Monitoring of patients given second-generation antipsychotic agents.
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Adolescent↗
Biomedical subjects
Thomas Delate
Publications and source records attributed to Thomas Delate.
Coronary artery disease and hypertension: outcomes of a pharmacist-managed blood pressure program.
STUDY OBJECTIVE: To assess the effectiveness of a pharmacist-managed service in improving hypertension control among patients with coronary artery disease. DESIGN: Prospective cohort study. Setting. Health maintenance organization. PATIENTS: Three hundred seventy-six patients with uncontrolled hypertension and coronary artery disease. INTERVENTION: Pharmacist-managed, physician-supervised population-management approach to optimize evidence-based drug management. MEASUREMENTS AND MAIN RESULTS: Blood pressure reduction and control were evaluated, as well as the use of angiotensin-converting enzyme inhibitors and generic antihypertensive drugs during 7-month follow-up. At baseline, mean +/- SD age was 70.4 +/- 8.8 years, 247 (65.7%) were men, 201 (53.5%) had a history of myocardial infarction, and 237 (63.0%) had diabetes mellitus. Baseline mean systolic blood pressure was 151 mm Hg, and none had achieved their blood pressure goal. During follow-up, mean systolic blood pressure decreased 16.1 mm Hg overall (p<0.001), and 179 (47.6%) patients achieved their goal blood pressure (p<0.001). Blood pressure reductions were 14.7 and 18.4 mm Hg in patients with and patients without diabetes, respectively (p<0.001). The target dose for angiotensin-converting enzyme inhibitors was achieved in 252 (67.0%) patients compared with 102 (27.1%) at baseline (p<0.001). Generic fill rates for antihypertensive drugs continued to be higher than 95% during follow-up (p=0.723). CONCLUSION: A pharmacist-managed, physician-supervised population-management approach in patients with coronary artery disease significantly improved blood pressure control. Clinically meaningful reductions in blood pressure were achieved by using evidence-based, cost-effective drug regimens.
Aged↗
Assessment of clinical, service, and cost outcomes of a conversion program of sumatriptan to rizatriptan ODT in primary care patients with migraine headaches.
OBJECTIVE: Managed care organizations can increase the value of drug therapy by negotiating discounts on drug acquisition costs with pharmaceutical manufacturers and promoting use of preferred drugs, including the conversion of patients to preferred medications. This investigation was designed to assess conversion success, migraine drug utilizations, and patient satisfaction with a clinical pharmacist-managed conversion program from sumatriptan to rizatriptan ODT, both formulary drugs. METHODS: This was a retrospective cohort study conducted in a managed care organization for patients aged 18 years or older who had picked up at least one outpatient prescription for any sumatriptan dosage form at the pharmacy between January 2002 and June 2002. Patients. pharmacy and medical data were reviewed to assess eligibility (e.g., no history of rizatriptan failure) for conversion from sumatriptan to rizatriptan orally disintegrating tablet (ODT). There was no copayment difference for members for rizatriptan ODT versus sumatriptan. A questionnaire was developed to assess 2 domains: (1) patient satisfaction with the medication conversion process and (2) preference for rizatriptan ODT or sumatriptan. A random sample of 315 patients who initiated conversion to rizatriptan ODT was surveyed. Electronic pharmacy claims were reviewed to determine the number of patients who were successfully converted from sumatriptan to rizatriptan ODT. Pharmacy expenditures and total health care utilization and expenditures in the 180 days prior to (baseline) and after the conversion (followup) to rizatriptan ODT were compared for the cohorts of subjects who were successfully converted and those patients who were not successfully converted. RESULTS: Therapeutic conversion from sumatriptan to rizatriptan ODT was attempted in 457 patients; 214 (47%) were successfully converted. The only difference between the 2 cohorts at baseline for the 6 months prior to attempted conversion was a higher mean number of sumatriptan doses per patient per month (PPPM) in the 243 failed conversions (mean 3.5, SD 2.9) compared with the 214 successful conversions (mean 2.8, SD 2.8, P =0.003). The median triptan doses increased by 1.0 PPPM in both cohorts (P =0.882), from 2.0 to 3.0 doses PPPM in the group of successful conversions and from 2.7 to 4.0 in the group of unsuccessful conversions. The survey response rate was 55% for both successful and for unsuccessful conversions. More than 90% of the patients in both cohorts were satisfied with the level of care provided by the clinical pharmacy staff during medication conversion, and there was no difference between the 2 cohorts in patient satisfaction (P=0.761). Rizatriptan ODT was preferred by 68.0% and 8.5% of successful and failed conversion subjects, respectively (P <0.001). Using representative group purchase prices, triptan expenditures for successful conversion subjects were reduced by a median of -2 dollars (6 %) PPPM while triptan expenditures for unsuccessful conversions increased by a median of 8 dollars (P <0.001). There were no differences for either cohort in median PPPM changes in migraine-related office visits (0.0 median change in office visits, P =0.748) or office-visit costs (0 dollars median change, P =0.861) for preconversion versus postconversion attempts Regression modeling identified that lower total counts of sumatriptan doses filled during baseline period was an independent predictor of successful conversion to rizatriptan ODT (P <0.001). There was an average of 3.5 triptan medication fills per patient for successful conversion during the 6-month follow-up period, with 78% of these subjects filling at least 2 prescriptions for rizatriptan ODT during this period. CONCLUSIONS: This conversion program for sumatriptan to rizatriptan ODT was successful in converting almost half of primary care patients to the preferred product despite the absence of a copayment incentive for members to agree to the conversion. There were no measurable medical or economic consequences of the conversion, and patient satisfaction with the quality of care was maintained. Future efforts are likely to have a higher success rate if focused on converting patients with less-severe migraine headaches, as measured by the need for baseline rescue medication, since lower acuity was the only independent predictor of successful conversion in this conversion program for 2 triptan drugs.
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An examination of the association between therapeutic anticoagulation control and glycemic control for patients with diabetes on oral anticoagulation therapy.
BACKGROUND: Observations by pharmacists monitoring anticoagulated patients suggested that patients with diabetes often require more frequent international normalized ratio (INR) monitoring than patients without diabetes. The purpose of this investigation was to examine the association between glycemic control and therapeutic anticoagulation control. METHODS: Patients with diabetes who were receiving warfarin therapy monitored by the Kaiser Permanente of Colorado Clinical Pharmacy Anticoagulation Service were eligible for inclusion. Patients were included if they had a diagnosis of diabetes mellitus type 1 or 2, aged > or =18 years, and had initiated anticoagulant therapy > or =120 days before their most recent hemoglobin A1C measurement. The primary outcome was the correlation between hemoglobin A1C value and percent of time in the patient-specific INR range. Multivariate analysis was undertaken to regress percent of time in INR range on an A1C value > or =8.0 while adjusting for other possible explanatory variables. RESULTS: A total of 911 patients with diabetes were included in the study. Subjects with an A1C value > or =8.0 had similar characteristics as those subjects with an A1C value < 8.0. Correlation analysis revealed no relationship between percent of time spent in INR range and A1C value (Spearman Correlation Coefficient = 0.012, p = 0.805). Multivariate analysis revealed no relationship between percent of time spent in INR range and A1C value > or =8.0 (Odds Ratio = 1.00; 95% Confidence Interval = 0.99, 1.01) when adjusting for possible explanatory variables. CONCLUSIONS: For patients with diabetes on warfarin anticoagulation therapy, there is no association between glycemic control and therapeutic anticoagulation control. However, anticoagulation therapy providers should manage these patients with the same diligence and care as patients without diabetes.
Aged↗
A descriptive evaluation of routine complete blood count monitoring in patients receiving anticoagulation therapy.
CONTEXT: The most prevalent side effect associated with warfarin therapy is bleeding. Routine monitoring of laboratory tests, such as complete blood counts (CBC), may provide theoretical benefit in this patient population as a means of detecting occult bleeding through hemoglobin values that decrease compared to baseline. OBJECTIVE: To describe the clinical outcomes associated with routine CBC monitoring in a large, diverse sample of anticoagulated patients. DESIGN: Forty-seven month retrospective, observational study. SETTING: Large non-profit, group-model health maintenance organization with a centralized clinical pharmacy anticoagulation service that routinely orders baseline CBCs on all patients enrolled in the service with follow up CBCs repeated at 3 months and yearly thereafter. PATIENTS: Patients continuously enrolled in the anticoagulation service for warfarin therapy monitoring for at least one year between January 1, 2000 and December 5, 2003. MAIN OUTCOME MEASURES: Medical records were reviewed to determine clinical outcomes associated with hemoglobin decreases of > or =2.0 gm/dL. Clinical outcomes included both overt and occult bleeding events and a determination of major or minor bleeding in these events. RESULTS: Of the 4033 patients included in the analysis, 578 (14.3%) experienced at least one decrease in hemoglobin > or =2.0 gm/dL. Occult bleeding was confirmed in 121 patients (3.0% of all patients monitored) with a decrease of hemoglobin > or =2.0 gm/dL but only 13 of these patients (0.3% of all patients monitored) experienced major bleeding. The annual detection rate of occult bleeding through routine CBC monitoring was 0.8%. CONCLUSIONS: Although routine CBC monitoring provides some utility in detecting occult bleeding, the yield of clinically important decreases in hemoglobin detected was low. For most anticoagulated patients, routine CBC monitoring appears to be clinically unnecessary.
Aged↗
Clinical and financial outcomes associated with a proton pump inhibitor prior-authorization program in a Medicaid population.
OBJECTIVE: To examine the clinical and financial outcomes associated with a proton pump inhibitor (PPI) prior-authorization policy. STUDY DESIGN: Interrupted time-series analyses of antisecretory prescription drug claims. Separate 6-month retrospective cohort analyses were conducted to estimate the clinical and financial effects of the policy. PATIENTS AND METHODS: More than 1.2 million Medicaid enrollees, with subgroup analyses of 5965 continuously eligible, potential antisecretory medication users. Measures included antisecretory drug expenditures, proportions of patients with at least 1 gastrointestinal diagnosis and gastrointestinal-related ambulatory and inpatient medical service visit, and subsequent gastrointestinal-related and total medical service expenditures. RESULTS: There was a 90.9% decrease in PPI per-member-per-month expenditures and a 223.2% increase in histamine2-receptor antagonist (H2A) per-member-per-month expenditures in the month immediately following the implementation of the policy (P < .001 for both). A greater proportion (80.7%) of prior-authorization eligible enrollees who received a PPI had at least 1 diagnosis for a gastrointestinal condition than enrollees who received an H2A (64.1%) or no antisecretory drugs (48.4%) (P < .001 for both). Two-part, finite mixture regression analyses indicated that the enrollees who received an H2A or no antisecretory drugs were no more likely to have incurred greater total medical care expenditures than enrollees who received a PPI. CONCLUSION: Prior authorization for PPIs had the effect of reducing use of high-cost PPIs, while encouraging use of lower costing H2As without evidence of adverse medical consequences.
Adolescent↗
Trends in the use of antidepressants in a national sample of commercially insured pediatric patients, 1998 to 2002.
OBJECTIVE: The aim of this study was to estimate the prevalence of use of prescription antidepressants among children and adolescents by using nationwide data and to examine trends in use from 1998 to 2002. METHODS: Ambulatory prescription claims data for a nationwide random sample of more than 1.9 million life-years of commercially insured children (aged 18 years or younger) for the years 1998, 1999, 2000, 2001, and 2002 were examined retrospectively. The main outcome measure was trend in prevalence of antidepressant use. RESULTS: The overall prevalence of antidepressant use among children increased from 160 per 10000 (1.6 percent) in 1998 to 240 per 10000 (2.4 percent) in 2002, for an adjusted annual increase of 9.2 percent. The growth in the overall prevalence of antidepressant use was greater among girls (a 68 percent increase) than boys (a 34 percent increase). In 2002, antidepressant use was highest among girls aged 15 to 18 years, at 640 per 10000 (6.4 percent). The trend of increasing overall use of antidepressants among children and adolescents appears to have been driven primarily by greater use of selective serotonin reuptake inhibitors. CONCLUSIONS: The growth in the prevalence of use of antidepressant medications among youths appears to be continuing, and the rate of increase between 1998 and 2002 is similar to the rate of increase seen in the period of the second-generation antidepressants (late 1980s to mid-1990s).
Adolescent↗
Commentary on using the SF-36 or MOS-HIV in studies of persons with HIV disease.
The purpose was to compare and comment on use of the SF-36 and MOS-HIV instruments in studies of persons with HIV disease. Three medical information databases were searched to identify examples of HIV studies that included the MOS-HIV or SF-36. Thirty-nine and 14 published articles were identified for illustration in comparing the use of the MOS-HIV and SF-36 in HIV disease, respectively. Support for the reliability and construct validity of the MOS-HIV and SF-36 was found. Ceiling and floor effects were reported for both the MOS-HIV and SF-36; however, ceiling effects were more common for the MOS-HIV, in part due to fewer items in the physical, social, and role functioning domains. The MOS-HIV measures three domains hypothesized to be associated with the health deterioration of HIV disease not measured by the SF-36; however, these domains may not assess aspects of HIV disease that typify the majority of the persons with HIV disease today. National norms for the U.S. adult population (and other nations) are available for the SF-36. In addition, the SF-36 has been used in a wide variety of patient populations, enabling comparisons of HIV-infected persons with persons with other health conditions. No national norms for the MOS-HIV are available. We conclude that there is currently insufficient evidence in the literature to recommend the use of the MOS-HIV over the SF-36 in HIV-infected persons. Although the SF-36 is not targeted at HIV, it may be preferable to use the SF-36 over the MOS-HIV due to fewer ceiling effects, availability of national norms, and the vast amount of data for other populations in the U.S. and around the world. Head-to-head comparisons demonstrating the unique value of the MOS-HIV over the SF-36 are clearly needed. More importantly, additional work needs to be directed at comparing the MOS-HIV and other putatively HIV-targeted instruments to one another to help demarcate aspects of HRQOL that are truly generic versus specific to HIV disease. Using both a generic and targeted HRQOL measure is a good general strategy, but this has not been a typical practice in studies of HIV because the MOS-HIV is so similar in content to the SF-36.
Female↗
Conclusions of cost-effectiveness for an asthma intervention might not be warranted.
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Asthma↗
Randomized controlled trial of a dose consolidation program.
OBJECTIVE: To evaluate the effectiveness and financial impact of a drug dose consolidation (optimization) program using letter intervention. METHODS: This pilot program in a large, mid-Atlantic health plan utilized a randomized controlled trial research design. A review of adjudicated pharmacy claims records was performed monthly for 3 consecutive months from November 2002 through February 2003 to identify inefficient (i.e., >once-daily) regimens for any one of 68 dosage strengths of 37 single-source maintenance drugs with once-daily dosing recommendations. Prescribers who had prescribed one or more inefficient regimens were identified and randomized to one of the 2 intervention arms or a control arm. Prescribers in both intervention arms were sent personalized letters with information on their patients. inefficient regimens and suggested dose consolidation options. Patients of prescribers in one intervention arm received a complementary, patient-oriented letter. Pharmacy claims for patients in all arms were examined at 180 days after the date of the letter mailing for conversion to an efficient (once-daily) regimen. Financial modeling analysis calculated net savings as changes in pharmacy expenditures minus administrative costs. RESULTS: A total of 2,614 inefficient regimens, representing 6.7% of claims for the targeted medications, were identified. The rate of consolidation to a suggested dosing option was lower for the Physician Letter arm (7.3%) than for the Physician/Member Letter arm (10.2%) (P = 0.046). Both intervention arms had higher consolidation rates than the Control arm (3.9%) (P = 0.018 and P = 0.000, respectively.). Approximately 30% of the regimens in each study arm were never refilled after being targeted. Financial modeling indicated that a dose consolidation intervention could save 0.03 dollars to 0.07 dollars per member per month (PMPM) in 2003 dollars with full medication compliance but only 0.02 dollars to 0.03 dollars PMPM when savings were calculated with realistic, partial compliance rates. Subanalyses performed at the drug therapy class level revealed few opportunities to justify implementing a dose consolidation program. CONCLUSIONS: After taking into consideration program administrative costs, high rates of refill discontinuation, and dose consolidation that occurs naturally without intervention, the results indicated that a letter-based dose consolidation program did not appreciably decrease pharmacy expenditures.
Cost-Benefit Analysis↗
Effect of patient notification of formulary change on formulary adherence.
OBJECTIVE: To evaluate the impact of patient notification of impending formulary changes on formulary adherence. METHODS: This pilot program in a large, Midwest-based health insurer utilized a randomized controlled trial research design. A list of 30 chronic-use medications that were to change formulary status were selected for the pilot. A review of adjudicated pharmacy claims records was performed to identify patients receiving one or more of the formulary change medications on the list. Members of 112 individual health plans of this large health insurer, all of whom were subject to the same drug formulary, were randomized to either the intervention (letter) or control arm. Patients in the intervention arm were sent a targeted communication that described the patient.s formulary change medication(s) and provided therapeutic option(s) for the formulary change medication(s). Pharmacy claims for patients in both arms were examined at 110 days after the date of the mailing to determine if there was a switch to a formulary alternative. Multivariate regression modeling was performed to adjust for baseline differences between the arms. RESULTS: A total of 7,247 unique formulary change medication regimens were identified (3,817 in the control arm and 3,430 in the letter arm) for 6,518 subjects (3,387 in the control arm and 3,131 in the letter arm). A higher proportion of formulary change medication regimens in the intervention arm were switched to a formulary alternative compared with the control arm (19.2% vs. 12.0%, P<0.001). After adjustment for baseline differences, regression modeling indicated that subjects in the intervention arm were 1.33 times more likely to switch to a formulary alternative (P<0.001). CONCLUSION: A letter-based, formulary change notification program is a pragmatic and effective strategy to increase drug formulary adherence. Such a program does not restrict access to medications but, rather, provides education and personalized information that may allow patients to participate more actively in their pharmacotherapy decision making.
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