Long-term prescribed opioid use after hospitalization or emergency department presentation among opioid naïve adults (2014-2020)-A population-based descriptive cohort study.

AIMS: The aim of this work is to describe opioid initiation and long-term use after emergency department (ED) visits or hospitalizations in New South Wales, Australia, by patient, admission and clinical characteristics. METHODS: This is a population-based cohort study, including all hospitalizations and ED visits between 2014 and 2020, linked to medicine dispensings, deaths and cancer registrations (Medicines Intelligence Data Platform), among adults with no opioid dispensings in the previous year. Outcome measures were opioid initiations (dispensed within 7 days of discharge) and long-term use (90 days of continuous exposure, 90-270 days after initiation). RESULTS: The cohort included 16 153 096 admissions by 4.2 million opioid-naïve adults; 39.0% were ED presentations without hospital admission, 16.8% hospital admissions via ED and 44.2% direct hospital admissions. Opioids were initiated post-discharge for 6.2% of ED, 8.3% of hospital via ED and 10.0% of direct hospital admissions; of these 1.0%, 2.5% and 0.5% progressed to long-term opioid use, respectively. Initiation was lowest in obstetric admissions without surgery (1.0%), and highest among trauma admissions (25.4%), obstetric admissions with surgical intervention (19.8%) and non-trauma surgical admissions (12.0%). Long-term use was highest among medical admissions via ED (3.5%), trauma admissions (2.3%) and ED alone (1.0%). From 2014 to 2020, overall opioid initiations decreased 16% from 8.7% to 7.2%, and long-term opioid use decreased 33% from 1.3% to 0.8%. CONCLUSIONS: Both opioid initiation and long-term use decreased over time; however, the higher rates of long-term use following trauma, and medical admissions via ED, warrant further surveillance. Strategies supporting appropriate prescribing and access to multidisciplinary pain services will facilitate best practice care.

A cluster randomized controlled trial of a MedicineInsight Educational Quality Improvement Programme to improve the diagnosis and treatment of chronic hepatitis C in general practice (the EQUIP-HEPC trial).

The availability of direct-acting antivirals (DAAs) sparked efforts to eliminate hepatitis C virus (HCV) in Australia. We evaluated whether an educational intervention of a 1-h discussion among staff using audit and feedback data from the MedicineInsight GP programme would improve DAA uptake. Of 296 eligible general practices in MedicineInsight, 11% opted out. Randomization stratified by practice caseload allocated 130 practices to the intervention arm and 129 to control. The primary outcome was the number of patients started on DAAs over 6 months using the negative binomial regression model adjusted for DAA prescription history and clustering by practice. Data for analysis were available for 78% of practices, which included 101 practices and 2469 DAA-naive patients with confirmed/possible HCV in the intervention arm, and 100 practices and 2466 patients in the control arm. At baseline, 49.5% of practices had prescribed ≥1 DAA in the past year; 18.9% of HCV patients had already been treated with DAAs; the mean age of DAA-naive HCV patients was 43 years old, and 57% were men. Over 6 months, 43 patients in the intervention arm and 36 in the control arm started DAAs (adjusted IRR 1.19; 95% CI 0.67-2.11, p = 0.55). In the first 3 months, 27 vs 16 patients started DAAs (adjusted IRR 1.77, 0.88-3.58; p = 0.111). Few patients were started on DAAs, and a facilitated discussion in HCV management did not lead to a significant increase. Alternative measures, such as incentivizing GP initiations or patients, are suggested to address remaining barriers to DAA uptake in Australian primary care. Australian New Zealand Clinical Trial Registry (ANZCTR) Registration Number: ACTRN12619000508178p.

Utilisation of pre-exposure prophylaxis (PrEP) for HIV prevention in the Australian general practice setting: a longitudinal observational study.

BACKGROUND: Pre-exposure prophylaxis (PrEP) became available through the Australian Pharmaceutical Benefits Scheme (PBS) on 1 April 2018 for HIV infection prevention in patients ≥18years at medium-to-high HIV risk. The aims were to investigate PrEP utilisation in general practice since PBS listing, and factors associated with discontinuation. METHODS: This longitudinal study included patients aged 18-74years attending general practices participating in MedicineInsight, a large-scale national primary care database of deidentified electronic health records, between October 2017 and September 2019. RESULTS: PrEP utilisation increased 10-fold following PBS listing. On average, patients had 9.7 PrEP prescriptions per year; a medication possession ratio of 80.8%. Of 1552 patients prescribed PrEP from April 2018, most were male (98.3%), aged 18-39years (59.3%), resided in major cities (86.7%) and in the two most socioeconomically advantaged quintiles (70.0%). Almost half (49.1%) of the patients were identified as new to PrEP. At study end, 65.1% were on active PrEP (16.5%, of whom had non-continuous use), 19.2% had discontinued PrEP and 15.7% were lost to follow up. Patients who discontinued were more likely to attend low rather than high PrEP caseload practices (adjusted odds ratio [aOR] 1.7; 95% CI: 1.0-2.8; P =0.047). The odds of non-continuous therapy was 2.9-fold higher in patients with bipolar disorder (aOR 2.89; 95% CI: 1.10-7.6; P =0.045). CONCLUSIONS: Following PBS listing, PrEP utilisation increased and stopping therapy was associated with attending low caseload practices. General practice education, particularly among low caseload practices, could help address these disparities.

Validity of algorithms for identifying five chronic conditions in MedicineInsight, an Australian national general practice database.

BACKGROUND: MedicineInsight is a database containing de-identified electronic health records (EHRs) from over 700 Australian general practices. It is one of the largest and most widely used primary health care EHR databases in Australia. This study examined the validity of algorithms that use information from various fields in the MedicineInsight data to indicate whether patients have specific health conditions. This study examined the validity of MedicineInsight algorithms for five common chronic conditions: anxiety, asthma, depression, osteoporosis and type 2 diabetes. METHODS: Patients' disease status according to MedicineInsight algorithms was benchmarked against the recording of diagnoses in the original EHRs. Fifty general practices contributing data to MedicineInsight met the eligibility criteria regarding patient load and location. Five were randomly selected and four agreed to participate. Within each practice, 250 patients aged ≥ 40 years were randomly selected from the MedicineInsight database. Trained staff reviewed the original EHR for as many of the selected patients as possible within the time available for data collection in each practice. RESULTS: A total of 475 patients were included in the analysis. All the evaluated MedicineInsight algorithms had excellent specificity, positive predictive value, and negative predictive value (above 0.9) when benchmarked against the recording of diagnoses in the original EHR. The asthma and osteoporosis algorithms also had excellent sensitivity, while the algorithms for anxiety, depression and type 2 diabetes yielded sensitivities of 0.85, 0.89 and 0.89 respectively. CONCLUSIONS: The MedicineInsight algorithms for asthma and osteoporosis have excellent accuracy and the algorithms for anxiety, depression and type 2 diabetes have good accuracy. This study provides support for the use of these algorithms when using MedicineInsight data for primary health care quality improvement activities, research and health system policymaking and planning.

Prevalence, incidence and management of atopic dermatitis in Australian general practice using routinely collected data from MedicineInsight.

BACKGROUND/OBJECTIVES: The prevalence of atopic dermatitis (AD) has increased significantly in industrialised countries in recent decades but data about the incidence or prevalence of AD in Australia are sparse. We aimed to determine the prevalence and incidence of AD among patients seen in Australian general practice and the use of specified medicines. METHODS: This was a cross-sectional study of 2.1 million patients attending 494 general practices in the MedicineInsight program from 1 January 2017 to 31 December 2018. We assessed the prevalence (lifetime and current), incidence, management and severity of AD. RESULTS: The lifetime (ever diagnosed) prevalence of AD in this general practice population was 16.4% and was greater in females (17.3%) than males (15.3%). One in five patients with AD were classified as having moderate-to-severe disease. Prevalence over the last two years was 6.3%. The incidence of AD in 2018 was 2.0% and was greater in females (2.2%) and for patients aged 0-4 years (3.9%). Patients with AD had an increased risk of insomnia, anxiety and depression, compared to those with no recorded AD. For AD patients, topical corticosteroids were the most commonly prescribed AD medication (36.5%) and topical calcineurin inhibitors the least (0.1%), with systemic corticosteroids (15.6%) more commonly prescribed than other immunosuppressants (0.9%). CONCLUSIONS: Our findings provide important insights into the epidemiology of AD and its management in Australian general practice. This information is likely to be useful in planning effective interventions to support GPs in the optimal management of patients with AD.

Statin use in cancer survivors versus the general population: cohort study using primary care data from the UK clinical practice research datalink.

BACKGROUND: Cancer survivors may be at increased risk of cardiovascular diseases, but little is known about whether prescribing guidelines for the primary prevention of cardiovascular disease are adequately implemented in these patients. We compared levels of statin initiation and cessation among cancer survivors compared to the general population to determine differences in uptake of pharmaceutical cardiovascular risk prevention measures in these groups. METHODS: The study population included individuals aged ≥40 during 2005-13 within the UK Clinical Practice Research Datalink primary care database. Within this population we identified cancer survivors who were alive and under follow-up at least 1 year after diagnosis, and controls with no cancer history. Follow-up time prior to cancer diagnosis was included in the control cohort. Using logistic regression, we compared these groups with respect to uptake of statins within 1 month of a first high recorded cardiovascular risk score. Then, we used Cox modelling to compare persistence on statin therapy (time to statin cessation) between cancer survivors and controls from the main study population who had initiated on a statin. RESULTS: Among 4202 cancer survivors and 113,035 controls with a record indicating a high cardiovascular risk score, 23.0% and 23.5% respectively initiated a statin within 1 month (adjusted odds ratio 0.98 [91.8-1.05], p = 0.626). Cancer survivors appeared more likely to discontinue statin treatment than controls (adjusted hazard ratio 1.07 [1.01-1.12], p = 0.02). This greater risk of discontinuing was only evident after the first year of therapy (p-interaction < 0.001). INTERPRETATION: Although cardiovascular risk is thought to be higher in cancer survivors compared to the general population, cancer survivors were no more likely to receive statins, and marginally more likely to cease long-term therapy, than general population controls. There may be an opportunity to mitigate the suspected higher cardiovascular risk in the growing population of cancer survivors by improving uptake of lipid-lowering treatment and persistence on therapy.

Trends in use of medicines for opioid agonist treatment in Australia, 2013-2022.

BACKGROUND: There are limited longitudinal data on national patterns of opioid agonist treatment (OAT). This study describes 10-year trends in the sales of OAT medicines in Australia. METHODS: A descriptive and time-series analysis of methadone, sublingual (SL) buprenorphine (+/-naloxone), and long-acting injectable (LAI) buprenorphine sold in Australia between 2013 and 2022 was performed. Total units sold were converted into an estimate of the number of clients that could be treated over a 28-day period with that amount of medicine ('client-months'). RESULTS: Between January 2013 and December 2022, the estimated number of client-months on: any OAT increased by 50 % to 53,501, methadone decreased (-8.5%), SL buprenorphine increased (+78%), and LAI buprenorphine increased substantially after September 2019. In January 2013, 78 % of OAT client-months received methadone. By December 2022, 48 % received methadone, 26 % SL buprenorphine, and 26 % LAI buprenorphine. Between 2013 to 2022, OAT client-months per capita were highest in the state of New South Wales. Over the study period, greater increases in OAT were observed in very remote areas (88%) compared to major cities (53%). The number of client-months in non-community pharmacy settings remained stable from 2013 to 2019/20, before increasing markedly. The introduction of LAI buprenorphine was associated with an immediate, sustained increase of 1,636 OAT client-months, and further increases of 190 OAT client-months each month. CONCLUSION: Patterns of OAT have shifted over the last 10-years with buprenorphine (SL/LAI) now the most common OAT used in Australia. The introduction of LAI buprenorphine has expanded OAT access, particularly in non-community pharmacy settings, and in remote areas.

Agreement of acute serious events recorded across datasets using linked Australian general practice, hospital, emergency department and death data: implications for research and surveillance.

Introduction: Understanding the level of recording of acute serious events in general practice electronic health records (EHRs) is critical for making decisions about the suitability of general practice datasets to address research questions and requirements for linking general practice EHRs with other datasets. Objectives: To examine data source agreement of five serious acute events (myocardial infarction, stroke, venous thromboembolism (VTE), pancreatitis and suicide) recorded in general practice EHRs compared with hospital, emergency department (ED) and mortality data. Methods: Data from 61 general practices routinely contributing data to the MedicineInsight database was linked with New South Wales administrative hospital, ED and mortality data. The study population comprised patients with at least three clinical encounters at participating general practices between 2019 and 2020 and at least one record in hospital, ED or mortality data between 2010 and 2020. Agreement was assessed between MedicineInsight diagnostic algorithms for the five events of interest and coded diagnoses in the administrative data. Dates of concordant events were compared. Results: The study included 274,420 general practice patients with at least one record in the administrative data between 2010 and 2020. Across the five acute events, specificity and NPV were excellent (>98%) but sensitivity (13%-51%) and PPV (30%-75%) were low. Sensitivity and PPV were highest for VTE (50.9%) and acute pancreatitis (75.2%), respectively. The majority (roughly 70-80%) of true positive cases were recorded in the EHR within 30 days of administrative records. Conclusion: Large proportions of events identified from administrative data were not detected by diagnostic algorithms applied to general practice EHRs within the specific time period. EHR data extraction and study design only partly explain the low sensitivities/PPVs. Our findings support the use of Australian general practice EHRs linked to hospital, ED and mortality data for robust research on the selected serious acute conditions.

Evaluating the accuracy of data extracted from electronic health records into MedicineInsight, a national Australian general practice database.

Introduction: MedicineInsight is a database containing de-identified electronic health records (EHRs) from over 700 Australian general practices. Previous research validated algorithms used to derive medical condition flags in MedicineInsight, but the accuracy of data fields following EHR extractions from clinical practices and data warehouse transformation processes have not been formally validated. Objectives: To examine the accuracy of the extraction and transformation of EHR fields for selected demographics, observations, diagnoses, prescriptions, and tests into MedicineInsight. Methods: We benchmarked MedicineInsight values against those recorded in original EHRs. Forty-six general practices contributing data to MedicineInsight met our eligibility criteria, eight were randomly selected, and four agreed to participate. We randomly selected 200 patients >18 years of age within each participating practice from MedicineInsight. Trained staff reviewed the original EHRs for the selected patients and recorded data from the relevant fields. We calculated the percentage of agreement (POA) between MedicineInsight and EHR data for all fields; Cohen's Kappa for categorical and intra-class correlation (ICC) for continuous measures; and sensitivity, specificity, and positive and negative predictive values (PPV/NPV) for diagnoses. Results: A total of 796 patients were included in our analysis. All demographic characteristics, observations, diagnoses, prescriptions and random pathology test results had excellent (>90%) POA, Kappa, and ICC. POA for most recent pathology/imaging test was moderate (81%, [95% CI: 78% to 84%]). Sensitivity, specificity, PPV, and NPV were excellent (>90%) for all but one of the examined diagnoses which had a poor PPV. Conclusions: Overall, our study shows good agreement between the majority of MedicineInsight data and those from original EHRs, suggesting MedicineInsight data extraction and warehousing procedures accurately conserve the data in these key fields. Discrepancies between test data may have arisen due to how data from pathology, radiology and other imaging providers are stored in EHRs and MedicineInsight and this requires further investigation.

Characteristics of patients aged 50–74 years with a request for an immunochemical faecal occult blood test in the Australian general practice setting.

Objective To support improving participation in the National Bowel Cancer Screening Program (NBCSP), we aimed to identify Medicare-subsidised test requests for immunochemical faecal occult blood tests (FOBT) in Australian general practice for patients aged 50-74 years, eligible for the NBCSP, and describe sociodemographics, risk factors, indications and outcomes. Methods A cross-sectional study was conducted using de-identified data from 441 Australian general practice sites in the MedicineInsight database, recorded from 1 January 2018 to 31 December 2019. Results Of the 683 625 eligible patients, 45 771 (6.7%) had a record of a general practitioner (GP)-requested FOBT, either to aid diagnosis in symptomatic patients, or for screening; 144 986 (21.2%) patients had only an NBCSP FOBT. A diagnosis of polyps, gastrointestinal inflammatory condition or haemorrhoids, or a referral to a gastroenterologist or general surgeon, was more commonly recorded in the 6 months after a GP-requested FOBT than after an NBCSP FOBT. Uptake of NBCSP FOBTs was lower among those with obesity, high alcohol consumption and current smokers, who are at higher risk of bowel cancer. Conclusions This study describes the patient characteristics, reasons and outcomes associated with GP-requested FOBTs, identifies under-screened population sub-groups, and suggests involvement of GPs to improve participation in the NBCSP.

Prevalence of inflammatory bowel disease in the Australian general practice population: A cross-sectional study.

The burden of inflammatory bowel disease (IBD) in Australia is increasing but national data about the current prevalence are limited. We aimed to estimate the prevalence of IBD (including Crohn's disease, ulcerative colitis and unspecified IBD) as well as Crohn's disease and ulcerative colitis separately in a general practice population in Australia. We also assessed risk factors associated with Crohn's disease and ulcerative colitis. We conducted a cross-sectional study using data from MedicineInsight, a national database of general practice electronic health records, from 1 July 2017 to 30 June 2019. The prevalence of IBD was calculated and stratified by sociodemographic characteristics. Logistic regression analysis was conducted to assess risk factors associated with Crohn's disease and ulcerative colitis. The study comprised 2,428,461 regular patients from 481 practices. The estimated crude prevalence of IBD was 653 per 100,000 patients; Crohn's disease was 306 per 100,000 and ulcerative colitis was 334 per 100,000. Males were independently associated with a lower risk of Crohn's disease (OR: 0.86; 95% CI: 0.81, 0.90) but a greater risk of ulcerative colitis (OR: 1.12; 95% CI: 1.06, 1.17) than females. Compared to non-smokers, patients who were current smokers were associated with a greater risk of Crohn's disease (OR: 1.13; 95% CI: 1.04, 1.23) but a lower risk of ulcerative colitis (OR: 0.52; 95% CI: 0.47, 0.57). Other factors positively associated with both Crohn's disease and ulcerative colitis were age (≥ 25 years), non-Indigenous status and socioeconomic advantage. Our findings provide a current estimate of the prevalence of IBD, Crohn's disease and ulcerative colitis in a large national general practice population in Australia and an assessment of the factors associated with Crohn's disease and ulcerative colitis. These data can assist in estimating the health burden and costs, and planning for health services.

Exploring the physical health of patients with severe or long-term mental illness using routinely collected general practice data from MedicineInsight.

BACKGROUND AND OBJECTIVES: Australian information on the physical health of general practice patients with a mental illness is limited. The aim of this study was to explore the physical health of patients with a severe and/or long-term mental illness (SMI). METHOD: Analysis was performed of routinely collected data from patients visiting one of 452 general practice sites participating in the national MedicineInsight program during 2017-18. RESULTS: Of the 173,861 participants, 9.1% had recorded SMI. Almost three-quarters had a record of the selected long-term physical health conditions, compared with half of patients without recorded SMI (adjusted odds ratio: 2.2, 95% confidence interval: 2.1, 2.3). Patients with SMI were also more likely to have a history of smoking or moderate-to-heavy drinking. DISCUSSION: More patients with SMI had records of the investigated health conditions than those without SMI. They also had higher rates of modifiable risk factors. As patients with SMI are likely to visit their general practitioners often, this presents an opportunity for intervention that may improve patient outcomes.

Pregabalin prescribing patterns in Australian general practice, 2012-2018: a cross-sectional study.

BACKGROUND: In 2013 pregabalin was subsidised by Australia's Pharmaceutical Benefits Scheme (PBS) for neuropathic pain. Since the subsidy, pregabalin prescribing has been increasing in Australia and so has related harm. There are concerns it is being prescribed for indications other than neuropathic pain, which have little evidence of efficacy. AIM: To describe pregabalin prescribing in Australian general practice. DESIGN & SETTING: A cross-sectional study of patients attending 445 general practice sites in the national MedicineInsight database from March 2012-February 2018. METHOD: The following aspects were calculated: the proportion of prescriptions that were for pregabalin per year; the prevalence of pain conditions in patients prescribed pregabalin; and same-day prescribing of pregabalin with opioids or benzodiazepines. RESULTS: Prescribing increased from 13 per 10 000 to 104 per 10 000 prescriptions between 2012-2013 and 2017-2018. A total of 1 891 623 patients were identified of whom 114 123 (6.0%) were prescribed pregabalin; 49.7% (n = 56 772) had a recorded diagnosis of neuropathic pain. Among people prescribed pregabalin without a recorded diagnosis of neuropathic pain, 43.5% (n = 24 927) had a diagnosis of back problems, 8.8% (n = 5073) chronic pain, and 26.4% (n = 30 146) had no pain diagnosis. Pregabalin was prescribed the same day as an opioid to 38.1% of patients (95% confidence interval [CI] = 37.1% to 39.1%) and a benzodiazepine to 13.1% of patients (95% CI = 12.5% to 13.7%). Patients with a diagnosis of chronic pain had the highest rate of same-day prescribing of pregabalin with an opioid (70.4%, 95% CI = 68.9% to 71.9%) or a benzodiazepine (25.8%, 95% CI = 24.2% to 27.4%) CONCLUSION: Substantial increases in pregabalin prescribing were identified in Australian general practice, but only half of patients had a neuropathic pain diagnosis recorded, the only approved indication for subsidy. High rates of same-day prescribing with opioids and benzodiazepines may put patients at increased risk of harm.

The changing characteristics of patients with chronic hepatitis C prescribed direct acting antiviral medicines in general practice since listing of the medicines on the Australian Pharmaceutical Benefits Scheme.

BACKGROUND AND AIM: The primary objective of this study was to determine whether the characteristics of patients prescribed direct acting antiviral (DAA) medicines have changed since initial listing of the medicines on the Australian Pharmaceutical Benefits Scheme (PBS). METHODS: A cross-sectional study was conducted using data from MedicineInsight, an Australian database of general practice electronic health records, from March 2016 to August 2018. We compared sociodemographic, comorbidity, and clinical characteristics of patients aged at least 18 years who were prescribed at least one DAA in the first 4 months of PBS listing in 2016 with those prescribed at least one DAA in 2018. RESULTS: There were 2251 eligible adult patients prescribed a DAA during the study period, 62% were men and 59% were aged 50 years and older. Patients prescribed DAA medicines initially were older (aged ≥50 years: 67.9% vs 49.3%; P < 0.001), and more likely to have liver cirrhosis (14.2% vs 8.4%; P = 0.01) and an aminotransferase to platelet ratio index (APRI) score >1 (20.4% vs 8.9%; P < 0.001) than those prescribed DAA medicines in 2018. A greater proportion of patients in regional/remote (46.5% vs 35.6%; P < 0.001) and socioeconomically disadvantaged areas (44.4% vs 34.5%; P = 0.003) accessed treatment in 2018 compared with 2016. CONCLUSIONS: Despite evidence of decreasing uptake of DAA medicines across Australia, this study indicates broadened uptake among younger age groups and those residing in regional/remote and socioeconomically disadvantaged areas since 2016. While uptake of DAA medicines in some population subgroups appears to have improved, continuous efforts to improve uptake across the Australian population are essential.

Patterns of real-world opioid prescribing in Australian general practice (2013-18).

Little is known about private-market opioid prescribing and how Australian opioid policies impact prescribing across public and private markets in Australia. We aimed to investigate publicly subsidised and private-market opioid prescribing from 2013 to 2018. We used prescribing records from MedicineInsight, an Australian primary care database, to examine trends in prescriptions for non-injectable opioid formulations from October 2013 to September 2018. We examined annual opioid prescribing trends overall, by opioid agent, and by market (public and private). We further examined patterns of fentanyl patch prescribing focusing on co-prescribed medicines and use in opioid-naïve patients. Opioids accounted for 8% of all prescriptions over the study period and 468 893 patients were prescribed at least one opioid of interest. Prescribing rates for oxycodone/naloxone and tapentadol increased, whereas those for fentanyl patches, morphine and single-agent oxycodone decreased over the study period. Private-market prescribing rates of codeine (schedule 4) increased notably following its up-scheduling to prescription-only status. Among patients prescribed fentanyl patches, 29% were potentially opioid-naïve and 49% were prescribed another opioid on the same day. The private-medicines market is a small but growing component of opioid use in Australia and one way in which prescribers and patients can avoid access restrictions in the public market for these medicines. Although fentanyl patch prescribing declined, there is room for improvement in prescribing fentanyl patches among opioid-naïve patients, and co-prescribing of fentanyl patches with other sedatives.

Cumulative annual coverage of meningococcal B vaccination in Australian general practice for three at-risk groups, 2014 to 2019.

Neisseria meningitidis serogroup B (MenB) is the most common cause of meningococcal disease in adolescents and young adults. In Australia, MenB vaccination has been available through private prescription since 2014 and has been recommended for at-risk groups including adolescents, young adults who smoke and people medically at risk. For each of these at-risk groups, we estimated cumulative annual coverage of MenB vaccination between 2014 and 2019. We also evaluated factors associated with vaccination coverage in 2019. Our analyses used electronic health records in the national MedicineInsight database for people regularly attending general practices. Cumulative vaccination coverage increased among the at-risk groups between 2014 and 2019: from 0.09% to 1.65% for adolescents, from 0.01% to 0.15% for young adults who smoke, and from 0.35% to 12.09% for people medically at risk. However, vaccination coverage in 2019 remained very low across these groups. Data sparsity prevented the evaluation of factors associated with vaccination coverage for smokers. We observed variation in the relative risk of being vaccinated by age, sex, socioeconomic and clinical factors for adolescents and people medically at risk. Still, the absolute magnitude of coverage was low across all subgroups examined, and indicates a need for strategies to increase vaccination uptake among at-risk groups irrespective of patient and practice characteristics. Our study provides baseline data for monitoring menB vaccination uptake among recommended groups in light of limited national data, especially for medically at-risk groups.

Safety of live attenuated herpes zoster vaccine in adults 70-79 years: A self-controlled case series analysis using primary care data from Australia's MedicineInsight program.

BACKGROUND: Australia introduced a funded shingles vaccination program for older adults in November 2016, administered predominantly in primary care clinics. MedicineInsight, a nationally representative primary care database, was used to investigate the risk of pre-specified outcomes following live attenuated herpes zoster vaccine (ZVL) in Australia. METHODS: Individuals aged 70-79 years who received ZVL between 1 November 2016 and 31 July 2018 were identified from MedicineInsight. The self-controlled case series (SCCS) method was used to estimate the seasonally-adjusted relative incidence (RI) of seven pre-specified outcome events (injection site reaction (ISR) [positive control], burn [negative control], myocardial infarction (MI), stroke, rash, rash with an antiviral prescription, and clinical attendance) during a plausible post-vaccination at-risk window compared with times distant from vaccination. Sensitivity analyses examined the effect of common concomitant vaccinations and restriction to first outcome events. RESULTS: A total of 332,988 vaccination encounters among 150,054 individuals were identified during the study period; over 2 million clinical attendances were observed. There was an increased RI of ISR in the seven days following ZVL (RI = 77.4, 95% CI 48.1-124.6); the RI of clinical attendance (RI = 0.94, 95% CI 0.94-0.95) and stroke (RI = 0.58, 95% CI 0.44-0.78) were lower in the 42 days following administration of ZVL compared to control periods. There was no evidence of a change in the RI of MI (RI = 0.74, 95% CI 0.41-1.33), rash (RI = 0.97, 95% CI 0.88-1.08), or rash with antiviral prescription (RI = 0.83, 95% CI 0.62-1.10) in the 42 days following ZVL compared to control periods. CONCLUSION: No new safety concerns were identified for ZVL in this study based on a novel, Australian primary care data source. An expected increased risk of ISR was identified; findings in relation to cardiovascular disease were reassuring but require confirmation using additional data, including hospital records.

Insights into the management of chronic hepatitis C in primary care using MedicineInsight.

BACKGROUND AND OBJECTIVES: Direct-acting antivirals (DAAs) became available for patients with chronic hepatitis C (CHC) in primary care in March 2016, yet not all patients will have undergone pre-treatment assessment. The aim of this study was to assess where patients with CHC are situated in the diagnosis and care continuum, to encourage general practitioners (GPs) to improve pretreatment assessment and increase DAA treatment uptake. METHOD: This was a cross-sectional study of 4025 adult patients with CHC first recorded between 2013 and 2017, using the general practice data program MedicineInsight. RESULTS: Only half of all patients with confirmed CHC had a hepatitis C virus qualitative RNA recorded, and few patients had all recommended pretreatment assessments. The majority had low aspartate aminotransferase to platelet ratio index (APRI) scores. DISCUSSION: Incomplete pretreatment assessment is likely to be a reflection of the recent shift in management of CHC to primary care. The majority of patients have APRI results that suggest cirrhosis is unlikely, and they are potentially suitable for treatment in primary care. This highlights a substantial opportunity for GPs to recall patients for further assessment and treatment.

Single-arm, observational study of the ease of use of a redesigned pen device to deliver recombinant human follicle-stimulating hormone (follitropin alfa) for assisted reproductive technology treatment.

PURPOSE: Evaluation of patients' ease of use of the redesigned, disposable, ready-to-use follitropin alfa pen during controlled ovarian stimulation for assisted reproductive technology. METHODS: This single-center, observational, open-label, single-arm study recruited infertile normo-ovulatory women (aged 18-45 years). Nurses trained patients to self-administer recombinant human follicle-stimulating hormone daily using the follitropin alfa pen (300 IU, 450 IU, and 900 IU). Before treatment, patients completed Questionnaire A. Following self-administered treatment, on stimulation days 5-6 and 7-8 (within a day of receiving recombinant human chorionic gonadotropin), patients completed Questionnaire B. Nurses completed an ease-of-learning/teaching questionnaire. The primary endpoint was proportion of patients rating the pen as "easy/very easy" to use (Questionnaire B) on the final visit before recombinant human chorionic gonadotropin. Secondary endpoints included: proportion of patients rating the follitropin alfa pen as easy to learn, use, prepare, deliver, and dispose of (Questionnaires A and B). Proportions (95% confidence intervals [CIs]) were provided for primary and secondary endpoints. Adverse events were reported descriptively. RESULTS: Eighty-six patients received recombinant human follicle-stimulating hormone. Of the 72 patients who had completed the overall assessment questions, 66 (91.7%; 95% CI =82.7%-96.9%) found the pen "easy" to use. Also, 70/86 (81.4%) patients "strongly agreed/agreed" that, overall, it was easy to learn how to use the pen; 72/86 (83.7%) "strongly agreed/agreed" that easily understandable, verbal information was provided; and 70/86 (81.4%) were confident about using the pen correctly. In total, 24/26 nurses (92.3%; 95% CI =74.9%-99.1%) rated the pen as easy to use. Clinical pregnancy rate/patient/cycle/embryo transfer was 37%. Twenty-six ovarian hyperstimulation syndrome events were reported (none severe; 16 patients [19%]); of these, 13 occurred at embryo transfer. CONCLUSION: In this observational study, patients had a high acceptance of the redesigned follitropin alfa pen, with most finding it very easy/easy to use. Assisted reproductive technology nurses found the pen very easy/easy to teach.