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Objective: The aim of this study was to compare the provision of medicines information in medical journal advertising in Australia, Malaysia and the United States. Methods: A consecutive sample of 85 unique advertisements from each country was selected from the advertisements published between January 2004 to December 2006 in three widely circulated medical journals and one prescribing reference manual. The availability of brand name and generic name, indication, contraindications, dosage, side-effects, warnings, interactions and precautions was compared between the three countries. Results: We examined 255 distinct advertisements for 136 pharmaceutical products. Journal advertising in Australia, Malaysia and the US usually provided brand names and generic names (range 96 -100%). Information on dosage was significantly less likely to be mentioned (32%) in the US than in Australia (92%) and Malaysia (48%) (P < 0.001). Warning information was significantly less likely to be provided in Australia (5%) than in the US (81%) and Malaysia (9%) (P < 0.001). Apart from information on brand name, generic name, warnings and dosage, other product information significantly less likely to be provided in journal advertising in Malaysia than in Australia and the US (P < 0.001). Similar trends in the provision of product information for the same medicines published in these countries were noted. Brand name and generic name were always provided in the three countries (100%). However, information on the negative effects of medicines was less frequently provided in Malaysia than in Australia and the US. Conclusions: Journal advertising in Australia, Malaysia and the US failed to provide complete product information. Low quality of information provided in Malaysia indicates the need for effective regulation of provision of medicines information in journal advertising. Different standards of medicines information provided in these three countries suggest that pharmaceutical promotion needs to be better controlled at the international level.

Refereed/Peer-reviewed Background: While age and stage at diagnosis are known to affect treatment choices and survival from colorectal cancer (CRC), few studies have investigated the extent to which these effects are influenced by comorbidity. In this study, we describe the occurrence of comorbidity in CRC cases in South Australia and associations of comorbidity with age, stage and the age-stage relationship. Furthermore, we report on the association of individual comorbidities with age and stage at diagnosis. Methods: The South Australian Cancer Registry (SACR) provided CRC data (C18-C20, ICD-10) for 2004–2013 diagnoses. CRC data were linked with comorbidity data drawn from hospital records and health insurance claims. Logistic regression was used to model associations of comorbidity with age and stage. Results: For the 8462 CRC cases in this study, diabetes, peptic ulcer disease, and previous cancers were the most commonly recorded co-existing conditions. Most comorbidities were associated with older age, although some presented more frequently in younger people. Patients at both ends of the age spectrum (

Survivors of cancer frequently experience persistent and troublesome cognitive changes. Little is known about the role diet and nutrition plays in survivors’ cognition. We explored the feasibility of collecting cross-sectional online data from Australian survivors of breast and colorectal cancer to enable preliminary investigations of the relationships between cognition with fruit and vegetable intake, and the Omega-3 Index (a biomarker of long chain omega 3 fatty acid intake). A total of 76 participants completed online (and postal Omega-3 Index biomarker) data collection (62 breast and 14 colorectal cancer survivors): mean age 57.5 (±10.2) years, mean time since diagnosis 32.6 (±15.6) months. Almost all of the feasibility outcomes were met; however, technical difficulties were reported for online cognitive testing. In hierarchical linear regression models, none of the dietary variables of interest were significant predictors of self-reported or objective cognition. Age, BMI, and length of treatment predicted some of the cognitive outcomes. We demonstrated a viable online/postal data collection method, with participants reporting positive levels of engagement and satisfaction. Fruit, vegetable, and omega-3 intake were not significant predictors of cognition in this sample, however the role of BMI in survivors′ cognitive functioning should be further investigated. Future research could adapt this protocol to longitudinally monitor diet and cognition to assess the impact of diet on subsequent cognitive function, and whether cognitive changes impact dietary habits in survivors of cancer. Refereed/Peer-reviewed

Objective The aim of this study was to describe patterns of health service utilisation among the Australian population with cancer compared with the general population. Methods Data for all respondents aged ≥25 years from two successive National Health Surveys conducted between 2011 and 2014 were analysed. Respondents with a history of cancer were identified as the cancer group, whereas all other respondents who did not report having had a cancer were included in the non-cancer control group. Comparisons were made between the two groups using logistic regression models. Results The population with cancer was more likely to report having consulted their general practitioner, specialist, chemist, dietician, naturopath, nurse, optometrist, dentist, audiologist and other health professionals than the non-cancer population. The cancer population was also more likely to be admitted to hospital and to have visited an out-patient clinic, emergency department and day clinic. The presence of comorbidity and a current cancer were associated with a greater likelihood of receiving health services among the population with cancer. Conclusion The population with cancer used health services significantly more than the non-cancer population. Further studies are urgently needed to identify optimal approaches to delivery of care for this population, including barriers and enablers for their implementation. What is known about the topic? Multimorbidity is highly prevalent among the cancer population due to risk factors shared between cancer and other chronic diseases, and the development of new conditions resulting from cancer treatment and cancer complications. However, the Australian healthcare system is not set up optimally to address issues related to multimorbidity. What does this paper add? This study is the first step in quantifying health services use by the population with cancer compared with the general population without cancer. Cancer survivors have an increased need for specific health services, particularly among those with multimorbidity. What are the implications for practitioners? The development of integrated care models to manage multiple chronic diseases aligned with the Australian National Strategic Framework for Chronic Conditions is warranted. Further studies are urgently needed to identify optimal approaches to delivery of care for this population, including barriers and enablers for their implementation.

Objective: To compare how frequently selected chronic diseases developed in women with breast cancer receiving endocrine therapy, and in women without cancer. Design, setting and participants: Retrospective, rolling cohort study, analysing a random 10% sample of Pharmaceutical Benefits Scheme (PBS) data for the period 1 January 2003 – 31 December 2014. Women with breast cancer who first commenced endocrine therapy between January 2004 and December 2011 were identified, and age- and sex-matched (1:10) by comorbidity with control groups of women who did not have a dispensing record for antineoplastic agents during the study period or the comorbidity of interest at baseline. Main outcome measures: Development of any of eight pre-selected comorbidities, identified in PBS claims data with the RxRisk-V model. Results: Women with hormone-dependent breast cancer were significantly more likely than women in the control group to develop depression (overall hazard ratio [HR], 1.36; 95% CI, 1.26–1.46), pain or pain–inflammation (HR, 1.30; 95% CI, 1.23–1.38), osteoporosis (overall HR, 1.27; 95% CI, 1.17–1.39), diabetes (HR, 1.24; 95% CI, 1.10–1.41), cardiovascular disorders (overall HR, 1.22; 95% CI, 1.13–1.32), and gastric acid disorders (HR, 1.20; 95% CI, 1.13–1.28). The hazard ratios for developing cardiovascular disorders, depression and osteoporosis were highest during the first year of endocrine therapy. The risk of hyperlipidaemia was lower among women with breast cancer than in the control group (HR, 0.88; 95% CI, 0.81–0.96). There was no significant difference between the two groups in the risk of reactive airway diseases (HR, 1.05; 95% CI, 0.98–1.13). Conclusion: Comorbid conditions are more likely to develop in women who have been diagnosed with hormone-dependent breast cancer than in women without cancer. Our results further support the need to develop appropriate models of care to manage the multiple chronic disorders of breast cancer survivors. Refereed/Peer-reviewed

Relationships between consumer organizations and pharmaceutical manufacturers are the focus of transparency efforts in some jurisdictions, including Australia. This study describes the frequency and nature of industry sponsorship of Australian health consumer organizations and examines the link between sponsorship of the most highly funded organizations and manufacturers’ requests for public reimbursement of products for related health conditions. We downloaded 130 transparency reports covering the period January 2013 to December 2016 from the website of Medicines Australia and carried out a descriptive analysis. For the most heavily funded organizations and their sponsors, we examined Public Summary Documents of the Pharmaceutical Benefits Advisory Committee to identify relevant products under consideration for public reimbursement over the study period. Thirty-four pharmaceutical companies provided 1,482 sponsorships to 230 organizations, spending a total of AU$34,507,810. The top clinical areas in terms of amount of funding received were cancer, eye health, and nervous system disorders. The sponsors of the most highly funded groups were companies that in most cases had drugs under review for public reimbursement for conditions covered by these organizations. Interactions between the pharmaceutical industry and consumer organizations are common and require careful management to prevent biases that may favor sponsors’ interests above those of patients and the public. Refereed/Peer-reviewed

Objective To describe medication-related quality of care (MRQOC) for Australian aged care residents. Design Retrospective cohort using an administrative healthcare claims database. Setting Australian residential aged care. Participants A total of 17 672 aged care residents who were alive at 1 January 2013 and had been a permanent resident for at least 3 months. Main outcome measures Overall, 23 evidence-based MRQOC indicators which assessed the use of appropriate medications in chronic disease, exposure to high-risk medications and access to collaborative health services. Results Key findings included underuse of recommended cardiovascular medications, such as the use of statins in cardiovascular disease (56.1%). Overuse of high-risk medications was detected for medications associated with falls (73.5%), medications with moderate to strong anticholinergic properties (46.1%), benzodiazepines (41.4%) and antipsychotics (33.2%). Collaborative health services such as medication reviews were underutilised (42.6%). Conclusion MRQOC activities in this population should be targeted at monitoring and reducing exposure to antipsychotics and benzodiazepines, improving the use of preventative medications for cardiovascular disease and improving access to collaborative health services. Similarity of suboptimal MRQOC between Australia and other countries (UK, USA, Canada and Belgium) presents an opportunity for an internationally collaborative approach to improving care for aged care residents.

Medicines Access Programs (MAP) offer access to publicly unfunded medicines at the discretion of pharmaceutical companies. Limited literature is available on their extent and scope in Australia and New Zealand. This study aims to identify MAPs for cancer medicines that were operational in 2014-15 in Australia and New Zealand and describe their characteristics. A preliminary list of MAPs was sent to hospital pharmacists in Australia and New Zealand to validate and collect further information. Pharmaceutical companies were contacted directly to provide information regarding MAPs offered. Key stakeholders were interviewed to identify issues with MAPs. Fifty-one MAPs were identified covering a range of indications. The majority of MAPs were provided free of charge to the patient for medicines that were registered or in the process of being registered but were not funded. Variability in the number of MAPs across institutions and characteristics was observed. Australia offered more MAPs than New Zealand. Only two of 17 pharmaceutical companies contacted agreed to provide information on their MAPs. Eight stakeholder interviews were conducted. This identified that while MAPs are widely operational there is lack of clinical monitoring, inequity to access, operational issues and lack of transparency. Our results suggest a need for a standardised and mandated policy to mitigate issues with MAPs. Refereed/Peer-reviewed

Background: Coexistence of multiple chronic diseases is highly prevalent among the cancer population. This study aims to assess changes in the prevalence of chronic conditions among the population with cancer compared to the Australian general population between 2007 and 2014. Methods: Data from three successive National Health Surveys conducted by the Australian Bureau of Statistics between 2007 and 2014 were utilized. Comparisons were made between the samples of the Australian population aged 25 years and above with a history of cancer and those respondents who did not report having had a cancer using logistics regression models. Results: People with a history of cancer had significantly higher odds of reporting non-infectious comorbidity compared to the non-cancer groups across the three surveys. There were no significant changes in the prevalence of diseases affecting circulatory, musculoskeletal, digestive, nervous system, blood and blood forming organs, eye, skin and infectious and parasitic diseases over time among the population with cancer. The prevalence of mental and behavioural problems, endocrine, nutritional and metabolic diseases, and diseases of respiratory and genitourinary system has increased over time among the cancer survivors. Conclusion: Comorbidity is more prevalent among the cancer population than the general population without cancer. The prevalence of comorbidity was fairly stable for most but not all comorbidities in the population with cancer over the eight-year study period. Further studies on the impacts of coordinated care models for the management of multi-morbidity experienced by cancer survivors that align with the 'National Strategic Framework for Chronic Conditions' are needed. Refereed/Peer-reviewed

Background The increasing use of androgen deprivation therapy has prompted further evaluation of its potential adverse effects as the treatment may exacerbate or increase the risk of developing new comorbid diseases. This study aims to assess the patterns of comorbidities among Australian men with prostate cancer treated with androgen deprivation therapy. Methods Pharmaceutical Benefits Scheme (PBS) 10% data between 1 January 2003 and 31 December 2014 was utilised in this retrospective cohort study. Men who had received their first androgen deprivation therapy between 2004 and 2010 were selected as the prostate cancer cohort. Comorbidities were identified using the dispensing claims data and classified with the Rx-Risk-V model. Comparisons were made between the prostate cancer cohort and specific control groups (age-matched and sex-matched without any dispensing of anti-neoplastic agents during the study period and without the individual comorbidity of interest evaluated at baseline at 1:10 ratio) for the development of nine individual comorbidities over time using Cox regression models. Results The prostate cancer cohort had a significant higher risk of developing cardiovascular conditions (hazard ratio 1.37, 95% CI:1.26–1.48), depression (1.86, 95% CI: 1.73–2.01), diabetes (1.30, 95% CI: 1.15–1.47), gastric acid disorders (1.48, 95% CI:1.39–1.57), hyperlipidaemia (1.18, 95% CI: 1.09–1.29), osteoporosis (1.65, 95% CI: 1.48–1.85) and pain/pain-inflammation(1.47, 95% CI: 1.39–1.55) compared to the control groups. The hazard ratios for cardiovascular conditions and depression were highest in the first year and declined over time. There were no significant differences between the two groups for reactive airway diseases and Alzheimer’s disease. Conclusion Men with prostate cancer treated with androgen deprivation therapy had a higher likelihood of developing new comorbidities than men who did not receive androgen deprivation therapy. Our results support the need for developing coordinated care models that effectively address multiple chronic diseases experienced by prostate cancer survivors. Refereed/Peer-reviewed

Objective: To describe the burden of disease in the Australian residential aged care population. Methods: Cross-sectional analysis of Aged Care Funding Instrument data. Results: Dementia (48%), depression (22.5%) and arthritis (14.2%) were the most prevalent chronic diseases in this population. Unclassified conditions such as falls, pain and urinary incontinence were also significant burdens in this population (17.1%). Circulatory, musculoskeletal and unclassified conditions were the most prevalent comorbidities across all common medical groups. Dementia and depression were the most common comorbid mental health conditions across all medical groups. Conclusion: The challenges for evaluating clinical care in Australian residential aged care are many. Delivering good clinical care should be a priority for aged care providers given the high burden of chronic disease and comorbidity. An informative starting point could be to target management of the most prevalent and burdensome conditions and comorbidities. Refereed/Peer-reviewed

In Australia, a number of managed entry agreements have been developed to enable national coverage of new medicines. Non-outcome based agreements are usually pricing arrangements that involve price or volume rebate agreements. In February 2013, there were at least 71 special pricing arrangements in place, including 26 for medicines restricted to use in hospitals. Health outcome based agreements can be made at the individual or population level. At the individual level, there were 28 medicines funded subject to continuation rules involving documentation of adequate benefit within the individual; some of these medicines also had price agreements in place. At the population level, only one outcome-based agreement has been implemented so far, for bosentan, a medicine marketed for pulmonary hypertension. In May 2010, a memorandum of understanding signed between the Australian Government and Medicines Australia, the peak pharmaceutical industry organisation, included the possibility for industry to request consideration of a ‘Managed Entry Scheme’ as part of the funding submission process for medicines with high clinical needs. It includes the possibility of a randomised controlled trial (RCT)-based entry scheme. Although this form of managed entry has yet not been trialed in Australia, several 2012/2013 funding recommendations included requests by the decision making committee for further evidence development. Refereed/Peer-reviewed

Introduction Methotrexate is the ‘anchor’ of rheumatoid arthritis (RA) treatment and leflunomide is commonly added in resistant disease, or where methotrexate is contraindicated.[1] In Australia, biological disease-modifying anti-rheumatic drugs (bDMARDs) are considered when response to conventional DMARD therapy is inadequate.[1, 2] They are expensive and criteria have been developed to restrict their use on the Australian Commonwealth Government subsidised Pharmaceutical Benefits Scheme (PBS). Prior to 2010, to qualify for bDMARDs, a patient must have been treated for at least 12 weeks with: (i) weekly methotrexate; (ii) combination therapy with methotrexate and at least two other DMARDs; and (iii) received treatment with leflunomide or cyclosporine.[2] In August 2010, these restrictions were modified so they could be accessed by patients who failed to respond to 6 months of therapy, which must include at least 3 months of methotrexate (unless contraindicated) and 3 months of hydroxychloroquine, leflunomide or sulfasalazine.[2] We aimed to assess the influence of these changes on the use and expenditure on leflunomide and bDMARDs.

Aim: To assess the prevalence of comorbidities and measures of physical and mental health among the cancer patients and survivors compared with the general population. Methods: Data collected by the Australian Bureau of Statistics from 2011-2012 National Health Survey were utilized for this cross-sectional study. Comparisons were made between adults aged 25 years and over with history of cancer (n = 2170) and those respondents who did not report having had a cancer (n = 11592) using logistic regression models. Analyses were repeated according to cancer status (current cancer vs. cancer survivor). Results: People with history of cancer had significantly higher odds of reporting mental and behavioral problems (overall cancer group adjusted odds ratio 1.36, 95 percent confidence interval 1.20-1.54; current cancer 2.53, 1.97-3.27; cancer survivor 1.20, 1.05-1.38), circulatory conditions (overall cancer group 1.25, 1.12-1.39; current cancer 1.38, 1.08-1.76; cancer survivor 1.22, 1.09-1.38), musculoskeletal conditions (overall cancer group 1.37, 1.24-1.52; current cancer 1.66, 1.30-2.12; cancer survivor 1.33, 1.19-1.48) and endocrine system disorders (overall cancer group 1.19, 1.06-1.34; current cancer 1.29, 1.00-1.66; cancer survivor 1.17, 1.04-1.33) compared with the noncancer group. Cancer patients and survivors were more likely to report poor health status, a higher level of distress, and a greater number of chronic conditions compared with the noncancer group. Conclusion: Poor health and comorbidity is more prevalent among cancer patients and survivors than the noncancer population. Our results further support the need to develop models of care that effectively address multiple chronic conditions experienced by the cancer population. Refereed/Peer-reviewed

Summary Background Cancer drugs challenge health-care systems because of their high prices. No cross-country price comparison of cancer drugs for a large number of countries has been published. We aimed to survey the prices of cancer drugs in high-income countries (Europe, Australia, and New Zealand). Methods Based on comparability in terms of the economic situation and of the pharmaceutical system, we surveyed official list prices per unit at ex-factory price level of 31 originator cancer drugs in 16 European countries, Australia, and New Zealand as of June, 2013. Drug price data for the European countries were provided by the Pharma Price Information (PPI) service; Australian and New Zealand drug price data were retrieved from the respective pharmaceutical schedules. Findings In Austria, Denmark, Finland, Germany, Italy, Norway, Sweden, and the UK, price information was available for all or all but one drug surveyed whereas the availability of price data was restricted for some drugs in other countries, especially in New Zealand and Portugal. The difference of a drug price between the highest priced country and the lowest priced country varied between 28% and 388%. A few drugs had lower outliers, especially Greek and UK prices, and upper outliers (particularly prices in Switzerland, Germany, and Sweden). Overall, Greek prices ranked at a low level, whereas Sweden, Switzerland, and Germany showed price data in similarly high ranges. Interpretation Our results showed variations in ex-factory prices of originator cancer drugs in the 18 surveyed countries. However, the surveyed prices do not include discounts negotiated by funding organisations because these discounts are confidential. Because pricing authorities can also only use these official undiscounted prices when they set prices through the common policy of external price referencing, they risk overpaying. Our findings provide an evidence base for policy makers to decide whether further policy measures related to drug prices are needed. Funding None.

Background Australian government expenditures on chemotherapy medicines are increasing faster than any other area of health care with an average annual growth rate of 63% from 2009/10 to 2013/14. Funding decisions on new, high-cost cancer medicines are challenging because of insufficient evidence on benefits and risks of new cancer medicines and high prices requested by pharmaceutical companies. We reviewed the current approval, reimbursement and pricing strategies for cancer medicines and the development of new regulatory and funding pathways in Australia.

Objective: To compare the performance of Charlson index and Rx-Risk score using data from Australian Department of Veterans' Affairs. Study Design and Setting: A study of older adults (N = 94,714) who had both Charlson and Rx-Risk scores based on their hospital diagnoses and prescription medication dispensings during the baseline year (January 2005-December 2005). Predictive ability of 1-year and 3-year mortality was compared by Akaike information criterion model fit statistic and c statistic in logistic regression models. We also compared the scores for identifying specific medical conditions. Results: Both indices were significant predictors of all-cause mortality (P < 0.0001). Of the population identified with a condition from either score, Rx-Risk score identified more than 95% of patients with gastric, respiratory, or cardiovascular condition, compared with Charlson index only identifying 2%, 31%, and 14%, respectively. The indices were comparable regarding diabetes. The Charlson index identified 83% of patients with dementia and 67% of those with cancers, whereas Rx-Risk score identified 38% and 43%, respectively. Conclusion: Both the Charlson and Rx-Risk scores predict mortality, but neither index identified all comorbidities. Based on data availability, preferences, and research purposes, investigators can use either Charlson index or Rx-Risk score to adjust for comorbidity. Refereed/Peer-reviewed

Objective: To examine the association between co-morbidities and the use of antidiabetic medications or adjunctive cardiovascular medicines among Australian veterans with diabetes. Methods: Data were sourced from the Australian Department of Veterans' Affairs Health Claims database. All veterans aged 65 years and over who were dispensed medicines for diabetes from July to December 2006 were included. Dispensings of antidiabetic and adjunctive cardiovascular medicines over the first six months of 2007 were examined. Log binominal regression models were used to calculate the relative risks of the dispensing of medications for various co-morbidities, taking into account potential confounders. Conclusions: Consistent with guideline recommendations, in this cohort more intensive antidiabetic and cardiovascular therapy is used in those with more severe disease as measured by related co-morbidities. Cardiovascular medicines however may be underutilised in those with un-related co-morbidities. Results: Among the 14,802 veterans who were dispensed medicines for diabetes, 70% had five or more co-morbidities. Patients who had diabetes-related co-morbidities had significantly less dispensing of metformin monotherapy and more dispensing of insulin than those without these conditions. Patients who had cardiovascular disease were more likely to have three or more oral antidiabetics dispensed (RR = 1.16, 95% CI: 1.04-1.30), particularly those who had heart failure (RR = 1.24, 95% CI: 1.05-1.47). Patients with renal disease were more likely to have glitazones dispensed (RR = 1.46, 95% CI: 1.24-1.72). Adjunctive cardiovascular medicines were significantly less likely to be dispensed to those with established heart conditions and non-related co-morbidities, particularly dementia. Refereed/Peer-reviewed

Purpose To examine the prescribing of prochlorperazine secondary to the prescribing of a medicine which could lead to symptoms for which prochlorperazine is indicated and commonly used. Given the range of potential hypotensive, sedative, dystonic and other extra-pyramidal side effects associated with prochlorperazine, its association with hip fracture was also examined. Methods Prescription/event sequence symmetry analyses were undertaken from 1st January 2003 to 31st December 2006, using administrative claims data from the Department of Veterans' Affairs, Australia. This method assesses asymmetry in the distribution of an incident event (either prescription of another medicine or hospitalization) before and after the initiation of prochlorperazine. Crude and adjusted sequence ratios (ASR) with 95% confidence intervals (CI) were calculated. Results A total of 34 235 persons with incident use of prochlorperazine were identified during the study period. Statistically significant positive associations were found for a number of commonly used medicines, including cardiovascular medicines, NSAIDs, opioids and sedatives and the subsequent initiation of prochlorperazine that ranged from 1.07 (95%CI 1.01–1.14) for diuretics to 1.50 (95%CI 1.40–1.61) for statins. Prescription event analysis showed a 49% (95%CI 1.19–1.86) increased risk of hospitalisation for hip fracture following dispensing of prochlorperazine. Conclusions Prescribers should consider the possible contributing role of newly initiated medicines with the potential to cause of dizziness, and where possible address this through dose reduction or cessation of the medicine, rather than prescribing prochlorperazine. Copyright © 2010 John Wiley & Sons, Ltd.

Objectives: the study aimed to examine the prevalence of comorbidity, the prescribing of potentially inappropriate medications and treatment conflicts in a large sample of older people who have been dispensed an antidepressant medicine. Conclusion: we observed a high level of potentially inappropriate prescribing and treatment conflicts that may arise when caring for older patients dispensed an antidepressant with comorbidity. These have the potential to place a large number of older people with depression at increased risk for adverse events. Methods: a cross-sectional study of administrative claims data from the Department of Veterans' Affairs, Australia, 1 April-31 July 2007, of veterans aged =65 years was conducted. Comorbidities determined using the pharmaceutical-based comorbidity index, Rx-Risk-V. Concomitant medicines that may be potentially inappropriate for patients with depression and areas of treatment conflicts were determined from Australian clinical guidelines or reference compendia. Results: a total of 39,695 subjects were included, with a median of 5 comorbid conditions (inter-quartile range 3-6). Ninety percent of medicine use was attributed to the treatment of comorbid conditions. Eighty-seven percent of the study cohort was identified as having at least one comorbid condition that may cause a potential treatment conflict when an antidepressant is used. Those conditions of most concern included cardiovascular diseases, anxiety disorders, arthritis or pain management and osteoporosis. Refereed/Peer-reviewed

Background This study aimed to determine persistence, adherence, and time without therapy with cardiovascular medicines over all episodes of use among veterans following hospitalization for ischemic heart disease. Methods Retrospective cohort study using Department of Veterans' Affairs database including 9635 veterans with a hospitalization for acute myocardial infarction, angina, or ischemic heart disease, and who had been dispensed cardiovascular medicines in the 3 months posthospitalization. The main outcome measures were duration of first treatment episode, duration of overall treatment episode, and adherence with recommended therapies: angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), lipid-lowering therapy, calcium channel blockers (CCBs), β-blockers, and antiplatelet therapy. Results The median duration of overall treatment was 6.2 years [95% confidence interval (CI): 6.0-6.4] for lipid-lowering therapy, 5.4 years (95% CI: 5.1-5.5) for ACE inhibitors/ARBs, 5.0 years (95% CI: 4.8-5.1) for antiplatelets, 3.4 years (95% CI: 3.3-3.6) for β-blockers, and 2.8 years (95% CI: 2.6-3.0) for CCBs. Adherence was 72% for CCBs, 75% for ACE inhibitors/ARBs, 84% for lipid-lowering therapy, and 84% for antiplatelets other than aspirin. The median time without therapy was 4.5 months or less for ACE inhibitors/ARBs, antiplatelets, and lipid-lowering therapy. Conclusion Problems with medication adherence can relate to either persistence or compliance during treatment. This novel method provides a way to determine which of these factors is most problematic when considering chronic therapies. We found that Australian veterans with established cardiovascular disease are persistent with their cardiovascular therapy, with only small gaps in therapy.

Background:Depression is one of the leading contributors to the burden of non-fatal diseases in Australia. Although there is an overall increasing trend in antidepressant use, the relationship between use of antidepressants and depressive symptomatology is not clear, particularly in the older population.Methods:Data for this study were obtained from the Australian Longitudinal Study of Ageing (ALSA), a cohort of 2087 people aged over 65 years at baseline. Four waves of home interviews were conducted between 1992 and 2004 to collect information on sociodemographic and health status. Depressive symptoms were measured by the Center for Epidemiologic Studies – Depression Scale. Use of antidepressants was based on self-report, with the interviewer able to check packaging details if available. Longitudinal analysis was performed using logistic generalized estimating equations to detect if there was any trend in the use of antidepressants, adjusting for potential confounding factors.Results:The prevalence of depressive symptoms was 15.2% in 1992 and 15.8% in 2004 (p> 0.05). The prevalence of antidepressant users increased from 6.5% to 10.9% (p< 0.01) over this period. Among people with depressive symptoms, less than 20% were taking antidepressants at any wave. Among people without depressive symptoms, the prevalence of antidepressant use was 5.2% in 1992 and 12.0% in 2004 (p< 0.01). Being female (OR = 1.67, 95%CI: 1.25–2.24), having poor self-perceived health status (OR = 1.17, 95%CI: 1.04–1.32), having physical impairment (OR = 1.48, 95%CI: 1.14–1.91) and having depressive symptoms (OR = 1.62, 95%CI: 1.24–2.13) significantly increased the use of antidepressants, while living in community (OR = 0.51, 95%CI: 0.37–0.71) reduced the risk of antidepressant use.Conclusions:Use of antidepressants increased, while depressive symptoms remained stable, in the ALSA over a 12-year period. Use of antidepressants was low for people with depressive symptoms.

Objective: To assess the provision of consumer medicines information in Australian community pharmacies. Method: Two methods were employed. One was an exit survey involving consumers just leaving a community pharmacy (n = 554). A total of 42 pharmacies from 6 states were selected randomly. Another was a telephone survey conducted with people aged 15 and over (n =2,005). The sample was stratified by region at the level of capital city, regional urban and rural with minimum quotas for each category. Results: In the exit survey, 13 (6.4%) of the 208 respondents collecting a script received written instructions such as the Consumer Medicines Information(CMI), including 7 (15%) receiving their prescription for the first time and 6 (4%) who came for a subsequent supply.In the phone survey, 876 (46%)of the 1,576 respondents who ever get prescriptions or OTC medicines declared they never or rarely receive written information on how to use a medicine apart from what is on the bottle or packaging. Conclusion The strategy of CMI distribution via pharmacies in Australia has failed to reach acceptable levels. Further strategies have to be implemented by the professional and consumer organisations to ensure consumers receive appropriate essential medicine information. Refereed/Peer-reviewed

Background: Several organizations have raised concerns about the excessive secrecy maintained by regulatory authorities around the world, in particular in the European Union, France, UK, Canada and Australia. However, limited research has assessed the provision of information by regulatory authorities. This study aimed to assess the type and availability of information provided on the regulatory authorities’ websites. Methods: Regulatory authorities’ websites in six countries (USA, Canada, UK, France, Australia and New Zealand) and at the European level (European Medicines Evaluation Agency) were surveyed by two reviewers between October 2005 and March 2006. The survey instrument included 16 criteria organized in 3 domains: information on marketed drugs, information on assessment of drugs and information on drug safety. Results: There was a great variability in the level of information provided. Several medicine agencies did not provide basic information on marketed drugs, such as the summary of products’ characteristics. Information on registration dossiers was scant on most websites except that of the US Food and Drug Administration. The European Medicines Evaluation Agency, the French agency and the Canadian agency released public assessment reports that contained only summarized information of registration data. Only one country, Canada, provided full access to pharmacovigilance data. The periodic safety update reports that companies have to provide regularly to regulatory authorities were not available in any country. Conclusion: Information on which regulatory authorities base their decisions for licensing new drugs and the rationales behind these decisions were often not publicly available.

This chapter presents the health care system in Australia, the regulation and funding of medicines, the medicine supply chain, and the successive medicine pricing policies that have been implemented over the last two decades. We include an analysis of the impact of these policies on prices of pharmaceuticals in Australia compared to prices in other similar countries. The Pharmaceutical Benefits Scheme (PBS) is the Australian public insurance program that provides subsidised prescription medicines to all Australian residents. The Scheme is also the process by which medicine prices are regulated. Reference pricing and value based pricing have been the cornerstones of the pricing of subsidised pharmaceuticals since the introduction of mandatory economic evaluation in 1993. In the 1990s, Australian medicine prices were found to be competitive compared to similar countries. Since 2000 there has been a change in the structure of the medicine market driven by a large increase in the number of generic medicines as a result of the end of patent protection of commonly used branded medicines. A number of pricing reforms were implemented successively in 2005, 2007, 2010 and 2014 with the objective to align PBS prices for generic medicines with pharmacy purchase prices. The price reforms included a series of mandatory price reductions and the introduction of price disclosure cycles, the latter which require manufacturers of generic medicines to provide information about their market prices to pharmacists so that PBS-listed medicines prices can be adjusted in line with the market price Overall, these policies have been effective in decreasing medicines prices and pharmaceutical expenditure. However, there are still higher prices of generic medicines compared to some countries such as New Zealand and the United Kingdom. The high prices for new medicines requested by the pharmaceutical industry may now represent the most pressing challenge faced by the Australian PBS and will require further development of pricing agreements.

Objectives: Doctors perceive the interactions with pharmaceutical representatives as professionally appropriate. However, studies have shown that the interaction is associated with less rational prescribing of medications. No previous study has assessed doctors' opinions of the presentation of pharmaceutical representatives and the quality of claims provided to the doctors in Australia and Malaysia. The aim of this study was to compare the opinions of Australian and Malaysian doctors of sales explanations and quality of claims provided by the pharmaceutical representatives. Conclusions: Doctors in Australia and Malaysia held generally positive views of the presentations of pharmaceutical representatives, although the information being presented varied. Methods: We recruited samples of primary care doctors in Australia and Malaysia to evaluate pharmaceutical sales visits. After a visit, doctors were asked to fill out a questionnaire on the main product and claims discussed during the visit. Descriptive statistics were employed, and Chi-square analysis and clustered linear regression were used to assess differences between doctors from both countries. Results: The majority of doctors reported that the presentations were convincing as well as likely to change their prescribing habits and improved their knowledge. The majority of marketing claims recorded by doctors in Australia and Malaysia were classified as vague claims. Approximately one-third of the claims were unambiguous (Australia 31% and Malaysia 33%). In a majority of the presentations (Australia, 65%, Malaysia, 84%), doctors indicated that the primary claims by the pharmaceutical representatives were entirely or nearly accurate. Refereed/Peer-reviewed

Currently, direct-to-consumer advertising of prescription-only medicines is legal in only two industrialised countries, the United States and New Zealand. However, in countries where direct-to-consumer advertising is not allowed, including Australia, Canada and countries in the European Union, pharmaceutical companies have found ways to sidestep this prohibition through intensive use of the internet, social media and print and broadcast media — for example, by running “help-seeking” or “disease-awareness” campaigns.1 These unbranded promotional campaigns feature a condition treated by the manufacturer’s product, and often encourage viewers or readers to ask their doctor about a newly available treatment. However, there are many examples of drug company-funded disease-awareness campaigns that exaggerate disease risks and prevalence, and misrepresent treatment effectiveness.2 Aspects of ordinary life (such as menopause or unhappiness) are “medicalised”, and conditions that are often mild (such as irritable bowel syndrome and restless legs syndrome) are portrayed as serious illnesses. Disease-awareness campaigns can affect consultation and prescribing rates, with potential negative effects on public health if they encourage inaccurate health beliefs and incite consumers to request inappropriate treatments from health care providers.

Introduction: People living with dementia may experience and express pain in different ways to people without dementia. People with dementia are typically prescribed fewer analgesics than people without dementia indicating a potential difference in how pain is identified and treated in these populations. The objectives of this study are to (1) investigate the prevalence of analgesic load, pain and daytime sedation in people with and without dementia in Australian residential aged care facilities (RACFs), and (2) investigate the clinical and diagnostic associations between analgesic load, pain and daytime sedation in people with and without dementia in Australian RACFs. Methods/analysis: This will be a cross-sectional study of 300 permanent residents of up to 10 low-level and high-level RACFs in South Australia with and without dementia. Trained study nurses will administer validated and dementia-specific assessments of self-reported and clinician-observed pain, sedation and other clinical and humanistic outcomes. Medicine-use data will be extracted directly from each resident's medication administration chart. Binary and multinominal logistic regression will be used to compute unadjusted and adjusted ORs and 95% CIs for factors associated with pain, analgesic load and daytime sedation. These factors will include dementia severity, behavioural and psychological symptoms, quality of life, resident satisfaction, attitudes towards medicines, activities of daily living and nutritional status. Ethics and dissemination: Institutional ethics approval has been granted. The findings will be disseminated through public lectures, professional and scientific conferences and in peer-reviewed journal articles. The findings of this study will allow for a better understanding of the prevalence and factors associated with analgesic use, pain and other outcomes in residential care. The findings of this study will be used to inform the development and implementation of strategies to improve the quality of life of people with dementia Refereed/Peer-reviewed

Background: Co-morbidity of both cardiac and non-cardiac conditions is common in the elderly with heart failure (HF) and can be associated with adverse clinical outcomes. Objectives: The aims of this study were to examine the prevalence of comorbidity and potential treatment conflicts that may result in adverse clinical outcomes in a large cohort of elderly HF patients. Methods: We conducted a cross-sectional study using administrative claims data (1 April to 31 July 2007) from the Department of Veterans’ Affairs, Australia, on all veterans aged ≥65 years with HF. Co-morbidities were defined using the pharmaceutical based co-morbidity index Rx-Risk-V. Potential treatment conflicts for patients with HF and co-morbid diseases were identified from Australian clinical guidelines or reference compendia and their prevalence in the data were determined. Results: A total of 6730 patients were included in the study, with a median of 6 co-morbid conditions (interquartile range [IQR] 4–7) and 11 (IQR 8–15) unique medicines. Almost the entire HF cohort (97.8%) were identified as having at least one co-morbid condition that may cause a potential treatment conflict, with 55% having three or more. The conditions identified as being of greatest concern, based on their prevalence and potential for treatment conflict, were chronic airways disease, depression, chronic pain/inflammatory disease, glaucoma, diabetes mellitus and diseases treatable with corticosteroids. Conclusions: Potential treatment conflicts are common in the highly co-morbid population of elderly patients with HF, and may influence the therapeutic management of not only HF but all conditions present.

Background: This study assessed whether the number of comorbid conditions unrelated to diabetes was associated with a delay in therapeutic progression of diabetes treatment in Australian veterans. Conclusions/significance: Increasing numbers of unrelated conditions decreased the likelihood of therapeutic progression in veterans with diabetes. These results have implications for the development of quality measures, clinical guidelines and the construction of models of care for management of diabetes in elderly people with comorbidities. Methodology/principal findings: A retrospective cohort study was undertaken using data from the Australian Department of Veterans' Affairs (DVA) claims database between July 2000 and June 2008. The study included new users of metformin or sulfonylurea medicines. The outcome was the time to addition or switch to another antidiabetic treatment. The total number of comorbid conditions unrelated to diabetes was identified using the pharmaceutical-based comorbidity index, Rx-Risk-V. Competing risk regression analyses were conducted, with adjustments for a number of covariates that included age, gender, residential status, use of endocrinology service, number of hospitalisation episodes and adherence to diabetes medicines. Overall, 20134 veterans were included in the study. At one year, 23.5% of patients with diabetes had a second medicine added or had switched to another medicine, with 41.4% progressing by 4 years. The number of unrelated comorbidities was significantly associated with the time to addition of an antidiabetic medicine or switch to insulin (subhazard ratio [SHR] 0.87 [95% CI 0.84-0.91], P

Objectives: To determine the validity of two medication‐based co‐morbidity indices, the Medicines Disease Burden Index (MDBI) and Rx‐Risk‐V in the Australian elderly population. Methods: In Phase I, the sensitivity and specificity of both indices were determined in 767 respondents from wave 6 of the Australian Longitudinal Study of Ageing (ALSA). Medication‐defined index disease categories were compared to self‐reported medical conditions. Correlation with self‐rated health was examined and Cox proportional hazards models were used to assess the predictive validity for mortality. Phase II verified the predictive ability of Rx‐Risk‐V in a sample of 213,191 veterans from Australian Department of Veterans' Affairs (DVA) database. Results: MDBI and Rx‐Risk‐V scores could be calculated for 28% and 73% of the ALSA sample respectively. Both indices had high specificities and low to moderate sensitivities compared to self‐reported medical conditions. Total weighted scores were significantly related to self‐rated health (p

Background The prevalence of comorbidity is high, with 80% of the elderly population having three or more chronic conditions. Comorbidity is associated with a decline in many health outcomes and increases in mortality and use of health care resources. The aim of this study was to identify, review and summarise studies reporting the prevalence of comorbidity of chronic diseases in Australia. Methods A systematic review of Australian studies (1996 – May 2007) was conducted. The review focused specifically on the chronic diseases included as national health priorities; arthritis, asthma, cancer, cardiovascular disease (CVD), diabetes mellitus and mental health problems. Results A total of twenty five studies met our inclusion criteria. Over half of the elderly patients with arthritis also had hypertension, 20% had CVD, 14% diabetes and 12% mental health problem. Over 60% of patients with asthma reported arthritis as a comorbidity, 20% also had CVD and 16% diabetes. Of those with CVD, 60% also had arthritis, 20% diabetes and 10% had asthma or mental health problems. Conclusion There are comparatively few Australian studies that focused on comorbidity associated with chronic disease. However, they do show high prevalence of comorbidity across national health priority areas. This suggests integration and co-ordination of the national health priority areas is critical. A greater awareness of the importance of managing a patients' overall health status within the context of comorbidity is needed together with, increased research on comorbidity to provide an appropriate scientific basis on which to build evidence based care guidelines for these multimorbid patients.

Australia has a National Medicines Policy with aims that include quality use of medicines, but policy stakeholders failed to protect Australia from the COX-2 (cyclo-oxygenase-2) inhibitor disaster. Drug regulators did not warn prescribers appropriately about potential cardiovascular risks. The Pharmaceutical Benefits Scheme did not limit unjustified drug expenditures on COX-2 inhibitors. Drug companies ran intense and misleading promotional campaigns on COX-2 inhibitors without adequate controls. Independent drug information was insufficient to counter the effects of the millions of dollars spent on advertising. Core elements of the National Medicines Policy—in particular the drug approval process, the post-marketing surveillance system, the control of drug promotion, and the quality of independent drug information—require major reappraisal if we want to avoid similar disasters in the future.

Objectives To analyse the media and political reactions to the initial decision of the Pharmaceutical Benefits Advisory Committee (PBAC) to reject funding of the quadrivalent human papilloma virus (HPV) vaccine in Australia. Methods A case study, informed by media reports and government documents, was utilised to examine the reactions of key stakeholders; PBAC, consumers, consumer organisations, pharmaceutical industry, politicians, health professionals and the media to the initial decision to reject funding of HPV vaccine. Results The initial decision to reject funding of the HPV vaccine led to unprecedented public response with over 300 newspaper articles and calls by consumers, health professionals and politicians to intervene in the decision making process. Misunderstanding of the decision making process, particularly cost-effectiveness assessments, the need for an independent process, the legislated inability of a timely and transparent response from policy makers and the lack of a risk mitigation strategy all played a role in the public outcry. Conclusions Despite 15 years of implementation of cost-effectiveness assessments there is still a need for improving stakeholder understanding of the decision making process and for timely transfer of complete information. Risk mitigation strategies should be considered as part of the communication plan for all decisions.

Objective There are many medicines listed on the Australian Pharmaceutical Benefits Scheme (PBS) in which point of sale price is less than the level of the general patient co-payment. In these circumstances, the patient covers the total cost of the medicine from their own pocket with no government subsidy. The aim of the present study was to compare the consumer prices of under general co-payment prescription medicines between banner group pharmacies with open discounting policies and community pharmacies without; and to assess the impact of the April 2012 PBS price disclosure policies on the discounts offered. Methods The consumer prices of 31 under co-payment medicines were collected from banner group pharmacy websites and individual pharmacies both before and after April 2012. PBS maximum prices were obtained from the PBS website. Absolute and relative price differences between PBS and pharmacy groups were calculated. Results Before April 2012, banner group pharmacies provided discounts to patients of around 40% per prescription, whereas other pharmacies provided discounts of around 15%. Total price savings were on average $9 per prescription at banner group pharmacies and $3.50 at other pharmacies. Percentage discounts did not change greatly after April 2012, when price decreases occurred on the PBS. Conclusions Banner group pharmacies with pricing strategies are able to provide greater discounts to patients compared with other pharmacies. Community pharmacies still have the ability to provide substantial discounts after the April 2012 price reductions. What is known about the topic? There is currently little known about the under co-payment medicines market in Australia and the price discounts available to patients. What does this paper add? This research shows that patients who purchase under co-payment medicines are able to save money if they purchase from pharmacies with openly advertised discounting policies. Price reductions related to the implementation of the price disclosure policy had a small effect on the discounts offered by community pharmacies to patients. What are the impacts for practitioners? The effect of discounting on under co-payment medicines to patients may increase their ability to afford essential medicines. Questions remain on whether the effect of discounting on under co-payment medicines may affect the quality of professional services provided to patients by pharmacists. Refereed/Peer-reviewed

Objective: To compare the demographic, socioeconomic, and medical characteristics of patients who had a General Practitioner Management Plan (GPMP) with those for patients without GPMP. Methods: Cohort study of patients with chronic diseases during the time period 1 July 2006 to 30 June 2008 using the Australian Department of Veterans’ Affairs (DVA) claims database. Results: Of the 88 128 veterans with chronic diseases included in the study, 23 015 (26%) veterans had a GPMP and 11 089 (13%) had a Team Care Arrangement (TCA). Those with a GPMP had a higher number of comorbidities (P < 0.001), and a higher use of services such as health assessment and medicine review (P < 0.001) than did those without GPMP. Diabetes was associated with a significantly increased use of GPMP compared with all other chronic diseases except heart failure. Conclusions: GPMPs are used in a minority of patients with chronic diseases. Use is highest in people with diabetes. What is known about the topic?: Despite the fact that the Chronic Disease Management (CDM) program is appreciated by patients and allied health professionals, limited research has assessed how it is used in practice. What does this paper add?: In the Veteran population, use of a General Practitioner Management Plan (GPMP) was associated with a higher number of comorbidities and of prior hospitalisations. Across chronic diseases use of GPMPs was low but was higher in people with diabetes. What are the implications for practitioners?: Further research into the effect of CDM program on improvement of health outcomes is required. Refereed/Peer-reviewed

Background Pharmaceutical representatives provide medicines information on their promoted products to doctors. However, studies have shown that the quality of this information is often low. No study has assessed the medicines information provided by pharmaceutical representatives to doctors in Malaysia and no recent evidence in Australia is present. We aimed to compare the provision of medicines information by pharmaceutical representatives to doctors in Australia and Malaysia. Methods Following a pharmaceutical representative's visit, general practitioners in Australia and Malaysia who had agreed to participate, were asked to fill out a questionnaire on the main product and claims discussed during the encounter. The questionnaire focused on provision of product information including indications, adverse effects, precautions, contraindications and the provision of information on the Pharmaceutical Benefit Scheme (PBS) listings and restrictions (in Australia only). Descriptive statistics were produced. Chi-square analysis and clustered linear regression were used to assess differences in Australia and Malaysia. Results Significantly more approved product information sheets were provided in Malaysia (78%) than in Australia (53%) (P < 0.001). In both countries, general practitioners reported that indications (Australia, 90%, Malaysia, 93%) and dosages (Australia, 76%, Malaysia, 82%) were frequently provided by pharmaceutical representatives. Contraindications, precautions, drug interactions and adverse effects were often omitted in the presentations (range 25% - 41%). General practitioners in Australia and Malaysia indicated that in more than 90% of presentations, pharmaceutical representatives partly or fully answered their questions on contraindications, precautions, drug interactions and adverse effects. More general practitioners in Malaysia (85%) than in Australia (60%) reported that pharmaceutical representatives should have mentioned contraindications, precautions for use, drug interaction or adverse effects spontaneously (P < 0.001). In 48% of the Australian presentations, general practitioners reported the pharmaceutical representatives failed to mention information on PBS listings to general practitioners. Conclusions Information on indications and dosages were usually provided by pharmaceutical representatives in Australia and Malaysia. However, risk and harmful effects of medicines were often missing in their presentations. Effective control of medicines information provided by pharmaceutical representatives is needed.

Background Provision of consumer information and patient education are considered an essential part of chronic disease management programmes developed for patients with heart failure. This study aimed to review the quality and availability of consumer information materials for people with heart failure in Australia. Methods The availability of consumer information was assessed through a questionnaire-based survey of the major organisations in Australia known, or thought, to be producing or using consumer materials on heart failure, including hospitals. The questionnaire was designed to explore issues around the use, production and dissemination of consumer materials. Only groups that had produced consumer information on heart failure were asked to complete the totality of the questionnaire. The quality of information booklets was assessed by using a standardised checklist. Results Of 101 organisations which were sent a questionnaire, 33 had produced 61 consumer resources on heart failure including 21 information booklets, 3 videos, 5 reminder fridge magnets, 7 websites, 15 self-management diaries and 10 self-management plans. Questionnaires were completed for 40 separate information resources. Most had been produced by hospitals or health services. Two information booklets had been translated into other languages. There were major gaps in the availability of these resources as more than half of the resources were developed in 2 of the 8 Australian states and territories, New South Wales and Victoria. Quality assessment of 19 information booklets showed that most had good presentation and language. Overall eight high quality booklets were identified. There were gaps in terms of topics covered, provision of references, quantitative information about treatment outcomes and quality and level of scientific evidence to support medical recommendations. In only one case was there evidence that consumers had been involved in the production of the booklets. Conclusion Key findings arising from the study included the need to develop a nationally coordinated approach for increasing the dissemination of information resources on heart failure. While the more recent publication of a booklet by the National Heart Foundation may have improved the situation, dissemination of written information materials may remain sub-optimal, especially among patients who are not enrolled in chronic heart failure management programmes.

Background A number of surveys have examined use of complementary and alternative medicines (CAM) in Australia. However, there are limited Australian data on use of CAM and over-the-counter (OTC) medicines in the elderly population. The main aims of this study were to examine self-medication practices with CAM and OTC medicines among older Australians and variables associated with their use. Methods The Australian Longitudinal Study of Ageing (ALSA) is an ongoing multidisciplinary prospective study of the older population which commenced in 1992 in South Australia. Data collected in 4 waves of ALSA between 1992 and 2004 were used in this study with a baseline sample of 2087 adults aged 65 years and over, living in the community or residential aged care. OTC medicines were classified according to the World Health Organization Anatomical Therapeutic Chemical (ATC) classification. CAM were classified according a modified version of the classification adopted by the Therapeutics Goods Administration (TGA) in Australia. Results The prevalence of CAM or OTC use ranged from 17.7% in 2000-2001 to 35.5% in 2003-2004. The top classes of CAM and OTC medicines used remained relatively constant over the study period. The most frequent classes of CAM used were vitamins and minerals, herbal medicines and nutritional supplements while the most commonly used OTC were analgesics, laxatives and low dose aspirin. Females and those of younger age were more likely to be CAM users but no variable was associated with OTC use. Conclusion Participants seemed to self-medicate in accordance with approved indications, suggesting they were informed consumers, actively looking after their own health. However, use of analgesics and aspirin are associated with an increased risk of adverse drug events in the elderly. Future work should examine how self-medication contributes to polypharmacy and increases the risk of adverse drug reactions.