Medicines and the media: news reports of medicines recommended for government reimbursement in Australia.

BACKGROUND: Previous analyses of the listings of trastuzumab on the Australian Pharmaceutical Benefits Scheme (PBS) and HPV vaccine on the National Immunisation Program (NIP) suggest a media influence on policy makers. We examined the timing and content of Australian newspaper reports of medicines in relation to Pharmaceutical Benefits Advisory Committee (PBAC) decisions. METHODS: We identified newspaper reports (2005-2008) of medicines recommended for PBS listing in 2006-2007, analysing the content for mentions of the medicine, PBS and medicine costs to the patient and the government and counting the numbers of articles published in the six months before, the month of, and the six months after the relevant PBAC meeting. Case studies examined reporting for infliximab for Crohn's Disease, pemetrexed for mesothelioma, and ADHD (Attention Deficit Hyperactivity Disorder) medicines atomoxetine and methylphenidate. RESULTS: Of 79 eligible medicines, 62 had news reports. Most often reported were HPV vaccine (1230 stories), trastuzumab (410), pemetrexed (83), botulinum toxin (71), lapatinib (65), methylphenidate (57), atomoxetine (54), infliximab (49), rotavirus vaccine (45). Eighteen medicines had ≥20 news reports (total 2350 stories); nine of these cost more than AU$10,000 per course or year of treatment. For these 18 medicines, 31% of stories appeared in the six months prior to the PBAC meeting, 14% in the meeting month and 33% in the six months post-meeting. 38% of the stories had ≥3 medicine mentions, 37% referred to the PBS, 24% to cost to the patient, and 9% cost to Government.There was active patient lobby group campaigning in support of listing of infliximab and pemetrexed; the stories for ADHD were often more negative, referring to the dangers of the medicines and sometimes questioning the appropriateness of treatment and public subsidy. There was little discussion of the PBAC's evidence-based decision-making processes. CONCLUSIONS: While there was no general trend to increased news reporting associated with PBAC meetings, some drugs did attract media attention. With more new and expensive drugs, decisions on public funding will become increasingly difficult. The media have an important role in enhancing public understanding of the issues around resource allocation. Specialist journalists, guidelines and checklists may help reporting.

Costs of medicines and health care: a concern for Australian women across the ages.

BACKGROUND: Evidence from Australia and other countries suggests that some individuals struggle to meet the costs of their health care, including medicines, despite the presence of Government subsidies for low-income earners. The aim of our study was to elucidate women's experiences with the day to day expenses that relate to medicines and their health care. METHODS: The Australian Longitudinal Study on Women's Health (ALSWH) conducts regular surveys of women in three age cohorts (born 1973-78, 1946-51, and 1921-26). Our data were obtained from free text comments included in surveys 1 to 5 for each cohort. All comments were scanned for mentions of attitudes, beliefs and behaviours around the costs of medicines and health care. Relevant comments were coded by category and themes identified. RESULTS: Over 150,000 responses were received to the surveys, and 42,305 (27%) of these responses included free-text comments; 379 were relevant to medicines and health care costs (from 319 individuals). Three broad themes were identified: costs of medicines (33% of relevant comments), doctor visits (49%), and complementary medicines (13%). Age-specific issues with medicine costs included contraceptive medicines (1973-78 cohort), hormone replacement therapy (1946-51 cohort) and osteoporosis medications (1921-26 cohort). Concerns about doctor visits mostly related to reduced (or no) access to bulk-billed medical services, where there are no out-of-pocket costs to the patient, and costs of specialist services. Some women in the 1973-78 and 1946-51 cohorts reported 'too much income' to qualify for government health benefits, but not enough to pay for visits to the doctor. In some cases, care and medicines were avoided because of the costs. Personal feelings of embarrassment over financial positions and judgments about bulk-billing practices ('good ones don't bulk-bill') were barriers to service use, as were travel expenses for rural women. CONCLUSIONS: For some individuals, difficulty in accessing bulk-billing services and increasing out-of-pocket costs in Australia limit affordability of health services, including medications. At greatest risk may be those falling below thresholds for subsidised care such as self-funded retirees and those on low-middle incomes, in addition to those on very low incomes, who may find even small co-payments difficult to manage.

Pharmaceutical industry funding of educational events for pharmacists in Australia: an analysis of data from the first 6 months of a mandatory disclosure programme.

OBJECTIVE: The aim of the study was to assess the extent of pharmacist participation in pharmaceutical industry-sponsored educational events in Australia. METHODS: A descriptive analysis was performed of 14 649 educational events provided by 43 companies between July and December 2007, using publicly available reports posted on the Medicines Australia website. Pharmacist participation was assessed according to duration and type of event, whether continuing professional education credits were awarded, type of venue, hospitality provided and cost of hospitality. KEY FINDINGS: Most of the 14 649 industry-sponsored events reported in this mandatory reporting programme were targeted at doctors (specialists and general practitioners). Pharmacists were present at 621 events (4.2%); 209 events were pharmacist-only events. Of pharmacist-only events, 68% were held in hospitals and professional rooms and 13% in restaurants. In contrast, 32% of events involving doctors were held in restaurants (difference in proportions 18.9%; 95% confidence interval 13.5-22.9%) Sixty-six per cent of pharmacist-only events were 1 h or less in duration; 81% were 2 h or less. Almost 40% were reported as training or in-service activities, generally conducted in hospitals. Only three events had continuing professional education credits assigned. The most common topics discussed were oncology, diabetes, haematology, cardiology and gastroenterology; a specific medicine was mentioned in the descriptor for 23 of the 209 (11%) events. Hospitality provided was generally modest, averaging AU$36.24 per pharmacist across all pharmacist-only events, and lower in hospital (AU$9.21 per head) than those held in restaurants (AU$51.42). CONCLUSIONS: The data from this first report suggest pharmacists were not a major target for industry-funded educational events. Exposure to such events will likely increase as pharmacists take on enhanced prescribing roles and it is important that this is captured under the mandatory disclosure requirements that have been introduced in a number of jurisdictions. It is also desirable that such schemes include generic medicines manufacturers and that pharmacy professional bodies use these data to monitor and manage the level and impact of interactions between pharmacists and industry.

The impact of pharmacy computerised clinical decision support on prescribing, clinical and patient outcomes: a systematic review of the literature.

OBJECTIVES: Computerised clinical decision support systems (CDSSs) are being used increasingly to support evidence-based decision-making by health care professionals. This systematic review evaluated the impact of CDSSs targeting pharmacists on physician prescribing, clinical and patient outcomes. We compared the impact of CDSSs addressing safety concerns (drug interactions, contraindications, dose monitoring and adjustment) and those focusing on medicines use in line with guideline recommendations (hereafter referred to as Quality Use of Medicines, or QUM). We also examined the influence of clinical setting (institutional versus ambulatory care), system- or user-initiation of CDSS, prescribing versus clinical outcomes reported and use of multi-faceted versus single interventions on system effectiveness. METHODS: We searched Medline, Embase, CINAHL and PsycINFO (1990-2009) for methodologically adequate studies (experiments and strong quasi-experiments) comparing a CDSS with usual pharmacy care. Individual study results are reported as positive trends or statistically significant results in the direction of the intentions of the CDSS being tested. Studies are aggregated and compared as the proportions of studies showing the effectiveness of the CDSS on the majority (> or = 50%) of outcomes reported in the individual study. KEY FINDINGS: Of 21 eligible studies, 11 addressed safety and 10 QUM issues. CDSSs addressing safety issues were more effective than CDSSs focusing on QUM (10/11 versus 4/10 studies reporting statistically significant improvements in favour of CDSSs on > or = 50% of all outcomes reported; P = 0.01). A number of QUM studies noted the limited contact between pharmacists and physicians relating to QUM treatment recommendations. More studies demonstrated CDSS benefits on prescribing outcomes than clinical outcomes (10/10 versus 0/3 studies; P = 0.002). There were too few studies to assess the impact of system- versus user-initiated CDSS, the influence of setting or multi-faceted interventions on CDSS effectiveness. CONCLUSIONS: Our study demonstrated greater effectiveness of safety-focused compared with QUM-focused CDSSs. Medicine safety issues are traditional areas of pharmacy activity. Without good communication between pharmacists and physicians, the full benefits of QUM-focused CDSSs may not be realised. Developments in pharmacy-based CDSSs need to consider these inter-professional relationships as well as computer-system enhancements.

Depression screening in adults by pharmacists in the community: a systematic review.

BACKGROUND: Improving the identification of depression in adults in primary care can produce clinical and economic benefits. Community Pharmacists may play a role in screening for depression. OBJECTIVE: To systematically review and evaluate the evidence for the feasibility, impact and cost-effectiveness of community pharmacists screening adults for depression. METHODS: An electronic literature search using the databases EMBASE, PubMed and CINAHL Complete from January 2000 to September 2019 was undertaken to identify studies involving community pharmacists screening for depression. Data relating to sample size, population demographics and medical conditions of adults screened were extracted. Details around the screening model, process-related outcomes, clinical outcomes and economic outcomes were also extracted. RESULTS: Ten studies using eight unique depression screening tools were identified. Ease of administration was the most common selection criterion (n = 4) while no reason was given in four studies. Seven studies reported that through screening, pharmacists could identify adults with undiagnosed depression. Pharmacists referred adults screening positive for assessment in seven studies and followed up participants in two studies. No study assessed the impact of screening on depressive symptoms or the cost-effectiveness of pharmacists screening for depression. CONCLUSION: Community pharmacists are able to use depression screening tools to identify undiagnosed adults having symptoms of depression. However, there is little evidence around the impact of this screening on clinical and economic outcomes. Larger, well-designed studies that use a highly accurate, easily administered screening tool and include patient referral and follow-up and pharmacist training are warranted to provide evidence on the impact of community pharmacists screening adults for depression.

Transparency in pricing arrangements for medicines listed on the Australian Pharmaceutical Benefits Scheme.

Australia's system for assessing the cost-effectiveness of drugs for listing under the Pharmaceutical Benefits Scheme (PBS) is recognised internationally. A variety of mechanisms, such as evidence-based rules for determining eligibility for initial or continuing subsidy, price-volume agreements, rebates, and caps on government expenditure are used to contain PBS expenditures. In this paper we assess the extent of use of special pricing arrangements in Australia and how and where they are communicated to health professionals and the community. We searched publicly available documents published by the Pharmaceutical Benefits Advisory Committee (PBAC) and the Pharmaceutical Benefits Pricing Authority (PBPA). We found 73 medicines where special pricing arrangements had been applied and where prices appearing on the Schedule of Pharmaceutical Benefits might differ from those considered to be "cost-effective" by the PBAC. Reporting of these special pricing agreements was inconsistent and generally non-transparent. In some, the lack of transparency may have reflected the desire of manufacturers to disguise the true negotiated price, lest it weaken their negotiation position in other jurisdictions.

The role of evidence in consumer choice of non-prescription medicines.

OBJECTIVES: To identify factors influencing Australian consumer decision-making and attitudes towards non-prescription medicine (NPM) purchases, pharmacy's role in providing these medications and views around sources of evidence for effectiveness of these products. METHODS: Cross-sectional survey of a general population sample of 1731 adults using an Australian online consumer panel stratified by gender, age and location (State/Territory). Beliefs about NPM purchases and evidence of their efficacy were assessed using a 5-point Likert scale (strongly disagree-strongly agree). Non-parametric measures (Ridit analysis and Mann-Whitney U-test) were used to explore associations between responses and previous experience with medicines. KEY FINDINGS: The most important factors when purchasing NPMs were effectiveness and safety. However, personal experience was the most common method of determining effectiveness. Most respondents believed buying NPMs in pharmacies gave access to advice, but were less likely to agree that pharmacies were associated with safe and effective treatments. Around half the respondents agreed that it is wrong to sell treatments lacking scientific evidence; many also agreed that it is up to consumers to decide what they want even without scientific evidence. Individuals experiencing an ineffective NPM were less likely to trust scientific evidence of efficacy as the sole source of effectiveness information; regular prescription medicine users often agreed that scientific evidence is needed to support effectiveness. CONCLUSIONS: Consumers have conflicting views regarding the need for scientific evidence and the desire for patient autonomy in NPM purchases. This presents a challenge for pharmacists wishing to maintain professional obligations to provide evidence-based treatments to consumers.

The role of value for money in public insurance coverage decisions for drugs in Australia: a retrospective analysis 1994-2004.

OBJECTIVE: To analyze the relative influence of factors in decisions for public insurance coverage of new drugs in Australia. DATA SOURCES: Evidence presented at meetings of the Australian Pharmaceutical Benefits Advisory Committee (PBAC) that makes recommendations on coverage of drugs under Pharmaceutical Benefits Scheme. STUDY SELECTION: All major submissions to the PBAC between February 1994 and December 2004 (n = 858) if one of the outcomes measured was life year gained (n=138) or quality-adjusted life years (QALYs) gained (n=116). RESULTS: Clinical significance, cost-effectiveness, cost to government, and severity of disease were significant influences on decisions. Compared to the average submission, clinical significance increased the probability of recommending coverage by 0.21 (95% confidence interval [CI] 0.02 to 0.40), whereas a drug in a life-threatening condition had an increased probability of being recommended for coverage of 0.38 (0.06 to 0.69). An increase in $A10,000 from a mean incremental cost per QALY of $A46,400 reduced the probability of listing by 0.06 (95% CI 0.04 to 0.1). CONCLUSIONS: The PBAC provides an example of the long-term stability and coherence of evidence-based coverage and pricing decisions for drugs that weighs up the evidence on clinical effectiveness, clinical need, and value for money. There is no evidence of a fixed public threshold value of life years or QALYs, but willingness to pay is clearly related to the characteristics of the clinical condition, perceived confidence in the evidence of effectiveness and its relevance, as well as total cost to government.

A cross-sectional analysis of pharmaceutical industry-funded events for health professionals in Australia.

OBJECTIVES: To analyse patterns and characteristics of pharmaceutical industry sponsorship of events for Australian health professionals and to understand the implications of recent changes in transparency provisions that no longer require reporting of payments for food and beverages. DESIGN: Cross-sectional analysis. PARTICIPANTS AND SETTING: 301 publicly available company transparency reports downloaded from the website of Medicines Australia, the pharmaceutical industry trade association, covering the period from October 2011 to September 2015. RESULTS: Forty-two companies sponsored 116 845 events for health professionals, on average 608 per week with 30 attendees per event. Events typically included a broad range of health professionals: 82.0% included medical doctors, including specialists and primary care doctors, and 38.3% trainees. Oncology, surgery and endocrinology were the most frequent clinical areas of focus. Most events (64.2%) were held in a clinical setting. The median cost per event was $A263 (IQR $A153-1195) and over 90% included food and beverages. CONCLUSIONS: Over this 4-year period, industry-sponsored events were widespread and pharmaceutical companies maintained a high frequency of contact with health professionals. Most events were held in clinical settings, suggesting a pervasive commercial presence in everyday clinical practice. Food and beverages, known to be associated with changes to prescribing practice, were almost always provided. New Australian transparency provisions explicitly exclude meals from the reporting requirements; thus, a large proportion of potentially influential payments from pharmaceutical companies to health professionals will disappear from public view.

Health Care Spending: Changes in the Perceptions of the Australian Public.

BACKGROUND: Increasing demand for services and rising health care costs create pressures within the Australian health care system and result in higher health insurance premiums and out-of-pocket costs for consumers. OBJECTIVE: To measure changes in consumer views on the quality of the Australian health care system, contributors to rising costs and attitudes towards managing these costs. METHODS: Two computer-assisted telephone interviews were conducted in 2006 (533 respondents) and 2015 (1318 respondents) and results compared. RESULTS: More respondents in 2015 rated the Australian health care system 'very adequate' than in 2006 (22.3% vs 8.3%; Odds Ratio OR 3.2, 99% CI 2.1, 5.1) with fewer 'concerned' or 'fairly concerned' about the health care costs (69.0% vs 85.7%; OR 0.37, 99% CI 0.25, 0.53). The 2015 respondents were more likely to identify new treatments for cancer (77% vs 65.7%; OR 1.75, 99% CI 1.30, 2.35) and community expectations for access to the latest technologies (73.8% vs 67%; OR 1.39, 99% CI 1.04, 1.86) as contributors to rising health care costs. While more 2015 respondents agreed that patients should pay a greater part of the health care costs, this remained a minority view (37.9% vs 31.7%; OR 1.32, 99% CI 0.99, 1.76). They were less likely to agree that doctors should offer medical treatments regardless of the cost and chance of benefit (63.6% vs 82.9%; OR 0.36, 99% CI 0.25, 0.50). CONCLUSIONS: Satisfaction with the Australian health care system has increased over time. Consumers recognise the cost pressures and have lower expectations that all services should be provided regardless of their costs and potential benefit. Public consultation on the allocation of health care resources and involvement in health care decision-making remains important. There should be community consultation about the principles and values that should guide resource allocation decisions.

Effect of the adult pneumococcal polysaccharide vaccine on cardiovascular disease: a systematic review and meta-analysis.

Animal models and clinical studies suggest a mechanistic link between the pneumococcal polysaccharide vaccine (PPV) and a cardiovascular protective effect. However, conflicting results exist from several large observational studies in humans. We set out to systematically review current literature and conduct meta-analyses of studies on PPV and cardiovascular outcomes. Medline, Embase and CENTRAL were searched for randomised controlled trials (RCTs) and observational studies in adults, using PPV as the intervention, up to 30 April 2014. Studies that compared PPV with a control (another vaccine, no vaccine or placebo) and recorded ischaemic events were included in this review. Two investigators extracted data independently on study design, baseline characteristics and summary outcomes. Study quality was examined using the Newcastle-Ottawa Quality Assessment Scale. Pooled estimates using random effects models and their 95% CIs were calculated separately for the outcomes of acute coronary syndrome (ACS) events and stroke. No RCT data were available. A total of 230 426 patients were included in eight observational studies and recorded as ACS events. PPV was associated with significantly lower odds of ACS events in patients 65 years and older (pooled OR=0.83 (95% CI 0.71 to 0.97), I(2)=77.0%). However, there was no significant difference in ACS events when younger people were included (pooled OR=0.86 (95% CI 0.73 to 1.01), I(2)=81.4%). Pooling of four studies, covering a total of 192 210 patients, did not find a significantly reduced risk of stroke in all patients (pooled OR=1.00 (95% CI 0.89 to 1.12), I(2)=55.3%), or when restricted to those 65 years and older (pooled OR=0.96 (95% CI 0.87 to 1.05), I(2)=22.5%). In this meta-analysis of observational studies, the use of PPV was associated with a significantly lower risk of ACS events in the older population, but not stroke. An adequately powered and blinded RCT to confirm these findings is warranted.

Health systems and sustainability: doctors and consumers differ on threats and solutions.

BACKGROUND: Healthcare systems face the problem of insufficient resources to meet the needs of ageing populations and increasing demands for access to new treatments. It is unclear whether doctors and consumers agree on the main challenges to health system sustainability. METHODOLOGY: We conducted a mail survey of Australian doctors (specialists and general practitioners) and a computer assisted telephone interview (CATI) of consumers to determine their views on contributors to increasing health care costs, rationing of services and involvement in health resource allocation decisions. Differences in responses are reported as odds ratios (OR) and 99% confidence intervals (CI). RESULTS: Of 2948 doctors, 1139 (38.6%) responded; 533 of 826 consumers responded (64.5% response). Doctors were more concerned than consumers with the effects of an ageing population (OR 3.0; 99% CI 1.7, 5.4), and costs of new drugs and technologies (OR 5.1; CI 3.3, 8.0), but less likely to consider pharmaceutical promotional activities as a cost driver (OR 0.29, CI 0.22, 0.39). Doctors were more likely than consumers to view 'community demand' for new technologies as a major cost driver, (OR 1.6; 1.2, 2.2), but less likely to attribute increased costs to patients failing to take responsibility for their own health (OR 0.35; 0.24, 0.49). Like doctors, the majority of consumers saw a need for public consultation in decisions about funding for new treatments. CONCLUSIONS: Australian doctors and consumers hold different views on the sustainability of the healthcare system, and a number of key issues relating to costs, cost drivers, roles and responsibilities. Doctors recognise their dual responsibility to patients and society, see an important role for physicians in influencing resource allocation, and acknowledge their lack of skills in assessing treatments of marginal value. Consumers recognise cost pressures on the health system, but express willingness to be involved in health care decision making.

Response rates and representativeness: a lottery incentive improves physician survey return rates.

PURPOSE: To test the effect of a AU dollars 2 scratch lottery ticket on response rates to a national mailed questionnaire of Australian general practitioners (GPs) and medical specialists. METHODS: A randomized controlled trial was conducted and the incentive sent to half of the participants with the first mailing. A single follow-up mailing without incentive was sent to all non-respondents. Survey respondents were then informed of the research question regarding incentives and allowed to withdraw their study data. Differences in response rates between doctors receiving and not receiving the incentive, and between respondents and non-respondents, were examined. RESULTS: The overall response rate was 47% (443 respondents). Twenty-two respondents (5%) withdrew their data after being informed of the research question. Of the remaining 421 respondents, 233 had received the incentive (response rate 49.7%) and 188 had not (40.1%, p=0.0032). The absolute increase in response rate with the incentive (9.6%, 95%CI 3.2, 15.9) was quantitatively similar in effect to the reminder mailing (11.8%). The incentive had a larger effect among the GP sample compared with specialists (13.4 vs. 5.9%), although the difference was not statistically significant (p=0.20). There were no systematic differences in demographic characteristics between respondents and non-respondents. CONCLUSIONS: Increased response rates associated with a small incentive may reduce the need for a second mailed reminder, but strong views about the use of incentives may negatively influence the participation of some practitioners. While the overall response rate was low, there was no evidence of bias in our sample.