Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomised controlled, superiority trial.

BACKGROUND: Two billion peripheral intravenous catheters (PIVCs) are used globally each year, but optimal dressing and securement methods are not well established. We aimed to compare the efficacy and costs of three alternative approaches to standard non-bordered polyurethane dressings. METHODS: We did a pragmatic, randomised controlled, parallel-group superiority trial at two hospitals in Queensland, Australia. Eligible patients were aged 18 years or older and required PIVC insertion for clinical treatment, which was expected to be required for longer than 24 h. Patients were randomly assigned (1:1:1:1) via a centralised web-based randomisation service using random block sizes, stratified by hospital, to receive tissue adhesive with polyurethane dressing, bordered polyurethane dressing, a securement device with polyurethane dressing, or polyurethane dressing (control). Randomisation was concealed before allocation. Patients, clinicians, and research staff were not masked because of the nature of the intervention, but infections were adjudicated by a physician who was masked to treatment allocation. The primary outcome was all-cause PIVC failure (as a composite of complete dislodgement, occlusion, phlebitis, and infection [primary bloodstream infection or local infection]). Analysis was by modified intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000769987. FINDINGS: Between March 18, 2013, and Sept 9, 2014, we randomly assigned 1807 patients to receive tissue adhesive with polyurethane (n=446), bordered polyurethane (n=454), securement device with polyurethane (n=453), or polyurethane (n=454); 1697 patients comprised the modified intention-to-treat population. 163 (38%) of 427 patients in the tissue adhesive with polyurethane group (absolute risk difference -4·5% [95% CI -11·1 to 2·1%], p=0·19), 169 (40%) of 423 of patients in the bordered polyurethane group (-2·7% [-9·3 to 3·9%] p=0·44), 176 (41%) of 425 patients in the securement device with poplyurethane group (-1·2% [-7·9% to 5·4%], p=0·73), and 180 (43%) of 422 patients in the polyurethane group had PIVC failure. 17 patients in the tissue adhesive with polyurethane group, two patients in the bordered polyurethane group, eight patients in the securement device with polyurethane group, and seven patients in the polyurethane group had skin adverse events. Total costs of the trial interventions did not differ significantly between groups. INTERPRETATION: Current dressing and securement methods are commonly associated with PIVC failure and poor durability, with simultaneous use of multiple products commonly required. Cost is currently the main factor that determines product choice. Innovations to achieve effective, durable dressings and securements, and randomised controlled trials assessing their effectiveness are urgently needed. FUNDING: Australian National Health and Medical Research Council.

'You don't throw these things out:' an exploration of medicines retention and disposal practices in Australian homes.

BACKGROUND: Consumers most commonly discard unwanted medicines in household rubbish or drains, however, there are global concerns over the extent, environmental impact and health risks. When consumers procure or store medicines for future use, this can impact negatively on quality use of medicines and consumer safety. We sought greater insight into the extent of these practices by exploring the volume and types of medicines in Australian homes, and self-reported practices related to medicine accumulation, use and disposal. This qualitative study formed part of a larger project that included a general population survey on household medicine disposal practices. METHODS: Semi-structured telephone interviews were undertaken with a subset of respondents (n = 166) from the survey. Participants were eligible if they were experienced medicine users, i.e. used five or more prescribed, over the counter, and/or complementary and alternative medicines. Participants were asked to collect and name all medicines in their household; further detail was obtained about medicines used only when required or no longer used, such as expiry dates and quantity remaining. The quantitative data on the number and type of medicines stored at home were analysed descriptively. All interviews were transcribed verbatim and thematically analysed. RESULTS: A total of 2301 medicines were identified as 1424 medicines not in everyday use (unused, unwanted, expired or when required) in 166 households, and 877 regularly used medicines by 119 participants. Medicines were often stored in multiple locations, particularly kitchens. Although accidental ingestion in children and pets and decreased efficacy were recognised health risks, this did not always translate to appropriate storage, usage or disposal practices. Individual risk-benefit assessments were applied to decisions to retain, use or dispose of medicines, including expired medicines. CONCLUSIONS: Inappropriate medicine storage, use, and/or disposal practices raises public health concerns, particularly as there is a free returned medicines scheme available, and that this particular participant group were considered experienced medicine users. Healthcare professionals must act to address consumer misconceptions around the quality use of medicines, including medicine retention, storage and disposal. Future research is warranted to explore consumer practices in this context and confirm these findings in a younger, or healthier population.

PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE RECOMMENDATIONS IN AUSTRALIA.

OBJECTIVES: The aim of this study was to examine submissions made to the Pharmaceutical Benefits Advisory Committee (PBAC) and assess whether the predicted financial impact was associated with a recommendation. The second objective was to assess whether the financial and utilization estimates for listing the proposed medicine were reliable. METHODS: Data were extracted from public summary documents of major submissions considered by the PBAC from 2012 to 2014. Information collected included whether submissions were accepted, rejected, or deferred; estimated use; and financial impact. For those submissions that were recommended in 2012 and listed on the Pharmaceutical Benefits Scheme (PBS) by January 2014, a comparison was made between predicted and actual use and cost in 2014, based on PBS utilization. RESULTS: In 2012 to 2014, the PBAC considered 142 unique major submissions; of those, 65 were recommended for listing. A higher financial cost to the government was a statistically significant factor in predicting rejection (p = .004 for cost > AUD 30 million Australian dollars [20.7 million Euros] compared with cost-saving). Of the submissions that were recommended in 2012 and listed by 2014, the actual use was higher than predicted for 5/19 medications. The estimated cost was outside the predicted bracket of cost for 10/19 medications, with 8/19 medications having threefold underestimated expenditure, and 2/19 items having lower than predicted expenditure. CONCLUSIONS: This study highlights that the predicted financial impact of a medication to the PBS budget is associated with a PBAC recommendation and also highlights that predicted use may not reflect actual prescribing practices.

Does policy change to allow pharmacist provision of influenza vaccination increase population uptake? A systematic review.

Objective The aims of this study were to estimate the effect of pharmacists' vaccinating for influenza on overall vaccination rates and to assess whether any effect differs for at-risk subgroups compared with the general population. Methods A systematic review was undertaken, adhering to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Databases were searched during July 2019 and included Medline (Ovid), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus and the Cochrane Library. Results The largest difference reported in overall population vaccination rates associated with pharmacists undertaking influenza vaccinations was an increase of 10%; the smallest showed no discernible effect. The effect was graduated: pharmacists with the most autonomy demonstrated the largest rate increases. There was evidence of substitution by pharmacists, but the effect size was small. Conclusions The effect of allowing pharmacists to administer influenza vaccinations appears positive, but small. Given that pharmacists are likely to provide vaccinations at a lower cost than doctors, there may be cost-savings to the health system and consumers. Future research may include evaluating pharmacist-provided vaccinations compared with (or in combination with) other strategies, such as advertising, to increase access and uptake across the range of providers, as well as ongoing research to address vaccine hesitancy. What is known about the topic? In Australia, and many other countries, community pharmacies provide an alternative and accessible option for influenza vaccination; however the effect on overall vaccination rates remains unclear. What does this paper add? This systematic review of the international literature suggests that pharmacist-provided vaccinations increase uptake; substitution of doctors by pharmacists may result in cost savings. What are the implications for practitioners? The findings of this study are important for health policy makers and health workforce researchers aiming to maximise population vaccination rates and workforce efficiency. In the absence of available Australian data, data from the international experience of legislating pharmacists to vaccinate against influenza are summarised and critiqued. Results can be used when determining the best health workforce and policy mix with regard to the vaccination workforce.

When is a medicine unwanted, how is it disposed, and how might safe disposal be promoted? Insights from the Australian population.

Objective The aim of the present study was to explore disposal practices of unwanted medicines in a representative sample of Australian adults, compare this with previous household waste surveys and explore awareness of the National Return and Disposal of Unwanted Medicines (RUM) Project. Methods A 10-min online survey was developed, piloted and conducted with an existing research panel of adult individuals. Survey questions recorded demographics, the presence of unwanted medicines in the home, medicine disposal practices and concerns about unwanted medicines. Descriptive statistical analyses and rank-ordered logit regression were conducted. Results Sixty per cent of 4302 respondents reported having unwanted medicines in their household. Medicines were primarily kept just in case they were needed again and one-third of these medicines were expired. Two-thirds of respondents disposed of medicines with the household garbage and approximately one-quarter poured medicines down the drain. Only 17.6% of respondents had heard of the RUM Project, although, once informed, 91.7% stated that they would use it. Respondents ranked the risk of unintended ingestion as the most important public health message for future social marketing campaigns. Conclusions Respondents were largely unaware of the RUM Project, yet were willing to use it once informed. Limited awareness could lead to environmental or public health risks, and targeted information campaigns are needed. What is known about the topic? There is a growing international evidence base on how people dispose of unwanted medicines and the negative consequences, particularly the environmental effects of inappropriate disposal. Although insight into variation in disposal methods is increasing, knowledge of how people perceive risks and awareness of inappropriate disposal methods is more limited. What does this paper add? This study provides evidence of inappropriate medicines disposal and potential stockpiling of medicines in Australian households that could contribute to environmental and/or public health risks. It also reveals possible trends towards a higher frequency of inappropriate disposal practices in the Australian context. Insights into respondents' perceptions of associated risks and awareness of a national scheme for appropriate disposal of medicines have not previously been reported. What are the implications for practitioners? The findings of the present study provide important insights for all health professionals as stakeholders in the quality use of medicines. It is important for those health professionals who assist consumers to manage their medicines to have strategies in place that routinely identify potential stockpiling and inform consumers about appropriate methods of medicines disposal. Although the findings of this study are specific to the Australian context, they may usefully inform policy, public health campaigns and the individual practices of health professionals and other stakeholders in promoting the quality use of medicines nationally and internationally.

Evaluation of the National Return of unwanted medicines (RUM) program in Australia: a study protocol.

BACKGROUND: The National Return of Unwanted Medicines (NatRUM) program in Australia is one of the few nationally coordinated, free-to-consumer schemes to dispose of unwanted medicines globally. This scheme has been in operation since 1996, however, little is known about public awareness of the scheme and its effectiveness in reducing unsafe disposal practices. The study objectives are to undertake a review of (1) the current use of the NatRUM scheme by consumers; and (11) to investigate disposal practices and beliefs of the general population. METHODS/DESIGN: A two-stage, mixed-methods study will be undertaken. Stage One will include a nation-wide audit of a representative sample of unwanted medicine bins, collected by community pharmacies, for incineration. The audit will detail the type and amount of unwanted medicines collected and if they are subsidised on the national formulary (Pharmaceutical Benefits Scheme). Stage Two will include: (i) a large, representative, general population survey; and (ii) more detailed interviews with a sub-set of this sample, who take five or more medications. Results will quantitatively describe the awareness of the NatRUM scheme, disposal practices and the volume of unwanted medicines stored in the home. It will qualitatively describe beliefs and perceptions about storage and disposal practices. DISCUSSION: It is anticipated that this study will provide valuable insights about how Australians dispose of unwanted medicines, their awareness of the NatRUM scheme and how the scheme might be strengthened. Results will inform the Federal Department of Health and NatRUM Ltd. Board at a local level, as well as other countries who are yet to develop or implement coordinated disposal schemes. A number of challenges are expected, including ensuring the consistency of medicines terminology during the bin audit and recruiting a representative sample of Australians for the general population survey. Results of this study will be widely disseminated to support the translation of findings into practice.

Triple therapy in type 2 diabetes; a systematic review and network meta-analysis.

Aims. The purpose was to evaluate the evidence for triple therapy regimen using medicines available in Australia for type 2 diabetes. Methods. A systematic literature review was performed to update the relevant evidence from 2002 to 2014 on triple therapy for type 2 diabetes. A multiple-treatments network meta-analysis was undertaken to summarise the comparative efficacy and harms of different triple therapies. Results. Twenty seven trials were identified, most were six months of duration. The following combinations were included in the network meta-analysis: metformin (MET) + sulfonylureas (SU) (used as reference combination); MET + SU+ dipeptidyl peptidase 4 inhibitors (DPP-4-i); MET + SU+ thiazolidinediones (TZD); MET + SU+ glucagon-like peptide-1 receptor agonists (GLP-1-RA); MET + SU+ insulins; MET + TZD + DPP-4-i; and MET + SU+ sodium/glucose cotransporter 2 inhibitors (SGLT2-i). For HbA1c reduction, all triple therapies were statistically superior to MET+SU dual therapy, except for MET + TZD + DPP-4-i. None of the triple therapy combinations demonstrated differences in HbA1c compared with other triple therapies. MET + SU + SGLT2-i and MET + SU + GLP-1-RA resulted in significantly lower body weight than MET + SU + DPP-4-i, MET+SU+insulin and MET + SU + TZDs; MET + SU + DPP-4-i resulted in significantly lower body weight than MET + SU + insulin and MET + SU + TZD. MET + SU + insulin, MET + SU + TZD and MET + SU + DPP-4-i increased the odds of hypoglycaemia when compared to MET + SU. MET + SU + GLP-1-RA reduced the odds of hypoglycaemia compared to MET + SU + insulin. Conclusion. Care when choosing a triple therapy combination is needed as there is often a risk of increased hypoglycaemia events associated with this regimen and there are very limited data surrounding the long-term effectiveness and safety of combined therapies.