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Purpose: The management of type 2 diabetes mellitus (T2DM) is complex. The aim of this work is to explore factors that predict the need for add-on therapy in patients with T2DM in the community.Methods: We accessed longitudinal, pharmacy payment claim records from the national Pharmaceutical Benefits Scheme (PBS) (Subsidises costs of medicines: government pays difference between patient co-payments, lower in concessional patients, and additional cost of drug.) for the period January 2006 to September 2014 (EREC/MI3127) from a 10% random sample of the Australian population validated to be representative of the population by the Australian Bureau of Statistics (ABS). Likely, T2DM patients were identified as those having been dispensed a single anti-hyperglycaemic drug (monotherapy). The time taken and possible factors that might lead to the addition of a second therapy were examined. An examination was made of trends in the co-prescription of either antihypertensive or anti-hyperlipidaemic agents in relation to the time (± 3 years) of initiating an anti-hyperglycaemic agent.Results: Most (83%) presumed T2DM patients were initiated with metformin. The average time until the second agent was added was 4.8 years (95% CI 4.7-4.9). Satisfactory adherence, age, male gender, initiating therapy after 2012 and initiating with a sulphonylurea drug all were significant risks for add-on therapy. There was no overall trend in the initiation of antihypertensive and/or anti-hyperlipidaemic agents with respect to the time of anti-hyperglycaemic initiation.Conclusion: The usefulness of a longitudinal dataset of pharmacy-claim records is demonstrated. Over half of all older and socioeconmically disadvantaged T2DM patients captured in this longitudinal claims database will be prescribed a second anti-hyperglycaemic agent within 5 years of their first drug therapy. Several factors can predict the risk of prescription of add-on therapy, and these should be considered when prescribing medications to treat T2DM. [ABSTRACT FROM AUTHOR]

Aims: Allopurinol hypersensitivity (AH) can rarely be manifest as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) that have high mortality rates. Less serious, but still significant, skin and systemic hypersensitivity reactions form part of the AH spectrum. One hundred per cent of Han Chinese with SJS/TEN due to allopurinol have been found to be at least heterozygous for HLA-B*5801, the carriage rate for this allele in the Han Chinese population being about 15%. The association has been found to be weaker in Caucasians whose HLA-B*5801 carriage rate is less than 6%. We examined the relationship between the different skin hypersensitivity reactions to allopurinol and the HLA-B locus in Australian patients. Methods: We examined 23 patients referred with AH. Results: Five of six Australian SJS/TEN patients were heterozygous for HLA-B*5801 and four were of South-East Asian origin. Five AH patients without SJS/TEN were all Caucasian and only one of these was positive for HLA-B*5801. Twelve patients with allopurinol-induced maculopapular exanthema were negative for HLA-B*5801, including one South-East Asian. Conclusions: Cases of AH manifesting as SJS/TENS in Australians are more likely to be in those of Asian heritage. The place of routine testing for HLA-B*5801 prior to commencing allopurinol therapy requires further investigation. However, Han Chinese origin patients commencing allopurinol might be informed of the test and may elect to have it performed as there are alternative hypouricaemic medicines, such as probenecid thereby reducing the risk of a catastrophic reaction to allopurinol. [ABSTRACT FROM AUTHOR]

Background: International data suggest that suboptimal use of allopurinol is common. Allopurinol dose should be lower in renal impairment, but higher when gout is not controlled. The aim of the study was to examine trends in the usage of allopurinol in the Australian community. Methods: Community dispensing data on the urate-lowering drugs allopurinol and probenecid were obtained from databases kept by Medicare Australia and the Drug Utilization Sub-Committee, for January 1992 to December 2005. Results: Allopurinol comprised 98.4% of all prescriptions for urate-lowering drugs dispensed during 2005. Most prescriptions were for allopurinol 300 mg, but there was a steady shift towards use of allopurinol 100 mg in all states and territories over the period of the study. There were marked variations in prescribing rates across the country. New South Wales had the highest rate of subsidized prescribing for allopurinol 300 mg (39.3 per 1000 population). Tasmania had the highest rate for allopurinol 100 mg (14.3 per 1000 population), which coincided with an educational programme to decrease allopurinol dose in patients with renal impairment. Prescribing rates in the Northern Territory were substantially lower than all other regions, at 10.8 and 3.3 prescriptions per 1000 population for allopurinol 300 and 100 mg, respectively. Conclusion: The increased uptake of allopurinol 100 mg suggests greater adherence to dosing guidelines and that there is value in educational programmes to optimize drug usage. Variability in utilization rates across regions indicates the need for research on factors responsible. Precise understanding of dosing trends requires access to deidentified, individual dosing data. [ABSTRACT FROM AUTHOR]

Background: This study investigated the ‘gift-relationship’ between pharmaceutical companies and doctors. Methods: The study was based on a survey questionnaire of 823 medical specialists from across Australia. The aim of this study was to investigate gifts offered to medical specialists in Australia by pharmaceutical companies, financial support actively sought by medical specialists for activities other than research and to consider what is ethically appropriate. Results: A high percentage of specialists received offers of food (96%), items for the office (94%), personal gifts (51%) and journals or textbooks (50%). Most specialists were invited to product launches, symposia or educational events (75–84%) and 52% received offers of travel to conferences. A high proportion of offers were accepted (66–79%) except invitations to product launches (49%), sponsored symposia (53%) and offers of travel that included partners (27%). Fifteen per cent of specialists requested financial support from pharmaceutical companies for activities and items, including conferences, travel, educational activities, salaries and donations to specific funds. The study outlined guidelines on gifts from pharmaceutical companies and differing standards applying to gifts and grants for travel. We found that, although most gifts and requests for support complied with professional and pharmaceutical industry guidelines, some – including personal gifts, tickets to sporting events, entertainment and travel expenses for specialists’ partners – did not. Conclusion: To ensure that physicians’ judgements are free from real or perceived influence from industry and to maintain public trust, we support a shift towards more conservative standards on gifts and support for travel evident in recent guidelines. [ABSTRACT FROM AUTHOR]

Background: Internationally, point prevalence surveys are the main source of antibiotic use data in residential aged care (RAC). Our objective was to describe temporal trends in antibiotic use and antibiotics flagged for restricted use, resident characteristics associated with use, and variation in use by RAC home, using electronic health record data., Methods: We conducted a retrospective cohort study of 9793 unique residents aged ≥65 years in 68 RAC homes between September 2014 and September 2017, using electronic health records. We modelled the primary outcome of days of antibiotic therapy /1000 resident days (DOT/1000 days), and secondary outcomes of number of courses/1000 days and the annual prevalence of antibiotic use. Antibiotic use was examined for all antibiotics and antibiotics on the World Health Organization's (WHO) Watch List (i.e. antibiotics flagged for restricted use)., Results: In 2017, there were 85 DOT/1000 days (99% CI: 79, 92), 8.0 courses/1000 days (99% CI: 7.6, 8.5), and 63.4% (99% CI: 61.9, 65.0) of residents received at least one course of antibiotics. There were 7.7 DOT/1000 days (99% CI: 6.69, 8.77) of antibiotics on the WHO Watch List administered in 2017. Antibiotic use increased annually by 4.09 DOT/1000 days (99% CI: 1.18, 6.99) before adjusting for resident factors, and 3.12 DOT/1000 days (99% CI: - 0.05, 6.29) after adjustment. Annual prevalence of antibiotic use decreased from 68.4% (99% CI: 66.9, 69.9) in 2015 to 63.4% (99% CI: 61.9, 65.0) in 2017, suggesting fewer residents were on antibiotics, but using them for longer. Resident factors associated with higher use were increasing age; chronic respiratory disease; a history of urinary tract infections, and skin and soft tissue infections; but dementia was associated with lower use. RAC home level antibiotic use ranged between 44.0 to 169.2 DOT/1000 days in 2016. Adjusting for resident factors marginally reduced this range (42.6 to 155.5 DOT/1000 days)., Conclusions: Antibiotic course length and RAC homes with high use should be a focus of antimicrobial stewardship interventions. Practices in RAC homes with low use could inform interventions and warrant further investigation. This study provides a model for using electronic health records as a data source for antibiotic use surveillance in RAC.

Background: Sympathetic activation is an important metabolic adaptation limiting weight gain. Propensity of weight gain associated with β-blocker therapy in the obese modern population is unknown., Objective: To determine whether chronic β-blocker therapy reduces energy expenditure (EE) and increases body weight., Methods: We undertook (i) a mechanistic study comparing EE, diet-induced thermogenesis and habitual activity between healthy volunteers (n=11) with uncomplicated hypertension treated with a β-blocker and anthropometrically matched controls (n=19) and (ii) three cross-sectional studies comparing body weight, body mass index (BMI) and waist circumference between β-blocker treated and untreated patients from ambulatory patients attending (a) diabetes outpatient clinic (n=214), (b) hypertension outpatient (n=84) and (c) participants in a multi-centre type 2 diabetes trial (ADVANCE) (n=11140)., Results: Among weight-matched β-blocker users, diet-induced thermogenesis, fat oxidation rate and weekly habitual activity were lower by 50% (P<0.01), 32% (P=0.04) and 30% (P<0.01), respectively, compared with controls. In β-blocker treated patients, the adjusted mean body weight was 9.2 ± 1.2 kg (P=0.0002) higher among those attending the diabetes clinic, 17.2 ± 3.2 kg (P=0.004) higher among those attending the hypertension clinic and 5.2 ± 0.7 kg (P=0.0003) higher at baseline among participants in the ADVANCE trial compared with patients not treated with β-blockers. BMI displayed a similar difference., Conclusions: EE is reduced and body weight increased in chronic β-blocker users. We hypothesise that chronic β-blockade causes obesity by blunting EE.

Background: Pharmaceutical industry involvement in biomedicine has produced major benefits but has also caused concern. At present, there is no consensus as to how medical and government organizations should relate to the pharmaceutical industry and this is partly due to the absence of systematic study of the various alternatives. In Australia industry cooperation has been elicited through the 'Quality Use of Medicines' (QUM) framework within the 'National Medicines Policy'. Little is known about the way employees of pharmaceutical companies respond to the QUM policy and strategies., Aims: To examine the engagement of the Australian pharmaceutical industry with QUM with a view to assisting medical, government and consumer organizations who may wish to collaborate with industry., Methods: We carried out a qualitative study using in-depth, semistructured interviews with industry employees, primarily from medical and regulatory affairs departments., Results: Employees of pharmaceutical companies claim that collaboration is important, and that they are altruistic and committed to QUM. At the same time, there is little evidence from this study to support the notion that QUM has brought about structural changes to industry or is positioned as the central goal or framework in designing a company's operational strategies. Moreover, there is a significant degree of ambivalence towards governments and medical organizations., Conclusions: Employees within the pharmaceutical industry claim a commitment to collaboration and QUM. While these claims cannot be taken entirely at face value, there is potential for meaningful collaboration with industry., (© 2011 The Authors. Internal Medicine Journal © 2011 Royal Australasian College of Physicians.)

Background: A prerequisite for access to biological agents for the treatment of rheumatoid arthritis under Australia's Pharmaceutical Benefits Scheme (PBS) is evidence of an adequate trial of conventional disease-modifying anti-rheumatic drugs (DMARDs). The aim of this study was to examine whether there were changes in prescribing DMARDs since the introduction of the PBS criteria for access to biologicals in August 2003., Methods: A retrospective study was undertaken of the national use of DMARDs in the period before and after the introduction of biologicals under the PBS. Dispensing data were analysed for changes in patterns of DMARD prescription rates (2000-2005)., Results: There were 2 887 746 prescriptions for DMARDs between August 2000 and June 2005. PBS prescriptions accounted for 95% of these. Government expenditure for the DMARDs was $A156m. Trends in the use of DMARDs remained relatively steady over the study period without a significant change around the time the PBS criteria for biologicals were introduced. Use of hydroxychloroquine and leflunomide increased steadily, use of methotrexate and sulfasalazine was stable and use of gold preparations and penicillamine was considerably lower during this 5-year period., Conclusion: Introduction of PBS criteria for access to biologicals did not alter the trends in use of DMARDs based on national dispensing data. This study emphasized the value that would accrue from availability of more comprehensive, de-identified, individual patient data that would enable more detailed examination of the use of medicines. These data are available, but cannot be easily accessed. It is time to make the data available for approved, ethical research in the interests of better outcomes from medicines supplied under PBS.

Background: Access to tumour necrosis factor inhibitors (TNFI) for the treatment of rheumatoid arthritis under the Australian Pharmaceutical Benefits Scheme (PBS) is governed by a set of arrangements, operational from August 2003. Patients must meet strict criteria for both starting and continuing TNFI. Examination of utilization data is important for assessing the broader implications of arrangements for access to expensive pharmaceuticals under schemes such as the PBS., Aim: To examine the uptake of TNFI over the first year of subsidized availability of etanercept under the PBS, and to compare these data to the predicted utilization and expenditure., Methods: Collection and analysis of prescription and expenditure data for the three listed TNFI: etanercept, infliximab and adalimumab processed under the PBS for the period August 2003 to July 2004., Results: A total of 8,053 prescriptions for TNFI was reimbursed at a total cost of 15.2 m Australian dollars. The total PBS expenditure on etanercept was just over 14 m Australian dollars, 14% of the predicted annual expenditure. The relative per capita uptake of etanercept was highest in the Australian Capital Territory and lowest in the Northern Territory. More than 50% of prescriptions for etanercept were for concessional patients (7.3 m Australian dollars)., Conclusion: Prescription rates and expenditure on etanercept were substantially below those forecast over the first year. There are opportunities to adjust the PBS restrictions for subsidized access to TNFI to benefit more patients.

Musculoskeletal conditions afflict most of us at some time in our lives, and we all have relatives and friends who suffer the pain and disability sometimes associated with conditions such as back or neck pain, fibrositis and osteoarthritis. The goal of those of us who try to help individuals with these conditions is to achieve effective, but also safe, management of their musculoskeletal disorders, the commonest symptom of which is pain. This goal can be achieved by better diagnosis and problem formulation (allowing better selection of treatment options); informed selection of non-drug and drug therapeutic options, based on relative cost-benefit considerations; and the judicious, appropriate and safe use of drugs, particularly non-steroidal anti-inflammatory drugs (NSAID). Setting realistic goals and maintaining regular surveillance of patients are also important considerations. Finally, the active involvement of the patient in their own management is associated with better and safer outcomes.

A healthy 19-year-old United States college student volunteer in a clinical research program underwent a bronchoscopy and died as a result of acute lignocaine toxicity. The major contributing factor in the tragedy was that the research protocol failed to specify an upper dose limit for lignocaine spray, although previous versions of the protocol had done so. We look at the implications of this case for Australian institutional ethics committees.

Aims: This study describes development and field testing of a set of indicators for drug and therapeutics committees (DTCs) in hospitals. It was intended that these indicators should be accessible, useful and relevant in the Australian setting., Methods: Candidate indicators were written following consultation and data collection. A framework of outcome, impact and process indicators was based on DTC goals, objectives and strategies. The candidate indicators were field tested over a 2 month period in teaching, city non-teaching, rural and private hospitals. The field tests provided response data for each indicator and evaluation of the indicators against criteria for accessibility, relevance, usefulness, clarity and resource utilisation. Consensus on which indicators to accept, modify or reject was reached at a workshop of stakeholders and experts, taking account of the field test results., Results: Thirty-five candidate indicators were tested in 16 hospitals. Twenty-two had a response from >80% of sites, 23 had a mean relevance rating >3.5, 19 had a mean usefulness rating >3.5, 27 were correctly interpreted by > 90% of sites and 25 could be collected in an acceptable time. The most acceptable indicators required least data collection or provided data deemed useful for purposes other than the field test. At the consensus workshop 13 indicators were accepted with no or minor change, nine were accepted after major modification and eight were discarded. It was recommended that a further five indicators should be merged or subsumed into one indicator., Conclusions: This study has developed and field tested a set of indicators for DTCs in Australia. The indicators have been taken up enthusiastically as a first attempt to monitor DTC performance but require ongoing validation and development to ensure continuing relevance and usefulness.

The prescribing behaviour of Australian and New Zealand rheumatologists was studied in 1994 using a questionnaire, and the results compared with a similar questionnaire administered in 1984. Perceived differences in efficacy and toxicity for disease-modifying anti-rheumatic drugs (DMARDs) and cytotoxics were reported. Over the decade, methotrexate and sulphasalazine have become the most commonly used anti-rheumatic agents, and methotrexate is clearly seen as the most effective drug. Wide variations in monitoring practices for DMARDs were reported, highlighting the need for cost-effectiveness studies on monitoring. There was low usage of functional outcome measurements in assessing patients.

Objective: To determine the pattern of use of non-steroidal anti-inflammatory drugs (NSAIDs) in the Australian community, 1990-1994., Design: Data from the national drug utilisation database were expressed in defined daily doses per 1000 population per day (DDDs/1000 population per day). Temporal trends were assessed and comparisons were made with NSAID use in other countries. Epidemiological data were used to estimate the likely impact of changing NSAID use on peptic ulcer hospitalisation rates., Setting: Australian community (excluding hospitals)., Main Outcome Measures: Estimated consumption of prescription NSAIDs, expressed in DDDs/1000 population per day., Results: NSAID use in the Australian community fell from 50.1 DDDs/1000 population per day in 1990 to 34.6 DDDs/1000 population per day in 1994 (down 31%). From this reduced exposure we estimated that the number of admissions for NSAID-related upper gastrointestinal complications will have fallen by about 400 per year. Market research data for this period show a lower percentage use of NSAIDs for osteoarthritis and a decrease in the proportion of use in age groups over 50 years., Conclusions: The level of use of non-steroidal anti-inflammatory drugs in Australia has been high in comparison with other countries, but in recent years has fallen markedly. This fall occurred in conjunction with regulatory interventions, educational campaigns and increased concern in the medical and lay press regarding the risks associated with the use of NSAIDs.

During a two-month prospective survey in a metropolitan teaching hospital's accident and emergency department, 239 consecutive drug-related attendances (excluding admissions to hospital that were primarily alcohol related) were identified. This represented 2.6% of total attendances. Of the 199 patients who presented to hospital with self-poisoning, a biological specimen was obtained from 158 (79%) for toxicological analysis, thus providing reliable data on the drugs that were involved in the overdoses. The most common drug groups that were identified were barbiturate (51% of cases) and benzodiazepine (49%) agents, alcohol with other drugs (44%), cannabinoids (32%) and opiate analgesic drugs (25%). Quinalbarbitone and amylobarbitone (Tuinal) and oxazepam were the most common "single" preparations. The use of cannabis and alcohol and the use of several drugs concurrently were more common than in previously reported surveys of self-poisoning. Discrepancies between the purported drug consumption and the toxicological results were frequent; complete agreement occurred in only 35% of the cases. The TOXI-LAB system was an adequate method for toxicological analysis. However, for epidemiological studies an additional back-up method is recommended to verify the presence of some drugs such as barbiturate and benzodiazepine agents.