Pharmacist-only supply of nicotine vaping products: proposing an alternative regulatory model for Australia.

Regulation of nicotine vaping products (NVPs) is an ongoing challenge across the world. Australia currently has a globally unique NVP regulatory model that requires a medical prescription to purchase and use NVPs, with further restrictions in progress in response to evidence of widespread illicit NVP sales. Against this background, we examine the new measures and consider a modification of the model to pharmacist-only supply as an option for increasing access to NVPs for smoking cessation, while retaining health practitioner oversight of supply. We describe the strengths and challenges of implementing a pharmacist-only NVP supply option in Australia. Compared with the current prescription-only model, pharmacist-only supply could increase access to a lower exposure nicotine product in a highly regulated therapeutic context while addressing youth access and purchasing for non-therapeutic use, reduce demand for illicit products for smoking cessation purposes and avoid overburdening medical services with consultations to obtain NVP prescriptions. This approach can also accommodate current government goals such as eliminating NVP advertising, youth-focused branding and supply from grocery and convenience stores.

Restricting supply of tobacco products to pharmacies: a scoping review.

OBJECTIVE: We synthesised the published literature on proposals to restrict tobacco supply to pharmacies, covering (1) policy concept/rationale/attempts, (2) policy impact and implementation and (3) policy and research recommendations. DATA SOURCES: We searched eight databases (PubMed, CINAHL, Scopus, Web of Science, Embase, IPA, ProQuest and OATD) for publications with at least an English-language abstract. We searched reference lists of included publications manually. STUDY SELECTION: One author screened all publications, and a second author reviewed a 10% subset. We focused on approaches to restrict the supply of tobacco products to pharmacies, without any restrictions on study design, location, participants or publication date. DATA EXTRACTION: Data extraction adhered to the JBI Scoping Review Methodology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. DATA SYNTHESIS: We included 18 publications. Among the 13 studies conducted in specific geographical contexts, 8 were from Aotearoa/New Zealand. Most publications (n=8) focused on effectiveness domains, indicating potential reductions in retailer density, smoking prevalence, disease burden, cost and increased opportunities for cessation advice. Seven explored policy acceptability among experts, pharmacists and people who smoke. Publications noted that pharmacy-only supply aligns with other programmes involving pharmacists, such as needle exchange programmes, but conflicts with efforts to phase out tobacco sales from the US and Canadian pharmacies. CONCLUSIONS: Progress in tobacco retailing policy (eg, licensing, retailer incentives) and research (eg, assessment of policy equity and durability, application in other geographical contexts) are needed before a pharmacy-only tobacco supply model would be feasible.

Medication Lubricants for Oral Delivery of Drugs: Oral Processing Reduces Thickness, Changes Characteristics, and Improves Dissolution Profile.

Swallowing oral solid dosage forms is challenging for those who have medication swallowing difficulties, including patients with dysphagia. One option is to mix the drug (whole or crushed) with a thick vehicle (medication lubricant). Previous in vitro studies consistently suggest that thick vehicles could impact the dissolution of solid dosage forms, potentially influencing their therapeutic effectiveness, but do not account for changes that happen during oral processing and swallowing. This study aims to investigate the potential impact of medication lubricants on drug release and examine the effect of oral processing. In vitro dissolution of whole and crushed paracetamol tablets mixed with five commercially available medication lubricants (two IDDSI level 2, two IDDSI level 3, and one IDDSI level 4) were tested with and without oral processing; a medication lubricant with/without paracetamol was placed in the mouth (five healthy volunteers), prepared for swallowing, but then expectorated and assessed for physical characteristics and drug release. Medication lubricants, both alone and mixed with crushed paracetamol tablets, showed a significant decrease in viscosity after oral processing. Without oral processing, IDDSI level 3 and 4 lubricants significantly delayed the dissolution of paracetamol tablets. After oral processing, particularly with crushed tablets, there was a substantial increase in the dissolution rate. These findings suggest that dissolution testing overestimates the impact of medication lubricants on drug dissolution. Therefore, using in vitro dissolution tests to predict the dissolution rate of medications mixed with thick vehicles is discouraged. It is essential to consider ways to incorporate the effects of the oral environment and oral processing on thick vehicles used for oral medication administration.

Evaluating the implementation of a prescription only regulatory model for nicotine vaping products: A qualitative study on the experiences and views of healthcare professionals.

BACKGROUND: Deciding how to regulate nicotine vaping products (NVPs) is a challenge for many countries. Balanced regulation should consider the potential harms to young people from uptake of NVPs alongside the possible benefits of NVPs as a smoking cessation aid. One option is to make NVPs only available via medical prescription to adults who smoke. From October 2021, Australia adopted a unique model that allows prescription access to NVPs that meet a product standard without requiring the NVPs to be approved as therapeutic goods. This research explored the impact of this regulatory model on the smoking cessation practices of health professionals, and their views on the model. METHODS: Semi-structured interviews were conducted with 39 Australian health professionals recruited from professional networks and social media. Health professionals were eligible if they provided smoking cessation advice as part of their role, and included medical practitioners (n = 9), pharmacists (n = 9), and other health professionals that provided smoking cessation counselling (n = 21). Interviews were mostly completed by phone and online teleconferencing software. Questions focused on smoking cessation practices, advice and information provided to patients about NVPs, views about the effectiveness of the model for supporting use of NVPs for smoking cessation and preventing youth uptake, and barriers and facilitators to prescribing and dispensing NVPs. Coding and analysis used a combination of inductive and deductive approaches. RESULTS: Findings indicated a lack of consensus amongst the participants about NVPs as a cessation or harm reduction tool. Participants broadly agreed that the model has not been effective in improving quality control of NVPs, or in reducing youth access. Many participants eligible to prescribe or dispense NVPs felt that the current regulatory model placed an undue time and responsibility burden on clinicians. CONCLUSION: Our research identified several limitations associated with the current Australian prescription-only regulatory model. These were perceived by healthcare professionals to limit the potential for the regulations to reduce youth use and to increase access to safer NVP products for people who smoke to use for smoking cessation.

Effects of a prebiotic formulation on the composition of the faecal microbiota of people with functional constipation.

PURPOSE: Prebiotics are defined as substances which selectively promote beneficial gut microbes leading to a health benefit for the host. Limited trials have been carried out investigating their effect on the microbiota composition of individuals afflicted by functional constipation with equivocal outcomes. In a 21-day randomised, controlled clinical trial involving 61 adults with functional constipation, a prebiotic formulation with partially hydrolysed guar gum and acacia gum as its main ingredients, significantly increased complete spontaneous bowel motions in the treatment group. This follow-up exploratory analysis investigated whether the prebiotic was associated with changes to the composition, richness, and diversity of the faecal microbiota. METHODS: Participants provided a faecal specimen at baseline and on day 21 of the intervention period. Whole genome metagenomic shotgun sequencing comprehensively assessed taxonomic and functional composition of the microbiota. RESULTS: Linear mixed effects regression models adjusted for potential confounders showed a significant reduction in species richness of 28.15 species (95% CI - 49.86, - 6.43) and Shannon diversity of 0.29 units (95% CI - 0.56, - 0.02) over the trial period in the prebiotic group. These changes were not observed in the control group, and functional composition was unchanged in both groups. CONCLUSION: In adults with functional constipation, the intake of a prebiotic formulation was associated with a decline of species richness and Shannon diversity. Further research regarding the associations between prebiotics and the composition and function of the gut microbiota is warranted.

Deprescribing Tool for Older PeoPle with Limited-life Expectancy (De-TOPPLE) version 1: Development and validation using a modified Delphi technique.

Deprescribing decision making in older adults with limited life expectancy is often challenging for clinicians. We aimed to develop and validate a Deprescribing Tool for Older People with Limited-life Expectancy (De-TOPPLE). Modified Delphi technique was used to gain experts' consensus on the tool and further develop using their feedback. Experts [Round-1 (n = 13), Round-2 (n = 7)] had clinical and/or research background on geriatric medicine, geriatrics, family medicine or pharmacotherapy. Round-1 consensus was achieved on approach taken by the tool to evaluate risk and benefit; distinguishing medications as preventive, symptom control or dual-purpose; referring to established deprescribing process; stepwise approach to deprescribing; and the overall concept. Common feedback was to reflect upon harm-benefit analysis, distinguish medication types earlier, qualify adverse events, use time-to-benefit (TTB), prioritise symptom relief, monitor post-deprescribing, include shared decision making and define terms for clinical familiarisation. After tool update, Round-2 consensus was achieved on usability in clinical setting, flexibility of implicit judgement, ceasing preventive medication with inadequate TTB, ceasing symptom control medication with inadequate symptom relief, ceasing dual-purpose medication (DPM) with inadequate TTB and symptom relief, and continuing DPM with adequate TTB and symptom relief. De-TOPPLE version 1 was developed and validated through two rounds of the Delphi process. Clinical use of the tool needs final validation following the addition of contextual statements to the tool.

The prevalence and perceived effectiveness of using a medication-swallowing lubricant in aged care facilities across Australia.

Objective: To explore the extent of use and perceived effectiveness of using a medication lubricant that is specifically designed to help people who struggle to swallow their solid medications whole. Method: Health care workers of varying professional levels in aged care facilities (ACFs) across Australia who are involved in medication administration were invited to participate in a structured online survey. Results: Of the 355 health care workers who completed the survey, 48% had used the medication lubricant to aid administration of whole and/or crushed solid oral dosage forms, and of these 89% agreed with the statement that "it is effective method to facilitate medication swallowing in residents." The main benefits of using the medication lubricant were considered to be easier medication administration to residents (49%), reduction in need for crushing of medications (34%), and better adherence with medications (33%). Conclusions: This study showed that using a medication lubricant for aged care residents may facilitate the process of medication administration for health care workers, which they perceive to improve residents' adherence with medications. Serious complications associated with solid dosage form modification may also be decreased by using a medication lubricant, as the need for modifying medications is reduced. Therapeutic Goods Administration (TGA)-approved medication lubricants could therefore be a valuable tool to aid the medication administration for patients who have difficulties swallowing medications. Future research may consider the clinical efficacy and acceptability of medication lubricants specifically for people with swallowing difficulties.

Health literacy in Pakistani migrants in Australia-An emerging and neglected culturally and linguistically diverse community.

ISSUE ADDRESSED: Pakistani migrants are one of the fastest-growing culturally and linguistically diverse (CALD) communities in Australia, but there is currently a lack of information regarding their health literacy. This study aimed to investigate the health literacy of Pakistani migrants residing in Australia. METHODS: Using a cross-sectional study design, health literacy was measured using the Urdu version of Health Literacy Questionnaire (HLQ). Descriptive statistics and linear regression were used to describe the health literacy profile of respondents and to examine its association with their demographic characteristics. RESULTS: The responses of 202 Pakistani migrants were included. The median age of the respondents was 36 years, 61.8% were males and 87.6% had a university education. The majority spoke Urdu at home and almost 80% were Australian permanent residents or citizens. Pakistani respondents scored high on HLQ domains; feeling understood by health providers (Scale 1), social support for health care (Scales 4), engaging with health care providers (Scale 6) and understanding health information (Scale 9). The respondents scored low on HLQ domains; having sufficient information (Scale 2), actively managing health (Scale 3), appraisal of health information (Scale 5), navigating the health care system (Scale 7) and ability to find information (Scale 8). In the regression model, university education and age were significantly associated with health literacy in almost all the domains, but the effect size was small for age. Speaking English at home and being a permanent resident were also associated with better health literacy in two to three HLQ domains. CONCLUSIONS: Health literacy strengths and weaknesses of Pakistani migrants residing in Australia were identified. Health care providers and organisations may use these findings to tailor health information and services to better support health literacy in this community. SO WHAT?: This study will inform future interventions to better support health literacy and reduce health disparities in Pakistani migrants residing in Australia.

Improving Wastewater-Based Tobacco Use Estimates Using Anabasine.

In wastewater-based epidemiology (WBE), nicotine metabolites have been used as biomarkers for monitoring tobacco use. Recently, the minor tobacco alkaloids anabasine and anatabine have been suggested as more specific biomarkers for tobacco use since nicotine use can be from both tobacco and non-tobacco sources. This study aimed to provide an in-depth evaluation of the suitability of anabasine and anatabine as WBE biomarkers of tobacco and subsequently estimate their excretion factors for WBE applications. Pooled urine (n = 64) and wastewater samples (n = 277), collected between 2009 and 2019 in Queensland, Australia, were analyzed for nicotine and its metabolites (cotinine and hydroxycotinine), as well as anabasine and anatabine. Anabasine performed as the better biomarker, showing a similar per capita load in pooled urine (2.2 ± 0.3 µg/day/person) and wastewater samples (2.3 ± 0.3 µg/day/person), while the per capita load of anatabine in wastewater was 50% higher than its load in urine. It is estimated that 0.9 µg of anabasine was excreted per cigarette smoked. Triangulation of tobacco sales data and tobacco use estimated from either anabasine or cotinine showed that anabasine-based estimates were 5% higher than sales data, while cotinine-based estimates were between 2 and 28% higher. Our results provided concrete evidence to confirm the suitability of anabasine as a specific biomarker for monitoring tobacco use by WBE.

Perceived Usability of Tablet Crushers: Comparison of Devices by People with and without Limited Hand Functions.

Tablet crushing is a common practice used by patients and their carers, mainly to facilitate swallowing. Various tablet-crushing devices with different designs are currently available on the market. This study aimed to compare the usability of different tablet-crushing devices in people with and without limited hand functions. The hand function of 100 adults recruited from the general community (40 of whom self-reported a limited hand function) was assessed using the hand and finger function subscale of the Arthritis Impact Measurement Scale version 2. The hand strength was measured using a dynamometer. Participants crushed tablets using 11 crushing devices and completed a Rapid Assessment of Product Usability and Universal Design questionnaire for each device. Hand-held twist-action crushers with an ergonomic grip received the highest usability scores among both groups, irrespective of the cost (p < 0.05). Crushers with bags were scored lower by those with limited hand functions, although the score improved if the device was automatic. Preferences regarding electronic crushers significantly changed once the cost was revealed. Economical twist-action crushers with ergonomic grips and without bags or cups were the most favoured crushers.

Functional constipation and the effect of prebiotics on the gut microbiota: a review.

Functional constipation is a significant health issue impacting the lives of an estimated 14 % of the global population. Non-pharmaceutical treatment advice for cases with no underlying medical conditions focuses on exercise, hydration and an increase in dietary fibre intake. An alteration in the composition of the gut microbiota is thought to play a role in constipation. Prebiotics are non-digestible food ingredients that selectively stimulate the growth of a limited number of bacteria in the colon with a benefit for host health. Various types of dietary fibre, though not all, can act as a prebiotic. Short-chain fatty acids produced by these microbes play a critical role as signalling molecules in a range of metabolic and physiological processes including laxation, although details are unclear. Prebiotics have a history of safe use in the food industry spanning several decades and are increasingly used as supplements to alleviate constipation. Most scientific research on the effects of prebiotics and gut microbiota has focussed on inflammatory bowel disease rather than functional constipation. Very few clinical studies evaluated the efficacy of prebiotics in the management of constipation and their effect on the microbiota, with highly variable designs and conflicting results. Despite this, broad health claims are made by manufacturers of prebiotic supplements. This narrative review provides an overview of the literature on the interaction of prebiotics with the gut microbiota and their potential clinical role in the alleviation of functional constipation.

A systematic review on methods for developing and validating deprescribing tools for older adults with limited life expectancy.

OBJECTIVES: A number of deprescribing tools are available to assist clinicians to make decisions on medication management. We aimed to review deprescribing tools that may be used with older adults that have limited life expectancy (LLE), including those at the palliative and end-of-life stage, and consider the rigour with which the tools were developed and validated. KEY FINDINGS: Literature was searched in PubMed, Embase, CINHAL and Google Scholar until February 2021 for studies involving the development and/or consensus validation of deprescribing tools targeting those aged ≥65 years with LLE. We were interested in the tool development process, tool validation process and clinical components addressed by the tool.Six studies were included. The approaches followed for tool development were systematic review (n = 3), expert-literature review (n = 2) and concept data (n = 1). The content included a list of disease-non-specific medications divided with or without recommendations (n = 4) and disease-specific medications with recommendations (n = 2). The tool validation was performed using the Delphi method (n = 4) or GRADE framework (n = 2) with panel size ranging from 8 to 17 and 60-80% consensus agreement with or without a rating scale. LLE targeted were ≤1 year (n = 2) or ≤3 months (n = 1). SUMMARY: There is a limited number of deprescribing tools with consensus validation available for use in older adults with LLE. These tools are either targeted for disease-specific medication/medication class guided by the GRADE framework or targeted for a list of medications or medication classes irrespective of disease that are developed using a combination of approaches and validated using a Delphi method.

Higher blood nicotine concentrations following smokeless tobacco (pituri) and cigarette use linked to adverse pregnancy outcomes for Central Australian Aboriginal pregnancies.

BACKGROUND: In central Australia, Aboriginal women use wild tobacco plants, Nicotiana spp. (locally known as pituri) as a chewed smokeless tobacco, with this use continuing throughout pregnancy and lactation. Our aim was to describe the biological concentrations of nicotine and metabolites in samples from mothers and neonates and examine the relationships between maternal self-reported tobacco use and maternal and neonatal outcomes. METHODS: Central Australian Aboriginal mothers (and their neonates) who planned to birth at the Alice Springs Hospital (Northern Territory, Australia) provided biological samples: maternal blood, arterial and venous cord blood, amniotic fluid, maternal and neonatal urine, and breast milk. These were analysed for concentrations of nicotine and five metabolites. RESULTS: A sample of 73 women were enrolled who self-reported: no-tobacco use (n = 31), tobacco chewing (n = 19), or smoking (n = 23). Not all biological samples were obtained from all mothers and neonates. In those where samples were available, higher total concentrations of nicotine and metabolites were found in the maternal plasma, urine, breast milk, cord bloods and Day 1 neonatal urine of chewers compared with smokers and no-tobacco users. Tobacco-exposed mothers (chewers and smokers) with elevated blood glucose had higher nicotine and metabolite concentrations than tobacco-exposed mothers without elevated glucose, and this was associated with increased neonatal birthweight. Neonates exposed to higher maternal nicotine levels were more likely to be admitted to Special Care Nursery. By Day 3, urinary concentrations in tobacco-exposed neonates had reduced from Day 1, although these remained higher than concentrations from neonates in the no-tobacco group. CONCLUSIONS: This research provides the first evidence that maternal pituri chewing results in high nicotine concentrations in a wide range of maternal and neonatal biological samples and that exposure may be associated with adverse maternal and neonatal outcomes. Screening for the use of all tobacco and nicotine products during pregnancy rather than focusing solely on smoking would provide a more comprehensive assessment and contribute to a more accurate determination of tobacco and nicotine exposure. This knowledge will better inform maternal and foetal care, direct attention to targeted cessation strategies and ultimately improve long-term clinical outcomes, not only in this vulnerable population, but also for the wider population. NOTE TO READERS: In this research, the central Australian Aboriginal women chose the term 'Aboriginal' to refer to themselves, and 'Indigenous' to refer to the broader group of Australian First Peoples. That choice has been maintained in the reporting of the research findings.

An Exploratory Study of the Safety and Efficacy of a Trigonella foenum-graecum Seed Extract in Early Glucose Dysregulation: A Double-Blind Randomized Placebo-Controlled Trial.

Background: This was an exploratory study to assess the safety and efficacy of a specialized Trigonella foenum-graceum L. seed extract for supporting healthy blood glucose metabolism in a pre-diabetic cohort. Methods: Fifty-four participants were randomised to receive 500 mg/day of T. foenum-graecum seed extract or matching placebo daily for 12 weeks. Fasting blood glucose (FBG), post-prandial glucose (PPBG), HbA1c, fasting insulin (FI), post-prandial insulin (PPI) and C-peptide were assessed at baseline, week 6 and week 12. Lipid levels, liver enzymes and C-reactive protein (CRP), along with safety markers and tolerability were also assessed at baseline and week 12. Results: By week 12 there was a significant difference in FBG (p < 0.001), PPBG (p = 0.007) and triglycerides (p = 0.030) between treatment groups, with no changes in HbA1c (p = 0.41), FI (p = 0.12), PPI (p = 0.50) or C-peptide (p = 0.80). There was no difference in total cholesterol (p = 0.99), high-density lipoprotein (p = 0.35), low density lipoprotein (p = 0.60) or CRP (p = 0.79). There was no change in safety markers and the treatment was well tolerated. Conclusions: The results of the study indicated that T. foenum-graecum seed extract may influence blood glucose metabolism and larger studies are warranted to evaluate efficacy and potential mechanisms of action.

A randomized controlled trial assessing the safety and efficacy of palmitoylethanolamide for treating diabetic-related peripheral neuropathic pain.

BACKGROUND: Peripheral neuropathy is a common complication of diabetes. The management of the associated neuropathic pain remains difficult to treat. OBJECTIVE: This study explored the safety, tolerability and efficacy of a palmitoylethanolamide (PEA) formulation in treating diabetic-related peripheral neuropathic pain (PNP). Secondary outcomes included systemic inflammation, sleep and mood changes in patients diagnosed with type 1 and type 2 diabetes and PNP. DESIGN: This study was a single-centre, quadruple-blinded, placebo-controlled trial with 70 participants receiving 600 mg of PEA or placebo daily, for 8 weeks, with a 94% rate of study participation completion. Primary outcomes were neuropathic pain and specific pain types (the BPI-DPN and NPSI). The secondary outcomes were sleep quality (MOS sleep scale), mood (DASS-21), glucose metabolism and inflammation. RESULTS: There was a significant reduction (P ≤ 0.001) in BPI-DPN total pain and pain interference, NPSI total score and sub-scores, except for evoked pain (P = 0.09) in the PEA group compared with the placebo group. The MOS sleep problem index and sub-scores significantly improved (P ≤ 0.001). DASS-21 depression scores significantly reduced (P = 0.03), but not anxiety or stress scores. Interleukin-6 and elevated C-reactive protein levels significantly reduced in the PEA group (P = 0.05), with no differences in fibrinogen between groups (P = 0.78) at treatment completion. There were no changes in safety pathology parameters, and the treatment was well tolerated. CONCLUSIONS: The study demonstrated that the PEA formulation reduced diabetic peripheral neuropathic pain and inflammation along with improving mood and sleep. Further studies on the mechanistic effectiveness of PEA as an adjunct medicine and as a monotherapy pain analgesic are warranted. CLINICAL TRIAL REGISTRATION: Registry name: Australian New Zealand Clinical Trials Registry (ANZCTR), Registration number: ACTRN12620001302943, Registration link: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380826 , Actual study start date: 20 November 2020.

Development and validation of a tool to understand health care professionals' attitudes towards deprescribing (HATD) in older adults with limited life expectancy.

BACKGROUND: Understanding the perspective of health care professionals (HCPs) is significant to the implementation of deprescribing in older adults with limited life expectancy (LLE) but a tool to assess this is lacking. OBJECTIVE: This study aimed to develop and validate a survey tool for assessing HCPs attitudes towards deprescribing (HATD) in older adults with LLE. METHODS: An online survey was used to collect data to determine the psychometric properties of a 49-item questionnaire generated from literature review, expert opinion and pretesting. 108 HCPs (doctors, nurses and pharmacists) with experience or interest in palliative care or a member of a palliative care team/organisation completed the survey. RESULTS: Principal component analysis of the participants' data resulted in a 23-item questionnaire structured in five factors, named HATD tool. The factors were related to concerns about deprescribing (7 items), perceived burden of medications on patients (7 items), organisational support for deprescribing (4 items), assurance to deprescribing (2 items) and perceived involvement of patients in medication management (3 items). The HATD tool had valid descriptive statistics (Kaiser-Meyer-Olkin measure: 0.708; Bartlett's test of sphericity: p < 0.001, determinant: 1.35E-5; variance explained: 60.4%; nonredundant residuals with absolute values > 0.05: 39%). The reliability statistics of all the factors were ≥0.750 for both Cronbach's alpha (α) and composite reliability (CR) except for the patient-involvement factor (α = 0.644 but CR = 0.787). CONCLUSIONS: The 23-itemed HATD tool is a valid and reliable tool to assess the attitudes and beliefs of HCPs towards deprescribing in older adults with LLE in the Australian setting.

Impact of deprescribing dual-purpose medications on patient-related outcomes for older adults near end-of-life: a systematic review and meta-analysis.

INTRODUCTION: The decision to deprescribe medications used for both disease prevention and symptom control (dual-purpose medications or DPMs) is often challenging for clinicians. We aim to establish the impact of deprescribing DPMs on patient-related outcomes for older adults near end-of-life (EOL). METHODS: This systematic review was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline. Literature was searched on PubMed, EMBASE, CINAHL, PsycINFO and Google Scholar until December 2019 for studies on deprescribing intervention with a control group (with or without randomisation); targeting ⩾65-year olds, at EOL, with at least one life-limiting illness and at least one potentially inappropriate DPM. We were interested in any patient-related outcomes. Studies with similar outcome assessment criteria were subjected to meta-analysis and narrative synthesis otherwise. The risk of bias was assessed using Cochrane Risk of Bias and ROBINS-I tools for randomised controlled trials (RCTs) and quasi-experimental non-randomised controlled studies, respectively. RESULTS: Five studies covering 689 participants with mean age 81.6-85.7 years, the majority (74.6-100%) with dementia were included. The risk of bias was moderate to low. The deprescribing of DPMs lowered the risk of mortality (risk ratio (RR) = 0.59, 95% confidence interval (CI) = 0.44-0.79) and referral to acute care facilities (RR = 0.40, 95% CI = 0.22-0.73), but did not have a significant impact on the risk of falls, non-vertebral fracture, emergency presentation, unplanned hospital admission, or general practitioner visits. No significant difference was observed in the quality of life, physical and cognitive functions between the intervention and control groups. CONCLUSION: There is some evidence that deprescribing of DPMs for older adults near the EOL can lower the risk of mortality and referral to acute care facilities, but there are insufficient good-quality studies powered to confirm a benefit in terms of quality of life, physical or cognitive function, health service utilisation and adverse events. PLAIN LANGUAGE SUMMARY: What is the health impact of withdrawal or dose reduction of medication used for disease prevention and symptom control in older adults near end-of-life? Introduction: Older adults (aged ⩾ 65 years) with advanced diseases such as cancer, dementia, and organ failure tend to have a limited life expectancy. With the progression of these diseases towards the end-of-life, the intensity for day-to-day supportive care becomes increasingly necessary. The use of medications for symptom management is a critical part of such care, but the use of medications for long-term disease prevention can become irrelevant due to the already shortened life expectancy and may become harmful due to alterations in physiology and pharmacology associated with age and frailty. This necessitates the withdrawal or dose reduction of inappropriate medications, the process called deprescribing. The decision to deprescribe medications used for both disease prevention and symptom control (DPMs) in this population is often challenging for clinicians. In this context, whether deprescribing of DPMs can improve patient-related health outcomes is unknown.Methods: Evidence from the literature was reviewed and analysed, and the quality of studies was assessed. Five studies were identified, which had 689 participants with an average age above 80 years and mostly suffering from dementia.Results: The analysis of these studies showed deprescribing of DPMs lowered the risk of death and referral to acute care facilities at 12 months but had no significant impact on falls, non-vertebral fractures, emergency presentations, unplanned hospital admission, general practitioner visits, quality of life, physical and mental functions.Conclusion: In conclusion, there were insufficient numbers of high-quality studies powered to confirm whether deprescribing of DPMs reduces adverse events, health service use, or improves the quality of life or functioning in older adults near the end of life.

Deprescribing tool for use in older Australians with life-limiting illnesses and limited life expectancy: a modified-Delphi study protocol.

BACKGROUND: Making a meaningful decision on deprescribing of potentially inappropriate medications in older adults with life-limiting illnesses (LLIs) and limited life expectancy (LLE) is often challenging. Therefore, we aimed to elicit opinion and gain consensus on a deprescribing tool for use in this population. METHODS AND ANALYSIS: A modified-Delphi method will be used to obtain a consensus from a panel of experts in geriatric therapeutics on a deprescribing tool for use in people aged ≥65 years with LLIs and LLE. Through an online survey, in the initial round, the panel will anonymously elicit their opinion on a series of items related to the conceptual model of the deprescribing tool, its practicality and deprescribing of medications, while on the controlled feedback in subsequent rounds till a consensus is reached or the panellists stop revising their answers. In each round, panel members will be using a 5-point Likert scale to rate their agreement with the statement. Consensus will be considered on ≥75% of agreement on the statements. ETHICS AND DISSEMINATION: All the participants will receive an invitation and participant information but they need to consent for the participation. Ethics approval has been granted from the University of Queensland Health and Behavioural Sciences, Low and Negligible Risk Ethics Sub-Committee (reference: 2020001069). The results of this project will be disseminated through conferences and a peer-reviewed clinical journal.

Does the content and source credibility of health and risk messages related to nicotine vaping products have an impact on harm perception and behavioural intentions? A systematic review.

AIMS: To systematically review the literature on (i) whether and how various risk messages about nicotine vaping products (NVPs) alter harm perception and behavioural intentions of smokers and non-smokers and (ii) how trust in sources of NVP risk communication affects message reception and behavioural intentions. METHODS: Seven electronic databases and reference lists of relevant articles were searched for articles published up to April 2020. Experimental and quasi-experimental studies on message effects and cross-sectional studies on source credibility were included. The Newcastle-Ottawa Scale and the Evidence Project Risk of Bias Tool were used to assess the quality of observational and intervention studies, respectively. For each outcome variable, we indicated whether there was an effect (as a 'yes' or 'no') and used effect direction plots to display information on the direction of effects. RESULTS: Nicotine addiction messages resulted in greater health and addiction risk perceptions, relative risk messages comparing the health risks of NVPs to cigarette smoking increased the perception that NVPs are less harmful than combustible cigarettes, and a nicotine fact sheet corrected misperceptions of nicotine and NVPs. Smokers' intention to purchase, try or switch to NVPs was higher when exposed to a relative risk message and lower when exposed to nicotine addiction warnings. Trust in NVP risk information from public health agencies was associated with lower odds of; (i) NVP use and (ii) perceiving NVPs as less harmful, whereas those who trusted information from NVP companies were more likely to perceive NVPs as less harmful than combustible cigarettes. CONCLUSIONS: Relative risk messages may help improve the accuracy of harm perceptions of nicotine vaping products and increase smokers' intentions to quit smoking and/or to switch to vaping, although the literature is nascent.