Publications

PURPOSE: The growing presence of female veterans within the Department of Veterans Affairs (VA) health care system highlights the need to assess the quality of and access to gender-specific care for menopause. We assessed the use of hormone therapy (HT) among female veterans before and after the release of the Women's Health Initiative clinical trial results and evaluated whether the structure of women's health care services within the VA system affects the use of HT.

METHODS: We identified all female veterans using HT in 2001 by using the VA pharmacy benefits management database and administrative data. Subjects identified as using HT in 2001 were evaluated to determine estrogen use status in 2003 and 2004. We calculated the change in HT use over time and performed multivariate analyses to identify patient and utilization determinants of HT discontinuation.

RESULTS: In 2001, 36,222 female veterans used HT. By 2004, 23,924 (66%) had discontinued HT. Subjects who had used a VA women's clinic or were younger (40-54 years of age) were significantly less likely to discontinue HT. However, Hispanic ethnicity, African American race, and clinical diagnoses such as heart disease and mastectomy were significantly associated with discontinuation.

CONCLUSION: Discontinuation rates in the VA system parallel those in the private sector. However, patients with any use of VA women's clinics were less likely to discontinue HT, indicating a practice setting variation that may indicate either more specific care or differential implementation of the new HT guidelines. Further research is warranted to assess whether a disparity occurs according to practice setting (or provider factors) with rapid shifts in guidelines.

BACKGROUND: Studies that have assessed antibiotic appropriateness in acute respiratory tract infections (RTIs) with a likely bacterial etiology have focused only on antibiotic choice and ignored other important aspects of prescribing, such as dosing, drug-drug interactions, and duration of treatment.

OBJECTIVE: The aim of this study was to determine the prevalence and predictors of inappropriate antibiotic prescribing practices in outpatients with acute bacterial RTIs (community-acquired pneumonia [CAP], sinusitis, or acute exacerbations of chronic bronchitis [AECB]).

METHODS: This retrospective, cross-sectional study enrolled outpatients with CAP, sinusitis, or AECB who were evaluated in a Veterans Affairs emergency department over a 1-year period. Using electronic medical records, trained research assistants completed data-collection forms that included patient characteristics (eg, marital status, history of alcohol abuse), diagnosis, comorbidities, concurrent medications, and antibiotics prescribed. To assess antimicrobial appropriateness, a trained clinical pharmacist reviewed the data-collection forms and applied a Medication Appropriateness Index (MAI), which rated the appropriateness of a medication using 10 criteria: indication, effectiveness, dosage, directions, practicality (defined as capability of being used or being put into practice), drug-drug interactions, drug-disease interactions, unnecessary duplication, duration, and expensiveness (defined as the cost of the drug compared with other agents of similar efficacy and tolerability). Previous studies have found good inter- and intrarater reliabilities between a clinical pharmacist's and an internal medicine physician's MAI ratings (kappa=0.83 and 0.92, respectively).

RESULTS: One hundred fifty-three patients were included (mean age, 58 years; 92% male; and 65% white). Overall, 99 of 153 patients (65%) had inappropriate antibiotic prescribing as assessed using the MAI. Expensiveness (60 patients [39%]), impracticality (32 [21%]), and incorrect dosage (15 [10%]) were the most frequently rated problem. Penicillins, quinolones, and macrolides were the most common antibiotic classes prescribed inappropriately. A history of alcohol abuse was associated with a lower likelihood of inappropriate prescribing compared with no history of alcohol abuse (adjusted odds ratio [AOR], 0.32; 95% CI, 0.10-0.98), while patients who were married were more likely to receive inappropriately prescribed antibiotics than those who were not married (AOR, 2.64; 95% CI, 1.25-5.59).

CONCLUSIONS: Inappropriate antibiotic prescribing based on the MAI criteria was common (65%) in this selected patient population with acute bacterial RTIs, and often involved problems with expensiveness (39%), impracticality (21%), and incorrect dosage (10%). Future interventions to improve antibiotic prescribing should consider aspects beyond choice of agent.

BACKGROUND: Previous research has shown that a manufacturer's promotional strategy for a brand name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion.

OBJECTIVE: To examine the relationships among promotional expenditures, generic entry, reformulation entry and new indication approval.

METHODS: We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising [DTCA], and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997-2004. We estimated econometric models of detailing, DTCA and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations and US FDA approval for new clinical indications for existing medications in the SSRI class. Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications was the main outcome measure.

RESULTS: Over the period 1997-2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft for social anxiety disorder (SAD) did not affect the manufacturers' detailing expenditures but did result in a greater likelihood of DTCA outlays.

CONCLUSION: The introduction of new product formulations appears to be a common strategy for attempting to extend market exclusivity for medications facing impending generic entry. Manufacturers who introduced a reformulation before generic entry shifted most promotion dollars from the original brand to the reformulation long before generic entry, and in some cases manufacturers appeared to target a particular promotion type for a given indication. Given the significant impact that pharmaceutical promotion has on demand for prescription drugs in the US, these findings have important implications for prescription drug spending and public health.

BACKGROUND: Despite the importance of equal access to prescription drugs by racial and ethnic groups, studies on access to prescription drugs have been incomprehensive.

OBJECTIVE: To describe the Medical Expenditure Panel Survey (MEPS) as a valuable data source to study racial and ethnic disparities in prescription drug use.

METHODS: Use of the MEPS database to study disparities in prescription drug use is detailed. This includes strengths and limitations of the database, as well as key methodological, sampling, and statistical issues to consider when using it.

RESULTS: Using MEPS allows researchers to control for sociodemographic and health status information when studying racial and ethnic disparities in prescription drug use. MEPS has taken measures to improve reliability of the information on the utilization of prescription drugs. An additional benefit of MEPS is that it has oversampled Hispanics, Blacks, and Asians; as such, it affords the statistical power to examine these minority groups. One limitation of MEPS is the inability of researchers to study some drug categories, because of limitations in statistical power. Moreover, the names of the prescription medications are not standardized in MEPS, and some information is not publicly available in MEPS databases. When conducting studies requiring information not publicly available, researchers may commute to the MEPS Data Center or may request the Data Center to run statistical programs for them.

CONCLUSIONS: Using MEPS to study racial and ethnic disparities in prescription drug use has significant benefits. Nonetheless, researchers need to keep in mind the limitations of using MEPS.

OBJECTIVES: We determined the prevalence and correlates of complementary and alternative medicine (CAM) use among patients with bipolar disorder.

METHODS: Patients with bipolar disorder recruited from a large urban mental health facility from 2004 to 2006 completed a baseline questionnaire on CAM use, demographics, treatment perspectives, and behaviors. Additional data on current medications and clinical features were ascertained via chart review. Multivariable logistic regression was used to determine the patient sociodemographic, clinical, and treatment factors associated with use of different CAM practices.

RESULTS: Of 435 patients, the mean age was 49 years; 77% were white, 13% were black, and 10% other race/ethnicity. Patients reported a wide range of CAM use, including prayer/spiritual healing (54%), meditation (53%), vitamins or herbs (50%), and weight loss supplements (22%). Multivariable analyses controlling for sociodemographic, clinical, and treatment factors revealed that patients of other racial/ethnic groups (other than whites or Blacks), those diagnosed with bipolar spectrum disorders (other than bipolar I disorder), and those prescribed anticonvulsants (eg, valproic acid, carbamazepine), or atypical antipsychotics were most likely to use CAM.

CONCLUSIONS: A substantial number of patients diagnosed with bipolar disorder is using CAM. CAM use may be popular among patients with this illness because conventional pharmacotherapy for managing bipolar symptoms can also disrupt quality of life. Mental health providers should be aware of CAM use among patients with bipolar disorder and assess the potential impact of CAM use on treatment course.

Anemia has been shown to predict adverse events in patients presenting with acute coronary syndromes and non-ST-elevation myocardial infarctions (MIs). Less is known about the value of blood transfusions in this setting. We sought to evaluate the impact of red blood cell transfusions on outcomes. Transfusion in anemic patients admitted with suspected acute coronary syndrome/non-ST-elevation MIs led to a significant increase in 30-day recurrent MI or death (odds ratio 3.05, 95% confidence interval 1.80 to 5.17, p <0.001). This relation persisted after adjusting for significant univariate predictors: hypotension on presentation, pulmonary edema, and increased troponin-I levels (odds ratio 2.57, 95% confidence interval 1.41 to 4.69, p <0.001). In conclusion, the risk versus benefit of transfusion in patients presenting with an acute coronary syndrome needs careful assessment.