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Background: Varenicline, bupropion and nicotine replacement therapy (NRT) are three effective pharmacotherapies for smoking cessation, but data about their safety in pregnancy are limited. We assessed the risk of adverse perinatal outcomes and major congenital anomalies associated with the use of these therapies in pregnancy in Australia.Methods: Perinatal data for 1,017,731 deliveries (2004 to 2012) in New South Wales and Western Australia were linked to pharmaceutical dispensing, hospital admission and death records. We identified 97,875 women who smoked during pregnancy; of those, 233, 330 and 1057 were exposed to bupropion, NRT and varenicline in pregnancy, respectively. Propensity scores were used to match exposed women to those who were unexposed to any smoking therapy (1:10 ratio). Propensity scores and gestational age at exposure were used to match varenicline-exposed to NRT-exposed women (1:1 ratio). Time-dependent Cox proportional hazards models estimated hazard ratios (HR) with 95% confidence intervals (95% CI) for any adverse perinatal event (a composite of 10 unfavourable maternal and neonatal outcomes) and any major congenital anomaly.Results: The risk of any adverse perinatal event was not significantly different between bupropion-exposed and unexposed women (39.2% versus 39.3%, HR 0.93, 95% CI 0.73-1.19) and between NRT-exposed and unexposed women (44.8% vs 46.3%, HR 1.02, 95% CI 0.84-1.23), but it was significantly lower in women exposed to varenicline (36.9% vs 40.1%, HR 0.86, 95% CI 0.77-0.97). Varenicline-exposed infants were less likely than unexposed infants to be born premature (6.5% vs 8.9%, HR 0.72, 95% CI 0.56-0.92), be small for gestational age (11.4% vs 15.4%, HR 0.68, 95% CI 0.56-0.83) and have severe neonatal complications (6.6% vs 8.2%, HR 0.74, 95% CI 0.57-0.96). Among infants exposed to varenicline in the first trimester, 2.9% had a major congenital anomaly (3.5% in unexposed infants, HR 0.91, 95% CI 0.72-1.15). Varenicline-exposed women were less likely than NRT-exposed women to have an adverse perinatal event (38.7% vs 51.4%, HR 0.58, 95% CI 0.33-1.05).Conclusions: Pregnancy exposure to smoking cessation pharmacotherapies does not appear to be associated with an increased risk of adverse birth outcomes. Lower risk of adverse birth outcomes in varenicline-exposed pregnancies is inconsistent with recommendations that NRT be used in preference to varenicline. [ABSTRACT FROM AUTHOR]

Introduction: The principal aim of this study was to assess the accessibility of subsidized cessation medications to socioeconomically disadvantaged smokers, including smokers living in regional and remote communities.Methods: Analyses used baseline questionnaire and linked Pharmaceutical Benefits Scheme data for 18 686 regular smokers participating in the 45 and Up Study, a large-scale Australian cohort study of people aged 45 years and older. Participants who were dispensed nicotine replacement therapy, varenicline, or bupropion were identified from the Pharmaceutical Benefits Scheme data, which provide an essentially complete record of participants' access to subsidized pharmaceuticals. Associations between the supply of each pharmacotherapy and a range of sociodemographic and health-related variables were evaluated using multiple logistic regression.Results: The odds that participants were supplied with a cessation medication declined markedly with increasing age for participants older than 60 years and were substantially higher for participants who smoked 20 or more cigarettes/day than for participants who smoked fewer than 10 cigarettes/day. Participants with no formal qualification and those residing in socioeconomically disadvantaged areas had higher odds of receiving nicotine replacement therapy or varenicline than university-educated participants and participants living in the least disadvantaged areas. There was no evidence that participants residing in regional and remote communities had lower odds of receiving a cessation medication than participants residing in major cities.Conclusions: Older Australian smokers' access to cessation pharmacotherapies is determined predominantly by age and daily cigarette consumption and does not appear to be limited by educational achievement, socioeconomic disadvantage, or remoteness.Implications: Promoting the use of cessation medications is a principal measure proposed to achieve Australia's National Tobacco Strategy 2012-2018 goal of reducing cigarette consumption among socioeconomically disadvantaged smokers. The results of this large-scale cohort study indicate that access to cessation pharmacotherapies is determined primarily by age and daily cigarette consumption, and is not limited by socioeconomic circumstances, providing some reassurance that existing government subsidies are sufficient to ensure that pharmaceutical aids are accessible to all Australian smokers. [ABSTRACT FROM AUTHOR]

Background Prevalence studies usually depend on self-report of disease status in survey data or administrative data collections and may over- or under-estimate disease prevalence. The establishment of a linked data collection provided an opportunity to explore the accuracy and completeness of capture of information about diabetes in survey and administrative data collections. Methods Baseline questionnaire data at recruitment to the 45 and Up Study was obtained for 266,848 adults aged 45 years and over sampled from New South Wales, Australia in 2006-2009, and linked to administrative data about hospitalisation from the Admitted Patient Data Collection (APDC) for 2000-2009, claims for medical services (MBS) and pharmaceuticals (PBS) from Medicare Australia data for 2004-2009. Diabetes status was determined from response to a question 'Has a doctor EVER told you that you have diabetes' (n = 23,981) and augmented by examination of free text fields about diagnosis (n = 119) or use of insulin (n = 58). These data were used to identify the sub-group with type 1 diabetes. We explored the agreement between self-report of diabetes, identification of diabetes diagnostic codes in APDC data, claims for glycosylated haemoglobin (HbA1c) in MBS data, and claims for dispensed medication (oral hyperglycaemic agents and insulin) in PBS data. Results Most participants with diabetes were identified in APDC data if admitted to hospital (79.3%), in MBS data with at least one claim for HbA1c testing (84.7%; 73.4% if 2 tests claimed) or in PBS data through claim for diabetes medication (71.4%). Using these alternate data collections as an imperfect 'gold standard' we calculated sensitivities of 83.7% for APDC, 63.9% (80.5% for two tests) for MBS, and 96.6% for PBS data and specificities of 97.7%, 98.4% and 97.1% respectively. The lower sensitivity for HbA1c may reflect the use of this test to screen for diabetes suggesting that it is less useful in identifying people with diabetes without additional information. Kappa values were 0.80, 0.70 and 0.80 for APDC, MBS and PBS respectively reflecting the large population sample under consideration. Compared to APDC, there was poor agreement about identifying type 1 diabetes status. Conclusions Self-report of diagnosis augmented with free text data indicating diabetes as a chronic condition and/or use of insulin among medications used was able to identify participants with diabetes with high sensitivity and specificity compared to available administrative data collections. [ABSTRACT FROM AUTHOR]