Hospital outpatients' responses to taking medications with driving warnings

OBJECTIVE The study investigates the knowledge, intentions, and driving behavior of persons prescribed medications that display a warning about driving. It also examines their confidence that they can self-assess possible impairment, as is required by the Australian labeling system. METHOD We surveyed 358 outpatients in an Australian public hospital pharmacy, representing a well-advised group taking a range of medications including those displaying a warning label about driving. A brief telephone follow-up survey was conducted with a subgroup of the participants. RESULTS The sample had a median age of 53.2 years and was 53 percent male. Nearly three quarters (73.2%) had taken a potentially impairing class of medication and more than half (56.1%) had taken more than one such medication in the past 12 months. Knowledge of the potentially impairing effects of medication was relatively high for most items; however, participants underestimated the possibility of increased impairment from exceeding the prescribed dose and at commencing treatment. Participants' responses to the safety implications of taking drugs with the highest level of warning varied. Around two thirds (62.8%) indicated that they would consult a health practitioner for advice and around half would modify their driving in some way. However, one fifth (20.9%) would drive when the traffic was thought to be less heavy and over a third (37.7%) would modify their medication regime so that they could drive. The findings from the follow-up survey of a subsample taking target drugs at the time of the first interview were also of concern. Only just over half (51%) recalled seeing the warning label on their medications and, of this group, three quarters (78%) reported following the warning label advice. These findings indicated that there remains a large proportion of people who either did not notice or did not consider the warning when deciding whether to drive. There was a very high level of confidence in this group that they could determine whether they were personally affected by the medication, which may be a problem from a safety perspective. CONCLUSION This study involved persons who should have had a very high level of knowledge and awareness of medication warning labeling. Even in this group there was a lack of informed response to potential impairment. A review of the Australian warning system and wider dissemination of information on medication treatment effects would be useful. Clarifying the importance of potential risk in the general community context is recommended for consideration and further research.

Biological markers of stress in pediatric acute burn injury

BACKGROUND Burns and their associated wound care procedures evoke significant stress and anxiety, particularly for children. Little is known about the body's physiological stress reactions throughout the stages of re-epithelialization following an acute burn injury. Previously, serum and urinary cortisol have been used to measure stress in burn patients, however these measures are not suitable for a pediatric burn outpatient setting. AIM To assess the sensitivity of salivary cortisol and sAA in detecting stress during acute burn wound care procedures and to investigate the body's physiological stress reactions throughout burn re-epithelialization. METHODS Seventy-seven participants aged four to thirteen years who presented with an acute burn injury to the burn center at the Royal Children's Hospital, Brisbane, Australia, were recruited between August 2011 and August 2012. RESULTS Both biomarkers were responsive to the stress of burn wound care procedures. sAA levels were on average 50.2U/ml higher (p<0.001) at 10min post-dressing removal compared to baseline levels. Salivary cortisol levels showed a blunted effect with average levels at ten minutes post dressing removal decreasing by 0.54nmol/L (p<0.001) compared to baseline levels. sAA levels were associated with pain (p=0.021), no medication (p=0.047) and Child Trauma Screening Questionnaire scores at three months post re-epithelialization (p=0.008). Similarly, salivary cortisol was associated with no medication (p<0.001), pain scores (p=0.045) and total body surface area of the burn (p=0.010). CONCLUSION Factors which support the use of sAA over salivary cortisol to assess stress during morning acute burn wound care procedures include; sensitivity, morning clinic times relative to cortisol's diurnal peaks, and relative cost.

Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations

Purpose The LUX-Lung 3 study investigated the efficacy of chemotherapy compared with afatinib, a selective, orally bioavailable ErbB family blocker that irreversibly blocks signaling from epidermal growth factor receptor (EGFR/ErbB1), human epidermal growth factor receptor 2 (HER2/ErbB2), and ErbB4 and has wide-spectrum preclinical activity against EGFR mutations. A phase II study of afatinib in EGFR mutation-positive lung adenocarcinoma demonstrated high response rates and progression-free survival (PFS). Patients and Methods In this phase III study, eligible patients with stage IIIB/IV lung adenocarcinoma were screened for EGFR mutations. Mutation-positive patients were stratified by mutation type (exon 19 deletion, L858R, or other) and race (Asian or non-Asian) before two-to-one random assignment to 40 mg afatinib per day or up to six cycles of cisplatin plus pemetrexed chemotherapy at standard doses every 21 days. The primary end point was PFS by independent review. Secondary end points included tumor response, overall survival, adverse events, and patient-reported outcomes (PROs). Results A total of 1,269 patients were screened, and 345 were randomly assigned to treatment. Median PFS was 11.1 months for afatinib and 6.9 months for chemotherapy (hazard ratio [HR], 0.58; 95% CI, 0.43 to 0.78; P = .001). Median PFS among those with exon 19 deletions and L858R EGFR mutations (n = 308) was 13.6 months for afatinib and 6.9 months for chemotherapy (HR, 0.47; 95% CI, 0.34 to 0.65; P = .001). The most common treatmentrelated adverse events were diarrhea, rash/acne, and stomatitis for afatinib and nausea, fatigue, and decreased appetite for chemotherapy. PROs favored afatinib, with better control of cough, dyspnea, and pain. Conclusion Afatinib is associated with prolongation of PFS when compared with standard doublet chemotherapy in patients with advanced lung adenocarcinoma and EGFR mutations.

The schooling experience of six adolescent boys who have been diagnosed with Attention Deficit/ Hyperactivity Disorder (AD/HD)

This thesis explored the experience of schooling of six adolescent boys diagnosed with AD/HD from the perspectives of the boys, their mothers and their teachers. The study utilised social constructionism as the theoretical orientation and an explanatory theory of AD/HD, the Dynamic Developmental Theory (DDT) of AD/HD as a framework. Findings included the importance of making and managing friendships for young people with AD/HD, the importance of being informed about AD/HD as well classroom strategies that support the learning of students for teachers, and the apparent role that medication in concert with an engaging classroom environment can play in the successful schooling of boys with AD/HD.

A pilot randomised trial of Medilixir cream shows some promising results, but control treatment may have been inappropriate

Aim To test the efficacy of Medilixir [cream] against the standard treatment of aqueous cream in the provision of relief from the symptoms of postburn itch. Design RCT with two parallel arms. Setting Professor Stuart Pegg Adult Burns Centre, Royal Brisbane and Women's Hospital, Brisbane, Australia. Participants Fifty-two patients aged between 18 and 80 years, admitted directly to the burns centre between 10 March and 22 July 2008, were able to provide informed consent, and had shown no allergic reaction to a patch test with the study medication, were randomised. Patients admitted from intensive care or high dependency were excluded. Main results Effect estimates and confidence intervals were not reported for any of the outcomes; only group means/proportions and P-values from hypothesis testing were provided. More patients in the intervention group reported itch reduction compared to comparison treatment (91 vs. 82%, P=0.001). Itch recurrence after cream application occurred later in the intervention group compared to the control group (P<0.001). Use of antipruritic medication was significantly greater in the control group (P=0.023). There was no difference in sleep disturbance between groups (not quantified). On average, Medilixir took longer to apply than aqueous cream (157s for Medilixir vs. 139s for aqueous cream; mean difference 17s), but authors noted that the groups did not differ significantly (CI for mean difference and P-values were not reported).

Understanding the abnormal brain activity in epilepsy as a potential predictor of the onset of an epileptic seizure

The Brain Research Institute (BRI) uses various types of indirect measurements, including EEG and fMRI, to understand and assess brain activity and function. As well as the recovery of generic information about brain function, research also focuses on the utilisation of such data and understanding to study the initiation, dynamics, spread and suppression of epileptic seizures. To assist with the future focussing of this aspect of their research, the BRI asked the MISG 2010 participants to examine how the available EEG and fMRI data and current knowledge about epilepsy should be analysed and interpreted to yield an enhanced understanding about brain activity occurring before, at commencement of, during, and after a seizure. Though the deliberations of the study group were wide ranging in terms of the related matters considered and discussed, considerable progress was made with the following three aspects. (1) The science behind brain activity investigations depends crucially on the quality of the analysis and interpretation of, as well as the recovery of information from, EEG and fMRI measurements. A number of specific methodologies were discussed and formalised, including independent component analysis, principal component analysis, profile monitoring and change point analysis (hidden Markov modelling, time series analysis, discontinuity identification). (2) Even though EEG measurements accurately and very sensitively record the onset of an epileptic event or seizure, they are, from the perspective of understanding the internal initiation and localisation, of limited utility. They only record neuronal activity in the cortical (surface layer) neurons of the brain, which is a direct reflection of the type of electrical activity they have been designed to record. Because fMRI records, through the monitoring of blood flow activity, the location of localised brain activity within the brain, the possibility of combining fMRI measurements with EEG, as a joint inversion activity, was discussed and examined in detail. (3) A major goal for the BRI is to improve understanding about ``when'' (at what time) an epileptic seizure actually commenced before it is identified on an eeg recording, ``where'' the source of this initiation is located in the brain, and ``what'' is the initiator. Because of the general agreement in the literature that, in one way or another, epileptic events and seizures represent abnormal synchronisations of localised and/or global brain activity the modelling of synchronisations was examined in some detail. References C. M. Michel, G. Thut, S. Morand, A. Khateb, A. J. Pegna, R. Grave de Peralta, S. Gonzalez, M. Seeck and T. Landis, Electric source imaging of human brain functions, Brain Res. 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Can ginger ameliorate chemotherapy-induced nausea? Protocol of a randomized double blind, placebo-controlled trial

Background Preliminary research shows ginger may be an effective adjuvant treatment for chemotherapy-induced nausea and vomiting but significant limitations need to be addressed before recommendations for clinical practice can be made. Methods/Design In a double–blinded randomised-controlled trial, chemotherapy-naïve patients will be randomly allocated to receive either 1.2 g of a standardised ginger extract or placebo per day. The study medication will be administrated as an adjuvant treatment to standard anti-emetic therapy and will be divided into four capsules per day, to be consumed approximately every 4 hours (300 mg per capsule administered q.i.d) for five days during the first three cycles of chemotherapy. Acute, delayed, and anticipatory symptoms of nausea and vomiting will be assessed over this time frame using a valid and reliable questionnaire, with nausea symptoms being the primary outcome. Quality of life, nutritional status, adverse effects, patient adherence, cancer-related fatigue, and CINV-specific prognostic factors will also be assessed. Discussion Previous trials in this area have noted limitations. These include the inconsistent use of standardized ginger formulations and valid questionnaires, lack of control for anticipatory nausea and prognostic factors that may influence individual CINV response, and the use of suboptimal dosing regimens. This trial is the first to address these issues by incorporating multiple unique additions to the study design including controlling for CINV-specific prognostic factors by recruiting only chemotherapy-naïve patients, implementing a dosing schedule consistent with the pharmacokinetics of oral ginger supplements, and independently analysing ginger supplements before and after recruitment to ensure potency. Our trial will also be the first to assess the effect of ginger supplementation on cancer-related fatigue and nutritional status. Chemotherapy-induced nausea and vomiting are distressing symptoms experienced by oncology patients; this trial will address the significant limitations within the current literature and in doing so, will investigate the effect of ginger supplementation as an adjuvant treatment in modulating nausea and vomiting symptoms. Trial registration

Asthma interventions in primary schools : a review

Objective To explore, in depth, the literature for evidence supporting asthma interventions delivered within primary schools and to identify any “gaps” in this research area. Methods A literature search using electronic search engines (i.e. Medline, PubMed, Education Resources Information Center (ERIC), International Pharmaceutical Abstracts (IPA), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase and Informit) and the search terms “asthma”, “asthma intervention” and “school-based asthma education program” (and derivatives of these keywords) was conducted. Results Twenty-three articles met the inclusion criteria; of these eight were Randomised Controlled Trials. There was much variety in the type, content, delivery and outcome measures in these 23 studies. The most common intervention type was asthma education delivery. Most studies demonstrated improvement in clinical and humanistic markers, for example, asthma symptoms medication use (decrease in reliever medication use or decrease in the need for rescue oral steroid), inhaler use technique and spacer use competency, lung function and quality of life. Relatively few studies explored the effect of the intervention on academic outcomes. Most studies did not report on the sustainability or cost effectiveness of the intervention tested. Another drawback in the literature was the lack of details about the intervention and inconsistency in instruments selected for measuring outcomes. Conclusion School-based asthma interventions regardless of their heterogeneity have positive clinical, humanistic, health economical and academic outcomes.

Consumers persepctive on pharmacists integration into private primary healthcare clinics in Malaysia

Background: Pharmacists are considered medication experts but are underutilised mainly at the periphery of the primary healthcare team. General medical practitioners (GPs) in Malaysian private healthcare clinics are granted rights to prescribe and dispense medications, thus furhter limiting pharmacists involvement in ensuring safe use of medicines. The integration of pharmacist into private primary healthcare clinics has the potential to reduce medication-relation problems. Objective: To explore the views of consumers on the integration of pharmacists within private primary healthcare clinics in Malaysia. Method: A purposive sample of healthcare consumers in Selangor and Kuala Lumpur, Malaysia were invited to participate in focus groups and semi-structured interviews. Sessions were audio recorded and transcribed verbatim and thematically analysed using NVivo 10. Results: A total of 24 healthcare consumers particpated in two focus groups and six semi-structured interviews. Four major themes were identified: (1) Pharmacists role viewed mainly as supplying medications, (2) Readiness to accept pharmacists in private healthcare clinics, (3) Willingness to pay for pharmacy services, and (4) Concerns about GPs resistance to pharmacist integration. Consumers felt that a pharmacist integrated into private prumary healthcare clinics could offer potential benefits such as counter-checking prescriptions to ensure correct medication is supplied and counselling consumers on their medications and the potential side effects. The potential to increase in costs to consumers and GPs reluctance were perceived as barriers to integration. Conclusion: This study provides insights into consumers perspectives on the roles of pharmacists within private primary healthcare clinics in Malaysia. Consumers generally supported pharmacist integration into private primary healthcare clinics. However, for pharmacists to expand their capacity in providing integrated and collaborative primary care services to consumers, barriers to pharmacist integration need to be addressed.

Psychotropics and challenging behaviour in people with an intellectual disability

Hilmer and Gnjidic drew attention to the pharmacological management of behavioural problems in nursing home residents, and called for a reduction in inappropriate prescribing and the development of alternative management strategies.1 We extend these concerns to another vulnerable population — people with intellectual disability. Historically, this population is one of the most medicated groups in modern society.

A multi-level ecological model of psychotropic prescribing to adults with intellectual disability

Purpose – Simple linear accounts of prescribing do not adequately address reasons “why” doctors prescribe psychotropic medication to people with intellectual disability (ID). Greater understanding of the complex array of factors that influence decisions to prescribe is needed. Design/methodology/approach – After consideration of a number of conceptual frameworks that have potential to better understand prescribing of psychotropic medication to adults with ID, an ecological model of prescribing was developed. A case study is used to outline how the model can provide greater understanding of prescribing processes. Findings – The model presented aims to consider the complexity and multi-dimensional nature of community-based psychotropic prescribing to adults with ID. The utility of the model is illustrated through a consideration of the case study. Research limitations/implications – The model presented is conceptual and is as yet untested. Practical implications – The model presented aims to capture the complexity and multi-dimensional nature of community-based psychotropic prescribing to adults with ID. The model may provide utility for clinicians and researchers as they seek clarification of prescribing decisions. Originality/value – The paper adds valuable insight into factors influencing psychotropic prescribing to adults with ID. The ecological model of prescribing extends traditional analysis that focuses on patient characteristics and introduces multi-level perspectives that may provide utility for clinicians and researchers.

Jane

This case study describes the use of antipsychotic medication by an adult woman with learning disabilities. The study first provides detailed clinical information about Jane, drawing on a comprehensive mental health assessment and then provides a thematic analysis of Jane's experiences of antipsychotic medication.

A pilot study to assess the appropriateness of prescribing from a collaborative pharmacist prescribing study in a surgical pre admission clinic

Background Current evidence to support non-medical prescribing is predominantly qualitative, with little evaluation of appropriateness. This study aims to evaluate the appropriateness of prescribing, and significance of omissions, from a doctor pharmacist collaborative prescribing model in an elective surgery pre admission clinic (PAC). Method A modified version of the Medication Appropriate Index (MAI) was developed, piloted and subsequently used by an expert panel, comprised of a surgeon, anaesthetist, clinical pharmacologist, pharmacist, resident medical officer (RMO) and clinical nurse. The tool was used to rate the appropriateness of prescribing of medications, and the significance of omissions in a 5% sample (N=19) of the total cohort from a randomised, controlled two arm trial of doctor-pharmacist collaborative prescribing. Results When reviewer assessments were combined, 32 out of 294 (10.9%) medications assessed for appropriateness in the control arm were classed as inappropriate, compared to 13 of 266 (4.9%) in the intervention arm. Out of 89 regular medications in the control arm, 25 (28%) were omitted from the medication charts, compared to 1 out of 55 (2%) in the intervention arm (p<0.001, fishers exact) On average, 52% of omissions in the control arm were judged to have potential for patient harm or ward inconvenience. Conclusion For the appropriateness of prescribing, overall results were similar between arms, as judged by individual panel members. Medication charts in the control arm contained significantly more omissions than in the intervention arm, a number of which were rated by the panel members as having the potential for patient harm or ward inconvenience.

Perception of prescription medicine sample packs among Australian professional, government, industry, and consumer organizations, based on automated textual analysis of one-on-one interviews

Background Prescription medicine samples provided by pharmaceutical companies are predominantly newer and more expensive products. The range of samples provided to practices may not represent the drugs that the doctors desire to have available. Few studies have used a qualitative design to explore the reasons behind sample use. Objective The aim of this study was to explore the opinions of a variety of Australian key informants about prescription medicine samples, using a qualitative methodology. Methods Twenty-three organizations involved in quality use of medicines in Australia were identified, based on the authors' previous knowledge. Each organization was invited to nominate 1 or 2 representatives to participate in semistructured interviews utilizing seeding questions. Each interview was recorded and transcribed verbatim. Leximancer v2.25 text analysis software (Leximancer Pty Ltd., Jindalee, Queensland, Australia) was used for textual analysis. The top 10 concepts from each analysis group were interrogated back to the original transcript text to determine the main emergent opinions. Results A total of 18 key interviewees representing 16 organizations participated. Samples, patient, doctor, and medicines were the major concepts among general opinions about samples. The concept drug became more frequent and the concept companies appeared when marketing issues were discussed. The Australian Pharmaceutical Benefits Scheme and cost were more prevalent in discussions about alternative sample distribution models, indicating interviewees were cognizant of budgetary implications. Key interviewee opinions added richness to the single-word concepts extracted by Leximancer. Conclusions Participants recognized that prescription medicine samples have an influence on quality use of medicines and play a role in the marketing of medicines. They also believed that alternative distribution systems for samples could provide benefits. The cost of a noncommercial system for distributing samples or starter packs was a concern. These data will be used to design further research investigating alternative models for distribution of samples.

Prescribing for nausea in palliative care : A cross-sectional national survey of Australian palliative medicine doctors

Background: Nausea can be a debilitating symptom for patients with a life-limiting illness. While addressing reversible components, nonpharmacological strategies and antiemetics are the main therapeutic option. The choice of medication, dose, and route of administration remain highly variable. Objective: The aim of this study was to codify the current clinical approaches and quantify any variation found nationally. Methods: A cross-sectional study utilizing a survey of palliative medicine clinicians examined prescribing preferences for nausea using a clinical vignette. Respondent characteristics, the use of nonpharmacological interventions, first- and second-line antiemetic choices, commencing and maximal dose, and time to review were collected. Results: Responding clinicians were predominantly working in palliative medicine across a range of settings with a 49% response rate (105/213). The main nonpharmacological recommendation was “small, frequent snacks.” Metoclopramide was the predominant first-line agent (69%), followed by haloperidol (26%), while second-line haloperidol was the predominant agent (47%), with wide variation in other nominated agents. Respondents favoring metoclopramide as first-line tended to use haloperidol second-line (65%), but not vice versa. Maximal doses for an individual antiemetic varied up to tenfold. Conclusion: For nausea, a commonly encountered symptom in palliative care, clinicians' favored metoclopramide and haloperidol; however, after these choices, there was large variation in antiemetic selection. While most clinicians recommended modifying meal size and frequency, use of other nonpharmacological therapies was limited.