Background Adequate medication knowledge of patients is critical for medication safety, particularly among psychiatric patients exposed to complex pharmacotherapy. However, data on patients treated in psychiatric day hospital settings are limited. Objectives This study aimed to assess medication knowledge and identify factors associated with knowledge gaps in this population. Design Cross-sectional observational study. Methods A total of 101 patients from a psychiatric day hospital were included. Medication knowledge was assessed using a structured interviewer-administered questionnaire covering drug name, indication, dosage and administration schedule (possible score range: 0–6). Group differences and associations were analysed using Mann–Whitney U tests, Kruskal–Wallis tests and Spearman correlations. Results The median medication knowledge score was 4.3 (interquartile range (IQR) 3.0–5.8). A moderate negative correlation was observed between the number of medications taken and knowledge (ρ = −0.404, p < 0.001). Knowledge was not associated with sex (p = 0.29) or age (ρ = −0.093, p = 0.353). Knowledge differed significantly across drug classes (p < 0.001), being highest for nervous system drugs. Discrepancies between prescribed and reported medication were frequent, with 29 patients reporting 44 additional undocumented medications. The internet (31.7%) and medical specialists (30.7%) were the most reported sources of medication-related information. Conclusion Medication knowledge among psychiatric day hospital patients varied considerably and was lower among patients receiving a higher number of medications. Frequent discrepancies between documented and patient-reported medication use were observed, indicating a potential risk for unsafe medication use. In addition, insufficient medication knowledge may represent a clinically relevant risk factor for medication-related problems. Targeted, patient-centred education strategies should be prioritized to improve medication safety in this setting.
Background Potentially inappropriate medication (PIM) prescribing in older adults contributes to adverse drug events and healthcare utilization. Synchronous specialist teleconsultation may expand access to medication review, but its association with prescribing appropriateness across multiple specialties remains uncertain. Objectives To assess changes in documented and specialist-recommended PIM regimens immediately following specialist teleconsultation. Design Retrospective, paired pre-post observational cohort study. Methods We analyzed 14,995 completed teleconsultation encounters involving 13,580 unique adults aged 60 years or older in the Brazilian TeleAMES program from March 2020 through February 2025. Each encounter contributed a medication regimen documented by the primary care clinician before consultation and a regimen recommended by the specialist after consultation. PIMs were classified according to the 2023 American Geriatrics Society (AGS) Beers Criteria. The primary outcome was the encounter-level proportion with at least one PIM. Paired binary comparisons and generalized estimating equation (GEE) models with patient-level clustering were used. Regression models included time (before versus after) as the sole predictor and were not adjusted for baseline covariates. Results The proportion of encounters with at least one PIM decreased from 32.7% to 29.6%, an absolute reduction of 3.1 percentage points and a relative reduction of 9.5% (p = 0.03). The mean PIM count also decreased (incidence rate ratio [IRR], 0.971; 95% confidence interval [CI], 0.952-0.991; p = 0.004). Count rates declined for drug-disease contraindications (IRR, 0.631; 95% CI, 0.601-0.663; p < 0.001), high-risk drug-drug interactions (IRR, 0.766; 95% CI, 0.672-0.873; p < 0.001), and medications requiring renal dose adjustment (IRR, 0.929; 95% CI, 0.901-0.958; p < 0.001). The largest specialty-specific absolute reductions were observed in Cardiology (34.2% to 21.4%) and Endocrinology (38.1% to 22.3%). Conclusion Immediately after specialist teleconsultation, specialist-recommended regimens contained fewer PIMs, particularly within high-risk prescribing domains. Because post-consultation lists represented recommendations rather than confirmed dispensing, implementation, or medication use, and because no concurrent control group was available, these findings indicate an association with documented prescribing changes rather than a causal reduction in medication exposure.
The ethical and risk-based implementation and monitoring of artificial intelligence (AI) and machine learning within pharmacovigilance systems presents significant challenges, made more complicated by evolving regulatory landscapes. A pharmacovigilance organization requires a robust governance framework for ensuring patient safety and maintaining regulatory compliance as technology rapidly advances. This perspective review proposes a control plan as a structured, living document solution for effectively governing AI models, including statistical based machine learning, large language models, and generative AI. It integrates existing principles and requirements by suggesting critical elements such as performance parameters for the model and its infrastructure, criteria for successful human monitoring, triggers for model modification, identified risks with mitigation strategies, and appropriate explainability of AI outcomes. The objective of a control plan is to ensure transparency to regulators, safeguard patient safety, and build confidence in the organization’s risk-based management approach. The proposed AI control plan provides a structured approach to governing and monitoring AI systems within pharmacovigilance, enhancing operational transparency and regulatory compliance. It consolidates various established best practices and regulatory considerations into a unified framework. The adaptive nature of a control plan is crucial for responsible and effective AI utilization as technology and regulations evolve.
We report a case of multisystem adverse drug events in a 19-year-old female with a normal body mass index (BMI, 22.23 kg/m 2 ) following a subcutaneous injection of 0.5 mg tirzepatide. Gastrointestinal symptoms appeared within 2 hours of administration, progressing to involve cardiovascular and renal systems over the next 5 days. Clinical manifestations included sinus tachycardia (128 beats per minute), acute kidney injury (serum creatinine 84.7μmol/L), and high anion gap metabolic acidosis (pH 7.293). These complications were likely secondary to gastrointestinal reactions, rather than direct drug toxicity. Common adverse drug events associated with tirzepatide include mild to moderate gastrointestinal symptoms (e.g., nausea, diarrhea, vomiting). This case demonstrates that tirzepatide potentially induces severe systemic reactions in individuals using it for “off-label” indications, even at very low doses. To our knowledge, this is a previously unreported case demonstrating a temporal association between low-dose tirzepatide (less than the standard starting dose of 2.5 mg) and the onset of multisystem complications.
Background Digoxin dosing guidance during continuous renal replacement therapy (CRRT) is scarce, relying on two case reports with pharmacokinetic modeling not subsequently validated by TDM and expert opinion. Objective To examine varying digoxin dosing regimen effects on serum digoxin concentrations (SDCs) in patients receiving continuous venovenous hemodiafiltration (CVVHDF). Design Retrospective, multicenter, single-health-system case series. Methods Adult patients admitted to an intensive care unit over a 3.5-year period who received digoxin, with concurrent SDC monitoring and CVVHDF were included. The primary outcome of this study was to describe digoxin dosing and associated SDCs in adult patients receiving CVVHDF. Secondary outcomes aimed to determine the safety and tolerability of digoxin for patients receiving CVVHDF, including the incidence of bradycardia, digoxin immune fab administration, and in-hospital mortality. Results Six patients met criteria for inclusion, yielding fourteen digoxin levels drawn during CVVHDF. The median CRRT effluent rate was 30.7 mL/kg/hr with a median digoxin level of 0.9 (IQR 0.7-1.1) ng/mL. Both levels ≥ 1.2 ng/mL (above the safety-oriented upper threshold) occurred in patients following a loading dose exceeding 8 mcg/kg ideal body weight. Ten total SDC were drawn in 4 patients receiving 125 mcg every 48-hours maintenance regimens and all resulted in pre-steady state levels < 1.2 ng/mL. Two patients (33.3%) experienced bradycardia, both of whom were receiving concomitant amiodarone. No patients received digoxin immune fab, and two patients (33.3%) experienced in-hospital mortality. Conclusion A maintenance regimen of 125 mcg every 48 hours during CVVHDF achieved levels below the safety SDCs, although notably all levels reflect the first several doses during CVVHDF and may not reflect steady state monitoring. These data help address the current gap in data describing digoxin dosing during CRRT. Although this adds limited insight for digoxin dosing during CRRT, standard dosing and monitoring recommendations remain unconfirmed.
