Barbara Mason

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.

Pharmacists' Interventions Using an Electronic Medication-Event Monitoring Device'S Adherence Data versus Pill Counts

OBJECTIVE: To compare adherence data from an electronic medication-event monitoring device (MEMS, Aprex) with pill counts in assisting pharmacists in making recommendations regarding diabetes therapy. DESIGN: Two-month, double-blind, randomized, controlled trial. SETTING: Veterans Affairs Medical Center ambulatory care clinics. PATIENTS: Forty-seven patients with poor to fair metabolic control of diabetes mellitus were enrolled. Patients were excluded if they were receiving insulin, had a concurrent infection, required child-resistant caps or medication reminder devices, or could not return for follow-up visits. Twenty patients were randomized to the MEMS and 27 to the control group (pill counts). Fasting plasma glucose concentrations were measured monthly and glycohemoglobin concentrations were measured at baseline and 60 days. Thirty-two patients were evaluable: 15 using MEMS and 17 using pill counts. INTERVENTION: Investigators made pharmacologic or educational recommendations to the patients healthcare provider based on both laboratory data and MEMS readings in the treatment group or laboratory data and pill counts in the control group. MAIN OUTCOME MEASURE: Quantities and types of recommendations regarding diabetes therapy made by pharmacists using adherence data from the two methods were tabulated. RESULTS: In the MEMS group, 47 percent of the recommendations related to patient education compared with 12 percent in the control group (p=0.028). MEMS data would have changed four recommendations in the control group to involve patient education. CONCLUSIONS: MEMS data resulted in different numbers and types of recommendations than pill counts. Pharmacists then could make specific recommendations regarding patient education before resorting to pharmacologic manipulations.

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.

Assessment of Sulfonylurea Adherence and Metabolic Control

This study was designed to compare sulfonylurea adherence assessment by providers, patients self-report, pill counts, and a medication event monitoring system (MEMS-3®) device, and correlate the estimates of metabolic control by provider, patient, and laboratory. Forty-seven outpatient veterans with fair to poor metabolic control of non-insulin-dependent diabetes mellitus were enrolled and received monthly refills of sulfonylurea in vials with a cap containing an electronic medication monitoring microprocessor. Pill counts and fasting plasma glucoses were measured monthly, and glycohemoglobin and a 24-hour diet recall were obtained at 0 and 60 days. Investigators then asked providers and patients to assess adherence and metabolic control. Forty-seven percent were nonadherent to medication using MEMS-3®, 29% using pill counts, 29% using provider assessment, and 31 % using self-report. Thirty-one percent of providers and 53% of patients assessed metabolic control differently than laboratory values. Assessment of medication adherence by provider, patient, and pill counts did not explain metabolic control as closely as assessment by MEMS-3®.

Possible serotonin syndrome associated with tramadol and sertraline coadministration

Objective To report a possible case of serotonin syndrome associated with coadministration of tramadol hydrochloride and sertraline hydrochloride. Case Summary A 42-year-old woman developed atypical chest pain, sinus tachycardia, confusion, psychosis, sundowning, agitation, diaphoresis, and tremor. She was taking multiple medications, including tramadol and sertraline. The tramadol dosage had recently been increased, resulting in what was believed to be a serotonergic syndrome. Discussion Serotonin syndrome is a toxic hyperserotonergic state that develops soon after initiation or dosage increments of the offending agent. Patients may differ in their susceptibility to the development of serotonin syndrome. The (+) enantiomer of tramadol inhibits serotonin uptake. Tramadol is metabolized to an active metabolite, Ml, by the CYP2D6 enzyme. If this metabolite has less serotonergic activity than tramadol, inhibition of CYP2D6 by sertraline could have been a factor in the interaction. Conclusions Clinicians should be aware of the potential for serotonin syndrome with concomitant administration of sertraline and tramadol.

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.

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.

Book Review: Communicating with Today's Patient: Essentials to Save Time, Decrease Risk, and Increase Patient Compliance:

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