Journal of Pharmacy Practice and Research最新文献

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).

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.

In the United States, venous thromboembolisms (VTE) and acute coronary syndrome (ACS) are significant causes of morbidity and mortality. Anticoagulant medicines, such as heparin, are often indicated to stop or prevent clot formation, and early administration of heparin has been associated with reduced mortality. There is no literature evaluating whether administration of heparin is expedited when pharmacists are involved in patient care in the emergency department (ED). The purpose of this study was to determine whether the presence of an ED pharmacist decreased time to heparin administration for patients with VTE or ACS. This study was approved by the institutional review board at the Sisters of Charity of Leavenworth (SCL) Health Institutional Review Board (reference number: 2021-047). This retrospective cohort analysis evaluated patients who presented to the ED between 1 January 2019 and 30 May 2022 and received an order for unfractionated heparin with a confirmed diagnosis of VTE or ACS. The chi-square test and Wilcoxon ranked-sum test were used to detect differences between groups. A total of 65 patients were included in the analyses. Comparison of the median time between order and administration of heparin revealed that patients with an order placed while a pharmacist was present in the ED received heparin sooner than patients without an ED pharmacist present (32 min vs 50 min, p = 0.02). Time to administration of heparin was significantly shorter when a pharmacist was present in the ED at the time the order was placed by the care team. Findings suggest that the presence of an ED pharmacist expedites time to heparin administration.

Ensuring good storage practices (GSPs) of medicine outlets is important to maintain and ensure the safety, quality, and efficacy of dispensed medicines. The objective of this scoping review was to determine the most common GSP compliance issues within pharmacies and medicine outlets. PRISMA extension for scoping reviews guidelines were followed, and PubMed and Google Scholar were searched to identify the relevant primary literature from January 2016 and February 2022. All study designs in English were eligible for inclusion as long as they reported quantitative data for the fulfilment of individual GSP activities. Duplicate independent screening of the search results was undertaken. Quality assessment was performed on studies for final inclusion. Data extraction was performed by one reviewer, and the observed aggregate percentage compliance (% compliance), along with 95% confidence interval for the root GSP operation, was calculated. Of the 380 records identified, 15 articles were included. The studies were conducted in 10 countries and the majority were participatory research studies. Fire safety had the lowest aggregate % compliance (0.9%). Controlled substance, climate, light, ventilation and temperature and stock and bookkeeping operations all had overall aggregate % compliance levels below 50%. Despite evidence of basic controls and measures, we identified low compliance for many GSP operations. To ensure the integrity of medicines, it is important to increase the enforcement of security measures, invest resources in personnel training, account for informal vendor practices, and facilitate sharing global data publicly from external and governing body inspections and reviews of storage practices.

Vaccines are temperature-sensitive, and they may lose effectiveness without correct storage. Research in remote Australia raised questions regarding the integrity of the vaccine cold chain to Aboriginal communities and prompted the development of a video resource, Vaccine Story, to raise awareness of maintaining the cold chain. This study describes the development and evaluation of the Vaccine Story video. Local engagement helped to refine and produce the video. Ethics approval was gained from the Menzies School of Health Research Human Ethics Committee (20–3807) and the Central Australian Human Ethics Committee (17–2869) in 2020. The evaluation was considered low risk to all participants. An online anonymous survey tested the appropriateness and effectiveness of the Vaccine Story video to enhance knowledge and awareness of risks to the vaccine cold chain and the potential implementation of the Vaccine Story video. Diverse health professionals and other staff (n = 83) completed the survey. Responses highlighted a lack of training around the packing and transport of vaccines, particularly for non-clinical support staff. Respondents stated the health messaging in the Vaccine Story video was effective. Over half of respondents (52%) recommend the use of the video as a training tool. The Vaccine Story video addresses some concerns regarding vaccine transportation and storage in remote Aboriginal communities through strengthening understanding of the importance of cold chain.