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AIMS: The COVID-19 pandemic created unprecedented pressure on healthcare services. This study investigates whether disease-modifying antirheumatic drug (DMARD) safety monitoring was affected during the COVID-19 pandemic. METHODS: A population-based cohort study was conducted using the OpenSAFELY platform to access electronic health record data from 24.2 million patients registered at general practices using TPP's SystmOne software. Patients were included for further analysis if prescribed azathioprine, leflunomide or methotrexate between November 2019 and July 2022. Outcomes were assessed as monthly trends and variation between various sociodemographic and clinical groups for adherence with standard safety monitoring recommendations. RESULTS: An acute increase in the rate of missed monitoring occurred across the study population (+12.4 percentage points) when lockdown measures were implemented in March 2020. This increase was more pronounced for some patient groups (70-79 year-olds: +13.7 percentage points; females: +12.8 percentage points), regions (North West: +17.0 percentage points), medications (leflunomide: +20.7 percentage points) and monitoring tests (blood pressure: +24.5 percentage points). Missed monitoring rates decreased substantially for all groups by July 2022. Consistent differences were observed in overall missed monitoring rates between several groups throughout the study. CONCLUSION: DMARD monitoring rates temporarily deteriorated during the COVID-19 pandemic. Deterioration coincided with the onset of lockdown measures, with monitoring rates recovering rapidly as lockdown measures were eased. Differences observed in monitoring rates between medications, tests, regions and patient groups highlight opportunities to tackle potential inequalities in the provision or uptake of monitoring services. Further research should evaluate the causes of the differences identified between groups.
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AIMS: The COVID-19 pandemic caused significant disruption to routine activity in primary care. Medication reviews are an important primary care activity ensuring safety and appropriateness of prescribing. A disruption could have significant negative implications for patient care. Using routinely collected data, our aim was first to describe codes used to record medication review activity and then to report the impact of COVID-19 on the rates of medication reviews. METHODS: With the approval of NHS England, we conducted a cohort study of 20 million adult patient records in general practice, in-situ using the OpenSAFELY platform. For each month, between April 2019 and March 2022, we report the percentage of patients with a medication review coded monthly and in the previous 12 months with breakdowns by regional, clinical and demographic subgroups and those prescribed high-risk medications. RESULTS: In April 2019, 32.3% of patients had a medication review coded in the previous 12 months. During the first COVID-19 lockdown, monthly activity decreased (-21.1% April 2020), but the 12-month rate was not substantially impacted (-10.5% March 2021). The rate of structured medication review in the last 12 months reached 2.9% by March 2022, with higher percentages in high-risk groups (care home residents 34.1%, age 90+ years 13.1%, high-risk medications 10.2%). The most used medication review code was Medication review done 314530002 (59.5%). CONCLUSIONS: There was a substantial reduction in the monthly rate of medication reviews during the pandemic but rates recovered by the end of the study period. Structured medication reviews were prioritized for high-risk patients.
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COVID-19 , Registros Eletrônicos de Saúde , Atenção Primária à Saúde , Humanos , COVID-19/epidemiologia , Inglaterra/epidemiologia , Adulto , Pessoa de Meia-Idade , Masculino , Feminino , Idoso , Estudos de Coortes , SARS-CoV-2 , Adulto Jovem , Idoso de 80 Anos ou mais , Medicina EstatalRESUMO
BACKGROUND: The Medicines Intelligence (MedIntel) Data Platform is an anonymised linked data resource designed to generate real-world evidence on prescribed medicine use, effectiveness, safety, costs and cost-effectiveness in Australia. RESULTS: The platform comprises Medicare-eligible people who are ≥18 years and residing in New South Wales (NSW), Australia, any time during 2005-2020, with linked administrative data on dispensed prescription medicines (Pharmaceutical Benefits Scheme), health service use (Medicare Benefits Schedule), emergency department visits (NSW Emergency Department Data Collection), hospitalisations (NSW Admitted Patient Data Collection) plus death (National Death Index) and cancer registrations (NSW Cancer Registry). Data are currently available to 2022, with approval to update the cohort and data collections annually. The platform includes 7.4 million unique people across all years, covering 36.9% of the Australian adult population; the overall population increased from 4.8 M in 2005 to 6.0 M in 2020. As of 1 January 2019 (the last pre-pandemic year), the cohort had a mean age of 48.7 years (51.1% female), with most people (4.4 M, 74.7%) residing in a major city. In 2019, 4.4 M people (73.3%) were dispensed a medicine, 1.2 M (20.5%) were hospitalised, 5.3 M (89.4%) had a GP or specialist appointment, and 54 003 people died. Anti-infectives were the most prevalent medicines dispensed to the cohort in 2019 (43.1%), followed by nervous system (32.2%) and cardiovascular system medicines (30.2%). CONCLUSION: The MedIntel Data Platform creates opportunities for national and international research collaborations and enables us to address contemporary clinically- and policy-relevant research questions about quality use of medicines and health outcomes in Australia and globally.
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Bases de Dados Factuais , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Idoso , New South Wales/epidemiologia , Adulto , Adolescente , Adulto Jovem , Análise Custo-Benefício , Hospitalização/estatística & dados numéricos , Medicamentos sob Prescrição/uso terapêutico , Medicamentos sob Prescrição/economia , Idoso de 80 Anos ou mais , Farmacoepidemiologia/métodosRESUMO
Electronic health records (EHRs) and other administrative health data are increasingly used in research to generate evidence on the effectiveness, safety, and utilisation of medical products and services, and to inform public health guidance and policy. Reproducibility is a fundamental step for research credibility and promotes trust in evidence generated from EHRs. At present, ensuring research using EHRs is reproducible can be challenging for researchers. Research software platforms can provide technical solutions to enhance the reproducibility of research conducted using EHRs. In response to the COVID-19 pandemic, we developed the secure, transparent, analytic open-source software platform OpenSAFELY designed with reproducible research in mind. OpenSAFELY mitigates common barriers to reproducible research by: standardising key workflows around data preparation; removing barriers to code-sharing in secure analysis environments; enforcing public sharing of programming code and codelists; ensuring the same computational environment is used everywhere; integrating new and existing tools that encourage and enable the use of reproducible working practices; and providing an audit trail for all code that is run against the real data to increase transparency. This paper describes OpenSAFELY's reproducibility-by-design approach in detail.
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COVID-19 , Registros Eletrônicos de Saúde , Software , Humanos , Reprodutibilidade dos Testes , COVID-19/epidemiologia , Projetos de PesquisaRESUMO
BACKGROUND: Sustained-release (SR) tapentadol was listed on Australia's Pharmaceutical Benefits Scheme (PBS) in 2014 for chronic severe pain requiring long-term opioid treatment. Dispensings have increased since listing despite declining trends in other PBS-listed opioids. Preferential prescribing of SR opioids may increase the risk of dependence and accidental overdose, particularly when used to treat acute pain. AIMS: To explore the quality use of publicly subsidised tapentadol in Australia. METHODS: We examined annual initiation rates and patterns of use of tapentadol (SR) in the dispensing records of a 10% random sample of PBS-eligible Australians (2014-2021). We used national tapentadol sales data to assess the proportion of sales attributable to the PBS. RESULTS: Tapentadol initiation increased from 2014, peaking at 7.5/1000 adult population in 2019 before declining to 5.3/1000 in 2021. We identified 63 766 new users between 2014 and 2020, of whom 92.8% discontinued in the first year following initiation, 58.0% had only a single dispensing and 34.3% had no other opioids dispensed in the 3 months before or after initiation. 27.8% of new users were dispensed tapentadol on the same day as potentially interacting medicines. There was a sustained drop in the proportion of sales attributable to the PBS from June 2020 onwards, from an average of 69.1%, to 63.9% of pack sales. CONCLUSIONS: Patterns of use suggest tapentadol (SR) is generally used for short duration. Although most tapentadol sold in Australia is subsidised, there is evidence of a shift towards private sales.
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Analgésicos Opioides , Tapentadol , Tapentadol/uso terapêutico , Humanos , Austrália/epidemiologia , Analgésicos Opioides/uso terapêutico , Analgésicos Opioides/economia , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Adulto , Dor Crônica/tratamento farmacológico , Preparações de Ação Retardada , Padrões de Prática Médica/estatística & dados numéricos , Adulto JovemRESUMO
AIMS: We quantified concomitant medicine use and occurrence of potential drug-drug interactions in people living with HIV in Australia who are treated with antiretroviral therapy (ART). METHODS: In this cohort study using dispensing claims of a 10% random sample of Australians, we identified 2230 people dispensed ART between January 2018 and December 2019 (mean age 49.0 years, standard deviation 12.0 years, 88% male). We examined concomitant medicine use by identifying nontopical medicines dispensed within 90-days of any antiretroviral medicine dispensing during a 12-month follow-up period. For every antiretroviral and nonantiretroviral pair, we identified and classified possible drug-drug interactions using the University of Liverpool HIV drug interactions database. RESULTS: A total of 1728 (78%) people were dispensed at least 1 and 633 (28%) 5 or more unique medicines in addition to ART in a 12-month period; systemic anti-infectives and medicines acting on the nervous system were the most common (68% and 56%, respectively). Among comedicated people, 1637 (95%) had at least 1 medicine combination classified as weak interactions, 558 (32%) interactions requiring close monitoring/dose adjustment and 94 (5%) that should not be coadministered. Contraindication or interactions requiring close monitoring/dose adjustment were more common among people receiving protease inhibitors (50-73% across different antiretrovirals), non-nucleoside reverse transcriptase inhibitors (35-64%), people using single-tablet combinations containing elvitegravir (30-46%) and those using tenofovir disoproxil (26-30%). CONCLUSION: Concomitant medicine use is widespread among people living with HIV in Australia. Despite a relatively low prevalence of contraindicated medicines, almost a third received medicines that require close monitoring or dose adjustment.
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Fármacos Anti-HIV , Infecções por HIV , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Estudos de Coortes , Austrália/epidemiologia , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Inibidores da Transcriptase Reversa , Antirretrovirais/uso terapêutico , Interações Medicamentosas , Fármacos Anti-HIV/uso terapêuticoRESUMO
Dose-prediction software is recommended to enable area under the curve over 24 h (AUC24 )-guided dosing of the antibiotic vancomycin. However, uncertainty remains about how best to implement software in the clinic. We describe the activity, over 18 months, of a consultative therapeutic drug monitoring Advisory Service (the Service) for vancomycin that used dose-prediction software alongside clinical expertise, identifying factors that influence attainment of therapeutic targets. Of the 408 vancomycin dose reports provided for 182 courses of therapy, most (57%) recommended a dose change. The majority (82.8%, 193/233) of recommended dose adjustments were accepted by treating teams. A dose report was not published for 125 courses of therapy, with reasons including patient in intensive care unit or service error. An estimated 26.6 h of staff time was allocated to Service activities each month. Publication of a dose report facilitated attainment of therapeutic targets (P = .002). Software integration could improve Service outcomes, avoiding errors and reducing staff workload.
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Consultores , Vancomicina , Humanos , Monitoramento de Medicamentos , Antibacterianos , Unidades de Terapia IntensivaRESUMO
Pharmacy dispensing data are useful for estimating adherence to therapy. Here, we implement multiple adherence measures to antiretroviral therapy (ART) and provide an online tool for visualising results. We conducted a cohort study for 2,042 people dispensed ART in Australia. We assessed adherence using the Proportion of Days Covered (PDC) within 360 days of follow-up as a continuous measure and dichotomised (PDC ≥80%). We defined a covered day as the 1) exposure to ≥3 antiretrovirals at the same time 2) exposure to any antiretroviral 3) lowest number of days covered per antiretroviral 4) average of days covered over all antiretrovirals 5) highest number of days covered per antiretroviral. For each method, we conducted sensitivity analyses. The median PDC ranged between 93.3%-98.3%. Between 67.0%-87.7% of individuals were classified as adherent, with higher values for measure 2 (85.5%-89.7%) and lower values for measure 3 (67.0%-70.9%). Censoring loss to follow-up had a higher impact on adherence estimates than considering a grace period. The variation in adherence estimates can be substantial, especially when dichotomising adherence. Researchers should consider operationalising multiple measures to estimate adherence bounds and identify a range of people at risk of non-adherence for targeted interventions.
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Infecções por HIV , Assistência Farmacêutica , Farmácias , Humanos , Infecções por HIV/tratamento farmacológico , Estudos de Coortes , Antirretrovirais/uso terapêutico , Adesão à Medicação , Estudos RetrospectivosRESUMO
OBJECTIVES: To determine the numbers and types of medicines dispensed around the time of death to people who die by suicide; to compare the medicines recently dispensed and those recorded in post mortem toxicology reports. DESIGN, SETTING, PARTICIPANTS: Analysis of linked National Coronial Information System (NCIS) and Pharmaceutical Benefits Scheme (PBS) data from the Australian Suicide Prevention using Health Linked Data (ASHLi) study, a population-based case series study of closed coronial cases for deaths of people in Australia aged ten years or more during 1 July 2013 - 10 October 2019 deemed by coroners to be the result of intentional self-harm. MAIN OUTCOME MEASURES: Proportions of people to whom medicines were dispensed around the time of death, by medicine group, class, and specific medicine; comparison of medicines recently dispensed and those detected by post mortem toxicology. RESULTS: Toxicology reports were available for 13 541 of 14 206 people who died by suicide (95.3%; 10 246 men, 75.7%); poisoning with medicines contributed to 1163 deaths (8.6%). At least one PBS-subsidised medicine had been dispensed around the time of death to 7998 people (59.1%). For three medicine classes, the proportions of people in whom the medicines were detected post mortem and their death was deemed medicine-related were larger for those without records of recent dispensing than for people for whom they had been dispensed around the time of death: antidepressants (17.7% v 12.0%), anxiolytics (16.3% v 14.8%), and sedatives/hypnotics (24.3% v 16.5%). At least one recently dispensed medicine not detected post mortem was identified for 6208 people (45.8%). CONCLUSIONS: A considerable proportion of people who died by suicide were not taking psychotropic medicines recently dispensed to them, suggesting non-adherence to pharmacotherapy, and a smaller than expected proportion were using antidepressants. Conversely, medicines that had not recently been dispensed were detected post mortem in many people for whom poisoning with medicines was a contributing factor, suggesting medicine stockpiling.
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Suicídio , Masculino , Humanos , Austrália/epidemiologia , Toxicologia Forense , Psicotrópicos/uso terapêutico , AntidepressivosRESUMO
BACKGROUND: Depression and anxiety affect 4-14% of Australians every year; symptoms may have been exacerbated during the COVID-19 pandemic. We examined recent patterns of antidepressant use in Australia in the period 2015-2021, which includes the first year of the pandemic. METHODS: We used national dispensing claims for people aged ⩾10 years to investigate annual trends in prevalent and new antidepressant use (no antidepressants dispensed in the year prior). We conducted stratified analyses by sex, age group and antidepressant class. We report outcomes from 2015 to 2019 and used time series analysis to quantify changes during the first year of the COVID-19 pandemic (March 2020-February 2021). RESULTS: In 2019, the annual prevalence of antidepressant use was 170.4 per 1000 women and 101.8 per 1000 men, an increase of 7.0% and 9.2% from 2015, respectively. New antidepressant use also increased for both sexes (3.0% for women and 4.9% for men) and across most age groups, particularly among adolescents (aged 10-17 years; 46-57%). During the first year of the COVID-19 pandemic, we observed higher than expected prevalent use (+2.2%, 95% CI = [0.3%, 4.2%]) among females, corresponding to a predicted excess of 45,217 (95% CI = [5,819, 84,614]) females dispensed antidepressants. The largest increases during the first year of the pandemic occurred among female adolescents for both prevalent (+11.7%, 95% CI = [4.1%, 20.5%]) and new antidepressant use (+15.6%, 95% CI = [8.5%, 23.7%]). CONCLUSION: Antidepressant use continues to increase in Australia overall and especially among young people. We found a differential impact of the COVID-19 pandemic in treated depression and anxiety, greater among females than males, and greater among young females than other age groups, suggesting an increased mental health burden in populations already on a trajectory of increased use of antidepressants prior to the pandemic. Reasons for these differences require further investigation.
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COVID-19 , Pandemias , Masculino , Adolescente , Humanos , Feminino , COVID-19/epidemiologia , Austrália/epidemiologia , Antidepressivos/uso terapêutico , Ansiedade/tratamento farmacológico , Ansiedade/epidemiologia , Depressão/tratamento farmacológico , Depressão/epidemiologia , Depressão/diagnósticoRESUMO
AIMS: Public health responses to reduce SARS-CoV-2 transmission have profoundly affected the epidemiology and management of other infections. We examined the impact of COVID-19 restrictions on antibiotic dispensing in Australia. METHODS: We used national claims data to investigate antibiotic dispensing trends from November 2015 to October 2020 and whether changes reflected reductions in primary care consultations. We used interrupted time series analysis to quantify changes in monthly antibiotic dispensing and face-to-face and telehealth GP consultations and examined changes by recipient age, pharmacy State and prescriber specialty. RESULTS: Over the study period, an estimated 19 921 370 people had 125 495 137 antibiotic dispensings, 71% prescribed by GPs. Following COVID-19 restrictions, we observed a sustained 36% (95% CI: 33-40%) reduction in antibiotic dispensings from April 2020. Antibiotics recommended for managing respiratory tract infections showed large reductions (range 51-69%), whereas those recommended for non-respiratory infections were unchanged. Dispensings prescribed by GPs decreased from 63.5 per 1000 population for April-October 2019 to 37.0 per 1000 for April-October 2020. Total GP consultation rates remained stable, but from April 2020, 31% of consultations were telehealth. CONCLUSION: In a setting with a low COVID-19 incidence, restrictions were associated with a substantial reduction in community dispensings of antibiotics primarily used to treat respiratory infections, coincident with reported reductions in respiratory viral infections. Our findings are informative for post-pandemic antimicrobial stewardship and highlight the potential to reduce inappropriate prescribing by GPs and specialists for respiratory viral infections.
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Gestão de Antimicrobianos , COVID-19 , Antibacterianos/uso terapêutico , Humanos , Prescrição Inadequada/prevenção & controle , Pandemias , Padrões de Prática Médica , SARS-CoV-2RESUMO
BACKGROUND: Medicine prescribing for children is impacted by a lack of paediatric-specific dosing, efficacy and safety data for many medicines. OBJECTIVES: To estimate the prevalence of medicine use among children and the rate of 'off-label' prescribing according to age at dispensing. METHODS: We used population-wide primarily outpatient dispensing claims data for 15% of Australian children (0-17 years), 2013-2017 (n = 840,190). We estimated prescribed medicine use and 'off-label' medicine use according to the child's age (<1 year, 1-5 years, 6-11 years, 12-17 years) defined as medicines without age-appropriate dose recommendations in regulator-approved product information. Within off-label medicines, we also identified medicines with and without age-specific dose recommendations in a national prescribing guide, the Australian Medicines Handbook Children's Dosing Companion (AMH CDC). RESULTS: The overall dispensing rate was 2.0 dispensings per child per year. The medicines with the highest average yearly prevalence were systemic antibiotics (435.3 per 1000 children), greatest in children 1-5 years (546.9 per 1000). Other common medicine classes were systemic corticosteroids (92.7 per 1000), respiratory medicines (91.2 per 1000), acid-suppressing medicines in children <1 year (47.2 per 1000), antidepressants in children 12-17 years (40.3 per 1000) and psychostimulants in children 6-11 years (27.0 per 1000). We identified 12.2% of dispensings as off-label based on age, but 66.3% of these had age-specific dosing recommendations in the AMH CDC. Among children <1 year, off-label dispensings were commonly acid-suppressing medicines (35.5%) and topical hydrocortisone (33.1%); in children 6-11 years, off-label prescribing of clonidine (16.0%) and risperidone (13.1%) was common. Off-label dispensings were more likely to be prescribed by a specialist (21.7%) than on-label dispensings (7.5%). CONCLUSIONS: Prescribed medicine use is common in children, with off-label dispensings for medicines without paediatric-specific dosing guidelines concentrated in classes such as acid-suppressing medicines and psychotropics. Our findings highlight a need for better evidence to support best-practice prescribing.
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Antibacterianos , Uso Off-Label , Austrália/epidemiologia , Criança , Humanos , Lactente , Padrões de Prática Médica , PrevalênciaRESUMO
AIM: In May 2019, Australia's Pharmaceutical Benefits Scheme (PBS) tightened the prescribing restrictions for publicly subsidized high and standard strength proton-pump inhibitors (PPIs). We aimed to determine the impacts on PPI use in Australia. METHODS: Population-based interrupted time series analysis of PBS dispensing claims for a 10% sample of PBS-eligible Australian residents from January 2017 to December 2020 and national prescription and over-the-counter sales to pharmacies from January 2017 to October 2020. We examined trends in monthly PPI dispensings, switches from higher to lower strength formulations, and volume (kg) dispensed and sold. RESULTS: From May 2019, we observed a small, immediate decrease (-7830 [95%CI: -8818 to -6842]) in standard strength PPI dispensings/month, which rebounded to exceed pre-intervention levels by December 2020. High strength dispensings decreased until the end of the study period to less than half their pre-intervention average/month; low strength dispensings/month increased until the end of the study period to more than double their pre-intervention average/month. We observed transient increases in switches to lower strength formulations post-intervention. The kilograms of PPIs sold/month followed a similar pattern to PBS kilograms dispensed/month with the exception of standard strength formulations where PBS dispensings decreased by -74 (95%CI: -93 to -55) but total sales remained unchanged (comprising PBS and private prescriptions, and over-the-counter sales). CONCLUSIONS: Tightened prescribing restrictions had an immediate and sustained impact on PPI use in Australia, with decreased high strength use and increased low strength use. Some patients likely switched to private market prescriptions for standard strength PPI, given the observed patterns in total volume sold/dispensed.
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Medicamentos sem Prescrição , Inibidores da Bomba de Prótons , Austrália , Prescrições de Medicamentos , Humanos , Análise de Séries Temporais Interrompida , Medicamentos sem Prescrição/uso terapêutico , Padrões de Prática Médica , Inibidores da Bomba de Prótons/uso terapêuticoRESUMO
BACKGROUND: P2Y12 inhibitor therapy is recommended for 12 months in patients hospitalised for acute myocardial infarction (AMI) unless the bleeding risk is high. AIMS: To describe real-world use of P2Y12 inhibitor therapy following AMI hospitalisation. METHODS: We used population-level linked hospital data to identify all patients discharged from a public hospital with a primary diagnosis of AMI between July 2011 and June 2013 in New South Wales and Victoria, Australia. We used dispensing claims to examine dispensing of a P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) within 30 days of discharge and multilevel models to identify predictors of post-discharge dispensing and persistence of therapy to 1 year. RESULTS: We identified 31 848 patients hospitalised for AMI, of whom 56.8% were dispensed a P2Y12 inhibitor within 30 days of discharge. The proportion of patients with post-discharge dispensing varied between hospitals (interquartile range: 25.0-56.5%), and significant between-hospital variation remained after adjusting for patient characteristics. Patient factors associated with the lowest likelihood of post-discharge dispensing were: having undergone coronary artery bypass grafting (odds ratio (OR): 0.17; 95% confidence intervals (CI): 0.15-0.20); having oral anticoagulants dispensed 180 days before or 30 days after discharge (OR: 0.39, 95% CI: 0.35-0.44); major bleeding (OR: 0.68, 95% CI: 0.61-0.76); or being aged ≥85 years (OR: 0.68, 95% CI: 0.62-0.75). A total of 26.8% of patients who were dispensed a P2Y12 inhibitor post-discharge discontinued therapy within 1 year. CONCLUSION: Post-hospitalisation use of P2Y12 inhibitor therapy in AMI patients is low and varies substantially by hospital of discharge. Our findings suggest strategies addressing both health system (hospital and physician) and patient factors are needed to close this evidence-practice gap.
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Infarto do Miocárdio , Intervenção Coronária Percutânea , Assistência ao Convalescente , Idoso de 80 Anos ou mais , Humanos , Armazenamento e Recuperação da Informação , Infarto do Miocárdio/induzido quimicamente , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/epidemiologia , Alta do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Cloridrato de Prasugrel/uso terapêutico , Lacunas da Prática Profissional , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Resultado do Tratamento , VitóriaRESUMO
PURPOSE: Cardiac function assessment is important for detecting and managing trastuzumab-associated cardiotoxicity. Our study estimates rates and predictors of cardiac assessment among patients receiving trastuzumab for HER2-positive early breast cancer (HER2+EBC) in Australia. METHODS: We conducted a retrospective cohort study of Australians initiating (neo)adjuvant trastuzumab for HER2+EBC between 1 January 2015 and 15 April 2019. We used administrative claims to determine the number of patients receiving guideline-recommended assessment, i.e. evidence of baseline cardiac assessment (between 120 days before and 30 days after trastuzumab initiation) and regular on-treatment cardiac assessments (at least every 120 days). We examined factors associated with baseline and regular on-treatment cardiac assessment. RESULTS: Our study includes 5621 patients (median age 56 years), of whom 4984 (88.7%) had a baseline cardiac function test. Among 4280 patients with at least 12 months of follow-up, 2702 (63.1%) had guideline-recommended cardiac assessment. Rates of guideline-recommended assessment increased with later year of diagnosis (60.9% in 2015 vs 68.3% in 2018, OR 1.34, 95% CI 1.06-1.69). Patients with higher baseline comorbidities and greater socioeconomic disadvantage were less likely to have guideline-recommended cardiac assessment. Cardiac assessment practices varied by State/Territory. There was no association between baseline cardiac risk or anthracycline use and the likelihood of receiving guideline-recommended cardiac assessment. CONCLUSION: The majority of patients receiving (neo)adjuvant trastuzumab had guideline-recommended baseline and on-treatment cardiac assessment. Variations in cardiac assessment predominantly related to system-level factors, such as year of diagnosis and geography, rather than individual patient factors.
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Neoplasias da Mama , Austrália/epidemiologia , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/epidemiologia , Quimioterapia Adjuvante , Feminino , Humanos , Pessoa de Meia-Idade , Receptor ErbB-2/genética , Estudos Retrospectivos , Trastuzumab/efeitos adversosRESUMO
BACKGROUND: Interrupted time series analysis is increasingly used to evaluate the impact of large-scale health interventions. While segmented regression is a common approach, it is not always adequate, especially in the presence of seasonality and autocorrelation. An Autoregressive Integrated Moving Average (ARIMA) model is an alternative method that can accommodate these issues. METHODS: We describe the underlying theory behind ARIMA models and how they can be used to evaluate population-level interventions, such as the introduction of health policies. We discuss how to select the shape of the impact, the model selection process, transfer functions, checking model fit, and interpretation of findings. We also provide R and SAS code to replicate our results. RESULTS: We illustrate ARIMA modelling using the example of a policy intervention to reduce inappropriate prescribing. In January 2014, the Australian government eliminated prescription refills for the 25 mg tablet strength of quetiapine, an antipsychotic, to deter its prescribing for non-approved indications. We examine the impact of this policy intervention on dispensing of quetiapine using dispensing claims data. CONCLUSIONS: ARIMA modelling is a useful tool to evaluate the impact of large-scale interventions when other approaches are not suitable, as it can account for underlying trends, autocorrelation and seasonality and allows for flexible modelling of different types of impacts.
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Antipsicóticos , Modelos Estatísticos , Austrália , Previsões , Humanos , Análise de Séries Temporais Interrompida , Projetos de PesquisaRESUMO
OBJECTIVE: To examine relationships between changing general practitioner after entering residential aged care and overall medicines prescribing (including polypharmacy) and that of psychotropic medicines in particular. DESIGN: Retrospective data linkage study. SETTING, PARTICIPANTS: 45 and Up Study participants in New South Wales with dementia who were PBS concession card holders and entered permanent residential aged care during January 2010 - June 2014 and were alive six months after entry. MAIN OUTCOME MEASURES: Inverse probability of treatment-weighted numbers of medicines dispensed to residents and proportions of residents dispensed antipsychotics, benzodiazepines, and antidepressants in the six months after residential care entry, by most frequent residential care GP category: usual (same as during two years preceding entry), known (another GP, but known to the resident), or new GP. RESULTS: Of 2250 new residents with dementia (mean age, 84.1 years; SD, 7.0 years; 1236 women [55%]), 625 most frequently saw their usual GPs (28%), 645 saw known GPs (29%), and 980 saw new GPs (44%). The increase in mean number of dispensed medicines after residential care entry was larger for residents with new GPs (+1.6 medicines; 95% CI, 1.4-1.9 medicines) than for those attended by their usual GPs (+0.7 medicines; 95% CI, 0.4-1.1 medicines; adjusted rate ratio, 2.42; 95% CI, 1.59-3.70). The odds of being dispensed antipsychotics (adjusted odds ratio [aOR], 1.59; 95% CI, 1.18-2.12) or benzodiazepines (aOR, 1.69; 95% CI, 1.25-2.30), but not antidepressants (aOR, 1.32; 95% CI, 0.98-1.77), were also higher for the new GP group. Differences between the known and usual GP groups were not statistically significant. CONCLUSIONS: Increases in medicine use and rates of psychotropic dispensing were higher for people with dementia who changed GP when they entered residential care. Facilitating continuity of GP care for new residents and more structured transfer of GP care may prevent potentially inappropriate initiation of psychotropic medicines.
Assuntos
Demência/tratamento farmacológico , Clínicos Gerais/estatística & dados numéricos , Instituição de Longa Permanência para Idosos/estatística & dados numéricos , Polimedicação , Psicotrópicos/provisão & distribuição , Idoso , Idoso de 80 Anos ou mais , Antidepressivos/provisão & distribuição , Antidepressivos/uso terapêutico , Antipsicóticos/provisão & distribuição , Antipsicóticos/uso terapêutico , Benzodiazepinas/provisão & distribuição , Benzodiazepinas/uso terapêutico , Feminino , Humanos , Prescrição Inadequada/prevenção & controle , Prescrição Inadequada/estatística & dados numéricos , Masculino , New South Wales/epidemiologia , Psicotrópicos/uso terapêutico , Estudos RetrospectivosRESUMO
PURPOSE: Opioids provide effective analgesia for most cancer patients, but little is known about individual-level opioid use after cancer diagnosis. We examined the patterns of and factors associated with opioid use in older people diagnosed with cancer. METHODS: We used the Department of Veterans' Affairs (DVA) client data linked with the New South Wales (NSW) Cancer Registry and the Repatriation Pharmaceutical Benefits Scheme data. We included people aged ≥65 years diagnosed with cancer in NSW, Australia in 2005 to 2015. We examined patterns of opioid use in the 12 months after cancer diagnosis and used cause-specific hazards models to examine factors associated with opioid use. RESULTS: Of 13 527 people diagnosed with cancer, 51% were dispensed opioids after their diagnosis. We observed the highest proportions of use in people diagnosed with pancreas, liver, or lung cancers. Opioid use was associated with female sex, younger age, more advanced degree of cancer spread, opioid use before cancer diagnosis, and multimorbidity. Forty-four percentages of all people dispensed opioids had a history of opioid use in the 12 months before their cancer diagnosis; these people had higher median number of different opioids and opioid dispensings, and a shorter time to first opioid dispensing than opioid-naive people. CONCLUSION: Our study suggests that many older cancer patients were dispensed opioids before their cancer diagnosis. Previously opioid-treated people had more intense opioid use patterns after diagnosis than opioid-naïve people. Acknowledging the history of opioid use is important as it may complicate pain treatment in clinical practice.
Assuntos
Analgésicos Opioides , Neoplasias , Idoso , Analgésicos Opioides/uso terapêutico , Austrália , Prescrições de Medicamentos , Feminino , Humanos , Neoplasias/tratamento farmacológico , Neoplasias/epidemiologia , New South Wales/epidemiologia , Padrões de Prática MédicaRESUMO
An amendment to this paper has been published and can be accessed via a link at the top of the paper.
RESUMO
Following the 2013 public subsidy of pregabalin in Australia for neuropathic pain not responding to other medicines, use and misuse increased substantially. We used pharmaceutical dispensing claims for a 10% sample of Australians to quantify initiation, discontinuation and dispensing of other analgesics before and after initiation. We identified 130 770 people initiating pregabalin between 2013/14 and 2017/18 (median age: 61 years; 56.8% female). Discontinuation rates at 1-year increased from 77.0% in 2013/14 to 85.9% in 2017/18; 38% only had 1 dispensing. Approximately 1/3 (37.5%) initiated on the lowest strength capsule (25 mg) with only 31.2% later up-titrating to a higher strength. 47.4% and 53.0% were dispensed opioids within 180 days before and after pregabalin initiation, respectively. Many individuals are using pregabalin for short treatment durations and low dose ranges not consistent with treatment of neuropathic pain, which is generally a chronic condition. This may suggest poorer tolerability than observed in clinical trials, or use for other conditions, some of which may be for indications where the balance of benefits and risk is less clear.