Target users' acceptance of a pharmacist-led prescribing service for pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV).

Background: Pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) is a highly effective way to reduce virus transmission. There have been increasing calls to improve access to PrEP in Canada. One way to improve access is by having more prescribers available. The objective of this study was to determine target users' acceptance of a PrEP-prescribing service by pharmacists in Nova Scotia. Methods: A triangulation, mixed-methods study was conducted consisting of an online survey and qualitative interviews underpinned by the Theoretical Framework of Acceptability (TFA) constructs (affective attitude, burden, ethicality, intervention coherence, opportunity cost, perceived effectiveness and self-efficacy). Participants were those eligible for PrEP in Nova Scotia (men who have sex with men or transgender women, persons who inject drugs and HIV-negative individuals in serodiscordant relationships). Descriptive statistics and ordinal logistic regression were used to analyze survey data. Interview data were deductively coded according to each TFA construct and then inductively coded to determine themes within each construct. Results: A total of 148 responses were captured by the survey, and 15 participants were interviewed. Participants supported pharmacists' prescribing PrEP across all TFA constructs from both survey and interview data. Identified concerns related to pharmacists' abilities to order and view lab results, pharmacists' knowledge and skills for sexual health and the potential for experiencing stigma within pharmacy settings. Conclusion: A pharmacist-led PrEP-prescribing service is acceptable to eligible populations in Nova Scotia. The feasibility of PrEP prescribing by pharmacists should be pursued as an intervention to increase access to PrEP.

Community pharmacists' acceptance of prescribing pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV).

Background: Pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) prevention is highly effective. Pharmacists can increase PrEP accessibility through pharmacist prescribing. This study aimed to determine pharmacists' acceptance of a pharmacist PrEP prescribing service in Nova Scotia. Methods: A triangulation mixed methods study consisting of an online survey and qualitative interviews was conducted with Nova Scotia community pharmacists. The survey questionnaire and qualitative interview guide were underpinned by the 7 constructs of the Theoretical Framework of Acceptability (affective attitude, burden, ethicality, opportunity costs, intervention coherence, perceived effectiveness and self-efficacy). Survey data were analyzed descriptively and with ordinal logistic regression to determine associations between variables. Interview transcripts were deductively coded according to the same constructs and then inductively coded to identify themes within each construct. Results: A total of 214 community pharmacists completed the survey, and 19 completed the interview. Pharmacists were positive about PrEP prescribing in the constructs of affective attitude (improved access), ethicality (benefits communities), intervention coherence (practice alignment) and self-efficacy (role). Pharmacists expressed concerns about burden (increased workload), opportunity costs (time to provide the service) and perceived effectiveness (education/training, public awareness, laboratory test ordering and reimbursement). Conclusion: A PrEP prescribing service has mixed acceptability to Nova Scotia pharmacists yet represents a model of service delivery to increase PrEP access to underserved populations. Future service development must consider pharmacists' workload, education and training as well as factors relating to laboratory test ordering and reimbursement.

Anti-Epileptic Medication Exposure Influences Functional Status in New Zealand Stroke Patients: A Retrospective Population-Level Study.

BACKGROUND: Patients who develop seizures after stroke have disproportionately poorer outcomes and increased mortality. OBJECTIVE: Our objective was to investigate whether exposure to anti-epileptic medications influenced long-term functional status after stroke. METHODS: We used linked health administrative data from a cohort of adult stroke patients in New Zealand. Demographics and prescription information were obtained from the National Minimum Dataset and Pharmaceutical Collection, respectively. Activities of daily living (ADL) scores for the same patients were obtained using the International Resident Assessment Instrument. Beta regression was used to investigate the relationship between anti-epileptic drug (AED) exposure and functional status. RESULTS: The study included 3606 patients with a single ischaemic stroke between 2012 and 2017. In total, 15% were dispensed an AED in the 3 months before or after stroke. The adjusted odds ratio (OR) for AED exposure was 1.29 (95% confidence interval [CI] 1.15-1.45). Overall AED exposure, categorical body mass index (BMI), ethnicity, length of hospital stay, and exposure to paracetamol, opioids, anti-psychotics, and anti-nausea medications were significantly associated with changes in the mean ADL score percentages. Considering the exposure timeframe, the ORs for AED exposure only after stroke and for exposure both before and after stroke were 1.52 (95% CI 1.31-1.78) and 1.09 (95% CI 0.93-1.27), respectively. CONCLUSION: Stroke patients with AED exposure had greater odds of a higher ADL score, indicating a poorer long-term functional status than those unexposed to AEDs. The timeframe of exposure impacted on functional status, with patients exposed only after stroke having increased odds of higher ADL scores than those exposed both before and after stroke.

Medication-related harm in New Zealand general practice: a retrospective records review.

BACKGROUND: The extent of medication-related harm in general practice is unknown. AIM: To identify and describe all medication-related harm in electronic general practice records. The secondary aim was to investigate factors potentially associated with medication-related harm. DESIGN AND SETTING: Retrospective cohort records review study in 44 randomly selected New Zealand general practices for the 3 years 2011-2013. METHOD: Eight GPs reviewed 9076 randomly selected patient records. Medication-related harms were identified when the causal agent was prescribed in general practice. Harms were coded by type, preventability, and severity. The number and proportion of patients who experienced medication-related harm was calculated. Weighted logistic regression was used to identify factors associated with harm. RESULTS: In total, 976 of 9076 patients (10.8%) experienced 1762 medication-related harms over 3 years. After weighting, the incidence rate of all medication-related harms was 73.9 harms per 1000 patient-years, and the incidence of preventable, or potentially preventable, medication-related harms was 15.6 per 1000 patient-years. Most harms were minor (n = 1385/1762, 78.6%), but around one in five harms were moderate or severe (n = 373/1762, 21.2%); three patients died. Eighteen study patients were hospitalised; after weighting this correlates to a hospitalisation rate of 1.1 per 1000 patient-years. Increased age, number of consultations, and number of medications were associated with increased risk of medication-related harm. Cardiovascular medications, antineoplastic and immunomodulatory agents, and anticoagulants caused most harm by frequency and severity. CONCLUSION: Medication-related harm in general practice is common. This study adds to the evidence about the risk posed by medication in the real world. Findings can be used to inform decision making in general practice.

Effectiveness of patient decision aids in women considering psychotropic medication use during pregnancy: a literature review.

Women face complicated decisions regarding psychotropic medication use during pregnancy. Patient decision aids (PDAs) could be a valuable tool to assist with decision-making. The objective of this review was to evaluate the effectiveness of PDAs in this population. A systematic search of the literature was conducted using PRISMA guidelines. Three major databases were searched to identify articles published between 2006 and June 2020. Studies were included if they evaluated use of a PDA for women considering medication for mental illness during pregnancy. A total of 4629 titles were returned from the search; however, only three studies met inclusion criteria and were selected for analysis. Two were pilot randomised controlled trials in women considering antidepressant use during pregnancy, and one was a non-randomised study in women considering medication for the treatment of opioid use disorder (OUD). The PDAs had good acceptability across all three studies. The randomised trials assessed knowledge, decisional conflict, depression, and anxiety, with non-significant trends towards reduced decisional conflict and anxiety in the PDA groups. PDAs have the potential to assist women with mental illnesses to make decisions regarding medication use during pregnancy; however, current evidence is too limited to evaluate the effectiveness of PDAs for this population.

Higher BMI Confers a Long-Term Functional Status Advantage in Elderly New Zealand European Stroke Patients.

OBJECTIVE: Obesity is a risk factor for ischaemic stroke but provides a survival advantage. The relationship between body mass index (BMI) and long-term function is less clear. The presence of an obesity paradox can inform clinical care and identify vulnerable patients who need additional support post-stroke. MATERIALS AND METHODS: This study used linked health administrative data of a population based cohort of adult patients who experienced an ischaemic stroke between 2012 and 2017 in New Zealand. Patient demographics were obtained from the National Minimum Dataset (NMDS). BMI and Activities of Daily Living scores (ADLs) for the same patients were obtained from the International Resident Assessment Instrument (InterRAI™). RESULTS: Linked data was obtained for 3731 patients. Ninety-five percent of the cohort were aged 65 or older and the average age of stroke was 84.5 years. The majority of patients (55%) identified as New Zealand European. Beta regression indicated BMI and European ethnicity were negatively associated with ADL score. Univariate analysis confirmed patients with underweight stroke had significantly higher ADL scores than other BMI categories (p<0.001), however functional status for patients with overweight and obesity were comparable. Further, Asian and Pacific Peoples had higher ADL scores than Europeans (p<0.05). A higher BMI was advantageous to all ADL subscores. CONCLUSION: An abridged obesity paradox was evident in our cohort of stroke patients where a BMI in the overweight, but not obese range conferred a long-term functional status advantage. Collectively these results suggest underweight and non-European patients may require additional supportive clinical care post-stroke.

Monitoring the use of dabigatran etexilate for stroke prevention: compliance with renal function guidelines.

INTRODUCTION Dabigatran etexilate has become widely used in New Zealand, but information relating to when renal function monitoring is being undertaken is lacking. AIM To investigate if clinically appropriate renal function monitoring is being undertaken in New Zealand primary care for stroke prevention in non-valvular atrial fibrillation patients prescribed dabigatran etexilate. METHODS New Zealand non-valvular atrial fibrillation patients' prescription and primary care health data were extracted from national administrative databases for the period 1 July 2011 to 31 December 2015. The proportion of patients who had serum creatinine measurements at close proximity to treatment initiation and 12-months post initiation were assessed with 95% confidence intervals (CIs) and compared with Fisher's exact test. Log-rank tests for univariate analysis (gender, age, ethnicity and deprivation) effects on serum creatinine testing at dabigatran etexilate treatment initiation and 12-months post initiation were performed. RESULTS Overall, 1,948 patients who had been dispensed dabigatran etexilate with available primary care health data were identified. A total of 1,752 (89.9% [CI: 88.5-91.2]) patients had a renal function test at dabigatran etexilate initiation. There were 929 (72.8% [CI: 70.2-75.2]) patients who received ≥1 year supply of dabigatran etexilate and of these 207 (22.3% [CI: 19.6.6-25.1]) had a serum creatinine test 1 year after initiation. Demographic univariate analysis yielded insignificant log-rank tests for association with having serum creatinine measurements, except for Pacific Peoples. DISCUSSION There appears to be sub-optimal adherence to renal function monitoring for non-valvular atrial fibrillation patients who receive more than 12-months' treatment with dabigatran etexilate in New Zealand primary care.

Health services for sexually transmitted infections: Where are we at in New Zealand? A narrative literature review.

INTRODUCTION Sexually transmitted infection (STI) rates continue to rise in New Zealand. To effectively prevent, test and diagnose STIs in a timely manner to limit their health effects, health services must be appropriate and accessible for all. AIM The aim of this review was to identify and collate the existing literature and identify gaps in research relating to STI health service delivery in New Zealand. METHODS A critical narrative literature review was conducted. A keyword search of PubMed (2010 to October 2020), EMBASE (2010 to October 2020) and Google Scholar (2010 to October 2020) was conducted. The electronic search was supplemented with manual screening of references from identified articles. Eligible studies reported on STI service delivery in New Zealand. Articles not meeting these criteria were excluded. Articles solely reporting on the human papillomavirus vaccine or condom use statistics or perceptions were also excluded. Data extracted included study year, authors, aim, methods and outcome results. RESULTS A total of 179 articles were identified, including 16 that met study inclusion criteria. Nine studies focused on STI testing, five on health-seeking behaviours and two had other foci. The results reflected substantial gaps in the funding and delivery of best-practice STI management across all New Zealand. DISCUSSION New strategies are needed to improve access to low-cost or free services for sexual health care in general and clinic-wide systems implemented to enable routine delivery of advice about STI prevention and testing by clinicians to patients.

The Use of Gentamicin for Treatment of Urogenital and Extragenital Gonorrhea: A Systematic Review of Efficacy Data.

OBJECTIVE: To evaluate clinical efficacy data for gentamicin in the treatment of gonorrhea. DATA SOURCES: A keyword search of PubMed (1966 to April 2020), EMBASE (1947 to April 2020), and International Pharmaceutical Abstracts (1970 to April 2020) was conducted. The electronic search was supplemented with manual screening of references from identified articles and a search of ClinicalTrials.gov to identify ongoing trials. STUDY SELECTION AND DATA EXTRACTION: Comparator and noncomparator studies reporting microbiological outcomes of treatment with gentamicin for gonorrhea in humans were included. Data extracted included study year, authors, aim, setting, population, dosing protocols, and outcome results. Risk of bias was assessed according to the Cochrane Risk of Bias Assessment Tool. DATA SYNTHESIS: A total of 407 articles were identified, of which 11 met inclusion criteria. Two studies were randomized controlled trials, and 1 additional randomized noncomparator study was identified. All other studies were nonrandomized and noncomparator in nature. The highest quality evidence suggests that gentamicin is not noninferior to ceftriaxone (both in addition to azithromycin) for treatment of gonorrhea but may achieve cure rates >90%. Conflicting evidence exists regarding the efficacy of gentamicin-based regimens for the specific treatment of extragenital gonorrhea. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Results of this review could affect patient care and clinical practice because they clearly demonstrate the role of gentamicin for the treatment of gonorrhea as a second-line agent. Future research should confirm findings, especially for the role of gentamicin in extragenital infections. CONCLUSIONS: Gentamicin-based regimens should be reserved for second-line treatment of urogenital and extragenital gonorrhea infections.

A Narrative Review of Continuing Professional Development Needs for Pharmacists with Respect to Pre-exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV).

Pre-exposure prophylaxis (PrEP) for the human immunodeficiency virus (HIV) is rapidly increasing in use worldwide, with many countries now publicly funding use for high risk populations. Pharmacists, as front-line care providers, must have the necessary knowledge, skills and attitudes to effectively provide care to PrEP patients. The aim of this review was to identify priority areas and key gaps for continuing professional development (CPD) needs relating to PrEP for practicing pharmacists. An electronic search of PubMed, EMBASE, International Pharmaceutical Abstracts and CPD-related journals was supplemented with a manual search of references to identify articles describing pharmacists' knowledge, perceptions and experience with PrEP. A total of eight articles were identified across four countries. Pharmacists were consistently found to lack knowledge and awareness of PrEP, express low confidence/comfort with patient care practices, report a lack of experience and/or intentions to provide patient care, but overall had positive perceptions of PrEP therapy. Older pharmacists with more experience commonly reported greater knowledge gaps than recently trained pharmacists. CPD should therefore aim to increase pharmacists' baseline knowledge and awareness of PrEP and treatment guidelines, as well as be directed towards older pharmacists with more experience.

Exposure Response Supports Therapeutic Drug Monitoring for Dabigatran Etexilate in Patients with Atrial Fibrillation.

Background Dabigatran etexilate has become widely used for the prevention of stroke in patients with nonvalvular atrial fibrillation (NVAF). Currently, there is limited information in real-world patients relating to dabigatran etexilate exposure and response. Methods This retrospective cohort study used administrative health data for NVAF patients dispensed dabigatran etexilate between July 1, 2011 and December 31, 2015. Outcomes of cerebrovascular accident (CVA), systemic embolism, and hemorrhage were extracted. Simulated pharmacokinetic parameters were obtained using a published population pharmacokinetic model of dabigatran etexilate. Area under the curve calculated for a 24-hour period at steady state (AUC ss ), the exposure parameter, was derived using these simulations and the dosing data and the exposure-response relationship were investigated. The risk of adverse outcomes at AUC ss quartiles was compared using Poisson regression and expressed using incidence rate ratios (95% confidence interval) adjusted for known potential confounders. Results In total, 2,660 NVAF patients had been dispensed dabigatran etexilate. For these patients there was a decreased risk of hemorrhage (0.51, 0.32-0.79) when dabigatran AUC ss was in the second quartile range of 1.70 to 1.96 mg h/L and thromboembolism/CVA (0.34, 0.16-0.76) when in the third quartile range of 1.97 to 2.26 mg h/L. An increased risk of hemorrhage (1.68, 1.18-2.38) was observed when AUC ss was in the fourth quartile range of 2.27 to 12.76 mg h/L. Conclusion An exposure-response relationship for dabigatran etexilate was described, where the most effective response was observed when AUC ss was in the range of 1.70 to 2.26 mg h/L. Hence, it is feasible to develop guidance for optimal dosing to improve outcomes for patients with NVAF.

Deaths by poisoning in New Zealand, 2008-2013.

Introduction: While a number of developed countries have witnessed a decline in carbon monoxide (CO) deaths and increasing numbers of opioid-related fatalities, it is not known whether these or other trends have occurred in New Zealand. The aim of this study was, therefore, to review deaths due to poisoning in New Zealand, describe the causative substances, and identify any trends. Methods: Retrospective study reviewing New Zealand's poison-related death findings recorded in the National Coronial Information System (NCIS) database over the 6-year period 2008-2013. Results: We identified 1402 poisoning-related deaths recorded in the NCIS database representing a mortality rate of 5.4 deaths/100,000 population per year. The mortality rate due to poisoning was higher in males (6.96/100,000) than females (3.83/100,000). Fatalities peaked in the 40-50-year age group with the highest proportion of intentional deaths occurring in people aged 80-90 years. Pharmaceuticals accounted for 731 fatalities (52%) and chemicals 431 (31%), with multiple exposures occurring in 399 cases (28.5%). While CO was the leading cause of death throughout the period (n = 303, 21.6%), there was a significant reduction in the rate of CO fatalities from 1.69/100,000 population in 2008 to 0.94/100,000 in 2013 (IRR (95% CI) 2013/2008 0.56 (0.37-0.83)). There was, however, no statistically significant change in either the opioid-related death rate or the total number of deaths. Methadone was the leading pharmaceutical cause of fatality and the third most common cause overall, followed by morphine and codeine, with zopiclone and clozapine equally ranked as the sixth most common cause. Conclusion: While New Zealand has not suffered an "opioid epidemic" and has experienced a significant decline in CO deaths, the overall death rate due to poisoning has remained high. The development of accessible, timely, and relevant toxicovigilance systems would support the early implementation of interventions to reduce the leading causes of fatal poisoning.

Service provision in the wake of a new funding model for community pharmacy.

BACKGROUND: Recently, New Zealand has taken a system wide approach providing the biggest reform to New Zealand community pharmacy for 70 years with the aim of providing more clinically orientated patient centred services through a new funding model. The aim of this study was to understand the types of services offered in New Zealand community pharmacies since introduction of the new funding model, what the barriers are to providing these services. METHOD: A survey of all community pharmacies were undertaken between August, 2014 and February, 2015. Basic descriptive statistics were completed and group comparisons were made using the chi squared test with significance set at p < 0.05. RESULTS: 528 responses were received. Education and advice on prescription and non-prescription medicines were the two top listed services provided. There were no significant differences in service provision between rural and metro based pharmacies. Many pharmacies were considering introducing new patient centred services. Four of the top ten frequently provided services have no public funding attached. Costs and staff availability are the most common barriers to undertake services, more predominantly in patient centred services. CONCLUSION: This study was the first to provide an evaluation of service provision in response to a new funding model for New Zealand Community Pharmacies. A broad range of services are being undertaken in New Zealand community pharmacies including patient-centred services. A number of barriers to service provision were identified. This study provides a baseline for the current levels of service provision upon which future studies can compare to and evaluate any changes in service provision with differing funding models going forward.

Choice of Renal Function Estimator Influences Adverse Outcomes with Dabigatran Etexilate in Patients with Atrial Fibrillation.

Background Clinical significance of dosing dabigatran with different estimates of renal function for treatment of atrial fibrillation (AF) is unknown. Renal function is routinely estimated by the chronic kidney disease epidemiology initiative equation (CKD-EPI) and used to guide dosing. The aim of this study was to investigate the risk of adverse outcomes for patients with AF when different estimators of renal function are used. Material and Methods AF patient data were extracted from national administrative databases. Renal function was estimated using Cockcroft-Gault, CKD-EPI, and CKD-EPI adjusted for body surface area (CKD-EPI-BSA). Outcomes of cerebrovascular accident (CVA), systemic embolism (SE), and hemorrhage were extracted. Results In total, 2,425 patients were identified, of which there were hospitalizations for 138 (5.7%) hemorrhagic events, 45 (1.9%) CVA/SE, and 33 (1.4%) unspecified CVA. The level of agreement between Cockcroft-Gault with CKD-EPI and CKD-EPI-BSA yielded a weighted kappa statistic of 0.47 and 0.71, respectively. CKD-EPI and CKD-EPI-BSA significantly overestimated renal function in elderly patients resulting in higher recommended doses compared with Cockcroft-Gault. The hazard ratio for a hemorrhagic event was 2.32 (95% confidence interval, 1.22-4.42; p = 0.01) when a high dose was given compared with normal dose, based on Cockcroft-Gault. Conclusion Both CKD-EPI and CKD-EPI-BSA equations significantly overestimated renal function in the elderly population compared with the Cockcroft-Gault equation. This may lead to dose selection errors for dabigatran, particularly for those with severe impairment, increasing the risk of adverse outcome. Hence, CKD-EPI and CKD-EPI-BSA equations should not be substituted for the Cockcroft-Gault equation in the elderly for the purpose of renal dosage adjustments.

A feasibility study: Use of actigraph to monitor and follow-up sleep/wake patterns in individuals attending community pharmacy with sleeping disorders.

INTRODUCTION: Community pharmacists are in a suitable position to give advice and provide appropriate services related to sleep disorders to individuals who are unable to easily access sleep clinics. An intervention with proper objective measure can be used by the pharmacist to assist in consultation. OBJECTIVES: The study objectives are to evaluate: (1) The effectiveness of a community pharmacy-based intervention in managing sleep disorders and (2) the role of actigraph as an objective measure to monitor and follow-up individuals with sleeping disorders. METHODS AND INSTRUMENTS: The intervention care group (ICG) completed questionnaires to assess sleep scale scores (Epworth Sleepiness Scale [ESS] and Insomnia Severity Index [ISI]), wore a wrist actigraph, and completed a sleep diary. Sleep parameters (sleep efficiency in percentage [SE%], total sleep time, sleep onset latency, and number of nocturnal awakenings) from actigraphy sleep report were used for consultation and to validate sleep diary. The usual care group (UCG) completed similar questionnaires but received standard care. RESULTS: Pre- and post-mean scores for sleep scales and sleep parameters were compared between and within groups. A significant difference was observed when comparing pre- and post-mean scores for ISI in the ICG, but not for ESS. For SE%, an increase was found in the number of subjects rated as "good sleepers" at post-assessment in the ICG. CONCLUSIONS: ISI scores offer insights into the development of a community pharmacy-based intervention for sleeping disorders, particularly in those with symptoms of insomnia. It also demonstrates that actigraph could provide objective sleep/wake data to assist community pharmacists during the consultation.

Rising antimicrobial resistance: a strong reason to reduce excessive antimicrobial consumption in New Zealand.

Steadily rising rates of antimicrobial resistance, in a range of common bacterial pathogens, are a major threat to human health in New Zealand in the near future. The single largest contributor to this threat is the high level of antimicrobial consumption in New Zealand. Antimicrobial consumption in New Zealand needs to be reduced if we are to slow the spread of antimicrobial-resistant bacteria. Reporting the per capita antimicrobial consumption within each District Health Board (DHB), in relation to targets for reductions from present levels of consumption, could provide an impetus for DHBs to address this threat to the health of their populations.

Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings.

BACKGROUND: A see on cardiovascular diseases and bladder cancer. The changes to the patterns of rosiglitazone and pioglitazone utilisation in Australia following the timing of these various health authority warnings such as the Australian Therapeutic Good Administration (TGA), European Medicines Agency (EMA) press releases or U.S. Food and Drug Administration (FDA) is unknown. This study investigated the utilisation patterns of rosiglitazone and pioglitazone in Australia before and after warnings of major drug authorities. METHODS: We evaluated rosiglitazone and pioglitazone dispensing using the Pharmaceutical Benefit Scheme (PBS) subsidised drug dispensing data for the Australian population from February 2004 to July 2012. The World Health Organisation Anatomic Therapeutic Chemical (ATC)/Defined Daily Dose (DDD) system was used to compare the drug utilisation patterns following the announcements of EMA, FDA, and TGA safety warnings, which first occurred in May 2007. The DDD/1000 population/day were examined in a series of time-series regression analysis with the drug safety warnings specified as interventions. RESULTS: Rosiglitazone utilisation increased steadily from 2004 until reaching a peak at 1.96/1000 population/day in January 2007. Then rosiglitazone use decreased significantly after the initial EMA press release and FDA warning on cardiovascular risk in May 2007 (with a 15.04% average monthly decline, p-value <0.001), however use did not significantly decrease after the TGA warning or subsequent EMA and FDA warnings. Pioglitazone utilisation proceeded rosiglitazone in September 2008 and remained above 1.5/1000/day during 2009-2010. However, pioglitazone utilisation has slightly declined after the FDA, EMA, and TGA warnings related to bladder cancer. CONCLUSIONS: Drug safety warnings were associated with a decrease in rosiglitazone and pioglitazone utilisation in Australia. Rosiglitazone began to decline prior to TGA warnings in December 2007, which suggests that Australian prescribers may have acted in response to scientific evidence or international safety warnings (EMA, FDA), prior to the response of the TGA. Minor effects were observed after bladder cancer warnings on pioglitazone utilisation.

A study protocol: a community pharmacy-based intervention for improving the management of sleep disorders in the community settings.

BACKGROUND: Sleep disorders are very common in the community and are estimated to affect up to 45% of the world's population. Pharmacists are in a position to give advice and provide appropriate services to individuals who are unable to easily access medical care. The purpose of this study is to develop an intervention to improve the management of sleep disorders in the community. The aims are- (1) to evaluate the effectiveness of a community pharmacy-based intervention in managing sleep disorders, (2) to evaluate the role of actigraph as an objective measure in monitoring certain sleep disorders and (3) to evaluate the extended role of community pharmacists in managing sleep disorders. This intervention is developed to monitor individuals undergoing treatment and overcome the difficulties in validating self-reported feedback. METHOD/DESIGN: This is a community-based intervention, prospective, controlled trial, with one intervention group and one control group, comparing individuals receiving a structured intervention with those receiving usual care for sleep-related disorders at community pharmacies. DISCUSSION: This study will demonstrate the utilisation and efficacy of community pharmacy-based intervention to manage sleep disorders in the community, and will assess the possibility of implementing this intervention into the community pharmacy workflow. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry: ACTRN12612000825853.

Improving the use of benzodiazepines--is it possible? A non-systematic review of interventions tried in the last 20 years.

BACKGROUND: Benzodiazepines are often used on a long term basis in the elderly to treat various psychological disorders including sleep disorders, some neurological disorders and anxiety. This is despite the risk of dependence, cognitive impairment, and falls and fractures. Guidelines, campaigns and prescribing restrictions have been used to raise awareness of potentially inappropriate use, however long term use of benzodiazepine and related compounds is currently increasing in Australia and worldwide. The objective of this paper is to explore interventions aimed at improving the prescribing and use of benzodiazepines in the last 20 years. METHODS: Medline, EMBASE, PsychINFO, IPA were searched for the period 1987 to June 2007. RESULTS: Thirty-two articles met the study eligibility criteria (interventions solely focusing on increasing appropriate prescribing and reducing long term use of benzodiazepines) and were appraised. Insufficient data were presented in these studies for systematic data aggregation and synthesis, hence critical appraisal was used to tabulate the studies and draw empirical conclusions. Three major intervention approaches were identified; education, audit and feedback, and alerts. CONCLUSIONS: Studies which used a multi-faceted approach had the largest and most sustained reductions in benzodiazepines use. It appears that support groups for patients, non-voluntary recruitment of GPs, and oral delivery of alerts or feedback may all improve the outcomes of interventions. The choice of outcome measures, delivery style of educational messages, and requests by GPs to stop benzodiazepines, either in a letter or face to face, showed no differences on the success rates of the intervention.