Concurrent use of hormonal long-acting reversible contraception by women of reproductive age dispensed teratogenic medications, Australia, 2013-2021: a retrospective cohort study.

OBJECTIVES: To examine patterns in the dispensing of category X medications (Therapeutic Goods Administration categorisation system for prescribing medicines in pregnancy) to women aged 15-49 years in Australia during 2008-2021, and patterns of concurrent use of hormonal long-acting reversible contraception (LARC) and other hormonal contraception. STUDY DESIGN: Retrospective cohort study; analysis of 10% random sample of national Pharmaceutical Benefits Scheme dispensing data. PARTICIPANTS, SETTING: Women aged 15-49 years dispensed category X medications, Australia, 1 January 2013 - 31 December 2021. MAIN OUTCOME MEASURES: Incident and prevalent dispensing of category X medications, by medication class, age group, and year; contraceptive overlap (proportions of women dispensed hormonal LARC or other hormonal contraception that overlapped the first dispensing of category X medications), by medication class. RESULTS: Among 15 627 women aged 15-49 years dispensed category X medications during 2013-2021, the prevalence of dispensing increased from 4.6 in 2013 to 8.7 per 1000 women aged 15-49 years in 2021; the largest increase was for the dispensing of dermatological agents, from 3.9 to 7.9 per 1000 women aged 15-49 years. LARC overlap was inferred for 2059 women at the time of first dispensing of category X medications (13.2%); 3441 had been dispensed any type of hormonal contraception (22.1%). The proportion with LARC overlap was smallest for those dispensed dermatological agents (1806 of 14 331 women, 12.6%); for this drug class, both LARC overlap (adjusted odds ratio [aOR], 0.17; 95% confidence interval [CI], 0.14-0.20) and any hormonal contraception overlap (aOR, 0.28; 95% CI, 0.25-0.32) were less likely for those aged 15-19 years than for women aged 25-29 years. CONCLUSIONS: Concurrent use of highly effective hormonal contraception at the time of first dispensing of category X medications is low in Australia, raising concerns about potential fetal harms during unintended pregnancies. Awareness of the importance of hormonal contraception and its uptake by women prescribed category X medications should be increased.

The Role of Breastmilk in Macrophage-Tumour Cell Interactions in Postpartum Breast Cancer.

BACKGROUND: Lactation is associated with long-term reduced risk of breast cancer. However, there is a transient increased risk of breast cancer in the 5 to 10 years postpartum and this is associated with a high incidence of metastasis and mortality. Breastmilk is a physiological fluid secreted by the mammary glands intimately connected with breast cells and the microenvironment that may affect postpartum breast cancer development and progression. This study aims to investigate the effect of breastmilk on interactions between breast cancer cells and macrophages in vitro. METHODS: Human breastmilk from healthy donors (n = 7) was pooled and incubated with breast cancer (MCF-7 and MDA-MB-231) and macrophage (RAW264.7) cell lines to assess cell proliferation, viability, migration, and expression of key genes associated with epithelial-mesenchymal transition (EMT) and macrophage phenotype. Indirect co-culture studies assessed the effect of breastmilk on interactions between breast cancer cells and macrophages. RESULTS: Breastmilk increased the proliferation and viability of breast cancer cells, reduced EMT markers, and reduced cell migration in MDA-MB-231 cells. Breastmilk decreased mRNA expression of interleukin 1B (IL1B) and interleukin 10 (IL10) in macrophages. Reduced EMT marker expression was observed in breast cancer cells co-cultured with macrophages pre-treated with breastmilk. Macrophages co-cultured with breast cancer cells pre-treated with breastmilk exhibited increased expression of a pro-inflammatory cytokine tumor necrosis factor A (TNFA) and pro-inflammatory nitric oxide synthase 2 (NOS2), and reduced expression of cytokines IL10 and transforming growth factor B1 (TGFB1) which are associated with the alternatively-activated macrophage phenotype. CONCLUSIONS: Breastmilk has the potential to promote breast cancer proliferation, however, it can also reduce breast cancer progression through inhibition of breast cancer cell migration and regulation of macrophage polarisation. These findings suggest that breastmilk has potential to shape the tumour microenvironment in postpartum breast cancer.

The Effects of Prenatal Iron Supplementation on Offspring Neurodevelopment in Upper Middle- or High-Income Countries: A Systematic Review.

Iron supplementation is commonly recommended for the prevention and treatment of maternal iron deficiency (ID) or iron deficiency anemia (IDA). However, the impacts of prophylactic of therapeutic prenatal iron supplementation on child neurodevelopment in upper middle-income (UMI) and high-income countries (HICs), where broad nutritional deficiencies are less common, are unclear. To investigate this, we conducted a systematic review, searching four databases (Medline, CINAHL, EMBASE, Cochrane Library) through 1 May 2023. Randomized controlled trials (RCTs) assessing oral or intravenous iron supplementation in pregnant women reporting on child neurodevelopment (primary outcome: age-standardized cognitive scores) were eligible. We included three RCTs (five publications) from two HICs (Spain and Australia) (N = 935 children; N = 1397 mothers). Due to clinical heterogeneity of the RCTs, meta-analyses were not appropriate; findings were narratively synthesized. In non-anemic pregnant women, prenatal iron for prevention of IDA resulted in little to no difference in cognition at 40 days post-partum (1 RCT, 503 infants; very low certainty evidence). Similarly, the effect on the intelligence quotient at four years was very uncertain (2 RCTs, 509 children, very low certainty evidence). No RCTs for treatment of ID assessed offspring cognition. The effects on secondary outcomes related to language and motor development, or other measures of cognitive function, were unclear, except for one prevention-focused RCT (302 children), which reported possible harm for children's behavioral and emotional functioning at four years. There is no evidence from UMI countries and insufficient evidence from HICs to support or refute benefits or harms of prophylactic or therapeutic prenatal iron supplementation on child neurodevelopment.

Maternal modifiable factors and risk of congenital heart defects: systematic review and causality assessment.

OBJECTIVE: Primary prevention strategies are critical to reduce the global burden of congenital heart defects (CHDs); this requires robust knowledge of causal agents. We aimed to review associations between CHDs and maternal advanced age, obesity, diabetes, hypertension, smoking and alcohol consumption and assess the causal nature of the associations. DESIGN: Systematic review of reviews with application of a Bradford Hill criteria score-based causal assessment system. DATA SOURCES: We searched PubMed, Embase and Episteminokos (January 1990-April 2023). ELIGIBILITY CRITERIA: Systematic reviews of original epidemiological studies reporting association (relative risk) between one or more of the above maternal factors and CHDs overall (any type) in subsequent offspring. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers selected eligible reviews, assessed the risk of bias and assigned the strength of evidence for causality. RESULTS: There was strong evidence of a causal relationship between CHDs and maternal obesity (prepregnancy and early pregnancy) and pre-existing diabetes (six of seven Bradford Hill criteria met). For pre-existing hypertension (strength and biological gradient not met), and advanced age (strength, consistency and biological gradient not met), causal evidence was moderate. Evidence for the causal contribution of gestational diabetes, gestational hypertension, smoking and alcohol consumption was weak (strength, consistency, temporality and biological gradient not met). CONCLUSIONS: CHDs can be reduced with stronger action to reduce maternal obesity and pre-existing diabetes prevalence. Investigating environmental exposures that have received limited attention, such as air pollutants and chemical exposures, is important to further inform prevention.

Effect of brewer's yeast or beta-glucan on breast milk supply following preterm birth: the BLOOM study - protocol for a multicentre randomised controlled trial.

BACKGROUND: Many individuals who experience preterm birth struggle with early breast milk supply, which can translate into suboptimal longer-term breastfeeding outcomes. Further investigations into the potential role of early non-pharmacological and pharmacological interventions in improving breast milk production soon after birth is growing. While natural galactagogues, such as brewer's yeast, are widely perceived by women to be safer than pharmaceutical galactagogues and are taken by many women, evidence to support their efficacy is largely absent. The BLOOM study has been designed to determine the efficacy and safety of brewer's yeast and beta-glucans, derived from Saccharomyces cerevisiae, when administered soon after birth for increasing early breast milk supply in mothers who have delivered preterm. METHODS: The BLOOM study is a multicentre, double-blinded, randomised controlled trial that will assess if brewer's yeast or beta-glucan can increase early breast milk production following preterm birth. Target population are mothers of preterm infants born at less than 34 weeks' gestation who intend to provide breast milk for their infant, are less than 72 h following birth and able to give informed consent. Participants will be randomly allocated into three parallel groups at 1:1:1 ratio (n = 33 per group) to receive either brewer's yeast, beta-glucan or placebo capsules for seven days. The primary outcome is total expressed breast milk volume over a 24-hour period on day 7 of intervention. Participants and their infants will be followed until the infant reaches term corrected age or is discharged home from the neonatal unit (whichever occurs first). DISCUSSION: The use of brewer's yeast as a galactagogue to enhance milk production is extremely common amongst breastfeeding mothers, however, there are no trials evaluating its efficacy and safety. This will be the first randomised controlled trial to evaluate the efficacy and safety of two commonly used galactagogues, brewer's yeast and beta-glucan, compared with placebo in improving maternal breast milk supply following preterm birth. The trial will also evaluate whether early intervention with galactagogues soon after a preterm birth improves longer-term breastfeeding outcomes. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12622000968774 (registered on 8 July 2022) and UTN U1111-1278-8827.

Urinary Ferritin as a Noninvasive Means of Assessing Iron Status in Young Children.

BACKGROUND: Iron deficiency (ID) is the most common nutritional deficiency affecting young children. Serum ferritin concentration is the preferred biomarker for measuring iron status because it reflects iron stores; however, blood collection can be distressing for young children and can be logistically difficult. A noninvasive means to measure iron status would be attractive to either diagnose or screen for ID in young children. OBJECTIVES: This study aimed to determine the correlation between urinary and serum ferritin concentrations in young children; to determine whether correcting urinary ferritin for creatinine and specific gravity improves the correlation; and to determine a urine ferritin cut point to predict ID. METHODS: Validation study was conducted using paired serum and urine collected from 3-y-old children (n = 142) participating in a longitudinal birth cohort study: the ORIGINS project in Perth, Western Australia. We calculated the sensitivity, specificity, positive, and negative predictive values of urinary ferritin amount in identifying those with ID at the clinical cut point used by the World Health Organization (serum ferritin concentration of <12 ng/mL). RESULTS: Urine ferritin, corrected for creatinine, correlated moderately with serum ferritin [r = 0.53 (0.40-0.64)] and performed well in predicting those with ID (area under the curve: 0.85; 95% confidence interval: 0.75, 0.94). Urine ferritin <2.28 ng/mg creatinine was sensitive (86%) and specific (77%) in predicting ID and had a high negative predictive value of 97%; however, the positive predictive value was low (40%) owing to the low prevalence of ID in the sample (16%). CONCLUSIONS: Urine ferritin shows good diagnostic performance for ID. This noninvasive biomarker maybe a useful screening tool to exclude ID in healthy young children; however, further research is needed in other populations.

A summary of the 2023 Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) hypertension in pregnancy guideline.

INTRODUCTION: Hypertensive disorders of pregnancy (HDP) affect up to 10% of all pregnancies annually and are associated with an increased risk of maternal and fetal morbidity and mortality. This guideline represents an update of the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) guidelines for the management of hypertensive disorders of pregnancy 2014 and has been approved by the National Health and Medical Research Council (NHMRC) under section 14A of the National Health and Medical Research Council Act 1992. In approving the guideline recommendations, NHMRC considers that the guideline meets NHMRC's standard for clinical practice guidelines. MAIN RECOMMENDATIONS: A total of 39 recommendations on screening, preventing, diagnosing and managing HDP, especially preeclampsia, are presented in this guideline. Recommendations are presented as either evidence-based recommendations or practice points. Evidence-based recommendations are presented with the strength of recommendation and quality of evidence. Practice points were generated where there was inadequate evidence to develop specific recommendations and are based on the expertise of the working group. CHANGES IN MANAGEMENT RESULTING FROM THE GUIDELINE: This version of the SOMANZ guideline was developed in an academically robust and rigorous manner and includes recommendations on the use of combined first trimester screening to identify women at risk of developing preeclampsia, 14 pharmacological and two non-pharmacological preventive interventions, clinical use of angiogenic biomarkers and the long term care of women who experience HDP. The guideline also includes six multilingual patient infographics which can be accessed through the main website of the guideline. All measures were taken to ensure that this guideline is applicable and relevant to clinicians and multicultural women in regional and metropolitan settings in Australia and New Zealand.

Trends in clinical management of lactational mastitis among women attending Australian general practice: a national longitudinal study using MedicineInsight, 2011-2022.

OBJECTIVE: To examine longitudinal trends in clinical management of lactational mastitis in women attending general practice. DESIGN: Open cohort study. SETTING: Australian general practice using data from MedicineInsight. PARTICIPANTS: Women aged 18 to 44 years with one or more clinical encounters for lactational mastitis between January 2011 and July 2022. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was the proportion of prescribed oral antibiotics based on the antibiotic type. Secondary outcome measures were the proportion of women prescribed other medications (eg, antifungals, lactation suppressants) or ordered selected clinical investigations including breast ultrasound, blood test, breast milk culture, nipple swab culture or breast aspirate. Outcomes were examined based on the calendar year and individual- or clinical practice-level characteristics. RESULTS: Among 25 002 women who had one or more clinical encounters related to mastitis, 90.9% were prescribed oral antibiotics. While the proportion of women prescribed an oral antibiotic remained consistent from 2011 to 2022 (91.1% vs 92.5%), there were changes in the proportion receiving prescriptions for di/flucloxacillin (46.1% vs 60.4%) and cefalexin (38.6% vs 26.5%). Fewer than 12% of women were clinically investigated for their mastitis encounter, most commonly a breast ultrasound (7.1%), followed by a selected blood test (3.8%). Requests for breast milk cultures, nipple swab cultures or breast aspirates occurred in less than 1.1% of individuals. Significant increases were evident with respect to ordering of all clinical investigations, with rates at least doubling between 2011 and 2022 (6.6% vs 14.7%). Large variability in clinical management was evident according to both individual- (eg, concessional status) and clinical practice-level characteristics (eg, remoteness). CONCLUSIONS: Australian general practitioners commonly prescribe oral antibiotics to women with mastitis and largely in line with clinical guidelines. Their use of clinical investigations as part of mastitis management has increased over the last decade.

General practitioners' management of mastitis in breastfeeding women: a mixed method study in Australia.

BACKGROUND: Mastitis is a common reason new mothers visit their general practitioner (GP). In Australia, the Therapeutic Guidelines: Antibiotic provides practical advice to GPs managing a range of infections, including mastitis. It is not known if Australian GPs prescribe antibiotics and order investigations as recommended for the management of mastitis. METHODS: A convergent mixed methods design integrated quantitative analysis of a general practice dataset with analysis of interviews with GPs. Using the large-scale primary care dataset, MedicineInsight, (2021-2022), antibiotics prescribed and investigations ordered for mastitis encounters were extracted. Mastitis encounters were identified by searching 'Encounter reason', 'Test reason' and 'Prescription reason' free text field for the term 'mastitis'; 'granulomatous mastitis' was excluded. Clinical encounters for mastitis occurring within 14 days of a previous mastitis encounter were defined as belonging to the same treatment episode. Semi-structured interviews were conducted with 14 Australian GPs using Zoom or telephone in 2021-2022, and analysed thematically. The Pillar Integration Process was used to develop a joint display table; qualitative codes and themes were matched with the quantitative items to illustrate similarities/contrasts in findings. RESULTS: During an encounter for mastitis, 3122 (91.7%) women received a prescription for an oral antibiotic; most commonly di/flucloxacillin ([59.4%]) or cefalexin (937 [27.5%]). Investigations recorded ultrasound in 303 (8.9%), blood tests (full blood examination [FBE]: 170 [5.0%]; C-reactive protein [CRP]: 71 [2.1%]; erythrocyte sedimentation rate [ESR]: 34 [1.0%]) and breast milk or nipple swab cultures in approximately 1% of encounters. Analysis using pillar integration showed consistency between quantitative and qualitative data regarding mastitis management. The following themes were identified: - GPs support continued breastfeeding. - Antibiotics are central to GPs' management. - Antibiotics are mostly prescribed according to Therapeutic Guidelines. - Analgesia is a gap in the Therapeutic Guidelines. - Low use of breast milk culture. CONCLUSIONS: Prescribing antibiotics for mastitis remains central to Australian GPs' management of mastitis. Interview data clarified that GPs were aware that antibiotics might not be needed in all cases of mastitis and that delayed prescribing was not uncommon. Overall, GPs followed principles of antibiotic stewardship, however there is a need to train GPs about when to consider ordering investigations.

Accessibility of oral emergency contraceptives in Australian community pharmacies.

OBJECTIVES: To assess the availability of over-the-counter emergency contraceptive pills in the Australian community pharmacy setting. STUDY DESIGN: Representative national telephone survey. RESULTS: Only 70% of the 233 pharmacies surveyed stocked ulipristal acetate (UPA) emergency contraceptive pills, compared to levonorgestrel, which was stocked in 98%. When ulipristal acetate was stocked, it was on average $13 more expensive. CONCLUSIONS: Despite being recommended as the first-line oral emergency contraceptive, UPA is less likely to be available, and when available, it is likely to be more expensive. These findings support anecdotal reports UPA is challenging to access and less commonly used. IMPLICATIONS: Strategies are urgently required to improve equitable access to all methods of oral emergency contraception within the Australian community pharmacy setting and ensure pharmacists are aware of key differences between the available methods. This will ensure that they are prepared to facilitate shared decision making based on the individual needs of each woman.

Longitudinal trends in uptake of hormonal long-acting reversible contraception devices throughout the COVID-19 pandemic: an Australian population-based study.

BACKGROUND: Little is known about the degree to which the COVID-19 pandemic, and associated restrictions and disruptions to health services, impacted the accessibility of hormonal long-acting reversible contraception (LARC) devices within Australia. Here, we explore longitudinal patterns of dispensing of the contraceptive implant and hormonal intrauterine devices (IUDs) within Australia, before and during the COVID-19 pandemic. METHODS: Population-based cohort study; analysis of 10% random sample of national Pharmaceutical Benefits Scheme dispensing data, for females aged 15-49 years dispensed a hormonal LARC device between February 2017 and November 2021. RESULTS: Interrupted time-series analysis demonstrated overall that there were no significant differences in monthly dispensing rates of hormonal LARC following the Australian onset of the pandemic in April 2020, with no subsequent change in the trend. However, when stratified by LARC type, a significant increase was evident during the pandemic period (April 2020-November 2021) in the rate of hormonal IUD dispensing per month (0.20 per 10 000 95% CI 0.01 to 0.38)), compared with a decrease for the implant (-0.08 per 10 000 (95% CI -0.16 to 0.01)). Increases in hormonal IUD dispensing during the pandemic were most pronounced for those aged 20-24 years, new users, those without a Commonwealth concession card, and in the State of Victoria. CONCLUSIONS: Within Australia in the defined pandemic period, access to hormonal LARC devices was not negatively impacted. Rather a significant increase in dispensing of hormonal IUDs was evident.

A Scoping Review of Oncosexology Policy and Practice Tools Focused on Adolescents and Young Adults.

Background: Despite being considered a key component of quality-of-life, sexual health concerns in adolescents and young adults (AYA) patients with cancer (aged 15-39 years old) are often unmet due to barriers from both patients and health care professionals (HCPs). Investigation into policy and practice tools in this scope of practice is also limited. Aim: To review the literature on policy and practice tools in AYA oncosexology. Method: A scoping review was conducted using four databases: Medline, EMCARE, EMBASE, and PsycINFO, based on the Joanna Briggs Institute Scoping Review methodology. Retrieved articles were extracted into Covidence, followed by two screening rounds. Descriptive and basic content analyses were performed for evidence synthesis. Results: Seventy-four articles were included after screening rounds and citation searches. Overall, oncosexology policy and practice tools were categorized into screening tools (11 articles), guidelines (38 articles), training programs (15 articles), service delivery initiatives (5 articles), and the evaluation of their feasibility/challenges to implementation (5 articles). Among these, only ten articles were specifically about the AYA population. They helped identify and resolve sexual health concerns in AYA patients with cancer by providing strategies to overcome communication barriers, treatment options, and information resources for patients, and by advocating for more HCP education on this topic. Conclusion: The results warrant the need for more research, implementation and expansion of policy and practice tools for sexual health issues in AYA patients with cancer.

The Effect of Iron Supplements on the Gut Microbiome of Females of Reproductive Age: A Randomized Controlled Trial.

BACKGROUND: Iron deficiency is the most common nutritional deficiency worldwide, particularly for young children and females of reproductive age. Although oral iron supplements are routinely recommended and generally considered safe, iron supplementation has been shown to alter the fecal microbiota in low-income countries. Little is known about the effect of iron supplementation on the fecal microbiota in high-income settings. OBJECTIVES: To assess the effect of oral iron supplementation compared with placebo on the gut microbiome in nonpregnant females of reproductive age in a high-income country. METHODS: A 21-d prospective parallel design double-blind, randomized control trial conducted in South Australia, Australia. Females (18-45 y) were randomly assigned to either iron (65.7 mg ferrous fumarate) or placebo. Fecal samples were collected prior to commencing supplements and after 21 d of supplementation. The primary outcome was microbiota ß-diversity (paired-sample weighted unique fraction metric dissimilarity) between treatment and placebo groups after 21 d of supplementation. Exploratory outcomes included changes in the relative abundance of bacterial taxa. RESULTS: Of 82 females randomly assigned, 80 completed the trial. There was no significant difference between the groups for weighted unique fraction metric dissimilarity (mean difference: 0.003; 95% confidence interval: -0.007, 0.014; P = 0.52) or relative abundance of common bacterial taxa or Escherichia-Shigella (q > 0.05). CONCLUSIONS: Iron supplementation did not affect the microbiome of nonpregnant females of reproductive age in Australia. This trial was registered at clinicaltrials.gov as NCT05033483.

How the structural determinants of health inequities impact access to prescription medication for pregnant women in Australia: a narrative review.

Structural factors that contribute to health disparities (e.g., population-level policies, cultural norms) impact the distribution of resources in society and can affect medication accessibility; even in high-income countries like Australia. Industry practices and regulatory approaches (e.g., a conservative approach to testing medicines in pregnant women) influence the availability of safety and efficacy data necessary for the licencing and funding of prescription medications used during pregnancy. Consequently, pregnant women may be prescribed medications outside of regulatory or funder-approved indications, posing risks for both prescribers and pregnant women and potentially compromising equitable access to medications. This review examines the regulatory and legislative structural factors that contribute to health disparities and perpetuate the deeply ingrained social norm that we should be protecting pregnant women from clinical research rather than safeguarding them through such research. Addressing these challenges requires a renewed commitment to integrated, woman-centred maternal healthcare and strengthened collaboration across all sectors. Funding: Australian Government Research Training Program Stipend from the University of Technology Sydney, National Health and Medical Research Council (NHMRC) Fellowship, Channel 7 Children's Research Foundation Fellowship (CRF-210323).

Patterns in the provision of government-subsidised hormonal postpartum contraception in Queensland, Australia between 2012 and 2018: a population-based cohort study.

BACKGROUND: Short birth intervals and unintended pregnancy are associated with poorer maternal and infant outcomes. There is a risk of pregnancy during the immediate postpartum period unless contraception is initiated. This retrospective cohort study aimed to capture the current patterns of hormonal contraceptive provision within 12 months postpartum in a high-income country. METHODS: We used a linked administrative dataset comprising all women who gave birth in Queensland, Australia between 1 July 2012 and 30 June 2018 (n=339 265 pregnancies). We described our cohort by whether they were provided with government-subsidised hormonal contraception within 12 months postpartum. The associations between hormonal postpartum contraceptive provision and demographic and clinical characteristics were examined using univariate and multivariate logistic regression and presented in terms of crude and adjusted odds ratios with 95% confidence intervals. RESULTS: A majority of women (60.2%) were not provided with government-subsidised hormonal postpartum contraception within 12 months postpartum. Women who were younger (<25 years), were overweight or obese, smoked, were born in Australia, were non-Indigenous, gave birth in a public hospital, or were in the lowest socioeconomic status group were more likely to be provided with postpartum contraception after adjusting for other covariates, compared with their counterparts. CONCLUSIONS: Strategies to increase the provision and uptake of contraception in the immediate postpartum period are needed to prevent short birth intervals and unintended pregnancy and ensure women's fertility intentions are enacted. Ongoing research is needed to examine the factors influencing women's access to contraceptive services and, further, the types of contraception provided.

Longitudinal trends in domperidone dispensing to mothers of very preterm infants and its association with breast milk feeding at infant discharge: a retrospective study.

OBJECTIVE: This study aims: (a) to evaluate patterns of domperidone dispensing to mothers of very preterm (<32 weeks gestation) infants born before and after 2014 when international recommendations were made to limit its use and (b) to examine characteristics associated with domperidone dispensing and impacts on breast milk feeding rates at infant hospital discharge. DESIGN: Retrospective audit using linked electronic medical records and hospital pharmacy records. SETTING: Tertiary-referral neonatal intensive care unit at the Women's and Children's Hospital in South Australia. PATIENTS: Mothers of preterm infants admitted to neonatal intensive care from January 2004 to December 2018. MAIN OUTCOME MEASURES: Rate of domperidone dispensing compared pre-2014 and post-2014 recommendations using interrupted time series analyses, and breast milk feeding rates at infant discharge based on domperidone treatment status, adjusted for other factors known to influence breast milk production. RESULTS: Overall, domperidone was dispensed to 691 (41%) of 1688 mothers. Prior to 2014 recommendations, the proportion of women dispensed domperidone was stable. Following the recommendations, there was a significant reduction in trend (-2.55% per half year, 95% CI -4.57% to -0.53%;), reflecting less domperidone dispensing.Breast milk feeding rates at discharge remained consistently lower in infants of women dispensed domperidone than those who were not (adjusted OR 0.58, 95% CI 0.45 to 0.75). CONCLUSION: Domperidone dispensing in mothers of hospitalised very preterm infants has declined over time following international regulatory warnings. Breast milk feeding rates remain lower in mothers prescribed domperidone, suggesting further research is needed to optimise lactation support for mothers of very preterm infants.

Expanding community pharmacists' scope of practice in relation to contraceptive counselling and referral: a protocol for a pragmatic, stepped-wedge, cluster randomised trial (ALLIANCE).

INTRODUCTION: Improving access to effective contraception has the potential to reduce unintended pregnancy and abortion rates. Community pharmacists could play an expanded role in contraceptive counselling and referral to contraceptive prescribers particularly when women are already attending community pharmacy to obtain emergency contraceptive pills (ECPs) or to have medical abortion (MA) medicines dispensed. The ALLIANCE trial aims to compare the subsequent uptake of effective contraception (hormonal or intrauterine) in women seeking ECP or MA medicines, who receive the ALLIANCE community pharmacy-based intervention with those who do not receive the intervention. METHODS AND ANALYSIS: ALLIANCE is a stepped-wedge pragmatic cluster randomised trial in Australian community pharmacies. The ALLIANCE intervention involves community pharmacists delivering structured, patient-centred, effectiveness-based contraceptive counselling (and a referral to a contraceptive prescriber where appropriate) to women seeking either ECPs or to have MA medicines dispensed. Women participants will be recruited by participating pharmacists. A total of 37 pharmacies and 1554 participants will be recruited. Pharmacies commence in the control phase and are randomised to transition to the intervention phase at different time points (steps). The primary outcome is the self-reported use of effective contraception at 4 months; secondary outcomes include use of effective contraception and the rate of pregnancies or induced abortions at 12 months. A process and economic evaluation of the trial will also be undertaken. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Monash University Human Research Ethics Committee (#34563). An explanatory statement will be provided and written consent will be obtained from all participants (pharmacy owner, pharmacist and women) before their commencement in the trial. Dissemination will occur through a knowledge exchange workshop, peer-reviewed journal publications, presentations, social media and conferences. TRIAL REGISTRATION NUMBER: ACTRN12622001024730.

Intrahepatic cholestasis of pregnancy - Diagnosis and management: A consensus statement of the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ): Executive summary.

Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy liver disease, characterised by pruritus and increased total serum bile acids (TSBA), Australian incidence 0.6-0.7%. ICP is diagnosed by non-fasting TSBA ≥19 µmol/L in a pregnant woman with pruritus without rash without a known pre-existing liver disorder. Peak TSBA ≥40 and ≥100 µmol/L identify severe and very severe disease respectively, associated with spontaneous preterm birth when severe, and with stillbirth, when very severe. Benefit-vs-risk for iatrogenic preterm birth in ICP remains uncertain. Ursodeoxycholic acid remains the best pharmacotherapy preterm, improving perinatal outcome and reducing pruritus, although it has not been shown to reduce stillbirth.

Dispensing of psychotropic medications to Australian children and adolescents before and during the COVID-19 pandemic, 2013-2021: a retrospective cohort study.

OBJECTIVE: To determine longitudinal patterns of dispensing of antidepressant, anxiolytic, antipsychotic, psychostimulant, and hypnotic/sedative medications to children and adolescents in Australia during 2013-2021. DESIGN: Retrospective cohort study; analysis of 10% random sample of Pharmaceutical Benefits Scheme (PBS) dispensing data. PARTICIPANTS, SETTING: People aged 18 years or younger dispensed PBS-subsidised psychotropic medications in Australia, 2013-2021. MAIN OUTCOME MEASURES: Population prevalence of dispensing of psychotropic medications to children and adolescents, by psychotropic class, gender, and age group (0-6, 7-12, 13-18 years). RESULTS: The overall prevalence of psychotropic dispensing to children and adolescents was 33.8 per 1000 boys and 25.2 per 1000 girls in 2013, and 60.0 per 1000 boys and 48.3 per 1000 girls in 2021. The prevalence of psychotropic polypharmacy was 5.4 per 1000 boys and 3.7 per 1000 girls in 2013, and 10.4 per 1000 boys and 8.3 per 1000 girls in 2021. Prevalent dispensing during 2021 was highest for psychostimulants (boys, 44.0 per 1000; girls, 17.4 per 1000) and antidepressants (boys, 20.4 per 1000; girls, 33.8 per 1000). During 2021, the prevalence of dispensing was higher than predicted by extrapolation of 2013-2019 data for many classes, including antidepressants (boys: +6.1%; 95% CI, 1.1-11.1%; girls: +22.2%; 95% CI, 17.4-26.9%), and psychostimulants (boys: +14.5%; 95% CI, 8.0-21.1%; girls: +27.7%; 95% CI, 18.9-36.6%). The increases were greatest for girls aged 13-18 years (antidepressants: +20.3%; 95% CI, 16.9-23.7%; psychostimulants: +39.0%; 95% CI, 27.9-50.0%). CONCLUSIONS: The prevalence of both psychotropic dispensing and psychotropic polypharmacy for children and adolescents were twice as high in 2021 as in 2013. The reasons and appropriateness of the marked increases in psychotropic dispensing during the COVID-19 pandemic, particularly to adolescent girls, should be investigated.

Online platforms for prescription and supply of hormonal contraception in Australia: a mapping review.

Online platforms have emerged as a convenient way for individuals to access contraception. However, the extent to which such services exist in Australia and how they operate is currently unknown. We aimed to identify Australian online contraception platforms and evaluate the services they provide to determine the degree to which they may facilitate equitable access to contraception. We conducted an internet search to identify online contraception platforms operating in Australia. Data were extracted from each of the platforms relating to operating policies, services provided and associated payment processes, as well as prescribing and screening processes for assessing user suitability. As of July 2022, eight online contraception platforms operating within Australia were identified. All platforms offered oral contraception, with two also offering the vaginal ring, and one emergency oral contraception. None of the platforms provided access to long-acting reversible contraception. Significant variability existed in product and membership costs across platforms, with only one platform providing access to subsidised medicines. Five platforms restricted services to those already using oral contraception. Overall, online questionnaires were deemed to be adequately screening for important contraindications to using oral contraception. While online contraception platforms may be a valuable option for some individuals who face access barriers and are willing to pay out-of-pocket for to have their contraception sent straight to their home, they do not necessarily ensure that individuals can access their contraceptive method of choice or address recognised financial and structural barriers to contraceptive care.