Publications

2012

Lo-Ciganic, Wei-Hsuan, Janice C Zgibor, Clareann H Bunker, Kirsten B Moysich, Robert P Edwards, and Roberta B Ness. (2012) 2012. “Aspirin, Nonaspirin Nonsteroidal Anti-Inflammatory Drugs, or Acetaminophen and Risk of Ovarian Cancer.”. Epidemiology (Cambridge, Mass.) 23 (2): 311-9. https://doi.org/10.1097/EDE.0b013e3182456ad3.

BACKGROUND: Aspirin, nonaspirin nonsteroidal anti-inflammatory drugs (NA-NSAIDs) and acetaminophen all have biologic effects that might reduce the risk of ovarian cancer. However, epidemiologic data on this question are mixed.

METHODS: A population-based, case-control study in western Pennsylvania, eastern Ohio, and western New York State included 902 women with incident epithelial ovarian cancer who were diagnosed between February 2003 and November 2008 as well as 1802 matched controls. Regular use (at least 2 tablets per week for 6 months or more) of aspirin, NA-NSAIDs, and acetaminophen before the reference date (9 months before interview date) was assessed by in-person interview. We used logistic regression to calculate adjusted odds ratios (ORs) and 95% confidence intervals (CIs).

RESULTS: The OR for aspirin use was 0.81 (95% CI = 0.63-1.03). Decreased risks were found among women who used aspirin continuously (0.71 [0.54-0.94]) or at a low-standardized daily dose (0.72 [0.53-0.97]), who used aspirin for the prevention of cardiovascular disease (0.72 [0.57-0.97]), who used aspirin more recently, or who used selective cyclooxygenase-2 inhibitors (0.60 [0.39-0.94]). No associations were observed among women using nonselective NA-NSAIDs or acetaminophen.

CONCLUSIONS: Risk reductions of ovarian cancer were observed with use of aspirin or selective cyclooxygenase-2 inhibitors. However, the results should be interpreted with caution due to the inherent study limitations and biases.

Khaledi, Maryam Karimi, Katie J Suda, and Chasity M Shelton. (2012) 2012. “Tardive Dyskinesia After Short-Term Treatment With Oral Metoclopramide in an Adolescent.”. International Journal of Clinical Pharmacy 34 (6): 822-4. https://doi.org/10.1007/s11096-012-9685-4.

CASE: The objective of this case report is to report the development of tardive dyskinesia in an African-American adolescent male after short-term treatment with metoclopramide 10 mg orally three times daily secondary to delayed gastric emptying. The patient developed symptoms of tardive dyskinesia after 2 days of therapy with metoclopramide. Metoclopramide was discontinued and diphenhydramine 50 mg was initially administered intravenously followed with 25 mg orally every 4 hours as needed. While there are case reports of drug-induced tardive dyskinesia after intravenous administration of metoclopramide, this is to our knowledge the first report of tardive dyskinesia after short-term treatment with oral metoclopramide in an adolescent.

CONCLUSION: Awareness of the risk of development of this adverse effect even with short-term treatment with metoclopramide and in younger patients is important.

Marcum, Zachary A, and Walid F Gellad. (2012) 2012. “Medication Adherence to Multidrug Regimens.”. Clinics in Geriatric Medicine 28 (2): 287-300. https://doi.org/10.1016/j.cger.2012.01.008.

Despite the fact that medication adherence has been extensively described in the literature over the last several decades, a quote by Becker and Maiman from over 35 years ago best captures the current state of our understanding: “Patient compliance[sic adherence] has become the best documented, but least understood, health behavior.” Future research is greatly needed to identify and translate safe and effective interventions into routine clinical practice to improve adherence. Only then can we begin to make significant improvements to the medication use process and, in turn, the health of older adults.

Gellad, Walid F, Julie M Donohue, Xinhua Zhao, Yuting Zhang, and Jessica S Banthin. (2012) 2012. “The Financial Burden from Prescription Drugs Has Declined Recently for the Nonelderly, Although It Is Still High for Many.”. Health Affairs (Project Hope) 31 (2): 408-16. https://doi.org/10.1377/hlthaff.2011.0469.

Prescription drug spending and pharmacy benefit design have changed greatly over the past decade. However, little is known about the financial impact these changes have had on consumers. We examined ten years of nationally representative data from the Medical Expenditure Panel Survey and describe trends in two measures of financial burden for prescription drugs: out-of-pocket drug costs as a function of family income and the proportion of all out-of-pocket health care expenses accounted for by drugs. We found that although the percentage of people with high financial burden for prescription drugs increased from 1999 to 2003, it decreased from 2003 to 2007, with a slight increase in 2008. The decline is evidence of the success of strategies to lower drug costs for consumers, including the increased use of generic drugs. However, the financial burden is still high among some groups, notably those with public insurance and those with low incomes. For example, one in four nonelderly people devote more than half of their total out-of-pocket health care spending to prescription drugs. These trends suggest that the affordability of prescription drugs under the future insurance exchanges will need to be monitored, as will efforts by states to increase prescription drug copayments under Medicaid or otherwise restrict drug use to reduce public spending.

Donohue, Julie M, Zachary A Marcum, Walid F Gellad, Judith R Lave, Aiju Men, and Joseph T Hanlon. (2012) 2012. “Medicare Part D and Potentially Inappropriate Medication Use in the Elderly.”. The American Journal of Managed Care 18 (9): e315-22.

OBJECTIVES: Inappropriate medication use, which is common in older adults, may be responsive to out-of-pocket costs. We examined the impact of Medicare Part D on inappropriate medication use among Medicare beneficiaries.

STUDY DESIGN: Pre-post with comparison group.

METHODS: Using data from 34,679 elderly beneficiaries in Medicare plans from 2004 to 2007, we used Healthcare Effectiveness Data and Information Set measures of prescribing quality: (1) any use of Drugs to Avoid in the Elderly (DAE), (2) a proportion of total medication use attributable to DAEs, and (3) any Potentially Harmful Drug-Disease Interactions in the Elderly (DDE). Rates of inappropriate use among 3 groups transitioning from no drug coverage or limited coverage ($150 or $350 quarterly caps) to Part D in 2006 were compared with those with constant drug coverage.

RESULTS: DAE use increased slightly among those moving from no coverage to Part D (from 15.72%-17.61%) whereas the comparison group's use decreased (20.97%-18.32%) [relative odds ratio (ROR) = 1.34, 95% confidence interval [CI] 1.22-1.48, P <.0001]. However, the proportion of total drug use attributable to DAEs declined among the no coverage group after Part D (3.01%-1.98%), a significant difference relative to the comparison group (ROR = 0.84, 95% CI 0.72-0.98, P = .03). Rates of DDE were low (1%) both before and after Part D.

CONCLUSIONS: While use of high-risk drugs increased slightly among those gaining Part D drug coverage, high-risk drug use actually declined as a proportion of total drug use, and the prevalence of drug-disease interactions remained stable.

Donohue, Julie M, Nancy E Morden, Walid F Gellad, Julie P Bynum, Weiping Zhou, Joseph T Hanlon, and Jonathan Skinner. (2012) 2012. “Sources of Regional Variation in Medicare Part D Drug Spending.”. The New England Journal of Medicine 366 (6): 530-8. https://doi.org/10.1056/NEJMsa1104816.

BACKGROUND: Sources of regional variation in spending for prescription drugs under Medicare Part D are poorly understood, and such variation may reflect differences in health status, use of effective treatments, or selection of branded drugs over lower-cost generics.

METHODS: We analyzed 2008 Medicare data for 4.7 million beneficiaries for prescription-drug use and expenditures overall and in three drug categories: angiotensin-converting-enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs), 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins), and selective serotonin-reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Differences in per capita expenditures across hospital-referral regions (HRRs) were decomposed into annual prescription volume and cost per prescription. The ratio of prescriptions filled as branded drugs to all prescriptions filled was calculated. We adjusted all measures for demographic, socioeconomic, and health-status differences.

RESULTS: Mean adjusted per capita pharmaceutical spending ranged from $2,413 in the lowest to $3,008 in the highest quintile of HRRs. Most (75.9%) of that difference was attributable to the cost per prescription ($53 vs. $63). Regional differences in cost per prescription explained 87.5% of expenditure variation for ACE inhibitors and ARBs and 56.3% for statins but only 36.1% for SSRIs and SNRIs. The ratio of branded-drug to total prescriptions, which correlated highly with cost per prescription, ranged across HRRs from 0.24 to 0.45 overall and from 0.24 to 0.55 for ACE inhibitors and ARBs, 0.29 to 0.60 for statins, and 0.15 to 0.51 for SSRIs and SNRIs.

CONCLUSIONS: Regional variation in Medicare Part D spending results largely from differences in the cost of drugs selected rather than prescription volume. A reduction in branded-drug use in some regions through modification of Part D plan benefits might lower costs without reducing quality of care. (Funded by the National Institute on Aging and others.).

Gellad, Walid F, Sherrie L Aspinall, Steven M Handler, Roslyn A Stone, Nicholas Castle, Todd P Semla, Chester B Good, Michael J Fine, Maurice Dysken, and Joseph T Hanlon. (2012) 2012. “Use of Antipsychotics Among Older Residents in VA Nursing Homes.”. Medical Care 50 (11): 954-60. https://doi.org/10.1097/MLR.0b013e31825fb21d.

BACKGROUND: Antipsychotic medications are commonly prescribed to nursing home residents despite their well-established adverse event profiles. Because little is known about their use in Veterans Affairs (VA) nursing homes [ie, Community Living Centers (CLCs)], we assessed the prevalence and risk factors for antipsychotic use in older residents of VA CLCs.

METHODS: This cross-sectional study included 3692 Veterans age 65 or older who were admitted between January 2004 and June 2005 to one of 133 VA CLCs and had a stay of ≥90 days. We used VA Pharmacy Benefits Management data to examine antipsychotic use and VA Medical SAS datasets and the Minimum Data Set to identify evidence-based indications for antipsychotic use (eg, schizophrenia, dementia with psychosis). We used multivariable logistic regression and generalized estimating equations to identify factors independently associated with antipsychotic receipt.

RESULTS: Overall, 948/3692(25.7%) residents received an antipsychotic, of which 59.3% had an evidence-based indication for use. Residents with aggressive behavior [odds ratio (OR)=2.74, 95% confidence interval (CI), 2.04-3.67] and polypharmacy (9+ drugs; OR=1.84, 95% CI, 1.41-2.40) were more likely to receive antipsychotics, as were users of antidepressants (OR=1.37, 95% CI, 1.14-1.66), anxiolytic/hypnotics (OR=2.30, 95% CI, 1.64-3.23), or drugs for dementia (OR=1.52, 95% CI, 1.21-1.92). Those residing in Alzheimer/dementia special care units were also more likely to receive an antipsychotic (OR=1.66, 95% CI, 1.26-2.21). Veterans with dementia but no documented psychosis were as likely as those with an evidence-based indication to receive an antipsychotic (OR=1.10, 95% CI, 0.82-1.47).

CONCLUSIONS: Antipsychotic use is common among VA nursing home residents aged 65 and older, including those without a documented evidence-based indication for use. Further quality improvement efforts are needed to reduce potentially inappropriate antipsychotic prescribing.

Gellad, Walid F, Chester B Good, Megan E Amuan, Zachary A Marcum, Joseph T Hanlon, and Mary Jo Pugh V. (2012) 2012. “Facility-Level Variation in Potentially Inappropriate Prescribing for Older Veterans.”. Journal of the American Geriatrics Society 60 (7): 1222-9. https://doi.org/10.1111/j.1532-5415.2012.04042.x.

OBJECTIVES: To describe facility-level variation in two measures of potentially inappropriate prescribing prevalent in Veterans Affairs (VA) facilities-exposure to high-risk medications in elderly adults (HRME) and drug-disease interactions (Rx-DIS)-and to identify facility characteristics associated with high-quality prescribing.

DESIGN: Cross-sectional.

SETTING: VA Healthcare System.

PARTICIPANTS: Veterans aged 65 and older with at least one inpatient or outpatient visit in 2005-2006 (N = 2,023,477; HRME exposure) and a subsample with a history of falls or hip fractures, dementia, or chronic renal failure (n = 305,059; Rx-DIS exposure).

MEASUREMENTS: Incident use of any HRME (iHRME) and incident Rx-DIS (iRx-DIS) and facility-level rates and facility-level predictors of iHRME and iRx-DIS exposure, adjusting for differences in patient characteristics.

RESULTS: Overall, 94,692 (4.7%) veterans had iHRME exposure. At the facility level, iHRME exposure ranged from 1.6% at the lowest facility to 12.8% at the highest (median 4.7%). In the subsample, 9,803 (3.2%) veterans had iRx-DIS exposure, with a facility-level range from 1.3% to 5.8% (median 3.2%). In adjusted analyses, veterans seen in facilities with formal geriatric education had lower odds of iHRME (odds ratio (OR) = 0.86, 95% confidence interval (CI) = 0.77-0.96) and iRx-DIS (OR = 0.95, 95% CI = 0.88-1.01). Patients seen in facilities caring for fewer older veterans had greater odds of iHRME (OR = 1.54, 95% CI = 1.35-1.75) and iRx-DIS exposure (OR = 1.22, 95% CI = 1.11-1.33).

CONCLUSION: Substantial variation in the quality of prescribing for older adults exists across VA facilities, even after adjusting for patient characteristics. Higher-quality prescribing is found in facilities caring for a larger number of older veterans and facilities with formal geriatric education.

Zhang, Yuting, Walid F Gellad, Lei Zhou, Yi-Jen Lin, and Judith R Lave. (2012) 2012. “Access to and Use of $4 Generic Programs in Medicare.”. Journal of General Internal Medicine 27 (10): 1251-7.

BACKGROUND: Although four-dollar programs ($4 per 30-day supply for selected generic drugs) have become important options for seniors to obtain affordable medications, little is known about access to these programs and the characteristics of those who use them.

OBJECTIVES: We quantify access to $4 programs based on driving distance; evaluate factors affecting the program use and potential cost-savings associated with switching to $4 programs in Medicare.

DESIGN: Observational study.

SETTING: US Medicare Part D data, 5% random sample, 2007

PARTICIPANTS: 347,653 elderly beneficiaries without Medicaid coverage or low-income subsidies.

MAIN MEASURES: We evaluated how use of $4 programs was affected by driving distance to the store and the beneficiary's demographic and socioeconomic status, insurance coverage, health status, comorbidities, and medication use. For those who did not use the $4 programs, we calculated potential savings from switching to $4 generics.

KEY RESULTS: Eighty percent of seniors in Medicare Part D filled prescriptions for generic drugs that were commonly available at $4 programs. Among them, only 16.3% filled drugs through $4 programs. Beneficiaries who lived in poor areas, had less insurance, more co-morbidities, and used more drugs and lived closer to $4 generic retail pharmacies, were more likely to use these programs. Blacks were less likely to use the program relative to Whites (15.0% vs. 16.4%; OR=0.75, 95% CI 0.71-0.80). While 53.2% of nonusers would save by switching to $4 program after incorporating travelling costs, 58% of those who could save would have net annual out-of-pocket savings of less than $20.

CONCLUSIONS: The take-up rate of $4 programs was low in 2007 among Medicare beneficiaries. As more stores offer $4 programs and increasing numbers of drugs become generic, more beneficiaries could potentially benefit, as could the Medicare program.