Drug safety
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Valid algorithms for identification of cardiovascular (CV) deaths allow researchers to reliably assess the CV safety of medications, which is of importance to regulatory science, patient safety, and public health. ⋯ Two existing algorithms based on medical claims diagnoses with or without death certificates can accurately identify SCD to support pharmacoepidemiologic studies. Developing valid algorithms identifying MI- and stroke-related death should be a research priority. PROSPERO 2017 CRD42017078745.
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Observational Study
Evaluation of Harm Associated with High Dose-Range Clinical Decision Support Overrides in the Intensive Care Unit.
Medication-related clinical decision support (CDS) alerts have been shown to be effective at reducing adverse drug events (ADEs). However, these alerts are frequently overridden, with limited data linking these overrides to harm. Dose-range checking alerts are a type of CDS alert that could have a significant impact on morbidity and mortality, especially in the intensive care unit (ICU) setting. ⋯ Overriding high dose-range CDS alerts was found to be common and often appropriate, suggesting that more intelligent dose checking is needed. Some alerts were clearly inappropriately presented to the provider. Inappropriate overrides were associated with an increased risk of ADEs, compared to appropriately overridden alerts.
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The healthcare industry, and specifically the pharmacovigilance industry, recognizes the need to support the increasing amount of data received from individual case safety reports (ICSRs). To cope with this increase, more healthcare and qualified professionals are required to capture and evaluate the data. To address the evolving landscape, it will be necessary to embrace assistive technologies such as artificial intelligence (AI) at scale. ⋯ Interviewees suggested that AI would allow for pharmacovigilance resources, time, and skills to shift the work from a volume-based to a value-based focus. The results suggest that pharmacovigilance professionals wish to use their qualifications, skillsets and experience in work that provides more value for their efforts. Machine learning algorithms have the potential to enhance DS professionals' decision-making processes and support more efficient and accurate case processing.
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Acute liver injury (ALI) is a major reason for stopping drug development or removing drugs from the market. Hospitalisation for ALI is relatively rare for marketed drugs, justifying studies in large-scale databases such as the nationwide Système National des Données de Santé (SNDS), which covers 99% of the French population. ⋯ This nationwide study describes drugs associated with ALI, according to absolute population burden and per-patient and per-tablet risk. Some of these associations may be spurious, others causal, and others yet were unexpected. Systematic analysis of drug classes will look for outliers within each class that could raise signals of unexpected hepatic toxicity.