Therapeutic Advances in Drug Safety

PURPOSE: This study was designed to investigate the prophylactic effect of oral olanzapine in postoperative nausea and vomiting after gynecologic laparoscopic surgery. METHODS: ASA I-II, aged 18-75 years, planned to undergo gynecologic laparoscopic surgery with general anesthesia in adult female patients. Using the randomized numbers table, the patients were placed in two groups. Oral olanzapine 5 mg or placebo was given 1 h before anesthesia...

BACKGROUND: The effect of drug-drug interaction between tacrolimus and caspofungin on the pharmacokinetics of tacrolimus in different CYP3A5 genotypes has not been reported in previous studies. OBJECTIVES: To investigate the effect of caspofungin on the blood concentration and dose of tacrolimus under different CYP3A5 genotypes. DESIGN: We conducted a retrospective cohort study in The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital from January 2015 to December 2022...

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To perform optimal monitoring of the safety profile in the postmarketing phase, Marketing Authorization Holders and National Regulatory Authorities (NRAs) must evaluate the adverse drug reactions (ADRs) that occurred and characterize their nature, frequency, and severity. Management is possible through Individual Case Safety Reports (ICSRs), which are the reports of organized and processed data. Globally, the International Council for Harmonisation (ICH) E2B guideline suggests harmonized activities for the ICSR electronic content and transmission...

BACKGROUND: Polypharmacy is a growing phenomenon among elderly individuals. However, there is little information about the frequency of polypharmacy among the elderly population treated in emergency departments (EDs) and its prognostic effect. This study aims to determine the prevalence and short-term prognostic effect of polypharmacy in elderly patients treated in EDs. METHODS: A retrospective analysis of the Emergency Department Elderly in Needs (EDEN) project's cohort was performed...

BACKGROUND: Connective tissue diseases (CTD), including systemic lupus erythematosus and rheumatoid arthritis (RA), have long been treated with hydroxychloroquine (HCQ). However, prolonged HCQ use poses a risk of adverse effects, particularly retinopathy. OBJECTIVE: To detect early retinal changes assessed by optical coherence tomography angiography (OCTA) in CTD patients with long-term HCQ treatment and to explore the relationship between OCTA parameters and the concentrations of HCQ and its metabolites...

BACKGROUND: Atrial fibrillation (AF) and obesity are common conditions globally; yet, there remains suboptimal pharmacological management contributing to high rates of hospitalization in patients with AF. The altered pathophysiology of both obese and underweight individuals may influence the pharmacology of medications, including those used to manage AF. This, in turn, increases the risk of adverse events and impacts patient risk for stroke and rehospitalization. Despite the well-established complications of obesity, research investigating the relationship between obesity and AF is scant...

BACKGROUND: Drug-induced interstitial lung disease (DILD) is an increasingly common cause of morbidity and mortality. However, due to the lack of specificity, DILD detection remains an unsolved public health challenge. OBJECTIVES: For the first time, we aimed to examine DILD reports submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to identify demographic characteristics and top drugs associated with DILD at a group level (including age, sex, drug class, and country stratification) and individual drug level...

BACKGROUND: Medication errors (MEs) by caregivers at home are a cause of morbidity and mortality, shortly after discharge from the hospital. OBJECTIVES: The objective of this study was to determine the rate and types of MEs at the homes of children discharged from a hospital in Ghana and to explore the factors associated with these errors. DESIGN: This was a cross-sectional study of infants and children discharged from the hospital to review medication administration practices...

BACKGROUND: Following the roll-out of the Pfizer-BioNTech BNT162b2, Moderna mRNA-1273, and Janssen Ad26.COV2.S coronavirus disease 2019 (COVID-19) injections in the United States, millions of individuals have reported adverse events (AEs) using the vaccine adverse events reports system (VAERS). The objective of this analysis is to describe the myocarditis data in VAERS and the COVID-19 vaccines as potential determinants of myocarditis. METHODS: We used VAERS data to examine the frequency of reporting myocarditis since the beginning of the mass vaccination campaign and compared this with historical values in VAERS and COVID-19 vaccine administration data from the Our World in Data database...

BACKGROUND: Studies have shown conflicting results when using thrombopoietin-related drugs (TPORD) for thromboembolic events (TEEs). Our study aimed to explore the correlation between TPORDs and TEEs. METHOD: Drug-targeted Mendelian randomization (MR) and multivariate MR (MVMR) analysis were used to explore the causal relationship between TPORDs and TEEs such as venous thromboembolism (VTE), deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI) and ischemic stroke (STR)...

BACKGROUND: Logistic regression-based signal detection algorithms have benefits over disproportionality analysis due to their ability to handle potential confounders and masking factors. Feature exploration and developing alternative machine learning algorithms can further strengthen signal detection. OBJECTIVES: Our objective was to compare the signal detection performance of logistic regression, gradient-boosted trees, random forest and support vector machine models utilizing Food and Drug Administration adverse event reporting system data...

BACKGROUND: Candesartan cilexetil is a widely used angiotensin II receptor blocker with minimal adverse effects and high tolerability for the treatment of hypertension. Candesartan is administered orally as the prodrug candesartan cilexetil, which is wholly and swiftly converted to the active metabolite candesartan by carboxylesterase during absorption in the intestinal tract. In populations with renal or hepatic impairment, candesartan's pharmacokinetic (PK) behavior may be altered, necessitating dosage adjustments...

BACKGROUND: The circulation of falsified medical products is a global threat and is expected to be higher in low- and middle-income countries. OBJECTIVE: This study was conducted to assess the understanding, readiness, and response of Eritrea's healthcare professionals (HCPs), and identify potential areas of intervention to combat circulation of falsified medical products. DESIGN: This was a nationwide population-based cross-sectional survey, conducted in December 2021...

BACKGROUND AND OBJECTIVE: Drug-related problems (DRPs) are often seen when a patient is transitioning from one healthcare sector to another, for example, when a patient moves from the hospital to a General Practice (GP) setting. This transition creates an opportunity for information on medication changes and follow-up plans to be lost. A cross-sectoral hospital pharmacist intervention was developed and pilot-tested in a large GP clinic. The intervention included medication history, medication reconciliation, medication review, follow-up telephone calls, identification of possible DRPs and communication with the GP...

BACKGROUND: Propofol combined with alfentanil is suitable for intravenous anesthesia for day-case hysteroscopy. OBJECTIVE: To investigate the median effective dose (ED50 ) and 95% effective dose (ED95 ) of alfentanil compounded with propofol for day-case hysteroscopy. DESIGN: In all, 29 patients who volunteered for painless hysteroscopy in 2022 were recruited. 1.5 mg/kg propofol was given as a sedative to all patients. The trial was conducted using the modified Dixon sequential method, with an initial dose of 10 μg/kg of alfentanil, and the subject's alfentanil dose depended on whether the prior hysteroscopy had failed, which was defined as inadequate cervical dilatation and hysteroscope placement with the patient exhibiting body movement, frowning, or a MOAA/S score >1...

BACKGROUND: Quetiapine is an antipsychotic with dose-related receptor affinity, which is commonly prescribed by specialties outside of psychiatry. Quetiapine can have adverse effects including weight gain, hyperglycemia, and falls. Therefore, quetiapine is a good focus medication to assess the need for an antipsychotic stewardship protocol. OBJECTIVE: To assess the need for an antipsychotic stewardship protocol at a large, urban academic medical center by evaluating quetiapine usage...

The relatively new discipline of pharmacovigilance (PV) aims to monitor the safety of drugs throughout their evolution and is essential to discovering new drug risks. Due to their specific and complex physiology, children, pregnant women, and elderly adults are more prone to adverse drug reactions (ADRs). Additionally, the lack of clinical trial data exacerbates the challenges faced with pharmacotherapy in these populations. Elderly patients tend to have multiple comorbidities often requiring more extensive medication, which adds additional challenges for healthcare professionals (HCPs) in delivering safe and effective pharmacotherapy...

BACKGROUND: Adverse effects (AEs) have been reported with all antiretroviral therapy (ART) medications, and it was among the most common cause for switching or terminating therapy and drug non-adherence. Even though AEs of ART medications are common and to be expected, little study has been conducted on the understanding of patients on the AEs. Therefore, this study aimed to assess patients' knowledge, attitude, and practice (KAP) toward ART medications' AEs and associated factors. METHODS: A cross-sectional study design was applied using an interviewer-administered questionnaire from June to September 2021 on human immunodeficiency virus/acquired immunodeficiency syndrome patients on follow-up at Tikur Anbessa Specialized Hospital, Ethiopia...

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