Overall quality of evidence for the efficacy of anticoagulation management services is moderate to high, given the number of randomized controlled trials and non- randomized controlled trials with comparison groups or pre/post designs. There have been several recent systematic reviews of pharmacist-led anticoagulation management services compared with usual care or other models. Evidence shows that the effect of anticoagulant management services on time to therapeutic range is moderately positive, but evidence is low or mixed onbleeding events and thromboembolic events. Use of dosing protocols or nomograms for newer oral anticoagulants The introduction of NOACs, including the direct thrombin inhibitors (DTIs) (e.g., dabigatran, argatroban) and factor Xa inhibitors (e.g., rivaroxaban, apixaban), may be associated with lower rates of some bleeding events compared with warfarin; however, the direct thrombin inhibitors are associated with a higher risk of major bleeding when used for management of heparin-induced thrombocytopenia. While NOACs may offer different risks and benefits from older oral anticoagulants, careful dosing to balance the risks of thrombotic and hemorrhagic adverse events is required for NOACs, just as it is for older drugs. A protocol or nomogram is a dosing tool that specifies the proper amount of drug (e.g., dose, infusion rate) to be given to a patient based on specific criteria (e.g., patient characteristics such as weight, kidney or liver function, laboratory results). The goal of a dosing protocol or nomogram is to rapidly achieve and maintain a therapeutic range while guiding dosage adjustments and minimizing subtherapeutic or supratherapeutic concentrations. The use of dosing nomograms has been shown to improve the safety and effectiveness of older anticoagulants, particularly heparin therapy. Dosing protocols or nomograms are used for many drugs with a narrow window between their effective doses and doses at which they produce adverse effects; examples include several antibiotics (e.g., gentamicin, vancomycin) as well as anticoagulants (e.g., warfarin, heparin). Dosing protocols or nomograms may reflect different patient characteristics, such as kidney or liver function, depending on how a drug is metabolized. Interventions to support safe transitions and continuation of patients’ anticoagulants post discharge Transitioning patients from one setting to another is a particularly vulnerable time when safety lapses can result in negative clinical outcomes, preventable adverse events, and avoidable hospital readmissions. The Joint Commission describes transitions of care as “the movement of patients between healthcare practitioners, settings, and home, as their conditions and care needs change.”90 Care transitions can also be cause for concern with anticoagulants, given they are the most common causes of ADEs in healthcare settings. Anticoagulants vary in their complexity, dosing, and requirements for transitioning to home from a hospital or ED.
Conclusions about harms due to anticoagulants There appears to be moderate evidence of pharmacist-provided anticoagulation management services, as well as some, albeit limited, evidence of different models being as effective. The studies of dosing protocols for the NOACs are largely observational, non-RCT studies without control groups or tests of significance, and with very small sample sizes. Thus, there is insufficient evidence to indicate the effectiveness of using dosing protocols/ nomograms for NOACs to prevent bleeding. There is a paucity of literature and strong evidence on interventions, services, and programs for the safe transition of anticoagulant therapy post discharge from the hospital or ED. Harms due to diabetic agents Individuals who have diabetes are not usually hospitalized for glucose control but are for other acute and chronic conditions. As inpatients, they are at risk for hypoglycemia and hyperglycemia by having their blood glucose levels (BGL) outside the recommended ranges for hospitalized patients (a target glucose range of 140–180 mg/dL); they may not have available or be consulting with a specialized diabetes or glucose management team skilled in diabetes medication administration. Diabetes exacerbations are known to contribute to morbidity and mortality, and can be avoided through better medication management, including through the use of standardized insulin protocols. During the past decade, the United Kingdom—more than any other nation—has documented diabetes medication errors through the National Diabetes Audit and instituted quality improvement projects to reduce errors and improve outcomes. 91 The data compiled through the National Diabetes Audit constitute one of the best sources of information on safety practices and are referred to below. Diabetes is a growing chronic condition in the United States. Ambulatory patients with diabetes too frequently experience poor management of BGL, hypoglycemia (blood glucose below 70 mg/ dL) and hyperglycemia (200 mg/dL or a fasting blood glucose level above 126 mg/dL). The clinical standards regarding BGL have evolved over the past two decades, beginning with a 2001 landmark study by Van den Berghe that documented increased morbidity and mortality due to hyperglycemia in the inpatient setting. 92 The study catalyzed a change in inpatient diabetes medication management toward standard protocols based on the American Diabetes Association’s recommendations and away from the practice of sliding-scale insulin. In addition, there has been a move away from aggressive glycemic targets; adherence to strict targets has led to an increase in episodes of hypoglycemia. Tight glucose control is not indicated in the hospital setting. BGL <180 mg/dL is associated with lower rates of mortality and stroke compared with a target glucose <200 mg/dL, whereas no significant additional benefit was found with more strict glycemic control (<140 mg/dL). Thus, the ranges for acceptable BGL have eased over time.
There are numerous reasons that standardized insulin protocols or other ways of reducing medication administration errors are important patient safety practices (PSPs). A growing number of aging U.S. adults have diabetes, contributing to increases in the number of inpatients with multiple chronic conditions, which make diabetes even more difficult to manage and control. If diabetes is well controlled during inpatient stays, other conditions can be more effectively treated and instances of BGL out of recommended range can be reduced. These practice changes have implications for inpatient costs, quality of care, readmission rates, and patient reported outcomes. Standardized insulin protocols Standardized protocols are used in many situations because they reduce variability in human behavior and thus reduce the chance of error. Standardized insulin protocols and the insulin regimens to which they apply are intended to maintain relatively constant BGL in a person and reduce fluctuations. However, insulin medication must be adjusted based on an individual’s activity and nutrition intake; an insulin bolus may be needed at mealtime, for example. Insulin regimens include basal insulin or a basal plus bolus correction insulin, which is the preferred treatment for non-critically ill hospitalized patients with poor oral intake. An insulin regimen with basal, prandial, and correction components is the preferred treatment for non- critically ill hospitalized patients who are able to intake nutrition orally. Standardized protocols are implemented through different forms, including specialized medical teams and paper and electronic order sets. Sole use of sliding-scale insulin in the inpatient hospital setting is strongly discouraged. The teach-back method is also called “closing the loop” and can be effective in increasing patients’ ability to retain knowledge that helps them manage health conditions. Teach-back tests comprehension by asking patients to say in their own words what they understand the clinician has instructed them to do. Teach-back has been used with many different kinds of patients and in multiple settings, but to be effective, the patient must have the cognitive ability to comprehend the information, the physical skills to successfully self-administer insulin and other diabetes medication, be able to perform self-monitoring of blood glucose, and have adequate oral intake. The setting for teach- back is typically outpatient. Conclusions about diabetic agents Diabetes is a growing chronic condition in all age groups, and strategies for improving medication management will have significant impact on mortality and morbidity. Using standardized insulin protocols to reduce hypoglycemia in the hospital and teach-back methods in other settings to improve the ability of diabetes patients to better understand and self-manage their own insulin and other antihyperglycemic medication needs are both patient safety practices that have potential. Teach-back in diabetes medication management
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