Associate Professor Therese Kairuz

Introduction: Novel tobacco products require independent research to assess their safety. This study assessed the current literature for trials comparing levels of biomarkers of exposure (BoE) between conventional cigarettes (CC) and heat-not-burn (HNB) devices. Methods: Ten databases were searched using terms including: "heat not burn,""iqos,""teeps,""mrtp,""tobacco heating,"and "glo"between January 1, 2010 and August 13, 2019. Randomized controlled trials (RCTs) assessing comparative BoE levels in humans using either CC or novel HNB devices were eligible. BoE were tabulated, and differences between the intervention and control groups were analyzed and combined using a random-effects meta-analysis. Results: Ten nonblinded, RCTs were eligible, involving a total of 1766 participants. Studies regularly reported on 12 BoE (including nicotine). HNB devices assessed included the "IQOS"and "glo"devices and "precursor"(being developed) HNB devices. In comparison to CC, all 12 BoEs assessed were significantly lower for participants assigned to an HNB device. In comparison to smoking abstinence, HNB devices were statistically equivalent for eight BoEs and significantly elevated for four BoEs. Conclusions: This review found that the potential for harm to humans is reduced when using HNB devices compared to CC as indicated by significant reductions in BoE levels. Whilst these results support tobacco manufacturer claims of improved safety, the small number of studies included, limited range of BoE assessed, and involvement of the tobacco industry necessitate further independent research to confirm the HNB devices as being a safer alternative to CC. Implications: This study supports claims made by tobacco manufacturers on the improved safety of HNB tobacco devices in comparison to CC. These novel devices lead to reduced exposure to key biomarkers, which are linked to the health consequences attributed to tobacco use. This has strong implications for international public health as well as further research and policy development relating to the safety aspects and legalities of novel tobacco products.

Resettled refugees in Australia have been shown to exhibit a high prevalence of limited health literacy and are at greater risk of mismanaging their medication and not being able to access the healthcare services they need. The aim of the current study is to explore the barriers to accessing medicines and pharmacy services in Queensland, Australia, among resettled refugees from Africa; this research was conducted from the perspectives of healthcare professionals and people who help the refugees to resettle in their adopted country (resettlement workers). A 'generic qualitative' approach was used in this study. In-depth interviews were conducted among healthcare professionals (two GPs, nine pharmacists and three nurse practitioners) and resettlement workers. Participants were recruited via a purposive snowball sampling method in the cities of Brisbane and Townsville, Queensland, Australia. Twenty-four in-depth interviews were conducted; 14 with healthcare professionals. Three key themes emerged from the data: (1) Communication Barriers; (2) Navigating the Health System; and (3) Belief Systems and Culture. Perceptions of those 'at the coalface'-healthcare professionals and people who are responsible for assisting refugees to resettle in Australia-provide insight into the language and cultural challenges experienced by resettled refugees from Africa regarding access to the Australian health system, including medicines and pharmacy services.

Clinical pharmacists provide beneficial services to adult patients, though their benefits for paediatric hospital patients are less defined. Five databases were searched using the MeSH terms ¿clinical pharmacist¿, ¿paediatric/paediatric¿, ¿hospital¿, and ¿intervention¿ for studies with paediatric patients conducted in hospital settings, and described pharmacist-initiated interventions, published between January 2000 and October 2017. The search strategy after full-text review identified 12 articles matching the eligibility criteria. Quality appraisal checklists from the Joanna Briggs Institute were used to appraise the eligible articles. Clinical pharmacist services had a positive impact on paediatric patient care. Medication errors intercepted by pharmacists included over- and under-dosing, missed doses, medication history gaps, allergies, and near-misses. Interventions to address these errors were positively received, and implemented by physicians, with an average acceptance rate of over 95%. Clinical pharmacist-initiated education resulted in improved medication understanding and adherence, improved patient satisfaction, and control of chronic medical conditions. Conclusion: This review found that clinical pharmacists in paediatric wards may reduce drug-related problems and improve patient outcomes. The benefits of pharmacist involvement appear greatest when directly involved in ward rounds, due to being able to more rapidly identify medication errors during the prescribing phase, and provide real-time advice and recommendations to prescribers.What is Known:¿ Complex paediatric conditions can require multiple pharmaceutical treatments, utilised in a safe manner to ensure good patient outcomes¿ The benefits of pharmacist interventions when using these treatments are well-documented in adult patients, though less so in paediatric patientsWhat is New:¿ Pharmacists are adept at identifying and managing medication errors for paediatric patients, including incorrect doses, missed doses, and gaps in medication history¿ Interventions recommended by pharmacists are generally well-accepted by prescribing physicians, especially when recommendations can be made during the prescribing phase of treatment.

This meta-analysis examined depression as a consequence of diabetes by conducting a meta-analysis, using data from longitudinal studies. Databases were systematically searched for relevant studies. Incidence of depression is presented as cumulative incident proportion (CIP). Pooled effect sizes were calculated using random-effects model. The data were reconstructed to compute relative risk (RR) and CIP. The 16 studies selected for review generated 16 datasets of which 11 studies reporting binary estimates (RR) and 5 studies reporting time-to-event estimates [hazard ratio (HR)]. Both RR and HR were significant at 1.27 (95¿% CI 1.17¿1.38) and 1.23 (95¿% CI 1.08¿1.40) for incident depression associated with diabetes mellitus. Our observations also revealed greater cumulative incidence of depression in diabetes than in non diabetes groups. Our study shows that diabetes is a significant risk factor for the onset of depression.

The primary objective of this study was to examine the association between depression, anxiety symptoms, and glycemic control in Malaysian women with type 2 diabetes mellitus (T2DM). Another objective was to examine the association between glycemic control and mental status, measured by mental composite score (MCS). This study was conducted on 611 randomly sampled Malaysian women with T2DM who were treated as outpatients at medication therapy adherence clinics (MTAC). The Delusions-Symptoms-States Inventory: State of Anxiety and Depression (DSSI/SAD) and Center for Epidemiologic Studies Depression Scale 10 (CES-D 10) were used. Five most recent readings of hemoglobin A1c (HbA1c), fasting, and random glucose levels were recorded. Regression analysis was used to correlate glycemic control with depression, anxiety symptoms, and MCS, while considering potential confounders. For depression symptoms, an increase of one category was associated with a small average HbA1c increase of 0.10¿% (95¿% CI -0.38, 0.68), whereas for anxiety symptoms, there was a small decrease in average HbA1c of 0.44¿% (95¿% CI -1.17, 0.28); both were not significant. Very poorly controlled HbA1c was not significantly associated with symptoms of depression (OR 1.43, 95¿% CI 0.45¿4.55) or anxiety (OR 0.47, 95¿% CI 0.15¿1.49). MCS was found to have a strong inverse correlation with HbA1c. That is, women who reported poor MCS had a significantly higher, and therefore very poorly controlled, HbA1c (OR 1.70, 95¿% CI 1.01¿2.88). The presence of depression and anxiety symptoms was not significantly associated with glycemic control in women with T2DM, supporting the hypothesis that argues against the existence of a link between depression, anxiety, and glycemic control.

Aims We estimated the incidence and risk of diabetes associated with depressive symptoms using data from longitudinal studies. Materials and methods Databases were systematically searched for relevant studies. Incidence of diabetes is presented as cumulative incident proportion (CIP). Pooled effect sizes were calculated using random-effects model. The data were reconstructed to compute relative risk (RR). Results The 16 studies selected for review generated 16 datasets of which 8 studies reporting binary estimates (RR) and 8 studies reporting time-to-event estimates (hazard ratio (HR)). Both RR and HR were significant at 1.67 (95% CI: 1.30-2.15) and 1.45 (95% CI: 1.12-1.87) for incident diabetes associated with depressive symptoms. Conclusion Our observations revealed greater cumulative incidence of diabetes in depressed than in non depressed groups. Depression should be included among risk factors that required regular screening for diabetes. © 2014 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Background: Resources to help the older aged (=65 year olds) manage their medicines should probably target those in greatest need. The older-aged have many different types of living circumstances. There are different locations (urban, rural), different types of housing (in the community or in retirement villages), different living arrangements (living alone or with others), and different socioeconomic status (SES) circumstances. However, there has been limited attention to whether these living circumstances affect adherence to medicines in the =65 year olds. Aim of the review: The aim was to determine whether comparative studies, including logistic regression studies, show that living circumstances affect adherence to medicines by the =65 year olds. Methods: A literature search of Medline, CINAHL and the Internet (Google) was undertaken. Results: Four comparative studies have not shown differences in adherence to medicines between the =65 year olds living in rural and urban locations, but one study shows lower adherence to medicines for osteoporosis in rural areas compared to metropolitan, and another study shows greater adherence to antihypertensive medicines in rural than urban areas. There are no comparative studies of adherence to medicines in the older-aged living in indigenous communities compared to other communities. There is conflicting evidence as to whether living alone, being unmarried, or having a low income/worth is associated with nonadherence. Preliminary studies have suggested that the olderaged living in rental, low SES retirement villages or leasehold, middle SES retirement villages have a lower adherence to medicines than those living in freehold, high SES retirement villages. Conclusions: The =65 year olds living in rural communities may need extra help with adherence to medicines for osteoporosis. The =65 year olds living in rental or leasehold retirement villages may require extra assistance/resources to adhere to their medicines. Further research is needed to clarify whether living under certain living circumstances (e.g. living alone, being unmarried, low income) has an effect on adherence, and to determine whether the =65 year olds living in indigenous communities need assistance to be adherent to prescribed medicines. © Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2013.

Background: Low health literacy is expected to be associated with medication non-adherence and early research indicated that this might be the case. Further research suggested that the relationship may be more equivocal. Aim of the review: The goal of this paper is initially to clarify whether there is a clear relationship between health literacy and non-adherence. Additionally, this review aims to identify factors that may influence that relationship and ultimately to better understand the mechanisms that may be at work in the relationship. Method: English language original research or published reviews of health literacy and non-adherence to orally administered medications in adults were identified through a search of four bibliographic databases (PubMed, EMBASE, CINAHL, and EBSCO Health). Results: The search protocol produced 78 potentially relevant articles, of which 16 articles addressed factors that contribute to non-adherence and 24 articles reported on the results of research into the relationship between non-adherence and health literacy. Factors that contribute to non-adherence can be categorised into patient related factors, including patient beliefs; medication related factors; logistical factors; and factors around the patient-provider relationship. Of the 23 original research articles that investigated the relationship between non-adherence and health literacy, only five reported finding clear evidence of a relationship, four reported mixed results and 15 articles reported not finding the expected relationship. Research on possible mechanisms relating health literacy to non-adherence suggest that disease and medication knowledge are not sufficient for addressing non-adherence while self-efficacy is an important factor. Other findings suggest a possible U-shaped relationship between non-adherence and health literacy where people with low health literacy are more often non-adherent, largely unintentionally; people with moderate health literacy are most adherent; and people with high health literacy are somewhat non-adherent, sometimes due to intentional non-adherence. Conclusion: It is clear that relevant research generally fails to find a significant relationship between non-adherence and health literacy. A U-shaped relationship between these two conditions would explain why linear statistical tests fail to identify a relationship across all three levels of health literacy. It can also account for the conditions under which both positive and negative relationships may be found. © Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2013.

Background: Changes in the roles of the contemporary pharmacist has seen a decline in the number and variety of extemporaneously compounded dosage forms. Pharmacy curricula refl ect this change with a reduction in the emphasis on extemporaneous compounding practice. Aim: To elicit information about extemporaneously compounded dosage forms and perceptions of compounding practice from pharmacists and pharmacy students. Method: Self-administered surveys were mailed to 1063 pharmacists and offered online to 896 pharmacy undergraduates across the 4 years of a Bachelor of Pharmacy program in Queensland. Results: 382 (36%) pharmacists and 455 (51%) students completed the survey. Most pharmacists (96%) reported compounding a product in the 12 months prior to the survey, particularly semi-solids (89%) and liquids (64%) for external use. Most pharmacies (> 96%) owned basic compounding equipment, such as a slab and spatula, mortar and pestle, and cylindrical/conical measures. Half of the pharmacies used mechanical rather than electronic balances. Students expressed greater confi dence in their ability to use basic compounding equipment and to perform basic compounding tasks as they progressed through the 4-year degree course. Pharmacists' views on students' ability to compound basic products at the end of their degree were generally similar to the proportion of fi nal-year students who reported they could confi dently complete the task. Conclusion: Despite a decline in extemporaneously compounded products in community pharmacy, pharmacy graduates need to be competent in compounding techniques.

Aims The aim of this study was to investigate the association between pregnancy complications, mental health-related problems, and type 2 diabetes mellitus (T2DM) in Malaysian women. Materials and methods A case-control study of women with T2DM (n = 160) matched by age range to controls without T2DM (n = 160). Data were collected in the Negeri Sembilan and PutraJaya regions in Malaysia, from two hospital outpatient clinics, PutraJaya Hospital and Tuanku Jaa'far Hospital Seremban, and one health clinic at Seremban. Validated, interviewer-administered questionnaires were used to obtain the data. The unadjusted and adjusted estimates were calculated using the Mantel-Haenszel method. Results Neither depression (RR 0.74, 95% CI: 0.39-1.41) nor anxiety (RR 1.00, 95% CI: 0.53-1.88) symptoms increased the risk of T2DM significantly. However, gestational diabetes (RR 1.35, 95% CI: 1.02-1.79), and =3 pregnancies (RR 1.39, 95% CI: 1.08-1.79) were significant risk factors for the development of T2DM. T2DM was not a significant risk factor for either depression (RR 1.26, 95% CI: 0.91-1.74) or anxiety symptoms (RR 1.13, 95% CI: 0.59-2.19). Conclusion In this study, T2DM is not a significant risk factor for depression and anxiety; similarly, neither are depression and anxiety significant risk factors for T2DM. Although prevalence of depression and anxiety is not alarming, the findings reported here should alert clinicians to screen and treat anxiety and depression in people with diabetes and also note the importance of monitoring women with complications in pregnancy for risk of later T2DM. © 2013 Diabetes India.

This meta-analysis examined the reciprocal relationship between depression and diabetes mellitus type 2 (T2DM) by conducting a bias adjusted meta-analysis of longitudinal studies using relative and absolute risk estimates. Specifically, the data were reconstructed to compute relative risk (RR), risk difference (RD), and the number needed to be exposed for one additional person to be harmed (NNEH) or benefited (NNEB). The 25 studies selected for review generated 29 datasets of which 15 examined endpoint A (depression as a risk factor for T2DM), and 14 examined endpoint B (T2DM as a risk factor for depression). For both endpoints, there was a small relative risk increase (for both the RR and hazard ratio (HR)) though with significant heterogeneity between studies. This however translated to a non-significant NNEH of 87 (NNEB 161 to 8 to NNEH 35) and NNEH of 233 (NNEB 28 to 8 to NNEH 23) for studies examining endpoint A and endpoint B respectively. This study suggests that the magnitude of the relative risk increase for depression as a risk factor or consequence of T2DM is small without significant impact on absolute risk indices. While these risks may be considered in terms of individual patient management, they are unlikely to have an impact on a population perspective. © 2013 Elsevier B.V.

Objective: Over the last two decades the pharmacy profession has seen a major revision to patient-focused teaching and practice. This study evaluated the perceived impact of experiential clinical pharmacy placements on students' preparedness to provide patient-centered care. Methods: This cross-sectional study among Bachelor of Pharmacy (BPharm) final-year students used a validated self-administered questionnaire, administered before and after the students' clinical placements undertaken at hospitals. Subjects' responses were rated on a 7-point Likert scale anchored at 1 (not at all) and 7 (very well prepared). The Wilcoxon test was applied to assess the differences in pre- and post-mean scores of individual items. Results: One hundred six students agreed to participate in the study. Despite the low percentage of clinical curricular content coverage, significant augmentation in post-placement overall mean scores in aspects of patient-centered care was found; therapeutic (4.8 vs 3.5; 38.3% change), psycho-social (4.9 vs 4.1, 19.5% change) and communication skills (5.05 vs 3.9, 30.8% change) aspects of patient-centered care were noted. The mean score for each item in the three aspects increased from pre- to post-clinical placements and were statistically significant (p<0.05). Conclusion: Perceived patient centered care skills grow as the students' complete coursework, and changes to that coursework, including clinical learning, can impact both actual and perceived patient-centered-care competencies. The findings highlight areas for curriculum improvement and this evaluation reinforces the need for experiential placements in the BPharm curriculum. There is value in the development of pharmacy practice skills which occurs during undergraduate placements through experiential learning. © 2013 Elsevier Inc.

Background: The Australian Pharmaceutical Formulary (APF) has diversified in content and grown in size. Change can be indicative of progress within, and influences on, a profession. Aim: To determine variations to the formulary sections of the 22 editions of the APF (1902 to 2012) with respect to dosage forms, ingredients and compounding methods. Method: Each formula in the APF was entered into a customised Excel spreadsheet with descriptors including formula type, dosage form, active ingredient and route of administration. Data were analysed using features in Excel. Results: A total of 1197 different formulae were identified in the 22 editions of the APF. The first edition consisted almost entirely of formulae (81% of the total number of pages) and this percentage decreased considerably to 3% to 5% in APFs published since 2002. The greatest number of formulae (n = 496) were included in 1934 (APF6), the edition which also had the greatest number of new formulae (n = 307). Most new formulae appeared for the first time between 1930 and 1964 (APF 5 to 9). A total of 47 different dosage forms were identified and the top 5 in descending order were mixtures (17%), solutions (8%), ointments (7%), eye drops (6%) and creams (5%). Most of the formulae contained in APF22 originated from APF9. Conclusion: The number of formulae has decreased in the APF over time, with recent deletions based on lack of safety and efficacy data or due to the availability of commercial products. There have been comparatively few alterations to the formulary section in the last decade.