British journal of clinical pharmacology最新文献

{"title":"Navigating challenges and opportunities in orphan medicines: A spotlight commentary on rare diseases.","authors":"Andrej Belančić, Elvira Meni Maria Gkrinia, Robert Likić, Dinko Vitezić","doi":"10.1002/bcp.70013","DOIUrl":"https://doi.org/10.1002/bcp.70013","url":null,"abstract":"","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143432503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adherence and persistence with direct oral anticoagulants by dose regimen: A systematic review.","authors":"Raúl Quirós López, Francesc Formiga Pérez, Jan Beyer-Westendorf","doi":"10.1002/bcp.70003","DOIUrl":"https://doi.org/10.1002/bcp.70003","url":null,"abstract":"<p><strong>Introduction: </strong>Direct oral anticoagulants (DOACs) are used in patients with non-valvular atrial fibrillation (NVAF) to prevent complications such as embolic events. Poor adherence to DOACs increases the risk of these complications. This manuscript reviews the impact of once-daily (OD) vs twice-daily (BID) dosing regimens on adherence and persistence to the authorized DOACs (dabigatran, rivaroxaban, apixaban and edoxaban) in patients with NVAF, aiming to provide insights into guide clinical decision-making.</p><p><strong>Methods: </strong>A systematic review was performed. First, a bibliographical search was carried out in PubMed, Scopus and the Cochrane Library. Articles that provided quantitative data comparing adherence and/or persistence associated with OD vs BID regimens of DOACs among patients receiving treatment for NVAF were included. Two analyses of adherence and persistence were conducted, one based on the overall outcomes and another, more restricted, to minimize the risk of overestimating results. Additionally, univariate analyses were conducted based on the number of follow-up days and the DOAC molecule.</p><p><strong>Results: </strong>Thirty-nine studies, involving 976 494 patients, were analysed. The OD regimen demonstrated significantly higher adherence and persistence (P < .05) than the BID regimen in most outcomes. Adherence favoured OD in 53.1% of cases, while only 12.2% favoured BID. Similarly, persistence was higher with the OD regimen in 67.7% of cases compared to 14.9% for the BID regimen. These results remained consistent over time; nevertheless, variations were observed depending on the specific DOAC molecules.</p><p><strong>Conclusion: </strong>Adherence and persistence of treatment with DOACs in patients with NVAF were greater for the OD than for the BID regimen.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143432472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Solanidine-derived CYP2D6 phenotyping elucidates phenoconversion in multimedicated geriatric patients.","authors":"Jens Andreas Sarömba, Julian Peter Müller, Jolanta Tupiec, Anjali Roeth, Berkan Kurt, Florian Kahles, Thea Laurentius, Cornelius Bollheimer, Julia C Stingl, Katja S Just","doi":"10.1002/bcp.70004","DOIUrl":"https://doi.org/10.1002/bcp.70004","url":null,"abstract":"<p><strong>Aims: </strong>Phenoconversion, a genotype-phenotype mismatch, challenges a successful implementation of personalized medicine. The aim of this study was to detect and determine phenoconversion using the solanidine metabolites 3,4-seco-solanidine-3,4-dioic acid (SSDA) and 4-OH-solanidine as diet-derived cytochrome P450 2D6 (CYP2D6) biomarkers in a geriatric, multimorbid cohort with high levels of polypharmacy.</p><p><strong>Methods: </strong>Blood samples and data of geriatric, multimedicated patients were collected during physician counsel (CT: NCT05247814). Solanidine and its metabolites were determined via liquid chromatography/tandem mass spectrometry and used for CYP2D6 phenotyping. CYP2D6 genotyping was performed and activity scores (AS) were assigned. Complete medication intake was assessed. A shift of the AS predicted via genotyping as measured by phenotyping was calculated.</p><p><strong>Results: </strong>Solanidine and its metabolites were measured in 88 patients with complete documentation of drug use. Patients had a median age of 83 years (interquartile range [IQR] 77-87) and the majority (70.5%, n = 62) were female. Patients took a median of 15 (IQR 12-17) medications. The SSDA/solanidine metabolic ratio correlated significantly with the genotyping-derived AS (P < .001) and clearly detected poor metabolizers. In the model adjusted for age, sex, Charlson Comorbidity Index and estimated glomerular filtration rate each additional CYP2D6 substrate/inhibitor significantly lowered the expected AS by 0.53 (95% confidence interval 0.85-0.21) points in patients encoding functional CYP2D6 variants (R² = 0.242).</p><p><strong>Conclusions: </strong>Phenotyping of CYP2D6 activity by measurement of diet-derived biomarkers elucidates phenoconversion in geriatric patients. These results might serve as a prerequisite for the validation and establishment of a bedside method to measure CYP2D6 activity in multimorbid patients for successful application of personalized drug prescribing.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143432519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exposure to pseudoephedrine during pregnancy and major congenital malformations: Findings from a large population-based cohort of pregnancies.","authors":"Saar Dor, Tal Michael, Yael Levi, Gali Pariente, Eitan Lunenfeld, Amalia Levy, Shira Birenstock-Cohen, Sharon Daniel","doi":"10.1002/bcp.70001","DOIUrl":"https://doi.org/10.1002/bcp.70001","url":null,"abstract":"<p><strong>Aims: </strong>The aim of this study was to assess the risk of major congenital malformations following first-trimester pseudoephedrine (PSE) exposure.</p><p><strong>Methods: </strong>A population-based observational cohort study was conducted on pregnancies of women aged 15-49 years, insured by Clalit Health Services in southern Israel, who gave birth or had elective pregnancy terminations due to suspected fetal malformation at Soroka Medical Center (1999-2017). The study focused on Clarinase, a drug that contains a high dose of PSE (120 mg) and 5 mg of loratadine. Multivariable negative binomial regression models were used to evaluate the risk for major congenital malformations, adjusting for potential confounders.</p><p><strong>Results: </strong>Of 251 543 pregnancies, 313 (0.12%) were exposed to high-dose PSE in the first trimester. PSE exposure was not associated with major congenital malformations overall (adjusted relative risk [aRR] = 0.90, 95% confidence interval [CI] 0.558-1.45; P = 0.66) or by organ system (cardiovascular: aRR = 0.938, 95% CI 0.499-1.762; central nervous system: aRR = 0.618, 95% CI 0.086-4.451; musculoskeletal: aRR = 1.800, 95% CI 0.801-4.042; gastrointestinal: aRR = 1.013, 95% CI 0.142-7.241; genitourinary: aRR = 0.704, 95% CI 0.225-2.204).</p><p><strong>Conclusions: </strong>First-trimester PSE exposure was not an independent risk factor for major congenital malformations, either overall or by organ system.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143432479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First-in-human safety, tolerability, pharmacokinetics and pilot food-effect study of the candidate antimalarial compound MMV367.","authors":"Andrea Kuemmerle, Nand Singh, Denis Gossen, Annick Janin, Raman Sharma, Anthony Cahn, Rachel A Gibson, Somasekhara R Menakuru, Erin Lambourne, Tom Dove, Francisco-Javier Gamo, Laura Sanz, Benoit Bestgen, Stephan Chalon","doi":"10.1002/bcp.70000","DOIUrl":"https://doi.org/10.1002/bcp.70000","url":null,"abstract":"<p><strong>Aim: </strong>To evaluate the safety, tolerability and pharmacokinetics in healthy participants of orally administered MMV367 (GSK3772701), a novel antimalarial interfering with Plasmodium falciparum acyl coenzyme A synthetase 10/11 function.</p><p><strong>Methods: </strong>This first-in-human study enrolled 47 healthy male and female participants. Part 1 was a randomised, double-blind, placebo-controlled study in which four sequential fasted cohorts received MMV367 single ascending doses (100, 300, 750 and 1500 mg) or placebo (six active, two placebo per cohort). Part 2 was a randomised, open-label crossover (fed-fasted) pilot food-effect study of MMV367 440 mg (n = 8). In Part 3 MMV367 400 mg was administered once daily for 3 days in a single cohort (six active, two placebo).</p><p><strong>Results: </strong>Treatment-emergent adverse events (TEAEs) occurred in 36.8% (14/38) of participants receiving MMV367 vs 44.4% (4/9) with placebo. There were two MMV367-related TEAEs, and no serious or severe TEAEs or clinically relevant changes in electrocardiograms, vital signs or laboratory tests. In Part 1 (fasted), maximum plasma concentrations occurred between 2.0 and 5.0 h post dose, with a geometric mean half-life of 16.5-18.4 h. Approximate dose proportionality was demonstrated across the dose range (100-1500 mg). In Part 2, MMV367 relative bioavailability (fed vs fasted) was 161.4% (90% confidence interval 148.3, 175.6) for maximum observed concentration (C_max), 130.4% (122.2, 139.1) for the area under the curve (AUC) until the last measurable concentration and 132.9% (124.1, 142.3) for AUC extrapolated to infinity. In Part 3, geometric mean day 1:3 exposure ratios (geometric co-efficient of variability) were 1.9 (4.9%) for C_max and 2.1 (7.7%) for the AUC for the defined interval between doses after once-daily dosing for 3 days.</p><p><strong>Conclusions: </strong>MMV367 demonstrated acceptable safety, tolerability and pharmacokinetic profiles supporting further development as an antimalarial drug.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143432483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the impact of general practice pharmacist-led person-centred medicines reviews on medicines appropriateness and patient-reported outcome measures.","authors":"Clare Kinahan, Ciara Kirke, Leon O'Hagan, Frank Moriarty, Kevin D Murphy, Laura J Sahm, Cian O'Mahony, Emma J Coyle, Stephen Byrne, Kieran Dalton","doi":"10.1111/bcp.16372","DOIUrl":"https://doi.org/10.1111/bcp.16372","url":null,"abstract":"<p><strong>Aim: </strong>The aim of this study was to investigate the impact of pharmacist-led person-centred medicines reviews in general practices on medicines appropriateness, polypharmacy indicators (high-risk prescribing markers), and patient-reported outcome measures (PROMs).</p><p><strong>Methods: </strong>Four pharmacists conducted person-centred medicines reviews in ten general practices between January 2021 and December 2022 for patients with hyperpolypharmacy (prescribed ≥10 regular medicines) and/or at high risk of medicines-related harm. Prescribing recommendations were provided to the general practitioner and followed up with patients and/or healthcare professionals. In this single arm study, pre and post intervention: (1) polypharmacy indicators were documented, and for a sample of patients, the (2) Person-Centred Medication Appropriateness Index (PC-MAI) scores and (3) PROMs were gathered.</p><p><strong>Results: </strong>Of the 1471 included patients, the mean age was 76 years, 88.4% had hyperpolypharmacy, whilst the mean number of medicines was 13.8 pre and 12.3 post review. Of the 1056 polypharmacy indicator occurrences identified, 70.7% were resolved post review. Of the 194 patients with pre-review and post-review PC-MAI scores, 99% had a reduction; the mean reduction was 17.3 (95% confidence interval [CI] 15.8-18.8, P < .0001) per patient and 1.2 (95% CI 1.0-1.3, P < .0001) per medicine. PROMs were collected for 179 patients; 87.7% reported the review helped their medicines understanding, 63.1% their experience of side effects, 36.9% their ability to take medicines correctly, and 30.5% the impact of medicines on their daily activities.</p><p><strong>Conclusions: </strong>General practice pharmacist-led person-centred medicines reviews for patients with hyperpolypharmacy and/or at high risk of medicines-related harm delivered substantial improvements in medicines appropriateness and patient-reported outcomes, thus providing evidence to support their wider implementation.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying longitudinal medication adherence patterns of antipsychotic treatments: A real-world cohort study in Catalonia, Spain.","authors":"Marina Fuente-Moreno, Caitriona Cahir, Valéria Lima Passos, Kathleen Bennett, Caroline Walsh, Patricia Hermida-González, Jorge Peláez de Loño, Maria Eugènia Rey Abella, Luisa Baladon, Maria Rubio-Valera, Antoni Serrano-Blanco, Ignacio Aznar-Lou","doi":"10.1111/bcp.16399","DOIUrl":"https://doi.org/10.1111/bcp.16399","url":null,"abstract":"<p><strong>Aims: </strong>Suboptimal adherence to antipsychotics leads to poorer outcomes and relapse. Several factors, including the formulation and number of antipsychotics, may influence medication adherence. This study aimed to identify longitudinal adherence patterns to oral and long-acting injectable (LAI) antipsychotics in monotherapy/polypharmacy through group-based trajectory modelling (GBTM).</p><p><strong>Methods: </strong>This was a retrospective cohort study that linked prescription and dispensing data of adult patients with a new antipsychotic prescribed between 2015 and 2019 in Catalonia (Spain). GBTM was used to classify patients following a similar longitudinal pattern of adherence. The response variable was adherence, estimated through the continuous medication availability measure (CMA), in each 30-day period during 12 months of follow-up. Baseline and treatment characteristics were used to characterize the trajectories identified.</p><p><strong>Results: </strong>Among the 7730 patients included in the study, we identified seven clinically distinct trajectory groups of adherence to antipsychotics: non-initiation (19%), low implementation (9%), immediate discontinuation (6%), mid-discontinuation (5%), late-discontinuation (5%), high implementation (21%), and full implementation (35%). Trajectories with better adherence were more likely to receive the prescription from a psychiatrist, receive LAIs and have previous exposure to other antipsychotics. Intermittent medication use and high levels of polypharmacy were characteristics of the \"low\" and \"high implementation\" groups.</p><p><strong>Conclusions: </strong>Targeting newly prescribed patients by improving the clinician-patient relationship could be particularly valuable, as they seem more likely to not initiate or discontinue treatment immediately compared to patients in other groups. Patients on polypharmacy should have more regular adherence monitoring and LAIs should be considered, as they appear to be associated with better adherence.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Papaverine safety during pregnancy: Insights from a large population-based cohort of pregnancies.","authors":"Yael Levi, Tal Michael, Saar Dor, Gali Pariente, Eitan Lunenfeld, Amalia Levy, Shira Birenstock-Choen, Sharon Daniel","doi":"10.1111/bcp.16404","DOIUrl":"https://doi.org/10.1111/bcp.16404","url":null,"abstract":"<p><strong>Aims: </strong>Papaverine hydrochloride functions as an antispasmodic and vasodilator medication. Data concerning the teratogenic risk of papaverine is currently lacking. The aims of this paper are to examine the association between first-trimester exposure to papaverine and major congenital malformations and the association between third trimester exposure to papaverine and late adverse pregnancy outcomes.</p><p><strong>Methods: </strong>We conducted a population-based retrospective cohort study that included pregnant women 15-49 years old insured by 'Clalit Health Services' in southern Israel, who gave birth or had an elective pregnancy termination due to suspected fetal malformation at Soroka Medical Center between 1999 and 2017. Multivariate negative binomial regression models were used to examine the associations between papaverine during the first trimester and major congenital malformations, and between papaverine during the third trimester and late adverse pregnancy outcomes, adjusting for potential confounders.</p><p><strong>Results: </strong>The study included a total of 254 333 pregnancies, of which 3604 (1.41%) were exposed to papaverine during the first trimester, and 1253 (0.49%) during the third trimester. No significant associations were found between first-trimester exposure to papaverine and total congenital major malformations or specific malformations according to organ systems in the multivariate analysis (adjusted RR for: total major malformations = 1.021; 95% confidence interval (CI) [0.895-1.165], cardiovascular = 1.073; 95% CI [0.905-1.273], central nervous system = 0.784; 95% CI [0.484-1.271], musculoskeletal = 0.823; 95% CI [0.588-1.153], gastrointestinal = 0.887; 95% CI [0.457-1.718], genitourinary = 1.076; 95% CI [0.805-1.438]). Additionally, we did not detect significant associations between third-trimester exposure to papaverine and late adverse pregnancy outcomes.</p><p><strong>Conclusions: </strong>Exposure to papaverine during pregnancy was not associated with adverse pregnancy outcomes in the population studied, compared with non-exposed pregnancies.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medication adherence and hospitalizations in older patients with coronary heart disease in Vietnam.","authors":"Tan Van Nguyen, Hang Thi Thuy Nguyen, Dung Ngoc Truong, Viet Quoc Nguyen, Huy Quang Nguyen, Huy Quoc Nguyen, Trinh Thi Kim Ngo, Erkihun Amsalu, Wei Jin Wong, Tu Ngoc Nguyen","doi":"10.1111/bcp.16405","DOIUrl":"https://doi.org/10.1111/bcp.16405","url":null,"abstract":"<p><strong>Aims: </strong>This study aimed to assess medication adherence among older people with coronary heart disease and its relationship with hospitalizations.</p><p><strong>Methods: </strong>This is a prospective cohort study conducted at the outpatient clinics of a major hospital in Vietnam from November 2022 to June 2023. Consecutive older patients with coronary heart disease were recruited and followed for 6 months. Medication adherence was defined using the five-item Medication Adherence Report Scale (MARS-5). Multivariable logistic regression models were applied to examine the impact of medication adherence on hospitalization due to cardiovascular disease (CVD) and all-cause hospitalization.</p><p><strong>Results: </strong>There were 643 participants, mean age 73 ± 8 years, 74.3% were male. Overall, 76.4% (491/643) were classified as 'adherent'. Over 6 months follow-up, 23.3% of the participants were admitted to hospital and of these hospitalizations, 9.2% were due to CVD. The CVD-related hospitalization rate was significantly higher in the non-adherent group compared to the adherent group (13.8% vs. 7.7%, P = 0.023, respectively). In logistic regression models, medication adherence was associated with significantly reduced odds of CVD-related hospitalization (adjusted odds ratio [OR] 0.48, 95% confidence interval [CI] 0.27-0.86). Medication adherence was also associated with a trend of reduced all-cause hospitalization (adjusted OR 0.75, 95% CI 0.49-1.15).</p><p><strong>Conclusions: </strong>This study showed a positive relationship between medication adherence and reduced risk of CVD-related hospitalization in older people with coronary heart disease. Healthcare providers should consider incorporating adherence assessment into the long-term care for older patients with coronary heart disease.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143188366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Social media as a source of drug safety information in the paediatric population.","authors":"Ingrid Vilimelis-Piulats, Ariadna Pérez-Ricart, Maite Bosch Peligero, Albert Calvo, Josep Maria Suñé Negre, Juan-Carlos Juárez-Gimenez","doi":"10.1111/bcp.16392","DOIUrl":"https://doi.org/10.1111/bcp.16392","url":null,"abstract":"<p><strong>Aims: </strong>The paediatric population is vulnerable to suffering adverse drug events (ADEs) such as negative outcomes due to medication (NOMs)-drug related problems (DRPs), especially adverse drug reactions (ADRs) and medication errors (MEs). Social media (SM) is considered an interesting tool for pharmacovigilance. This study aims to assess descriptions of ADRs, NOM-DRPs and MEs in SM.</p><p><strong>Methods: </strong>Observational, ambispective study assessing NOM-DRPs, ADRs and MEs in posts of child-rearing public parenting forums from inception until December 2021 of drugs dispensed in outpatient setting. ADEs were classified, assessing causality by Liverpool Causality Assessment Tool and seriousness by the World Health Organization criteria. Summary of product characteristics were used to determine ADR prevalence.</p><p><strong>Results: </strong>In total, 3573 posts of 2 child-rearing public parenting forums were retrieved; 906 (25%) contained descriptions of medicine of which 823 (91%) were analysed; 425 posts (52%) described 636 NOM-DRPs (1 NOM-DRP median per child, interquartile range [IQR] 1-8), from which 161 (26%) were ADRs in 105 posts (1.5 ADR median per child, IQR 1-4) and 95 (15%) were MEs in 64 posts (1 ME median per child, IQR 1-4). From posts mined with medicines mentions, 70% included NOM-DRPs, 18% ADRs and 10% MEs. More ADRs occurred in females and infants. Most ADRs (158; 98%) were evaluated as possible and 17 ADRs (11%) were serious. Uncommon 19 (12%), (14, 9%), very rare (3, 2%) and rare (1, 1%) ADRs were also found.</p><p><strong>Conclusion: </strong>Results suggest that information retrieved from SM may be useful to assess paediatric ADEs and provide valuable pharmacovigilance complementary data.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}