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.

Living with unsettled baby behaviours: Qualitative interview study exploring parental perceptions and experiences of help-seeking.

AIM: To explore parents' perceptions/experiences of help-seeking for unsettled baby behaviours, including views and experiences of obtaining advice from primary healthcare professionals. DESIGN: Semi-structured qualitative interviews. METHODS: Recruitment occurred via social media, general practice and health visiting teams. Remote semi-structured interviews were conducted with parents of babies. Babies were under 12 months old at time of interview, and parents had perceived unsettled baby behaviours in their first 4 months of life. Interviews were transcribed and data analysed using reflexive thematic analysis. RESULTS: Based on interviews with 25 mothers, four main themes were developed. 'The need for answers' highlighted parental uncertainty about what constitutes normal baby behaviour, leading to help-seeking from multiple sources. 'The importance of health professionals' and 'Experiencing health professional support' identified perceptions about limited access, communication, mixed advice and how these influenced parental perception/management of behaviours. 'Foundations to help-seeking' highlighted important roles of social support and online help for valued shared experiences, emotional and practical support. CONCLUSION: Health professional access and advice are important to parents, despite the increasing role of online help and importance of social support. More support and improved access to reliable sources of information is needed for parents. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Findings will inform future research and clinical practice to address parental uncertainties. Qualitative research with front-line health professionals is necessary. IMPACT: Findings can inform the development of resources to support professionals/families managing unsettled babies. REPORTING METHOD: Standards for Reporting Qualitative Research. PUBLIC INVOLVEMENT: A public contributor was involved throughout all stages of the research. Emerging findings were discussed at a parent group. WHAT DOES THIS PAPER CONTRIBUTE TO THE WIDER GLOBAL CLINICAL COMMUNITY?: Addressing parental uncertainties is important; about what is normal, non-pharmacological approaches and when pharmacological intervention is required. A digital information/self-management intervention may be useful for parents/clinicians.

Selective serotonin reuptake inhibitors (SSRIs) in women of reproductive age: a systematic review of local formularies.

BACKGROUND: Depression is the second most common chronic condition affecting women of reproductive age; 23.4% of women enter pregnancy with depression and use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy is often necessary for maternal wellbeing. However, SSRI use during pregnancy can cause congenital malformations, postpartum haemorrhage (PPH), and persistent pulmonary hypertension of the newborn (PPHN). In UK primary care, prescribing formularies are one medium by which prescribers are provided with local medicines advice. AIM: To review all local prescribing formularies with respect to prescribing SSRIs in women of reproductive age, during pregnancy, and during breastfeeding. DESIGN & SETTING: A systematic review of prescribing formularies in England and Wales. METHOD: A systematic keyword search of all clinical commissioning group and Integrated Care Board websites in England and Local Health Board websites in Wales was undertaken between December 2021-22 to identify prescribing formularies. Data were extracted on prescribing guidance for SSRIs. RESULTS: Seventy-four prescribing formularies were reviewed. Of these, 14.9% (n = 11/74) provided links to the Medicines and Healthcare products Regulatory Agency guidance on congenital abnormalities associated with SSRIs, 28.4% (n = 21/74) provided links to guidance on PPH risk, and 1.4% (n = 1/74) provided links to guidance on PPHN. Specific local guidance was given on SSRI prescribing for women of reproductive age, during pregnancy, and during breastfeeding in 12.2% (n = 9/74), 23.0% (n = 17/74), and 21.6% (n = 16/74) of formularies, respectively. CONCLUSION: Our results suggest that prescribers may be poorly informed by local formularies about the risks of SSRI use around pregnancy. This could place babies at increased risk of unintentional SSRI exposure.

Education to improve timeliness of shingles diagnosis in primary care: a cluster randomised study within a trial with nested qualitative study.

BACKGROUND: Herpes zoster (shingles) is normally diagnosed clinically. Timely diagnosis is important so that antiviral treatment can be started soon after rash onset. AIM: To assess whether a practice-level educational intervention, aimed at non-clinical patient-facing staff, improves the timely assessment of patients with shingles. DESIGN AND SETTING: This was a cluster randomised study within a trial (SWAT) with nested qualitative study in general practices in England. METHOD: Practices were cluster randomised 1:1, stratified by centre and minimised by practice list size and Index of Multiple Deprivation score. Intervention practices were sent educational materials, highlighting the common presenting features of shingles and what action to take if suspected. The primary and secondary outcomes were the mean proportion of patients per practice seen within 72 and 144 h of rash onset, respectively. Comparison between groups was conducted using linear regression, adjusting for randomisation variables. Semi-structured interviews with practice staff in intervention practices explored views and opinions about the intervention. RESULTS: In total, 67 practices were enrolled; 34 randomised to the intervention and 33 to the control. The mean difference in proportion of patients seen within 72 and 144 h was -0.132 (95% confidence interval [CI] = -0.308 to 0.043) and -0.039 (95% CI = -0.158 to 0.080), respectively. In intervention practices, 90.9% reported distributing the educational materials; however, engagement with these was suboptimal. Twelve participants were interviewed, and the poster component of the intervention was said to be easiest to implement. CONCLUSION: Our educational intervention did not improve the timely assessment of patients with shingles. This may be the result of poor intervention engagement.

Preconception indicators and associations with health outcomes reported in UK routine primary care data: a systematic review.

BACKGROUND: Routine primary care data may be a valuable resource for preconception health research and informing provision of preconception care. AIM: To review how primary care data could provide information on the prevalence of preconception indicators and examine associations with maternal and offspring health outcomes. DESIGN AND SETTING: Systematic review of observational studies using UK routine primary care data. METHOD: Literature searches were conducted in five databases (March 2023) to identify observational studies that used national primary care data from individuals aged 15-49 years. Preconception indicators were defined as medical, behavioural and social factors that may impact future pregnancies. Health outcomes included those that may occur during and after pregnancy. Screening, data extraction and quality assessment were conducted by two reviewers. RESULTS: From 5,259 records screened, 42 articles were included. The prevalence of 30 preconception indicators was described for female patients, ranging from 0.01% for sickle cell disease to >20% for each of advanced maternal age, previous caesarean section (among those with a recorded pregnancy), overweight, obesity, smoking, depression and anxiety (irrespective of pregnancy). Few studies reported indicators for male patients (n=3) or associations with outcomes (n=5). Most studies had low risk of bias, but missing data may limit generalisability. CONCLUSION: Findings demonstrate that routinely collected UK primary care data can be used to identify patients preconception care needs. Linking primary care data with health outcomes collected in other datasets is underutilised but could help quantify how optimising preconception health and care can reduce adverse outcomes for mothers and children.

Dysautonomia Causing Severe Orthostatic Hypotension: An Important, Early Finding in Neurodegenerative Disorders.

Orthostatic hypotension is common and dangerous; it has neurogenic and nonneurogenic causes. We present the case of a 40-year-old man with severe neurogenic hypotension, caused by young-onset multiple system atrophy. In patients presenting with neurogenic orthostatic hypotension, underlying neurodegenerative diseases should always be considered. (Level of Difficulty: Advanced.).

Pregnancy protection and pregnancies in women prescribed ACE inhibitors or ARBs: a cross-sectional study in primary care.

BACKGROUND: The teratogenic risks of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are well documented, but prescribing these in younger women in primary care is becoming increasingly frequent. AIM: To record how frequently women of childbearing age, who are prescribed an ACE inhibitor or ARB, receive preconception advice and/or are prescribed contraception, and how many pregnancies, terminations, and miscarriages occur in this population. Additionally, to ascertain whether patterns in the above differ across age groups. DESIGN AND SETTING: Cross-sectional study conducted among patients from 141 general practices in East London. METHOD: Women aged 15-45 years who were issued a prescription for an ACE inhibitor or ARB between 1 October 2018 and 1 January 2019 inclusive were included. An electronic search strategy was designed to extract pseudonymised data concerning preconception and contraception advice, contraception, and pregnancies from the electronic clinical system; this was applied to the selected cohort on 1 January 2019. Data were analysed in 5-year age groups. RESULTS: Of 302 939 women aged 15-45 years, 2651 (0.9%) were prescribed an ACE inhibitor or an ARB in a 3-month period. Of these, 2159 (81.4%) had no advice and no contraception prescription recorded, 35 (1.3%) had preconception advice recorded, and 230 (8.7%) had contraception advice recorded. A total of 100 pregnancies and 21 terminations/miscarriages were recorded in the 12 months preceding the index date (1 January 2019). CONCLUSION: This study found that the recording of pre-pregnancy advice and contraception in women of childbearing age who were prescribed an ACE inhibitor or an ARB was suboptimal; this may place women and their babies at risk of exposure to teratogens during pregnancy. The findings indicate that there is a need for improved safety strategies based in primary care.