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Background: Poor recognition of medicine-induced dry mouth can have a number of adverse effects, including difficulties with speech, chewing and swallowing dry foods, gum disease, dental caries and oral candidosis. This study examined the prevalence of use of medicines that cause dry mouth and claims for dental services funded by the Department of Veterans' Affairs (DVA) in an Australian cohort.Methods: We used the DVA administrative health claims data to identify persons using medicines that can cause dry mouth at 1st of September 2016 and determine their DVA dental claims in the subsequent year. Results were stratified by gender, residence in community or residential aged cared facility and number of medicines.Results: We identified 50 679 persons using medicines known to cause dry mouth. Of these, 72.6% were taking only one medicine that may cause dry mouth, and 21.6% were taking two. Less than half (46.2%) of all people taking at least one of these medicines had a dental claim in the following year. A smaller proportion of women (35.9%) made claims than men (56.9%), χ2  = 2248.77, P < 0.0001.Conclusions: Targeted interventions raising awareness of the relationship between some medicines and dry mouth, and the importance of dental visits are warranted. [ABSTRACT FROM AUTHOR]

Renly Lim, Mhairi Kerr, Elizabeth E Roughead Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia Background: It is not known if the medicines and services for COPD are used in Australia according to the COPD-X guideline. This study examined the use of medicines and health services for COPD among an Australian cohort to determine if they were consistent with recommendations.Methods: The administrative claims data from the Australian Government Department of Veterans’ Affairs were used and included persons aged ≥50 years who were using medicines for COPD in April 2016. Use of medicines was identified using the Anatomical, Therapeutic and Chemical Classification and Pharmaceutical Benefits Scheme. Use of services was identified using the Medicare Benefits Schedule and Australian Government Department of Veterans’ Affairs Fee Schedule.Results: Of the 143,261 persons aged ≥50 years, 12,623 (8.8%) were on medicines for COPD. Of the total COPD population, 42% were managed on monotherapy, 36% on dual therapy, 21% on triple therapy, and 1.5% on more than three COPD medicines. Monotherapy comprised tiotropium (80%) predominantly. Services to practitioners who may provide pulmonary rehabilitation service showed less than 10% of the cohort had a claim for a visit to an exercise physiologist and less than a third had a claim for a physiotherapist visit in the prior 12 months. Services to assist with care coordination in the form of general practitioner management plans were only claimed by half of the cohort, while services supporting appropriate medicine use were claimed by less than one in six cases, despite high levels of inhaler use and multiple inhaler use.Conclusion: More than three-quarters of COPD persons aged 50 years and above were managed on either monotherapy or dual therapy, consistent with the guideline recommendations. Almost one-quarter was on three or more therapies, which will create challenges for multiple device management. Many services that may benefit persons with COPD appear to be underutilized. Keywords: Australia, chronic obstructive pulmonary disease, health services administration, medicine utilization

Louise E Bartlett, Nicole L Pratt, Elizabeth E Roughead Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute for Health Research, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia Purpose: Many studies of persistence involving fixed dose combinations (FDCs) of cardiovascular medicines have not adequately accounted for a user’s prior experience with similar medicines. The aim of this research was to assess the effect of prior medicine experience on persistence to combination therapy. Patients and methods: Two retrospective cohort studies were conducted in the complete Pharmaceutical Benefits Scheme prescription claims dataset. Initiation and cessation rates were determined for combinations of: ezetimibe/statin; and amlodipine/statin. Initiators to combinations of these medicines between April and September 2013 were classified according to prescriptions dispensed in the prior 12 months as either: experienced to statin or calcium channel blocker (CCB); or naïve to both classes of medicines. Cohorts were stratified according to formulation initiated: FDC or separate pill combinations (SPC). Cessation of therapy over 12 months was determined using Kaplan–Meier survival analysis. Risk of cessation, adjusted for differences in patient characteristics was assessed using Cox proportional hazard models. Results: There were 12,169 people who initiated combinations of ezetimibe/statin; and 26,848 initiated combinations of amlodipine/statin. A significant proportion of each cohort were naïve initiators: ezetimibe/statin cohort, 1,964 (16.1%) of whom 81.9% initiated a FDC; and amlodipine/statin cohort, 5,022 (18.7%) of whom 55.4% initiated a FDC. Naïve initiators had a significantly higher risk of ceasing therapy than experienced initiators regardless of formulation initiated: ezetimibe/statin cohort, naïve FDC versus experienced FDC HR=3.0 (95% CI 2.8, 3.3) and naïve SPC versus experienced SPC HR=4.4 (95% CI 3.8, 5.2); and amlodipine/statin cohort naïve FDC versus experienced FDC HR=2.0 (95% CI 1.8, 2.2) and naïve SPC versus experienced SPC HR=1.5 (95% CI 1.4,1.6). Conclusion: Prescribers are initiating people to combinations of two cardiovascular medicines without prior experience to at least one medicine in the combination. This is associated with a higher risk of ceasing therapy than when combination therapy is initiated following experience with one component medicine. The use of FDC products does not overcome this risk. Keywords: polypill, adherence, persistence, antihypertensive, lipid lowering therapy, statin

Background: The application of digital technologies has shown benefits in enhancing pharmacovigilance activities but consumers views on the use of these tools for this purpose are not well described., Aim: To explore consumers' views on using digital tools to report adverse drug reactions (ADRs) and identify key features that consumers want in digital tools for ADR reporting., Method: An online survey was conducted among adults who had taken medicine in the previous six-months in Australia. The development of questions was guided by the Combined Technology Acceptance Model and Theory of Planned Behaviour (C-TAM-TPB) framework. Responses to closed-ended questions were analysed using descriptive statistics and chi-square/Fisher's exact test, while free-text responses were analysed using qualitative content analysis., Results: A total of 494 responses were included in the analysis. Eighty-seven percent of respondents preferred using digital tools for reporting ADRs. Consumers indicated a free-text space for describing ADRs (90%) as important or very important features of digital tools for ADR reporting, followed by acknowledgement of their report submission (87%) and receiving summary of previously reported ADRs (87%). Women (p < 0.001), advanced smartphone users (p < 0.001), and previous digital healthcare tool users (p = 0.017) showed higher intention to use digital tools. Consumers emphasized the importance of ease-of-use, accessibility, receiving medicine safety information, feedback, and advice for reporting ADRs via digital tools., Conclusion: Consumers prefer using digital tools for reporting ADRs and place high value on features such as a free-text space for describing ADRs, acknowledgement of report submissions, and access to summaries of previously submitted reports., Competing Interests: Conflicts of interest: The authors have no conflicts of interest to declare., (© 2024. The Author(s).)

Context: Women achieving pregnancy with infertility treatment may be at increased risk of stillbirth and neonatal death., Objective: To assess associations between clomiphene citrate (CC) use and perinatal death., Design: Whole of population data linkage cohort., Setting: South Australia., Participants: All women giving birth between July 2003 and December 2015 (n=242,077)., Methods: All births of at least 20 weeks were linked to government records of dispensed medications. A pregnancy was considered exposed to CC if a prescription was dispensed from 90 days before through to the end of a conception window. Descriptive statistics for stillbirths and neonatal deaths were stratified by multiplicity. For singletons, multivariable logistic regression models were used to examine the association of CC exposure with the combined outcome of perinatal death., Main Outcome Measures: Stillbirths and neonatal deaths (with 28 days of birth) combined as perinatal deaths., Results: Among singletons, the prevalence of stillbirth was 6.6 per 1,000 births, with neonatal deaths of 2.1 per 1,000 live births. Among singletons conceived with CC, stillbirth and neonatal death had prevalence of 10.2 and 3.1 per 1,000, respectively. For the combined outcome of perinatal death, the odds ratio was 1.54 (95% confidence interval 1.15, 2.07), stable upon adjustment for factors conveying biological (e.g. obesity, pre-gestational diabetes) and social (e.g. disadvantage) risks for perinatal death., Conclusion: Risk of perinatal death may be increased in pregnancies that follow use of CC. While established confounding factors related to infertility were taken into account, there may be some residual contribution of underlying infertility., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.)

Background: Hip osteoarthritis (OA) is a prevalent and burdensome condition that leads to impaired quality of life and a substantial economic burden. Encouraging physical activity, particularly walking, is crucial for OA management, but many individuals with hip OA fail to meet recommended activity levels. Prefabricated contoured foot orthoses have shown promise in improving hip muscle efficiency during walking in laboratory settings, but their real-world feasibility and efficacy remain uncertain., Objective: The aim of this study was to assess the feasibility of conducting a fully powered randomised controlled trial (RCT) to evaluate the effectiveness of prefabricated contoured foot orthoses, prescribed via telehealth, in people with hip OA., Methods: This feasibility trial randomised 27 participants with hip OA into two groups: prefabricated contoured foot orthoses or flat shoe inserts. Feasibility outcomes were assessed, including recruitment rate, adherence, logbook completion, and dropout rate. Patient-reported outcomes and accelerometer-measured physical activity were collected as secondary outcomes., Results: While the recruitment rate was low (0.88 people/week), adherence to the intervention (59%), logbook completion (93%), and dropout rates (7%) met or exceeded our predefined feasibility parameters. Participants found the intervention acceptable, and practicality was demonstrated with minor adverse events. Preliminary efficacy testing indicated that prefabricated contoured foot orthoses positively affected physical activity (adjusted mean difference = 2590 [260 to 4920] steps/day), with comparable outcomes for hip-related quality of life and pain., Conclusion: This trial supports proceeding to a fully powered RCT to assess the effect of teleheath prescribed prefabricated contoured foot orthoses on physical activity in people with hip OA., Study Registration Number: National Institutes of Health Trial Registry (NCT05138380)., (© 2024 The Author(s). Physiotherapy Research International published by John Wiley & Sons Ltd.)

This study aimed to investigate the current knowledge and experiences of consumers in Australia on adverse drug reaction (ADR) reporting and their reasons for reporting or not reporting ADRs, with a focus on the use of digital tools for ADR reporting., Methods: A cross-sectional online survey was conducted among adults who had taken medicine in Australia. A structured questionnaire with multiple choice or Likert scale responses with an option for participants to provide free-text responses and pretested for face validity was used. Consumer characteristics, knowledge, and ADR reporting practices were analyzed using descriptive statistics and the chi-square test or Fisher's exact test., Results: A total of 544 survey responses were included in the analysis. The majority of respondents were women (68%), and 22% were aged between 65 and 74 years. Fifty-eight percent (n = 317) of respondents knew that they could report ADRs to either the Therapeutic Goods Administration (TGA), state or territory government health department, or healthcare professionals. Three-quarters (n = 405) of respondents stated that they had experienced an ADR; of these, 36% reported an ADR to either the TGA, state or territory government health department, or healthcare professionals. Among those who reported ADRs, 58% were unaware that they could use digital tools to report ADRs. The main reason for not reporting was that they did not think the ADR was serious enough to report (39%)., Conclusion: Over half of consumers knew that they could report ADR; however, improved consumer awareness about using digital tools for ADR reporting and increased ADR reporting is needed., (© 2024. The Author(s).)

Background: Dementia is a global public health priority. The World Health Organization adopted a Global Action Plan on Dementia, with dementia awareness a priority. This study examined the knowledge, attitudes, and self-confidence with skills required for providing dementia care among primary health care providers in Vietnam., Methods: A cross-sectional study was conducted with 405 primary health care providers who worked at commune health stations and district health centers in eight provinces across Vietnam., Results: The results showed that primary health care providers had poor knowledge and little confidence but more positive attitudes toward dementia care and management., Conclusions: The results suggest the training needs for building capacity amongst primary health care providers, which will be critical as Vietnam's population ages., (© 2023. The Author(s).)

Background: This study was conducted to assess Vietnam's dementia service delivery., Methods: Using WHO methodology, website searches of key organisations focused on three aspects of Vietnam's healthcare system: (1) Health and social workforce; (2) Services, supports and treatment programs; and (3) Promotion of awareness and understanding. Data were analysed using content analysis., Results: While key members of the healthcare workforce receive some education in dementia competencies during their training, the skill-mix of staff in the current workforce appears inadequate to address the complex needs of people with dementia. Although Vietnam's general healthcare system comprises a good variety of service types, there is a lack of dementia-specific services. Available diagnosis and treatment services are concentrated in the hospital system and are mainly located in metropolitan areas, impacting their accessibility. While both community-based and institutional long-term care is available, institutional care is not universally accessible and home-based care is mainly provided by family carers who don't have access to dementia care training. There is no active dementia prevention or public awareness campaign., Conclusions: To improve the ability of Vietnam's service delivery to meet the needs of people with dementia and their carers, the skill-mix of the healthcare workforce should be strengthened by ensuring that dementia core competencies are embedded within undergraduate and graduate education programs and making post-qualification dementia care training available. The capacity of existing community-level health and social services should be expanded to ensure that integrated, specialised and comprehensive health and social services are accessible to all people with dementia. Expanding access to institutional long-term care and making dementia education available to family and other informal carers could increase choice and improve quality of care. Finally, Vietnam could look to other countries in the region with regards to the development of a dementia prevention and public awareness campaign.

Background: Residents of aged-care facilities have high rates of adverse drug events. This study aimed to identify risk factors for adverse drug events in aged-care residents., Method: This was a secondary study using data from a multicentre randomised controlled trial. Data from 224 residents for whom there was 6 months of baseline information were analysed. We assessed the risk of adverse drug events and falls (post hoc) in the subsequent 6 months. Adverse events were identified via a key word search of the resident care record and adjudicated by a multidisciplinary panel using a modified version of the Naranjo criteria. Covariates identified through univariable logistic regression, including age, sex, medicines, physical activity, cognition (Montreal Cognitive Assessment), previous adverse events and health service use were included in multivariable models., Results: Overall, 224 residents were included, with a mean age of 86 years; 70% were female. 107 (48%) residents had an adverse drug event during the 6-month follow-up. Falls and bleeding were experienced by 73 (33%) and 28 (13%) residents, respectively. Age (odds ratio [OR] 1.05, 95% confidence interval [CI] 1.01-1.10), weight (OR 1.02, 95% CI 1.002-1.04), previous fall (OR 2.58, 95% CI 1.34-4.98) and sedative or hypnotic medicine use (OR 1.98, 95% CI 1.52-2.60) were associated with increased risk of adverse drug events. Increased cognition (OR 0.89, 95% CI 0.83-0.95) was protective. Risk factors for falls were previous fall (OR 3.27, 95% CI 1.68-6.35) and sedative or hypnotic medicines (OR 3.05, 95% CI 1.14-8.16). Increased cognition (OR 0.88, 95% CI 0.83-0.95) was protective., Conclusion: Our results suggest residents with a previous fall, reduced cognition, and prescription of sedative or hypnotic medicines were at higher risk of adverse drug events and should be considered for proactive prevention., (© 2022. The Author(s).)

Aim: To examine the incidence and nature of medicine-related problems over time experienced by nursing home residents. Method: We analyzed records collected in the Reducing Medicine-Induced Deterioration and Adverse Events (ReMInDAR) trial. The trial pharmacists provided services to reduce medicine-induced deterioration and adverse reactions for residents every 8-weeks over a year. The problems identified by the pharmacists were documented in reports and subsequently classified independently by research pharmacists using the D.O.C.U.M.E.N.T system. The number and type of problems at each service and time to develop a new problem post first session were assessed. All analyses were performed using R software (Version 4.1.1). Results: The cohort was 115 nursing home residents who received 575 services. In the 12-months, a total of 673 medicine-related problems or symptom reports were identified in 112 residents. Most residents (75%) experienced a new medicine-related problem by the fourth month post the first assessment. After the first session, the proportion of residents with a new medicine-related problem or symptom report declined at each repeated pharmacy session (59% at visit 2 vs. 28% at visit 6, p < 0.01). Conclusion: Residents living in nursing homes frequently experience medicine-related problems. Our results suggest clinical pharmacist services performed every 4-months may have the potential to reduce the medicine-related problems in nursing homes., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Dorj, Lim, Ellett, Kelly, Andrade, Widagdo, Pratt, Bilton and Roughead.)

Objectives: This study aimed to identify the prevalence and correlates of depressive symptomatology among Vietnamese older people., Method: We used baseline survey data collected in 2018 from the Longitudinal Study of Ageing and Health in Vietnam (LSAHV) conducted across seven regions and comprising 6,050 people aged 60 years and over of whom 4962 completed the brief 11-item Center for Epidemiological Studies-Depression (CES-D) scale. Clinically significant depressive symptomatology was a CES-D score of 8.8 or higher. The association between demographic, physical, and mental factors with depressive symptomatology was examined using univariate and multivariable logistic regression., Results: The prevalence of depressive symptomatology was 31.3% (95% CI 29.8% - 32.9%). Depressive symptomatology was highest among people living in the Central Coast region (46.8%, 95% CI 44.5% - 49.2%). Factors associated with depressive symptomatology from the multivariable model included female sex (OR 1.3, 95% CI: 1.1-1.6), rural residence (OR 1.4, 95%CI: 1.1-1.7), not having a partner (OR 1.6, 95% CI: 1.3-1.9), low income (OR 1.8, 95% CI: 1.5-2.1), and health-limitations on activities (OR 1.3, 95% CI: 1.1-1.6). Poorer self-rated mental health (OR 2.1, 95% CI:1.8-2.5) or general health status (OR 1.5, 95% CI: 1.3-1.9) was associated with a higher prevalence of depressive symptomatology, as was poorer function with respect to different activities of daily living, and dissatisfaction with current life (OR 6.1, 95% CI: 4.4-8.4)., Conclusions: Depressive symptomatology was frequent among older Vietnamese. Efforts to improve mental health in older persons in Vietnam, including prevention, early intervention and better medical care, appear warranted., (Copyright © 2022 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.)

Background: Isolation and social distancing restrictions due to COVID-19 have the potential to impact access to healthcare services., Aims: To assess the use of pathology services during the COVID-19 pandemic initial restrictions., Methods: Repeated cross-sectional study of pathology tests utilisation during a baseline time period early in 2020 compared with pre-lockdown and lockdown due to COVID-19 in South Australia. The outcome measure was changed in a number of pathology tests compared to baseline period, particularly change in the number of troponin tests to determine potential impacts of lockdown on urgent care presentations., Results: In the community setting, the ratio of a number of pathology tests pre-lockdown and post-lockdown versus baseline period decreased from 1.02 to 0.53 respectively. The exception was microbiology molecular tests, where the number of tests was more than three times higher in the lockdown period. The number of troponin tests in emergency departments decreased in the lockdown period compared to the baseline time period; however, there was no evidence of an association between tests result (positive vs negative) and time period (odds ratio (OR) 1.09; 95% confidence interval (CI) 0.97-1.22). There was an inverse relationship between age and time period (OR 0.995; 95% CI 0.993-0.997), indicating that fewer troponin tests were conducted in older people during the lockdown compared with the baseline period., Conclusion: COVID-19 restrictions had a significant impact on the use of pathology testing in both urgent and non-urgent care settings. Further studies are needed to investigate the effect on health outcomes as a result of the COVID-19 restrictions., (© 2021 Royal Australasian College of Physicians.)

Objective: To determine the proportion of pregnancies resulting in birth that were conceived with the use of clomiphene citrate (CC) and the frequency of multiple pregnancy., Design: Whole-of-population cohort study, constructed through data linkage. Comprehensive Australian Government records of dispensed medications were linked to state Perinatal Registry records for all births of at least 20 weeks' gestation., Setting: The state of South Australia., Patient(s): Women who maintained pregnancy for at least 20 weeks and gave birth between July 2003 and December 2015, a total of 150,713 women with 241,561 pregnancies., Intervention(s): Not applicable., Main Outcome Measure(s): Ongoing pregnancy occurring in proximity to CC, defined as dispensing from 90 days before to the end of a conception window derived from newborn date of birth and gestational age., Result(s): Linkage to dispensed prescription records was achieved for 97.9% of women. Women who conceived with CC tended to be older and socioeconomically advantaged and more likely than other women to have a history of miscarriage. Ongoing pregnancies associated with CC comprised 1.6% of the total; 5.7% were multiple births (mostly twins, 94.6%) compared with 1.5% in the remainder (98.5% twins)., Conclusion(s): In South Australia, 1.6% of pregnancies (1 in 60) of at least 20 weeks' gestation were conceived proximal to CC dispensing. Of these, 5.7% were multiple pregnancies. This takes the proportion of women who achieved an ongoing pregnancy with medical assistance from 4.4%, based on reports from assisted reproductive technology clinics, to 6% in total., (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Case-crossover studies have been widely used in various fields including pharmacoepidemiology. Vines and Farrington indicated in 2001 that when within-subject exposure dependency exists, conditional logistic regression can be biased. However, this bias has not been well studied., Methods: We have extended findings by Vines and Farrington to develop a weighting method for the case-crossover study which removes bias from within-subject exposure dependency. Our method calculates the exposure probability at the case period in the case-crossover study which is used to weight the likelihood formulae presented by Greenland in 1999. We simulated data for the population with a disease where most patients receive a cyclic treatment pattern with within-subject exposure dependency but no time trends while some patients stop and start treatment. Finally, the method was applied to real-world data from Japan to study the association between celecoxib and peripheral edema and to study the association between selective serotonin reuptake inhibitor (SSRI) and hip fracture in Australia., Results: When the simulated rate ratio of the outcome was 4.0 in a case-crossover study with no time-varying confounder, the proposed weighting method and the Mantel-Haenszel odds ratio reproduced the true rate ratio. When a time-varying confounder existed, the Mantel-Haenszel method was biased but the weighting method was not. When more than one control period was used, standard conditional logistic regression was biased either with or without time-varying confounding and the bias increased (up to 8.7) when the study period was extended. In real-world analysis with a binary exposure variable in Japan and Australia, the point estimate of the odds ratio (around 2.5 for the association between celecoxib and peripheral edema and around 1.6 between SSRI and hip fracture) by our weighting method was equal to the Mantel-Haenszel odds ratio and stable compared with standard conditional logistic regression., Conclusion: Case-crossover studies may be biased from within-subject exposure dependency, even without exposure time trends. This bias can be identified by comparing the odds ratio by the Mantel-Haenszel method and that by standard conditional logistic regression. We recommend using our proposed method which removes bias from within-subject exposure dependency and can account for time-varying confounders., (© 2021. The Author(s).)

Aims: Medication cessation and service disengagement often precedes relapse in people with severe mental illnesses but currently specialist mental health services only become involved after a relapse. Early detection of non-adherence is needed to enable intervention to avert relapse. This paper aims to demonstrate how digitally automated non-adherence risk monitoring from Medicare data with active follow-up can work and perform in practice in a real-world mental health service setting., Methods: AI 2 software is an automated risk monitoring tool to detect non-adherence using Medicare data. It was implemented prospectively in a cohort of 354 registered patients of a community mental health clinic between July 2019 and February 2020. Patients flagged as at risk by the software were reviewed by two clinicians. We describe the risks automatically flagged for non-adherence and the clinical responses. We examine differences in clinical and demographic factors in patients flagged at increased risk of non-adherence., Results: In total, 46.7% (142/304) were flagged by the software as at risk of non-adherence, and 22% (31/142) received an intervention following clinician review of their case notes. Patients flagged by the software were older in age and had more prior mental health treatment episodes. More alerts were associated with patients who had been transferred from the mental health service to the care of their general practitioners, and those with more alerts were more likely to receive a follow-up intervention., Conclusion: Digitally automated monitoring for non-adherence risk is feasible and can be integrated into clinical workflows in community psychiatric and primary care settings. The technology may assist clinicians and services to detect non-adherence behaviour early, thereby triggering interventions that have the potential to reduce rates of mental health deterioration and acute illness relapse.

Introduction: Antidepressant use during the first trimester is reported in 4-8% of pregnancies. The use of some selective serotonin reuptake inhibitors during the first trimester has been identified as increasing the odds for congenital heart defects; however, little is known about the safety of non-selective serotonin reuptake inhibitor antidepressants., Objective: The objective of this study was to assess the odds of congenital heart defects associated with the use of antidepressants during the first trimester of pregnancy, and to update the literature as newer studies have been published since the latest systematic literature review and meta-analysis., Methods: PubMed and Embase were searched till 3 June, 2020. Study quality was assessed, and study details were extracted. Meta-analyses were performed using RevMan 5.4, which assessed: (1) any antidepressant usage; (2) classes of antidepressants; and (3) individual antidepressants., Results: Twenty studies were identified, encompassing 5,337,223 pregnancies. The odds ratio for maternal use of any antidepressant during the first trimester of pregnancy and the presence of congenital heart defects from the random effects meta-analysis was 1.28 (95% confidence interval [CI] 1.17-1.41). Significant odds ratios of 1.69 (95% CI 1.37-2.10) and 1.25 (95% CI 1.15-1.37) were reported for serotonin norepinephrine reuptake inhibitors and selective serotonin reuptake inhibitors, respectively. A non-statistically significant odds ratio of 1.02 (95% CI 0.82-1.25) was reported for the tricyclic antidepressants. Analyses of individual SSRIs produced significant odds ratios of 1.57 (95% CI 1.25-1.97), 1.36 (95% CI 1.08-1.72), and 1.29 (95% CI 1.14-1.45) for paroxetine, fluoxetine, and sertraline, respectively. The norepinephrine-dopamine-reuptake inhibitor bupropion also produced a significant odds ratio of 1.23 (95% CI 1.01-1.49)., Conclusions: The selective serotonin reuptake inhibitor and serotonin norepinephrine reuptake inhibitor classes of antidepressants pose a greater risk for causing congenital heart defects than the tricyclic antidepressants. However, this risk for individual antidepressants within each class varies, and information regarding some antidepressants is still lacking.

As a medicine safety issue, Drug-Drug Interaction (DDI) may become an unexpected threat for causing Adverse Drug Events (ADEs). There is a growing demand for computational methods to efficiently and effectively analyse large-scale data to detect signals of Adverse Drug-drug Interactions (ADDIs). In this paper, we aim to detect high-quality signals of ADDIs which are non-spurious and non-redundant. We propose a new method which employs the framework of Bayesian network to infer the direct associations between the target ADE and medicines, and uses domain knowledge to facilitate the learning of Bayesian network structures. To improve efficiency and avoid redundancy, we design a level-wise algorithm with pruning strategy to search for high-quality ADDI signals. We have applied the proposed method to the United States Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) data. The result shows that 54.45% of detected signals are verified as known DDIs and 10.89% were evaluated as high-quality ADDI signals, demonstrating that the proposed method could be a promising tool for ADDI signal detection., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Medications with anticholinergic or sedative effects are frequently used by older people but can increase risk of falls and adverse events; however, less is known about their effect on movement behaviour. Here we examine the cross-sectional association between medication use and movement behaviour in older adults living in residential aged care., Materials and Methods: Twenty-eight older adults living in residential aged care in metropolitan Australia participated. Medication data were collected from participants' medical charts and sedative load and anticholinergic burden were determined. Seven-day movement behaviour was objectively assessed by a wrist-worn triaxial accelerometer. Raw accelerations were converted to sleep, sedentary time, and time in light, moderate, and moderate-to-vigorous physical activity. To explore the relationship between medication and movement behaviour, Spearman's Rho correlations were conducted, as the data were not normally distributed., Results: Analyses indicated that while anticholinergic burden was not associated with movement behaviour, sedative load was negatively correlated with a number of variables, accounting for 14% variance in moderate-to-vigorous physical activity (MVPA), and 17% in the bout length of MVPA ( p  < .02)., Conclusion: The findings of this study showed a negative association between sedative load, due to medicines, and an individual's movement behaviour. The impact of this could be a reduction in the ability of this population to maintain or improve their functional mobility, which may overshadow any benefits of the medicine in some circumstances., Competing Interests: Alison Penington and Megan Corlis were employed by Helping Hand Organisation at the time of the study., (©2020 Parfitt et al.)

Purpose: To investigate the impact of the type of the intraocular lenses (IOLs) in first-eye cataract surgery in elderly people on the risk of hospitalisation due to falls and injuries., Methods: A retrospective cohort study was conducted using the Australian Government Department Veterans' Affairs claims data. All people aged 65 years and above who had first cataract surgery between January 2007 and July 2017 were identified. Two cohorts were established depending on the type of IOL-monofocal and multifocal. The risk of injuries and falls requiring hospitalisation in the first 3 months post the surgery was assessed using Cox proportional hazard models with age at entry as primary time scale and adjusting for gender, comorbidities and prior history of falls., Results: There were 45 728 people across the two cohorts with the majority receiving monofocal lenses (97%), followed by multifocal lenses (3%) at the time of first cataract surgery. The risk of injury and falls was lower (but not significant) in the multifocal cohort compared to monofocal cohort (adjusted hazard ratio (aHR) 0.56, 95% CI 0.26-1.17). The risk was also lower (but not significant) when stratifying by age group at the time of the surgery., Conclusions: Regardless of age, multifocal lenses did not appear to be associated with the higher risk of serious injuries and falls after first-eye cataract surgery compared to monofocal lenses., (© 2019 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Adverse drug events (ADEs) may occur and lead to severe consequences for the public, even though clinical trials are conducted in the stage of pre-market. Computational methods are still needed to fulfil the task of pharmacosurveillance. In post-market surveillance, the spontaneous reporting system (SRS) has been widely used to detect suspicious associations between medicines and ADEs. However, the passive mechanism of SRS leads to the hysteresis in ADE detection by SRS based methods, not mentioning the acknowledged problem of under-reporting and duplicate reporting in SRS. Therefore, there is a growing demand for other complementary methods utilising different types of healthcare data to assist with global pharmacosurveillance. Among those data sources, prescription data is of proved usefulness for pharmacosurveillance. However, few works have used prescription data for signalling ADEs. In this paper, we propose a data-driven method to discover medicines that are responsible for a given ADE purely from prescription data. Our method uses a logistic regression model to evaluate the associations between up to hundreds of suspected medicines and an ADE spontaneously and selects the medicines possessing the most significant associations via Lasso regularisation. To prepare data for training the logistic regression model, we adapt the design of the case-crossover study to construct case time and control time windows for the extraction of medicine use information. While the case time window can be readily determined, we propose several criteria to select the suitable control time windows providing the maximum power of comparisons. In order to address confounding situations, we have considered diverse factors in medicine utilisation in terms of the temporal effect of medicine and the frequency of prescription, as well as the individual effect of patients on the occurrence of an ADE. To assess the performance of the proposed method, we conducted a case study with a real-world prescription dataset. Validated by the existing domain knowledge, our method successfully traced a wide range of medicines that are potentially responsible for the ADE. Further experiments were also carried out according to a recognised gold standard, our method achieved a sensitivity of 65.9% and specificity of 96.2%., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Aim: To determine the extent to which evidence-based medication safety practices have been implemented in public and private mental health inpatient units across Australia., Methods: The Reducing Adverse Medication Events in Mental Health survey was piloted in Victoria, Australia, in 2015, and rolled out nationally in 2016. In total, 235 mental health inpatient units from all States and Territories in Australia were invited to participate. The survey included questions about the demographics of the mental health unit, evidence-based strategies to improve prescription writing, the administration and dispensing of medicines and pharmacy-led interventions, and also questions relating to consumer engagement in medication management and shared decision-making., Results: The response rate was 45% (N = 106 units). Overall, the survey found that 57% of the mental health units had fully or partially implemented evidence-based medication safety practices. High levels of implementation (80%) were reported for the use of standardized medication charts such as the National Inpatient Medication Chart as a way to improve medication prescription writing. Most (71%) of the units were using standardized forms for recording medication histories, and 56% were using designated forms for Medication Management Plans. However, less than one-fifth of the units had implemented electronic medication management systems, and the majority of units still relied on paper-based documentation systems.Interventions to improve medicine administration and dispensing were not highly utilized. Individual patient-based medication distribution systems were fully implemented in only 9% of the units, with a high reliance (81%) on ward stock or imprest systems. Tall Man lettering for labelling was implemented in only one-third of the units.Pharmacy services were well represented in mental health units, with 80% having access to onsite pharmacist services providing assessments of current medications and clinical review services, adverse drug reaction reporting and management services, patient and carer education and counselling, and medicines information services. However, pharmacists were involved in only half of medical reconciliations. Their involvement in post-discharge follow-up was limited to 4% of units., Conclusions: Gaps in medication safety practices included limited use of individual patient supply systems for medication distribution, a high reliance on ward stock systems and high reliance on paper-based systems for medication prescribing and administration. With regards to service provision, clinical pharmacist involvement in medical reconciliation services, therapeutic drug monitoring and interdisciplinary ward rounds should be increased. Discharge and post-discharge services were major gaps in service provision.

Background: In asthma, underuse of cost-effective preventive treatments increases morbidity and mortality. The cost of medicines contributes to underuse ("nonadherence"), but the extent to which people with asthma skip or reduce doses or let prescriptions go unfilled when faced with cost pressures is unknown., Objective: To estimate the extent of cost-related underuse behaviors and associated factors., Methods: Using previously validated summary indicators, we conducted an online cross-sectional survey of adults and parents of children 5 to 17 years with asthma in Australia (a high-income country) and developed logistic regression models for adults and children with asthma, controlling for key clinical and demographic factors., Results: The survey was completed by n = 792 adults (mean age, 47 [standard deviation, 17] years, male 47%, concession 60%) and n = 609 parents of children (5-10 years 51%, male 60%, concession 59%) with asthma. Cost-related underuse was reported by 52.9% adults and 34.3% parents, predominantly decreasing or skipping doses to make medicines last longer. Higher odds of cost-related underuse were observed with younger adults (adults: odds ratio [OR]: 1.19; 95% confidence interval [CI]: 1.12, 1.27), males (adults: OR: 1.49; 95% CI: 1.06, 2.08), having concerns about medicines (adults: OR: 3.12; 95% CI: 2.17, 4.35; parents: OR: 2.63; 95% CI: 1.56, 4.55), less comfortable talking to prescribers about cost (parents: OR: 1.22; 95% CI: 1.12, 1.33) or changing medicines (adults: OR: 1.12; 95% CI: 1.03, 1.22), feeling less engaged with prescribers about medicine decisions (parents: OR: 1.11; 95% CI: 1.01, 1.23), and with poorer asthma control (adults, poor control: OR: 1.87; 95% CI: 1.13, 3.09; parents, poor control: OR: 3.87; 95% CI: 1.99, 7.54), and requiring specialist (parents: OR: 1.83; 95% CI: 1.16, 2.87) or urgent health care visits (adults: OR: 1.54; 95% CI: 1.06, 2.23). Income and concession card status were not associated with cost-related underuse., Conclusions: Adults and parents of children with asthma indicate high rates of cost-related underuse of asthma medicines, even in the context of national medicines subsidies. Urgent targeting of interventions to promote discussion of medicines and costs between doctor and patients, particularly young adult males, is needed., (Copyright © 2019 American Academy of Allergy, Asthma & Immunology. All rights reserved.)

Objective Out-of-pocket costs strongly affect patient adherence with medicines. For asthma, guidelines recommend that most patients should be prescribed regular low-dose inhaled corticosteroids (ICS) alone, but in Australia most are prescribed combination ICS-long-acting β2-agonists (LABA), which cost more to patients and government. The present qualitative study among general practitioners (GPs) explored the acceptability, and likely effect on prescribing, of lower patient copayments for ICS alone. Methods Semistructured telephone interviews were conducted with 15 GPs from the greater Sydney area; the interviews were transcribed and thematically analysed. Results GPs reported that their main criteria for selecting medicines were appropriateness and effectiveness. They did not usually discuss costs with patients, had low awareness of out-of-pocket costs and considered that these were seldom prohibitive for asthma patients. GPs strongly believed that patient care should not be compromised to reduce cost to government. They favoured ICS-LABA combinations over ICS alone because they perceived that ICS-LABA combinations enhanced adherence and reduced costs for patients. GPs did not consider that lower patient copayments for ICS alone would affect their prescribing. Conclusion The results suggest that financial incentives, such as lower patient copayments, would be unlikely to encourage GPs to preferentially prescribe ICS alone, unless accompanied by other strategies, including evidence for clinical effectiveness. GPs should be encouraged to discuss cost barriers to treatment with patients when considering treatment choices. What is known about the topic? Australian guidelines recommend that most patients with asthma should be treated with low-dose ICS alone to minimise symptom burden and risk of flare ups. However, most patients in Australian general practice are instead prescribed combination ICS-LABA preventers, which are indicated if asthma remains uncontrolled despite treatment with ICS alone. It is not known whether GPs are aware that the combination preventers have a higher patient copayment and a higher cost to government. What does this paper add? This qualitative study found that GPs favoured combination ICS-LABA inhalers over ICS alone because they perceived ICS-LABA combinations to have greater effectiveness and promote patient adherence. This aligned with GPs' views that their primary responsibility was patient care rather than generating cost savings for government. However, it emerged that GPs rarely discussed medicine costs with patients, had low knowledge of medicine costs to patients and the health system and reported that patients rarely volunteered cost concerns. GPs believed that lower patient copayments for asthma preventer medicines would have little effect on their prescribing practices. What are the implications for practitioners? This study suggests that, when considering asthma treatment choices, GPs should empathically explore with the patient whether cost-related medication underuse is an issue, and should be aware of the option of lower out-of-pocket costs with guideline-recommended ICS alone treatment. Policy makers must be aware that differential patient copayments for ICS preventer medicines are unlikely to act as an incentive for GPs to preferentially prescribe ICS alone preventers, unless the position of these preventers in guidelines and evidence for their clinical effectiveness are also reiterated.

Competing Interests: Conflict of interest: none declared

Background: In Australia, many patients who are initiated on asthma controller inhalers receive combination inhaled corticosteroid/long-acting beta 2 -agonist (ICS/LABA) despite having asthma of sufficiently low severity that ICS-alone would be equally effective and less costly for the government., Methods: We conducted a discrete choice experiment (DCE) in a nationally representative sample of adults (n = 792) and parents of children (n = 609) with asthma. Mixed multinomial models were estimated and calibrated to reflect the estimated market shares of ICS-alone, ICS/LABA and no controller. We then simulated the impact of varying patient co-payment on demand and the financial impact on government pharmaceutical expenditure., Results: Preference for inhaler decreased with increasing costs to the patient or government, increasing chance of a repeat visit to the doctor, and if fewer symptoms were present. Adults preferred high-strength controllers, but parents preferred low-strength inhalers for children (general beneficiaries only). The DCE predicted a higher proportion choosing controller treatment (89%) compared to current levels (57%) at the current co-payment level, with proportionately higher uptake of ICS-alone and a lower average cost per patient [32.73 Australian dollars (AU$) c.f. AU$38.54]. Reducing the co-payment on ICS-alone by 50% would increase its market share to 50%, whilst completely removing the co-payment would only have a small marginal impact on market share, but increased average cost of treatment to the government to AU$41.04 per person., Conclusions: Patient-directed financial incentives are unlikely to encourage much switching of medicines, and current levels of under-treatment are not explained by patient preferences. Interventions directed at prescribers are more likely to promote better use of asthma medicines.

Based on data from the Longitudinal Study of Australian Children linked with pharmacy dispensing data from the Australian Government's Pharmaceutical Benefits Scheme, we calculated the 1-year prevalence of psychotropic medicine supply in children and adolescents with Autism Spectrum Disorder (ASD) as reported by parents in 2014. The majority of children and adolescents with ASD in Australia were not treated with psychotropic medicine. One-third had claims for at least one psychotropic medication, most commonly medications for attention-deficit/hyperactivity disorder (ADHD), and antidepressants. Antipsychotics were supplied to less than one in twenty children and approximately one in ten adolescents. In line with findings from North America, psychotropic medicine was more often supplied to children and adolescents with ASD and comorbid ADHD.