A pharmacotherapy review of the novel,oral antithrombotics

Coagulation disorders account for a high incidence of death in the U.S. due to stroke, myocardial infarction, and venous thromboembolism. In the past few years, numerous agents have been brought to market for the treatment of thromboembolism or prevention of thromboembolism. Similar to warfarin, these agents can cause bleeding disorders, which may exacerbate dental care treatment plans. This literature review examines the newer agents for the treatment of thromboembolism disorders, common side effects and drug interactions, the specific medical conditions each agent treats, and the dental perspective on how to medically management patients prescribed these medications.     

Implementation and Preliminary Clinical Outcomes of a Pharmacist‐managed Venous Thromboembolism Clinic for Patients Treated With Rivaroxaban Post Emergency Department Discharge

Objective

The objective was to describe the implementation, work flow, and differences in outcomes between a pharmacist‐managed clinic for the outpatient treatment of venous thromboembolism (VTE) using a non‐vitamin K oral anticoagulant versus care by a primary care provider (PCP).

Methods

Patients in the studied health system that are diagnosed with low‐risk VTE in the emergency department are often discharged without hospital admission. These patients are treated with a non‐vitamin K oral anticoagulant and follow‐up either in a pharmacist‐managed VTE clinic or with their PCP. Pharmacists in the VTE clinic work independently under a collaborative practice agreement (CPA). An evaluation of 34 patients, 17 in each treatment arm, was conducted to compare the differences in treatment‐related outcomes of rivaroxaban when managed by a pharmacist versus a PCP.

Results

The primary endpoint was a 6‐month composite of anticoagulation treatment‐related complications that included a diagnosis of major bleeding, recurrent thromboembolism, or fatality due to either major bleeding or recurrent thromboembolism. Secondary endpoints included number of hospitalizations, adverse events, and medication adherence. There was no difference in the primary endpoint between groups with one occurrence of the composite endpoint in each treatment arm (p = 1.000), both of which were recurrent thromboembolic events. Medication adherence assessment was formally performed in eight patients in the pharmacist group versus no patients in the control group. No differences were seen among other secondary endpoints.

Conclusions

The pharmacist‐managed clinic is a novel expansion of clinical pharmacy services that treats patients with low‐risk VTEs with rivaroxaban in the outpatient setting. The evaluation of outcomes provides support that pharmacist‐managed care utilizing standardized protocols under a CPA may be as safe as care by a PCP.

     

A Mixed‐Method Approach to Evaluate a Pharmacist Intervention for Veterans With Hypertension

This paper examines blood pressure (BP) control after 6 months of an intensive pharmacist‐managed intervention in a mixed‐methods randomized controlled trial conducted at the Iowa City Veteran Affairs Health Care System and two community‐based outreach clinics. Patients received the pharmacist intervention for the first 6 months. The study coordinator conducted a summative evaluation with 37 patients 18 to 24 months following the initial 6‐month intervention period. BP was significantly reduced in diabetic patients following an intensive pharmacist intervention (−8.0/−4.0±14.4/9.1 mm Hg systolic/diastolic, P<.001 and P=.001, respectively). BP was reduced even more in nondiabetic patients (−14.0/−5.0±1.9/10.0 mm Hg, P<.001). Medication adherence significantly improved from baseline to 6 months (P=.017). BPs were significantly lower at 6 months following an intensive pharmacist intervention. Patients also expressed a high level of satisfaction with and preference for co‐management of their hypertension, as well as other chronic diseases.

Hypertension (HTN) affects more than 1 million US veterans and is a risk factor for heart disease, stroke, renal failure, peripheral vascular disease, and death. Every 3‐mm Hg reduction in systolic blood pressure (BP) could reduce cardiovascular mortality by 5% and stroke mortality by 8%.¹ However, HTN remains inadequately treated.², ³ Although older studies found that a majority of patients with HTN were poorly controlled, a recent Veterans Administration (VA) study found that only 23% of hypertensive patients had suboptimal BP control.⁴ One of the many ways the Veterans Health Administration (VHA) has been able to achieve these improved results is by implementing team‐based care utilizing pharmacists to manage hypertension. Even with these assertive efforts, there is still room for improvement for controlling hypertension. VA/Department of Defense (DoD) guidelines suggest that pharmacists be used to help with medication adjustments to improve BP control.⁵ Although clinical trials have found that higher BP control rates can be achieved, this requires increasing intensity of therapy over time to maintain long‐term BP control. Such aggressive management is not typical in practice where clinical inertia and patient nonadherence create barriers to achieving BP control.Within the Iowa City VA Health Care System, pharmacists currently provide ad hoc consultation on patients with HTN with the ability to adjust dosages of primary care provider (PCP) prescribed medications. The Iowa City VA has a pharmacist‐run anticoagulation clinic and pharmacists independently manage patients referred to them by PCPs for hyperlipidemia, diabetes mellitus, and smoking cessation with the ability to prescribe and adjust medications and order appropriate laboratory tests. Within the health system, there is no guidance on how to use pharmacist interventions after BP has been controlled or if patients can be referred back to primary care.⁶, ⁷, ⁸, ⁹, ¹⁰, ¹¹, ¹² In this study, PCPs gave the pharmacist authority to prescribe BP medications and order appropriate laboratory tests to assess renal function and electrolytes. To date, few randomized studies have evaluated team‐based strategies to sustain the effect of such interventions. Thus, the primary goal of the main study is to evaluate how to sustain long‐term BP control in Veterans with HTN following a 6‐month intensive pharmacist intervention. As part of the parent study, all patients received the intervention for 6 months and then were subsequently randomized to either continued intervention or referral back to usual care following simple education. The final results of the randomized clinical trial will not be available until after 2014. The purpose of the present paper is to report BP control following the initial 6‐month intervention and to describe findings from a summative evaluation of the intervention that was conducted 18 to 24 months later (Figure).Open in a separate windowFigure 1Study overview. VAHCS indicates Veteran Affairs Health Care System; BP, blood pressure; F/U, follow‐up.