Comorbidities in Australian women with hormone-dependent breast cancer: a population-based analysis.

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.

Ten years of publicly funded biological disease-modifying antirheumatic drugs in Australia.

Biological disease-modifying antirheumatic drugs (bDMARDs) for rheumatoid arthritis (RA) treatment were among the first high-cost medicines to be subsidised in Australia. High-cost medicines pose several challenges to the Australian National Medicines Policy, which aims to provide timely access to effective medicines at a cost individuals and the community can afford. Thus, novel restriction criteria were developed to encourage cost-effective use of bDMARDs. Government expenditure on bDMARD subsidies for RA treatment grew to about $383 million in 2014. Evidence that initiation and continuation criteria for bDMARDs meet usually applied cost-benefit criteria is lacking. The combined expenditure on tocilizumab, certolizumab pegol and golimumab (added to the Australian Government's Pharmaceutical Benefits Scheme in 2010) was $93 million in 2014, which is 210% over the initial estimate. Present and future challenges with regard to bDMARDs for RA and other high-cost drugs include improved expenditure predictions, monitoring of cost-effectiveness in relation to actual use and strategic development, regulation and use of biosimilars. Ten years of documentation on clinical and laboratory findings indicating eligibility to initiate and continue on bDMARDs remains un-used. These data represent an untapped opportunity to promote quality of use of bDMARDs and biosimilars and to improve cost predictions for high-cost drugs.

Discounting of medicines in Australian community pharmacies.

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.

Does antidepressant medication use affect persistence with diabetes medicines?

PURPOSE: This study aimed to examine the effect of antidepressant use on persistence with newly initiated oral antidiabetic medicines in older people. METHODS: A retrospective study of administrative claims data from the Australian Government Department of Veterans' Affairs, from 1 July 2000 to 30 June 2008 of new users of oral antidiabetic medicines (metformin or sulfonylurea). Antidepressant medicine use was determined in the 6 months preceding the index date of the first dispensing of an oral antidiabetic medicine. The outcome was time to discontinuation of diabetes therapy in those with antidepressant use compared with those without. Competing risks regression analyses were conducted with adjustment for covariates. RESULTS: A total of 29,710 new users of metformin or sulfonylurea were identified, with 7171 (24.2%) dispensed an antidepressant. Median duration of oral antidiabetic medicines was 1.81 years (95% CI 1.72­1.94) for those who received an antidepressant at the time of diabetes medicine initiation, by comparison to 3.23 years (95% CI 3.10­3.40) for those who did not receive an antidepressant. Competing risk analyses showed a 42% increased likelihood of discontinuation of diabetes medications in persons who received an antidepressant (subdistribution hazard ratio 1.42, 95% CI 1.37­1.47, p < 0.001). CONCLUSIONS: The results of this large population-based study demonstrate that depression may be contributing to non-compliance with medicines for diabetes and highlight the need to provide additional services to support appropriate medicine use in those initiating diabetes medicines with co-morbid depression.

Chronic disease management: does the disease affect likelihood of care planning?

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.

Major bleeding risk associated with warfarin and co-medications in the elderly population.

PURPOSE: Warfarin management in the elderly population is complex as medicines prescribed for concomitant diseases may further increase the risk of major bleeding associated with warfarin use. We aimed to quantify the excess risk of bleeding-related hospitalisation when warfarin was co-dispensed with potentially interacting medicines. METHODS: A retrospective cohort study was undertaken over a 4-year period from July 2002 to June 2006 to examine bleeding risk associated with medications co-administered in patients taking warfarin using an administrative claims database from the Australian Department of Veterans' Affairs. All veterans aged 65 years and over who were new users of warfarin were followed until death or study end. Risk of bleeding was assessed using a Poisson GEE model adjusting for age, gender, socioeconomic status, co-morbidity index, previous bleeding related hospitalisations and indicators of health service use. RESULTS: Overall, 17661 veterans who used warfarin at any time during the study period were included. The overall incidence rate of bleeding-related hospitalisations was 4.1 (95% CI 3.7-4.6) per 100 person-years in veterans who were not receiving potentially interacting medicines. Bleeding-related hospitalisation rates were significantly increased when warfarin was co-prescribed with low-dose aspirin (Adjusted rate ratio (AdjRR) 1.44, 95% CI 1.00-2.07), clopidogrel (AdjRR 2.23, 95% CI 1.48­3.36), clopidogrel with aspirin (AdjRR 3.44, 95% CI 1.28-9.23), amiodarone (AdjRR 3.33, 95% CI 1.38­8.00) and antibiotics (AdjRR 2.34, 95% CI 1.55-3.54). CONCLUSIONS: Models assessing bleeding risk with warfarin should take account of the range of potentially harmful medicine combinations used in elderly people with comorbid conditions.

Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.

BACKGROUND: Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. METHODS AND FINDINGS: We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently by two authors and a narrative synthesis performed following the MOOSE guidelines. Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review. CONCLUSIONS: With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies. Please see later in the article for the Editors' Summary.

Assessing overall duration of cardiovascular medicines in veterans with established cardiovascular disease.

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), beta-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 beta-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.

Increased risk of hip fracture in the elderly associated with prochlorperazine: is a prescribing cascade contributing?

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.

Comorbidity of chronic disease and potential treatment conflicts in older people dispensed antidepressants.

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. METHODS: a cross-sectional study of administrative claims data from the Department of Veterans' Affairs, Australia, 1 April-31 July 2007, of veterans aged > or =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. 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.

Antidepressant use and depressive symptomatology among older people from the Australian Longitudinal Study of Ageing.

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.

Quality of claims, references and the presentation of risk results in medical journal advertising: a comparative study in Australia, Malaysia and the United States.

BACKGROUND: Journal advertising is used by pharmaceutical companies to disseminate medicine information to doctors. The quality of claims, references and the presentation of risk results in Australia and the US has been questioned in several studies. No recent evidence is available on the quality of claims, references and the presentation of risk results in journal advertising in Australia and the US and no Malaysian data have been published. The aim of this study was to compare the quality of claims, references and the presentation of risk results in journal advertising in these three countries. METHODS: A consecutive sample of 85 unique advertisements from each country was selected from journal advertising published between January 2004 to December 2006. Claims, references and the presentation of risk results in medical journal advertising were compared between the three countries. RESULTS: Less than one-third of the claims were unambiguous claims (Australia, 30%, Malaysia 17%, US, 23%). In Malaysia significantly less unambiguous claims were provided than in Australia and the US (P < 0.001). However, the unambiguous claims were supported by more references than other claims (80%). Most evidence was obtained from at least one randomized controlled trial, a systematic review or meta-analysis (Australia, 84%, Malaysia, 81%, US, 76%) with journal articles being the most commonly cited references in all countries. Data on file were significantly more likely to be cited in the US (17%) than in Australia (2%) and Malaysia (4%) (P < 0.001). Advertisements that provided quantitative information reported risk results exclusively as a relative risk reduction. CONCLUSIONS: The majority of claims were vague suggesting poor quality of claims in journal advertising in these three countries. Evidence from a randomized controlled trial, systematic review or meta- analysis was commonly cited to support claims. However, the more frequent use of data that have not been published and independently reviewed in the US compared to Australia and Malaysia raises questions on the quality of references in the US. The use of relative rather than absolute benefits may overemphasize the benefit of medicines which may leave doctors susceptible to misinterpreting information.

Medicines information provided by pharmaceutical representatives: a comparative study in Australia and Malaysia.

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.

Inclusion of Older People Reflective of Real-World Clinical Practice in Cardiovascular Drug Trials.

Background Underrepresentation of older people in clinical trials remains. This study aimed to examine the inclusion of older people and associated safety and efficacy reports from clinical trials of new molecular entities for cardiovascular disease indications since commencement of the US Food and Drug Administration Drug Trial Snapshot (DTS) Program. The DTS provides concise information on participants included in clinical trials supporting US Food and Drug Administration approval of new drugs. Methods and Results A cross-sectional analysis between January 1, 2015 and April 30, 2019 of DTS data including approval date, indication, number of trials and participants, age distribution, efficacy, and safety statements was conducted. Participation-to-prevalence ratio (PPR) was used to describe representation of older participants in trials relative to disease population. Efficacy and safety statements regarding age were compared with drug prescribing information. A total of 72 079 participants from 10 DTS reports were identified and 39 625 (55.0%) were aged ≥65 years old. Overall, 63.6% of cardiovascular disease DTS reports were representative of people aged ≥65 years old for specific cardiovascular disease conditions. Underrepresentation was observed in 4 DTS: 2 for heart failure (PPR 0.48 and 0.62), 1 for pulmonary arterial hypertension (PPR 0.72), and 1 for venous thromboembolism (PPR 0.38). Participants in clinical trials for new drugs for the treatment of atrial fibrillation (PPR 0.99 and 1.21) and hypercholesterolemia (PPR 0.84 and 0.97) were reflective of the older population for these diseases. An increased risk of adverse events in older participants was reported in 40% DTS safety statements but no differences were reported in the drug product information. Conclusions Despite the fact that >60% of cardiovascular disease trial participants for new molecular entities included in the DTS program were representative of the older population in real-world clinical practice, concerns remain for conditions including heart failure or venous thromboembolism. Drug product information safety statements regarding age differences in adverse events were not reflective of trial findings. An increased directive is needed to facilitate the generation of real-world evidence and appropriate reporting within drug product information for these potentially at-risk patient populations.

Self-medication with over-the-counter drugs and complementary medications in South Australia's elderly population.

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.

Prevalence of comorbidity of chronic diseases in Australia.

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.

The Australian funding debate on quadrivalent HPV vaccine: a case study for the national pharmaceutical policy.

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.

Quality and availability of consumer information on heart failure in Australia.

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.

Influence of medication risks and benefits on treatment preferences in older patients with multimorbidity.

Multimorbidity is associated with use of multiple medicines, increased risk of adverse events and treatment conflicts. This study aimed to examine how older patients with multimorbidity and clinicians balance the benefits and harms associated with a medication and in the presence of competing health outcomes. Interviews were conducted with 15 participants aged ≥65 years with 2 or more chronic conditions. Three clinical scenarios were presented to understand patient preference to take a medicine according to i) degree of benefit, ii) type of adverse event and impact on daily living and iii) influence of comorbid conditions as competing health outcomes. Semi-structured interviews were also conducted with participants (n=15) and clinicians (n=5) to understand patient preferences and treatment decisions, in the setting of multimorbidity. The median age of participants was 79 years, 55% had 5 or more conditions and 47% took 8 or more medicines daily. When the level of benefit of the medicine ranged from 14% to 70%, 80% of participants chose to take the medicine, but when adverse effects were present, this was reduced to 0-33% depending upon impact on daily activities. In the presence of competing health outcomes, 13%-26% of patients chose to take the medicine. Two-thirds of patients reported that their doctor respects and considers their preferences and discussed medication benefits and harms. Interviews with clinicians showed that their overall approach to treatment decision-making for older individuals with multimorbidity was based upon 2 main factors, the patients' prognosis and their preferences. The degree of benefit gained was not the driver of patients' preference to take a medicine; rather, this decision was influenced by type and severity of adverse effects. Inclusion of patient preferences in the setting of risks and benefits of medicines with consideration and prioritization of competing health outcomes may result in improved health outcomes for people with multimorbidity.