Pharmacoepidemiology and Drug Safety最新文献

{"title":"Predictors of Direct Oral Anticoagulant Use in Northern Italy: A Population-Based Study.","authors":"Luisa Ojeda-Fernández, Greta Agostini, Anna Zanovello, Patrick Prada, Ida Fortino, Claudia Augurio, Marta Baviera","doi":"10.1002/pds.70300","DOIUrl":"10.1002/pds.70300","url":null,"abstract":"<p><strong>Purpose: </strong>Evidence on head-to-head comparison between direct oral anticoagulants (DOACs) is lacking, and the reasons for choosing one type of DOAC and switching from one DOAC to another are scarce. This study investigated the use of DOACs in an unselected population in Northern Italy during a recent period.</p><p><strong>Methods: </strong>Using the health administrative database of the Lombardy region, subjects aged 45 years and older who started DOAC therapy between 2019 and 2022 were included in the analysis. Logistic regression analysis was used to evaluate predictors associated with DOAC prescription, and results were presented as ORs with 95% CI. DOAC switching was assessed by estimating the prevalence and cumulative incidence according to the first prescribed DOAC.</p><p><strong>Results: </strong>Overall, 159 993 new users for DOAC were identified. Apixaban users increased from 29.0% to 34.3%, whereas dabigatran users decreased from 20.7% to 11.5% over time. Across all pair-wise comparisons, older age and female sex were predictors for edoxaban prescription. Comorbidities were mainly associated with the use of apixaban; however, dabigatran was preferred in patients with a history of ischemic heart disease or myocardial infarction and rivaroxaban in those with peripheral artery disease. Both apixaban and edoxaban were preferentially prescribed to patients with a history of bleeding. The switching rate of DOACs was 5.6% with apixaban as the most preferred drug as a second choice. Dabigatran was mainly chosen as a second DOAC after a vascular ischaemic event.</p><p><strong>Conclusion: </strong>Given the lack of evidence on factors influencing clinician behavior in the use of DOACs, our findings provide insight into this topic in a real-world setting. As the use of these agents increases, further evidence is needed to better explore this issue. Our data could contribute to the development of recommendations in clinical practice.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 12","pages":"e70300"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12705910/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145763619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends in Medication Use Among Young Adults and the Covid-19 Pandemic Effect.","authors":"Meital Zur, Avishai M Tsur, Limor Friedensohn, Ilan Matok","doi":"10.1002/pds.70273","DOIUrl":"10.1002/pds.70273","url":null,"abstract":"<p><strong>Introduction: </strong>The COVID-19 pandemic caused unprecedented disruptions in healthcare delivery, and changes in medication utilization patterns. While previous studies examined specific therapeutic classes or populations, there is limited longitudinal evidence on medication trends among young adults throughout and beyond the pandemic.</p><p><strong>Aim: </strong>To analyze trends in medication dispensation before, during, and after the COVID-19 pandemic among young adults.</p><p><strong>Methods: </strong>We conducted a population-based, retrospective cohort study including active-duty Israeli Defense Forces personnel between January 2017 and August 2023. Monthly dispensing rates per 1000 persons were analyzed using an interrupted time series (ITS) design, implemented via generalized linear models with log link and population offsets. Models included linear time trends, month fixed effects to account for seasonality, and negative binomial fallback for overdispersion. Pre-pandemic data (January 2017-March 2020) were used to estimate baseline trends, from which counterfactual predictions were generated for March 2020-August 2022. Goodness-of-fit was evaluated with RMSE and MAPE.</p><p><strong>Results: </strong>Pre-pandemic trends varied across therapeutic groups. Adrenergic inhalants (IRR 1.008, 95% CI 1.004-1.011, p = 0.0001), antidiarrheals (IRR 1.005, 95% CI 1.001-1.008, p = 0.004), and ADHD medications (IRR 1.024, 95% CI 1.020-1.027, p < 0.001) exhibited significant upward slopes, whereas antibacterials, antidepressants and hormonal contraceptives showed no significant baseline trend. Seasonality was significant for all groups (p < 0.001). During the pandemic, cumulative differences revealed excesses for adrenergic inhalants (+93.98 per 1000), antidepressants (+87.03), and hormonal contraceptives (+679.21), alongside deficits for antibacterials (-201.99), antidiarrheals (-112.89), and ADHD medications (-294.69).</p><p><strong>Conclusions: </strong>Medication usage patterns can be classified into three classes: medications affected by the pandemic due to the inciting pathogen, disease symptoms, or pandemic social disruption; medications unaffected by the pandemic, affected by global disease trends; and medications with a trend change whose relation to the pandemic is unclear. These findings offer a novel framework for anticipating and managing medication needs in future pandemics.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 12","pages":"e70273"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12670204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145654855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Applying High-Dimensional Propensity Scores in a Study of Inhaled Corticosteroids and COVID-19 Outcomes.","authors":"Marleen Bokern, John Tazare, Christopher T Rentsch, Jennifer K Quint, Ian J Douglas, Anna Schultze","doi":"10.1002/pds.70248","DOIUrl":"10.1002/pds.70248","url":null,"abstract":"<p><strong>Background: </strong>In pharmacoepidemiologic studies of COVID-19, there were concerns about bias from residual confounding. We investigated the effects of inhaled corticosteroids (ICS) on COVID-19 outcomes, applying high-dimensional propensity scores (HDPS) to adjust for unmeasured confounding.</p><p><strong>Methods: </strong>We selected patients with chronic obstructive pulmonary disease on 01 March 2020 from Clinical Practice Research Datalink (CPRD) Aurum, comparing ICS/LABA/(+/-LAMA) and LABA/LAMA users. ICS effects on the outcomes COVID-19 hospitalisation and death were assessed through IPT-weighted and unweighted Cox regression. HDPS were estimated from primary care observations, prescriptions and hospitalisations. SNOMED-CT codes and dictionary of medicines and devices codes from CPRD Aurum were mapped to International Classification of Disease 10th revision codes and British National Formulary paragraphs, respectively. We estimated propensity scores (PS) combining prespecified and HDPS covariates, selecting the top 100, 250, 500, 750 and 1000 covariates ranked by confounding potential.</p><p><strong>Results: </strong>When excluding triple therapy users, conventional PS-weighted estimates showed weak evidence of increased COVID-19 hospitalisation risk among ICS users (HR 1.19 [95% CI: 0.92-1.54]). Results varied slightly based on the number of covariates included in HDPS (HR using 100 HDPS covariates excluding triple therapy 1.01 [95% CI: 0.76-1.33], HR using 250 HDPS covariates excluding triple therapy 1.24 [95% CI: 0.83-1.87]). Conventional PS-weighted models showed weak evidence of a harmful association of ICS with COVID-19 death when excluding triple therapy users (HR 1.24 [95% CI: 0.87-1.75]). HDPS-weighting moved estimates toward the null (HR using 250 HDPS covariates excluding triple therapy 1.08 [95% CI: 0.73-1.59]).</p><p><strong>Conclusions: </strong>HDPS may have better controlled confounding for COVID-19 deaths in this case. HDPS results can be sensitive to the number of covariates included, highlighting the importance of sensitivity analyses.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 12","pages":"e70248"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12644305/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145597034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury.","authors":"Vincent Lo Re, Craig W Newcomb, Dean M Carbonari, Charles E Leonard, Christopher T Rentsch, Judith C Maro","doi":"10.1002/pds.70275","DOIUrl":"10.1002/pds.70275","url":null,"abstract":"<p><strong>Background: </strong>Medications associated with acute liver injury (ALI) are primarily identified by case reports. High-throughput screening of real-world data could be leveraged to detect hepatotoxicity signals.</p><p><strong>Objective: </strong>To apply tree-based scan statistics in real-world data to identify drugs associated with hospitalization for severe ALI among patients without liver/biliary disease and with chronic liver disease (CLD).</p><p><strong>Methods: </strong>We implemented a self-controlled case-crossover design in Veterans Health Administration data (2000-2023) among patients hospitalized for laboratory-confirmed severe ALI. We identified all newly dispensed drugs within 365 days prior to their hospitalization and used conditional Bernoulli tree-based scan statistics to identify potential associations (p < 0.3). We performed analyses separately in patients without liver/biliary disease and with CLD.</p><p><strong>Results: </strong>Among 12 860 patients without liver/biliary disease and 17 512 with CLD hospitalized for severe ALI, we evaluated associations with 450 and 543 drugs, respectively. Drugs associated with severe ALI among patients without liver/biliary disease included: acid-suppressives (ranitidine [p < 0.001], omeprazole [p = 0.004]), antiemetics (ondansetron [p < 0.001], promethazine [p = 0.06]), antibiotics (amoxicillin/clavulanate [p = 0.008], ciprofloxacin [p = 0.02], mupirocin [p = 0.032], ethambutol [p = 0.275]), anticoagulants (heparin [p = 0.015]), and chemotherapy (pazopanib [p = 0.275]). Drugs associated with severe ALI among CLD patients were: diuretics (spironolactone, furosemide [both p < 0.001]), antiemetics (ondansetron, metoclopramide, promethazine [all p < 0.001]), appetite stimulants (p < 0.001), analgesics (morphine, oxycodone, fentanyl [all p < 0.001]), chemotherapy (sorafenib [p < 0.001]), antibiotics (ciprofloxacin [p = 0.011], metronidazole [p = 0.020]), antipsychotics (prochlorperazine [p = 0.105]), vitamins (p = 0.134), acid-suppressives (omeprazole [p = 0.164]), and gastrointestinal/liver disease treatments (lactulose, senna, docusate, silicones, antiflatulents [all p < 0.001]; sucralfate [p = 0.005], albumin [p = 0.228]).</p><p><strong>Conclusions: </strong>High-throughput screening using tree-based scan statistics detected potentially hepatotoxic drugs for investigation in future pharmacoepidemiology studies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 12","pages":"e70275"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12678845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145678378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association Between First-Trimester Medication Exposure in Pregnancy and Congenital Anomalies: A Scoping Review of Cohorts, Exposure, Trimester and Congenital Anomaly Definitions.","authors":"Stephanie Tan, Ebony Quintrell, Shannon Morgan, Amina Rhaman, Danielle Russell, Leaf Kardol, Caitlin Wyrwoll, Bianca Varney, Annelies Robijn, Jonathan Brett, Erin Kelty","doi":"10.1002/pds.70293","DOIUrl":"10.1002/pds.70293","url":null,"abstract":"<p><strong>Background: </strong>The risk of congenital anomalies following first-trimester medication exposure is an important indicator of medication safety during pregnancy. Retrospective cohort studies using routinely collected data are commonly used to assess this risk, yet methodological inconsistencies-such as how cohorts, exposures, timings and outcomes are defined-can compromise reproducibility and validity. This scoping review examined the methodologies used in retrospective cohort studies assessing the association between first-trimester prenatal medication exposure and congenital anomalies.</p><p><strong>Methods: </strong>Medline, PsycInfo, Embase, CINAHL and Global Health were searched for retrospective cohort studies published in English between 2014 and 2024 examining the association between first-trimester medication exposure and congenital anomalies. Screening and data extraction were performed by two reviewers, using Covidence.</p><p><strong>Results: </strong>A total of 156 studies were included. Most were conducted in Europe (56%) using database or registry studies (87%). Common exclusions included stillbirths (58%), multiple pregnancies (41%) and exposure to teratogenic medications (39%). Exposure was typically defined as a minimum of one prescription dispensed during the first trimester (79%); however, the definition of pregnancy start varied across studies: 29% used the date of the last menstrual period, while 42% used the estimated day of conception. The end of the first trimester was defined as Week 12 (16%), Week 13 (30%) or Week 14 (15%). The types of included anomalies differed, with chromosomal anomalies (48%), minor anomalies (14.5%) and genetic anomalies (13.5%) commonly excluded. Comparison groups included untreated individuals without the condition (65%), untreated individuals with the condition (22%) or those receiving alternative treatments (23%).</p><p><strong>Conclusion: </strong>Substantial methodological variation exists in studies examining first-trimester medication exposure and congenital anomalies. This variation may arise both from inherent differences in data sources and from discretionary methodological decisions made by investigators. Standardised definitions would be beneficial to improve consistency, reliability and interpretability of research in this field.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 12","pages":"e70293"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145763539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dipeptidyl Peptidase 4 Inhibitors: Novel Therapeutic Agents in the Management of Type II Diabetes Mellitus.","authors":"Chinyere Aloke, Oluwasola Abayomi Adelusi, Olalekan Olugbenga Onisuru, Emmanuel Amarachi Iwuchukwu, Ikechukwu Achilonu","doi":"10.1002/pds.70277","DOIUrl":"10.1002/pds.70277","url":null,"abstract":"<p><strong>Background: </strong>Mounting evidence indicates that Type 2 diabetes mellitus (T2DM) is a public health challenge globally, and its occurrence is anticipated to surge in the forthcoming years. Dipeptidyl peptidase-4 (DPP-4) serves as a target for its treatment, with its inhibitors effectively preserving the levels of glucose-dependent insulinotropic peptide and glucagon-like peptide 1(GLP-1). This review presents an overview of the therapeutic possibilities of six frequently employed DPP-4 inhibitors (DPP-4is) (Sitagliptin, saxagliptin, vildagliptin, linagliptin, alogliptin and teneligliptin) in managing T2DM, focussing on their characteristics, mechanism of action, advantages and side effects in comparison with alternative oral antidiabetic drugs as well as the possibility of using in silico method in advancing its timely and cost-effective production.</p><p><strong>Methods: </strong>A literature search was conducted using the major search engines such as PubMed/Medline, Scopus, and Google Scholar, etc. employing terms like 'Type 2 diabetes mellitus (T2DM), DPP-4 inhibitors, and Dipeptidyl peptidase-4', etc. to identify relevant studies.</p><p><strong>Results: </strong>Our findings indicate that DPP-4is stimulate secretion of insulin and suppress secretion of glucagon by elevating endogenous GLP-1 concentrations without an intrinsic hypoglycaemia risk. Although these agents share a common mechanism of action, their considerable structural heterogeneity may lead to distinct pharmacological characteristics. Literature shows that DPP-4is have a promising safety profile in comparison with other oral antidiabetic medications, however, certain safety aspects require additional exploration. Different DPP-4is have demonstrated comparable safety and tolerability, whether used alone or in combination with other antidiabetic medications. Besides, it has been shown that in silico method could be employed in development of DPP-4is. Further research is necessary to ascertain whether differences among DPP-4 inhibitors might influence the occurrence of specific adverse effects.</p><p><strong>Conclusion: </strong>DPP-4 inhibitors remain effective and well-tolerated options for managing T2DM.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 12","pages":"e70277"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12683481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145701446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of the US Food and Drug Administration's COVID-19 Disease Severity Categorization for Use in Real-World Data.","authors":"Silvia Perez-Vilar, Wei Hua, Andrew Kwist, Yuxin Ma, Diane Dong, Rongping Zhang, Yong Ma, Andrea Chavez, Nina Huang, Virginia Sheikh, Yiyun Chiang, Cedric Salone, Natalie Pica, Yunfan Zhu, Natasha Pratt, Gita Nadimpalli, Suzann Pershing, Michael Wernecke, Fran E Cunningham, David J Graham","doi":"10.1002/pds.70252","DOIUrl":"10.1002/pds.70252","url":null,"abstract":"<p><strong>Background: </strong>The US Food and Drug Administration proposed a five-level disease severity categorization for baseline COVID-19 (asymptomatic, mild, moderate, severe, critical).</p><p><strong>Aims: </strong>We conducted a pilot study aimed to validate the performance of the ICD-10-CM diagnosis code for COVID-19 (U07.1) and operational definitions (code-based algorithms) for each disease severity category in Medicare administrative data.</p><p><strong>Materials & methods: </strong>We sampled 250 community-dwelling beneficiaries aged ≥ 18 years with a U07.1 code on an inpatient hospital or ambulatory claim between April 1, 2020 and June 18, 2022. We used stratified sampling based on care setting and COVID-19 treatment status and adjusted results using sampling weights. Using medical records as the reference standard, we calculated positive predictive values (PPV) and 95% confidence intervals (CI). We conducted prespecified secondary analyses to improve algorithm performance by using refined disease definitions.</p><p><strong>Results: </strong>We received medical records for 190 (77%) beneficiaries. Of these, 171 had a positive SARS-CoV-2 test result. The PPV of the COVID-19 diagnosis code was 89% (CI: 83%-93%) overall, 88% (CI: 80%-93%) in the ambulatory setting, and 93% (CI: 82%-97%) in the inpatient setting. The operational definition for disease severity varied in performance by severity level and measurement strategy. The best performance was: PPV for asymptomatic and mild combined 69% (CI: 59%-77%), PPV for moderate 58% (CI: 34%-78%); PPV for severe 42% (CI: 27%-59%); and PPV for critical 85% (CI: 57%-96%).</p><p><strong>Discussion: </strong>The code, U07.1, reliably identified beneficiaries with COVID-19 in both ambulatory and inpatient settings. The operational definition to classify COVID-19 disease severity notably improved performance when we implemented selected refinements.</p><p><strong>Conclusion: </strong>Researchers should consider the moderate performance of the proposed operational definitions when using administrative claims data to assess COVID-19 disease severity.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70252"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145482416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Increasing Prevalence of Long-Term Antidepressant Use in Australia: A Retrospective Observational Study.","authors":"R A D L M K Ranwala, Elizabeth E Roughead, Jean-Pierre Calabretto, Andre Q Andrade","doi":"10.1002/pds.70267","DOIUrl":"10.1002/pds.70267","url":null,"abstract":"<p><strong>Background: </strong>Long-term antidepressant use may reduce the risk-benefit profile due to the increased likelihood of withdrawal symptoms and higher incidence of side effects. This epidemiological study investigates historical trends in long-term antidepressant use, which was defined as maintaining continuous antidepressant use for at least 365 days, allowing for gaps in dispensing of up to 60 days in the Australian community from 2014 to 2023.</p><p><strong>Method: </strong>A retrospective analysis was conducted using a 10% sample of data from the Australian Pharmaceutical Benefits Scheme (PBS), including patients aged over 10 years who had been dispensed a PBS-listed antidepressant between January 2014 and December 2023.</p><p><strong>Results: </strong>From 2014 to 2023, the prevalence of long-term antidepressant use increased from 66.1 to 84.6 per 1000 population. Age-stratified analysis showed that the 10-24 age group had the highest relative increase in long-term user prevalence (110%) and in the proportion of long-term users (35%). The average duration of the treatment episode increased by 25% across all ages, with the 10-24 group showing the largest rise (56%). The percentage of long-term users with apparent dose reductions showed minimal change over time.</p><p><strong>Conclusions: </strong>The study highlights a growing trend in long-term antidepressant use across all age groups, particularly among those aged 10-24, warranting further investigation into the underlying factors. The extended treatment duration, coupled with limited medicine apparent dose reduction efforts, may suggest overprescription and underuse of deprescribing strategies. A more comprehensive mental health approach is needed, integrating effective deprescribing practices and emerging technological interventions.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70267"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12619122/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145523842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of Adverse Medicine Events by Pharmacists in Residential Aged Care Facilities: Secondary Analysis of Data From ReMInDAR Trial.","authors":"Abebe Basazn Mekuria, Renly Lim, Andre Q Andrade, Debra Rowett, Elizabeth E Roughead","doi":"10.1002/pds.70261","DOIUrl":"10.1002/pds.70261","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Pharmacists often identify symptoms during medication reviews that may or may not be adverse medicine events (AMEs), but these have not yet been quantified. This study aimed to quantify the extent of these symptoms representing AMEs by comparing them with a known set of AMEs and symptoms listed in existing medicine-related symptom assessment tools.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Method: &lt;/strong&gt;A secondary analysis of data from the Reducing Medicine-Induced Deterioration and Adverse Reactions (ReMInDAR) trial was conducted. Adverse events or symptoms were extracted from pharmacists' progress notes, and their frequency and Medicine Likeliness Ratio (probability of being medicine-related) were determined. Pharmacist-recorded adverse events were compared to a subset of AMEs identified by a clinical panel, and agreement was assessed using Cohen's κ. Pharmacist-recorded adverse events or symptoms were also compared with those in the PHArmacotherapeutical Symptom Evaluation-20 questions (PHASE-20), and the Patient Reported Outcome Measure, Inquiry into Side Effects (PROMISE).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Result: &lt;/strong&gt;Pharmacists recorded 3.1 symptoms per person; 68.8% of the symptoms had a medicine-likeness ratio ≥ 40.0%. The most prevalent medicine-related events recorded by pharmacists included falls (13.6%), swelling (7.1%), constipation (5.4%), nocturia (4.2%), shortness of breath (4.0%), bleeding (4.0%), nausea and vomiting (3.1%), dizziness (2.8%), drowsiness (2.3%), and rash (2.0%). Of the subset of 273 AMEs identified by the panel, 14.7% corresponded to adverse events recorded by pharmacists. The agreement between pharmacist-recorded and panel-identified AMEs was significant but low (κ = 0.074, p = 0.008). The majority of frequently detected medicine-related symptoms were in PROMISE (56.4% of recorded AMEs) and PHASE-20 (81.3% of recorded AMEs).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;While pharmacists recorded a notable number and variety of adverse events or symptoms, underreporting and discrepancies were still observed. As items in the PHASE-20 aligned with most recorded events, further research is warranted to determine if it can help pharmacists in improving the detection and monitoring of AMEs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;Pharmacists often notice symptoms during medication reviews that may or may not be caused by the medicines. This study aimed to measure how often the symptoms reported by pharmacists were side effects of the medicines in use. We looked at data from a previous trial in aged care homes and reviewed the notes pharmacists wrote about possible symptoms or side effects. We then compared these to a list of known medicine-related problems identified by medical experts. On average, pharmacists recorded about three symptoms per person, and more than two-thirds of these were likely to be related to medicines. The most common side effects or symptoms included falling, swelling, difficulty passing stools, needing t","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70261"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12592833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145459466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Research Sprints: An Intensive 1-Week Approach to Training Collaborative Work in Pharmacoepidemiologic Research.","authors":"Mette Reilev, Jesper Hallas","doi":"10.1002/pds.70238","DOIUrl":"https://doi.org/10.1002/pds.70238","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 11","pages":"e70238"},"PeriodicalIF":2.4,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145401601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}