Drug, Healthcare And Patient Safety[JOURNAL]
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200 papers
Chemotherapy-Induced Toxicities in Pediatric Cancer Patients in Tanzania [Letter].
Mwita S
Drug Healthc Patient Saf · 2026 · PMID 42293770 · Full text
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Metoclopramide and Risk of Pheochromocytoma Crisis: A Causality Assessment Using Literature and VigiBase Data.
Bahta M, Dawit A, Okubazghi M … +1 more , Russom M
Drug Healthc Patient Saf · 2026 · PMID 42226769 · Full text
INTRODUCTION: The association between metoclopramide and pheochromocytoma crisis has been documented in literature. However, evidence has primarily relied on case reports and small-scale experimental studies rather than...
INTRODUCTION: The association between metoclopramide and pheochromocytoma crisis has been documented in literature. However, evidence has primarily relied on case reports and small-scale experimental studies rather than rigorous causal assessments. Therefore, this study aimed to assess the causal relationship between metoclopramide use and the occurrence of pheochromocytoma crisis by analyzing data from the literature and World Health Organization (WHO) global pharmacovigilance database. METHODS: This study was a descriptive analysis and causality assessment of metoclopramide and pheochromocytoma crisis. Data were retrieved from published literature and the WHO global pharmacovigilance database (VigiBase) on February 13, 2025. In addition to the causality results extracted from VigiBase, causality assessment at the individual level for published case reports was conducted using the Naranjo Adverse Drug Reaction Probability Scale. Causality assessment at the population level was conducted using the Austin Bradford-Hill causality assessment framework. RESULTS: A total of 62 de-duplicate cases were found in VigiBase and the literature. Almost all cases were classified as serious with 12 fatalities. In many instances, the drug-induced crisis served as the first clinical indication of an undiagnosed (occult) tumor. A causality assessment using the Naranjo algorithm conducted by the current authors classified the 18 published cases as "probable" (13) and "possible" (5). In VigiBase, causality assessment at the individual level was reported for 10 cases, with possible (6), probable (2), and reasonable possibilities (2). The results of the causality assessment at the population level using Hill's criteria revealed compelling evidence across all nine criteria. CONCLUSION: A reasonable causal relationship exists between metoclopramide and pheochromocytoma crisis, supporting its contraindication in patients with known or suspected pheochromocytoma.Clinicians should monitor patients, consider underlying pheochromocytoma, and be aware of this risk. Further international case-control studies are recommended to confirm this causal association.
Paracetamol Overdose in Somali Children Under Five: An Emerging Public Health Concern.
Hassan WM
Drug Healthc Patient Saf · 2026 · PMID 42181901 · Full text
Paracetamol (acetaminophen) is widely used for pain and fever management in children under five; however, accidental overdose is an increasing public health concern in low-resource settings such as Somalia. This narrativ...
Paracetamol (acetaminophen) is widely used for pain and fever management in children under five; however, accidental overdose is an increasing public health concern in low-resource settings such as Somalia. This narrative review highlights key risk factors, clinical consequences, and prevention strategies relevant to the Somali context based on published literature. Misconceptions about dosing, reliance on age rather than weight, and unrestricted access contribute to inappropriate administration and increased risk of hepatotoxicity and acute liver failure. While metabolic pathways in young children differ from adults, increased vulnerability in this setting is more strongly associated with malnutrition, dosing errors, and delayed access to healthcare. Toxicity results from accumulation of N-acetyl-p-benzoquinone imine (NAPQI), leading to oxidative stress and liver injury. Early treatment with N-acetylcysteine (NAC) is essential, yet delayed presentation and limited availability of antidotes in Somalia worsen outcomes. There is currently limited published data on the incidence of paracetamol overdose and NAC availability in Somalia. Strengthening caregiver education, pharmacy-based counseling, access to essential antidotes, and national poison surveillance systems is critical to reducing preventable pediatric liver injury in Somalia.
Trends and Outcomes of Naloxone Use for Iatrogenic Opioid Overdose in Patients on General Wards in a Swiss Hospital: A Ten-Year Retrospective Case Series Analysis.
Würsten M, Meyer-Massetti C, Leuppi-Taegtmeyer A … +1 more , Goetschi AN
Drug Healthc Patient Saf · 2026 · PMID 42158930 · Full text
INTRODUCTION: Opioids carry an inherent high risk of adverse drug events (ADEs), although these are generally predictable and avoidable through proper management and monitoring. Naloxone, an opioid antagonist, is used to...
INTRODUCTION: Opioids carry an inherent high risk of adverse drug events (ADEs), although these are generally predictable and avoidable through proper management and monitoring. Naloxone, an opioid antagonist, is used to counteract severe opioid overdoses. AIM: This study aimed to estimate the incidence of iatrogenic opioid overdoses and describe prescribing patterns before, during and after them. METHODS: We conducted a ten-year retrospective case series analysis of naloxone use among inpatients at a large, multisite university hospital in Switzerland from January 2014 to December 2023. Cases were included if an adult patient had received naloxone after opioid administration and overdose. We excluded patients who received naloxone during surgery or in intensive care units. RESULTS: Of the 671 uses of naloxone identified, 121 (18.0%) met our inclusion criteria. Yearly naloxone use incidence was 11.0 per 10,000 inpatients, increasing slightly from 2014 to 2023. The median daily opioid dose requiring naloxone was 73 morphine milligram equivalents (MME). According to the Schumock and Thornton scale criteria, we considered 82 (67.8%) of the 121 opioid overdoses to have been potentially preventable The median opioid doses received before hospital admission (29.4 MME) were higher than at discharge (15.0 MME). Nevertheless, 71 (68.3%) of 104 discharged patients were still prescribed at least one opioid. CONCLUSION: This study found that iatrogenic opioid overdoses were relatively uncommon. However, the considerable number of preventable opioid overdoses estimated leads us to conclude that opioid stewardship programmes should be recommended across Switzerland.
Computed Tomography Diagnostic Reference Levels Worldwide and in Jordan: Implications for Patient Dose Reduction.
Oglat AA, Shdaifat S, Sayah MA … +2 more , Abukonna A, Khogali WMA
Drug Healthc Patient Saf · 2026 · PMID 42099537 · Full text
Computed tomography (CT) contributes substantially to medical radiation exposure, making diagnostic reference levels (DRLs) essential for dose optimization and patient protection. This narrative review summarizes interna...
Computed tomography (CT) contributes substantially to medical radiation exposure, making diagnostic reference levels (DRLs) essential for dose optimization and patient protection. This narrative review summarizes international CT DRL practices and examines the current status of DRL development in Jordan. Published studies and key guidance documents addressing adult and pediatric CT DRLs, including CTDIvol, dose-length product (DLP), and size-specific dose estimate (SSDE) where available, were reviewed to identify common implementation approaches, frequently used dose metrics, and evidence gaps relevant to Jordan. The reviewed literature shows marked inter-country variation in DRL methodology, updating cycles, and regulatory integration. In Jordan, available studies demonstrate useful local and multicenter data, but routine CT practice still lacks a unified national DRL framework. Reported Jordanian values also show inter-institutional variability, highlighting the need for standardized data collection, regular auditing, and coordinated national oversight. Establishing national DRLs based on transparent methodology and periodic revision would strengthen radiation protection, improve protocol consistency, and support safer CT practice in Jordan.
Exosome Therapy for Livedoid Vasculitis Following COVID-19 Vaccination: A Case Report.
Lin TK, Chang CF, Jong GP
Drug Healthc Patient Saf · 2026 · PMID 42095157 · Full text
Livedoid vasculitis is a vascular autoimmune disorder affecting the skin. It most commonly occurs in young women. The occurrence of this condition after the coronavirus 2019 (COVID-19) vaccination is rare. The available...
Livedoid vasculitis is a vascular autoimmune disorder affecting the skin. It most commonly occurs in young women. The occurrence of this condition after the coronavirus 2019 (COVID-19) vaccination is rare. The available literature suggests limited use of exosomes in the treatment of livedoid vasculitis. We present the case of a 65-year-old Chinese man who developed livedoid vasculitis after COVID-19 vaccination. We posit that the etiology in this case may be either COVID-19 vaccine-induced immune stimulation or activation of the condition by a rare vaccine component. This case is unique, with no previously reported precedents. The patient was treated intravenously for 1 month with stem cell-derived exosome therapy, using stem cells derived from exfoliated human deciduous teeth. This resulted in improvement in the livedoid vasculitis, with no reemergence of symptoms. This case highlights the therapeutic benefits of exosome treatment for livedoid vasculitis after COVID-19 vaccination. However, large-scale studies are needed before this outcome can be generalized.
Diagnostic Challenges in a Pediatric Case of Recurrent Blistering Skin Reactions: Ibuprofen-Induced Fixed Drug Exanthema versus Infection-Triggered Erythema Multiforme.
Möhrle R, Toni I, Wagner N … +3 more , Schliep S, Hoerning A, Neubert A
Drug Healthc Patient Saf · 2026 · PMID 42051372 · Full text
A 12-year-old patient was hospitalized with suspected recurrent Stevens-Johnson syndrome (SJS) caused by ibuprofen. The patient presented with aphthous lesions on the lips and oral mucosa, accompanied by fever and cough....
A 12-year-old patient was hospitalized with suspected recurrent Stevens-Johnson syndrome (SJS) caused by ibuprofen. The patient presented with aphthous lesions on the lips and oral mucosa, accompanied by fever and cough. Further examination revealed more severe symptoms. The exact classification of his skin reaction and the underlying cause were challenging due to the coexistence of multiple potential triggers. The diagnostic overlap among various skin reactions requires careful evaluation of the clinical presentation and histopathological findings in relation to potential drug exposure and/or infectious triggers. Cutaneous reactions such as SJS and fixed drug exanthema are predominantly associated with drug exposure, whereas Erythema multiforme (EM) and rash and mucositis (MIRM) are mainly linked to infectious triggers. The diagnosis of a skin reaction and its trigger is highly relevant for therapy and prevention of further episodes. In this patient, administration of ibuprofen, as well as infections with Herpes simplex virus (HSV) and (M. pneumoniae) were considered potential triggers, highlighting the complexity of this case. The patient recovered following extensive therapy and was discharged after two weeks.
Trends and Types of Medical Errors Reporting Following the Implementation of Electronic Health Record System.
A'aqoulah A, Alqahtani M, Bin Dayel DF … +4 more , Zarbah B, Kalmey F, Shattat G, Abusaris R
Drug Healthc Patient Saf · 2026 · PMID 41948571 · Full text
INTRODUCTION: Constant supervision is required in a hospital setting because medication errors are a common occurrence and can be potentially harmful to patients. OBJECTIVE: To examine patterns in medication error rates,...
INTRODUCTION: Constant supervision is required in a hospital setting because medication errors are a common occurrence and can be potentially harmful to patients. OBJECTIVE: To examine patterns in medication error rates, types, and departmental distributions at tertiary hospitals from 2013 to 2023. METHODS: In this cross-sectional research, the internal hospital medication error database was utilized, collecting data on dosage errors which included Wrong Dose, Drug Omission, Timing Error, and the departments assignment of errors include ICU, General Ward, Pharmacy, Emergency Department for a continuous duration of 11 years. RESULTS: The reports for medication errors at tertiary hospitals for the years 2013-2023 altogether displayed fairly consistent behavior. Maximum error count was in the year 2019 with 6108 errors while the minimum was in the year 2015 with errors summing up to 725. The results showed fallen in medication errors to 1279 errors by 2023. Important types of errors were wrong/unclear dose prescriptions that used to peak in 2019 with 1307 and also duplication of medication errors increased with 297 additional errors between 2013 to 2023. The changes between types of errors made (χ = 1297.75, p-value < 0.001), hospital centers (χ = 1668.97, p-value < 0.001) and sections of the hospital in which they were carried out (χ = 3086.19, p-value < 0.001) proved vital through chi-square tests done and thus showcasing the shifting control of medication error detection and reporting brought by electronic health record (EHRs) system and training. CONCLUSION: Medication errors showed variability with peaks, troughs, and fluctuations, demonstrating the inter-year coping mechanisms of EHRs system and personnel. Decision makers need to improve the system alongside staff education and some focused departmental attention. Although there has been some improvement in reporting errors, reporting new emerging errors, such as duplication of procedures, necessitates further vigilance in the dispensation of services to patients.
Trend of Reported Bleeding in Warfarin Compared with Direct Oral Anticoagulants in Japan.
Takami A, Terashima G, Tajima T … +2 more , Yamashita K, Igarashi A
Drug Healthc Patient Saf · 2026 · PMID 41938683 · Full text
BACKGROUND: Evidence on bleeding events associated with oral anticoagulants in real-world settings is limited. Thus, we compared the incidence rate of oral anticoagulant-associated bleeding between warfarin and direct or...
BACKGROUND: Evidence on bleeding events associated with oral anticoagulants in real-world settings is limited. Thus, we compared the incidence rate of oral anticoagulant-associated bleeding between warfarin and direct oral anticoagulants (DOACs). METHODS: This is a retrospective observational study using the Japanese Adverse Drug Event Report Database (JADER) and the nationwide health insurance claims database. We investigated the number of case reports with "bleeding" or "hemorrhage" using the JADER. The drugs of interest included warfarin, dabigatran, edoxaban, rivaroxaban, or apixaban. Main outcome measures included the number of case reports of bleeding and the estimated annual incidence rate of oral anticoagulant-associated bleeding using the Japanese Adverse Drug Event Report (JADER) and the nationwide estimated number of patients with prescriptions. RESULTS: In JADER, we found 16,125 oral anticoagulant-associated bleeding in 15,970 case reports of patients between April 1, 2004, and March 31, 2024. The most common suspected oral anticoagulant administered to patients was apixaban (33.4%), followed by rivaroxaban (26.0%), warfarin (16.6%), edoxaban (13.3%), and dabigatran (10.7%). The incidence rates of anticoagulant-associated bleeding in patients who were prescribed dabigatran, edoxaban, rivaroxaban, and apixaban were higher compared to those in patients who were prescribed warfarin. The estimated annual incidence rate was remarkably high in patients who received apixaban, reaching 1976.90 per 1,000,000 patients. CONCLUSION: Compared with warfarin, the incidence rates of oral anticoagulant-associated bleeding were higher with dabigatran, edoxaban, rivaroxaban, or apixaban. In a real-world setting in Japan, the risk of oral anticoagulant-associated bleeding appears to be higher with DOACs than with warfarin.
Prosthetic Loosening in a Total Hip Arthroplasty Patient After Breast Cancer Chemotherapy and Hormonal Therapy: A Case Report.
Li J, Li S, Li C … +2 more , Chen Z, Ding Y
Drug Healthc Patient Saf · 2026 · PMID 41926512 · Full text
BACKGROUND: Studies have shown that there are a lot of risk factors that could cause periprosthetic osteolysis and aseptic loosening, threatening the life-span of the hip prosthesis. Breast cancer is one of the most freq...
BACKGROUND: Studies have shown that there are a lot of risk factors that could cause periprosthetic osteolysis and aseptic loosening, threatening the life-span of the hip prosthesis. Breast cancer is one of the most frequent malignancy in women. However, the use of breast cancer chemotherapy and hormonal therapy has been shown to significantly elevate the risk of osteoporosis. Chemotherapy can systematically suppress the anabolism of various organs, ultimately leading to bone metabolism dysfunction and osteolysis. Aromatase inhibitors (AI) function by inhibiting the conversion of androgens to estrogen, thereby reducing systemic estrogen levels, which is essential for maintaining bone mass; however, prolonged estrogen deprivation can lead to osteoporosis, which has been proven to pose a significant threat to the survival of hip implants. CASE PRESENTATION: In this case, the patient suffered hip joint tuberculosis and took intertrochanteric osteotomy procedure at age 24. Seventeen years after, she took Total Hip Arthroplasty (THA). She then undertook chemotherapy and hormonal therapy for breast invasive ductal carcinoma (BI-RADS category III), 1 year after her primary THA. Three years later, she was diagnosed with aseptic loosening of her hip prosthesis. A summary and analysis of her treatment were conducted. CONCLUSION: Breast cancer chemotherapy and hormonal therapy might be a threat to the stability of THA prosthesis. More attention should be paid when a Total Hip Arthroplasty patient received chemotherapy and hormonal therapy. Further research is needed to fully understand the impact of breast cancer treatments, as current therapies like hormonal therapy can increase the risk of osteoporosis and fractures.
Capecitabine Dosage as an Independent Prognostic Factor for the Development of Hand-Foot Syndrome: A Competing Risk Analysis.
Chantharakhit C, Patumanond J, Phinyo P … +1 more , Chai-Adisaksopha C
Drug Healthc Patient Saf · 2026 · PMID 41890396 · Full text
PURPOSE: Capecitabine, an oral prodrug of 5-fluorouracil, commonly causes hand-foot syndrome (HFS). Although clinical predictors of HFS have been reported, causal evidence supporting dosage as an independent prognostic f...
PURPOSE: Capecitabine, an oral prodrug of 5-fluorouracil, commonly causes hand-foot syndrome (HFS). Although clinical predictors of HFS have been reported, causal evidence supporting dosage as an independent prognostic factor remains limited. Because competing events may preclude HFS, this study evaluated the prognostic role of capecitabine dosage in grade 2-3 HFS using a competing risk analysis. PATIENTS AND METHODS: A retrospective observational cohort study was conducted. Capecitabine dosage was the exposure of interest. Potential confounders including sex, combination chemotherapy, and estimated glomerular filtration rate (eGFR) were identified using a directed acyclic graph. The primary endpoint was time from treatment initiation to grade 2-3 HFS. A multivariable competing risk analysis was performed using the Lambert model, with loss to follow-up, severe diarrhea, sepsis, and death defined as competing events. Capecitabine dosage was categorized (2000-4000 mg/day) to facilitate clinical interpretability. RESULTS: Among 596 patients, 132 (22.2%) developed grade 2-3 HFS, with a median onset time of 63 days (interquartile range, 42-84). Higher capecitabine dosage was independently associated with an increased risk of HFS, with the greatest effect observed at 4000 mg/day compared with 2000 mg/day (aHR 4.41; 95% CI, 1.31-14.81; p = 0.016), demonstrating a clear dose-dependent increase in risk. In addition, higher dosage was associated with a shorter model-predicted median time to HFS onset. CONCLUSION: This study confirms capecitabine dosage as an independent prognostic factor for grade 2-3 HFS, with significantly increased risk at 4000 mg/day and a shorter median time to HFS onset as dosage increases. These findings underscore the importance of careful dosing and support the implementation of evidence-based strategies for dose adjustment in high-risk patients.
Endoscopic Examination and Long-Term Use of Proton Pump Inhibitors for Gastroesophageal Reflux Disease Treatment in Japan.
Takami A, Terashima G, Shiotsuki Y … +2 more , Yamashita K, Igarashi A
Drug Healthc Patient Saf · 2026 · PMID 41883354 · Full text
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 prac...
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.
Prevalence of Missed Medication Doses and Outcomes of Hospitalized Patients Living with HIV in Uganda.
Angut MM, Atwijukiire H, Mushabe B … +6 more , Shamim K, Namanda B, Mondo C, Seremba E, Kabugo C, Baluku JB
Drug Healthc Patient Saf · 2026 · PMID 41878271 · Full text
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...
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.
Long-Term Safety and Effectiveness of Calcium Channel Blockers in Hypertension: A Systematic Review.
Aisyah N, Aurellia JS, Insani WN
Drug Healthc Patient Saf · 2026 · PMID 41873338 · Full text
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 ex...
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.
Chemotherapy-Induced Toxicities in Pediatric Cancer Patients: A Cross-Sectional Survey Using a Child- and Caregiver-Reported Outcome Tool in Tanzania.
Katabalo DM, Njile E, Kidenya BR … +2 more , Liwa AC, Schroeder K
Drug Healthc Patient Saf · 2026 · PMID 41868450 · Full text
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...
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.
A Rapid Mapping Review of Medication Burden in Adults with an Intellectual Disability: What We Know and What We Do Not Know.
Marquis S, O'Leary R, Marquis NE … +1 more , Baumbusch J
Drug Healthc Patient Saf · 2026 · PMID 41853486 · Full text
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...
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.
Hypersensitivity Reaction to Hyaluronidase After Peribulbar Anesthesia for Cataract Surgery: Two Case Reports.
Cheng C, Han Y, Liu X … +2 more , Yu W, Yang N
Drug Healthc Patient Saf · 2026 · PMID 41709951 · Full text
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 critic...
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.
Adverse Events Associated with Tirzepatide: Updated Pharmacovigilance Analysis Using FAERS (2022 Q1-2025 Q1) with an Adapted Time-to-Onset Method.
Gu S
Drug Healthc Patient Saf · 2026 · PMID 41531800 · Full text
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 pharmacov...
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 at Standard Doses in a Child with Subclinical Elevation of Thyrotrophin: A Case Report.
Khorgami M, Dalili M, Karimian B
Drug Healthc Patient Saf · 2025 · PMID 41458572 · Full text
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 pri...
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.
Assessment of Knowledge, Attitudes, and Practices on Antibiotic Use and Resistance Among Healthcare Workers in Monrovia, Liberia: A Facility-Based Cross-Sectional Study.
Shobayo BI, Taylor VS, Freeman BM … +2 more , Kokro JS, Chea SKP
Drug Healthc Patient Saf · 2025 · PMID 41287831 · Full text
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 adminis...
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.
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