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BackgroundMedication prescribing and dispensing often regarded as one of the most effective ways to manage and improve population health. Prescribed and dispensed medications can be monitored through data linkage for each patient. We hypothesised that changes in patient care resulting from COVID-19, changed the way patients access their prescribed medication.ObjectiveTo develop an efficient approach for evaluation of the impact of COVID-19 on drug dispensing patterns.MethodsRetrospective observational study using national patient-level dispensing records in Wales-UK. Total dispensed drug items between 01-Jan-2016 and 31-Dec-2019 (counterfactual pre-COVID-19) were compared to 2020 (COVID-19 year). We compared trends of dispensed items in three main British National Formulary (BNF) sections(Cardiovascular system, Central Nervous System, Immunological & Vaccine) using European Age-Standardized rates. We developed an online tool to enable monitoring of changes in dispensing as the pandemic evolves.ResultAmongst all BNF chapters, 52,357,639 items were dispensed in 2020 compared to 49,747,141 items in 2019 demonstrating a relative increase of 5.25% in 2020(95%CI[5.21,5.29]). Comparison of monthly patterns of 2020 and 2019 dispensed items showed a notable difference between the total number of dispensed drug items each month, with an average difference (D) of +290,055 and average Relative Change (RC) of +5.52%. The greatest RC was observed in a substantial March-2020 increase (D=+1,501,242 and RC=+28%), followed by second peak in June (D=+565,004, RC=+10.97%). May was characterised by lower dispensing (D=-399,244, RC=-5.9%). Cardiovascular categories were characterised, across all age groups, by dramatic March-2020 increases, at the epidemic peak, followed by months of lower than expected dispensing, and gradual recovery by September. The Central Nervous System category was similar, but with only a short decline in May, and quicker recovery. A stand-out grouping was Immunological and Vaccine, which dropped to very low levels across all age groups, and all months (including the March dispensing peak).ConclusionsAberration in clinical service delivery during COVID-19 led to substantial changes in community pharmacy drug dispensing. This change may contribute to a long-term burden of COVID-19, raising the importance of a comprehensive and timely monitoring of changes for evaluation of the potential impact on clinical care and outcomes

IntroductionThe emergence of the novel respiratory SARS-CoV-2 and subsequent COVID-19 pandemic have required rapid assimilation of population-level data to understand and control the spread of infection in the general and vulnerable populations. Rapid analyses are needed to inform policy development and target interventions to at-risk groups to prevent serious health outcomes. We aim to provide an accessible research platform to determine demographic, socioeconomic and clinical risk factors for infection, morbidity and mortality of COVID-19, to measure the impact of COVID-19 on healthcare utilisation and long-term health, and to enable the evaluation of natural experiments of policy interventions.Methods and analysisTwo privacy-protecting population-level cohorts have been created and derived from multisourced demographic and healthcare data. The C20 cohort consists of 3.2 million people in Wales on the 1 January 2020 with follow-up until 31 May 2020. The complete cohort dataset will be updated monthly with some individual datasets available daily. The C16 cohort consists of 3 million people in Wales on the 1 January 2016 with follow-up to 31 December 2019. C16 is designed as a counterfactual cohort to provide contextual comparative population data on disease, health service utilisation and mortality. Study outcomes will: (a) characterise the epidemiology of COVID-19, (b) assess socioeconomic and demographic influences on infection and outcomes, (c) measure the impact of COVID-19 on short -term and longer-term population outcomes and (d) undertake studies on the transmission and spatial spread of infection.Ethics and disseminationThe Secure Anonymised Information Linkage-independent Information Governance Review Panel has approved this study. The study findings will be presented to policy groups, public meetings, national and international conferences, and published in peer-reviewed journals.

IntroductionAcute Kidney Injury (AKI) effects up to 20% of emergency hospital admissions. It can be identified from serum creatinine (SCr) levels and as such an e-alert system has been introduced to hospitals in England and Wales to identify AKI. This system relies on manual review by pathology laboratory staff to prevent false alerts in dialysis patients. Objectives and ApproachOur aim is to use routinely collected dialysis timeline and dialysis treatment data in order to create dialysis treatment spells using Structured Query Language (SQL), which can then be compared with dialysis prevalence results in the UK renal registry. Furthermore, we will link this data with biochemical results in Secure Anonymised Information Linkage (SAIL) Databank to create an AKI cohort. Through identifying when patients are on renal replacement therapy (RRT) at a specific time we are able to exclude false positive AKI Alerts. This is done in two ways – one from a timeline within the data which is used in the UK renal registry. The other using individual dialysis sessions to get accurate coverage, as short periods of acute dialysis are often not been recorded in UK renal registry data. ResultsUsing the renal dataset in SAIL we were able identify more renal dialysis patients than the UK renal registry between (2009-17). By applying this to Swansea and Bridgend pathology data in SAIL we were able to identify 60,072 SCr tests in dialysis patients between 2011 and 2013 out of 1,776,101 SCr tests. In this cohort, without ruling out dialysis patients there would be 91,140 AKI alerts, however 19.6% (17,855) of the alerts are during dialysis treatments spells. Conclusion / ImplicationsWe were able to recreate the ‘e-Alert’ algorithm using SQL with SAIL and get an accurate picture of RRT in Wales, enabling more accurate AKI analysis.

Objectives To explore associations between exposure to antidepressants, their discontinuation, depression [medicated or unmediated] and preterm birth [

Most randomised controlled trials (RCTs) are relatively short term and, due to costs and available resources, have limited opportunity to be re-visited or extended. There is no guarantee that effects of treatments remain unchanged beyond the study. Here, we illustrate the feasibility, benefits and cost-effectiveness of enriching standard trial design with electronic follow up. We completed a 5-year electronic follow up of a RCT investigating the impact of probiotics on asthma and eczema in children born 2005–2007, with traditional fieldwork follow up to two years. Participants and trial outcomes were identified and analysed after five years using secure, routine, anonymised, person-based electronic health service databanks. At two years, we identified 93% of participants and compared fieldwork with electronic health records, highlighting areas of agreement and disagreement. Retention of children from lower socio-economic groups was improved, reducing volunteer bias. At 5 years we identified a reduced 82% of participants. These data allowed the trial’s first robust analysis of asthma endpoints. We found no indication that probiotic supplementation to pregnant mothers and infants protected against asthma or eczema at 5 years. Continued longer-term follow up is technically straightforward.

Aims Chronic kidney disease (CKD) is common in type 2 diabetes and limits the treatment choices for glycaemic control. Our aim was to examine real-world prescribing for managing hyperglycaemia in the presence of CKD. Methods The SAIL (Secure Anonymised Information Linkage) databank was used to examine prescribing during the period from the 1st of January to 30th December 2014. CKD was defined as:- none or mild CKD, eGFR ≥60 mL/min/1.73m2; moderate CKD eGFR Results We identified 9585 subjects who received any form of glucose lowering therapy (8363 had no/mild CKD; 1137 moderate CKD; 85 severe CKD). There was a linear association between insulin use and CKD severity with approximately 54% of those with severe CKD receiving insulin. Sulphonylureas use did not differ among the CKD groups and was approximately 40%. Metformin showed a linear decrease across the groups, however approximately 21% in the severe CKD group received metformin. The use of dipeptidyl peptidase 4 inhibitors (DPP-4i) was approximately 20% and did not differ among groups. The DPP-4 inhibitor choice was:- 1% vildagliptin, 9% saxagliptin, 58% sitagliptin, and 32% linaglitpin. With respect to sitagliptin and saxagliptin, 72% and 62% received an inappropriately high dose in the setting of CKD. Conclusions We observed that a considerable proportion of patients with type 2 diabetes and CKD were receiving metformin and non dose-adjusted DPP-4 inhibitors. Careful consideration of medication use and dosaging is required in the setting of CKD and type 2 diabetes.

Aim: To explore antidiabetic medicine prescribing to women before, during and after pregnancy in different regions of Europe.Methods: A common protocol was implemented across seven databases in Denmark, Norway, The Netherlands, Italy (Emilia Romagna/Tuscany), Wales and the rest of the UK. Women with a pregnancy starting and ending between 2004 and 2010, (Denmark, 2004-2009; Norway, 2005-2010; Emilia Romagna, 2008-2010), which ended in a live or stillbirth, were identified. Prescriptions for antidiabetic medicines issued (UK) or dispensed (non-UK) during pregnancy and/or the year before or year after pregnancy were identified. Prescribing patterns were compared across databases and over calendar time.Results: 1,082,673 live/stillbirths were identified. Pregestational insulin prescribing during the year before pregnancy ranged from 0.27% (CI95 0.25-0.30) in Tuscany to 0.45% (CI95 0.43-0.47) in Norway, and increased between 2004 and 2009 in all countries. During pregnancy, insulin prescribing peaked during the third trimester and increased over time; third trimester prescribing was highest in Tuscany (2.2%) and lowest in Denmark (0.5%). Of those prescribed an insulin during pregnancy, between 50.5% in Denmark and 88.8% in the Netherlands received an insulin analogue alone or in combination with human insulin, this proportion increasing over time. Oral products were mainly metformin and prescribing was highest in the 3 months before pregnancy. Metformin use during pregnancy increased in some countries. Conclusion: Pregestational diabetes is increasing in many areas of Europe. There is considerable variation between and within countries in the choice of medication for treating pregestational diabetes in pregnancy, including choice of insulin analogues and oral antidiabetics, and very large variation in the diagnosis and treatment of gestational diabetes despite international guidelines.

OBJECTIVE: To examine the effect of maternal exposure to asthma medications on the risk of congenital anomalies.DESIGN: Meta-analysis of aggregated data from three cohort studies.SETTING: Linkage between healthcare databases and EUROCAT congenital anomaly registries.POPULATION: 519 242 pregnancies in Norway (2004-2010), Wales (2000-2010) and Funen, Denmark (2000-2010).METHODS: Exposure defined as having at least one prescription for asthma medications issued (Wales) or dispensed (Norway, Denmark) from 91 days before to 91 days after the pregnancy start date. Odds ratios (ORs) were estimated separately for each register and combined in meta-analyses.MAIN OUTCOME MEASURES: ORs for all congenital anomalies and specific congenital anomalies.RESULTS: Overall exposure prevalence was 3.76%. For exposure to asthma medication in general, the adjusted OR (adjOR) for a major congenital anomaly was 1.21 (99% CI 1.09-1.34) after adjustment for maternal age and socioeconomic position. The OR of anal atresia was significantly increased in pregnancies exposed to inhaled corticosteroids (3.40; 99% CI 1.15-10.04). For severe congenital heart defects, an increased OR (1.97; 1.12-3.49) was associated with exposure to combination treatment with inhaled corticosteroids and long-acting beta-2-agonists. Associations with renal dysplasia were driven by exposure to short-acting beta-2-agonists (2.37; 1.20-4.67).CONCLUSION: The increased risk of congenital anomalies for women taking asthma medication is small with little confounding by maternal age or socioeconomic status. The study confirmed the association of inhaled corticosteroids with anal atresia found in earlier research and found potential new associations with combination treatment. The potential new associations should be interpreted with caution due to the large number of comparisons undertaken.TWEETABLE ABSTRACT: This cohort study found a small increased risk of congenital anomalies for women taking asthma medication.

BACKGROUND: Hypothesised associations between in utero exposure to selective serotonin reuptake inhibitors (SSRIs) and congenital anomalies, particularly congenital heart defects (CHD), remain controversial. We investigated the putative teratogenicity of SSRI prescription in the 91 days either side of first day of last menstrual period (LMP).METHODS AND FINDINGS: Three population-based EUROCAT congenital anomaly registries- Norway (2004-2010), Wales (2000-2010) and Funen, Denmark (2000-2010)-were linked to the electronic healthcare databases holding prospectively collected prescription information for all pregnancies in the timeframes available. We included 519,117 deliveries, including foetuses terminated for congenital anomalies, with data covering pregnancy and the preceding quarter, including 462,641 with data covering pregnancy and one year either side. For SSRI exposures 91 days either side of LMP, separately and together, odds ratios with 95% confidence intervals (ORs, 95%CI) for all major anomalies were estimated. We also explored: pausing or discontinuing SSRIs preconception, confounding, high dose regimens, and, in Wales, diagnosis of depression. Results were combined in meta-analyses. SSRI prescription 91 days either side of LMP was associated with increased prevalence of severe congenital heart defects (CHD) (as defined by EUROCAT guide 1.3, 2005) (34/12,962 [0.26%] vs. 865/506,155 [0.17%] OR 1.50, 1.06-2.11), and the composite adverse outcome of 'anomaly or stillbirth' (473/12962, 3.65% vs. 15829/506,155, 3.13%, OR 1.13, 1.03-1.24). The increased prevalence of all major anomalies combined did not reach statistical significance (3.09% [400/12,962] vs. 2.67% [13,536/506,155] OR 1.09, 0.99-1.21). Adjusting for socio-economic status left ORs largely unchanged. The prevalence of anomalies and severe CHD was reduced when SSRI prescriptions were stopped or paused preconception, and increased when >1 prescription was recorded, but differences were not statistically significant. The dose-response relationship between severe CHD and SSRI dose (meta-regression OR 1.49, 1.12-1.97) was consistent with SSRI-exposure related risk. Analyses in Wales suggested no associations between anomalies and diagnosed depression.CONCLUSION: The additional absolute risk of teratogenesis associated with SSRIs, if causal, is small. However, the high prevalence of SSRI use augments its public health importance, justifying modifications to preconception care.