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Short-term prognosis of polypharmacy in elderly patients treated in emergency departments: results from the EDEN project Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2024-02-05 Jesus Ruiz Ramos, Aitor Alquézar-Arbé, Ana Juanes Borrego, Guillermo Burillo Putze, Sira Aguiló, Javier Jacob, Cesáreo Fernández, Pere Llorens, Francisco de Borja Quero Espinosa, Susana Gordo Remartinez, Rocio Hernando González, Miguel Moreno Martín, Sara Sánchez Aroca, Alicia Sara Knabe, Rebeca González González, Marina Carrión Fernández, Alberto Artieda Larrañaga, Maria Adroher Muñoz, Jeong-Uh Hong
Background:Polypharmacy is a growing phenomenon among elderly individuals. However, there is little information about the frequency of polypharmacy among the elderly population treated in emergency departments (EDs) and its prognostic effect. This study aims to determine the prevalence and short-term prognostic effect of polypharmacy in elderly patients treated in EDs.Methods:A retrospective analysis
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Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2024-02-05 Antonio Lomeli-Silva, Homero Contreras-Salinas, Mayra Yolanda Barajas-Virgen, Maria Soledad Romero-Lopez, Lourdes Yolotzin Rodríguez-Herrera
To perform optimal monitoring of the safety profile in the postmarketing phase, Marketing Authorization Holders and National Regulatory Authorities (NRAs) must evaluate the adverse drug reactions (ADRs) that occurred and characterize their nature, frequency, and severity. Management is possible through Individual Case Safety Reports (ICSRs), which are the reports of organized and processed data. Globally
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Evaluation of early retinal changes in patients on long-term hydroxychloroquine using optical coherence tomography angiography Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2024-01-28 Huanhuan Zhao, Menglu Pan, Yaping Liu, Fangyue Cheng, Zongwen Shuai
Background:Connective tissue diseases (CTD), including systemic lupus erythematosus and rheumatoid arthritis (RA), have long been treated with hydroxychloroquine (HCQ). However, prolonged HCQ use poses a risk of adverse effects, particularly retinopathy.Objective:To detect early retinal changes assessed by optical coherence tomography angiography (OCTA) in CTD patients with long-term HCQ treatment
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Drug-induced interstitial lung disease: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System from 2004 to 2021 Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2024-01-28 Tingting Jiang, Hui Su, Jing Xu, Chen Li, Ni Zhang, Yanping Li, Yuanlin Wu, Rui Ni, Yue Ming, Ziwei Li, Li Li, Yao Liu
Background:Drug-induced interstitial lung disease (DILD) is an increasingly common cause of morbidity and mortality. However, due to the lack of specificity, DILD detection remains an unsolved public health challenge.Objectives:For the first time, we aimed to examine DILD reports submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to identify demographic characteristics
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Direct oral anticoagulant use in hospitalized patients with atrial fibrillation across body mass index categories: design and rationale for a retrospective cohort study Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2024-01-28 Fahad Shaikh, Rochelle Wynne, Ronald L. Castelino, Sally C. Inglis, Patricia M. Davidson, Caleb Ferguson
Background:Atrial fibrillation (AF) and obesity are common conditions globally; yet, there remains suboptimal pharmacological management contributing to high rates of hospitalization in patients with AF. The altered pathophysiology of both obese and underweight individuals may influence the pharmacology of medications, including those used to manage AF. This, in turn, increases the risk of adverse
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Medication errors by caregivers in the homes of children discharged from a pediatric department in Ghana Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2024-01-28 George Tsey Sabblah, Florence van Hunsel, Katja Taxis, Mahama Duwiejua, Seth Kwaku Seaneke, Eugène van Puijenbroek
Background:Medication errors (MEs) by caregivers at home are a cause of morbidity and mortality, shortly after discharge from the hospital.Objectives:The objective of this study was to determine the rate and types of MEs at the homes of children discharged from a hospital in Ghana and to explore the factors associated with these errors.Design:This was a cross-sectional study of infants and children
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Association of thrombopoietin-related drugs with thromboembolic events: Mendelian randomization and a real-world study Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2024-01-28 Cuilv Liang, Qiying Chen, Yin Zhang
Background:Studies have shown conflicting results when using thrombopoietin-related drugs (TPORD) for thromboembolic events (TEEs). Our study aimed to explore the correlation between TPORDs and TEEs.Method:Drug-targeted Mendelian randomization (MR) and multivariate MR (MVMR) analysis were used to explore the causal relationship between TPORDs and TEEs such as venous thromboembolism (VTE), deep vein
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Determinants of COVID-19 vaccine-induced myocarditis Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2024-01-28 Jessica Rose, Nicolas Hulscher, Peter A. McCullough
Background:Following the roll-out of the Pfizer-BioNTech BNT162b2, Moderna mRNA-1273, and Janssen Ad26.COV2.S coronavirus disease 2019 (COVID-19) injections in the United States, millions of individuals have reported adverse events (AEs) using the vaccine adverse events reports system (VAERS). The objective of this analysis is to describe the myocarditis data in VAERS and the COVID-19 vaccines as potential
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Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-09-28 Yanping Li,Yuanlin Wu,Tingting Jiang,Haiyan Xing,Jing Xu,Chen Li,Rui Ni,Ni Zhang,Guiyuan Xiang,Li Li,Ziwei Li,Lanlan Gan,Yao Liu
The relatively new discipline of pharmacovigilance (PV) aims to monitor the safety of drugs throughout their evolution and is essential to discovering new drug risks. Due to their specific and complex physiology, children, pregnant women, and elderly adults are more prone to adverse drug reactions (ADRs). Additionally, the lack of clinical trial data exacerbates the challenges faced with pharmacotherapy
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HIV/AIDS patients' knowledge, attitude, and practice toward anti-retroviral therapy medications' adverse effects and associated factors in Tikur Anbessa Specialized Hospital. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-09-01 Zenebe Negash,Yohannes Yibeltal,Akeberegn Gorems Ayele
Background Adverse effects (AEs) have been reported with all antiretroviral therapy (ART) medications, and it was among the most common cause for switching or terminating therapy and drug non-adherence. Even though AEs of ART medications are common and to be expected, little study has been conducted on the understanding of patients on the AEs. Therefore, this study aimed to assess patients' knowledge
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Clinical relevance of potential self-medication drug interactions in antineoplastic and immune-modulating therapy among online pharmacy customers. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-08-24 Florian Schindler,Timo Schinkoethe,Sven Mahner,Thomas Kolben,Rachel Wuerstlein,Carsten Culmsee,Nadia Harbeck,Tanja K Eggersmann
Background Modern oral antineoplastic and immune-modulating drugs offer an array of therapeutic advantages, and yet pose challenges in daily use for patients, physicians and pharmacists. In contrast to intravenous administration, these drugs are not subject to direct medical control. Recently, we have seen a huge rise in sales of non-prescription over-the-counter (OTC) medicines via the internet without
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Enhancing self-medication practices in the era of infodemic: the role of pharmacovigilance. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-08-23 Carlos-Alberto Calderon-Ospina
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Hospital admissions attributed to adverse drug reactions in tertiary care in Uganda: burden and contributing factors. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-07-29 Lillian Asio,Marble Nasasira,Ronald Kiguba
Background Adverse drug reactions (ADRs) contribute to the burden of disease globally and of particular concern are ADR-related hospital admissions. Objectives This study sought to determine the burden, characteristics, contributing factors and patient outcomes of ADRs that were the primary diagnosis linked to hospital admission among inpatients in Uganda. Design We conducted a cross-sectional secondary
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Funding and financial sustainability of pharmacovigilance: suggested models for funding pharmacovigilance in resource-limited African countries. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-07-24 Ambrose O Isah,Abimbola O Opadeyi,Henry Tumwijukye,Frank Cobelens,Diede Smith,Margareth Ndomondo-Sigonda,Linda Harmark,Paul Tanui,Edine Tiemersma,Blandina T Mmbaga,Gugu Mahlangu,Stephen A Ayinbuomwan,Rachida Soulaymani,Jayesh M Pandit
Background An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings is the lack of adequate funds to establish a functional National Pharmacovigilance System. Consequently, the crucial function of monitoring and ensuring the availability of safe medicines in these settings cannot be guaranteed considering the peculiarities of diseases and medicines used. Objectives
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Flow rate accuracy of infusion devices within healthcare settings: a systematic review. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-07-21 Opeyemi Atanda,Jonathan West,Tom Stables,Chris Johnson,Robert Merrifield,James Kinross
Background One in five patients admitted to the hospital treated with intravenous (IV) fluid therapy suffer complications due to inappropriate administration. Errors have been reported in 13-84% of the preparation and administration of IV medications. The safe delivery of IV fluids requires precise rate administration. Objectives This systematic review aims to determine the accuracy of infusion sets
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Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical study. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-06-24 Chang Liu,Qianqian Zhang,Peiye Hui,Yan Wang,Guohui Li,Guangchao Cao,Zicheng Xue,Jing Zhang,Heng Zhang,Xin Huang,Jiyong Wu,Fusehng Sun,Meixing Yan
Aims To investigate the safety of oral iron therapy in pregnant women with iron-deficiency anemia (IDA) in the real world. Methods A retrospective analysis was performed on 1792 pregnant patients with IDA who received oral iron supplements from 12 hospitals in Shandong Province from 1 April to 31 June 2021; follow-up and adverse reactions were recorded. They were divided into six groups according to
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Joint use of population pharmacokinetics and machine learning for optimizing antiepileptic treatment in pediatric population. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-06-21 Ivana Damnjanović,Nastia Tsyplakova,Nikola Stefanović,Tatjana Tošić,Aleksandra Catić-Đorđević,Vangelis Karalis
Purpose Unpredictable drug efficacy and safety of combined antiepileptic therapy is a major challenge during pharmacotherapy decisions in everyday clinical practice. The aim of this study was to describe the pharmacokinetics of valproic acid (VA), lamotrigine (LTG), and levetiracetam (LEV) in a pediatric population using nonlinear mixed-effect modeling, while machine learning (ML) algorithms were applied
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Survival outcomes of beta-blocker usage in HER2-positive advanced breast cancer patients: a retrospective cohort study. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-06-21 Hui-Hsia Hsieh,Tien-Yuan Wu,Chi-Hua Chen,Yu-Hung Kuo,Mann-Jen Hour
Background Clinical trials investigating the effects of beta-blockers (BBs) on cancer are underway. Evidence from preclinical research suggests that BBs could serve as anticancer agents and immune boosters. There is conflicting evidence regarding the effect of BB use on clinical outcomes in patients with breast cancer. Objectives The study aimed to determine whether BB use is associated with progression-free
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Assessing adverse drug reaction reports for antidiabetic medications approved by the food and drug administration between 2012 and 2017: a pharmacovigilance study. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-06-12 Britney A Stottlemyer,Michael C McDermott,Mackenzie R Minogue,Matthew P Gray,Richard D Boyce,Sandra L Kane-Gill
Objective Between 2012 and 2017, the U.S. Food and Drug Administration (FDA) approved 10 antidiabetic indicated therapies. Due to the limited literature on voluntarily reported safety outcomes for recently approved antidiabetic drugs, this study investigated adverse drug reactions (ADRs) reported in the FDA Adverse Event Reporting System (FAERS). Research Design and Methods A disproportionality analysis
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Risk of lower limb amputation in diabetic patients using SGLT2 inhibitors versus DPP4 inhibitors or GLP-1 agonists: a meta-analysis of 2 million patients. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-06-10 Yang Lu,Caiyun Guo
Background The objective of this review was to assess the risk of lower limb amputation (LLA) in type 2 diabetic patients based on the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) versus dipeptidyl peptidase 4 inhibitors (DPP4i) or glucagon-like peptide-1 receptor agonists (GLP1a). Methods PubMed, CENTRAL, Scopus, Web of Science, and Embase were referenced for articles published up to
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Serious neurological adverse events following immunization against SARS-CoV-2: a narrative review of the literature. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-05-21 Sara Eslait-Olaciregui,Kevin Llinás-Caballero,David Patiño-Manjarrés,Thomas Urbina-Ariza,Juan Fernando Cediel-Becerra,Camilo Alberto Domínguez-Domínguez
Amid the coronavirus disease 2019 (COVID-19) pandemic, massive immunization campaigns became the most promising public health measure. During clinical trials, certain neurological adverse effects following immunization (AEFIs) were observed; however, acceptable safety profiles lead to emergency authorization for the distribution and use of the vaccines. To contribute to pharmacovigilance and lessen
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Development and psychometric assessment of self-reported patient medication safety scale (SR-PMSS) Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-03-27 Ning Qin, Yinglong Duan, Shuangjiao Shi, Xiao Li, Haoqi Liu, Feng Zheng, Zhuqing Zhong, Guliang Xiang
Objectives:Patient medication safety can affect their clinical outcomes and plays an important role in patient safety management. However, few tools have been developed to assess patient medication...
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Developing and piloting a cross-sectoral hospital pharmacist intervention for patients in transition between hospital and general practice Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-03-18 Charlotte Arp Sørensen, Linda Jeffery, Jannik Falhof, Philipp Harbig, Klaus Roelsgaard, Solveig Gram, Charlotte Olesen
Background:Healthcare is challenged by a rapidly growing group of patients with multi-morbidity and polypharmacy. Increasing activity and specialization puts pressure on healthcare sectors. Medicat...
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Impact of risk communication on patient’s safety during the pandemic Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-03-17 Heyde-Patricia Zuluaga-Arias, Mayada Alkhakany, Manal M. Younus, Houda Sefiani, Angela Caro-Rojas, Sameh Al-Zubiedi, Wafi F. Albalawi, Thamir M. Alshammari
More than 2 years has passed since the pandemic was declared in 2019 due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was later declared to be the pathogen causing cor...
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Analysis of the nature and contributory factors of medication safety incidents following hospital discharge using National Reporting and Learning System (NRLS) data from England and Wales: a multi-method study Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-03-16 Fatema A. Alqenae, Douglas Steinke, Andrew Carson-Stevens, Richard N. Keers
Introduction:Improving medication safety during transition of care is an international healthcare priority. While existing research reveals that medication-related incidents and associated harms ma...
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Association between proton pump inhibitors and rhabdomyolysis risk: a post-marketing surveillance using FDA adverse event reporting system (FAERS) database Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-02-27 Ali F. Altebainawi, Lulwa A. Alfaraj, Amjad A. Alharbi, Fadwa F. Alkhuraisi, Thamir M. Alshammari
Background:This research aims to explore and compare the signals of rhabdomyolysis from the use of Proton pump inhibitors (PPIs) using the United States Food and Drug Administration Adverse Event R...
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Patient-centered pharmacovigilance: priority actions from the inherited bleeding disorders community Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-02-25 Fiona Robinson, Sonji Wilkes, Nathan Schaefer, Miriam Goldstein, Michelle Rice, Johanna Gray, Sharon Meyers, Leonard A. Valentino
Pharmacovigilance, the science and practice of monitoring the effects of medicinals and their safety, is the responsibility of all stakeholders involved in the development, manufacture, regulation,...
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Development of a checklist for the assessment of pharmacovigilance guidelines in Southern Africa: a document review Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-01-24 Nokuthula L. Makhene, Hanlie Steyn, Martine Vorster, Martie S. Lubbe, Johanita R. Burger
Introduction:National regulatory systems in Southern Africa reflect various stages of maturity, and pharmacovigilance (PV) practices are not aligned. In the absence of guidance for formulating PV g...
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Therapy of women with multiple sclerosis: an analysis of the use of drugs that may have adverse effects on the unborn child in the event of (unplanned) pregnancy Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2023-01-11 Marie-Celine Haker, Niklas Frahm, Michael Hecker, Silvan Elias Langhorst, Pegah Mashhadiakbar, Jane Louisa Debus, Barbara Streckenbach, Julia Baldt, Felicita Heidler, Uwe Klaus Zettl
Background:Although effective contraception is strongly recommended during the therapy of women with multiple sclerosis (MS) with some immunomodulatory drugs, unplanned pregnancies still occur. Ade...
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Comparison of two regimens of weekly paclitaxel plus gemcitabine in patients with metastatic breast cancer: propensity score–matched analysis of real-world data Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-12-23 Chengcheng Gong, Yizhao Xie, Yannan Zhao, Yi Li, Jian Zhang, Leiping Wang, Jun Cao, Zhonghua Tao, Xichun Hu, Biyun Wang
Purpose:Weekly gemcitabine + paclitaxel (wGT) administration is widely applied in real-world clinical practice. The 28-day and 21-day regimens of wGT are the most widely accepted regimens. We evalu...
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Safety of triazole antifungals: a pharmacovigilance study from 2004 to 2021 based on FAERS Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-12-16 Shuang Chai, Jing-Lun Zhan, Li-Mei Zhao, Xiao-Dong Liu
Background:Triazole antifungals are widely used as broad-spectrum antifungal activity; however, there are many undetected and unreported adverse events (AEs).Methods:Data from the Food and Drug Adm...
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A survey on self-medication for the prevention or treatment of COVID-19 and distrust in healthcare of veterans in a primary care setting in the United States Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-12-15 Eva Amenta, Larissa Grigoryan, Laura Dillon, Casey Hines-Munson, John Van, Barbara Trautner
Background:The SARS-CoV-2 (COVID-19) pandemic brought the public overwhelming and conflicting information. Rates of trust in healthcare professionals have been declining among laypersons over the p...
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Risk of venous thromboembolism among women receiving ospemifene: a comparative observational study Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-11-19 Beth L. Nordstrom, Bin Cai, Fabio De Gregorio, Lu Ban, Kathy H. Fraeman, Yuki Yoshida, Trevor Gibbs
Introduction:The primary aim of this study was to compare the incidence of venous thromboembolism (VTE) among women initiating ospemifene vs other selective estrogen receptor modulator (SERM) thera...
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Angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and cancer risk: an updated meta-analysis of observational studies Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-10-10 Kayeong Shin, Jiwoo Yang, Yeuni Yu, Eunjeong Son, Kihun Kim, Yun Hak Kim
Introduction:Debate on the association between the use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) and the risk of developing cancer has been ongoin...
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Therapeutic drug monitoring and safety evaluation of voriconazole in the treatment of pulmonary fungal diseases Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-10-08 Kunlu Shen, Yu Gu, Yu Wang, Yajie Lu, Yueyan Ni, Huanhiuan Zhong, Yi Shi, Xin Su
Aims:The gene polymorphism of voriconazole metabolism–related liver enzyme is notable in East Asia population. It casts a significant influence on the rational use of voriconazole. We conducted thi...
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Definition of self-medication: a scoping review Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-10-05 Daniela Baracaldo-Santamaría, Maria José Trujillo-Moreno, Andrés M. Pérez-Acosta, John Edwin Feliciano-Alfonso, Carlos-Alberto Calderon-Ospina, Franklin Soler
Self-medication (SM) is a global and growing phenomenon. It represents a public health problem due to antibiotic resistance, risk of adverse drug reactions, drug–drug interactions, disease masking,...
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Pharmacovigilance: reporting requirements throughout a product’s lifecycle Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-09-27 Sylvia Lucas, Jessica Ailani, Timothy R. Smith, Ahmad Abdrabboh, Fei Xue, Marco S. Navetta
Comprehensive methods for evaluating safety are needed to objectively assess the full risk profile of a medication. The confidence of the prescribing provider in the safety and effectiveness of pha...
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Increasing patient involvement through self-administration of medication. Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-09-12 Sofia Khaja
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Development of a deprescribing manual for frail older people for use in the COFRAIL study and in primary care Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-09-06 Nina-Kristin Mann, Sven Schmiedl, Achim Mortsiefer, Veronika Bencheva, Susanne Löscher, Manuela Ritzke, Eva Drewelow, Gregor Feldmeier, Sara Santos, Stefan Wilm, Petra A. Thürmann, for the COFRAIL study group
Introduction:Many older adults are affected by multimorbidity and subsequent polypharmacy which is associated with adverse outcomes. This is especially relevant for frail older patients. Polypharma...
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Safety surveillance and challenges in accelerated COVID-19 vaccine development Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-09-05 Abimbola Cole, Peggy Webster, Denny Van Liew, Maribel Salas, Omar Aimer, Marina A. Malikova
The COVID-19 pandemic, caused by a novel type of coronavirus, continues to infect people, increasing morbidity and mortality across the globe. Measures to slow the transmission of the virus have ha...
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Global safety monitoring of COVID-19 vaccines: how pharmacovigilance rose to the challenge Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-08-25 Annette Rudolph, Joseph Mitchell, Jim Barrett, Helena Sköld, Henric Taavola, Nils Erlanson, Carlos Melgarejo-González, Qun-Ying Yue
Pharmacovigilance (PV) came suddenly into the spotlight when several new vaccines, developed as a response to the COVID-19 pandemic, received emergency authorisation and were rolled out on a large ...
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Prevalence and global trends of polypharmacy among people living with HIV: a systematic review and meta-analysis Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-08-23 Mohammed I. Danjuma, Oyelola A. Adegboye, Ahmed Aboughalia, Nada Soliman, Ruba Almishal, Haseeb Abdul, Mohamad Faisal Hamad Mohamed, Mohamed Nabil Elshafie, Abdulatif AlKhal, Abdelnaser Elzouki, Arwa Al-Saud, Mas Chaponda, Mubarak Arriyo Bidmos
Background:There has been a rising prevalence of polypharmacy among people living with HIV (PLWH). Uncertainty however remains regarding the exact estimates of polypharmacy among these cohorts of p...
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Motivating deprescribing conversations for patients with Alzheimer’s disease and related dementias: a descriptive study Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-08-23 Mary T. Antonelli, John S. Cox, Cassandra Saphirak, Jerry H. Gurwitz, Sonal Singh, Kathleen M. Mazor
Introduction:Older adults with Alzheimer’s disease and related dementias (ADRD) are at increased risk of harm due to prescribing of potentially inappropriate medications. Encouraging patients and c...
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Patients’ attitudes toward deprescribing and their experiences communicating with clinicians and pharmacists Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-08-19 Kaylee M. Lukacena, James W. Keck, Patricia R. Freeman, Nancy Grant Harrington, Mark J. Huffmyer, Daniela C. Moga
Purpose:Developing effective deprescribing interventions relies on understanding attitudes, beliefs, and communication challenges of those involved in the deprescribing decision-making process, inc...
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Awareness, knowledge, and attitude toward adverse drug reaction (ADR) reporting among healthcare professionals in Ghana Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-08-06 Abena Ahwianfoa Yawson, Gordon Abekah-Nkrumah, Grace Adjei Okai, Charles Gyamfi Ofori
Background:Spontaneous reporting systems are the commonest means of reporting adverse drug reactions (ADRs) worldwide. Under-reporting remains a challenge particularly in developing countries among...
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Risk communication on vaccines during the COVID19 pandemic: is there room for small size or private initiatives? An Israeli experience Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-08-05 Irene R. Fermont, Ayalah Livneh, Michel Benhamou
The scientific communication landscape has undergone a significant disruption since the COVID-19 pandemic: a huge number of publications, ample use of preprint publications, a fast-spreading digita...
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Patients’ views on Self-administration of Medication during hospitalisation: a mixed-methods study Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-07-28 Loes Johanna Maria van Herpen-Meeuwissen, Charlotte Linde Bekker, Nicky Cornelissen, Barbara Maat, Hendrikus Antonius Walterus van Onzenoort, Bartholemeus Johannes Fredericus van den Bemt
Background:Inpatient Self-administration of Medication (SAM) increases patient involvement in medication management and may increase medication safety. Its implementation is impeded. Successful and...
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Could chlorophyllins improve the safety profile of beta-d-N4-hydroxycytidine versus N-hydroxycytidine, the active ingredient of the SARS-CoV-2 antiviral molnupiravir? Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-07-21 Nicole F. Clark, Andrew W. Taylor-Robinson, Kirsten Heimann
Plain Language Summary Could natural plant pigment (chlorophyll) derivatives (chlorophyllins) improve the safety of the antiviral Molnupiravir, used to treat COVID-19 disease? Molnupiravir, a specific SARS-CoV-2 antiviral, may cause adverse genetic changes and thereby create potential host cell damage (through genotoxicity and DNA stressors). In our opinion, this side effect of treatment could be reduced
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The patterns and implications of potentially suboptimal medicine regimens among older adults: a narrative review Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-07-04 Georgie B. Lee, Christopher Etherton-Beer, Sarah M. Hosking, Julie A. Pasco, Amy T. Page
In the context of an ageing population, the burden of disease and medicine use is also expected to increase. As such, medicine safety and preventing avoidable medicine-related harm are major public health concerns, requiring further research. Potentially suboptimal medicine regimens is an umbrella term that captures a range of indicators that may increase the risk of medicine-related harm, including
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Polypharmacy and potential drug–drug interactions among Greenland’s care home residents Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-06-26 Nadja Albertsen, Tine Gjedde Sommer, Thomas Mikkel Olsen, Anna Prischl, Hans Kallerup, Stig Andersen
Background: As lifetime expectancy in Greenland is steadily increasing, so is the proportion of elderly Greenlanders. Old age is associated with polypharmacy, and in this study, we aim to describe the prevalence and characteristics of polypharmacy among the care home residents in Greenland. Methods: Eight care homes in Greenland were visited between 2010 and 2016. Questionnaires including information
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A case report of drug-induced liver injury due to the infliximab biosimilar CT-P13 on switching from original infliximab in a patient with Crohn’s disease Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-05-24 Shin Kashima, Koji Sawada, Kentaro Moriichi, Mikihiro Fujiya
Inflammatory bowel diseases (IBDs) are chronic immune disorders of unclear etiology. Tumor necrosis factor (TNF) inhibitors are effective for IBD treatment and are cost-effective because they reduce hospital admissions and are associated with fewer surgery requirements and a better quality of life in IBD patients. A large number of clinical trials of infliximab biosimilar (CT-P13) have suggested that
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Analysis of drug-induced hand–foot syndrome using a spontaneous reporting system database Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-05-24 Yu Yoshida, Sayaka Sasaoka, Mizuki Tanaka, Kiyoka Matsumoto, Misaki Inoue, Riko Satake, Kazuyo Shimada, Ririka Mukai, Takaaki Suzuki, Mari Iwata, Fumiya Goto, Takayuki Mori, Koki Mori, Tomoaki Yoshimura, Mitsuhiro Nakamura
Purpose: The aim of our study was to assess the clinical features of hand–foot syndrome (HFS) associated with certain systemic chemotherapeutic drugs in a real-world setting using the Japanese Adverse Drug Event Report (JADER) database. Methods: HFS was defined using the preferred terms from the Medical Dictionary for Regulatory Activities. We used several indices, such as the reporting odds ratios
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Prescription for COVID-19 by non-medical professionals during the pandemic in Colombia: a cross-sectional study Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-05-24 Maria Jose Nino-Orrego, Daniela Baracaldo-Santamaría, Claudia Patricia Ortiz, Heyde Patricia Zuluaga, Sthefany Alejandra Cruz-Becerra, Franklin Soler, Andrés M. Pérez-Acosta, Daniel Ricardo Delgado, Carlos-Alberto Calderon-Ospina
Background: The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, and hydroxychloroquine that are not useful for preventing or treating COVID-19 and could expose patients to unnecessary adverse drug reactions (ADRs), drug-drug interactions
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Trends in potentially inappropriate opioid prescribing and associated risk factors among Korean noncancer patients prescribed non-injectable opioid analgesics Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-04-30 Yoojin Noh, Kyu-Nam Heo, Yun Mi Yu, Ju-Yeun Lee, Young-Mi Ah
Introduction: The aim of this study was to investigate trends in the prevalence of potentially inappropriate opioid prescribing (PIOP) and identify potential risk factors among Korean noncancer patients. Methods: We conducted a cross-sectional study of annual national patient sample data from the Korean Health Insurance Review and Assessment Service (HIRA-NPS) for the period 2012–2018. Noncancer patients
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Drug safety of frequently used drugs and substances for self-medication in COVID-19 Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-04-21 Daniela Baracaldo-Santamaría, Santiago Pabón-Londoño, Luis Carlos Rojas-Rodriguez
During the COVID-19 pandemic, the behavior of self-medication has increased. The dissemination of misleading information regarding the efficacy of certain drugs or substances for the prevention and treatment of COVID-19 has been the major contributing factor for this phenomenon. Alongside with the increase in self-medication behavior, the inherent risks to this act such as drug–drug interactions, adverse
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Neurodevelopmental outcomes in children exposed prenatally to levetiracetam Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-03-29 Bshra A. Alsfouk
Some old antiseizure medications (ASMs) pose teratogenic risks, including major congenital malformations and neurodevelopmental delay. Therefore, the use of new ASMs in pregnancy is increasing, particularly lamotrigine and levetiracetam. This is likely due to evidence of low risk of anatomical teratogenicity for both lamotrigine and levetiracetam. Regarding neurodevelopmental effects, lamotrigine is
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The response to the COVID-19 pandemic trusted in pharmacovigilance to diminish communication risk Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-03-29 Gustavo A. Quintero
SARS-CoV-2 is one of the most disruptive events in recent history and has become a threat to global health, perhaps the most important one in the world (along with Spanish flu) since the concept of pandemic had been introduced into the public health, approximately a century1 ago.
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Corrigendum Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-03-17
Corrigendum to “Prospective cohort study of nonspecific deprescribing in older medical inpatients being discharged to a nursing home”
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Alkalising agents in urinary tract infections: theoretical contraindications, interactions and synergy Ther. Adv. Drug Saf. (IF 4.4) Pub Date : 2022-03-16 Oisín N. Kavanagh
Introduction:Alkalising agents have the potential to enhance the efficacy of many antimicrobial agents used in the treatment of Urinary Tract Infections; they also have the potential to cause significant patient harm if used incorrectly. This work seeks to illustrate and quantify these risks and synergies by modelling drug solubility and supersaturation against pharmacokinetic data for commonly used