Relationship of Incorrect Dosing of Fibrinolytic Therapy and Clinical Outcomes

Mehta, R.H.; Alexander, Jay; Werf, F. Van de

doi:10.1016/j.accreview.2005.06.018

Cited by 4 publications

(6 citation statements)

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“…Thus, the association of AEs with poor outcomes may be due to confounding [ 4 ]. An example of this phenomenon is nicely illustrated in a recent secondary analysis of data from a randomized controlled trial showing that patients who received incorrect doses of a study drug were more likely to experience adverse clinical outcomes, irrespective of whether the treatment received was placebo or the active agent [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

The impact of adverse events in the intensive care unit on hospital mortality and length of stay

Forster

Kyeremanteng

Hooper

et al. 2008

BMC Health Serv Res

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Background: Adverse events (AEs) are patient injuries caused by medical care. Previous studies have reported increased mortality rates and prolonged hospital length of stay in patients having an AE. However, these studies have not adequately accounted for potential biases which might influence these associations. We performed this study to measure the independent influence of intensive care unit (ICU) based AEs on in-hospital mortality and hospital length of stay.

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Section: Introductionmentioning

confidence: 99%

The impact of adverse events in the intensive care unit on hospital mortality and length of stay

Forster

Kyeremanteng

Hooper

et al. 2008

BMC Health Serv Res

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“…The ASSENT-2 study by Mehta et al evaluated 30-day mortality, in-hospital stroke, and major bleeding related to dosing and administration of fibrinolytic therapy (alteplase versus tenecteplase). 25 Researchers defined incorrect dosing as any dose more or less than the weight-based dose of the prescribed fibrinolytic agent. Results demonstrated that overdosing doubles the risk of mortality, while underdosing of the fibrinolytic agent almost quadruples the risk of mortality (Fig.…”

Section: Timing Of Administrationmentioning

confidence: 99%

“…Twenty‐five percent of MI patients who received two of the most widely utilized fibrinolytic agents were administered the wrong dose, doubling their risk of death. The ASSENT‐2 study by Mehta et al evaluated 30‐day mortality, in‐hospital stroke, and major bleeding related to dosing and administration of fibrinolytic therapy (alteplase versus tenecteplase) 25 . Researchers defined incorrect dosing as any dose more or less than the weight‐based dose of the prescribed fibrinolytic agent.…”

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confidence: 99%

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Antiplatelet Therapy: Anti‐Ischemic Benefits versus Bleeding Risk

GIBSON

2008

J Interven Cardiology

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Balance between efficacy and safety is a major concern in therapeutic interventions of patients with acute coronary syndromes. Identifying and managing the risks that may negatively affect this balance can potentially minimize the incidence of morbidity and/or mortality among patients with acute coronary syndromes. Unstable angina and non-ST-elevation myocardial infarction are potentially life-threatening disorders and a major cause of hospitalization and emergency medical care. At the time of presentation, the use of algorithms that provide reasonable assessment of a patient's risk of cardiovascular events, such as the Thrombolysis in Myocardial Infarction risk score, can help clinicians identify which patients will most likely benefit from a specific strategy. The ultimate goal of treatment for non-ST-elevation myocardial infarction is to reduce short- and long-term morbidity and mortality, as well as salvage myocardial cells and cardiac function. Pharmacologic intervention with antiplatelet and/or antithrombotic agents has proven to be effective in achieving this goal in numerous outcome studies. However, clinicians must balance anti-ischemic efficacy with the need to minimize the risk of serious bleeding complications (e.g., hemorrhage). Issues related to safety include timing of the dose, duration of infusion, drug compatibility, errors in estimating a patient's weight and/or age, failure to adjust the dosage based upon renal function, and errors in drug preparation.

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“…There is a narrow "therapeutic window" for fibrinolytic-antithrombotic treatment, and the potential for adverse outcomes is high when an incorrect dose is administered. 9,10 High doses of fibrinolytic agent are associated with hemorrhagic complications, such as intracranial hemorrhage, and for the treatment of AMI low doses are associated with lower rates of infarct-related artery patency. 9 It is therefore crucial that not only the correct dose is administered by the physician but also that the labeled potency of the drug is accurate and consistent.…”

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confidence: 99%

Biological Standards for Potency Assignment to Fibrinolytic Agents Used in Thrombolytic Therapy

Thelwell

2014

Semin Thromb Hemost

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Thrombolytic drugs are used for the treatment of thrombotic disorders such as acute myocardial infarction, acute ischemic stroke, and pulmonary embolism. Biological standards are used for potency assignment to the range of fibrinolytic proteins used in thrombolytic therapy. The World Health Organization (WHO) International Standards are primary reference materials, calibrated in arbitrary units (international unit), assigned by collaborative study using the range of assay methods available at the time. Provided the standard and test material are equivalent, adhering to the principle of measuring like versus like, the exact nature of the assay method is unimportant. This approach has been applied successfully for several decades since the advent of fibrinolytic treatment, ensuring consistency for potency labeling and the correct dosing of patients. The emergence of generic biosimilar products and new recombinant variants poses a challenge to this system, where functional differences impact on the relative biological activity in different assay systems. A more demanding system of standardization may therefore be required on the basis of international reference materials with associated reference methods. WHO recognizes this, and where possible and practical is seeking to incorporate concepts of traceability, uncertainty, and commutability to International Standards. However, some caution is needed because limitations on the characterization of many complex biologicals remain real, and a flexible approach is required on the basis of real-world needs.

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Relationship of Incorrect Dosing of Fibrinolytic Therapy and Clinical Outcomes

Cited by 4 publications

References 0 publications

The impact of adverse events in the intensive care unit on hospital mortality and length of stay

The impact of adverse events in the intensive care unit on hospital mortality and length of stay

Antiplatelet Therapy: Anti‐Ischemic Benefits versus Bleeding Risk

Biological Standards for Potency Assignment to Fibrinolytic Agents Used in Thrombolytic Therapy

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