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Abstract Background This study aimed to examine current utilisation of prescribed medicines amongst Australian women of child-bearing age, with a particular focus on the extent of use of medicines in Category D and X risk groups, which are moderate and high risk teratogens, respectively. The use of those medicines may pose risk of birth defects in pregnant women. Methods A retrospective cross-sectional study was undertaken involving all women of child-bearing age (15 to 44 years) who were dispensed medicines in 2013 using the 10 % random sample of dispensing data from the Australian Government Department of Human Services. Dispensing patterns were reported by medicine, therapeutic class, pregnancy risk category and women's age. Results Over one-third of women aged 15 to 44 years received at least one prescribed medicine in 2013. Psychoanaleptics, antibiotics and analgesics were the top three classes. Around 9 % of all dispensings were for medicines from risk category D, with statins, agents acting on renin-angiotensin system, and some anti-epileptic agents being the most commonly used. Both statins and agents acting on renin-angiotensin system showed increasing use with age, estimated to be 35,600 women nationally for each group. Collectively between 2 % and 4 % of women used anti-epileptics from risk category D in each year of age, with overall use estimated to be 51,000 women nationally. Below 1 % of all dispensings were for category X medicines, mainly isotretinoin. Conclusions It is important for medical practitioners to offer counselling around pregnancy planning and the risk of birth defects when prescribing moderate or high risk teratogens to women in child-bearing age. For the antihypertensives and some anti-epileptics, alternative medicines with lower risk categorization are available.

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

The quality of nursing home care for older people, including medication use and related outcomes, has been problematic in a number of developed countries. This paper compares the policy approaches to drug prescribing and administration in nursing homes adopted by four countries. The United States has led the way in terms of regulating and inspecting nursing homes, with strict requirements for prescribing psycho-tropic medications, commonly known as "chemical restraints." These requirements have been facilitated by detailed data collection mandated by the US government. Although regulation has led to marked reductions in the prescribing of these agents, underused medications have received little attention. Despite similar problems with the use of psychotropic drugs, the United Kingdom, Australia and New Zealand have adopted a more generic approach to drug use in the nursing home setting, a situation that may reflect the different organization and ethos of healthcare systems in these countries. Developments in systematic medication data capture, greater collaboration and more educational feedback to prescribers and facilities would represent a major step forward in long-term care policy in these latter three countries, while a broader educational focus would further support improvements in the US setting.

BACKGROUND: The case-crossover design is suited to medication safety studies but is vulnerable to exposure misclassification. Using the example of tricyclic antidepressants and the risk of hip fracture, we present a data visualisation tool for observing exposure misclassification in case-crossover studies. METHODS: A case-crossover study was conducted using Australian Government Department of Veterans' Affairs claims data. Beneficiaries aged over 65 years who were hospitalised for hip fracture between 2009 and 2012 were included. The case window was defined as 1–50 days pre fracture. Control window one and control window two were defined as 101–150 and 151–200 days pre fracture, respectively. Patients were stratified by whether exposure status changed when control window two was specified instead of control window one. To visualise potential misclassification, each subject's tricyclic antidepressant dispensings were plotted over the 200 days pre fracture. RESULTS: The study population comprised 8828 patients with a median age of 88 years. Of these subjects, 348 contributed data to the analyses with either control window. The data visualisation suggested that 14% of subjects were potentially misclassified with control window one while 45% were misclassified with control window two. The odds ratio for the association between tricyclic antidepressants and hip fracture was 1.18 (95% confidence interval = 0.91–1.52) using control window one, whereas risk was significantly increased (odds ratio = 1.43, 95% confidence interval = 1.11–1.83) using control window two. CONCLUSIONS: Exposure misclassification was less likely to be present with control window one than with an earlier control window, control window two. When specifying different control windows in a case-crossover study, data visualisation can help to assess the extent to which exposure misclassification may contribute to variable results.

Background: Antidepressants are associated with adverse effects such as sedation and hypotension, which can result in falls and fractures. Few studies have assessed the risk of hip fracture due to mirtazapine, and no known studies have assessed whether the risk of hip fracture is higher in patients taking other antidepressant medicines in combination with mirtazapine. Objectives: This study aimed to examine the risk of hip fracture in older people due to mirtazapine use as well as switching between or concurrently using mirtazapine and other antidepressants. Method: A matched case–control study was conducted. Cases were people aged over 65 years who were eligible for Australian Government Department of Veterans' Affairs (DVA) benefits and who sustained a hip fracture between 2009 and 2012. Each case was matched with up to four randomly selected controls of the same gender and age (± 2 years). Multivariable conditional logistic regression was used to estimate associations between antidepressant use and hip fracture. In order to assess whether combined antidepressant effects differed from the sum of individual effects, the relative excess risk due to interaction (RERI) was calculated. Results: The study population comprised 8828 cases and 35,310 controls. The median age of these participants was 88 years and 63% were women. The risk of hip fracture was increased for mirtazapine (continuous use: odds ratio [OR] 1.27, 95% confidence interval [CI] 1.12–1.44). The combinations associated with increased odds of hip fracture were addition of selective serotonin reuptake inhibitors (SSRIs) to mirtazapine (OR 11, 95% CI 2.2–51; RERI 7.7, 95% CI −9.0 to 24), addition of tricyclic antidepressants (TCAs) to mirtazapine (OR 14, 95% CI 1.4–132; RERI 12, 95% CI −19 to 43) and continuous use of both SSRIs and mirtazapine (OR 2.4, 95% CI 1.4–4.2; RERI 0.4, 95% CI −0.9 to 1.7). RERIs indicated that the effect of each antidepressant pair equalled the sum of the effects of individual antidepressant use. There was no evidence of ...

Background: Few studies have assessed the risk of hip fracture following concurrent use of psychoactive medicines, and none has investigated combinations with selective serotonin reuptake inhibitors. Objectives: To assess the risk of hip fracture in older people as a result of concurrent use of selective serotonin reuptake inhibitors and other psychoactive medicines. Methods: A matched case–control design was employed. Cases were Australian Government Department of Veterans' Affairs beneficiaries aged over 65 years who experienced a hip fracture between 2009 and 2012. Each case was matched with up to four randomly selected controls of the same age (±2 years) and sex. Medicine-hip fracture associations were estimated via conditional logistic regression. The relative excess risk due to interaction (RERI) was calculated to determine whether combined effects differed from the sum of individual effects. Results: There were 8828 cases and 35,310 controls. The median age of subjects was 88 years and 63% were women. The risk of hip fracture was elevated for all medicines assessed individually, most notably selective serotonin reuptake inhibitors (initiation: odds ratio [OR] = 2.7, 95% confidence interval [CI] 2.1, 3.6) and opioids (initiation: OR = 2.3, 95% CI 1.9, 2.9). Combinations associated with an increased odds of hip fracture included addition of benzodiazepines to selective serotonin reuptake inhibitor therapy (OR = 3.0, 95% CI 1.9, 4.8; RERI = 0.9, 95% CI −0.5, 2.3), concurrent use of both opioids and selective serotonin reuptake inhibitors (OR = 2.2, 95% CI 1.9, 2.6; RERI = 0.1, 95% CI −0.3, 0.5), addition of opioids to selective serotonin reuptake inhibitor therapy (OR = 3.2, 95% CI 1.8, 5.5; RERI = −0.1, 95% CI −2.0, 1.7), and initiation of both benzodiazepines and selective serotonin reuptake inhibitors (OR = 4.7, 95% CI 1.7, 13; RERI = 1.3, 95% CI −3.8, 6.3). The RERI results suggested that the effect of each of these medicine combinations equalled the sum of the effects of individual medicine use. ...

Abstract Background To compare the results of a new-user cohort study design and the self-controlled case series (SCCS) design using the risk of hospitalisation for pneumonia in those dispensed proton pump inhibitors compared to those unexposed as a case study. Methods The Australian Government Department of Veterans' Affairs administrative claims database was used. Exposure to proton pump inhibitors and hospitalisations for pneumonia were identified over a 4 year study period 01 Jul 2007 -30 Jun 2011. The same inclusion and exclusion criteria were applied to both studies, however, the SCCS study included subjects with a least one hospitalisation for pneumonia. Results There were 105,467 subjects included in the cohort study and 6775 in the SCCS. Both studies showed an increased risk of hospitalisations for pneumonia in the three defined risk periods following initiation of proton pump inhibitors compared to baseline. With the highest risk in the first 1 to 7 days (Cohort RR, 3.24; 95% CI (2.50, 4.19): SCCS: RR, 3.07; 95% CI (2.69, 3.50)). Conclusions This study has shown that the self-controlled case series method produces similar risk estimates to a new-users cohort study design when applied to the association of proton pump inhibitors and pneumonia. Exposure to a proton pump inhibitor increases the likelihood of being admitted to hospital for pneumonia, with the risk highest in the first week of treatment.

OBJECTIVE: To determine time to opioid cessation post discharge from hospital in persons who had been admitted to hospital for a surgical procedure and were previously naïve to opioids. DESIGN, SETTING AND PARTICIPANTS: Retrospective cohort study using administrative health claims database from the Australian Government Department of Veterans' Affairs (DVA). DVA gold card holders aged between 18 and 100 years who were admitted to hospital for a surgical admission between 1 January 2014 and 30 December 2015 and naïve to opioid therapy prior to admission were included in the study. Gold card holders are eligible for all health services that DVA funds. MAIN OUTCOME MEASURES: The outcome of interest was time to cessation of opioids, with follow-up occurring over 12 months. Cessation was defined as a period without an opioid prescription that was equivalent to three times the estimated supply duration. The proportion who became chronic opioid users was defined as those who continued taking opioids for greater than 90 days post discharge. Cumulative incidence function with death as a competing event was used to determine time to cessation of opioids post discharge. RESULTS: In 2014–2015, 24 854 persons were admitted for a surgical admission. In total 3907 (15.7%) were discharged on opioids. In total 3.9% of those discharged on opioids became chronic users of opioids. The opioid that the patients were most frequently discharged with was oxycodone; oxycodone alone accounted for 43%, while oxycodone with naloxone accounted for 8%. CONCLUSIONS: Opioid initiation post-surgical hospital admission leads to chronic use of opioids in a small percentage of the population. However, given the frequency at which surgical procedures occur, this means that a large number of people in the population may be affected. Post-discharge assessment and follow-up of at-risk patients is important, particularly where psychosocial elements such as anxiety and catastrophising are identified.

Abstract Background To determine the suitability of using the self-controlled case series design to assess improvements in health outcomes using the effectiveness of beta blockers for heart failure in reducing hospitalisations as the example. Methods The Australian Government Department of Veterans' Affairs administrative claims database was used to undertake a self-controlled case-series in elderly patients aged 65 years or over to compare the risk of a heart failure hospitalisation during periods of being exposed and unexposed to a beta blocker. Two studies, the first using a one year period and the second using a four year period were undertaken to determine if the estimates varied due to changes in severity of heart failure over time. Results In the one year period, 3,450 patients and in the four year period, 12, 682 patients had at least one hospitalisation for heart failure. The one year period showed a non-significant decrease in hospitalisations for heart failure 4-8 months after starting beta-blockers, (RR, 0.76; 95% CI (0.57-1.02)) and a significant decrease in the 8-12 months post-initiation of a beta blocker for heart failure (RR, 0.62; 95% CI (0.39, 0.99)). For the four year study there was an increased risk of hospitalisation less than eight months post-initiation and significant but smaller decrease in the 8-12 month window (RR, 0.90; 95% CI (0.82, 0.98)). Conclusions The results of the one year observation period are similar to those observed in randomised clinical trials indicating that the self-controlled case-series method can be successfully applied to assess health outcomes. However, the result appears sensitive to the study periods used and further research to understand the appropriate applications of this method in pharmacoepidemiology is still required. The results also illustrate the benefits of extending beta blocker utilisation to the older age group of heart failure patients in which their use is common but the evidence is sparse.

BACKGROUND: The use of health services is likely to vary among veterans with an accepted disability of post-traumatic stress disorder (PTSD), however, the extent of variation is not known. We aimed to determine the extent and type of health services used by veterans with an accepted disability of PTSD. METHODS: The cohort included veterans who served post 1975, were eligible for all Australian Government Department of Veterans' Affairs funded health services, had PTSD as an accepted disability prior to July 2015 and were alive at the 30 June 2016. Veterans were assigned to groups based on their use of health services using K-means cluster analysis. RESULTS: The cohort comprised five clusters involving 2286 veterans. The largest cluster (43%) were a younger, general practitioner (GP) managed cluster who saw their GP quarterly and the psychiatrist twice a year. The second GP cluster (30%) had higher levels of physical comorbidity. The psychiatrist managed cluster (14%) had a mean of 12 psychiatrist visits and one PTSD hospitalisation in the year. The remaining two clusters involved GP and allied healthcare, but no psychologist care. High levels of antidepressant use occurred in all clusters, ranging from 44% up to 69%. The psychiatrist managed cluster had 47% on antipsychotics and 58% on anxiolytics. CONCLUSION: Our study highlights the heterogeneity in health service use. These results identify the significant health utilisation required for up to one-sixth of veterans with PTSD and the significant role of primary care physicians in supporting veterans with PTSD.

BACKGROUND: In elderly populations, paracetamol may be used regularly for conditions such as osteoarthritis. Paracetamol has been associated with respiratory disease through a proposed mechanism of glutathione depletion and oxidative stress. Given that chronic obstructive pulmonary disease (COPD) is frequently co-morbid with osteoarthritis, this study investigated whether the dose and timing of paracetamol exposure may induce COPD exacerbations. METHODS: The study population was 3523 Australian Government Department of Veterans' Affairs full entitlement holders who had existing COPD on 1 January 2011, who were dispensed at least one prescription of paracetamol between 1 January 2011 and 30 September 2015, and had no paracetamol dispensed in the 6 months prior to 1 January 2011. The outcome was time to first hospitalisation for COPD exacerbation after initiation of paracetamol. A weighted cumulative exposure approach was used. RESULTS: The association between paracetamol exposure and COPD exacerbation was protective or harmful depending on the dose, duration, and recency of exposure. Compared to non-use, current use at the maximum dose of 4 g daily for 7 days was associated with a lower risk (HR = 0.78, 95% CI = 0.67–0.92) and a higher risk after 30 days (HR = 1.27, 95% CI = 1.06–1.52). Risk declined to baseline after 2 months. For past use, there was a short-term increase in risk on discontinuation depending of dose, duration and time since stopping. CONCLUSIONS: Patients and doctors should be aware of the possible risk of COPD exacerbation with higher dose paracetamol 1 to 6 weeks after initiation or discontinuation, but no increased risk after 2 months. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12931-022-02010-z.

Background: Multiple studies have assessed the appropriateness of the use of medicines for nursing home residents; however, few have included duration of use in their assessment. The aim of this study was to assess the level and duration of use of medications recommended for short-term use in residents of aged care facilities in Australia. Methods: Australian Government Department of Veterans' Affairs (DVA) administrative claims data were used for this study. Veterans eligible for all health services subsidised by DVA were followed for one year from 1 July 2015 to 30 June 2016. The number of days covered for each medicine was calculated by multiplying the number of prescriptions dispensed during the year by the pack duration for the medicine. The pack duration was calculated by dividing the quantity supplied at each dispensing by the usual number of doses per day in older people according to Australian prescribing guidelines. The proportion of patients using each medicine and the number of days covered during the study period were determined. Results: 14, 237 residents met the inclusion criteria. One in five participants were dispensed antipsychotics, and the median duration of use was 180 days in the one-year period. More than one-third were dispensed a benzodiazepine, and the median duration of use was 240 days in the year. Half were dispensed an opioid analgesic with a median duration of use of 225 days in the year. Fifty-two percent were dispensed proton pump inhibitors with a median duration of use of 360 days in the year. A quarter received an antibiotic recommended for the management of urinary tract infection, with a median duration of use of 14 days in the year. Conclusion: Long-term use of antipsychotics, benzodiazepines, opioid analgesics and proton pump inhibitors is common in aged care residents. Ensuring appropriate duration of use for these medicines is necessary to reduce risk of harm.

ABSTRACTObjectivesAlthough outcomes for the majority of women diagnosed with primary breast cancer are good, with five-year survival exceeding 90%, some women will experience cancer recurrence and ultimately die from the disease. It is important for patients, clinicians and health service planners to know the risk of recurrence once initial treatment for primary breast cancer is completed. However, none of Australia's State or Territory cancer registries routinely report on cancer recurrence which could be used to evaluate this issue. To address this absence of direct reporting, we aimed to determine the incidence of cancer recurrence in Australian clinical practice after completion of treatment for primary breast cancer, using a range of linked health data sources.
ApproachWe performed a retrospective cohort study using linked health data from New South Wales (NSW), Australia. Data were linked from six data collections: i) Cancer Registry, ii) Admitted Patient Data Collection, iii) Pharmaceutical Benefits Scheme claims, iv) Medicare (outpatient) claims, v) Death Registry; and the vi) NSW 45 and Up Study. We identified 2416 women diagnosed with primary invasive breast cancer during 2003-2008 in NSW who had not had a recurrence by 18 months post-diagnosis. Unit-level hospital, pharmacy and outpatient claims were used to identify services indicative of recurrence. Incidence of recurrence was calculated and multivariate Cox regression used to identify baseline and active treatment characteristics predictive of cancer recurrence up to six years post-diagnosis.
ResultsA total of 217 women (9.0%) had a hospital, pharmacy or outpatient claim indicating breast cancer recurrence between 18 months and six years post-diagnosis. Overall annual cumulative incidence of recurrence was 3.3%. Recurrence was significantly higher for women with node-positive (4.8% vs. 2.5% annually, adjHR=1.7, 95%CI=1.3-2.3) or hormone receptor-negative (3.8% vs. 3.1% annually, adjHR=1.3, 95%CI=1.0-1.7) tumours. Women with tumours >2cm at diagnosis were more likely to experience recurrence within six years compared with those with a smaller initial tumour (4.8% vs. 2.7 annually, adjHR=1.5; 95%CI=1.1-2.0).
ConclusionsWomen with breast cancer in this Australian cohort experienced recurrence at 3.3%pa in the years following completion of treatment. Those at greatest risk of recurrence were women with node-positive or hormone-receptor negative tumours, or tumours >2cm at initial diagnosis, consistent with international findings. This method for ascertaining breast cancer recurrence can be used to assess population-level changes over time and to investigate the impact of specific treatments on outcomes in the absence of available Cancer Registry data.

Abstract Background Stroke patients may have multiple hospital separations relating to the same stroke. Understanding the pattern of hospitalisations for these patients enables first and recurrent events to be distinguished to better understand care. The aim of this study was to investigate reasons for hospital separations after transient ischaemic attack (TIA) or ischaemic stroke and construct episode of care criteria. Methods A retrospective observational study was conducted using the Australian Government Department of Veterans' Affairs administrative claims database. All patients hospitalised for TIA or ischaemic stroke in 2008–2009 were included. Reasons for hospital separations in the 60 days after TIA or ischaemic stroke were classified by a clinical panel as 'probably', 'possibly' or 'unlikely' to be related to the index separation. Based on panel assessment and time between separations, episode of care criteria for TIA and ischaemic stroke were constructed. Results Of the 4520 veterans alive after the index separation, 32% of TIA patients (n=782) and 63% of ischaemic stroke patients (n=1323) had another separation within 60 days. The clinical panel reviewed 460 unique reasons for readmission. Of the 3263 separations, 55% and 85% were classified as related to the index TIA and ischaemic stroke separation, respectively. Conclusions Patients hospitalised for ischaemic stroke are likely to have multiple hospital separations for treatment of the same event. Multiple separations for treatment of TIA were less frequent. Consideration of these related separations is recommended when assessing health service utilisation from claims databases.