Publications

2007

Butt, Adeel A, Amy C Justice, Melissa Skanderson, Michael O Rigsby, Chester B Good, and Kent Kwoh. (2007) 2007. “Rate and Predictors of Treatment Prescription for Hepatitis C.”. Gut 56 (3): 385-9.

BACKGROUND: The true treatment rate for hepatitis C virus (HCV) in veterans is unknown.

AIM: To determine the treatment prescription rates and predictors of treatment prescription for HCV in a large national population.

METHODS: The Department of Veterans Affairs National Patient Care Database (NPCD) was used to identify all HCV-infected people between the fiscal years 1999 and 2003 using the International classification of diseases, 9th revision codes. Demographic information, medical and psychiatric comorbidities, and drug and alcohol use diagnoses were retrieved. Pharmacy data were retrieved from the Department of Veterans Affairs Pharmacy Benefits Management (PBM) database. Logistic regression analysis was used to determine the predictors of treatment for HCV in HCV.

RESULTS: 113 927 veterans in the Department of Veterans Affairs care with a diagnosis of HCV were identified. The treatment prescription rate for HCV was 11.8%. Patients not prescribed treatment were older, more likely to be from minority races, have more alcohol and drug misuse, and have medical and psychiatric comorbid conditions. In a multivariate logistic regression model, the following factors were predictive of non-treatment for HCV: increasing age (odds ratio (OR) 0.77 for each 5-year increase in age; 95% confidence interval (CI) 0.76 to 0.78); black race (OR 0.64; 95% CI 0.6 to 0.68); Hispanic race (OR 0.88; 95% CI 0.8 to 0.96); alcohol abuse and dependence (OR 0.62; 95% CI 0.59 to 0.65); drug abuse and dependence (OR 0.78; 95% CI 0.74 to 0.82); anaemia (OR 0.18; 95% CI 0.16 to 0.21); hepatitis B infection (OR 0.72; 95% CI 0.62 to 0.83); coronary artery disease (OR 0.9; 95% CI 0.85 to 0.97); stroke (OR 0.75; 95% CI 0.67 to 0.85); bipolar disorder (OR 0.64; 95% CI 0.58 to 0.70); major depression (OR 0.72; 95% CI 0.67 to 0.77); mild depression (OR 0.56; 95% CI 0.53 to 0.59); and schizophrenia (OR 0.71; 95% CI 0.65 to 0.77). The following factors were associated with a higher likelihood of treatment prescription for HCV: liver cirrhosis (OR 1.6; 95% CI 1.5 to 1.7); and diabetes (OR 1.07; 95% CI 1.02 to 1.12).

CONCLUSIONS: A small number of HCV-infected veterans were prescribed treatment for HCV. Non-treatment is associated with increasing age, non-white race, drug and alcohol abuse, and dependence and comorbid illnesses. Reasons for non-treatment need further study.

Kilbourne, Amy M, Edward P Post, Mark S Bauer, John E Zeber, Laurel A Copeland, Chester B Good, and Harold Alan Pincus. (2007) 2007. “Therapeutic Drug and Cardiovascular Disease Risk Monitoring in Patients With Bipolar Disorder.”. Journal of Affective Disorders 102 (1-3): 145-51.

OBJECTIVES: We assessed whether patients with bipolar disorder received serum drug level and toxicity monitoring for mood stabilizers and assessment of cardiovascular disease (CVD)-related risk factors attributed to atypical antipsychotic medications.

METHODS: A population-based study of individuals with bipolar disorder was conducted between July 2004 and July 2006. Based on American Psychiatric and American Diabetes Association guidelines, we assessed whether patients received recommended drug level and toxicity monitoring tests on or within 6 months for mood stabilizers, and lipid and glucose tests for atypical antipsychotics. Multivariable regression was used to determine the patient factors associated with receipt of lab tests.

RESULTS: Of the 435 patients (mean age=49 years, 14.3% female, 22.8% nonwhite), 60.3% were currently prescribed mood stabilizers and 65.5% were prescribed atypical antipsychotics. Overall, 39.7% received a serum drug level for mood stabilizers, 38.8% received a thyroid function test for lithium, and the majority (71.4%-75.9%) received complete blood counts and hepatic function tests for valproate or carbamazepine. About half of patients prescribed atypical antipsychotics received cholesterol counts (49.6%), and 68.7% received serum glucose levels. After adjusting for patient factors, women prescribed atypical antipsychotics were less likely than men to receive cholesterol counts (OR=0.43; p<0.05).

LIMITATIONS: Single-site retrospective study and a relatively short observation period.

CONCLUSIONS: About half of patients received recommended lab tests for mood stabilizers and atypical antipsychotics. Additional research regarding whether the receipt of these lab tests is associated with improved outcomes will inform efforts to improve quality of care related to drug toxicities and CVD risk factors in patients with bipolar disorder.

Singla, Ish, Maliha Zahid, Chester B Good, Alanna Macioce, and Ali F Sonel. (2007) 2007. “Effect of Hyponatremia (”. The American Journal of Cardiology 100 (3): 406-8.

Hyponatremia is associated with adverse outcomes in patients with heart failure and ST-elevation myocardial infarction (STEMI). We evaluated the effect of hyponatremia on outcomes in patients with suspected acute coronary syndrome and non-STEMI. All patients had a sodium level determined at time of admission, at 24 and 48 hours, and at discharge. Of 1,478 patients, 341 (23.1%) were hyponatremic (sodium <135 mEq/L) on presentation. Patients who had hyponatremia on admission were significantly more likely to die or have recurrent myocardial infarction in the next 30 days (odds ratio 1.98, 95% confidence interval 1.35 to 2.89, p <0.001). This relation persisted after adjusting for factors such as age, left ventricular ejection fraction, use of diuretics before admission, hypotension on presentation, anemia, chronic renal insufficiency, pulmonary edema, and high troponin levels (odds ratio 1.7, 95% confidence interval 1.1 to 2.5, p = 0.01). In conclusion, hyponatremia on admission is associated with 30-day adverse outcome in patients presenting with suspected acute coronary syndrome/non-STEMI.

Ramani, Gautam, Maliha Zahid, Chester B Good, Alanna Macioce, and Ali F Sonel. (2007) 2007. “Comparison of Frequency of New-Onset Atrial Fibrillation or Flutter in Patients on Statins versus Not on Statins Presenting With Suspected Acute Coronary Syndrome.”. The American Journal of Cardiology 100 (3): 404-5.

The effect of statins on the incidence of new-onset atrial fibrillation (AF) in patients presenting with suspicion of acute coronary syndrome (ACS) is unknown. Our study population consisted of patients admitted to a tertiary care Veterans Administration hospital with suspicion of ACS between November 2001 and January 2006. All patients had an electrocardiogram on admission that was compared with a previous electrocardiogram to confirm new-onset AF or atrial flutter. Of 1,526 patients, 164 (10.8%) had new-onset AF and 601 (39.4%) were on a statin on admission. Patients with AF were significantly more likely to be older, Caucasian, have renal insufficiency and anemia, and less likely to be diabetic, on a statin or angiotensin-converting enzyme inhibitor on admission, or have chest pain as a presenting complaint. In univariate analysis, patients on statins were significantly less likely to have new-onset AF (odds ratio 0.40, 95% confidence interval 0.33 to 0.69, p <0.01). This relation persisted in the multivariate model (odds ratio 0.57, 95% confidence interval 0.39 to 0.83, p <0.01) after correcting for age, race, diabetes mellitus, chest pain, and use of angiotensin-converting enzyme inhibitor. In conclusion, patients presenting with suspicion of ACS were much less likely to have newonset AF if they were on a statin at time of presentation.

Whittle, Jeff, Joseph Conigliaro, Chester B Good, Mary E Kelley, and Melissa Skanderson. (2007) 2007. “Understanding of the Benefits of Coronary Revascularization Procedures Among Patients Who Are Offered Such Procedures.”. American Heart Journal 154 (4): 662-8.

BACKGROUND: To participate meaningfully in decisions regarding invasive procedure use, patients should understand the benefits and risks. Previous work has focused on risks; we assessed patient understanding of the benefits of coronary revascularization procedures.

METHODS: We interviewed 1650 patients and their treating physicians after elective coronary angiography performed at 3 Veterans Health Administration hospitals and 1 university hospital. We excluded patients for whom the decision to undergo revascularization was made before admission. This report focuses on 633 patients who had been offered coronary artery bypass surgery (CABG, n = 324) or percutaneous coronary interventions (PCIs) and responded to questions about expected benefits. Both patient and physician were asked to report the benefits they expected from revascularization. Forty-nine physicians reported on 490 patients.

RESULTS: Most patients were older (mean age 63.8 years), white (89.4%), and male (77.6%). Most patients expected improved symptoms (83%) and survival (83%). Physician-patient agreement regarding whether survival would improve was no better than chance (kappa = 0.02 for CABG, kappa = -0.01 for PCI, both P > .10). There was also poor agreement regarding whether symptoms were expected to improve, but this was better than chance (kappa = 0.09, P = .01 for CABG; kappa = 0.19, P = .02 for PCI). Physician-patient agreement was poor regardless of patient characteristics.

CONCLUSIONS: Patients have more optimistic expectations about benefits of coronary revascularization than the cardiologist offering the procedure. Further research should confirm this finding and clarify how physician-patient disagreement regarding the benefits of coronary revascularization affects patient participation in decision making.

Hravnak, Marilyn, Jeff Whittle, Mary E Kelley, Susan Sereika, Chester B Good, Said A Ibrahim, and Joseph Conigliaro. (2007) 2007. “Symptom Expression in Coronary Heart Disease and Revascularization Recommendations for Black and White Patients.”. American Journal of Public Health 97 (9): 1701-8.

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.

Donohue, Julie Marie, and Richard Gabriel Frank. (2007) 2007. “Estimating Medicare Part D’s Impact on Medication Access Among Dually Eligible Beneficiaries With Mental Disorders.”. Psychiatric Services (Washington, D.C.) 58 (10): 1285-91.

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.

Donohue, Julie M, Marisa Cevasco, and Meredith B Rosenthal. (2007) 2007. “A Decade of Direct-to-Consumer Advertising of Prescription Drugs.”. The New England Journal of Medicine 357 (7): 673-81.

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.

Huskamp, Haiden A, David G Stevenson, Julie M Donohue, Joseph P Newhouse, and Nancy L Keating. (2007) 2007. “Coverage and Prior Authorization of Psychotropic Drugs under Medicare Part D.”. Psychiatric Services (Washington, D.C.) 58 (3): 308-10.

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.