Assessing the impact of law enforcement to reduce over-the-counter (OTC) sales of antibiotics in low- and middle-income countries; a systematic literature review.

BACKGROUND: Many low- and middle-income countries (LMIC) are moving towards enforcing prescription-only access to antibiotics. This systematic literature review aims to assess the interventions used to enforce existing legislation prohibiting over-the-counter (OTC) sales of antibiotics in LMICs, their impact and examine the methods chosen for impact measurement including their strengths and weaknesses. METHODS: Both PubMed and Embase were systematically searched for studies reporting on impact measurement in moving towards prescription only access to antibiotics in LMICs. The PRISMA methodological review framework was used to ensure systematic data collection and analysis of literature. Narrative data synthesis was used due to heterogeneity of study designs. RESULTS: In total, 15 studies were included that assessed policy impact in 10 different countries. Strategies employed to enforce regulations prohibiting OTC sales of systemic antibiotics included retention of prescriptions for antibiotics by pharmacies, government inspections, engaging pharmacists in the design of interventions, media campaigns for the general public and educational activities for health care workers. A variety of outcomes was used to assess the policy impact; changes in antimicrobial resistance rates, changes in levels of antibiotic use, changes in trends of antibiotic use, changes in OTC supply of antibiotics, and changes in reported practices and knowledge of pharmacists, medicine sellers and the general public. Differences in methodological approaches and outcome assessment made it difficult to compare the effectiveness of law enforcement activities. Most effective appeared to be multifaceted approaches that involved all stakeholders. Monitoring of the impact on total sales of antibiotics by means of an interrupted time series (ITS) analysis and analysis of pharmacies selling antibiotics OTC using mystery clients were the methodologically strongest designs used. CONCLUSIONS: The published literature describing activities to enforce prescription-only access to antibiotics in LMICs is sparse and offers limited guidance. Most likely to be effective are comprehensive multifaceted interventions targeting all stakeholders with regular reinforcement of messages. Policy evaluation should be planned as part of implementation to assess the impact and effectiveness of intervention strategies and to identify targets for further activities. Robust study designs such as ITS analyses and mystery client surveys should be used to monitor policy impact.

Candidate biomarkers of PARP inhibitor sensitivity in ovarian cancer beyond the BRCA genes.

BACKGROUND: Olaparib (Lynparza™) is a PARP inhibitor approved for advanced BRCA-mutated (BRCAm) ovarian cancer. PARP inhibitors may benefit patients whose tumours are dysfunctional in DNA repair mechanisms unrelated to BRCA1/2. We report exploratory analyses, including the long-term outcome of candidate biomarkers of sensitivity to olaparib in BRCA wild-type (BRCAwt) tumours. METHODS: Tumour samples from an olaparib maintenance monotherapy trial (Study 19, D0810C00019; NCT00753545) were analysed. Analyses included classification of mutations in genes involved in homologous recombination repair (HRR), BRCA1 promoter methylation status, measurement of BRCA1 protein and Myriad HRD score. RESULTS: Patients with BRCAm tumours gained most benefit from olaparib; a similar treatment benefit was also observed in 21/95 patients whose tumours were BRCAwt but had loss-of-function HRR mutations compared to patients with no detectable HRR mutations (58/95). A higher median Myriad MyChoice® HRD score was observed in BRCAm and BRCAwt tumours with BRCA1 methylation. Patients without BRCAm tumours derived benefit from olaparib treatment vs placebo although to a lesser extent than BRCAm patients. CONCLUSIONS: Ovarian cancer patients with tumours harbouring loss-of-function mutations in HRR genes other than BRCA1/2 may constitute a small, molecularly identifiable and clinically relevant population who derive treatment benefit from olaparib similar to patients with BRCAm.

Scaffolding and working together: a qualitative exploration of strategies for everyday life with dementia.

Background: living with dementia has been described as a process of continual change and adjustment, with people with dementia and their families adopting informal strategies to help manage everyday life. As dementia progresses, families increasingly rely on help from the wider community and formal support. Methods: this article reports on a secondary analysis of qualitative data from focus groups and individual interviews with people with dementia and their carers in the North of England. In total, 65 people with dementia and 82 carers took part in the research: 26 in interviews and 121 in focus groups. Focus group and interview audio recordings were transcribed verbatim. A qualitative, inductive, thematic approach was taken for data analysis. Findings: the article applies the metaphor of scaffolding to deepen understanding of the strategies used by families. Processes of scaffolding were evident across the data where families, communities, professionals and services worked together to support everyday life for people with dementia. Within this broad theme of scaffolding were three sub-themes characterising the experiences of families living with dementia: doing things together; evolving strategies; and fragility and fear of the future. Conclusions: families with dementia are resourceful but do need increasing support (scaffolding) to continue to live as well as possible as dementia progresses. More integrated, proactive work is required from services that recognises existing scaffolds and provides appropriate support before informal strategies become unsustainable; thus enabling people with dementia to live well for longer.

Medication reconciliation at two teaching hospitals in Australia: a missed opportunity?

Medication reconciliation prevents medication related harm at patient hospitalisation. This cross-sectional study demonstrated that the Hunter New England Health Admission Medication History Form that supports the two processes is underutilised in two hospitals in New South Wales with many doctors unaware of the form and pharmacists facing understaffing and time constraints for completing it. Triaging of patients and, more collaboration between doctors and pharmacists are required for efficient in-hospital medication reconciliation.

Using carer biographical narratives to explore factors involved in proxy reporting of quality of life in people with dementia.

OBJECTIVES: Quality of life is an important focus of research on dementia, with interest in direct reports of people with dementia and proxy reports of their carers. By exploring the subjective perspectives of unpaid family carers and paid care workers, this study aims to understand how carers construct meaning in narratives about quality of life with dementia. METHOD: A case-centred approach involved biographical narrative interviews with 10 carers to explore what was important for people with dementia to have a good quality of life. Detailed narrative analysis attended to the linguistic and structural features of accounts to consider how dementia is conceptualised by carers in the framing of quality of life. RESULTS: An individual's perception of how dementia impacts on awareness and behaviour was central to their understanding of quality of life. Carers who constructed dementia as a loss of skills and abilities were able to represent quality of life in positive terms despite the challenges of dementia. Carers who constructed dementia as eroding identity represented quality of life less positively and centred on their own means of coping with a challenging care situation. CONCLUSION: Findings highlight the importance of helping carers develop positive constructions of quality of life that are associated with understanding dementia as a loss of skills and abilities, rather than as a loss of self. Engaging with subjectivity in carers' biographical narrative accounts is important in the development of quality of life assessment to understand the meanings and emotions that underlie proxy perspectives.

Essential medicines for cancer: WHO recommendations and national priorities.

OBJECTIVE: To examine, for essential anti-cancer medicines, the alignment of national lists of essential medicines and national reimbursable medicines lists with the World Health Organization's (WHO's) Model Lists. METHODS: National medicine lists for 135 countries with per-capita gross national incomes below 25 000 United States dollars in 2015 were compared with WHO's 2013 and 2015 Model Lists of Essential Medicines. Correlations between numbers of anti-cancer medicines included in national lists and gross national income (GNI), government health expenditure and number of physicians per 1000 population were evaluated. FINDINGS: Of the 25 anti-cancer medicines on the 2013 Model List and the 16 added via the 2015 revision of the Model List, 0-25 (median: 17) and 0-15 (median: 3) appeared in national lists, respectively. There was considerable variability in these numbers within and between World Bank income groups. Of the 16 new medicines included in the 2015 Model List, for example, 0-10 (median: 1) and 2-15 (median: 10) were included in the national lists of low-income and high-income countries, respectively. The numbers of these new medicines included in national lists were significantly correlated (P ≤ 0.0001) with per-capita GNI (r = 0.45), per-capita annual government health expenditure (r = 0.33) and number of physicians per 1000 population (r = 0.48). Twenty-one countries (16%) included the targeted anti-cancer medicines imatinib, rituximab and trastuzumab in their national lists. CONCLUSION: Substantial numbers of anti-cancer medicines are included in national lists of low- and middle-income countries but the availability, affordability, accessibility and administration feasibility of these medicines, at country-level, need assessment.

Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy.

OBJECTIVE: The efficacy and safety of olaparib, an oral poly(ADP-ribose) polymerase (PARP) inhibitor, was investigated in a subgroup of patients with germline BRCA1/2 mutated (gBRCA1/2m) advanced ovarian cancer who had received ≥3 prior lines of chemotherapy. Primary data from this Phase II study (Study 42, ClinicalTrials.govNCT01078662) have been reported previously. METHODS: Eligible patients were treated with oral olaparib 400mg bid capsule monotherapy until disease progression according to RECIST v1.1. Objective response rate (ORR) and duration of response (DoR) were assessed for patients with measurable disease at baseline. Safety and tolerability were assessed for all patients by adverse event (AE) incidence and changes in laboratory parameters. Platinum resistance status was obtained retrospectively, and responses to olaparib evaluated. RESULTS: In patients with gBRCA1/2m ovarian cancer, 154/193 (80%) had received ≥3 prior lines of chemotherapy, of whom 137/154 (89%) had measurable disease at baseline. ORR was 34% (46/137; 95% confidence interval [CI] 26-42) and median DoR was 7.9 (95% CI 5.6-9.6) months. ORR in platinum-resistant tumors was 30%. Median DoR for platinum-sensitive and platinum-resistant disease was similar: 8.2months (95% CI 5.6-13.5) compared with 8.0months (4.8-14.8), respectively. Six of the 193 (3%) patients had an AE with an outcome of death. None of these AEs at time of occurrence was considered causally related to olaparib. CONCLUSION: Following ≥3 prior lines of chemotherapy, olaparib 400mg bid (capsule form) monotherapy demonstrated notable antitumor activity in patients with gBRCA1/2m advanced ovarian cancer. No new safety signals were identified.

Couple-Based Psychosexual Support Following Prostate Cancer Surgery: Results of a Feasibility Pilot Randomized Control Trial.

INTRODUCTION: Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. AIMS: To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. METHODS: Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. MAIN OUTCOME MEASURES: The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. RESULTS: The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. CONCLUSION: The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this intervention, and future trials would benefit from a couple-focused measurement.

Access to Cytotoxic Medicines by Children With Cancer: A Focus on Low and Middle Income Countries.

BACKGROUND: The Essential Medicines Working Group of the International Society of Pediatric Oncology (SIOP) has proposed a list of antineoplastic drugs that should be available in low and middle income countries. PROCEDURE: Data were extracted on the listing of 18 essential and 8 ancillary antineoplastic medicines in the national essential medicines lists (NEMLs) or national reimbursable medicines lists (NRMLs) of 135 countries with gross national income (GNI) per capita of less than US $25,000. Correlations between numbers of medicines listed and GNI per capita, annual government health expenditure (AGHE) per capita, and the number of physicians per million people were examined. RESULTS: Listing of the 18 essential antineoplastic drugs ranged from 27% (thioguanine) to 95% (methotrexate). The median number of medicines listed was 7 (0-18) in low income countries (n = 26) and 14 in lower-middle (n = 42), upper-middle (n = 44), and high income countries (n = 20). For the ancillary eight medicines, the median was one (0-8) across the 135 countries. Correlations with GNI per capita (r = 0.17, P = 0.0266) and physician density (r = 0.25, P = 0.0017) were statistically significant; not so for AGHE per capita (r = 0.00, P = 0.5000). CONCLUSIONS: There was large variability within income groups in numbers of antineoplastic agents identified as essential in NEMLs and NRMLs. While not a direct measure of availability, listing is an important step, guiding procurement for the public sector. These results focus attention on deficits in NEMLs and NMRLs as a step to improving access to effective antineoplastic medicines for cancers in children in low and middle income countries.

Medicines for cancers in children: The WHO model for selection of essential medicines.

Pressures to include more cancer medicines in the WHO Model List of Essential Medicines (EML) pose challenges for the Expert Committee responsible for recommending changes to the list. How do medicines for cancer fit within a definition of essential medicines as those meeting the priority health needs of the population? Will identifying a medicine as "essential" offer some leverage to improve access to effective cancer medicines in low and middle-income countries (LMICs)? The addition of a number of medicines for the treatment of cancers in children to the Model List of Essential Medicines for Children (EMLc) in 2011 provides important insights into previous Expert Committee decision-making and offers a platform for future deliberations. As combination chemotherapy is required for effective treatment of many malignancies, a disease-based approach makes more sense than an agent-based approach. Inadequate financing to purchase essential medicines is a reality in many LMICs, thus a consideration of health impact is central to decisions on the selection and procurement of medicines. Inclusion in national EMLs should identify medicines that have priority for procurement in the public sector. This article will discuss some of the factors taken into account by the Expert Committee in developing the WHO EMLc. We argue that the disease-based approach coupled with the assessment of the magnitude of the clinical benefit provides an appropriate approach for considering further additions of medicines for pediatric cancers and for the review of the adult cancer section of the Model List.

Studies using Australia's Pharmaceutical Benefits Scheme data for pharmacoepidemiological research: a systematic review of the published literature (1987-2013).

PURPOSE: Research using dispensing claims is used increasingly to study post-market medicines use and outcomes. The purpose of this review is to catalogue more than 25 years of published literature using Australia's Pharmaceutical Benefits Scheme (PBS) dispensing records. METHODS: We searched MEDLINE, PreMEDLINE and Embase and conducted author searches for studies published from 1987 to 2013. Independent reviewers screened abstracts of 3209 articles and reviewed 264 full-text manuscripts. Included studies used PBS dispensing data to measure patterns and/or outcomes of prescribed medicines use or dispensing claims to derive a proxy for a specific disease cohort or health outcome. RESULTS: Of the 228 studies identified, 106 used PBS claims only (56 using claims-level data and 50 using individual-level data) and 63 studies linked individual-level PBS claims to other health data. Most commonly, studies examined trends in drug utilisation (33%), clinician and patient practices (26%), drug use and outcomes (18%) and evaluations of intervention impacts (17%). Sixty-two percent of studies using individual-level data were based on a subset of elderly Australians. Most studies focused on drug classes acting on the nervous system (36%), cardiovascular system (15%) and alimentary tract (11%). Few studies examined prescribed medicines use in children and pregnant women. CONCLUSIONS: Pharmaceutical Benefits Scheme claims represent a significant resource to examine Australia's billion-dollar annual investment in prescribed medicines. The body of research is growing and has increased in complexity over time. Australia has great potential to undertake world-class, whole-of-population pharmacoepidemiological studies. Recent investment in data linkage infrastructure will significantly enhance these opportunities.

Prevention of postpartum haemorrhage: cost consequences analysis of misoprostol in low-resource settings.

BACKGROUND: While inferior to oxytocin injection in both efficacy and safety, orally administered misoprostol has been included in the World Health Organization Model List of Essential Medicines for use in the prevention of postpartum haemorrhage (PPH) in low-resource settings. This study evaluates the costs and health outcomes of use of oral misoprostol to prevent PPH in settings where injectable uterotonics are not available. METHODS: A cost-consequences analysis was conducted from the international health system perspective, using data from a recent Cochrane systematic review and WHO's Mother-Baby Package Costing Spreadsheet in a hypothetical cohort of 1000 births in a mixed hospital (40% births)/community setting (60% births). Costs were estimated based on 2012 US dollars. RESULTS: Using oxytocin in the hospital setting and misoprostol in the community setting in a cohort of 1000 births, instead of oxytocin (hospital setting) and no treatment (community setting), 22 cases of PPH could be prevented. Six fewer women would require additional uterotonics and four fewer women a blood transfusion. An additional 130 women would experience shivering and an extra 42 women fever. Oxytocin/misoprostol was found to be cost saving (US$320) compared to oxytocin/no treatment. If misoprostol is used in both the hospital and community setting compared with no treatment (i.e. oxytocin not available in the hospital setting), 37 cases of PPH could be prevented; ten fewer women would require additional uterotonics; and six fewer women a blood transfusion. An additional 217 women would experience shivering and 70 fever. The cost savings would be US$533. Sensitivity analyses indicate that the results are sensitive to the incidence of PPH-related outcomes, drug costs and the proportion of hospital births. CONCLUSIONS: Our findings confirm that, even though misoprostol is not the optimum choice in the prevention of PPH, misoprostol could be an effective and cost-saving choice where oxytocin is not or cannot be used due to a lack of skilled birth attendants, inadequate transport and storage facilities or where a quality assured oxytocin product is not available. These benefits need to be weighed against the large number of additional side effects such as shivering and fever, which have been described as tolerable and of short duration.

Medicines availability for non-communicable diseases: the case for standardized monitoring.

BACKGROUND: In response to the global burden of non-communicable diseases (NCDs), the World Health Organization (WHO) has developed a Global Action Plan that includes a voluntary medicines target of 80% availability and affordability of essential medicines for the prevention and treatment of diabetes, cardiovascular disease and respiratory disease both in public and private health facilities. Reliable measures of medicines availability are needed to track progress towards meeting this target. The results of three studies measuring the availability of medicines for hypertension and diabetes conducted in Tanzania in 2012-2013 were compared to assess the consistency of the results across the studies. METHODS: Availability was defined by observation of the medicine (no minimum quantity) on the day of the survey. The three studies involved 24, 107 and 1297 health facilities. Estimates of the availability of medicines for hypertension and diabetes were compared for medicines availability overall, by managing authority (government, mission/faith-based, private-for-profit), by facility level (hospital, health centre, dispensary) and by setting (urban, rural). RESULTS: Comparisons of the availability of medicines were limited by differences in the definitions of the medicines and the classifications of the facilities surveyed. Metformin was variously reported as available in 33%, 39%, 46%, and 57% of facilities. Glibenclamide availability ranged from 19% to 52%. One study reported low levels of insulin availability (9-16% depending on insulin type) compared to 34% in a second study. Captopril (or angiotensin converting enzyme [ACE] inhibitor) availability ranged from 13% to 48%while availability of calcium channel blockers was 29% to 57% and beta-blockers 15% to 50%. Trends were similar across studies with lower availability in government compared to mission or private facilities, in dispensary and health centres compared to hospitals, and in rural compared to urban facilities. CONCLUSIONS: All three studies showed suboptimal availability of NCD medicines, however the estimates of availability differed. Regular monitoring using reproducible methods and measuring key medicines must replace ad-hoc studies, small selected samples and differences in definitions. Low and middle-income countries need to implement monitoring and evaluation systems to track progress towards meeting the NCD medicines target and to inform country-level interventions to improve access to NCD medicines.

Prescription medicines: decision-making preferences of patients who receive different levels of public subsidy.

OBJECTIVE: To compare the relative importance of medicine attributes and decision-making preferences of patients with higher or lower levels of insurance coverage in a publicly funded health care system. DESIGN AND SETTING: Cross-sectional telephone survey of randomly selected regular medicine users aged ≥18 years in the Hunter Valley, NSW, Australia. MAIN VARIABLES STUDIED: Questions about 27 medicine attributes and active involvement in decisions to start a new medicine. RESULTS: After adjustment, there were few differences between the 408 concession card holders (high insurance) and 410 general beneficiaries (low insurance) in their assessment of the importance of medicine attributes. For both groups, the explanation of treatment options, establishing the need for the medicine, and medicine efficacy and safety were the most important considerations. Medicine costs, the treatment burden and medicine familiarity were less important; the views of family and friends ranked lowest. There was a statistically significantly greater influence of the regular doctor for the concession card holders than general beneficiaries (93.6 vs. 84%, adjusted OR 2.80, 95% CI 1.31, 5.99). Concession card holders were more likely to favour doctors having more say in the decision-making process (crude OR 1.69, 95% CI 1.28, 2.24), and more likely to report the most recent treatment decision being made by the doctor alone, compared with general beneficiaries (61.2 vs. 40.3%). CONCLUSION: Medicine need, efficacy and safety are viewed as paramount for most patients, irrespective of insurance status. While patients report the importance of participation in treatment decisions, delegation of decision making to the doctor was common in practice.

Measurement of feline-specific pancreatic lipase aids in the diagnosis of pancreatitis in cats.

OBJECTIVE: To establish a reference interval for a feline-specific pancreatic lipase assay (Spec fPL test; Idexx Laboratories Inc) in healthy cats and determine the sensitivity and specificity of the Spec fPL test in a large group of ill cats with and without pancreatitis. ANIMALS: 41 healthy cats, 141 cats with clinical signs consistent with pancreatitis, and 786 stored sera with known feline pancreatic lipase immunoreactivity (fPLI) concentrations. METHODS: This was a prospective, cross-sectional, nonrandomized study. Based on a detailed review of the medical history and results of physical examination, CBC, serum biochemical profile, urinalysis, abdominal ultrasonography, and clinical outcome, each cat was categorized by 2 board-certified internists masked to the fPLI test results into 1 of 6 categories from definitely pancreatitis to definitely not pancreatitis. RESULTS: The reference interval for the Spec fPL test, determined from the central 95th percentile of results from healthy cats, was fPLI of 0.7 to 3.5 µg/L. An fPLI concentration of ≥ 5.4 µg/L was determined to be consistent with pancreatitis. With an fPLI of 5.4 µg/L as the diagnostic cutoff, the sensitivity of the Spec fPL test for feline pancreatitis (definitely pancreatitis and probably pancreatitis) was 79.4%, the specificity for cats characterized as probably not pancreatitis and definitely not pancreatitis was 79.7%, and positive and negative predictive values were 69% and 87%, respectively. CLINICAL RELEVANCE: These findings support the use of the Spec fPL test as a valuable diagnostic test for feline pancreatitis.

Bladder carcinoma in situ (CIS) in Australia: a rising incidence for an under-reported malignancy.

OBJECTIVES: To investigate the incidence of carcinoma in situ (CIS) in Australia and examine implications for its diagnosis and management, as CIS of the urinary bladder is a non-reportable disease in Australia. METHODS: Analysis of annual hospitalisation data using Australian Institute of Health and Welfare (AIHW) datasets showed an increase in CIS from 2001 onwards. To determine whether the increase seen with AIHW data represented a true increase in the rates offices, patient level data was examined using the Centre for Health record linkage (CHeReL) datasets. RESULTS: CHeReL linked data of 13,790 males and 5902 females, calculated the average incidence of CIS to be 20.9 per 100,000 and 6.5 per 100,000 respectively in those aged > 50 years, showing a rapid increase in the rates of CIS from 2001. There was an 11% (P = 0.04) and 14% (P = 0.02) annual increase in incidence of CIS in men and women and these rates increased with age. CONCLUSIONS: National data (AIHW) substantially underestimate the incidence of CIS in the Australian population. Patient level data suggest CIS rates are rapidly increasing in Australia despite high treatment rates. Closer surveillance and awareness of these high rates warrants further study and we recommend that CIS be considered a reportable disease.

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.

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.

Living with a diagnosis of frontotemporal dementia: An interpretative phenomenological analysis.

Frontotemporal dementia describes a spectrum of disorders which include behavioural changes, changes to affect, speech difficulties and physical issues. Although literature exists which identifies the need for the voices of people with dementia to be heard, there is a paucity of research which includes hearing the experiences of people diagnosed with FTD. The purpose of this research was to explore the lived experience of frontotemporal dementia from the persons' perspective using interpretative phenomenological analysis. The themes that emerged in the analysis were: the rocky road through assessment; the changing self; in touch with reality; and keeping going. Two overarching themes emerged which were: the need to hear the voice of people with frontotemporal dementia; and for people with frontotemporal dementia to exercise some control over the decision making process throughout their journey. Recommendations are presented for future practice and research.