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Journals Therapeutic Advances in Drug S...

Therapeutic Advances in Drug Safety

https://read.qxmd.com/read/37780667/opportunities-and-challenges-of-pharmacovigilance-in-special-populations-a-narrative-review-of-the-literature
#1
REVIEW
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 in these populations. Elderly patients tend to have multiple comorbidities often requiring more extensive medication, which adds additional challenges for healthcare professionals (HCPs) in delivering safe and effective pharmacotherapy...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37667777/hiv-aids-patients-knowledge-attitude-and-practice-toward-anti-retroviral-therapy-medications-adverse-effects-and-associated-factors-in-tikur-anbessa-specialized-hospital
#2
JOURNAL ARTICLE
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, attitude, and practice (KAP) toward ART medications' AEs and associated factors. METHODS: A cross-sectional study design was applied using an interviewer-administered questionnaire from June to September 2021 on human immunodeficiency virus/acquired immunodeficiency syndrome patients on follow-up at Tikur Anbessa Specialized Hospital, Ethiopia...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37636838/enhancing-self-medication-practices-in-the-era-of-infodemic-the-role-of-pharmacovigilance
#3
EDITORIAL
Carlos-Alberto Calderon-Ospina
No abstract text is available yet for this article.
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37636837/clinical-relevance-of-potential-self-medication-drug-interactions-in-antineoplastic-and-immune-modulating-therapy-among-online-pharmacy-customers
#4
JOURNAL ARTICLE
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 any advice from a healthcare professional. OBJECTIVES: The aim of this study was to investigate whether the risk of known potential drug-drug interactions between modern oral antineoplastic and immune-modulating drugs and OTC drugs differs between sales in traditional community pharmacies versus online pharmacies...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37529763/funding-and-financial-sustainability-of-pharmacovigilance-suggested-models-for-funding-pharmacovigilance-in-resource-limited-african-countries
#5
JOURNAL ARTICLE
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: The objective of this paper is to provide an overview as to the availability of potential sources of funds, which could be explored to ensure Medicine Safety and to proffer a potential framework likely to ensure sustainable funding of PV in Africa...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37529762/hospital-admissions-attributed-to-adverse-drug-reactions-in-tertiary-care-in-uganda-burden-and-contributing-factors
#6
JOURNAL ARTICLE
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 analysis of data from a prospective cohort study of adult inpatients aged 18 years and older at Uganda's Mulago National Referral Hospital from November 2013 to April 2014...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37492690/flow-rate-accuracy-of-infusion-devices-within-healthcare-settings-a-systematic-review
#7
REVIEW
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 and devices and examine the factors that affect the flow rate accuracy of devices...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37377748/safety-monitoring-of-oral-iron-supplements-in-pregnant-women-with-anemia-a-multi-center-observational-clinical-study
#8
JOURNAL ARTICLE
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 the treatment drugs. RESULTS: The overall adverse reaction rate was 15...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37359445/joint-use-of-population-pharmacokinetics-and-machine-learning-for-optimizing-antiepileptic-treatment-in-pediatric-population
#9
JOURNAL ARTICLE
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 to identify any relationships among the plasma levels of the three medications and patients' characteristics, as well as to develop a predictive model for epileptic seizures...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37359444/survival-outcomes-of-beta-blocker-usage-in-her2-positive-advanced-breast-cancer-patients-a-retrospective-cohort-study
#10
JOURNAL ARTICLE
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 survival (PFS) and overall survival (OS) in patients receiving anti-human epidermal growth factor receptor 2 (HER2) treatment for advanced breast cancer...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37332887/assessing-adverse-drug-reaction-reports-for-antidiabetic-medications-approved-by-the-food-and-drug-administration-between-2012-and-2017-a-pharmacovigilance-study
#11
JOURNAL ARTICLE
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 of spontaneously reported ADRs was conducted. FAERS reports from January 1, 2012 to March 31, 2022 were compiled, allowing a 5-year buffer following drug approval in 2017...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37332886/risk-of-lower-limb-amputation-in-diabetic-patients-using-sglt2-inhibitors-versus-dpp4-inhibitors-or-glp-1-agonists-a-meta-analysis-of-2%C3%A2-million-patients
#12
JOURNAL ARTICLE
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 5 February 2023. All types of studies comparing the drugs for LLA risk and reporting hazard ratios (HR) were included...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37223456/serious-neurological-adverse-events-following-immunization-against-sars-cov-2-a-narrative-review-of-the-literature
#13
REVIEW
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 the potential negative impact that vaccine hesitancy would have on immunization programs, we conducted a review of the scientific literature concerning the epidemiological data, clinical presentation, and potential mechanisms of these neurological AEFIs...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37007873/development-and-psychometric-assessment-of-self-reported-patient-medication-safety-scale-sr-pmss
#14
JOURNAL ARTICLE
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 safety. This study aimed to develop and validate the self-reported patient medication safety scale (SR-PMSS). METHODS: We developed SR-PMSS guided by the Donabedian Structure-Process-Outcome framework and used psychometric methods to test its validity and reliability...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/37007872/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
#15
JOURNAL ARTICLE
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. Adequate medication management is essential to avoid foetal harm in the event of an unplanned pregnancy. OBJECTIVE: The aim was to screen for medications used in women of childbearing age with MS that may pose a risk of side effects on foetal development. METHODS: Sociodemographic, clinical and medication data were collected from 212 women with MS by structured interviews, clinical examinations and medical records...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/36949767/impact-of-risk-communication-on-patient-s-safety-during-the-pandemic
#16
REVIEW
Heyde-Patricia Zuluaga-Arias, Mayada Alkhakany, Manal M Younus, Houda Sefiani, Angela Caro-Rojas, Sameh Al-Zubiedi, Wafi F Albalawi, Thamir M Alshammari
UNLABELLED: 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 coronavirus disease 2019 (COVID-19). During this time, many healthcare systems faced numerous challenges to control the high morbidity and mortality of the disease. Unlike previous pandemics, the actions against this pandemic started quickly on both the global and country levels...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/36949766/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
#17
JOURNAL ARTICLE
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 may be common following hospital discharge, there is limited information about their nature and contributory factors at a national level which is crucial to inform improvement strategy. AIM: To characterise the nature and contributory factors of medication-related incidents during transition of care from secondary to primary care...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/36949765/developing-and-piloting-a-cross-sectoral-hospital-pharmacist-intervention-for-patients-in-transition-between-hospital-and-general-practice
#18
JOURNAL ARTICLE
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. Medication errors in cross-sectoral transition of patients are often seen. The aim of the study was to explore drug-related problems (DRPs) in the transition of patients between sectors and to develop and pilot-test a cross-sectoral hospital pharmacist intervention to overcome some of these problems...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/36875514/association-between-proton-pump-inhibitors-and-rhabdomyolysis-risk-a-post-marketing-surveillance-using-fda-adverse-event-reporting-system-faers-database
#19
JOURNAL ARTICLE
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 Reporting System (FAERS) database. METHODS: Rhabdomyolysis and related terms submitted between 2013 and 2021 were retrieved from the FAERS database. The data were analyzed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Empirical Bayes Geometric Mean (EBGM) and the information component (IC)...
2023: Therapeutic Advances in Drug Safety
https://read.qxmd.com/read/36861041/patient-centered-pharmacovigilance-priority-actions-from-the-inherited-bleeding-disorders-community
#20
REVIEW
Fiona Robinson, Sonji Wilkes, Nathan Schaefer, Miriam Goldstein, Michelle Rice, Johanna Gray, Sharon Meyers, Leonard A Valentino
UNLABELLED: 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, distribution, prescription, and use of drugs and devices. The patient is the stakeholder most impacted by and the greatest source of information on safety issues. It is rare, however, for the patient to take a central role and exert leadership in the design and execution of pharmacovigilance...
2023: Therapeutic Advances in Drug Safety
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