Zuzana Juhásová, Fatma Karapinar-Çarkit, Daniala L Weir
{"title":"The use of international classification of diseases codes to identify hospital admissions linked with adverse drug events: Validation study.","authors":"Zuzana Juhásová, Fatma Karapinar-Çarkit, Daniala L Weir","doi":"10.1002/bcp.70116","DOIUrl":"https://doi.org/10.1002/bcp.70116","url":null,"abstract":"<p><strong>Aims: </strong>Several methods exist to identify hospital admissions related to adverse drug events (ADEs). Clinical adjudication by healthcare professionals is the gold standard but is labour-intensive. Spontaneous reporting and routinely collected healthcare data using a set of International Classification of Diseases (ICD) codes often underestimate the prevalence of ADE-related admissions. Expanding the set of ICD codes could improve detection; however, validation is limited. The objective was to describe the agreement between ADE-related ICD-10 codes and clinically adjudicated ADE-related admissions in 2 settings.</p><p><strong>Methods: </strong>This study analysed 2 datasets: 1102 readmissions from a hospital in the Netherlands (180 ADE-related) and 1228 admissions from a hospital in the Czech Republic (195 ADE-related). Clinical adjudication involved expert review including causality assessment to identify ADE-related hospital admissions. The sensitivities and specificities were calculated for a narrow code set (higher drug-likelihood codes containing words like drug-induced) and a broad code set of ICD-10 codes (including codes very likely, likely and possibly ADE-related).</p><p><strong>Results: </strong>The narrow ICD-10 set showed a sensitivity of 3% (95% confidence interval [CI] 2-6%) and a specificity of 99.6% (95% CI 99-100%). The broad set increased sensitivity to 27% (95% CI 23-32%), with specificity decreasing slightly to 92% (95% CI 91-94%). Preventable ADEs were identified less frequently with both ICD-10 code sets.</p><p><strong>Conclusions: </strong>Only 3% of ADE-related admissions were detected by the narrow ICD-code set and 27% by the broad code set without a significant drop in the specificity. ADE-related ICD codes seem to serve as triggers for 1 in 4 ADE-related hospital admissions.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198284","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}
Anaelle Lubila, Matthew Parsons, Iris Wood Campar, Hana Hassanin
{"title":"Assessing the feasibility of infusing slow normal saline through a three-metre-longline to maintain patency of a peripheral venous cannula: A pilot study.","authors":"Anaelle Lubila, Matthew Parsons, Iris Wood Campar, Hana Hassanin","doi":"10.1002/bcp.70123","DOIUrl":"https://doi.org/10.1002/bcp.70123","url":null,"abstract":"<p><strong>Aims: </strong>In studies requiring repeated blood sampling, a cannula is typically inserted into a peripheral vein and used for regular blood draws. In some studies, subtherapeutic doses of heparin is infused overnight to maintain cannula patency; however, there is limited evidence supporting its use in this context. Normal saline infusions have been proposed as an alternative for extending cannula lifespan. This study aims to address the clinical need for data on blood collection techniques in healthy participants.</p><p><strong>Methods: </strong>The study was conducted at the Surrey Clinical Research Facility (CRF)/Surrey Sleep Research Centre (SSRC) sleep laboratory, involved five healthy males and females aged 18-35 years receiving a 6-h normal saline infusion. The primary outcome included the difficulty of drawing blood at hourly intervals, the incidence of phlebitis, re-cannulation and adverse events, as well as the condition of the cannulas post-infusion, assessed during each hourly blood draw.</p><p><strong>Results: </strong>By the fourth interval, 80% of blood draws were made with no difficulty, reducing to 40% by the end of the study. Self-limiting discomfort (score of 1 on VIP scale) was observed in two participant's cannulas; this resolved quickly in both cases. All five cannulas remained patent throughout and after the 6-h normal saline infusion.</p><p><strong>Conclusions: </strong>While normal saline shows promise in maintaining peripheral cannula patency, a double-blinded clinical trial with a larger sample size is necessary to establish statistical significance in the comparison of heparin and normal saline.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198283","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}
Ramesh Sharma Poudel, Sabrina J M Burer, Kylie A Williams, Lisa G Pont
{"title":"Validity of the Medication Safety Self-Assessment for Long-Term Care tool in Australian long-term care: a RAND appropriateness method study.","authors":"Ramesh Sharma Poudel, Sabrina J M Burer, Kylie A Williams, Lisa G Pont","doi":"10.1002/bcp.70115","DOIUrl":"https://doi.org/10.1002/bcp.70115","url":null,"abstract":"<p><strong>Aims: </strong>The validity of using the Canadian Medication Safety Self-Assessment for Long-Term Care (MSSA-LTC) tool in the international context is unknown. This study aims to determine the face and content validity of the Canadian MSSA-LTC tool for assessing medication safety-related processes in the Australian long-term care (LTC) setting.</p><p><strong>Methods: </strong>A modified two-round RAND/UCLA Appropriateness Method was used to assess the face and content validity of the 129 items in the Canadian MSSA-LTC tool for use in the Australian LTC setting. An expert panel of health professionals with expertise in medication management in the Australian LTC setting rated each item separately for relevance to the Australian LTC context (face validity) and importance for medication safety (content validity). Items, where there was panel agreement that the item was definitely or potentially relevant for the Australian context/important for medication safety, were considered valid for the relevant attribute.</p><p><strong>Results: </strong>Nine expert panel members participated in the study. The expert panel rated 118 (91.5%) of the 129 items of the MSSA-LTC tool as acceptable relevant for the Australian LTC setting and, therefore, having face validity and all items (100%) as important for medication safety, thus having good content validity. The expert panel members were unable to agree about the relevance of nine items for use in the Australian LTC context and considered two items as not relevant for the Australian LTC context.</p><p><strong>Conclusions: </strong>The Canadian MSSA-LTC tool appears valid for measuring medication safety-related processes in Australian LTC with good face and content validity.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191531","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}
Johanna Villén, Johanna Laux, Björn Wettermark, Sofia Kälvemark Sporrong, Marmar Nekoro, Helle Håkonsen
{"title":"Towards greener prescribing? Swedish general practitioners' support for policies to reduce pharmaceutical pollution","authors":"Johanna Villén, Johanna Laux, Björn Wettermark, Sofia Kälvemark Sporrong, Marmar Nekoro, Helle Håkonsen","doi":"10.1111/bcp.70066","DOIUrl":"https://doi.org/10.1111/bcp.70066","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Prescribing pharmaceuticals is essential to improve health, but it also has substantial environmental impact. This study investigated the extent to which Swedish general practitioners (GPs) are willing to integrate environmental aspects into treatment decisions and their opinions on policies to reduce pharmaceutical pollution.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A questionnaire assessing environmental considerations in prescribing was developed and distributed to 1233 Swedish GPs and physicians in training (response rate: 22%) between September 2023 and June 2024. It included 3 patient cases to assess trade-offs between therapeutic effect and environmental impact of pharmaceuticals used for pain management, blood pressure reduction, and contraception. Questions about attitudes to policies to reduce the environmental impact of pharmaceuticals were also included. Data were analysed using descriptive and inferential statistics.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Most respondents were willing to prescribe a less effective pharmaceutical if it was environmentally preferable, 77% for pain management and blood pressure reduction, and 50% for contraception. Environmental impact was ranked as the least important factor in prescribing decisions when compared to cost, regional treatment guidelines, dosage intervals, and user-friendliness. A total of 68% of respondents agreed that physicians should consider environmental aspects when prescribing, however only a few often searched for environmental information when prescribing. Policies directed towards other stakeholders, such as authorities and the pharmaceutical industry, received substantial support.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Swedish GPs are willing to consider environmental factors when prescribing. However, other factors are more often considered and GPs attribute higher responsibility to other actors. Improving access to environmental information about pharmaceuticals could support greener prescribing.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 6","pages":"1623-1631"},"PeriodicalIF":3.1,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/bcp.70066","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144171500","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}
Rebecca Preyra, Lujain Ez Eddin, Fatemeh Ahmadi, Atefeh Jafari, Flory T. Muanda
{"title":"Safety of sulfamethoxazole–trimethoprim for the treatment of bacterial infection in outpatient settings: A systematic review and meta-analysis with active comparator disproportionality analysis","authors":"Rebecca Preyra, Lujain Ez Eddin, Fatemeh Ahmadi, Atefeh Jafari, Flory T. Muanda","doi":"10.1111/bcp.70051","DOIUrl":"https://doi.org/10.1111/bcp.70051","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Sulfamethoxazole–trimethoprim (SMX-TMP) is a widely used antibiotic for treating bacterial infections, but its safety in adult outpatients remains understudied. This systematic review and meta-analysis evaluated the safety profile of SMX-TMP and identified critical research gaps. The pharmacovigilance study aimed to validate and extend findings from meta-analyses to better understand the real-world safety of SMX-TMP.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We searched MEDLINE and Embase up to 12 August 2024, to identify studies comparing adverse drug events (ADEs) following SMX-TMP <i>vs</i>. other antibiotics in adult outpatients. Meta-analyses were performed where data allowed. A pharmacovigilance study using the Food and Drug Administration Adverse Event Reporting System was conducted to supplement our findings.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Our review, which included 43 studies, found SMX-TMP had a nearly 3-fold higher risk of rash compared to other antibiotics (pooled risk ratio 2.56, 95% confidence interval [1.69, 3.89], <i>I</i><sup>2</sup> = 0%, <i>n =</i> 4458 participants, 24 randomized control trials). Pharmacovigilance data confirmed a higher frequencies of skin disorders and other ADEs compared to various comparator drugs. Compared to azithromycin, SMX-TMP was associated with a 5-fold increase in Stevens–Johnson syndrome, a 3-fold increase in toxic epidermal necrolysis, and a 10-fold increase in drug reaction with eosinophilia and systemic symptoms. Additionally, SMX-TMP showed a 10-fold increase in reports of pancytopenia, a 6-fold increase in neutropenia, a 4-fold increase in both thrombocytopenia and aplastic anaemia, a 56-fold increase in hyperkalaemia, and a 10-fold increase in hyponatraemia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Our meta-analyses and pharmacovigilance study suggested SMX-TMP was associated with increased risk of ADEs compared to other antibiotics including amoxicillin/clavulanate, azithromycin and nitrofurantoin. Further robust research is essential to confirm these safety signals and guide clinical practice.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 6","pages":"1632-1648"},"PeriodicalIF":3.1,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/bcp.70051","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144171625","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}
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
{"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":"10.1111/bcp.70000","DOIUrl":"https://doi.org/10.1111/bcp.70000","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>To evaluate the safety, tolerability and pharmacokinetics in healthy participants of orally administered MMV367 (GSK3772701), a novel antimalarial interfering with <i>Plasmodium falciparum</i> acyl coenzyme A synthetase 10/11 function.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>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>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Treatment-emergent adverse events (TEAEs) occurred in 36.8% (14/38) of participants receiving MMV367 <i>vs</i> 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 <i>vs</i> fasted) was 161.4% (90% confidence interval 148.3, 175.6) for maximum observed concentration (<i>C</i><sub>max</sub>), 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 <i>C</i><sub>max</sub> and 2.1 (7.7%) for the AUC for the defined interval between doses after once-daily dosing for 3 days.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>MMV367 demonstrated acceptable safety, tolerability and pharmacokinetic profiles supporting further development as an antimalarial drug.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 6","pages":"1821-1833"},"PeriodicalIF":3.1,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/bcp.70000","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144171647","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":"Consideration of ethnic differences in approvals for anti-HIV medicines in Japan: Evaluation based on pharmacokinetic studies and post-marketing data.","authors":"Rumiko Shimazawa, Masayuki Ikeda","doi":"10.1002/bcp.70100","DOIUrl":"https://doi.org/10.1002/bcp.70100","url":null,"abstract":"<p><p>More than 30 anti-HIV drugs have been approved in Japan using data from dossiers submitted to the United States or European regulatory authorities since 1998. These drugs were approved with the same dosage and administration regimes as in the United States and Europe, using data from pivotal studies that rarely included any Japanese patients, whereas pharmacokinetics (PK) studies in Japanese subjects have been previously required by the Japanese authorities. There have not been any clinically meaningful ethnic differences observed in the PK data from Japanese studies, and no issues with efficacy or safety have been identified as these drugs were marketed. The absence of ethnic differences in PK, efficacy and safety data for over 30 anti-HIV medicines has reached the state of 'the need for bridging data will lessen with experience' in ICH-E5. It may not be necessary to consider biological ethnic differences in the approval of anti-HIV drugs anymore.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172656","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}
Alexandra Power-Hays, Ruth Namazzi, Min Dong, Caroline Kazinga, Charles Kato, Sadat Aliwuya, Kathryn McElhinney, Andrea L. Conroy, Adam Lane, Chandy John, Alexander A. Vinks, Teresa Latham, Robert O. Opoka, Russell E. Ware
{"title":"The feasibility of pharmacokinetic-based dosing of hydroxyurea for children with sickle cell anaemia in Uganda: Baseline results of the alternative dosing and prevention of transfusions trial","authors":"Alexandra Power-Hays, Ruth Namazzi, Min Dong, Caroline Kazinga, Charles Kato, Sadat Aliwuya, Kathryn McElhinney, Andrea L. Conroy, Adam Lane, Chandy John, Alexander A. Vinks, Teresa Latham, Robert O. Opoka, Russell E. Ware","doi":"10.1111/bcp.70071","DOIUrl":"https://doi.org/10.1111/bcp.70071","url":null,"abstract":"<p>Pharmacokinetic (PK)-guided dosing of hydroxyurea for children with sickle cell anaemia (SCA) could optimize dosing and improve outcomes, but its feasibility has not been demonstrated in low-resource settings where the majority of affected children live. Alternative Dosing And Prevention of Transfusions (ADAPT) is a prospective trial evaluating blood transfusions and the feasibility of determining PK-guided, hydroxyurea maximum tolerated doses (MTD) for children with SCA in Uganda, using portable high-performance liquid chromatography (HPLC) and a novel PK software programme (HdxSim). ADAPT enrolled 106 participants, and 100% completed PK testing. PK-guided doses were generated for 78%, of which 38% were within the protocol-defined range. Accurately, measuring serum hydroxyurea concentrations via HPLC and the potential for hydroxyurea degradation impacted the feasibility. Ensuring that people with SCA globally have access to hydroxyurea is imperative, and improving treatment strategies requires ongoing innovation including PK-guided dosing. ADAPT is registered at ClinicalTrials.gov (NCT05662098).</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 6","pages":"1865-1872"},"PeriodicalIF":3.1,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/bcp.70071","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144171867","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":"Spotlight commentary: De-labelling the truth: Clearing the fog around antibiotic allergy labels","authors":"Iva Mikulić, Robert Likić","doi":"10.1111/bcp.70085","DOIUrl":"https://doi.org/10.1111/bcp.70085","url":null,"abstract":"<p>The aim of this spotlight commentary is to review what is new in the field of drug hypersensitivity reactions (DHR) with a focus on hypersensitivity to antibiotics and drug allergy de-labelling by reviewing recent articles published in this journal and situating them within the broader context of current research from other journals.<span><sup>1</sup></span></p><p>According to Aronson et al, an adverse drug reaction (ADR) is defined as ‘an appreciably harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product, which predicts a hazard from future administration and warrants prevention or specific treatment, alteration of the dosage regimen, or withdrawal of the product’.<span><sup>2</sup></span> DHRs are classified as type B or idiosyncratic ADRs. DHRs encompass both drug allergies (with proven immune involvement) and non-allergic hypersensitivity (without proven immune mechanisms). Unlike type A ADRs, type B ADRs have previously been considered to be dose independent and unpredictable. However, they require a certain threshold drug/metabolite concentration to trigger a reaction, and some of them can now be estimated by pharmacogenomic and in vitro testing. While type B ADRs are traditionally thought to be ‘off-target’ and unrelated to the pharmacology of the drug, some reactions, such as those to vaccines, biologics and immune checkpoint inhibitors, involve the intended target of the drug. This shows that the classification of ADRs is not completely clear-cut and that the characteristics of type A and B can overlap.<span><sup>3, 4</sup></span></p><p>The pathophysiology of DHRs is not yet well understood. The known pathophysiological models are presented and summarized in the recently published article by Elzagallaai et al.<span><sup>4</sup></span> The authors attempt to explain how a low molecular weight drug molecule can trigger an immune response. In addition to the more well-known pathophysiological mechanisms of DHRs, such as the classical ‘hapten’ hypothesis, the reactive metabolite hypothesis, the pharmacological interaction with the immune system (p-i) concept, the danger/injury hypothesis and the altered peptide repertoire hypothesis, the authors introduce the inflammasome activation hypothesis and the cross-reactivity hypothesis in the article.<span><sup>4</sup></span></p><p>DHRs have varied clinical presentations, with the skin being the most commonly affected organ. The prevalence of cutaneous ADRs (CADRs) varies between 1 and 3% in adult patients treated with drugs and up to 10% of patients presenting at a hospital.<span><sup>5</sup></span> CADRs exhibit various clinical forms, of which 29–35 types have been reported. The most common forms include urticaria (with or without angioedema), maculopapular eruptions, fixed drug eruptions, erythema multiforme (EM) and vasculitis. Rarer but more severe forms include erythroderma, drug reaction with eosinophilia and systemic symptoms (DRESS) and ","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":"91 6","pages":"1619-1622"},"PeriodicalIF":3.1,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/bcp.70085","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144171600","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}
Chloé Cornille, Aurélie Lenglet, Bertrand Decaudin, François Puisieux, Lisa Mondet, Anne Toulemonde, Sophie Gautier, Grégory Tempremant, Jean-Paul Kornobis, Mathilde Dambrine, Thomas Renoncourt, Frédéric Bloch, Jean-Baptiste Beuscart
{"title":"A multidisciplinary meeting for generating a personalized pharmaceutical plan for older adults at hospital discharge: the IATROPREV study.","authors":"Chloé Cornille, Aurélie Lenglet, Bertrand Decaudin, François Puisieux, Lisa Mondet, Anne Toulemonde, Sophie Gautier, Grégory Tempremant, Jean-Paul Kornobis, Mathilde Dambrine, Thomas Renoncourt, Frédéric Bloch, Jean-Baptiste Beuscart","doi":"10.1002/bcp.70098","DOIUrl":"https://doi.org/10.1002/bcp.70098","url":null,"abstract":"<p><strong>Aims: </strong>The French government's IATROPREV program has been designed to assess the effectiveness and safety of medications prescribed to older adults discharged from acute geriatric units. IATROPREV includes the implementation of a personalized pharmaceutical plan validated at a multidisciplinary meeting attended by the patient's geriatrician, family physician, community pharmacist and hospital pharmacist. We hypothesized that a multidisciplinary meeting on discharge from hospital will enable the recommendations to be largely followed up.</p><p><strong>Methods: </strong>A prospective, observational, multicentre study was conducted to analyse the personalized pharmaceutical plan and follow-up at 45 and 90 days for patients discharged from an acute geriatric unit between February 2021 and August 2023.</p><p><strong>Results: </strong>Of 708 eligible patients, 380 (54%) were included. The main reason for non-inclusion was the family physician's refusal to participate. A total of 5977 recommendations (i.e., an average of 15 per patient) were issued during the multidisciplinary meeting. Seventy percent of these recommendations concerned medication adjustments. The remaining recommendations were related to clinical and laboratory follow-up, the management of home care, and vaccination updates. Follow-up data at 90 days were available for 295 (78%) of the 380 patients. At 90 days, the recommendation implementation rate was 83% (4178 out of 5977) overall, 86% for medication adjustments, 79% for patient monitoring, 87% for home care management and 56% for vaccinations.</p><p><strong>Conclusions: </strong>IATROPREV is designed for patients with major therapeutic complexity. It enables a significant number of treatment optimization recommendations to be implemented within 90 days, thanks in particular to the multidisciplinary meeting.</p>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172697","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}