Evaluating recruitment strategies for AUSPICE, a large Australian community-based randomised controlled trial.

OBJECTIVES: To examine the effectiveness of different strategies for recruiting participants for a large Australian randomised controlled trial (RCT), the Australian Study for the Prevention through Immunisation of Cardiovascular Events (AUSPICE). DESIGN, SETTING, PARTICIPANTS: Men and women aged 55-60 years with at least two cardiovascular risk factors (hypertension, hypercholesterolaemia, overweight/obesity) were recruited for a multicentre placebo-controlled RCT assessing the effectiveness of 23-valent pneumococcal polysaccharide vaccine (23vPPV) for preventing cardiovascular events. METHODS: Invitations were mailed by the Australian Department of Human Services to people in the Medicare database aged 55-60 years; reminders were sent 2 weeks later. Invitees could respond in hard copy or electronically. Direct recruitment was supplemented by asking invitees to extend the invitation to friends and family (snowball sampling) and by Facebook advertising. MAIN OUTCOME: Proportions of invitees completing screening questionnaire and recruited for participation in the RCT. RESULTS: 21 526 of 154 992 invited people (14%) responded by completing the screening questionnaire, of whom 4725 people were eligible and recruited for the study. Despite the minimal study burden (one questionnaire, one clinic visit), the overall participation rate was 3%, or an estimated 10% of eligible persons. Only 16% of eventual participants had responded within 2 weeks of the initial invitation letter (early responders); early and late responders did not differ in their demographic or medical characteristics. Socio-economic disadvantage did not markedly influence response rates. Facebook advertising and snowball sampling did not increase recruitment. CONCLUSIONS: Trial participation rates are low, and multiple concurrent methods are needed to maximise recruitment. Social media strategies may not be successful in older age groups. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12615000536561.

A pilot study of a pharmacist-led prescribing program for final-year medical students.

BACKGROUND: Junior doctors undertake a significant amount of prescribing; however, they are not well prepared for this, and report they would like more training in their undergraduate courses. To address this we tested a pharmacist-led prescribing program for final-year medical students. METHODS: Sixteen final-year students took part in the program. The program involved students writing prescriptions and getting feedback from clinical pharmacists, undertaking prescribing and calculation tutorials, and spending time in the pharmacy department. Evaluation included a pre- and post-assessment of their confidence and skills in prescribing, and a feedback session discussing the strengths and weakness of the program, and their perceptions about the role of pharmacists. Changes in the pre- and post-assessment of confidence and skills were examined with permutation and Mann-Whitney U tests. RESULTS: There was a significant improvement in students' confidence in prescribing, and a small but consistent improvement in prescribing skills. Of note, no student prescribed inappropriately and potentially harmfully after the program. Participants were positive about the program, and indicated a better understanding about the pharmacists' role and their ability to support them as junior doctors. CONCLUSIONS: This study has shown the potential effect of a pharmacist-led prescribing program on the skills and confidence in prescribing by medical students. It provided an interprofessional teaching opportunity, preparing students for a team-based approach to patient management.

Low awareness of adverse drug reaction reporting systems: a consumer survey.

OBJECTIVE: To determine levels of public awareness of consumer adverse drug reaction (ADR) reporting systems in Australia. DESIGN, SETTING AND PARTICIPANTS: Cross-sectional study conducted in 2012 of residents of the Hunter Valley region of New South Wales, who participated in a computer-assisted telephone interview (CATI), and a national sample, who completed an online Pureprofile survey. MAIN OUTCOME MEASURES: Proportion of respondents experiencing ADRs; the type of medicine involved; whether participants reported the adverse event and to whom; awareness and use of existing consumer ADR reporting mechanisms. RESULTS: There were 2484 CATI respondents and 2497 Pureprofile respondents. Side effects with medicines were very common (46.3% of respondents), most relating to prescription medicines (88.4%). Among respondents who had experienced a side effect, 84.6% reported the event to a health care professional, most often a general practitioner. Awareness of consumer ADR reporting schemes was low (10.4%). Of 217 respondents who had experienced a side effect and were aware of consumer reporting schemes, 46 (21.2%) had reported an ADR using one of these schemes. CONCLUSIONS: Consumers can contribute to our understanding of medicines safety, but there is low awareness of available reporting systems. Some consumers aware of ADR self-reporting systems appear prepared to use them, but promotion of and education on how to use reporting systems are required. Significant resources may be needed to support an enhanced consumer reporting scheme.

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.

Electronic information and clinical decision support for prescribing: state of play in Australian general practice.

BACKGROUND: Investments in eHealth worldwide have been mirrored in Australia, with >90% of general practices computerized. Recent eHealth incentives promote the use of up to date electronic information sources relevant to general practice with flexibility in mode of access. OBJECTIVE: To determine GPs' access to and use of electronic information sources and computerized clinical decision support systems (CDSSs) for prescribing. METHODS: Semi-structured interviews were conducted with 18 experienced GPs and nine GP trainees in New South Wales, Australia in 2008. A thematic analysis of interview transcripts was undertaken. RESULTS: Information needs varied with clinical experience, and people resources (specialists, GP peers and supervisors for trainees) were often preferred over written formats. Experienced GPs used a small number of electronic resources and accessed them infrequently. Familiarity from training and early clinical practice and easy access were dominant influences on resource use. Practice time constraints meant relevant information needed to be readily accessible during consultations, requiring integration or direct access from prescribing software. Quality of electronic resource content was assumed and cost a barrier for some GPs. CONCLUSIONS: The current Australian practice incentives do not prescribe which information resources GPs should use. Without integration into practice computing systems, uptake and routine use seem unlikely. CDSS developments must recognize the time pressures of practice, preference for integration and cost concerns. Minimum standards are required to ensure that high-quality information resources are integrated and regularly updated. Without standards, the anticipated benefits of computerization on patient safety and health outcomes will be uncertain.

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.

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.

Computerised prescribing: assessing the impact on prescription repeats and on generic substitution of some commonly used antibiotics.

OBJECTIVES: To assess the impact of two interventions on computer-generated prescriptions for antibiotics--(i) an educational intervention to reduce automatic computerised ordering of repeat antibiotic prescriptions, and (ii) a legislative change prohibiting the "no brand substitution" box being checked as a default setting in prescribing software--and to compare these findings with those of a similar survey we conducted in 2000. DESIGN AND SETTING: Prospective audit of consecutive prescriptions for four antibiotics (amoxycillin, amoxycillin/clavulanate, roxithromycin, and cefaclor) commonly prescribed for upper respiratory tract infections in community pharmacies in New South Wales and Queensland between 1 November 2008 and 31 January 2009. PRIMARY OUTCOME: rate of repeat prescription ordering on computer-generated versus handwritten prescriptions. Secondary outcome: rate of checking of the "no brand substitution" box on computer-generated versus handwritten prescriptions. RESULTS: Data were collected on 2807 prescriptions presented to 51 pharmacies (50 in NSW, one in Queensland), of which 2354 were computer-generated. Repeats were ordered on 1633 computer-generated prescriptions (69%) compared with 183 handwritten prescriptions (40%). These proportions were identical to those found in 2000, although the rates of computer prescribing were much higher in this study (84% v 54%). This difference in repeat prescribing was statistically significant (odds ratio adjusted for clustering at pharmacy level, 2.87; 95% CI, 2.32-3.55). Twenty-three (1%) of the computer-generated prescriptions had the "no brand substitution" box checked compared with 3 (0.7%) of the handwritten prescriptions (27% and 1%, respectively, in our previous survey). CONCLUSIONS: The legislative change which disallowed having the "no brand substitution" box checked as a default setting in prescribing software had a dramatic impact on the checking of the "no brand substitution" box. In contrast, there was no sustained effect of educating prescribers about software default settings relating to repeat prescribing of antibiotics. Other actions are required if unnecessary repeat prescriptions for some medicines, such as antibiotics, are to be reduced.

Barriers to student access to patients in a group of teaching hospitals.

OBJECTIVES: To determine the number of patients in our teaching hospitals who were, on any given day, both available and willing to see medical students. DESIGN AND SETTING: Repeated cross-sectional audit in four teaching hospitals in the greater Newcastle area of New South Wales (one tertiary referral hospital, two district general hospitals, and one hospital combining general medicine and surgery with specialised oncology services). Audits were conducted three times, 2 months apart. PARTICIPANTS: All adult inpatients in the four hospitals. MAIN OUTCOME MEASURES: Numbers of patients present and accessible to students, present but inaccessible, absent, or unfit to be seen for clinical reasons; numbers of patients who agreed to history-taking and physical examination by a medical student. RESULTS: Of 1960 patients, 959 (49%) were present and accessible to students. Only 11% were absent, and the most common reason students could not see patients was that the patients were said by nursing staff to be unfit to see medical students (25%). Of those present and accessible, 70% said they would agree to provide a history, and 67% that they would agree to physical examination. CONCLUSIONS: Across all four teaching hospitals about 200-250 patients are available and willing to see medical students on any given day. This is too few to provide our current student population of 500 with extensive clinical experience.

Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience.

OBJECTIVES: To characterise research relationships between medical specialists and the pharmaceutical industry in Australia. DESIGN AND SETTING: Questionnaire survey of medical specialists listed in the Medical Directory of Australia and believed to be in active practice, conducted in 2002 and 2003. MAIN OUTCOME MEASURES: Details of medical specialists' involvement in pharmaceutical industry-sponsored research, and reports of potentially undesirable research outcomes. RESULTS: Of 2120 specialists approached, 823 (39%) responded. Participation in pharmaceutical industry-sponsored research was more commonly reported by those in salaried practice (49%) than those in private practice (33%); P < 0.001. 216 reported that industry had made initial contact, compared with 117 who had initiated contact with industry. 14.0% of respondents reported premature termination of industry-sponsored trials, which they considered appropriate when in response to concerns about adverse drug effects. 12.3% of respondents reported that industry staff had written first drafts of reports, which they viewed as an acceptable practice for "internal" documents only. Of greatest concern to respondents were instances of delayed publication or non-publication of key negative findings (reported by 6.7% and 5.1% of respondents, respectively), and concealment of results (2.2%). Overall, 71 respondents (8.6%) had experienced at least one event that could represent breaches of research integrity. CONCLUSIONS: These data indicate a high level of engagement in research between the pharmaceutical industry and medical specialists, including those in private practice. Examples of possibly serious research misconduct were reported by 8.6% of respondents, equivalent to 21% of those with an active research relationship with industry.

Effect of computerised prescribing on use of antibiotics.

OBJECTIVES: To examine whether the use of current prescribing software systems might raise rates of repeat prescribing, with a consequent increase in use of antibiotics in the community. DESIGN AND SETTING: A prospective audit of consecutive prescriptions for amoxycillin, cefaclor, roxithromycin and amoxycillin/clavulanate presented to community pharmacies in the Hunter region of New South Wales and a follow-up survey of people who received a repeat prescription, October to November 2000. MAIN OUTCOME MEASURES: The frequency of repeat prescription ordering on computer-generated and handwritten prescriptions; the proportion of people who filled their repeat prescription. RESULTS: Data were collected for 1667 prescriptions presented to 35 pharmacies; 126 people who received repeat prescriptions completed the survey. The rate of repeat prescription ordering on computer-generated prescriptions was 69%, compared with 40% for handwritten prescriptions (odds ratio, 3.3; 95% CI, 2.6-4.2). Computer-generated repeat prescriptions were as likely to be filled as hand-written prescriptions (61% and 69%, respectively). CONCLUSIONS: The default settings on computerised prescribing packages result in a significant increase in the use of antibiotics. We estimate these settings result in about 500 000 additional prescriptions being filled annually in Australia for the four antibiotics in the study.