Osteoporosis treatment: a missed opportunity

Minimal trauma fractures remain a major cause of morbidity in Australia, affecting one in two women and one in four men over the age of 60 years.1 Mortality is increased after all minimal trauma fractures, even after minor fractures.2 Hip fractures are particularly devastating, leading to decreased quality of life, increased mortality and loss of functional independence.3

Defining osteoporosis

Bone mineral density (BMD) is expressed in relation to either “young normal” adults of the same sex (T score) or to the expected BMD for the patient’s age and sex (Z score). Osteoporosis is defined as a T score ≤ 2.5 SDs below that of a “young normal” adult, with fracture risk increasing twofold to threefold for each SD decrease in BMD.4,5 A BMD Z score less than −2 indicates that BMD is below the normal range for age and sex, and warrants a more intensive search for secondary causes. Importantly, osteoporosis is also diagnosed after a minimal trauma fracture, irrespective of the patient’s T score.

Absolute fracture risk

Treatment for osteoporosis is recommended for patients with a high absolute fracture risk. This includes older Australians (post-menopausal women and men aged over 60 years) with T scores ≤ −2.5 at the lumbar spine, femoral neck or total hip, and patients with a history of a minimal trauma fracture.6 There is a major gap between evidence and treatment in secondary fracture prevention, with fewer than 20% of patients presenting with a minimal trauma fracture being treated or investigated for osteoporosis.7,8 However, it is important that patients with a low fracture risk, including younger women without clinical risk factors and T scores ≤ −2.5 at “non-main-sites” (eg, lateral lumbar spine or Ward’s triangle in the hip) are not treated.9 Absolute fracture risk calculators incorporate osteoporosis risk factors with BMD to stratify fracture probability.10 It is therefore important for clinicians to assess absolute fracture risk. Two of several absolute fracture risk calculators are commonly used to aid clinicians in this regard: the Garvan Fracture Risk Calculator11 and the Fracture Risk Assessment Tool (FRAX) developed by the World Health Organization.

The Garvan Fracture Risk Calculator estimates absolute fracture risk over 5 and 10 years (http://www.garvan.org.au/bone-fracture-risk/). It may be used in men and women aged over 50 years, and incorporates age, sex, BMD at the spine or femoral neck, falls and fracture history. A potential limitation of this tool is that it does not include other clinical risk factors. The country-specific FRAX tool calculates the 10-year probability of hip fracture and major osteoporotic fracture in patients aged 40–90 years. It incorporates femoral neck BMD with ten clinical risk factors. Limitations include underestimation of fracture risk in patients with multiple minimal trauma fractures, an inability to adjust the risk for dose-dependent exposure, a lack of validation for use with BMD of the spine, and exclusion of falls.

Role of fracture risk calculators in 2016

The role of absolute fracture risk calculators in clinical practice is evolving. In addition to their individual limitations, there is a lack of evidence that their use leads to effective targeting of drug therapy to those deemed to be at high risk of fracture,12 and prospective studies are needed. In particular, country-specific intervention thresholds based on absolute fracture risk need to be validated clinically. However, fracture risk calculators are useful for identifying patients with low fracture risk who do not require treatment.

Special patient groups

Limited evidence-based guidance is available for treating osteoporosis in several groups, including patients with post-transplantation osteoporosis, type 1 diabetes mellitus, chronic kidney disease (creatinine clearance < 30 mL/minute), neurological, respiratory and haematological diseases, and young adults and pregnant women. Such patients require individualised management.

Osteoporosis prevention using non-pharmacological therapies

Lifestyle approaches (adequate dietary calcium intake, optimal vitamin D status, participation in resistance exercise, smoking cessation, avoidance of excessive alcohol, falls prevention) act as a framework for improving musculoskeletal health at a population-based level.6,13–16

Calcium and vitamin D

The current Australian recommended daily intake (RDI) of calcium is 1300 mg per day for women aged over 51 years, 1000 mg per day for men aged 51–70 years and 1300 mg per day for men aged over 70 years.17 Adverse effects of calcium supplementation include gastrointestinal bloating, constipation,18 and renal calculi.19 There is controversy about the efficacy of calcium in preventing osteoporotic fractures.6,19,20 Further work is required with studies powered to investigate cardiac outcomes in men and women receiving calcium supplementation to meet current RDIs. Higher dietary calcium intake is also associated with reductions in mortality, cardiovascular events and strokes.21 Dietary sources of calcium are the preferred sources. Calcium supplementation should be limited to 500–600 mg per day, and used only by those who cannot achieve the RDI with dietary calcium.15

The main source of vitamin D is through exposure to sunlight. Institutionalised or housebound older people are at particularly high risk of vitamin D deficiency. Inadequate vitamin D status is defined as a serum 25-hydroxyvitamin D (25(OH)D) level < 50 nmol/L in late winter/early spring; in older individuals such inadequate vitamin D levels are associated with muscular weakness and decreased physical performance.22 Increased falls and fractures occur at 25(OH)D levels < 25–30 nmol/L.23,24 Adults aged 50–70 years and those over 70 years require at least 600 IU to 800 IU of vitamin D₃ daily, with larger daily doses required to treat vitamin D deficiency.25

Exercise

Community-based high speed, power training, multimodal exercise programs increase BMD and muscle strength, with a trend to falls reduction.26 Thus, exercise is recommended both to maintain bone health and reduce falls. It should be individualised to the patient’s needs and abilities, increasing progressively as tolerated by the degree of osteoporosis-related disability.

Falls prevention

Falls are the precipitating factor in nearly 90% of all appendicular fractures, including hip fractures,3 and reducing falls risk is critical in managing osteoporosis. Reducing the use of benzodiazepines, neuroleptic agents and antidepressants reduces the risk of falls,27 and, among women aged 75 or more years, muscle strengthening and balance exercises reduce the risk of both falls and injuries.28

Antiresorptive therapy for osteoporosis

Post-menopausal osteoporosis results from an imbalance in bone remodelling, such that bone resorption exceeds bone formation. Antiresorptive drugs decrease the number, activity and lifespan of osteoclasts,29 preserving or increasing bone mass with a resulting reduction in vertebral, non-vertebral and hip fractures. These drugs include bisphosphonates (oral or intravenous),30–35 oestrogen36,37 and selective oestrogen receptor-modulating drugs,38 strontium ranelate and denosumab, a human monoclonal antibody against receptor activator of nuclear factor κB-ligand (RANKL).39

Antiresorptive treatments for osteoporosis are approved for reimbursement on the Pharmaceutical Benefits Scheme (PBS) for men and post-menopausal women following a minimal trauma fracture, as well as for those at high risk of fracture, on the basis of age (> 70 years) and low BMD (T score < −2.5 or −3.0). Bisphosphonates are also approved for premenopausal women who have had a minimal trauma fracture. In patients at high risk of fracture, osteoporosis therapy reduces the risk of vertebral fractures by 40–70%, non-vertebral fractures by about 25%, and hip fractures by 40–50%.30–40

Bisphosphonates

Mechanism of action and efficacy. Bisphosphonates are stable analogues of pyrophosphate. They bind avidly to hydroxyapatite crystals on bone and are then released slowly at sites of active bone remodelling in the skeleton, leading to recirculation of bisphosphonates. The terminal half-lives of bisphosphonates differ; for alendronate it is more than 10 years,41 while for risedronate it is about 3 months.42

Alendronate prevents minimal trauma fractures. Therapy with alendronate reduces vertebral fracture risk by 48% compared with placebo. Similar reductions in the risk of hip and wrist fractures were seen in women treated with alendronate who had low BMD and prevalent vertebral fractures.33,34,43 A randomised, double-blind, placebo-controlled trial of post-menopausal women assigned to risedronate therapy or placebo for 3 years showed vertebral and non-vertebral fracture risks were respectively reduced by 41% and 39% by risedronate.35 Three years of treatment with zoledronic acid in women with post-menopausal osteoporosis reduced the risk of morphometric vertebral fracture by 70% compared with placebo, and reduced the risk of non-vertebral and hip fracture by 25% and 41% respectively.30

Adverse effects. The main potential adverse effects of oral bisphosphonates are gastrointestinal (including reflux, oesophagitis, gastritis and diarrhoea). Oral bisphosphonates should not be given to patients with active upper gastrointestinal disease, dysphagia or achlasia. Intravenous bisphosphonates are associated with an acute phase reaction (fever, flu-like symptoms, myalgias, headache and arthralgia) in about a third of patients, typically within 24–72 hours of receiving their first infusion of zoledronic acid, but is reduced significantly on subsequent infusions.30 Treatment with antipyretic agents, including paracetamol, improves these symptoms. Treatment with bisphosphonates may also lower serum calcium concentrations, but this is uncommon in the absence of vitamin D deficiency.44,45 Bisphosphonates are not recommended for use in patients with creatinine clearance below 30–35 mL/min.

Less common adverse effects associated with long term bisphosphonate therapy include osteonecrosis of the jaw (ONJ) and atypical femoral fracture (AFF). Overemphasis of these uncommon adverse effects by patients has led to declining osteoporosis treatment rates.46

Jaw osteonecrosis. ONJ is said to occur when there is an area of exposed bone in the maxillofacial region that does not heal within 8 weeks after being identified by a health care provider, in a patient who was receiving or had been exposed to a bisphosphonate and did not have radiation therapy to the craniofacial region.47 Risk factors for ONJ include intravenous bisphosphonate therapy for malignancy, chemotherapeutic agents, duration of exposure to bisphosphonates, dental extractions, dental implants, poorly fitting dentures, glucocorticoid therapy, smoking, diabetes and periodontal disease.48,49 The risk of ONJ is about 1 in 10 000 to 1 in 100 000 patient-years in patients taking oral bisphosphonates for osteoporosis.47 Given the prolonged half-life of bisphosphonates, temporary withdrawal of treatment before extractions is unlikely to have a significant benefit and is therefore not recommended.50

Atypical femur fractures. Clinical trial data clearly support the beneficial effect of bisphosphonates in preventing minimal trauma fractures. However, oversuppression of bone remodelling may allow microdamage to accumulate, leading to increased bone fragility.51 Cases of AFF and severely suppressed bone remodelling after prolonged bisphosphonate therapy52 have prompted further research and recent guideline development.53 However, this finding is not universal. AFFs occur in the subtrochanteric region or diaphysis of the femur and have unique radiological features, including a predominantly transverse fracture line, periosteal callus formation and minimal comminution, as shown in Box 1.53 AFFs have been reported in patients taking bisphosphonates and denosumab, but about 7% of cases occur without exposure to either drug. AFFs appear to be more common in patients who have been exposed to long term bisphosphonate therapy, with a higher risk (113 per 100 000 person-years) in patients who receive more than 7–8 years of therapy.53 Although many research questions remain unanswered, including aetiology, optimal screening and management of these fractures, the risk of a subsequent AFF is reduced from 12 months after cessation of bisphosphonate treatment.

Duration of therapy. Concerns about the small but increased risk of adverse events after long term treatment with bisphosphonates (Box 2) have led to the development of guidelines on the optimal duration of therapy.54 For patients at high risk of fracture, bisphosphonate treatment for up to 10 years (oral) or 6 years (intravenous) is recommended. For women who are not at high risk of fracture after 3 years of intravenous or 5 years of oral bisphosphonate treatment, a drug holiday of 2–3 years may be considered (Box 3). However, it is critical to understand that “holiday” does mean “retirement”, and those patients should continue to have BMD monitoring after 2–3 years.

Hormone replacement therapy

Hormone replacement therapy (HRT) is effective in preventing and treating post-menopausal osteoporosis. Benefits need to be balanced against thromboembolic and vascular risk, breast cancer risk (for oestrogen plus progesterone), and duration of therapy. HRT is most suitable for recently menopausal woman (up until age 59 years), particularly for those with menopausal symptoms. In women with an early or premature menopause, HRT should be continued until the average age of menopause onset (about 51 years), or longer in the setting of a low BMD. Oral or transdermal oestrogen therapy (in women who have had a hysterectomy) and combined oestrogen and progesterone therapy preserve BMD,55 and were also shown to reduce the risk of hip, vertebral and total fractures compared with placebo in the Women’s Health Initiative (WHI).37,56

In the initial WHI analysis, combined oral oestrogen and progesterone therapy for 5.6 years in post-menopausal women aged 50–79 years (who were generally older than women who used HRT for control of menopausal symptoms), many of whom had cardiovascular risk factors, was shown to increase the risk of breast cancer, stroke and thromboembolic events.57 However, subsequent reanalysis of WHI data has established the efficacy and safety of HRT in younger women up until 10 years after menopause, or the age of 59 years, when the benefits of treatment outweigh the risks. In women with a history of hysterectomy, oral oestrogen therapy alone has a better benefit–risk profile, with no increases in rates of breast cancer or coronary heart disease.56

Women commencing HRT should be fully informed about its benefits and risks. Cardiovascular risk is not increased when therapy is initiated within 10 years of menopause,58,59 but the risk of stroke is elevated regardless of time since menopause. It is also recommended that doctors discuss smoking cessation, blood pressure control and treatment of dyslipidaemia with women commencing HRT.

Selective oestrogen receptor modulator (SERM) drugs

The SERM raloxifene has beneficial oestrogen-like effects on bone, but has oestrogen antagonist activity on breast and endometrium. Treatment with raloxifene for 3 years reduced vertebral fractures by 30–50% compared with placebo in post-menopausal women.38 However, there was no reduction in non-vertebral fractures. Consequently, raloxifene is useful in post-menopausal women with spinal osteoporosis, particularly those with an increased risk of breast cancer. Raloxifene therapy is also associated with a 72% reduction in the risk of invasive breast cancer.60 Raloxifene may exacerbate hot flushes, and women receiving raloxifene have a greater than threefold increased incidence of thromboembolic disease, comparable with those receiving HRT.36,56 Raloxifene therapy is also associated with an increased risk of stroke,61 particularly in current smokers.

Denosumab

Denosumab is a human monoclonal antibody with specificity for RANKL, which stimulates the development and activity of osteoclasts. Denosumab mimics the endogenous inhibitor of RANKL, osteoprotegerin, and is given as a 60 mg subcutaneous injection once every 6 months. Denosumab reduces new clinical vertebral fractures by 68%, with a 40% reduction in hip fracture and a 20% reduction in non-vertebral fractures compared with placebo over 3 years.39,62

The adverse effects of denosumab include small increases in the risks of eczema, cellulitis and flatulence.39 Hypocalcaemia, particularly in patients with abnormal renal function, has also been reported,63 and denosumab is contraindicated in patients with hypocalcaemia. Jaw osteonecrosis has been reported in patients receiving denosumab for osteoporosis, as have AFFs.64,65

Strontium ranelate

Strontium ranelate increases bone formation markers and reduces bone resorption markers, but is predominantly antiresorptive, as increases in the rate of bone formation have not been demonstrated.66 Strontium ranelate significantly reduces the risk of vertebral and non-vertebral fractures.67–69 The most frequent adverse effects associated with strontium ranelate are nausea, diarrhoea, headache, dermatitis and eczema.67,68 Cases of a rare hypersensitivity syndrome (drug reaction, eosinophilia and systemic symptoms [DRESS]) have been reported, and strontium ranelate should be discontinued if a rash develops. Strontium ranelate treatment was associated with an increased incidence of venous thromboembolism70 and, more recently, with a small increase in absolute risk of acute myocardial infarction. Strontium ranelate is contraindicated in patients with uncontrolled hypertension and/or a current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.71 This drug is now a second-line treatment for osteoporosis, only used when other medications for osteoporosis are unsuitable, in the absence of contraindications.

Anabolic therapy for osteoporosis

Teriparatide

Teriparatide increases osteoblast recruitment and activity to stimulate bone formation.40 In contrast to antiresorptive agents, which preserve bone microarchitecture and inhibit bone loss, teriparatide (recombinant human parathyroid hormone [1–34]) stimulates new bone formation and improves bone microarchitecture. Teriparatide reduced the risk of new vertebral fractures by 65% in women with osteoporosis who have had one or more baseline fractures40 and also reduced new or worsening back pain. Non-vertebral fractures are also reduced by 53% by teriparatide, but studies have been underpowered to detect reductions in the rate of hip fracture. Side effects include headache (8%), nausea (8%), dizziness and injection-site reactions. Transient hypercalcaemia (serum calcium level, > 2.60 mmol/L) after dosing also occurred in 3–11% of patients receiving teriparatide.

Teriparatide has a black box warning concerning an increased incidence of osteosarcoma in rats that were exposed to 3 and 60 times the normal human exposure over a significant portion of their lives. Teriparatide is therefore contraindicated in patients who may be at increased risk of osteosarcoma, including those with a prior history of skeletal irradiation, Paget’s disease of bone, an unexplained elevation in bone-specific alkaline phosphatase, bone disorders other than osteoporosis, and in adolescents and children.

In Australia, the maximum lifetime duration of teriparatide therapy is 18 months. However, the antifracture benefit increases the longer the patient remains on treatment, with non-vertebral fractures being reduced for up to 2 years of treatment compared with the first 6 months of treatment, and for up to 2 years following cessation of treatment.72 In addition, increases in the rates of trabecular and cortical bone formation continue for up to 2 years of treatment, refuting the outmoded concept of a limited “anabolic window” of action for this drug.73 Importantly, following teriparatide therapy, the accrued benefits will be lost if antiresorptive therapy is not immediately instituted. Teriparatide reimbursement through the PBS is restricted to patients who have had two minimal trauma fractures and who have a fracture after at least a year of antiresorptive therapy, and who have a BMD T score below −3. However, the rate of teriparatide use in Australia is among the lowest in the world (David Kendler, University of British Columbia, Canada, personal communication).

Future directions

Three new anti-osteoporosis drugs are in clinical development.

“Selective” antiresorptive drugs

A novel “selective” antiresorptive drug, odanacatib, is a cathepsin K inhibitor that has the advantage of not suppressing bone formation, as do traditional or “non-selective” antiresorptive drugs. Clinical trial data in the largest ever osteoporosis trial, published in abstract form, show that odanacatib, given as a weekly tablet, reduces vertebral, non-vertebral and hip fractures with risk reductions similar to those seen with bisphosphonates. Adverse events were reported and include atypical femur fractures, morphea and adjudicated cerebrovascular events.74 The benefit–risk profile of this drug is currently being clarified.

Anabolic drugs

The two other new drugs are anabolic agents. Abaloparatide, an analogue of parathyroid hormone-related protein (1–34), selectively acts on the type 1 parathyroid hormone receptor to stimulate bone formation. It is given as a daily injection.75 It reduces vertebral and non-vertebral fractures, but data for hip fracture are lacking.76 Abaloparatide reduced major osteoporotic fractures by 67% compared with placebo.77 Abaloparatide will also have a black box warning about osteogenic sarcoma in rats. The final drug, romosozumab, is a monoclonal antibody that targets an inhibitor of bone formation, sclerostin, and is given as 2-monthly injections for 12 months. Trial data comparing reductions in fractures with placebo are awaited, and a head-to-head trial comparing the antifracture efficacy of romosozumab with alendronate is ongoing.

Conclusion

Osteoporosis treatment represents a missed opportunity for medical practitioners. Despite a growing number of effective therapies, where the benefits far outweigh the risks, only a minority of patients presenting to the health care system with minimal trauma fractures are being either investigated or treated for osteoporosis.

The time to close this gap between evidence and treatment is long overdue and will require systems-based approaches supported by both the federal and state governments. One such approach is fracture liaison services, which have proven efficacy in cost-effectively reducing the burden of fractures caused by osteoporosis, and are increasingly being implemented internationally. General practitioners also need to take up the challenge imposed by osteoporosis and become the champions of change, working with the support of specialists and government to reduce the burden of fractures caused by osteoporosis in Australia.

Box 1 –
Bilateral atypical femoral fractures in an older woman after bisphosphonate therapy for 9 years*

* Note the characteristic findings of a predominantly transverse fracture line, periosteal callus formation and minimal comminution on the left, and the periosteal reaction on the lateral cortex on the right femur, indicating an early stress fracture.

Box 2 –
Balancing benefits and risks of bisphosphonate therapy with other lifetime risks*

* Adapted from Adler, et al.54

Box 3 –
Approach to the management of post-menopausal women on long term bisphosphonates therapy for osteoporosis*

DXA = dual-energy x-ray absorptiometry. * Adapted from Adler, et al.54 † Includes age > 70 years; clinical risk factors for fracture and osteoporosis; fracture risk score on fracture risk calculation tools above the Australian treatment threshold. ‡ Cessation of treatment for 2–3 years.

Low HIV testing rates among people with a sexually transmissible infection diagnosis in remote Aboriginal communities

The known Sexually transmissible infection (STI) guidelines recommend full STI screening, including testing for HIV and syphilis, for people diagnosed with any STI.

The new Analysis of clinical data for 2010–2014 from 65 remote Aboriginal communities indicated that about one-third of people with positive test results for chlamydia, gonorrhoea or trichomoniasis were tested for HIV within 30 days of the STI test, as were about one-half of those tested for syphilis.

The implications Adhering to HIV and syphilis screening recommendations is clearly an area for improvement in the delivery of sexual health services to remote communities.

A significant challenge in Aboriginal and Torres Strait Islander health is averting a major outbreak of human immunodeficiency virus infection (HIV) as has occurred in indigenous populations in other countries.1,2 Although the number of HIV diagnoses among Aboriginal people has been relatively stable over the past 20 years, there are now early warning signs of an increase. The number of cases is small, but standardised population rates of HIV diagnoses in Indigenous and non-Indigenous Australians have diverged over the past 5 years: the population rate is now almost twice as high for Aboriginal as for Australian-born non-Indigenous people (5.9 per 100 000 v 3.7 per 100 000 population). In addition, there are differences in the way HIV is transmitted in the two populations: a higher proportion of infections among Aboriginal people are attributed to injecting drug use (16% v 3%) or heterosexual sex (20% v 13%), and the proportion of female patients is higher (22% v 5%) than among non-Indigenous Australians.3

There are several risk factors for HIV, including social, psychological and individual aspects. However, of particular significance for the Aboriginal population are the higher endemic rates of sexually transmissible infections (STIs) such as chlamydia, gonorrhoea and trichomoniasis,4,5 as well as an ongoing outbreak of syphilis (almost 1000 cases across northern and remote Australia),6 all of which increase the risk of HIV transmission.7

One of the critical factors for preventing HIV in any population is timely, targeted and appropriate testing. In Australia, HIV and STI care guidelines include specific recommendations for Aboriginal and Torres Strait Islander populations,8,9 including testing for an undiagnosed HIV infection when another STI is diagnosed. Timely testing and diagnosis can prevent the spread of HIV, as people may reduce their sexual risk behaviour once they are aware of their positive status.10 Further, early detection can facilitate early treatment, and the risk of transmission remains extremely low if individuals can sustain an undetectable HIV viral load by adhering to highly active anti-retroviral treatments.11,12

Despite awareness for more than two decades of the very high notification rates of chlamydia, gonorrhoea, trichomoniasis and syphilis in many remote communities, there is a gap in our knowledge about the extent of HIV testing, including concurrent testing with other STI diagnostic testing. We report here on an analysis of clinical and laboratory records from 65 remote Aboriginal communities participating in the randomised, controlled community trial, STRIVE (STI in remote communities: improved and enhanced primary health care).13 The communities are located in four regions (two in the Northern Territory, one in northern Western Australia and one in Far North Queensland; anonymised in our reported results), and the approximate combined community population of people aged 16–34 years was 28 000 according to Australian Bureau of Statistics data. The trial examined whether a sexual health quality improvement program could increase STI testing to a level sufficient to reduce the community prevalence of STIs. Our aim was to determine the level of concurrent HIV testing of individuals who had received positive results for chlamydia, gonorrhoea or trichomoniasis, and of concurrent HIV testing of people tested for syphilis.

Methods

The STRIVE trial collected de-identified data from pathology laboratories for the period January 2010 – December 2014. The primary outcome of our study was the rate of concurrent HIV testing (same day testing, or within 30 or 90 days of the diagnostic test for chlamydia, gonorrhoea or trichomoniasis) of people who tested positive for any of these three STIs. HIV testing referred to any HIV screening test conducted by the laboratory; no HIV rapid tests were used by the participating health services.

The unit of analysis was the episode of STI testing (tests for any of the three STIs on the same date). All episodes of STI testing that resulted in a positive result for any of the three STIs were included in the denominator for calculating the HIV testing rate. We focused on chlamydia, gonorrhoea and trichomoniasis because urine or a swab is collected when testing for these STIs, but not blood (which is needed for HIV testing). We selected 30 days as the cut-off point because most people would return for STI treatment within this period, and there would be an opportunity to collect blood for HIV testing if it had not been collected at the initial consultation. We separately analysed the period 1–30 days (ie, excluding same day HIV testing) and testing within 90 days.

Secondary outcomes were the rate of concurrent syphilis testing (within 30 days of a positive STI test), and the rate of HIV testing (on the same day and within 30 days of the syphilis test) among people tested for syphilis (regardless of the test result), as syphilis testing requires collecting blood, thereby making HIV testing more convenient. We analysed syphilis separately from the other three STIs because it was difficult to distinguish between latent and infectious syphilis cases on the basis of the datasets to which we had access; for latent cases, the decision as to whether an HIV test should be ordered would be determined by the clinician.

We used multivariate logistic regression to determine factors independently associated with HIV testing and syphilis testing within 30 days of an STI test with a positive result. Age group, sex, year, geographic region, and year of the positive test were included in the model. We examined models adjusted for clustering by patient, clinic, and region, and also a model with a patient random effect, as it accounted for most variation; this final version is reported in this article. All analyses were conducted in Stata 14 (StataCorp).

Ethics approval

The STRIVE trial was approved by the Central Australian Human Research Ethics Committee (HREC) (reference, 2009.11.03), the HREC of the NT Department of Health and Families and the Menzies School of Health Research (reference, 09/98), the University of New South Wales HREC (B) (reference, HREC 10112), the WA Aboriginal Health Information and Ethics Committee (reference, 267-11/09), the WA Country Health Service Board Research Ethics Committee (reference, 2010: 04), and the Cairns and Hinterland, Cape York, Torres Strait and Northern Peninsula HREC (reference, HREC/09/QCH/122). Participating health services signed a site participation agreement before commencing involvement in STRIVE.

Results

During the 2010–2014 study period, there were 15 260 positive test results for STIs (chlamydia, gonorrhoea or trichomoniasis), including 4190 in men and 11 055 in women; there were 5015 positive chlamydia, 4546 positive gonorrhoea and 8954 positive trichomoniasis test results. Of the 15 260 positive test results, 31.8% were associated with an HIV test within 30 days, including 5.6% between 1 and 30 days (ie, excluding same day testing) (Box 1); 34.8% were associated with an HIV test within 90 days (data not shown). When analysed by geographical region, the proportion of people with a positive STI test who had an HIV test within 30 days ranged between 29.6% and 40.2%. Of all people tested for syphilis (regardless of the test result), 53.4% were also tested for HIV within 30 days (Box 2). Further, 44.1% of those who received a positive STI test result were tested for syphilis within 30 days of the STI test (Box 1).

Multivariate analysis found that HIV testing within 30 days of a positive STI test was more likely for men, in geographical regions 3 and 4 (v region 1; and less likely in region 2), and in association with positive STI test results during 2012, 2013 or 2014 (v 2010) or with positive STI tests for gonorrhoea or chlamydia (v other two STIs combined). Similar associations pertained to syphilis testing within 30 days of an STI test with a positive result (Box 3).

Discussion

We found a low rate of HIV testing within 30 days of an STI diagnostic test with a positive result in remote communities with persistently high rates of curable STIs. About one-third of all people with positive STI test results were tested for HIV within 30 days, irrespective of age group. The rate was significantly higher in men, which may reflect more full STI screens being undertaken in men presenting with symptoms or risk behaviour. There was a slightly higher rate of HIV testing when blood for syphilis testing was collected, but it was still less than optimal according to current clinical recommendations. Most HIV testing occurred on the same day as other STI testing (94%), suggesting that full STI screens were being undertaken.

The rate of HIV testing within 30 days of the STI test varied somewhat between health services in different geographical regions, but did not exceed 40.2% in any region. The low rate of HIV testing we observed is not confined to communities in northern Australia. Preliminary data from a study of four Aboriginal primary health care services in urban and regional areas of New South Wales also indicate that the rate of HIV testing associated with a positive STI diagnosis was low (42%), and, similar to what we found, most tests (82%) were conducted on the same day as the other STI test.14

We found that the rate of HIV testing within 30 days of an STI test with a positive result increased across the STRIVE study period; a formal analysis is evaluating whether this difference can be attributed to the intervention.

The strengths of our study include the large dataset, comprising data for patients with an STI diagnosis from 65 remote communities across the NT, WA and Queensland. In addition, capture of records of STI testing was complete, as each community participating in STRIVE has only one clinical service provider and used one of three pathology laboratories that provided data on all testing undertaken during the study period. A limitation is that we only had access to information for those who consented to HIV testing; it is therefore possible that some individuals were offered testing but declined. We did not collate the results of HIV testing in the study, and it is possible that some patients known to be HIV-positive were included in the study, who would therefore not have required HIV testing. However, this would only account for a very small number of people, given the low rate of HIV-positivity in remote health services.

HIV testing is important at the patient level and from a public health perspective, ensuring that people with HIV are identified quickly in order to reduce transmission by individuals who may not know their status, to enable rapid contact tracing, an efficient strategy for identifying undiagnosed infections,15 and so that patients with HIV can start treatment as early as possible.

Our study identified adherence to HIV screening recommendations as an area in the delivery of sexual health services to remote communities that clearly needs to be improved. Barriers to offering HIV testing in these settings should be investigated. Urgently needed are training and systems that increase awareness of clinical guidelines among clinical staff and support their implementing these guidelines when testing for STIs in remote communities. As nearly 40% of young people in the services we investigated had been diagnosed with at least one of the three STIs,4 and in view of the current syphilis outbreak, offering a full STI screen is likely to be an efficient way to improve HIV testing rates. Failure to increase HIV testing risks an outbreak that may be difficult to control in remote settings. HIV testing should be a priority, and its uptake should be routinely audited by those managing sexual health programs or remote area clinics.

Box 1 –
HIV testing of people aged 16–34 years attending 65 remote primary health care services within 30 days of a sexually transmissible infection (STI)* diagnostic test for which the result was positive, 2010–2014

	Any positive STI test^†	Testing within 30 days of the STI test (including same day)		Testing within 30 days of the STI test (excluding same day)
	Any positive STI test^†	HIV	Syphilis	HIV	Syphilis

Total	15 260	4858 (31.8%)	6727 (44.1%)	854 (5.6%)	1099 (7.2%)
Sex^‡
Men	4190	2035 (48.6%)	2355 (56.2%)	208 (5.0%)	209 (5.0%)
Women	11 055	2815 (25.5%)	4361 (39.4%)	646 (5.8%)	889 (8.0%)
Age group (years)
16–19	3924	1305 (33.3%)	1761 (44.9%)	259 (6.6%)	302 (7.7%)
20–24	3827	1282 (33.5%)	1777 (46.4%)	233 (6.1%)	300 (7.8%)
25–29	2486	819 (33.0%)	1106 (44.5%)	119 (4.8%)	171 (6.9%)
30–34	1597	498 (31.2%)	686 (42.9%)	83 (5.2%)	112 (7.0%)
≥ 35	3416	954 (27.9%)	1397 (40.9%)	163 (4.8%)	214 (6.3%)
Region
1	4320	1314 (30.4%)	1528 (35.4%)	121 (2.8%)	161 (3.7%)
2	7670	2269 (29.6%)	3639 (47.4%)	435 (5.7%)	633 (8.3%)
3	1087	437 (40.2%)	620 (57.0%)	131 (12.1%)	105 (9.7%)
4	2183	838 (38.4%)	940 (43.1%)	170 (7.8%)	200 (9.2%)
Year
2010	2658	765 (28.8%)	1095 (41.2%)	167 (6.3%)	193 (7.3%)
2011	2994	907 (30.3%)	1389 (46.4%)	196 (6.5%)	253 (8.5%)
2012	3044	935 (30.7%)	1372 (45.1%)	175 (5.7%)	220 (7.2%)
2013	3133	990 (31.6%)	1347 (43.0%)	138 (4.4%)	205 (6.5%)
2014	3425	1261 (36.8%)	1524 (44.5%)	181 (5.3%)	228 (6.7%)
Type of infection
Chlamydia	5015	1883 (37.5%)	2439 (48.6%)	361 (7.2%)	396 (7.9%)
Gonorrhoea	4546	1787 (39.3%)	2101 (46.2%)	279 (6.1%)	342 (7.5%)
Trichomoniasis	8954	2360 (26.4%)	3703 (41.4%)	437 (4.9%)	638 (7.1%)

* Chlamydia, gonorrhoea or trichomoniasis. † Missing values not included. ‡ Data missing for 15 people.

Box 2 –
HIV testing of people aged 16–34 years attending 65 remote primary health care services within 30 days of a test for syphilis, 2010–2014

	Syphilis test*	HIV testing within 30 days (including same day)

Total	46 744	24 961 (53.4%)
Sex
Men	19 718	11 743 (59.6%)
Women	26 961	13 192 (48.9%)
Age group (years)
16–19	6481	3640 (56.2%)
20–24	9306	5114 (55.0%)
25–29	8095	4512 (55.7%)
30–34	6295	3474 (55.2%)
≥ 35	16 553	8220 (49.7%)
Region
1	8221	4765 (58.0%)
2	27 533	13 369 (48.6%)
3	4978	2124 (42.7%)
4	6012	4703 (78.2%)
Year
2010	7576	2765 (36.5%)
2011	9546	3802 (39.8%)
2012	9812	5228 (53.3%)
2013	9559	6043 (63.2%)
2014	10 241	7123 (69.6%)

* Missing values not included.

Box 3 –
Multivariate model of HIV and syphilis testing within 30 days of a sexually transmissible infection (STI)* diagnostic test for which the result was positive (including same day as initial test)^†

	HIV test within 30 days			Syphilis test within 30 days
	Odds ratio	95% CI	P	Odds ratio	95% CI	P

Sex
Women	1			1.00
Men	2.67	2.43–2.92	< 0.01	2.12	1.95–2.31	< 0.01
Age group (years)
16–19	1			1.00
20–24	1.07	0.96–1.19	0.23	1.08	0.98–1.20	0.11
25–29	1.08	0.96–1.22	0.20	1.03	0.92–1.15	0.61
30–34	1.06	0.92–1.23	0.42	0.99	0.87–1.13	0.94
≥ 35	0.93	0.82–1.05	0.22	0.87	0.78–0.97	0.01
Region
1	1			1.00
2	0.87	0.79–0.95	< 0.01	0.52	0.50–0.57	< 0.01
3	1.52	1.30–1.77	< 0.01	1.43	1.24–1.66	< 0.01
4	1.28	1.14–1.44	< 0.01	0.74	0.67–0.83	< 0.01
Year
2010	1			1.00
2011	1.10	0.97–1.25	0.13	1.30	1.16–1.45	< 0.01
2012	1.14	1.01–1.30	0.04	1.25	1.12–1.40	< 0.01
2013	1.24	1.09–1.40	< 0.01	1.17	1.04–1.31	0.01
2014	1.61	1.42–1.82	< 0.01	1.24	1.11–1.39	< 0.01
Type of infection^‡
Chlamydia	1.28	1.10–1.34	< 0.01	1.22	1.11–1.34	< 0.01
Gonorrhoea	1.52	1.16–1.42	< 0.01	1.11	1.01–1.22	0.03
Trichomoniasis	0.87	0.84–1.05	0.24	1.10	0.99–1.21	0.08

* Chlamydia, gonorrhoea or trichomoniasis. † The model was adjusted for individual clustering by including an individual patient random effect. ‡ Reference group for each comparison consists of patients with the other two sexually transmissible infections.

Medicines to treat side effects of other medicines? Sometimes less is more beneficial

About two-thirds of people who are 75 years and older take five medicines or more. This is known as “polypharmacy”. Many of these people are on more than ten medicines a day (hyperpolypharmacy).

It can be appropriate to prescribe multiple medicines for someone with complex or multiple illnesses if there is evidence of the benefits, and harms are minimised. But we know taking multiple medicines strongly increases the risk of unwanted side effects such as drowsiness, dizziness, confusion, falls and injuries and even hospitalisations.

Older people may be taking medicines that are not working or no longer needed; medicines may have been prescribed to treat the side effects of other medicines (prescribing cascade); other treatment options may be more suitable; or they may have difficulty taking the medicines.

Reducing these inappropriate and unnecessary medicines in older people is one of the most important challenges of modern medicine.

For example, let’s consider Robert, a 60-year-old man who starts taking blood-pressure-lowering medicine to reduce his chance of having a heart attack or stroke. He tolerates this well for many years and continues taking the medicine, as his doctor told him he needs to take it for the rest of his life.

By the age of 80 he is on ten medicines for various conditions (including arthritis, reflux and sleeping problems) and starts to get dizzy spells. On occasions the dizziness has led to a fall, and his concerns about falling have made him less independent.

What can be done in Robert’s case? Reviews of studies where medicines are selectively and carefully stopped (also called “deprescribing”) show reducing specific types of medicines, such as blood-pressure-lowering medicine, can be done without causing harmful withdrawal effects. In the case of medicines such as antidepressants or sleeping tablets, reduction can even have the benefits of reducing the risk of falls and improving cognition.

However, discussions between doctor and patient about coming off medicines are not easy and there is little guidance on how to do it. We are used to talking about why medicines need to be started, but less familiar with stopping or reducing the doses of medicines.

The evidence for the benefit of many medicines is less clear for older patients as randomised controlled trials generally study younger populations with no other illnesses. This means, especially for older people, that the balance of potential benefits versus harms depends on what is important to the individual patient.

Robert’s priority might be living independently by avoiding dizziness and reducing his risk of having a fall. He therefore may prefer to reduce his blood-pressure medicine. His friend James may be more concerned about avoiding death or disability from a heart attack or stroke. He therefore may prefer to continue his medication and accept he may experience dizzy spells as a result.

Biases in the way we think often influence decisions on medicine. Patients may not realise change is an option, doctors may incorrectly assume patients always want to stay on their medicines, and older people may experience cognitive changes that make it more challenging for them to be involved in an informed decision. But all of these issues can be overcome with good communication.

Using Robert’s situation as an example, here are four steps to ensure an informed and shared decision about deprescribing.

1. You have options

Continuing, reducing the dose, or discontinuing blood-pressure medicine should all be identified as options to manage the problem of dizziness.

2. Discuss the harms and benefits

The likelihood of preventing a heart attack or stroke by continuing blood-pressure medicine versus preventing dizziness or falls by reducing or stopping the medicine should be discussed. This should take into account other medicines taken and the strength of the evidence for the relevant age group.

3. What does the patient want?

Robert’s concerns about reduced independence after a fall now, versus death or disability from a heart attack or stroke in the future, should be discussed. This includes talking about possible trade-offs between quality of life in the short term and life expectancy in the long term.

4. Make a decision

A decision about maintaining, reducing or stopping blood-pressure medicine should be made by Robert together with his doctor, carer and/or family, depending on who Robert wants to be involved. The decision made now can be changed later on.

If patients have any concerns about their medicines, experience troublesome symptoms or think a medicine may no longer be needed, they should talk to their GP or pharmacist about reviewing their medicines and discussing the potential for reducing or stopping. More information about medicines and older people is available on the NPS Medicinewise website.

Deprescribing, or carefully ceasing medicines, is not taking away care; it is a positive strategy that reduces avoidable harmful effects and can improve quality of life.

Jesse Jansen, Senior Research Fellow, Sydney School of Public Health, University of Sydney; Andrew McLachlan, Professor of Pharmacy (Aged Care), University of Sydney; Carissa Bonner, Postdoctoral Research Fellow, University of Sydney, and Vasi Naganathan, Associate Professor of Geriatric Medicine, University of Sydney

This article was originally published on The Conversation. Read the original article.

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Blocking overseas practitioners won’t solve rural doctor shortage

The nation needs to do more to encourage medical practitioners to work in under-served rural areas rather than simply seek to choke off the supply of overseas-trained doctors by tightening visa rules, AMA President Dr Michael Gannon has said.

Responding to a report in The Australian that the Health Department wants to axe visas for imported doctors to make room for a growing number of domestic medical graduates, Dr Gannon said the real issue was to improve the attractiveness of rural practice for doctors, regardless of where they come from.

A surge in the number of medical graduates in recent years has eased fears of a doctor shortage, leading some to argue the country no longer needs to rely on the recruitment of doctors from overseas to plug gaps in the medical workforce.

But, while acknowledging the big jump in medical graduates had altered the landscape, Dr Gannon said the Health Department’s proposal to remove 41 health jobs from the Skilled Occupations List was misdirected.

Related: Rural doctors want support

Dr Gannon said for several decades overseas-trained doctors had been a valued part of the health system, helping ameliorate the effects of a long period of under-investment in medical training.

He said it was important that those with special skills or talent continued to have the opportunity to work in Australia.

Instead of blocking doctors from overseas, the focus should be on addressing the misallocation that sees most doctors, whether locally trained or from overseas, congregating in practices in the major cities rather than moving into rural areas where they were most needed, Dr Gannon told ABC radio.

“We just have to look at a system which is not delivering on its stated intention, which is to get doctors where they’re really needed,” the AMA President said. “What we’ve seen now is that we’ve got a reasonable oversupply of GPs and other specialists in inner-metropolitan Australia, and I think what we need to work harder on is investing in incentives to get doctors to work in rural areas.”

Dr Gannon said country practice was a “very, very rewarding professional career”, and evidence showed that junior doctors given opportunities to train in rural areas were far more likely to work there.

The AMA has urged increased Commonwealth investment in rural training, and late last year the Government announced the establishment of a $93.8 million Integrated Rural Training Pipeline to improve the retention of postgraduate prevocational doctors in country areas.

Dr Gannon said that while the funding was welcome, it did not come close to replacing the Prevocational General Practice Placements Program (PGPPP) scrapped in the 2014 Budget, and much more effort was needed, particularly to encourage more procedural GPs to set up in the bush.

The AMA has proposed a Community Residency Program which would allow doctors in training to undertake rotations of up to 13 weeks to give them a good experience of life as a rural GP and to enhance their clinical experience.

“The abolition of the PGPPP has left general practice in a position where it is the only major medical specialty unable to offer doctors in training a structured prevocational training experience before they make a career choice,” Dr Gannon said.

“The Community Residency Program would provide them with opportunities to undertake important general practice prevocational training in an effort to encourage more young doctors to choose a career in general practice.”

The AMA President said it would complement the Government’s plan to establish a National Rural Generalist Pathway as a way to address rural workforce issues.

Adrian Rollins

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Costs force ill to skip care

Almost half of patients with depression, anxiety or other mental health conditions and a third of those suffering asthma, emphysema and other chronic respiratory illnesses are skipping treatment because of out-of-pocket costs.

As the Medicare rebate freeze forces a growing number of general practices to cut back on bulk billing and increase patient charges, researchers have found that out-of-pocket costs for medical services and medications are deterring many with chronic illnesses from seeing their doctor or filling their prescription, potentially making their health problems more difficult and costly to treat.

They found that those with mental illnesses were the most price sensitive – 44 per cent reported deferring an appointment or leaving a script unfilled because of cost, as did 32 per cent with asthma or chronic obstructive pulmonary disorder and 27 per cent of those with diabetes. Even a fifth of cancer patients reported skipping treatment because of the expense.

Out-of-pocket charges were cited as a barrier to care even for some of those without a long-term health problem – 9 per cent said deferred care because of cost.

Lead researcher Dr Emily Callander from James Cook University said that although, as a whole, Australia enjoyed good health outcomes, her study showed that out-of-pocket costs were a substantial barrier to care, particularly for vulnerable and at-risk patients like the chronically ill.

She said the problem was particularly acute for patients with mental health problems.

“Those with mental health conditions were shown to have particularly large out-of-pocket expenditure and be more likely to forgo care, which indicates that the costs of mental health services may be prohibitively high,” Dr Callander and her colleagues wrote.

Out-of-pocket costs high

The research, which is part of an international Commonwealth Fund health policy study and draws on data from a NSW Bureau of Health Information survey of 2200 respondents, found that out-of-pocket expenses for Australia patients were high by world standards.

It showed that Australians paid an average of $1185 in out-of-pocket costs, compared with $987 for Germans, $947 for Canadians, $639 for New Zealanders, $488 for British patients and $421 for the French.

Dr Callander’s said research showed expenses for patients with chronic illnesses can be particularly high.

Stroke survivors, for example, spent an average of $1110 a year on health costs, including up to $32,411 in the first 12 months following their stroke. Those with arthritis, meanwhile, paid out an average of $1513 a year on treatment, with some spending as much as $20,527.

Those with asthma, emphysema and COPD reported spending an average of $1642 a year on out-of-pocket expenses, while those with a mental illness spent $1350 a year and those with high cholesterol spent $1423 annually.

By comparison, those without a chronic illness spent on average $660 a year on out-of-pocket health costs.

Dr Callander said the point of her research was not that out-of-pocket costs were inherently wrong, but could have a much more significant effect on vulnerable patients, like the chronically ill, than the broader community.

“I don’t think that out-of-pocket costs per se are a bad thing,” the researcher said. “I am not saying that we should not have them.

“But while maybe a $30 GP out-of-pocket charge might not seem much to most of us, for someone with a chronic disease who is unemployed it might seem a lot. For them it might mean a choice between seeing the doctor or having some extra food.

“It is the disadvantaged – the people with low incomes and ones with chronic health problems – who are the worst affected.”

Chronic catch-22

The chronically ill are caught in a double-bind. They often face much higher health expenses than most, while the effect of their illness is often to make it difficult for them to work.

Dr Callander said it was well documented that people with chronic illnesses were on lower incomes, had less wealth, and were more likely to be in income poverty, “which is likely because of the effect that chronic health conditions have on their ability to participate in the labour force”.

And, of course, the more they defer or forgo treatment, the worse their health becomes and the more expensive the treatment required.

Dr Callander’s research found that the combined effect of high out-of-pocket expenses and low incomes was to force 25 per cent of chronically ill Australians to skip care, exceeded only by the United States, where 42 per cent of patients with a chronic illness said they deferred treatment because of cost. By comparison, just 8 per cent of chronically ill Swedish patients and 5 per cent of British patients admitted to the same thing.

While in the past research had concentrated on a lack of available services as a common barrier to care, Dr Callander said the effect of cost had often been overlooked.

“The [study shows] that the cost of health care does act as a barrier to receiving treatment, particularly for those with mental health conditions,” the researcher said. “These findings come at a vital time when there has been much discussion abour the possibility of raising the cost of healthcare to individuals.”

She said it was of “vital importance” that there be policies aimed at promoting affordable health care for at-risk and vulnerable patients, “to ensure that out-of-pocket cost is not a barrier to treatment and do not widen the gap in health status between those of high and low socioeconomic status”.

The study has been published in the Australian Journal of Primary Health.

Adrian Rollins

What are the top 10 drugs used in Australia?

For the first time in 20 years, statins have not topped the list of the most costly drug for the Australian government to fund.

Australian Prescriber has released the top 10 drugs used in Australia as well as the top 10 by cost to government. The figures are based on PBS and RPBS prescriptions.

Atorvastatin dropped out of the top 10 by cost to government, however it still topped the lists for daily dose and prescription counts.

The most expensive drug for the government is Adalimumab, a monoclonal antibody indicated for the treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis. Crohn’s Disease, Ulcerative colitis, Psoriasis and Hidradenitis Suppurativa which cost the government $311 616 305 for 176,062 prescriptions from July 2014 – June 2015.

Related: Millions wasted on discarded drugs

Two injectable drugs to treat age-related macular degeneration appeared for the first time. Aflibercept came in at third most expensive for the government, costing nearly $193 million for 123 123 prescriptions and Ranibizumab was fourth most expensive, costing nearly $180 million for 116 311 prescriptions.

On the most prescribed list were two statins (Atorvastatin in number 1 and Rosuvastatin in number 3) as well as proton-pump inhibitors (Esomeprazole in number 2 and Pantoprazole in number 5), analgesics (paracetamol in number 4) and type 2 diabetes (Metformin in number 6).

See the full list at Australian Prescriber.

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[Series] Serving transgender people: clinical care considerations and service delivery models in transgender health

The World Professional Association for Transgender Health (WPATH) standards of care for transsexual, transgender, and gender non-conforming people (version 7) represent international normative standards for clinical care for these populations. Standards for optimal individual clinical care are consistent around the world, although the implementation of services for transgender populations will depend on health system infrastructure and sociocultural contexts. Some clinical services for transgender people, including gender-affirming surgery, are best delivered in the context of more specialised facilities; however, the majority of health-care needs can be delivered by a primary care practitioner.

Your Family Doctor: Invaluable to your health

AMA Family Doctor Week, 24 – 30 July 2016

The AMA used this year’s Family Doctor Week to not only celebrate the hard work and dedication of Australia’s 30,000 GPs, but to put the re-elected Coalition Government on notice that changes in health care policy are urgently needed.

The traditional National Press Club address has been moved to August to allow for continued campaigning against the Medicare rebate freeze, cuts to public hospital funding, and cuts to bulk billing incentives for pathology and radiology.

Media outlets around the country, including the national WIN network of regional television stations, picked up on the message that GPs are the most cost-effective sector of the health system and need support.

AMA President, Dr Michael Gannon, said that the personalised care and preventive health advice provided by family doctors helps to keep people out of hospitals, and keep health costs down.

“Australian GPs provide the community with more than 137 million consultations, treat more than 11 million people with chronic disease, and dedicate more than 33 million hours tending to patients each year,” Dr Gannon said.

“Nearly 90 per cent of Australians have a regular GP, and enjoy better health because of that ongoing trusted relationship.”

The AMA used the week to outline a series of proposals for improving the health of Australians while also delivering savings to the Government.

The Pharmacist in General Practice Incentive Program (PGPIP) proposal would integrate non-dispensing pharmacists into GP-led primary care teams, allowing pharmacists to assist with medication management, provide patient education on their medications, and support GP prescribing with advice on medication interactions and newly available medications.

“Evidence shows that the AMA plan would reduce unnecessary hospitalisations from adverse drug events, improve prescribing and use of medicine, and governments would save more than $500 million,” Dr Gannon said.

“When the Government is looking to make significant savings to the Budget bottom line, the AMA’s proposal delivers value without compromising patient care or harming the health sector.”

Independent analysis from Deloitte Access Economics identified that the proposal would deliver $1.56 in savings for every dollar invested in it.

The AMA also stepped up the pressure for more appropriate funding for the Government’s trial of the Health Care Home model of care for patients with chronic disease.

In March, the Government committed $21 million to allow about 65,000 Australians to participate in initial two-year trials in up to 200 medical practices from 1 July 2017. However, the funding is not directed at services for patients.

“GPs are managing more chronic disease, but they are under substantial financial pressure due to the Medicare freeze and a range of other funding cuts,” Dr Gannon said.

“GPs cannot afford to deliver enhanced care to patients with no extra support. If the funding model is not right, GPs will not engage with the trial, and the model will struggle to succeed.”

With chronic conditions accounting for approximately 85 per cent of the total burden of disease in Australasia and 83 per cent of premature deaths in Australia, it was vital that Australians could turn to their family doctor for advice, Dr Gannon said.

“The Government uses concerns about the sustainability of the health system to justify funding cuts, but instead of making short-sighted and short-term savings, it should invest in preventing disease in the first place,” he said.

Family doctors in rural and regional communities, in particular, needed more support.

The AMA called on the Government to rethink its approach to prevocational training in general practice, and to revamp and expand its infrastructure grants program for rural and regional practices.

Maria Hawthorne

Your AMA Federal Council at work

AMA Representative (or Proxy) Name – 1 Name per line	Position on Council	Committee meeting Name	Date of meeting

Dr Tony Bartone	AMA Vice President	ACSQHC Primary Care Committee	5/7/2016
Dr Tony Bartone	AMA Vice President	Health Care Home Implementation Advisory Group	22/7/2016
Dr Brian Morton	Former AMACGP Chair	UGPA	24/5/2016
Dr David Rivett	Former AMACRD Chair	Rural and Regional Stakeholder Roundtable	6/4/2016
Professor Geoffrey Dobb	AMA Member	Health Star Rating Advisory Committee	8/4/2016
Dr Kean-Seng Lim	AMA Member	NeHTA (National E-Health Transition Authority) ePrescription Forum	12/5/2016
Dr John Gullotta	AMA Federal Councillor	NeHTA (National E-Health Transition Authority) eReferral Reference Group	5/5/2016
Professor Brian Owler	Former AMA President	Senate inquiry into outcomes of 42nd COAG meeting	27/4/2016
Professor Robyn Langham	AMA Federal Councillor	Development of the Clinical Quality Registries	4/4/2016
A/Professor David Mountain	AMA Federal Councillor	Senate inquiry hearing into paramedics national registration	20/4/2016

Medicinal cannabis can now be prescribed by NSW GPs

New regulation means that from 1st August 2016, NSW doctors can seek approval to write up scripts of medicinal cannabis for patients who need it.

Previously, patients could only legally access cannabis-based medicines through clinical trials. However thanks to changes under the Poisons and Therapeutic Goods Amendment (Designated Non-ARTG Products) Regulation 2016 (under the Poisons and Therapeutic Goods Act 1966), the drugs can now be prescribed for patients who have exhausted their standard treatment options.

“People who are seriously ill should be able to access these medicines if they are the most appropriate next step in their treatment,” NSW Premier Mike Baird said on Sunday.

How do doctors get approval to prescribe?

In order to prescribe the drugs, doctors will need to get approval from both the Commonwealth Therapeutic Goods Administration and NSW Health.

According to NSW Health, in making their decision, the Commonwealth “will consider the prescriber’s expertise, the suitability of the product to treat the patient’s condition, and the quality of the product.”

A committee of medical experts from NSW Health will review the prescriber’s application, and will consider “whether the unregistered cannabis-based product is being appropriately prescribed for the patient’s condition.”

What can be prescribed?

Some cannabis-based products have already been assessed for quality, safety and efficacy by the medicines regulator. These include:

Nabiximols (Sativex®) – registered in Australia with the Therapeutic Goods Administration for managing spasticity associated with multiple sclerosis.
Dronabinol – registered by the US Food and Drug Administration for anorexia in patients with AIDS and chemotherapyinduced nausea and vomiting, where standard treatment has failed.
Nabilone – registered by the US Food and Drug Administration for chemotherapyinduced nausea and vomiting.

Although applications aren’t limited to the above products, the products applied for must be legally produced and manufactured to appropriate quality standards. There must also be evidence that supports use for that product for the patient.

How do doctors apply?

For more information and to apply for authority to prescribe and supply cannabis products, visit NSW Health’s Pharmaceutical page. More information can also be found at their Cannabis and cannabis products information site.

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