Therapeutic Advances in Drug Safety最新文献

{"title":"Prevalence and predictors of prescribing errors in a primary care setting in Ghana.","authors":"Richard Delali Agbeko Djochie, Jonathan Boakye-Yiadom, Adwoa Oforiwaa Kwakye, Kwaku Gyamfi Oppong, Ivan Eduku Mozu, Constance Caroline Cobbold, Robert Peter Biney","doi":"10.1177/20420986251414590","DOIUrl":"10.1177/20420986251414590","url":null,"abstract":"<p><strong>Background: </strong>Prescribing errors are a significant cause of preventable harm in healthcare, particularly in low- and middle-income countries where system-level safeguards are often lacking. However, data on their prevalence and predictors in Ghana's primary healthcare facilities remain limited.</p><p><strong>Objectives: </strong>To determine the prevalence, types and predictors of prescribing errors in a primary-level health facility in a peri-urban municipality in Ghana.</p><p><strong>Design: </strong>Retrospective analytical cross-sectional study.</p><p><strong>Methods: </strong>We analysed data from the hospital's pre-existing prescribing error incident reporting database, which contains errors identified by pharmacists and documented during routine care between June 2021 and June 2024. Prescribing errors were classified using a structured tool based on the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) guidelines. Logistic regression analysis was conducted to identify predictors of prescribing errors, with statistical significance set at <i>p</i> < 0.05.</p><p><strong>Results: </strong>The prevalence of prescribing errors was 1.92% (95% CI: 1.71-2.13). The most common errors were frequency (27.8%), commission (26.2%) and dose errors (25.2%). Dose errors were more frequent among nurse prescribers (odds ratio (OR) = 3.02; <i>p</i> = 0.022) and less common in patients aged 41-65 years (OR = 0.24; <i>p</i> < 0.001). Commission errors were higher among doctors (OR = 2.79; <i>p</i> = 0.001), while frequency errors were less likely with doctors (OR = 0.28; <i>p</i> = 0.006). Incorrect drug selection occurred more often among nurse prescribers (OR = 6.35; <i>p</i> = 0.012) and non-insured patients (OR = 6.05; <i>p</i> = 0.006).</p><p><strong>Conclusion: </strong>Although prescribing errors were relatively infrequent, they were significantly influenced by prescriber type, patient age and health insurance status. These findings highlight the importance of continuous prescriber training, enhanced pharmacist participation in the medication-use process and the establishment of robust prescription monitoring systems to strengthen medication safety and optimize patient outcomes.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986251414590"},"PeriodicalIF":3.4,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12833174/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146067093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integration of pre‑existing cardiovascular comorbidity into CDK4/6 inhibitor selection for breast cancer.","authors":"Chanhyun Park, Kiyoung Kim, Nora B Abifaraj, Sydney D Bryant, Ji Haeng Heo","doi":"10.1177/20420986251414588","DOIUrl":"10.1177/20420986251414588","url":null,"abstract":"<p><strong>Background: </strong>Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors differ in cardiovascular (CV) safety. Ribociclib has been associated with a higher risk of CV adverse events compared to palbociclib and abemaciclib.</p><p><strong>Objectives: </strong>We examined patterns of CDK4/6 inhibitor selection among patients with breast cancer who had pre-existing cardiovascular disease (CVD) or cardiometabolic conditions (hypertension, hyperlipidemia, or diabetes).</p><p><strong>Design: </strong>We conducted a retrospective cohort study.</p><p><strong>Methods: </strong>Using 2017-2021 Merative MarketScan claims, we identified women ⩾18 years with breast cancer who initiated a first CDK4/6 inhibitor. The outcome was the type of CDK4/6 inhibitor. Primary factors were preexisting CVD and cardiometabolic risk factors measured in the prior 12 months. Multinomial logistic regression estimated unadjusted and adjusted odds of initiating palbociclib or abemaciclib versus ribociclib.</p><p><strong>Results: </strong>Among 5002 initiators (palbociclib <i>n</i> = 3734; ribociclib <i>n</i> = 328; abemaciclib <i>n</i> = 940), no risk factor significantly affected drug choice in unadjusted analyses; hypertension showed a non-significant trend toward lower initiation of palbociclib (odds ratio (OR) 0.94; 95% confidence interval (CI) = 0.75-1.18) and abemaciclib (OR 0.78; 95% CI = 0.60-1.00). After controlling for additional variables, hypertension was associated with 33% lower odds of initiating palbociclib (adjusted odds ratio (AOR) 0.67; 95% CI = 0.51-0.87) and 40% lower odds of initiating abemaciclib (AOR 0.60; 95% CI = 0.45-0.81) relative to ribociclib. Pre-existing CVD, hyperlipidemia, and diabetes were not associated with CDK4/6 inhibitor selection.</p><p><strong>Conclusion: </strong>Despite its potential higher risk of CV adverse events, ribociclib is more frequently prescribed to patients with breast cancer who have hypertension. Incorporating CV risk prediction into CDK4/6 inhibitor selection could help prevent costly CV complications.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986251414588"},"PeriodicalIF":3.4,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12833206/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146067060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of ciprofol-assisted sedation on tourniquet-related responses in foot and ankle surgery: a randomized clinical trial.","authors":"Yaoyang Ma, Bingqing Zhu, Shudong Wang, Danjun Lu, Wenlong Yan, Yi Yu, Ying Cao, Fang Kang, Juan Li","doi":"10.1177/20420986251414580","DOIUrl":"https://doi.org/10.1177/20420986251414580","url":null,"abstract":"<p><strong>Background: </strong>Tourniquet-related responses are a frequent clinical challenge during foot and ankle surgery under peripheral nerve block. Pharmacologic sedation and analgesia represent a common approach. Ciprofol, a novel intravenous sedative, remains underexplored in this surgical context.</p><p><strong>Objective: </strong>This study aimed to evaluate the impact of ciprofol-assisted sedation on tourniquet-related responses in patients undergoing foot and ankle surgery.</p><p><strong>Design: </strong>In total, 240 patients scheduled for foot and ankle procedures under peripheral nerve block with the use of a high thigh tourniquet were enrolled and randomized to undergo ciprofol (Group C) or propofol (Group P) sedation.</p><p><strong>Methods: </strong>In Group C, ciprofol was administered at an initial rate of 0.5 mg/(kg·h), with maintenance doses ranging from 0.5 to 2 mg/(kg·h) to maintain a BIS (bispectral index) between 65 and 80. Group P received an initial infusion of propofol at 2 mg/(kg·h), with maintenance between 2 and 8 mg/(kg·h). Primary outcomes included the incidence of intraoperative rescue analgesia and body movement. Secondary outcomes encompassed hemodynamic fluctuations, anesthesia success rate, injection-related discomfort, respiratory depression, blood pressure abnormalities, postoperative complications, and long-term complications.</p><p><strong>Results: </strong>There were no significant differences between groups in terms of the need for rescue analgesia or body movement during surgery. However, patients in the ciprofol group experienced significantly lower rates of injection pain and intraoperative hypotension relative to the propofol group (<i>p</i> < 0.05). No significant differences were found in postoperative adverse effects or long-term complications. In addition, both anesthesia completion rates and physician/patient satisfaction scores were similar between the two groups.</p><p><strong>Conclusion: </strong>BIS-guided sedation with ciprofol during foot and ankle surgery provides equivalent control of tourniquet-related responses compared to propofol. However, ciprofol demonstrates superior intraoperative hemodynamic stability and a more favorable safety profile, including reduced adverse event rates.</p><p><strong>Trial registration: </strong>http://www.chictr.org.cn; ChiCTR2400083924; May 7, 2024.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986251414580"},"PeriodicalIF":3.4,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12831880/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146053430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Machine learning risk prediction models for medication harm in hospitalised adult patients.","authors":"Jonathan Yong Jie Lam, Michael Barras, Ian A Scott, Hassan Masood, Ahmad Abdel-Hafez, Nazanin Falconer","doi":"10.1177/20420986251409325","DOIUrl":"10.1177/20420986251409325","url":null,"abstract":"<p><strong>Background: </strong>Medication harm is a significant healthcare challenge in hospitalised adult patients. Machine learning (ML) approaches offer the potential to improve prediction accuracy for medication harm by capturing complex relationships among clinical risk factors that traditional statistical models may not detect.</p><p><strong>Objective: </strong>To develop and evaluate ML models for predicting medication harm in hospitalised adult patients.</p><p><strong>Design: </strong>ML study involving secondary use of a prospectively collected hospital cohort dataset.</p><p><strong>Methods: </strong>This study used data from 279 adult patients admitted to general medical and geriatric wards of a tertiary hospital, among whom 40 experienced 51 medication harm events. Eight ML models were trained and evaluated for identifying patients at risk of medication harm. Medication harm cases were identified through detailed chart reviews, trigger tools, voluntary incident reporting, and International Classification of Diseases version 10 discharge coding. Data were pre-processed with missing values imputed using median imputation. Ten predictive features were selected using recursive feature elimination and clinical expert opinion. Models were trained using stratified 10-fold cross-validation with an 80/20 train-test split. Class imbalance was addressed using an oversampling approach.</p><p><strong>Results: </strong>A random forest model demonstrated the highest performance, achieving an area under the receiver operating characteristic curve of 0.76, precision of 0.50, recall of 0.62, F1 score of 0.54, accuracy of 0.86, specificity of 0.90, and an area under the precision-recall curve of 0.47. Predictive features of importance included length of stay, depression, dementia, insulin use, number of medications (⩾15), age (⩾65), opioid use, and antibiotic use.</p><p><strong>Conclusion: </strong>This study highlights the potential of ML models to predict medication harm, enabling early identification of high-risk patients for preventive interventions. Interdisciplinary collaboration is essential in developing robust, clinically relevant models that can be used to improve patient safety.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986251409325"},"PeriodicalIF":3.4,"publicationDate":"2026-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12816511/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and risk management in clinical trials for chronic wounds with tissue regenerative products.","authors":"Marina Alexandra Malikova, Connor Michael Roddy, Nolan Patrick Joyce, Katherine Nicole Cilley","doi":"10.1177/20420986251385861","DOIUrl":"10.1177/20420986251385861","url":null,"abstract":"<p><strong>Background: </strong>In tissue regenerative trials, investigators operate in the intersection of routine clinical care and research. Often, clinical trials are the only option to introduce innovative treatments to disadvantaged populations in safety-net hospitals (SNHs). It is necessary to maintain a balance between efficient study conduct and patient safety. Social determinants play a role in medication adherence in clinical trials and chronic disease management that may increase risks if not managed correctly.</p><p><strong>Objectives: </strong>We aimed to assess the safety of patients in tissue regenerative clinical trials while examining underlying causes to develop proactive risk mitigation strategies for high-risk patients.</p><p><strong>Design: </strong>A single-center, retrospective study was conducted for clinical trials with tissue regenerative products for chronic wounds at an SNH.</p><p><strong>Methods: </strong>Data obtained from 186 subjects were analyzed retrospectively for correlation between social determinants of health and adverse events by using Spearman correlation and Kruskal-Wallis tests.</p><p><strong>Results: </strong>Wound healing was achieved in 41.94% of patients who received investigational products. Overall, the diabetic foot ulcer group was noted to have a higher prevalence of serious adverse events (SAEs; 22.8% of enrolled subjects) and adverse events (78.3% of enrolled subjects) as compared to the venous stasis ulcer group, with 12.4% of SAEs and 71.0% adverse events observed in the study population. Kruskal-Wallis test demonstrated statistically significant correlation between polypharmacy (⩾5 drugs) and a higher number of adverse events (<i>p</i> = 0.0016). A Spearman correlation test showed that a higher number of comorbidities was associated with a higher number of adverse events (<i>p</i> = 0.0007).</p><p><strong>Conclusion: </strong>These findings in polypharmacy and comorbidities being associated with a higher number of adverse events highlighted the importance of safety monitoring of patients with high disease burden in clinical trials. Understanding the frequency/types of adverse events can provide important insights for those conducting trials in a particular indication. In addition, monitoring can help to address social determinants that contribute to higher numbers of adverse events, and proactively address disease burden with appropriate medical management to minimize risks in tissue regenerative clinical trials.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986251385861"},"PeriodicalIF":3.4,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12783561/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145953041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence of potentially inappropriate medication use and its association with hospitalization among older adults with chronic disease in the Amhara region, Ethiopia: a multicenter prospective cohort study.","authors":"Getachew Yitayew Tarekegn, Fisseha Nigussie Dagnew, Samuel Agegnew Wondm, Tilaye Arega Moges, Zufan Alamrie Asmare, Teklie Mengie Ayele, Sisay Sitotaw Anberbr, Dawit Haile Zeben, Tigabu Eskeziya Zerihun, Abel Temeche Kassaw, Desalegn Addis Mussie, Teferi Bihonegn Melese, Samuel Berihun Dagnew","doi":"10.1177/20420986251410989","DOIUrl":"10.1177/20420986251410989","url":null,"abstract":"<p><strong>Background: </strong>Potentially inappropriate medications (PIMs) are common among older adults with chronic diseases and are linked to adverse outcomes, including hospitalization. Evidence on PIM prevalence and its clinical impact in Ethiopia is limited. This study assessed the prevalence of PIM use and its association with hospitalization among older adults in the Amhara Region, Ethiopia.</p><p><strong>Objectives: </strong>To determine the prevalence of PIM use and identify factors associated with PIM exposure and hospitalization in older adults with chronic diseases.</p><p><strong>Design: </strong>Multicenter prospective cohort study.</p><p><strong>Methods: </strong>Between May 1 and November 30, 2024, 1700 adults aged ⩾60 years were enrolled from five comprehensive specialized hospitals in the Amhara region. PIM use was assessed using the 2023 American Geriatrics Society Beers criteria. Sociodemographic, clinical, medication, and hospitalization data were collected via structured interviews and medical chart reviews. Multivariable logistic regression identified factors independently associated with PIM use and hospitalization.</p><p><strong>Results: </strong>PIM use was identified in 41.1% of participants. Exposure to PIMs significantly increased the risk of hospitalization (adjusted odds ratio (AOR) = 3.70, 95% confidence interval (CI): 2.25-4.95, <i>p</i> = 0.023). Independent predictors of PIM use included khat chewing (AOR = 1.95), cor pulmonale (AOR = 2.28), degenerative diseases (AOR = 3.20), Charlson Comorbidity Index >4 (AOR = 4.50), prolonged chronic illness (AOR = 3.07), benzodiazepine use (AOR = 1.80), and concurrent benzodiazepine-opioid use (AOR = 4.02). Regular medication reviews were protective, reducing the risk of PIM use (AOR = 0.55).</p><p><strong>Conclusion: </strong>PIM use is highly prevalent among older adults with chronic diseases in the Amhara Region and is associated with increased hospitalization risk. Systematic medication reviews and improved prescribing practices are essential to enhance medication safety and reduce preventable hospital admissions.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986251410989"},"PeriodicalIF":3.4,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12783569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145953104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"General practitioner-pharmacist collaboration to enhance deprescribing of psychotropics, sedatives, and anticholinergics among older polypharmacy patients in primary care: study protocol of a cluster-randomized controlled trial (PARTNER).","authors":"Annette Haerdtlein, Kerstin Bernartz, Sophie Peter, Laura K Lepenies, Svetlana Puzhko, Yvonne Eberhardt, Michaela Maas, Stephanie Picker-Huchzermeyer, Vita Brisnik, Diana Falomir, Jochen Gensichen, Tim Steimle, Gunnar Huppertz, Michael Koller, Florian Zeman, Patrizio Vanella, Hanna M Seidling, Achim Mortsiefer, Christiane Muth, Tobias Dreischulte","doi":"10.1177/20420986251400042","DOIUrl":"10.1177/20420986251400042","url":null,"abstract":"<p><strong>Background: </strong>Appropriate deprescribing of psychotropic, sedative, and anticholinergic potentially inappropriate medication (PSA-PIM) in older adults with polypharmacy can reduce the risk of adverse drug reactions, but is inconsistently implemented in primary care. The PARTNER intervention was designed to address challenges in PSA-PIM deprescribing at both provider and patient levels.</p><p><strong>Objectives: </strong>To evaluate the effectiveness and cost-effectiveness of the PARTNER intervention, and to understand the mechanisms of its effects.</p><p><strong>Design: </strong>Multicenter, two-arm cluster-randomized controlled trial.</p><p><strong>Methods and analysis: </strong>The study aims to recruit at least 44 clusters and 352 patients (⩾65 years old with polypharmacy (⩾5 drugs) and use of ⩾1 PSA-PIM for ⩾6 months) across three study sites in Germany. Clusters consist of one general practice and one or more community pharmacies, randomly allocated to either the PARTNER intervention or control group. The PARTNER intervention includes: (A) education for general practitioners (GPs) and pharmacists on PSA-PIM deprescribing, (B) an interprofessional workshop, (C) drug-specific empowerment brochures for patients, (D) a patient-pharmacist consultation to enhance patient empowerment, and (E) a GP-patient consultation focusing on shared decision-making. The control group receives enhanced usual care, comprising a one-off patient-pharmacist consultation for medication safety checks without a specific focus on PSA-PIM deprescribing. The intervention's focus on PSA-PIM deprescribing is blinded to control group clusters throughout the study. The primary endpoint is a reduction in PSA-PIM exposure at 6 months (⩾0.15-point decrease in the Drug Burden Index). Secondary endpoints include falls, quality of life, healthcare utilization, and costs. The primary analysis will use a generalized linear mixed model to estimate the odds ratio for achieving the primary endpoint, adjusting for study center, age, sex, and pre-randomization PSA-PIM type and count. The process evaluation will explore the understanding of how and why the intervention succeeded or failed.</p><p><strong>Discussion: </strong>The PARTNER trial will provide evidence on the intervention's effectiveness, efficiency, and appropriateness, informing its potential for broader implementation.</p><p><strong>Trial registration: </strong>The trial has been registered with ClinicalTrials.gov (NCT05842928) on May 6, 2023; https://clinicaltrials.gov/search?term=NCT05842928.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986251400042"},"PeriodicalIF":3.4,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12783581/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145953086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medication errors and associated serious outcomes in COVID-19 antivirals: a real-world study based on FDA Adverse Event Reporting System database.","authors":"Xiaomo Xiong, Zhanghe Chen, Bingfang Yan","doi":"10.1177/20420986251396038","DOIUrl":"10.1177/20420986251396038","url":null,"abstract":"<p><strong>Background: </strong>The Food and Drug Administration (FDA) authorized three COVID-19 antivirals, including remdesivir, nirmatrelvir/ritonavir, and molnupiravir. Although medication errors involving these treatments have been reported, national-level evidence on their frequency and clinical impact remains limited.</p><p><strong>Objectives: </strong>This study aimed to evaluate medication errors and associated serious clinical outcomes linked to FDA-approved COVID-19 antivirals using national postmarketing safety data.</p><p><strong>Design: </strong>A retrospective pharmacovigilance study using postmarketing adverse event reports.</p><p><strong>Methods: </strong>We analyzed data from the FDA Adverse Event Reporting System (FAERS) from January 2020 to December 2024. COVID-19 antivirals were identified using both their generic and brand names. Medication errors were identified using MedDRA preferred terms categorized under \"medication errors and other product use errors.\" Serious outcomes included death, hospitalization, life-threatening conditions, disability, required medical intervention to prevent permanent harm, and other clinically significant events. Descriptive analyses summarized the report characteristics. Disproportionality analysis was performed using reporting odds ratios (RORs) with 95% confidence intervals (CIs) to evaluate associations between antivirals and medication errors, as well as between medication errors and serious outcomes.</p><p><strong>Results: </strong>Among 10,768 medication error reports involving COVID-19 antivirals, nirmatrelvir/ritonavir accounted for the highest number of reports, while molnupiravir had the highest proportion of medication errors relative to total reports. Remdesivir (ROR = 0.50, 95% CI: 0.48-0.53) and nirmatrelvir/ritonavir (ROR = 0.86, 95% CI: 0.84-0.88) were associated with lower odds of medication errors, whereas molnupiravir showed significantly increased odds (ROR = 3.98, 95% CI: 3.77-4.21). Medication errors were significantly associated with serious outcomes, including death (ROR = 1.31, 95% CI: 1.19-1.46), life-threatening events (ROR = 1.38, 95% CI: 1.21-1.57), and required interventions to prevent permanent harm (ROR = 3.84, 95% CI: 2.58-5.72).</p><p><strong>Conclusion: </strong>Medication errors involving COVID-19 antivirals remain a safety concern, particularly with molnupiravir. Errors were associated with serious outcomes, highlighting the need for targeted safety interventions in prescribing and dispensing practices to reduce preventable harm.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986251396038"},"PeriodicalIF":3.4,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12759129/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145901189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Complex chronic adverse events following immunization: a systemic critique and reform proposal for vaccine pharmacovigilance.","authors":"Tiff-Annie Kenny","doi":"10.1177/20420986251395925","DOIUrl":"10.1177/20420986251395925","url":null,"abstract":"<p><p>The COVID-19 pandemic has renewed attention to complex chronic health conditions that challenge conventional biomedical paradigms. Syndromes such as postural orthostatic tachycardia syndrome and myalgic encephalomyelitis/chronic fatigue syndrome have gained broader visibility through the lens of Long COVID. As global vaccination campaigns expanded, a subset of individuals began reporting similarly persistent, multisystem symptoms following COVID-19 immunization-informally referred to as post-COVID-19 vaccination syndrome. These presentations, which include dysautonomia, neuropathic pain, post-exertional malaise, and cognitive dysfunction, resemble post-infectious syndromes and may involve shared immune-related mechanisms. Although no causal relationship to vaccination has been established, these cases-together with comparable reports following other vaccines-highlight limitations in current vaccine safety systems for detecting and evaluating complex chronic outcomes. This article introduces the concept of complex chronic adverse events following immunization (CC-AEFIs) as a pragmatic, surveillance-oriented framework to support the systematic identification and investigation of such cases. CC-AEFIs are not syndromic diagnoses but a higher-order category encompassing persistent, multifactorial conditions that may follow immunization yet challenge existing pharmacovigilance definitions and tools. These conditions often involve multiple organ systems, delayed onset, fluctuating trajectories, diagnostic ambiguity, and symptom heterogeneity. Drawing on the author's lived experience as an affected patient and integrating clinical, regulatory, and experiential evidence, the analysis examines structural and epistemic limitations across the pharmacovigilance continuum-from underrecognition in clinical settings to analytic exclusion and constrained governance. It concludes by proposing reforms to strengthen safety-system responsiveness, including enhanced diagnostic training, longitudinal surveillance, patient-reported outcome integration, and analytic transparency. Addressing these limitations is essential to sustain public trust, ensure equitable care, and uphold the scientific integrity of immunization programs.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251395925"},"PeriodicalIF":3.4,"publicationDate":"2025-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12743803/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145857780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Orchestrating generative AI in pharmacovigilance: predicting and preempting the unpredictable.","authors":"Darmendra Ramcharran, Jeffery L Painter, Vijay Kara, Michael Glaser, Marco Vanini, Venkateswara Rao Chalamalasetti, Christopher Golds, Azza Abdelkarim, Andrew Bate, Jens-Ulrich Stegmann","doi":"10.1177/20420986251396023","DOIUrl":"10.1177/20420986251396023","url":null,"abstract":"<p><p>The advent of generative artificial intelligence (GenAI) has introduced both remarkable opportunities and significant challenges in the field of pharmacovigilance (PV). This perspective review reflects on emerging trends, practical use cases, and conceptual frameworks shaping the integration of GenAI in high-risk domains such as drug and vaccine safety monitoring. We draw on current experiments and early real-world applications to examine the potential benefits, inherent risks, and propose a framework for integrating GenAI into PV systems, emphasizing the necessity of rigorous testing, human oversight, and ethical considerations. Our goal is to support PV professionals and stakeholders in navigating this rapidly evolving landscape by identifying promising strategies and implementation pathways.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251396023"},"PeriodicalIF":3.4,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12718344/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145811033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}