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.

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.

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.

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.

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.

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.

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.

Translating and validating the Health Literacy Questionnaire into Urdu: a robust nine-dimension confirmatory factor model.

Pakistani migrants are one of the fastest-growing communities in Australia, and the majority speak Urdu at home. There is a lack of information regarding the health literacy of this population. This study aimed to translate the Health Literacy Questionnaire (HLQ) into Urdu and to explore its psychometric properties. A structured standardized procedure was followed to translate and validate HLQ into Urdu. Data were collected from 202 Pakistani migrants residing in Australia. The HLQ-Urdu was well understood by the respondents. The structural properties of HLQ-Urdu were close to the original HLQ. Data for all HLQ scales met pre-specified criteria for fit in the one-factor CFA model. The composite reliability was high, ranging from 0.84 to 0.91. A strict nine-factor CFA model was also fitted to the data with no cross-loadings or correlated residuals allowed, which showed excellent model fit statistics [χ2WLSMV = 1266.022 (df = 866, p = 0.000), comparative fit index = 0.995, Tucker-Lewis index = 0.994, root mean square error of approximation = 0.050 and standardized root mean square residual = 0.069]. The Urdu version of HLQ showed robust psychometric properties. This HLQ-Urdu tool is now ready to be used to assess health literacy in Pakistani migrants in Australia. Availability of health literacy tools in migrant languages may help healthcare providers better understand the health literacy needs of migrant communities.

Beliefs and Self-reported Practices of Health Care Professionals Regarding Electronic Nicotine Delivery Systems: A Mixed-Methods Systematic Review and Synthesis.

AIMS: This review explores the (1) beliefs and attitudes of health care professionals (HCPs) toward electronic nicotine delivery systems (ENDS) including use as a smoking cessation aid and/or harm reduction, safety and regulation, and (2) the extent and content of patient-HCP communication about ENDS. METHODS: PubMed, Embase, CINAHL, and PsycINFO were searched to identify articles published since 2003. The Mixed Methods Appraisal Tool and Strengthening the Reporting of Observational Studies in Epidemiology checklists were used to assess the quality of studies. Thematic synthesis was used to analyze qualitative data. RESULTS: A total of 45 articles (32 quantitative, 12 qualitative, and 1 mixed) were included. There was wide variation regarding beliefs about the efficacy of ENDS as a cessation aid. Although the majority of HCPs believes that ENDS are safer than combustible cigarettes, they also have concern about the short and long-term safety of ENDS, uptake by adolescents, and the potential for ENDS to act as a "gateway" to smoking cigarettes. Beliefs about ENDS are influenced by media stories and experiences provided by patients. Although most HCPs do not proactively recommend ENDS, they are more likely to support ENDS use among patients with smoking related comorbidities, heavy smokers with previous unsuccessful quit attempts, or patients who express interest in trying them. CONCLUSIONS: Overall, HCPs hold diverse views about the efficacy of ENDS and expressed wariness over their potential health effects. HCP endorsement of ENDS use seems to depend largely on patient health status, the presence of other competing risk factors and patient preferences. IMPLICATION: Although evidence on safety and efficacy of ENDS is emerging, HCPs should be honest with their clients, stating that the long-term safety is not yet established but what is known is that they appear to be a lower risk alternative to cigarettes. Our review highlights a need for further training and support for HCPs regarding ENDS use, which would enable them to guide their clients in making evidence-based decisions.

Factors affecting Australian aged care facility workers in administering oral medication to residents with swallowing difficulties.

Swallowing difficulties are common in older people and can complicate the administration of oral medications. The aim of this study was to explore factors affecting healthcare workers in their practices of oral medication administration to aged care residents with swallowing difficulties. A purposeful sample of 17 healthcare workers composed of clinical/care managers, registered nurses (RNs), enrolled nurses (ENs), and assistants in nursing (AINs) from three aged care facilities in Queensland, Australia participated in semi-structured interviews. Leximancer was used for quantitative content analysis. The responses centered on three main factors. Participants discussed workprocess-related factors including time, workload, and stress and frustrations resulting from work processes. Medication-related factors included strategies to facilitate medication administration, uncertainties around modifying medications, availability/cost of alternatives, multidisciplinary medication management, prescribing considerations, and polypharmacy. Resident-related factors were discussed around individualized needs of residents especially those with dementia-associated swallowing difficulties. Ideas differed among the four groups of participants. Managers discussed workprocess-related factors pertaining to staff and facility. RNs focused on how clinical aspects of the medication practices were affected by work processes. ENs were task-oriented and their responses focused on work processes. AIN responses centered on reliance on RNs in performing medication tasks. The findings suggest that healthcare workers' practices of medication administration to residents with swallowing difficulties are affected by various factors associated with work processes, medications, and resident characteristics. Although these factors affect all levels of healthcare workers, the needs of each group vary depending on their level of training and responsibilities.

Baltic amber teething necklaces: could succinic acid leaching from beads provide anti-inflammatory effects?

BACKGROUND: Baltic amber teething necklaces have been popularized as a safe and natural alternative to conventional or pharmacological medicines for the management of teething pain. However, claims made by retailers regarding the efficacy and mechanism of action of these necklaces lack scientific or clinical basis. The claim most closely resembling science is the assertion that succinic acid will leach out of the beads and through the skin of the wearer and carry out anti-inflammatory and analgesic effects. The objective of the current research is to scientifically assess this claim. METHODS: Beads from necklaces were powdered for identification by infrared spectroscopy, and dissolved in sulfuric acid for quantification of succinic acid using HPLC. Succinic acid release from beads was assessed by long-term submersion of amber beads (separated according to light, medium and dark brown colour) in solvents relevant to human skin conditions. The potential for succinic acid to have anti-inflammatory effects was assessed by measuring the release of inflammatory cytokines IL-1α, IL-1ß, IL-8 and TNFα, and the inflammatory messenger PGE2, from THP-1 human macrophages after treatment with succinic acid and LPS. RESULTS: Amber teething necklaces were positively identified as Baltic amber, by comparison of the beads' infrared spectrum to the literature, and by their succinic acid content (1.5 mg per bead; 1.44% w/w). However, whole amber beads submerged in octanol or pH 5.5 phosphate buffered saline did not release any measurable succinic acid, except for the light-coloured beads in octanol which broke into tiny fragments. Additionally, treatment of macrophages with succinic acid did not reduce the release of any inflammatory cytokines measured, and displayed toxicity to the cells at high concentrations. CONCLUSIONS: While amber teething necklaces are genuine Baltic amber, we have found no evidence to suggest that the purported active ingredient succinic acid could be released from the beads into human skin. Additionally, we found no evidence to suggest that succinic acid has anti-inflammatory properties.

The Use of a Brochure to Enable CAM-with-Chemotherapy Patient Education.

The majority of cancer patients receiving chemotherapy will consider taking complementary and alternative medicine (CAM) during their treatment. As biologically-active CAM may detrimentally interfere with chemotherapy treatment, cancer patients require evidence-based information on chemotherapy-CAM integration consequences. This study aimed to assess if the availability of a purpose-designed brochure within a cancer service aided doctors' discussions with their patients on CAM use and helped patients understand the effects of CAM during their chemotherapy treatment. Cancer care doctors consulting in an adult day unit completed a structured post-intervention feedback survey form (n = 17), and cancer patients receiving chemotherapy treatment were provided the brochure and completed the local health service consumer testing feedback form (n = 30). All cancer care doctors perceived a need for the brochure and recommended the brochure to their patients. All doctors thought the brochure made it easier for them to discuss CAM with their patients, and 59 % believed that it saved them time during patient consultations. Ninety percent of cancer patients reported the brochure had enough information to answer their CAM questions, and all patients thought the information was easy to read and understand. An evidence-based CAM-with-chemotherapy patient brochure was perceived to have enabled cancer care doctors to discuss CAM with their patients and to have answered patients' CAM questions.

The Pituri Learning Circle: central Australian Aboriginal women's knowledge and practices around the use of Nicotiana spp. as a chewing tobacco.

INTRODUCTION: Tobacco smoking has a range of known and predictable adverse outcomes, and across the world sustained smoking reduction campaigns are targeted towards reducing individual and public risk and harm. Conversely, more than 87 million women, mostly in low- and middle-income countries, use smokeless tobacco, yet the research examining the effect of this form of tobacco exposure on women is remarkably scant. In central Australia, the chewing of wild Nicotiana spp., a tobacco plant, commonly known as pituri and mingkulpa, is practised by Aboriginal groups across a broad geographical area. Until recently, there had been no health research conducted on the effects of chewing pituri. METHODS: This article reports on one component of a multidimensional pituri research agenda. A narrative approach utilising the methodology of the Learning Circle was used to interview three key senior central Australian Aboriginal women representative of three large geographical language groupings. The participants were selected by a regional Aboriginal women's organisation. With the assistance of interpreters, a semistructured interview, and specific trigger resources, participants provided responses to enable an understanding of the women's ethnobotanical pituri knowledge and practices around the use of pituri within the context of Aboriginal women's lives. Data were transcribed, and by using a constant comparison analysis, emergent themes were categorised. The draft findings and manuscript were translated into the participants' language and validated by the participants. RESULTS: Three themes around pituri emerged: (a) the plants, preparation and use; (b) individual health and wellbeing; and (c) family and community connectedness. The findings demonstrated similar participant ethnobotanical knowledge and practices across the geographical area. The participants clearly articulated the ethnopharmacological knowledge associated with mixing pituri with wood ash to facilitate the extraction of nicotine from Nicotiana spp., the results of which were biochemically verified. The participants catalogued the pleasurable and desired effects obtained from pituri use, the miscellaneous uses of pituri, as well as the adverse effects of pituri overdose and toxicity, the catalogue of which matched those of nicotine. The participants' overarching pituri theme was related to the inherent role pituri has in the connectiveness of people to family, friends and community. CONCLUSIONS: Central Australian Aboriginal women have a firmly established knowledge and understanding of the pharmacological principles related to the content of Nicotiana spp. and the extraction of nicotine from the plant. Widespread use of Nicotiana spp. as a chewing tobacco by Aboriginal populations in the southern, central and western desert regions of Australia is attested to by participants who assert that everyone uses it, with girls in these remote areas commencing use between 5 and 7 years of age. Central Australian Aboriginal people who chew Nicotiana spp. do not consider it to be a tobacco plant, and will strongly refute that they are tobacco users. Central Australian Aboriginal people do not consider that the Western health information regarding tobacco (as a smoked product) is applicable or aligned to their use of pituri. Nicotiana spp. users will deny tobacco use at health assessment. There is a requirement to develop and provide health information on a broader range of tobacco and nicotine products in ways that are considered credible by the Aboriginal population. Health messages around pituri use need to account for the dominant role that pituri occupies in the context of central Australian Aboriginal women's lives.
Information for readers: A consultative organisation of Aboriginal women has as a strategic intent and operational agenda the improvement of Aboriginal women's and children's health across the research region. The group seeks opportunities to enhance their knowledge based on legitimate collaborative research; accordingly, they sought to participate in a range of research activities regarding the use of pituri and women's health outcomes. Of particular note, the group's participants chose to be identified by name in the publication of this research activity. In this article, the term 'Aboriginal' has been chosen by the central Australian women to refer to both themselves and the Aboriginal people in their communities; 'Indigenous' has been chosen to refer to the wider Australian Aboriginal and Torres Strait Islander people. The term Nicotiana spp. is used when referring to the plants from a Western perspective; pituri is used when referring to the plants, the tobacco quid, and the practice of chewing from a general Aboriginal perspective; and mingkulpa is used when the participants are voicing their specific knowledge and practices.

Oral medication delivery in impaired swallowing: thickening liquid medications for safe swallowing alters dissolution characteristics.

Acetaminophen (paracetamol) is available in a wide range of oral formulations designed to meet the needs of the population across the age-spectrum, but for people with impaired swallowing, i.e. dysphagia, both solid and liquid medications can be difficult to swallow without modification. The effect of a commercial polysaccharide thickener, designed to be added to fluids to promote safe swallowing by dysphagic patients, on rheology and acetaminophen dissolution was tested using crushed immediate-release tablets in water, effervescent tablets in water, elixir and suspension. The inclusion of the thickener, comprised of xanthan gum and maltodextrin, had a considerable impact on dissolution; acetaminophen release from modified medications reached 12-50% in 30 min, which did not reflect the pharmacopeia specification for immediate release preparations. Flow curves reflect the high zero-shear viscosity and the apparent yield stress of the thickened products. The weak gel nature, in combination with high G' values compared to G'' (viscoelasticity) and high apparent yield stress, impact drug release. The restriction on drug release from these formulations is not influenced by the theoretical state of the drug (dissolved or dispersed), and the approach typically used in clinical practice (mixing crushed tablets into pre-prepared thickened fluid) cannot be improved by altering the order of incorporation or mixing method.

Crushed tablets: does the administration of food vehicles and thickened fluids to aid medication swallowing alter drug release?

PURPOSE: To evaluate the influence of co-administered vehicles on in vitro dissolution in simulated gastric fluid of crushed immediate release tablets as an indicator for potential drug bioavailability compromise. METHODS: Release and dissolution of crushed amlodipine, atenolol, carbamazepine and warfarin tablets were tested with six foods and drinks that are frequently used in the clinical setting as mixers for crushed medications (water, orange juice, honey, yoghurt, strawberry jam and water thickened with Easythick powder) in comparison to whole tablets. Five commercial thickening agents (Easythick Advanced, Janbak F, Karicare, Nutilis, Viscaid) at three thickness levels were tested for their effect on the dissolution of crushed atenolol tablets. RESULTS: Atenolol dissolution was unaffected by mixing crushed tablets with thin fluids or food mixers in comparison to whole tablets or crushed tablets in water, but amlodipine was delayed by mixing with jam. Mixing crushed warfarin and carbamazepine tablets with honey, jam or yoghurt caused them to resemble the slow dissolution of whole tablets rather than the faster dissolution of crushed tablets in water or orange juice. Crushing and mixing any of the four medications with thickened water caused a significant delay in dissolution. When tested with atenolol, all types of thickening agents at the greatest thickness significantly restricted dissolution, and products that are primarily based on xanthan gum also delayed dissolution at the intermediate thickness level. CONCLUSIONS: Dissolution testing, while simplistic, is a widely used and accepted method for comparing drug release from different formulations as an indicator for in vivo bioavailability. Thickened fluids have the potential to retard drug dissolution when used at the thickest levels. These findings highlight potential clinical implications of the addition of these agents to medications for the purpose of dose delivery and indicate that further investigation of thickened fluids and their potential to influence therapeutic outcomes 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.

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.

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.