Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study.

OBJECTIVES: To examine valsartan, losartan and irbesartan usage and switching patterns in the USA, UK, Canada and Denmark before and after July 2018, when the first Angiotensin-Receptor-Blocker (ARB) (valsartan) was recalled. DESIGN: Retrospective cohort study. SETTING: USA, Canadian administrative healthcare data, Danish National Prescription Registry and UK primary care electronic health records. PARTICIPANTS: Patients aged 18 years and older between January 2014 and December 2020. INTERVENTION: Valsartan, losartan and irbesartan. MAIN OUTCOME: Monthly percentages of individual ARB episodes, new users and switches to another ARB, ACE inhibitors (ACEI) or calcium channel blockers containing products. RESULTS: We identified 10.8, 3.2, 1.8 and 1.2 million ARB users in the USA, UK, Canada and Denmark, respectively. Overall proportions of valsartan, losartan and irbesartan use were 18.4%, 67.9% and 5.2% in the USA; 3.1%, 48.3% and 10.2% in the UK, 16.3%, 11.4% and 18.3% in Canada, 1%, 93.5% and 0.6% in Denmark. In July 2018, we observed an immediate steep decline in the proportion of valsartan use in the USA and Canada. A similar trend was observed in Denmark; however, the decline was only minimal. We observed no change in trends of ARB use in the UK. Accompanying the valsartan decline was an increase in switching to other ARBs in the USA, Canada and Denmark. There was a small increase in switching to ACEI relative to the valsartan-to-other-ARBs switch. We also observed increased switching from other affected ARBs, losartan and irbesartan, to other ARBs throughout 2019, in the USA and Canada, although the usage trends in the USA remained unchanged. CONCLUSION: The first recall notice for valsartan resulted in substantial decline in usage due to increased switching to other ARBs. Subsequent notices for losartan and irbesartan were also associated with increased switching around the time of the recall, however, overall usage trends remained unchanged.

Methods to refine and extend a Pregnancy Register in the UK Clinical Practice Research Datalink primary care databases.

PURPOSE: Real-world data represents a valuable tool for pregnancy research. However, an algorithmic approach is needed to ascertain pregnancy timings from this complex data. The Clinical Practice Research Datalink (CPRD) GOLD Pregnancy Register, based on UK Primary care data, has therefore proven to be a valuable research tool. The same algorithmic approach was applied to the CPRD Aurum data to generate an equivalent register in the larger database. METHODS: Records of female patients registered with a CPRD Aurum contributing practice between the 1st of January 1987 and the 30th of April 2021 were searched for evidence of pregnancy. The algorithm used to generate the CPRD GOLD Pregnancy Register was redeveloped and applied first to CPRD GOLD and then to CPRD Aurum. The resulting CPRD Aurum Pregnancy Register was validated against the CPRD GOLD register, linked Hospital Episode Statistics (HES) and the Office of National Statistics (ONS) live birth data. RESULTS: There are 16 833 427 pregnancy episodes in the CPRD Aurum Pregnancy Register from 6 724 615 women, more than double the number in CPRD GOLD. The distribution of pregnancy outcome types was comparable between the registers. Across the whole register, there was good concordance between pregnancy episodes found in CPRD Aurum and linked HES. However, both CPRD registers saw a declining number of pregnancy episodes from 2007 onwards, steeper than in HES or the ONS birth data. CONCLUSIONS: A pregnancy register has been created in CPRD Aurum. Changes in antenatal care policies in the UK have led to declining numbers of pregnancies in EHR primary care data. However, the creation of this pregnancy register has tripled the number of patients in the CPRD Pregnancy Registers and will increase the capacity to study pregnancy in CPRD data, particularly rare or emerging exposures, and outcomes.

Quality improvement of prescribing safety: a pilot study in primary care using UK electronic health records.

BACKGROUND: Quality improvement (QI) is a priority for general practice, and GPs are expected to participate in and provide evidence of QI activity. There is growing interest in harnessing the potential of electronic health records (EHR) to improve patient care by supporting practices to find cases that could benefit from a medicines review. AIM: To develop scalable and reproducible prescribing safety reports using patient-level EHR data. DESIGN AND SETTING: UK general practices that contribute de-identified patient data to the Clinical Practice Research Datalink (CPRD). METHOD: A scoping phase used stakeholder consultations to identify primary care QI needs and potential indicators. QI reports containing real data were sent to 12 pilot practices that used Vision GP software and had expressed interest. The scale-up phase involved automating production and distribution of reports to all contributing practices that used both Vision and EMIS software systems. Benchmarking reports with patient-level case review lists for two prescribing safety indicators were sent to 457 practices in December 2017 following the initial scale-up (Figure 2). RESULTS: Two indicators were selected from the Royal College of General Practitioners Patient Safety Toolkit following stakeholder consultations for the pilot phase involving 12 GP practices. Pilot phase interviews showed that reports were used to review individual patient care, implement wider QI actions in the practice, and for appraisal and revalidation. CONCLUSION: Electronic health record data can be used to provide standardised, reproducible reports that can be delivered at scale with minimal resource requirements. These can be used in a national QI initiative that impacts directly on patient care.