Douglas R. Geraets

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.

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

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

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

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.

Types of Interventions Made by Clinical Pharmacists in the IMPROVE Study

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.

Effect of Grapefruit Juice on the Pharmacokinetics and Pharmacodynamics of Quinidine in Healthy Volunteers

A study was conducted to examine the effect of grapefruit juice on the disposition of quinidine sulfate and changes of QT intervals after oral administration to twelve healthy male volunteers. Participants received two oral doses of quinidine sulfate tablets (400 mg) with 240 mL of water or grapefruit juice, each separated by a 1‐week washout period. Plasma samples for analysis of quinidine and its major metabolite, 3‐hydroxyquinidine, were collected for a 24‐hour period and analyzed by a high‐performance liquid chromatography method. For pharmacodynamic data, the electrocardiograms (ECGs) were performed for 12 hours, and the recordings were marked for ECG interval at all blood collection time periods. There was no significant difference in pharmacokinetic parameters of quinidine when administered with grapefruit juice or water, except for time to maximum concentration (tmax), which was 1.6 hours after administration with water and 3.3 hours after administration with grapefruit juice. Administration with grapefruit juice also resulted in a 33% decrease in the area under the concentration‐time curve (AUC) of 3‐hydroxyquinidine compared with water, but did not increase the AUC of quinidine or change the ratio of AUC of 3‐hydroxyquinidine to the AUC of quinidine. Pharmacodynamic parameters, including changes in the rate‐corrected QT (QTc) interval, closely paralleled the pharmacokinetic data, in that administration with grapefruit juice led to delayed maximal effect on QTc and reduction in maximal effect. Administration with grapefruit juice therefore delays the absorption of quinidine and inhibits the metabolism of quinidine to 3‐hydroxyquinidine.

Reduced Quality of Life in Veterans at Risk for Drug-Related Problems

The relationships between drug therapy and health‐related quality of life in 1054 patients who received care from Department of Veterans Affairs medical centers (VAMCs) were assessed. Patients at high risk for drug‐related problems were enrolled into a pharmaceutical care study at nine VAMCs. On enrollment, the short form (SF)‐36 was completed and medical records were examined for evidence of coexisting illness. Drug therapy in the year before enrollment was analyzed in relation to SF‐36 scores. Mean ± SD SF‐36 scores ranged from 37.99 ± 41.70 for role physical to 70.78 ± 18.97 for mental health domains, with all domain scores significantly below age‐adjusted national norms (p<0.05). Patients taking a drug that required therapeutic monitoring had significantly lower SF‐36 scores (p=0.0001 to p=0.0033) across all domains except for bodily pain and mental health, compared with patients not taking these agents.