Drug, Healthcare and Patient Safety最新文献

Purpose: Calcium channel blockers (CCBs) are widely used as first-line therapy for hypertension, but concerns remain regarding their long-term safety and effectiveness. This review aims to systematically summarize the existing evidence on the long-term safety and effectiveness of CCBs in patients with hypertension.

Methods: A systematic review was conducted using the PubMed database to identify randomized controlled trials (RCTs), cohort studies, and case-control studies assessing the long-term use (≥1 year) of CCBs in adult hypertensive populations. Eligible studies compared CCBs with other antihypertensive agents or placebo and reported outcomes related to systemic safety and effectiveness. The quality of each study was assessed using the Jadad and Newcastle-Ottawa Scales. Evidence was synthesized descriptively and stratified by organ system and clinical outcome.

Results: In total, 29 studies met the inclusion criteria, encompassing both RCTs and observational studies. Long-term CCB use was generally safe, with manageable risks. Renal protective effects were less consistent, while several studies reported a marginal increase in the incidence of new-onset diabetes. Associations with breast cancer remained inconclusive, and the risk of bone fractures appeared modestly reduced. Other systemic effects, including metabolic and reproductive changes, were generally mild. In terms of effectiveness, CCBs consistently reduced stroke incidence, although evidence regarding other cardiovascular outcomes, such as infarction, heart failure, and transient ischemic events, was inconsistent across studies.

Conclusion: Overall, CCBs are safe for long-term use and show sustained effectiveness in stroke and angina, although evidence for heart failure, myocardial infarction, and transient ischemic attack remains inconsistent.

This study asked the questions: what is known and what is not known about medication burden in adults with an intellectual disability. We used a rapid mapping review methodology to collate, describe and catalog the wide variety of evidence in this area. Ninety-one studies were included. Study characteristics, indicators of medication burden and sub-populations at increased risk were catalogued in a table and tabulated as tree maps. The authors concluded that there is evidence of a high medication burden in this population, and that the burden is highest in older adults with an ID, those living in supervised housing and those with diagnosed comorbidities and multi-morbidities. Areas that need further exploration are the total burden of medications used, including the age at which medications are first prescribed and the duration of medication use; the long-term effects of a high medication burden; and the long-term effects of anticholinergic burden. In addition, there is little information on the effects of demographic factors such as race and income.

Background: Hypersensitivity reaction to hyaluronidase, though rare, can occur following regional anesthesia in ophthalmic surgery and may mimic serious conditions such as orbital cellulitis. Prompt recognition is critical to avoid misdiagnosis and unnecessary interventions.

Case presentation: We report two cases of hypersensitivity reaction following hyaluronidase-augmented peribulbar anesthesia for cataract surgery. Case 1: A 90-year-old female with no prior allergy history developed progressive periorbital edema extending to the ipsilateral face and neck within 7 hours after surgery. Infection and hemorrhage were excluded via ultrasound. The reaction resolved promptly with antihistamines and systemic corticosteroids. Case 2: A 69-year-old female developed progressive bilateral periorbital edema extending to the forehead, accompanied by moderate pain within 7 hours postoperatively. While her C-reactive protein (CRP) level was within normal limits on the day of surgery, it rose significantly to 33.92 mg/L on postoperative day 1. Given this clinical and laboratory progression, an empirical and prophylactic therapeutic protocol was initiated, including a short course of systemic antibiotics alongside intensified anti-inflammatory treatment. All bacterial and fungal cultures returned negative, confirming a non-infectious etiology. Both patients achieved complete resolution of symptoms with uneventful recoveries maintained at both the one-week and one-month postoperative follow-up visits.

Conclusion: These cases illustrate that hyaluronidase hypersensitivity, though uncommon, should be considered in the differential diagnosis of acute postoperative periorbital inflammation. A combination of clinical vigilance, targeted imaging, and judicious use of laboratory tests is key to distinguishing this condition from infectious complications. Early diagnosis and a structured management approach are crucial to ensure patient safety and optimal outcomes.

Introduction: Long-term use of proton pump inhibitors (PPIs) requires careful observation with endoscopy in Japan. However, there are no studies examining whether monitoring is being properly carried out in clinical practice. Thus, we investigate the usage of PPIs by the presence or absence of endoscopic monitoring using a claims database.

Methods: This study was a retrospective observational cohort study using the nationwide claims database. We obtained data of patients diagnosed with GERD (excluding suspected cases) between April 2014 and March 2024. Inclusion criteria were patients aged 18 years or older, continuously prescribed drugs of interest (omeprazole, lansoprazole, rabeprazole, esomeprazole, and vonoprazan) for 8 weeks or more. To assess the duration of prescriptions over a one-year period, the medication possession ratio (MPR) showing the prescription days per year ratio was examined. MPR was compared between patients who underwent endoscopy [endoscopy(+) group] and those who did not [endoscopy(-) group] during the follow-up period of 12 months.

Results: A total of 398,253 patients [endoscopy(+) group: 142,653; endoscopy(-) group: 255,600] were included in the analysis. The median MPR was 0.534 in the endoscopy(+) group and 0.805 in the endoscopy(-) group; MPR was significantly higher in the endoscopy(-) group (p < 0.0001).

Conclusion: These findings revealed that the long-term administration of PPIs without monitoring esophageal mucosa by endoscopy in patients with GERD is a common practice in Japan. However, compliance with the package inserts suggesting adequate observation, including periodic endoscopic examinations, should be highlighted to ensure safety.

Background: Chemotherapy remains the cornerstone of pediatric cancer treatment, yet its cytotoxic nature often results in chemotherapy-induced toxicities, adverse effects arising from damage to healthy, rapidly dividing cells. Data describing these toxicities from the patient and caregiver perspective are scarce in sub-Saharan Africa. This study assessed the types, severity, and determinants of Chemotherapy-Induced Toxicities among pediatric cancer patients in Tanzania.

Methodology: A descriptive cross-sectional study was conducted over six months at Bugando Medical Center. Pediatric patients aged birth to 18 years receiving chemotherapy were enrolled. Toxicities were assessed using a locally validated, Swahili-translated version of the Pediatric Patient-Reported Outcomes Common Terminology Criteria for Adverse Events tool. Children aged ≥ 7 years self-reported their symptoms, while caregivers provided proxy reports for younger children and those who can not express themselves. Associations between chemotherapy-induced toxicities and demographic or treatment variables were analysed using multivariate logistic regression to adjust for potential confounding factors or variables (p < 0.05).

Results: Of 120 participants (55.8% male), all experienced at least one Chemotherapy-Induced Toxicity, with a mean of five per participant. The most common toxicities were alopecia (82.5%), taste changes (74.2%), vomiting (44.2%), and nausea (35%). Most events were mild (grade 1). In multivariable analysis, cancer classification was the only significant predictor of toxicity, with solid tumors showing higher odds of ≥ Grade 2 Chemotherapy-induced toxicities compared with hematologic cancers (AOR = 7.42, p = 0.047). Other factors showed no statistically significant associations.

Conclusion: Chemotherapy-induced toxicities were frequent, with most children experiencing multiple symptoms across organ systems. Cancer classification was the only factor significantly associated with higher-grade toxicities. Integrating child- and caregiver-reported outcome measures into pediatric oncology practice could enhance early identification of toxicities, support timely management, and inform national strategies to improve treatment safety and quality of life for children with cancer in Tanzania.

Background: Missed Medication Doses (MMD) are a common but preventable form of medication error that compromise treatment outcomes. Evidence on the burden and consequences of MMD among hospitalized people living with HIV (PLHIV) in Uganda remains limited.

Methods: We conducted a cross-sectional study at KNRH, Kampala, Uganda, reviewing medical records of PLHIV admitted to the infectious diseases unit between January 2022 and December 2023. Eligible files included treatment charts documenting prescribed and administered parenteral medications. Descriptive statistics summarized patient characteristics and prevalence of MMD. Associations between patient factors and MMD were assessed using chi-square tests and multivariable logistic regression. Outcomes examined included length of hospital stay, in-hospital mortality, and readmission.

Results: Of 814 records screened, 462 met the inclusion criteria. Patients were predominantly female (61.0%), with a mean age of 25.8 years (SD 14.4). Overall, 403 patients (87.2%; 95% CI: 84.1-90.0) experienced at least one MMD. Missed doses were common across nearly all medications, with omission rates exceeding 80% for ceftriaxone, paracetamol, metronidazole, omeprazole, metoclopramide, and levofloxacin, and approaching 100% for furosemide, co-amoxiclav, ondansetron, enoxaparin, albumin, and artesunate. Lower odds of MMD were independently associated with Luo ethnicity (aOR = 0.15, 95% CI: 0.03-0.59), separated marital status (aOR = 0.16, 95% CI: 0.03-0.73), and Muslim faith (aOR = 0.21, 95% CI: 0.07-0.61). Older age was associated with a modest increase in risk (aOR = 1.02 per year, p = 0.032). Length of hospital stay did not differ significantly between patients with and without MMD. Overall in-hospital mortality was high (69.0%) and was lower among patients with documented MMD compared to those without (p < 0.001).

Conclusion: Missed parenteral medication doses are highly prevalent among hospitalized PLHIV in Uganda. Strengthening medication administration and documentation systems is urgently needed to improve patient safety and outcomes.

Purpose: Tirzepatide, the first dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist with rapidly expanding clinical use, requires detailed post-marketing pharmacovigilance to monitor emerging safety signals. This study aims to identify and characterize specific adverse events (AEs) associated with tirzepatide utilizing FDA Adverse Event Reporting System (FAERS).

Patients and methods: The datasets were cleaned and standardized using Python, a programming language for data processing, and MySQL, a database management system, to ensure accuracy and consistency before analysis. Subsequently, AE signals were detected via four quantitative disproportionality algorithms, sorted and categorized by demographics, gender, and clinical prioritization, with a modified Weibull model developed to analyze AE onset timing.

Results: A total of 67,305 cases (75.83% female) and 137,583 adverse events were identified related to tirzepatide. One hundred and forty-four AE signals showed statistically significant signals suggesting a potential association with tirzepatide, with several new including postmenopausal haemorrhage and menstrual disorder (implying regulatory interference on sex hormones), Wernicke's encephalopathy and sleep disorder (malnutrition caused by low intake). Pancreatitis, impaired gastric emptying, dehydration and cholelithiasis carried higher risks with serious clinical outcomes. Sleep disorder, delayed gastric emptying, and medullary thyroid cancer are more common in males; starvation ketoacidosis and incorrect injection site, in females. The median time-to-onset (TTO) was 6.36 days (Interquartile Range (IQR) 0.85-31.2) with the Weibull shape parameter (β) of 0.44, indicating an early failure profile.

Conclusion: This study uncovered new risks of tirzepatide, including AEs associated with skin, menstruation, psychiatric and nervous system. Median TTO was corrected to within a week, highlighting the need for early monitoring before clinicians prescribe tirzepatide, and special attention should be given to patients who have pre-existing digestive dysfunction, malnutrition, or a family history of thyroid disease.

Digoxin toxicity poses a challenge for patients using the drug. Electrolyte disturbances, renal failure, and drug interactions are common predisposing factors. Hypothyroidism can increase the risk of digoxin toxicity primarily. This research reports a 7-year-old boy receiving digoxin 6 μg/kg/day presented with nausea and second-degree atrioventricular block secondary to ongoing digoxin toxicity. Initiation of levothyroxine for subclinical elevation of thyrotrophin resulted in rapid resolution of symptoms and normalization of digoxin levels.

Background: Globally, healthcare systems are currently facing a significant challenge in terms of antibiotic resistance. Healthcare professionals actively participate in the process of prescribing, dispensing and administering antibiotics.

Objective: We examined the knowledge, attitudes and practices regarding antibiotic use and antibiotic resistance among healthcare professionals working in a tertiary hospital located in Monrovia, Liberia.

Methods: A hospital-based cross-sectional survey was carried out from January to June, 2023 involving 61 healthcare workers at the ELWA Hospital, Liberia. A purposive sample of healthcare workers across diverse professional roles was surveyed using a structured questionnaire on antibiotic use and resistance. Data were analyzed in SPSS v25 using descriptive statistics to summarize participant characteristics and inferential tests to explore variable associations.

Results: Participants ages ranged from 20 to 60 years (mean = 40.7 ± 5) and nurses constituted the majority professional group (59%). Most respondents (68.9%) disagreed that antibiotics are effective against viral infections (OR = 0.45; p = 0.020). However, 36.1% believed antibiotics could be stopped when symptoms resolve and 24.6% believed leftover antibiotics could be reused (OR = 0.33; p = 0.002). Majority, 72.1% and 70.5%, reported never using antibiotics for body pain or headaches, respectively (OR = 3.67; p = 0.001 and OR = 4.78; p < 0.001). Despite this, 39.3% admitted to sometimes or always storing leftover antibiotics and 39.3% agreed or strongly agreed that stopping antibiotics early is safe (OR = 0.36; p = 0.016).

Conclusion: The study identified persistent gaps in healthcare workers' knowledge, attitudes, and practices regarding antibiotic use and resistance, despite encouraging awareness in some areas. Misconceptions such as premature discontinuation and reuse of leftover antibiotics were common. Findings underscore the need for targeted education and strengthened stewardship programs in Liberia's healthcare settings.

Background: Polypharmacy has emerged as a major global public health concern. To mitigate its adverse effects, deprescribing has been introduced and integrated into clinical practice. This study aims to analyze the current research landscape and identify emerging trends in deprescribing from a bibliometric perspective.

Methods: Relevant studies on deprescribing published prior to December 2024 were retrieved from the Web of Science Core Collection database. Bibliometric analysis and visualization of co-authorship, citation, co-citation, co-occurrence, and burst detection were performed using VOSviewer, CiteSpace, and Bibliometrix.

Results: A total of 1809 publications were identified, with a marked increase over the past decade. The field is dominated by contributions from developed countries, notably the United States, Australia, and Canada. Studies primarily focus on chronic conditions, such as psychiatric disorders, cardiometabolic diseases, and chronic pain, and the medications used to treat them. Influential publications highlighted barriers and facilitators of deprescribing, deprescribing tools, and deprescribing interventions and their associated outcomes. Burst detection analysis pointed to increasing attention on pharmaceutical care and implementation science.

Conclusion: This study presents the first comprehensive bibliometric overview of deprescribing. The findings demonstrate that the field has grown rapidly but remains dominated by developed countries and a limited set of chronic diseases. The integration of implementation science frameworks emerges as a promising approach to enhance the design and evaluation of deprescribing interventions. Future studies should broaden their scope to include a wider range of diseases and medications, and encourage greater participation from developing countries.