Samuel L. Ellis

Clinical and Economic Impact of Ambulatory Care Clinical Pharmacists in Management of Dyslipidemia in Older Adults: The IMPROVE Study

We examined the impact of ambulatory care clinical pharmacist interventions on clinical and economic outcomes of 208 patients with dyslipidemia and 229 controls treated at nine Veterans Affairs medical centers. This was a randomized, controlled trial involving patients at high risk of drug‐related problems. Only those with dyslipidemia are reported here. In addition to usual medical care, clinical pharmacists were responsible for providing pharmaceutical care for patients in the intervention group. The control group did not receive pharmaceutical care. Seventy‐two percent of the intervention group and 70% of controls required secondary prevention according to the National Cholesterol Education Program guidelines. Significantly more patients in the intervention group had a fasting lipid profile compared with controls (p=0.021). The absolute change in total cholesterol (17.7 vs 7.4 mg/dl, p=0.028) and low‐density lipoprotein (23.4 vs 12.8 mg/dl, p=0.042) was greater in the intervention than in the control group. There were no differences in patients achieving goal lipid values or in overall costs despite increased visits to pharmacists. Ambulatory care clinical pharmacists can significantly improve dyslipidemia in a practice setting designed to manage many medical and drug‐related problems.

The Cost Effectiveness of Anticoagulation Management Services for Patients with Atrial Fibrillation and at High Risk of Stroke in the US

BackgroundAnticoagulation therapy with warfarin is widely considered the standard of care for stoke prophylaxis in patients with atrial fibrillation who are at high risk of stroke. Community-based studies in the US have reported that the effectiveness of anticoagulation varies by management approach and that patients receiving warfarin have international normalised ratio (INR) values within the target therapeutic range less than half the time.ObjectiveTo estimate the lifetime societal costs and health benefits of warfarin therapy to prevent strokes, specifically in elderly patients (mean age 70 years) with atrial fibrillation who are at high risk of stroke, when anticoagulation is managed through usual care versus anticoagulation management services, where dedicated anticoagulation professionals (e.g. physician or pharmacist) monitor and oversee patients.MethodsSemi-Markov decision model with a 30-day cycle length and 10-year time horizon (to reflect the mean life expectancy of the study population). Univariate sensitivity analyses and Bayesian second-order multivariate probabilistic sensitivity analysis using Monte Carlo simulation were performed.Outcomes measures were costs and QALYs. Most of the probability and outcome estimates included were derived from the recent SPORTIF (Stroke Prevention using ORal Thrombin Inhibitor in atrial Fibrillation) V trial. Utility values were derived from a large, nationally representative sample of individuals in the Medical Expenditure Panel Survey and were adjusted for age, sex, race, ethnicity, income, education and co-morbidity. Resource utilisation was based on experience at the University Medicine Group Practice Anticoagulation Clinic (University of Colorado, Denver, CO, USA) and costs (

GLP-1 receptor agonists: a review of head-to-head clinical studies.

US; 2004 values) included were for warfarin and aspirin (acetylsalicylic acid) use and those associated with major bleeding, treatment of primary events, routine INR and biochemistry monitoring, ECGs, and clinic visits. Costs and outcomes were discounted by 3% per annum.ResultsThe anticoagulation management service improved effectiveness by 0.057 (95% credible interval 0, 0.36) QALYs and reduced costs by

An economic analysis of a randomized, controlled, multicenter study of clinical pharmacist interventions for high-risk veterans: The IMPROVE study

US2100 (95% credible interval −

Can clinical pharmacists affect SF-36 scores in veterans at high risk for medication-related problems?

US19 800,

Types of Interventions Made by Clinical Pharmacists in the IMPROVE Study

US300) [2004 values] compared with usual care. Results were sensitive to the extent of the increase in risk of primary events (all strokes and systemic embolic events attributable to usual care, but were robust to variation in other input variables). The anticoagulation management service was the dominant strategy in 91% of Monte Carlo simulations.ConclusionThe anticoagulation management service appears to cost less and provide greater effectiveness than usual care. To enhance stroke prophylaxis among high-risk patients with atrial fibrillation, physicians and Medicare plans may wish to consider augmenting ‘usual care’ by the addition of patient-monitoring technology strategies such as formally organised anticoagulation monitoring programmes.

Continuous Home Monitoring of Glucose: Improved glycemic control with real-life use of continuous glucose sensors in adult subjects with type 1 diabetes

Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are attractive options for the treatment of type 2 diabetes (T2D) because they effectively lower A1C and weight while having a low risk of hypoglycemia. The GLP-1 RA class has grown in the last decade with several agents available for use in the US and Europe and several more in development. Since the efficacy and tolerability, dosing frequency, administration requirements, and cost may vary between agents within the class, each agent may offer unique advantages and disadvantages. Through a review of phase III clinical programs for exenatide twice daily, exenatide once weekly, liraglutide, albiglutide, lixisenatide, and dulaglutide, eight head-to-head trials have evaluated the safety and efficacy of GLP-1 RA active comparators. The purpose of this review is to provide an analysis of these trials. The GLP-1 RA head-to-head clinical studies have demonstrated that all GLP-1 RA agents are effective therapeutic options at reducing A1C. However, differences exist in terms of magnitude of effect on A1C and weight as well as frequency and severity of adverse effects.

Cost-effectiveness of continuous glucose monitoring and intensive insulin therapy for type 1 diabetes

Study Objective. To determine if clinical pharmacists could affect economic resource use and humanistic outcomes in an ambulatory, high‐risk population.

Insulin glulisine: a new rapid-acting insulin analogue for the treatment of diabetes

Background.An objective of pharmaceutical care is for pharmacists to improve patients’ health-related quality of life (HRQOL) by optimizing medication therapy. Objectives.The objective of this study was to determine whether ambulatory care clinical pharmacists could affect HRQOL in veterans who were likely to experience a drug-related problem. Research Design. This was a 9-site, randomized, controlled trial involving Veterans Affairs Medical Centers (VAMCs). Patients were eligible if they met ≥3 criteria for being at high risk for drug-related problems. Enrolled patients were randomized to either usual medical care or usual medical care plus clinical pharmacist interventions. HRQOL was measured with the SF-36 questionnaire administered at baseline and at 6 and 12 months. Results.In total, 1,054 patients were enrolled; 523 were randomized to intervention, and 531 to control. After patient age, site, and chronic disease score were controlled for, the only domain that was significantly different between groups over time was the bodily pain scale, which converged to similar values at the end of the study. Patients’ rating of the change in health status in the past 12 months was statistically different between groups, intervention patients declining less (−2.4 units) than control subjects (−6.3 units) (P <0.004). This difference was not considered clinically meaningful. However, a dose-response relationship was observed for general health perceptions (P = 0.004), vitality (P = 0.006), and change in health over the past year (P = 0.007). Conclusions.These results suggest that clinical pharmacists had no significant impact on HRQOL as measured by the SF-36 for veterans at high risk for medication-related problems.

Slicing the Pie with Continuous Home Monitoring of Glucose: Improved Glycemic Control with Real-life use of Continuous Glucose Sensors in Adult Subjects with Type 1 Diabetes

The purpose of this study was to describe and evaluate the activities and interventions provided by ambulatory care clinical pharmacists during the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study. A total of 523 patients were randomized into the intervention arm at nine Veterans Affairs medical centers if they were considered to be at high risk for drug‐related problems. Patients randomized to the control group had no interventions and they are not reported. Using a standard form, pharmacists were asked to document the length of visit, method of contact, medical conditions addressed, and drug‐related problems addressed and resolved during each contact. Seventy‐eight ambulatory care clinical pharmacists documented 1855 contacts over 12 months, an average of 3.54 ± 2.31/patient. The length of visits was 15 minutes or more for 73% of contacts. In‐person contacts accounted for 1421 visits (76.6%), with the remainder being telephone contacts. During each contact the average number of drug‐related problems addressed and resolved were 1.64 ± 1.16 and 1.14 ± 0.98, respectively. More drug‐related problems were addressed and resolved when visits were 15 minutes or longer (p= 0.001) and when the contact was in person (p= 0.001). These data may provide information to clinical pharmacists developing pharmacy‐managed clinics for patients at high risk for drug‐related problems. The information may be a benchmark for types of interventions that can be made, as well as the time commitments required to make them.