Identifying and Characterizing Serious Adverse Drug Reactions Associated With Drug-Drug Interactions in a Spontaneous Reporting Database

Magro, Lara; Arzenton, Elena; Leone, Roberto; Stano, Marilisa Giustina; Vezzaro, Michele; Rudolph, Annette; Castagna, Irene; Moretti, Ugo

doi:10.3389/fphar.2020.622862

Cited by 29 publications

(24 citation statements)

References 52 publications

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Section: Discussionsupporting

confidence: 89%

“…As DDIs are usually predictable and manageable, ADRs caused by DDIs may be prevented by monitoring the patient closely or replacing the responsible drugs with other medications. To reduce the risk of DDIs and improve patient safety, it is essential that healthcare professionals regularly review the medication regimens, recognize potentially interacting drug pairs, and withdraw unnecessary drugs (Magro et al, 2020). A prospective study showed that the number of patients with pDDIs and actual DDIs decreased by 18% and 43%, respectively, with an intervention based on a computerized Frontiers in Pharmacology frontiersin.org clinical decision support system containing information on drug combinations (Bertsche et al, 2010).…”

Section: Discussionmentioning

confidence: 99%

“…In our study, 105 ADR reports were induced by actual DDIs, accounting for 18.32% of the ADR reports with more than one suspected drug. This percentage was close to the proportion reported by Magro et al (2020) . According to the online version of DRUGDEX ® system, they verified DDI among serious ADRs containing at least two suspected or concomitant drugs in the National Pharmacovigilance database from Veneto Region, and identified 17.4% ADR reports associated with a DDI.…”

Section: Discussionunclassified

“…Actual DDIs are identified on the basis of clinical evidence, such as laboratory test results or symptoms, consequently, the frequency of actual DDIs is much lower than that of pDDIs (Magro et al, 2012;Zheng et al, 2018). Over the past years, a substantial number of articles have been published about ADRs due to DDIs (Leone et al, 2010;Obreli-Neto et al, 2012a;Obreli Neto et al, 2012b;Kovacevic et al, 2019;Letinier et al, 2020;Magro et al, 2020). A 6-year retrospective study in Bengbu in China showed that among the ADRs reported between nervous system drugs in hospitalized patients, 12.14% of the ADRs were associated with potential and actual DDIs, and actual DDIs were present in 6.21% of all ADRs (Shi et al, 2014).…”

Section: Introductionmentioning

confidence: 99%

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Adverse drug reactions and correlations with drug–drug interactions: A retrospective study of reports from 2011 to 2020

et al. 2022

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Introduction: Adverse drug reactions (ADRs) represent a public health problem worldwide that deserves attention due to the impact on mortality, morbidity, and healthcare costs. Drug–drug interactions (DDIs) are an important contributor to ADRs. Most of the studies focused only on potential DDIs (pDDIs), while the detailed data are limited regarding the ADRs associated with actual DDIs.Methods: This retrospective study evaluated ADRs reported between 2011 and 2020 in a tertiary hospital. The causality and severity of ADRs were evaluated through the Naranjo Algorithm and Hartwig’s scale, respectively. Preventability classification was based on the modified Schoumock and Thornton scale. For ADRs with at least two suspected drugs, pDDIs were identified according to the Lexi-Interact. We further checked whether the ADR description in the reports corresponded to the clinical consequences of the pDDIs.Results: A total of 1,803 ADRs were reported, of which 36.77% ADRs were classified as mild, 43.26% as moderate, and 19.97% as severe. The assessment of causality showed that the distributions of definite, probable, and possible categories were 0.33%, 58.68%, and 40.99%, respectively. A total of 53.97% of ADRs were identified as preventable ADRs, while 46.03% were recognized as unpreventable. The severity of ADRs was significantly correlated with age, the number of suspected drugs and preventability. Antimicrobial agents were the most common implicated pharmacological group, and the most frequently affected system was the gastrointestinal system. Considering individual drugs, aspirin was the most frequently reported drug. Among 573 ADRs with at least two suspected drugs, 105 ADRs were caused by actual DDIs, of which only 59 and 6 ADRs were caused by actual DDIs in category D and X, respectively. The most frequent drugs involved in actual DDIs of category D were aspirin and heparin, with the majority of ADRs being gastrointestinal bleeding.Conclusion: This study analyzed the pattern of ADRs in detail and obtained clinical evidence about ADRs associated with actual DDIs. These findings may be useful to compare patterns between different centers and to design preventive strategies for ADRs. Continuous education and training should be provided for physicians regarding the knowledge and recognition of ADRs associated with DDIs.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Discussionunclassified

Section: Introductionmentioning

confidence: 99%

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Adverse drug reactions and correlations with drug–drug interactions: A retrospective study of reports from 2011 to 2020

et al. 2022

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“…What is more, warfarin therapy is fraught with several inherent problems, such as great diversity in dosing, delayed onset of action along with prolonged effect after discontinuation, a wide range of serious interactions, and a narrow therapeutic index. Collectively, all these problems designate warfarin as a "high alert medication" that calls for extraordinary caution and care (10)(11)(12)(13)(14).…”

Section: Introductionmentioning

confidence: 99%

Cost-Effectiveness of the Pharmacist-Managed Warfarin Therapy vs. Standard Care for Patients With Mechanical Mitral Valve Prostheses: An Egyptian Healthcare Perspective

Batran

Sabri

Ali

et al. 2022

Front. Cardiovasc. Med.

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BackgroundDespite warfarin therapy had been used for decades for patients with mechanical mitral valve prostheses (MMVPs), serious and life-threatening complications are still reported worldwide with a significant economic burden. This study is aimed at assessing the clinical and the cost-effectiveness of adopting pharmacist-managed warfarin therapy (PMWT) services for optimizing warfarin treatment in Egypt.MethodsA prospective randomized trial in which 59 patients with MMVPs were randomly assigned to receive the PMWT services or the standard care and followed up for 1 year. The primary outcome was percentage time in the therapeutic range (TTR). For the cost-effectiveness analysis, a Markov cohort process model with nine mutually exclusive health states was developed from a medical provider’s perspective. A lifetime horizon was applied. All costs and outcomes were discounted at 3.5% annually.ResultsThe study results revealed a significantly higher median TTR in the intervention group as compared to the control group; 96.8% [interquartile range (IQR) 77.9–100%] vs. 73.1% (52.7–95.1%), respectively, p = 0.008. A significant association between standard care and poor anticoagulation control (p = 0.021) was demonstrated by the multivariate regression analysis. For the cost-effectiveness analysis, the total cumulative quality-adjusted life-years (QALYs) and total costs per patient were 21.53 and 10.43; 436.38 and 1,242.25 United States dollar (USD) in the intervention and the control groups, respectively, with an incremental cost-effectiveness ratio (ICER) of −72.5796 for the intervention group.ConclusionThe PMWT strategy was proven to provide a significantly better anticoagulation control and to be a cost-saving approach in Egyptian patients with MMVPs. Nevertheless, the dominance of this strategy is sustained by maintaining the therapeutic International Normalized Ratio (INR) control within the recommended range. Our findings will benefit Egyptian policy-makers who may seek novel health strategies for better resource allocation.Clinical Trial Registration[ClinicalTrials.gov], identifier [NCT04409613].

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Colchicine for the primary prevention of cardiovascular events

Martí‐Carvajal

Sanctis

Hidalgo

et al. 2022

Cochrane Database of Systematic Reviews

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ObjectivesThis is a protocol for a Cochrane Review (intervention). The objectives are as follows:To assess the clinical benefit and harms of colchicine as primary prevention of cardiovascular outcomes in the general population. Background Description of the conditionCardiovascular diseases (CVDs) include coronary heart disease (CHD), sudden cardiac death/sudden cardiac arrest, cerebrovascular disease, stroke/transient ischemic attack, rheumatic heart disease, congenital heart disease, deep venous thrombosis, pulmonary embolism, and peripheral arterial disease. From 1990 to 2019, the prevalence of cases of total CVDs has been nearly doubled from 271 million (95% uncertainty interval: 257 to 285 million) to 523 million (95% UI: 497 to 550 million), respectively (Roth 2020). In addition, it has been estimated that CVDs caused 18.6 million (95% uncertainty interval: 17.1 to 19.7 million) deaths in 2019 (Roth 2020). Doubtlessly, CVDs yield a high socioeconomic burden in the general population (Flora 2019).The main cause of CVDs is atherosclerosis which is the result of cellular-molecular interactions in the artery wall (Gotlieb 1991); therefore, it is a chronic inflammatory disease with autoimmune foundations (

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Identifying and Characterizing Serious Adverse Drug Reactions Associated With Drug-Drug Interactions in a Spontaneous Reporting Database

Cited by 29 publications

References 52 publications

Adverse drug reactions and correlations with drug–drug interactions: A retrospective study of reports from 2011 to 2020

Adverse drug reactions and correlations with drug–drug interactions: A retrospective study of reports from 2011 to 2020

Cost-Effectiveness of the Pharmacist-Managed Warfarin Therapy vs. Standard Care for Patients With Mechanical Mitral Valve Prostheses: An Egyptian Healthcare Perspective

Colchicine for the primary prevention of cardiovascular events

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