Publications

2008

Gellad, Walid F, Sebastian Schneeweiss, Phyllis Brawarsky, Stuart Lipsitz, and Jennifer S Haas. (2008) 2008. “What If the Federal Government Negotiated Pharmaceutical Prices for Seniors? An Estimate of National Savings.”. Journal of General Internal Medicine 23 (9): 1435-40. https://doi.org/10.1007/s11606-008-0689-7.

BACKGROUND: The government is prohibited from directly negotiating drug prices for Medicare Part D, resulting in substantial policy debate. However, the government has an established mechanism for setting prices with pharmaceutical manufacturers for certain other federal programs–the Federal Supply Schedule (FSS).

OBJECTIVE: To estimate how much could be saved nationwide if prices equivalent to the 2006 FSS were achieved for the top 200 drug formulations dispensed to seniors.

DESIGN/SETTING: Cross-sectional analysis of drug utilization patterns and costs from the nationally representative Medical Expenditure Panel Surveys (MEPS), 2003-2004, and the 2006 FSS.

PARTICIPANTS: Seniors who filled a prescription for any of these common drugs (n = 6,135 individuals).

MEASURES: Prescription expenditures were obtained from MEPS, and a price/unit was calculated in 2006 dollars. This price/unit was compared to the 2006 FSS, and a savings/unit was calculated and summed across the observed units dispensed in MEPS.

RESULTS: The potential annual savings with FSS prices would be $21.9 billion [95% confidence interval (CI), $21.1 billion to $22.8 billion]. If FSS prices were substituted for only the top ten drugs, the annual savings would be $5.9 billion (95% CI, $5.7 billion, $6.1 billion).

CONCLUSIONS: Extension of existing price setting mechanisms to Medicare could save tens of billions of dollars if prices similar to those already achieved by other federal programs could be reached. Whether or not this is a political or economic possibility, the magnitude of these savings cannot be ignored.

2007

Kilbourne, Amy M, Laurel A Copeland, John E Zeber, Mark S Bauer, Elaine Lasky, and Chester B Good. (2007) 2007. “Determinants of Complementary and Alternative Medicine Use by Patients With Bipolar Disorder.”. Psychopharmacology Bulletin 40 (3): 104-15.

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.

Singla, Ish, Maliha Zahid, Chester B Good, Alanna Macioce, and Ali F Sonel. (2007) 2007. “Impact of Blood Transfusions in Patients Presenting With Anemia and Suspected Acute Coronary Syndrome.”. The American Journal of Cardiology 99 (8): 1119-21.

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.

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.