biktarvy between people who did or did not have a pre‐existing psychiatric diagnosis (p = 0.58). Concurrent medicines with known psychiatric adverse reactions were used by 10 people. A low rate of reported neuropsychiatric ADRs lead to discontinuation of Biktarvy, similar to rates in Biktarvy trials. This study adds to the post‐marketing surveillance data of Biktarvy tolerance amongst people living with human immunodeficiency virus (HIV).
Publisher: Wiley
Date: 24-05-2023
DOI: 10.1002/JPPR.1864
Abstract: Incidents involving mis‐selection and administration of neuromuscular blocking agents (NMBAs) leading to patient harm resulted in the initiation of activity in Victorian hospitals to review the management of this high‐risk group of medicines. Local risk mitigation strategies, such as in‐house labelling and restricting access, were considered partially effective, but it was recognised that a national approach was required. In 2015, hospital pharmacists — together with anaesthetist colleagues and peak patient safety organisations — made a submission to the Therapeutic Goods Administration (TGA) describing safety risks with NMBAs, with recommendations for improved NMBA labelling. This report describes the five‐year process which eventually led to the TGA mandating manufacturers to place alert labelling on NMBA products. As a result of this effort, a Victorian Therapeutics Advisory Group (VicTAG) grant enabled the development of a ‘NMBA Safer Practice Advisory Tool for Australian Hospitals’, providing a standard guide to monitor the safe use of NMBAs.
Publisher: Springer Science and Business Media LLC
Date: 20-02-2023
DOI: 10.1007/S00228-023-03457-9
Abstract: To develop a reliable assessment tool to monitor the quality of adverse drug reaction (ADR) reports and evaluate its performance within a quaternary hospital setting. Adverse drug reactions report QUality Algorithm (AQUA-12) was developed by a multidisciplinary team with the expertise in the management of ADRs. The design was based on data elements required to establish medication causality. Inter-rater reliability of AQUA-12 was evaluated over three rounds in two phases: development and prospective evaluation phases, by independent assessors both internal and external to the institutional ADR review processes. The characteristics and quality of ADR reports were subsequently assessed, and potential factors contributing to low-quality reports were identified. A total of 70 ADR reports were assessed, 20 in development and 50 in evaluation phases. The inter-rater reliability of AQUA-12 was found to be excellent in all three rounds (Cronbach’s alpha of ≥ 0.9, p 0.001 for all). Approximately one in five reports concerned immediate hypersensitivity reactions while delayed hypersensitivity reactions constituted 60% of all reactions. AQUA-12 identified 18 (25.7%) reports as ‘low-quality’ with a score of 10. Identification of suspected medications (37.1%), description of index ADR (27.1%), and key events (ADR narrative, 35.7%) were the top data elements incomplete or missing from all reports. Univariable analyses identified the severity of the reaction as a factor associated with low quality of reports ( p = 0.008). AQUA-12 is a practical and highly reliable assessment tool that can be utilised in hospital settings to regularly monitor the completeness of ADR reports to guide quality improvement initiatives.
Publisher: Wiley
Date: 05-2018
DOI: 10.1111/IMJ.13734
Publisher: Wiley
Date: 16-07-2021
DOI: 10.1002/JPPR.1716
Abstract: The first and most widely publicised pharmaceutical stewardship program has been for antimicrobials. Lack of care with antimicrobial management is a recognised risk to both patient and community safety. The core components of antimicrobial stewardship (AMS) can also be applied to other high‐risk medications, such as anticoagulants and analgesics. The authors discuss the implementation of anticoagulation and analgesic stewardship programs, based on the local AMS program principles, together forming the Antimicrobial, Anticoagulation, Analgesic (AAA) program. Amalgamated stewardship programs that focus on improving patient safety and optimising clinical outcomes beyond antimicrobials should be encouraged and adopted.
Publisher: Wiley
Date: 13-09-2023
DOI: 10.1111/MEDU.15215
Publisher: Elsevier BV
Date: 03-2020
DOI: 10.1016/J.SAPHARM.2019.05.011
Abstract: Medication reconciliation (medrec) is a mandated patient safety strategy by national, including Australian, accreditation bodies. Yet there are no validated performance measures. To determine the feasibility of implementing the World Health Organization (WHO) Medrec Standard Operating Protocol (SOP) in a range of Australian acute care facilities to achieve measurable and sustainable reductions in medication discrepancies occurring at admission. A multicentre, prospective national study was conducted in ten academic, urban and regional hospitals to implement the SOP using WHO High 5s project and quality improvement methodology. Sites collected data on the rate of medrec performed within 24 h of admission in a random selection of 50 patients aged ≥65 years admitted via the emergency department, monthly for four years. Medrec quality was reviewed in a subset of 30 patients using three performance measures. Barriers, enablers and benefits of SOP implementation were collected using qualitative surveys. Ten health services reviewed 42,003 patient records. Of these, 20,162 (49.5%) had medicines reconciled within 24 h of admission. Four services increased, two decreased, and in four, medrec completion rates remained static. Mean number of unintentional and undocumented intentional medication discrepancies per patient decreased: 0.21 to 0.16 (p = 0.001) and 0.34 to 0.08 (p = 0.003), respectively. Unintentional discrepancies decreased from 15.2% to 11.1% (p = 0.001). Barriers to full implementation included: medrec not seen as a priority, limited resources and lack of electronic systems integration. Enablers included: use of medrec measures for feedback, educational resources, and 7-day week clinical pharmacy services. Benefits included improvements in medication safety culture and multidisciplinary teamwork. The WHO SOP was feasible, although challenging, to implement in a range of acute health services, and produced measureable and sustainable improvements in medicines information accuracy on admission. Sustaining the quantum of quality and timely medrec requires investment in pharmacist resources and electronic systems integration.
No related grants have been discovered for Linda Graudins.