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Assessment and evaluation of prescribing competences: A systematic review and recommendations Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-16 John C. McLachlan, Asa Auta, Aderonke Ajiboye
AimsSince assessment of prescribing competence is a key promoter of student learning and achievement, we aim to summarize existing national‐level approaches, provide a systematic review of current literature, indicate the frequency of various methodologies, and make recommendations to promote and extend existing practice.MethodsRegulatory body websites were accessed for details of national examinations
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Bridging the gap between clinical pharmacology and rational drug prescribing 2.0: An up-date after 30 years Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-14 Erik M. Donker, Michiel J. Bakkum, Milan C. Richir, Jelle Tichelaar
Fully aware of the unusual timing of submitting a commentary 30 years later, we want to reflect on the June edition of the British Journal of Clinical Pharmacology (BJCP) (1993), which featured four research articles on education in clinical pharmacology and therapeutics (CPT) written by our former professor, Theo de Vries, and an editorial highlighting the imperative to improve CPT education, specifically
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The risk of delirium after sedation with propofol or midazolam in intensive care unit patients Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-14 Thomas G. van Gelder, Irene J. van Diem‐Zaal, Sandra M. A. Dijkstra‐Kersten, Nikki de Mul, Arief Lalmohamed, Arjen J. C. Slooter
AimKnowledge of risk factors may provide strategies to reduce the high burden of delirium in intensive care unit (ICU) patients. We aimed to compare the risk of delirium after deep sedation with propofol versus midazolam in ICU patients.MethodsIn this prospective cohort study, ICU patients who were in an unarousable state for ≥24 h due to continuous sedation with propofol and/or midazolam were included
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Sodium‐glucose cotransporter‐2 inhibitors and the risk of lung cancer among patients with type 2 diabetes Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-13 Samantha B. Shapiro, Hui Yin, Oriana H. Y. Yu, Laurent Azoulay
We sought to determine whether the use of sodium‐glucose cotransporter‐2 (SGLT‐2) inhibitors is associated with a decreased risk of incident lung cancers among patients with type 2 diabetes. We assembled a new‐user, active comparator cohort of SGLT‐2 inhibitor and dipeptidyl peptidase‐4 (DPP‐4) inhibitor users using the United Kingdom Clinical Practice Research Datalink. We fit Cox proportional hazards
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Statin use and the risk of Parkinson's disease in persons with diabetes: A nested case–control study Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-13 Kim Honkamaa, Anne Paakinaho, Anna‐Maija Tolppanen, Raimo Kettunen, Sirpa Hartikainen, Miia Tiihonen
AimsPersons with diabetes may have an elevated risk of Parkinson's disease (PD). Statin use could also modify the progression of PD. The aim was to study whether there is an association between statin exposure and risk of PD in persons with diabetes.MethodsA nationwide, nested case–control study restricted to people with diabetes was performed as part of nationwide register‐based Finnish study on PD
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Screening of dermatology drugs for aberrant use‐patterns: An application of epidemiologic estimates and measures of inequality in drug use Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-12 Thomas Delvin, Anette Bygum, Lars Christian Lund, Jacob Harbo Andersen, Jesper Hallas
AimsDermatology treatments require adherence for safe and effective use. Real‐world healthcare databases can reveal drug utilization patterns and uncover inappropriate or unexpected use. This study aimed to analyse dermatology drug utilization patterns using epidemiological and inequality measures, leveraging Danish nationwide registries. It also assessed the feasibility of this method for detecting
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Community partnership to optimize engagement in research: Reflections on the trans women HIV research initiative Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-12 Angela Underhill, Yasmeen Persad, Ashley Lacombe‐Duncan, Ian Armstrong, Hannah Kia, Carmen H. Logie, Wangari Tharao, Roberta Halpenny, Mona Loutfy
Cisnormativity, the assumption that sex and gender are concordant, binary, and consistent over one's life,1 shapes our knowledge systems and adversely affects the validity and reliability of many sexed and gendered analyses. In a compelling commentary, Bauer1 demonstrated how cisnormativity has contributed to errors and gaps in medical, epidemiological, and pharmacological science and beyond. In one
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Population pharmacokinetics of vancomycin in term neonates with perinatal asphyxia treated with therapeutic hypothermia Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-07 Marlotte A. A. van der Veer, Timo R. de Haan, Linda G. W. Franken, Reinier M. van Hest, Floris Groenendaal, Peter H. Dijk, Willem P. de Boode, Sinno Simons, Koen P. Dijkman, Henrica L. M. van Straaten, Monique Rijken, Filip Cools, Debbie H. G. M. Nuytemans, Anton H. van Kaam, Yuma A. Bijleveld, Ron A. A. Mathôt
Little is known about the population pharmacokinetics (PPK) of vancomycin in neonates with perinatal asphyxia treated with therapeutic hypothermia (TH). We aimed to describe the PPK of vancomycin and propose an initial dosing regimen for the first 48 h of treatment with pharmacokinetic/pharmacodynamic target attainment.
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Paliperidone poisoning and measurable plasma concentrations 2.5 years after last administered dose: A case report Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-07 Mariam Nersesjan, Maria Wagner, Kim Peder Dalhoff, Tonny Studsgaard Petersen, Søren Bøgevig, Henrik Horwitz
We report a poisoning with paliperidone palmitate, a once‐monthly, long‐acting injectable antipsychotic. The patient suffered from deep sedation and dystonia. She had been treated with extended release intramuscular paliperidone for several years and had received her last injection 8 days prior to admission. The plasma paliperidone was nearly five times higher than the upper reference range. Paliperidone
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Development and verification of mechanistic vaginal absorption and metabolism model to predict systemic exposure after vaginal ring and gel application Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-07 Kanika Thakur, Krishna Chaitanya Telaprolu, Daniel Paterson, Farzaneh Salem, Sumit Arora, Sebastian Polak
AimsThe current work describes the development of mechanistic vaginal absorption and metabolism model within Simcyp Simulator to predict systemic concentrations following vaginal application of ring and gel formulations.MethodsVaginal and cervix physiology parameters were incorporated in the model development. The study highlights the model assumptions including simulation results comparing systemic
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Feasibility and evaluation of high‐fidelity simulation education for acute clinical toxicology Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-05 David J. Brinkman, Nella S. Wackwitz, Erik Donker, Jelle Tichelaar
To prepare medical students appropriately for the management of toxicological emergencies, we have developed a simulation‐based medical education (SBME) training in acute clinical toxicology. Our aim is to report on the feasibility, evaluation and lessons learned of this training. Since 2019, each year approximately 180 fifth‐year medical students are invited to participate in the SBME training. The
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The relationship of pain intensity and opioid craving with delayed methadone dose: A preliminary study of individuals with opioid use disorder Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-03-05 R. Ross MacLean, Suzanne Spinola, Brian Pittman, Julia Meyerovich, Sara K. Szollosy, Noah R. Wolkowicz, Stacy Minnix, Mehmet Sofuoglu
AimsDespite a strong theoretical link between opioid craving and pain, little is known about the temporal relationship between pain and craving and the acute experience of pain in the context of methadone treatment. Using a cross‐over design, the current study evaluated the time course of pain and craving and objective experience of pain as a function of the last methadone dose.MethodsParticipants
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The association of pain impact and sleep disruption with opioid withdrawal during opioid-use disorder treatment Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-28 Jennifer D. Ellis, Daniel Han, Jami Mayo, J. Gregory Hobelmann, Patrick H. Finan, Andrew S. Huhn
Persons with opioid-use disorder (OUD) often experience opioid withdrawal and opioid craving, which can drive continued opioid use and treatment discontinuation. In addition, hyperalgesia is common among persons with OUD, yet few studies have examined the role of pain impact during OUD treatment. The purpose of the present study was to test whether opioid withdrawal and craving were elevated in the
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Issue Information Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-28
No abstract is available for this article.
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Issue Highlights Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-28
Figures from the editors selected issue highlights will be displayed each month in the journal image carousel on the BJCP homepage http://bpspubs.onlinelibrary.wiley.com/hub/journal/10.1111/(ISSN)1365-2125/ Serge Cremers My family and I enjoy hiking in the great outdoors, which is surprisingly close to New York City. We often hike with friends. One of them is a Professor at Cornell Tech, specialized
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Effects of rifampicin on the pharmacokinetics and safety of carotegrast methyl in healthy subjects: A randomized 2 × 2 crossover study Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-26 Hiromitsu Imai, Ichiro Oikawa, Tetsuya Koyama, Shunji Matsuki
To evaluate the effect of the combination of carotegrast methyl with rifampicin, a potent inhibitor of organic anion transporter polypeptide, on the pharmacokinetics (PKs), safety and tolerability of carotegrast methyl.
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Advanced prescription of injectable anticancer drugs: Safety assessment in a European Comprehensive Cancer Centre using the risk matrix approach Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-25 Alexandre Acramel, Sandy Blondeel-Gomes, Mathilde Dupré, Ornella Tangila Kayembe, Aude Rochereau, Laurence Escalup, Romain Desmaris, Nathalie Jourdan, Adeline Cordary, Pauline Vaflard, Paul Cottu, Audrey Bellesoeur
The purpose of this work was to assess failures in the advanced prescription of parenteral anticancer agents in an adult day oncology care unit with more than 100 patients per day.
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Prevalence of potentially inappropriate medications among newly treated patients with type 2 diabetes in UK primary care Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-27 Maria Luisa Faquetti, Géraldine Frey, Dominik Stämpfli, Stefan Weiler, Andrea M. Burden
AimsThe aim of this study was to estimate the prevalence of potentially inappropriate prescriptions (PIPs) in patients starting their first noninsulin antidiabetic treatment (NIAD) using two explicit process measures of the appropriateness of prescribing in UK primary care, stratified by age and polypharmacy status.MethodsA descriptive cohort study between 2016 and 2019 was conducted to assess PIPs
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Self‐management support with the Respiratory Adherence Care Enhancer instrument in asthma and chronic obstructive pulmonary disease: An implementation trial Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-26 Claire D. Visser, Lisanne L. M. Antonisse, Floor M. Alleda, Colin Bos, Privender Saini, Esther Kuipers, Henk‐Jan Guchelaar, Martina Teichert
AimSuboptimal self‐management with controller inhalation therapy in asthma and COPD is frequently observed with poor treatment outcomes. The developed ‘Respiratory Adherence Care Enhancer’ (RACE) instrument identifies and addresses individual barriers to self‐management with a theoretical underpinning. This study investigates the feasibility of pharmaceutical support with this instrument.MethodsAn
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Estimation of adherence to urate‐lowering therapy in people living with gout using Australia's Pharmaceutical Benefits Scheme and patient‐reported dosing Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-21 Marcel Schulz, Matthew J. Coleshill, Richard O. Day, Daniel F. B. Wright, Jonathan Brett, Nancy E. Briggs, Eindra Aung
AimsThe aim of this study was to estimate adherence to urate‐lowering therapy (ULT), predominately allopurinol, from Australia's Pharmaceutical Benefits Scheme (PBS) claims database in association with (1) patient‐reported doses and (2) World Health Organization's (WHO) defined daily doses (DDD), namely, allopurinol (400 mg/day) or febuxostat (80 mg/day).MethodsProportion of days covered (PDC) was
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Eculizumab dose tapering should take into account the nonlinearity of its pharmacokinetics Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-19 Olivier Le Tilly, Philippe Gatault, Saida Semlali, Rebecca Sberro-Soussan, Christophe Passot, Dominique Bertrand, Céline Desvignes, Sophie Caillard, Gilles Paintaud, Jean-Michel Halimi, David Ternant
Eculizumab is a monoclonal antibody targeting complement protein C5 used in renal diseases. As recommended dosing regimen leads to unnecessarily high concentrations in some patients, tailored dosing therapeutic drug monitoring was proposed to reduce treatment cost. The objectives of the present work were (i) to investigate the target-mediated elimination of eculizumab and (ii) whether a pharmacokinetic
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Genetic biomarkers of methotrexate response and safety in Crohn's disease: Data from the Spanish ENEIDA registry Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-18 Juliana Salazar, Esther Garcia-Planella, Agnès Fernández-Clotet, Maria Esteve, Javier P. Gisbert, David Busquets, Alfredo Lucendo, Lucía Márquez, Jordi Guardiola, María Dolores Martín-Arranz, Eva Iglesias, David Monfort, Albert Villoria, Fiorella Cañete, Olga Bell, Elena Ricart, Yamile Zabana, María Chaparro, Eugeni Domènech, Jordi Gordillo
Methotrexate (MTX) is used to induce and maintain remission in patients with steroid-dependent Crohn's disease (CD). Despite its proven efficacy, its use is limited due to associated adverse events. Polymorphisms involving folate pathway genes might influence MTX efficacy and toxicity. We aimed to assess the impact of certain polymorphisms on the therapeutic outcomes of MTX in CD.
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Maternal exposure to folate antagonists and susceptibility to congenital heart disease in offspring: A systematic review and meta‐analysis Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-19 Prajjwol Luitel, Rukesh Yadav, Prince Mandal, Niranjan Adhikari, Sujan Paudel, Anish Mudvari
AimsThe objective of this meta‐analysis was to determine whether maternal exposure to folate antagonists is associated with increased rates of congenital heart disease in offspring.MethodsA comprehensive search for articles in the MEDLINE (PubMed) and EMBASE databases published up to 21 August 2023 was performed. The search strategy was not limited by study design but only for articles in the English
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Quality indicators for appropriate in‐hospital pharmacotherapeutic stewardship: An international modified Delphi study Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-19 Rashudy F. Mahomedradja, Jelle Tichelaar, Lidwine B. Mokkink, Kim C. E. Sigaloff, Michiel A. van Agtmael
AimsIn‐hospital prescribing errors may result in patient harm, such as prolonged hospitalisation and hospital (re)admission, and may be an emotional burden for the prescribers and healthcare professionals involved. Despite efforts, in‐hospital prescribing errors and related harm still occur, necessitating an innovative approach. We therefore propose a novel approach, in‐hospital pharmacotherapeutic
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The development and evaluation of dose-prediction tools for allopurinol therapy (Easy-Allo tools) Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-15 Daniel F. B. Wright, Hailemichael Z. Hishe, Sophie L. Stocker, Nicola Dalbeth, Anne Horne, Jill Drake, Janine Haslett, Amanda J. Phipps-Green, Tony R. Merriman, Lisa K. Stamp
Dose escalation at the initiation of allopurinol therapy can be protracted and resource intensive. Tools to predict the allopurinol doses required to achieve target serum urate concentrations would facilitate the implementation of more efficient dose-escalation strategies. The aim of this research was to develop and externally evaluate allopurinol dosing tools, one for use when the pre-urate-lowering
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Economic evaluation of personalized vs. standard dosing of 5-fluorouracil in first-line chemotherapy for metastatic colorectal cancer in Australia Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-12 Daniel Erku, Jennifer H. Martin, Michael Michael, Peter Galettis, Paul Scuffham
Using pharmacokinetics (PK)-guided 5-fluorouracil (5-FU) for metastatic colorectal cancer (mCRC) improves overall survival (OS) and decreases toxicity, yet its value for money in the Australian setting is unknown. Our study assesses the cost-effectiveness of PK vs. body surface area (BSA) dosing of 5-FU for patients with mCRC.
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Bleeding in patients on concurrent treatment with a selective serotonin reuptake inhibitor (SSRI) and low-dose acetylsalicylic acid (ASA) compared with SSRI or low-dose ASA alone—A systematic review and meta-analysis Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-13 Magnus A. B. Axelsson, Carina Tukukino, Naldy Parodi López, Susanna M. Wallerstedt
The aim of this study was to systematically review whether concurrent treatment with an SSRI and low-dose ASA increases the risk of bleeding compared with treatment with an SSRI alone or ASA alone.
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Physiologically-based pharmacokinetic modelling of long-acting injectable cabotegravir and rilpivirine in pregnancy Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-10 Shakir Atoyebi, Fazila Bunglawala, Nicolas Cottura, Sandra Grañana-Castillo, Maiara Camotti Montanha, Adeniyi Olagunju, Marco Siccardi, Catriona Waitt
Long-acting cabotegravir and rilpivirine have been approved to manage HIV in adults, but data regarding safe use in pregnancy are limited. Physiologically-based pharmacokinetic (PBPK) modelling was used to simulate the approved dosing regimens in pregnancy and explore if Ctrough was maintained above cabotegravir and rilpivirine target concentrations (664 and 50 ng/mL, respectively).
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Determinants of early change in serum creatinine after initiation of dolutegravir-based antiretroviral therapy in South Africa Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-08 Rephaim Mpofu, Aida N. Kawuma, Roeland E. Wasmann, Godspower Akpomiemie, Nomathemba Chandiwana, Simiso Mandisa Sokhela, Michelle Moorhouse, Willem Daniel Francois Venter, Paolo Denti, Lubbe Wiesner, Frank A. Post, David W. Haas, Gary Maartens, Phumla Sinxadi
Dolutegravir increases serum creatinine by inhibiting its renal tubular secretion and elimination. We investigated determinants of early changes in serum creatinine in a southern African cohort starting first-line dolutegravir-based antiretroviral therapy (ART).
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An artificial intelligence algorithm for co-clustering to help in pharmacovigilance before and during the COVID-19 pandemic Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-08 Alexandre Destere, Giulia Marchello, Diane Merino, Nouha Ben Othman, Alexandre O. Gérard, Thibaud Lavrut, Delphine Viard, Fanny Rocher, Marco Corneli, Charles Bouveyron, Milou-Daniel Drici
Monitoring drug safety in real-world settings is the primary aim of pharmacovigilance. Frequent adverse drug reactions (ADRs) are usually identified during drug development. Rare ones are mostly characterized through post-marketing scrutiny, increasingly with the use of data mining and disproportionality approaches, which lead to new drug safety signals. Nonetheless, waves of excessive numbers of reports
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Appropriateness of direct oral anticoagulant prescribing in older subjects with atrial fibrillation discharged from acute medical wards Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-06 Antonio De Vincentis, Luca Soraci, Elena Arena, Angela Sciacqua, Giuseppe Armentaro, Francesco Aucella, Andrea Corsonello, Filippo Aucella, Raffaele Antonelli Incalzi
Knowledge on the prescriptive practice of direct oral anticoagulants (DOACs) in older subjects with atrial fibrillation (AF) hospitalized in acute medical wards is limited. This study aimed to evaluate the prevalence and appropriateness of DOAC prescriptions in hospitalized older subjects with AF, discharged from acute medical wards.
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Validating methods used to identify non-adherence adverse drug events in Canadian administrative health data Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-06 Maeve E. Wickham, Kimberlyn M. McGrail, Michael R. Law, Amber Cragg, Corinne M. Hohl
Medication non-adherence is a type of adverse drug event that can lead to untreated and exacerbated chronic illness, and that drives healthcare utilization. Research using medication claims data has attempted to identify instances of medication non-adherence using the proportion of days covered or by examining gaps between medication refills. We sought to validate these measures compared to a gold
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Development of a therapeutic drug-monitoring algorithm for outpatients receiving voriconazole: A multicentre retrospective study Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-06 Hideo Kato, Takumi Umemura, Mao Hagihara, Arifumi Shiota, Nobuhiro Asai, Yukihiro Hamada, Hiroshige Mikamo, Takuya Iwamoto
Although therapeutic drug monitoring (TDM) of voriconazole is performed in outpatients to prevent treatment failure and toxicity, whether TDM should be performed in all or only selected patients remains controversial. This study evaluated the association between voriconazole trough concentrations and clinical events.
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Population pharmacokinetics and dose optimization of levofloxacin in elderly patients with pneumonia Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-05 Yun-Ying He, Jing Sun, Yue-E Wu, Yong-Bin Wang, John van den Anker, Guo-Xiang Hao, De-Qing Sun, Wei Zhao
Levofloxacin is a quinolone antibiotic with a broad antibacterial spectrum. It is frequently used in elderly patients with pneumonia. The pharmacokinetic profile of elderly patients changes with age, but data on the pharmacokinetics of levofloxacin in these patients are limited. The aim of this study was to establish a population pharmacokinetic model of levofloxacin in elderly patients with pneumonia
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The future is now, old man Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-05 Marko Lucijanic, Robert Likic
The proper use of medicines—ensuring the right medicine is used at the right time and in the right way—is a fundamental principle for clinical pharmacologists, physicians, nurses and other healthcare professionals globally. Despite this being an apparent rule, real-life practice often reveals that errors in medical service provision are more common than exceptions. There are multiple stages in treatment
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Breast milk oxycodone concentrations in mothers given oxycodone for post-Caesarean delivery pain management Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-02 Aino Pesonen, Henriikka Hakomäki, Hannu Kokki, Veli-Pekka Ranta, Valtteri Rinne, Merja Kokki
Both effective analgesia and early breastfeeding play an important role in maternal and neonatal well-being after Caesarean delivery. We studied controlled-release oxycodone tablet treatment for postoperative pain management and determined the excretion of oxycodone into breast milk.
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Association of state-level prescription drug monitoring program implementation with opioid prescribing transitions in primary care in Australia Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-02 Ting Xia, Louisa Picco, Rachelle Buchbinder, Romi Haas, Suzanne Nielsen
This study aimed to evaluate whether voluntary and mandatory prescription drug monitoring program (PDMP) use in Victoria, Australia, had an impact on prescribing behaviour, focusing on individual patients' prescribed opioid doses and transition to prescribing of nonmonitored medications.
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A simulation study on model-informed precision dosing of amikacin for achieving target area under the concentration–time curve Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-02-02 Tomoyuki Yamada, Kazutaka Oda, Masami Nishihara, Masashi Neo
Amikacin requires therapeutic drug monitoring for optimum efficacy; however, the optimal model-informed precision dosing strategy for the area under the concentration–time curve (AUC) of amikacin is uncertain. This simulation study aimed to determine the efficient blood sampling points using the Bayesian forecasting approach for early achievement of the target AUC range for amikacin in critically ill
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A tale of 2 digital hospitals: A qualitative study of antimicrobial stewardship teams Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-01-31 Bethany A. Van Dort, Angus Ritchie, Jonathan Penm, Timothy J. Gray, Amrita Ronnachit, Melissa T. Baysari
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A phase I study to evaluate the safety, tolerance and pharmacokinetics of anti-Shiga toxin hyperimmune equine F (ab′)2 fragments in healthy volunteers Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-01-30 Yanina Hiriart, Paula Scibona, Augusto Ferraris, Waldo H. Belloso, Valeria Beruto, Facundo Garcia Bournissen, Vanesa Zylberman, Luciana Muñoz, Fernando Goldbaum, Linus Spatz, Mariana Colonna, Santiago Sanguineti, Ventura A. Simonovich
Shiga toxin-producing Escherichia coli-haemolytic uraemic syndrome (STEC-HUS) is considered a toxaemic disorder in which early intervention with neutralizing antibodies may have therapeutic benefits. INM004, composed of F (ab′)2 fragments from equine immunoglobulins, neutralizes Stx1/Stx2, potentially preventing the onset of HUS.
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Issue Information Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-01-30
No abstract is available for this article.
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Issue Highlights Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-01-30
Figures from the editors selected issue highlights will be displayed each month in the journal image carousel on the BJCP homepage http://bpspubs.onlinelibrary.wiley.com/hub/journal/10.1111/(ISSN)1365-2125/ Serge Cremers BJCP will publish more phase 1, 2 and experimental medicine papers this year. And several early phase clinical studies are part of this February issue of BJCP also. The first one involves
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Observational studies to emulate randomized trials: Some real-world barriers Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-01-15 Samy Suissa
The randomized controlled trial (RCT) forms the basis for drug approval by regulatory agencies. Observational studies using existing data from healthcare databases now also provide real-world evidence (RWE) in regulatory decision-making. Several initiatives are assessing the value of RWE by conducting observational studies that emulate published RCTs. While many RCTs are straightforward to emulate
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Food-derived compounds for CYP-phenotyping Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-01-11 Manuel Haschke
Phenotyping of drug metabolizing enzymes or drug transporters uses selected probe compounds to estimate the in vivo activity of the enzymes or transporters of interest. In the late 1970s, the antihypertensive drug debrisoquine and the antiarrhythmic sparteine were the first probe drugs used to phenotype CYP2D6, one of the major human CYP450 isoforms. Since then, a series of other compounds have been
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Pharmacokinetic of ceftazidime-avibactam in a critically ill patient under high-volume continuous venovenous haemodiafiltration: A first paediatric case report Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-01-04 Charlotte Collignon, Sihem Benaboud, Inès Gana, Matthieu Bendavid, Benjamin Fournier, Mehdi Oualha, Charles de Marcellus
Ceftazidime-avibactam is a novel cephalosporin/B-lactamase inhibitor developed in the context of increasing resistance. This case reports the pharmacokinetics of ceftazidime-avibactam in a critically ill child under continuous renal replacement (CRRT) therapy for fluid overload. The patient was a 6-month-old female with sepsis due to bloodstream infection to Stenotrophomonas maltophilia following stem
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PAttern of drug use in PEdiatrics: An observational study in Italian hOSpitals (the PAPEOS study) Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-01-01 Marta Di Salvo, Greta Santi Laurini, Domenico Motola, Giorgia Valpiani, Ester Sapigni, Adriana Pompilio, Elena Arzenton, Anna Marra
To assess the extent of off-label drug use and the occurrence of suspected adverse drug reactions (ADRs) among paediatric patients in Italian hospitals.
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Enteral administration of crushed rilpivirine in a patient with HIV: A case report Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2024-01-01 Gwendoline Ragonnet, Hélène Laroche, Nadège Néant, Samir Benkouiten, Maeva Cacilda Dos Santos, Olivia Faucher-Zaegel, Caroline Solas, Sylvie Bregigeon-Ronot
Antiretroviral therapy administration is challenging in patients with HIV requiring enteral nutrition. There are limited pharmacokinetic data available regarding the absorption of crushed rilpivirine (RPV) and its impact on drug bioavailability, plasma concentrations and, consequently, the efficacy of treatment. We present the case of a 60-year-old woman with HIV diagnosed with squamous cell carcinoma
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Clinical trials of pharmacological interventions for SARS-CoV-2 published in leading medical journals report adherence but not how it was assessed. Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-29 C. Lee, A. Otunla, I. Brennan, J. K. Aronson, D. Nunan
Adherence to pharmacological interventions in clinical trials is crucial for accurate identification of beneficial and adverse outcomes. The ways in which adherence to interventions should be reported in trial publications are described in the Template for Intervention Description and Replication (TIDieR), a 12-item extension of the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines
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Effect of changes in metabolic enzymes and transporters on drug metabolism in the context of liver disease: impact on pharmacokinetics and drug-drug interactions Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-26 Sara Armani, Andreas Geier, Thomas Forst, Uta Merle, David H. Alpers, Martin W. Lunnon
Changes in the pharmacokinetic and resulting pharmacodynamic properties of drugs are common in many chronic liver diseases, leading to adverse effects, drug interactions and increased risk of over- or underdosing of medications. Structural and functional hepatic impairment can have major effects on drug metabolism and transport. This review summarises research on the functional changes in phase I and
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Issue Information Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-28
No abstract is available for this article.
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Issue Highlights Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-28
Figures from the editors selected issue highlights will be displayed each month in the journal image carousel on the BJCP homepage http://bpspubs.onlinelibrary.wiley.com/hub/journal/10.1111/(ISSN)1365-2125/. Serge Cremers Welcome to the 50th birthday of the British Journal of Clinical Pharmacology! As described in the introductory editorial, it has been an eventful fifty years, and we truly hope that
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The British Journal of Clinical Pharmacology: The first 50 years Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-28 Serge Cremers, Geoffrey T. Tucker, Jeffrey K. Aronson, James M. Ritter, Adam F. Cohen
The British Journal of Clinical Pharmacology celebrates its 50th anniversary of publication in 2023. Here four previous Editors-in-Chief and the current Editor reflect on the Journal's history and the changes that have occurred during that time.
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Population pharmacokinetics of rotigotine extended-release microspheres for intramuscular injection in patients with early-stage Parkinson's disease Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-26 Hong Sun, Chong Dong, Mengyi Wu, Xiao Li, Hongtao Song, Yan Zhang, Chunli Liu, Pinglan Liu, Wanhui Liu, Piu Chan
Rotigotine extended-release microspheres is a weekly intramuscular injection formulation to treat Parkinson's disease. This study aimed to develop a population pharmacokinetics (PK) model for rotigotine extended-release microspheres to investigate its PK ethnic differences.
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Feasibility of a cannabidiol-dominant cannabis-based medicinal product for the treatment of long COVID symptoms: A single-arm open-label feasibility trial Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-17 Hannah Thurgur, Michael Lynskey, Anne Katrin Schlag, Carol Croser, David John Nutt, Elizabeth Iveson
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Plasma 6β-hydroxycortisol to cortisol ratio as a less invasive cytochrome P450 3A phenotyping method Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-15 Ryohei Hirano, Akitomo Yokokawa, Tomomi Furihata, Hiromi Shibasaki
A less invasive evaluation method of cytochrome P450 3A (CYP3A) activity provides an important tool for personalized medicine. We aimed to clarify the usefulness of the plasma 6β-hydroxycortisol to cortisol concentration (6β-OHF/F) ratio as a minimally invasive CYP3A phenotyping method.
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Developing an international concept-based curriculum for pharmacology education: The promise of core concepts and concept inventories Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-13 Clare Guilding, Roisin Kelly-Laubscher, Adeladlew Netere, Anna-Marie Babey, Carolina Restini, Margaret Cunningham, John P. Kelly, Jennifer Koenig, Kelly Karpa, Martin Hawes, Steven J. Tucker, Thomas A. Angelo, Paul J. White
Over recent years, studies have shown that science and health profession graduates demonstrate gaps in their fundamental pharmacology knowledge and ability to apply pharmacology concepts in practice. This article reviews the current challenges faced by pharmacology educators, including the exponential growth in discipline knowledge and competition for curricular time. We then argue that pharmacology
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Gabapentinoids in Ireland 2010 to 2020: An observational study of trends in gabapentinoid prescribing, law enforcement drug seizures and postmortem toxicology Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-10 Louise Durand, Aoife O'Kane, Julie Tierney, Mark Cronly, Kathleen E. Bennett, Yvonne Kavanagh, Eamon Keenan, Gráinne Cousins
We explored trends in gabapentinoid prescribing, drug seizures and postmortem toxicology using a national pharmacy claims database, law enforcement drug seizures data and a population-based postmortem toxicology database.
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Exploring the impact of ethnicity on drug pharmacokinetics using PBPK models: A case study with lansoprazole in Japanese subjects Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-10 Udoamaka Ezuruike, Liam Curry, Oliver Hatley, Iain Gardner
The aim of this study is to demonstrate the use of PBPK modelling to explore the impact of ethnic differences on drug PK.
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Confounding mitigation for the exposure-response relationship of bevacizumab in colorectal cancer patients Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-10 Sarah Lobet, Morgane Caulet, Gilles Paintaud, Nicolas Azzopardi, Céline Desvignes, Romain Chautard, Christophe Borg, Olivier Capitain, Aurélie Ferru, Olivier Bouché, Thierry Lecomte, David Ternant
The exposure-response relationship of bevacizumab may be confounded by various factors, including baseline characteristics, time-dependent target engagement and recursive relationships between exposure and response, requiring effective mitigation. This study aimed to investigate the exposure-response relationships of bevacizumab in metastatic colorectal cancer (mCRC) patients while mitigating potential
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Pharmacokinetics of asundexian with combined CYP3A and P-gp inhibitors and an inducer: Target in vitro and in vivo studies Br. J. Clin. Pharmacol. (IF 3.4) Pub Date : 2023-12-04 Friederike Kanefendt, Christine Brase, Natalia Jungmann, Robert Fricke, Anna Engelen, Sebastian Schmitz