Publications

OBJECTIVES: We examined whether symptoms of coronary heart disease vary between Black and White patients with coronary heart disease, whether presenting symptoms affect physicians' revascularization recommendations, and whether the effect of symptoms upon recommendations differs in Black and White patients.

METHODS: We interviewed Black and White patients in Pittsburgh in 1997 to 1999 who were undergoing elective coronary catheterization. We interviewed them regarding their symptoms, and we interviewed their cardiologist decision-makers regarding revascularization recommendations. We obtained coronary catheterization results by chart review.

RESULTS: Black and White patients (N=1196; 9.7% Black) expressed similar prevalence of chest pain, angina equivalent, fatigue, and other symptoms, but Black patients had more shortness of breath (87% vs 72%, P=.001). When we considered only those patients with significant stenosis (n=737, 7.1% Black) and controlled for race, age, gender, and number of stenotic vessels, those who expressed shortness of breath were less likely to be recommended for revascularization (odds ratio=0.535; 95% confidence interval=0.375, 0.762; P<.001), but there was no significant interaction with race.

CONCLUSIONS: Black patients reported shortness of breath more frequently than did White subjects. Shortness of breath was a negative predictor for revascularization for all patients with significant stenosis, but there was no difference in the recommendations by symptom by race.

OBJECTIVE: Medicare drug benefit (Part D) plans may restrict psychotropic medications more than state Medicaid programs do. This may have important implications for patients dually eligible for Medicare and Medicaid whose medications previously were covered under Medicaid. The objective of this study was to estimate rates of medication switching among dually eligible beneficiaries using antidepressants, antipsychotics, and mood stabilizers attributable to their enrollment in Medicare drug plans.

METHODS: Baseline data on medication usage patterns among 467 dually eligible beneficiaries with mental disorders from the Medicare Current Beneficiary Survey, formulary data from a sample of Medicare drug plans, and estimates of the utilization response to pharmacy management tools from the Medicaid literature were used to estimate the likelihood of switching medications conditional on use of drugs and assignment to particular Medicare drug plans.

RESULTS: Restrictions on psychotropic medications were common among the drug plans studied. Estimated rates of medication switching attributable to Medicare Part D were 6%-10% among dually eligible beneficiaries using antipsychotics, 5%-7% among those using antidepressants, and 2%-4% among those using mood stabilizers. Switching rates varied substantially across plans.

CONCLUSIONS: On average, relatively few dually eligible beneficiaries with mental disorders are likely to experience treatment disruptions because of formulary restrictions and utilization controls used by Medicare drug plans. However, beneficiaries in some plans will experience significant barriers to medication access. Given the substantial variation among Medicare drug plans' management of psychotropic medication use, clinicians and social service agencies should counsel their beneficiaries with mental disorders in navigating the complex Medicare drug plan market.

BACKGROUND: Evidence suggests that direct-to-consumer advertising of prescription drugs increases pharmaceutical sales and both helps to avert underuse of medicines and leads to potential overuse. Concern about such advertising has increased recently owing to the withdrawal from the market of heavily advertised drugs found to carry serious risks. Moreover, the Food and Drug Administration (FDA) has been criticized for its weak enforcement of laws regulating such advertising.

METHODS: We examined industry-wide trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotion to physicians during the past decade. We characterized the drugs for which such advertising is used and assessed the timing of advertising after a drug is introduced. Finally, we examined trends in the FDA's regulation of drug advertising.

RESULTS: Total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. Although during that time spending on direct-to-consumer advertising increased by 330%, it made up only 14% of total promotional expenditures in 2005. Direct-to-consumer campaigns generally begin within a year after the approval of a product by the FDA. In the context of regulatory changes requiring legal review before issuing letters, the number of letters sent by the FDA to pharmaceutical manufacturers regarding violations of drug-advertising regulations fell from 142 in 1997 to only 21 in 2006.

CONCLUSIONS: Spending on direct-to-consumer advertising has continued to increase in recent years in spite of the criticisms leveled against it. Our findings suggest that calls for a moratorium on such advertising for new drugs would represent a dramatic departure from current practices.

This study examined formulary coverage and use of utilization management tools for three classes of psychotropic medications (antidepressants, antipsychotics, and anticonvulsants) among Medicare Part D prescription drug plans serving individuals dually eligible for the Medicare and Medicaid programs. Plans must cover "all or substantially all" molecules (distinct drugs) in these classes. Plans serving "dual eligibles" generally covered at least one formulation of all molecules in the three classes. However, certain product formulations were not covered by a number of plans, and use of prior authorization was common for a minority of plans. The effect of Part D will depend on the restrictiveness of the prior authorization and appeals processes, which is currently unknown.

Depression is a highly prevalent condition that results in substantial functional impairment. Advocates have attempted in recent years to make the 'business case' for investing in quality improvement efforts in depression care, particularly in primary care settings. The business case suggests that the costs of depression treatment may be offset by gains in worker productivity and/or reductions in other healthcare spending. In this paper, we review the evidence in support of this argument for improving the quality of depression treatment. We examined the impact of depression on two of the primary drivers of the societal burden of depression: healthcare utilisation and worker productivity. Depression leads to higher healthcare utilisation and spending, most of which is not the result of depression treatment costs. Depression is also a leading cause of absenteeism and reduced productivity at work. It is clear that the economic burden of depression is substantial; however, critical gaps in the literature remain and need to be addressed. For instance, we do not know the economic burden of untreated and/or inappropriately treated versus appropriately treated depression. There remain considerable problems with access to and quality of depression treatment. Progress has been made in terms of access to care, but quality of care is seldom consistent with national treatment guidelines. A wide range of effective treatments and care programmes for depression are available, yet rigorously tested clinical models to improve depression care have not been widely adopted by healthcare systems. Barriers to improving depression care exist at the patient, healthcare provider, practice, plan and purchaser levels, and may be both economic and non-economic. Studies evaluating interventions to improve the quality of depression treatment have found that the cost per QALY associated with improved depression care ranges from a low of 2519 US dollars to a high of 49,500 US dollars. We conclude from our review of the literature that effective treatment of depression is cost effective, but that evidence of a medical or productivity cost offset for depression treatment remains equivocal, and this points to the need for further research in this area.

INTRODUCTION: Based on Infectious Diseases Society of America (IDSA) guidelines, inappropriate fluconazole therapy in patients with candidemia is defined as an empiric dose <6 mg/kg/d, <12 mg/kg/d after Candida glabrata identification, or continued fluconazole use after identification of Candida krusei. However, the extent to which inappropriate antifungal therapy is due to improper dosing or drug selection has not been well investigated. The objectives of this study were to assess the incidence of inappropriate fluconazole therapy in patients with candidemia and to identify variables associated with inappropriate therapy.

METHODS: Retrospective cohort study from four medical centers of hospitalized patients with candidemia prescribed fluconazole. Appropriateness of fluconazole dosages (adjusted for renal dysfunction) was assessed at the time of symptom onset and after Candida identification.

RESULTS: Patients (206) were identified. Sixty-one of 112 (55%) patients who were given empiric therapy received an initial dose of fluconazole <6 mg/kg. After identification of the Candida species, 97 of 206 (47%) patients received inadequate fluconazole therapy based on IDSA guideline recommendations due to a fluconazole dose <12 mg/kg after isolation of C. glabrata (12%), continued use of fluconazole after isolation of C. krusei (3%), or a dose <6 mg/kg for all other Candida species (32%). Using multivariate logistic regression, increased weight in 1-kg increments (OR: 1.02; p = 0.0142) and a creatinine clearance (CRCL) >50 ml/minute (OR: 3.17; p = 0.0003) were associated with increased risk of inadequate fluconazole therapy.

CONCLUSION: A high prevalence of suboptimal dosing of fluconazole given empirically or after Candida species identification was documented. Increased weight and CRCL were significant predictors of inadequate fluconazole doses.

BACKGROUND: High-dose fluconazole is an alternative for patients with candidemia caused by Candida glabrata or other Candida species with decreased fluconazole susceptibility. However, empiric high-dose fluconazole is not currently recommended and may result in higher drug costs and toxicity.

OBJECTIVE: To determine the cost-effectiveness of using empiric high-dose fluconazole in intensive care unit (ICU) with suspected invasive candidiasis.

DESIGN: Decision analytic model.

TARGET POPULATION: ICU patients with suspected invasive candidiasis.

TIME HORIZON: Lifetime.

PERSPECTIVE: Societal.

INTERVENTIONS: Low-dose fluconazole (loading dose of 800 mg followed by 400 mg daily) vs. high-dose fluconazole (loading dose of 1600 mg followed by 800 mg daily). Generic fluconazole costs were used for the analysis.

OUTCOME MEASURES: Incremental life expectancy and incremental cost per discounted life year (DLY) saved. RESULT OF BASE-CASE ANALYSIS: Based on current national levels of fluconazole resistance and ability to correctly identify patients with candidemia, high-dose fluconazole was the more effective but more expensive treatment strategy. Empiric high-dose fluconazole therapy decreased the mortality rate by 0.15% compared to low-dose strategy with a cost-effectiveness rate of $55,526 per DLY saved.

RESULTS OF SENSITIVITY ANALYSIS: Empirical high-dose fluconazole was an acceptable treatment strategy (using $100,000 per DLY saved as threshold) unless the physical age of an ICU survivor was 66 years or older. Empirical high-dose fluconazole was an acceptable treatment strategy using $50,000 per DLY saved with minor changes in parameters estimates.

LIMITATIONS: The estimates of our model may not be applicable to all ICU patients. Other hospitals with differences in fluconazole resistance, prevalence of invasive candidiasis, or duration of fluconazole therapy may produce different results.

CONCLUSION: These results suggest that empiric high-dose fluconazole therapy should reduce the mortality associated with invasive candidiasis at an acceptable cost.

Mortality significantly increases in patients with candidaemia who receive inappropriate fluconazole therapy. The goals of this study were to compare hospital length of stay and costs for non-neutropenic patients with candidaemia treated with fluconazole based on the empirical dose and time until initiation of therapy. A retrospective cohort study was conducted of patients with candidaemia who were prescribed fluconazole at the onset of candidaemia or later. Hospital-related costs were compared based on time to initiation of fluconazole therapy and empirical fluconazole dose. A total of 192 non-neutropenic patients (55% male; mean age+/-standard deviation, 56+/-17 years) were identified. Isolated Candida species included C. albicans (59%), C. glabrata (15%), C. parapsilosis (11%), C. tropicalis (6%), C. krusei (3%) or other Candida spp. (6%). Time to initiation of fluconazole was Day 0 (35.4%), Day 1 (14.1%), Day 2 (26.6%) or Day >or=3 (23.9%). Thirty-two patients (17%) received a dose of fluconazole >or=6 mg/kg on Day 0. Total costs were lowest for patients started on fluconazole on the culture day with adequate doses ($35,459+/-25,988) compared with all other patients ($52,158+/-53,492) (P=0.0088). After controlling for covariates, each 1-day delay in fluconazole therapy was associated with increased total hospital costs of $6392+/-3000 (P=0.0344), and an adequate fluconazole dose was associated with decreased total hospital costs of $18,744+/-7173 (P=0.0097). A delay or an inadequate dose or fluconazole in patients with candidaemia was associated with increased hospital costs. Improved methods to diagnose patients with candidaemia quickly are needed.

BACKGROUND: The presence of angiotensin receptor blockers (ARBs) on the formularies of Medicare Part D prescription drug plans (PDPs) is vitally important to the health of seniors who cannot tolerate angiotensin-converting enzyme (ACE) inhibitors.

OBJECTIVE: To determine whether ARBs are present on the formularies of PDPs and how the prescription cost-sharing for ARBs under Part D compares to cost-sharing before Part D.

DESIGN/PARTICIPANTS: Cross-sectional analyses of March 2006 Medicare Part D formularies (n = 1,446) and of ARB utilization and cost-sharing for adults over the age of 64 included in the nationally representative Medical Expenditure Panel Survey.

MAIN OUTCOME MEASURES: (1) Presence of ARBs on Part D formularies. (2) Average out-of-pocket costs for 30-day supply of ARBs before and after Part D (both in 2006 dollars).

RESULTS: All PDP formularies included at least 1 ARB. Most plans covered 2 ARBs (41%) and 35% covered all 7. The average monthly copay for the most commonly used ARB, valsartan, is $28 under part D, $14 before Part D for individuals with prescription coverage, and $53 before Part D for individuals without coverage.

CONCLUSIONS: Whereas ARBs are present on all Part D formularies, many seniors will pay more for these drugs under Part D. Any savings in copayments under Part D may be erased by the monthly premium and by more expensive cost-sharing when seniors reach the 'donut hole'.

BACKGROUND: Nonadherence to prescription drugs results in poorer control of chronic health conditions. Because of significant racial/ethnic disparities in the control of many chronic diseases, differences in the rates of and reasons for medication nonadherence should be studied.

OBJECTIVES: 1) To determine whether rates of and reasons for medication nonadherence vary by race/ethnicity among seniors; and 2) to evaluate whether any association between race/ethnicity and nonadherence is moderated by prescription coverage and income.

DESIGN/SETTING: Cross-sectional national survey, 2003.

PATIENTS: Medicare beneficiaries > or = 65 years of age, who reported their race/ethnicity as white, black, or Hispanic, and who reported taking at least 1 medication (n = 14,829).

MAIN OUTCOME MEASURES: Self-reported nonadherence (caused by cost, self-assessed need, or experiences/side effects) during the last 12 months.

RESULTS: Blacks and Hispanics were more likely than whites to report cost-related nonadherence (35.1%, 36.5%, and 26.7%, respectively, p < .001). There were no racial/ethnic differences in nonadherence caused by experiences or self-assessed need. In analyses controlling for age, gender, number of chronic conditions and medications, education, and presence and type of prescription drug coverage, blacks (odds ratio [OR] 1.38; 95% confidence interval [CI] 1.08-1.78) and Hispanics (1.35; 1.02-1.78) remained more likely to report cost-related nonadherence compared to whites. When income was added to the model, the relationship between cost-related nonadherence and race/ethnicity was no longer statistically significant (p = .12).

CONCLUSIONS: Racial/ethnic disparities in medication nonadherence exist among seniors, and are related to cost concerns, and not to differences in experiences or self-assessed need. Considering the importance of medication adherence in controlling chronic diseases, affordability of prescriptions should be explicitly addressed to reduce racial/ethnic disparities.