Publications

2012

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.

Aspinall, Sherrie L, Francesca E Cunningham, Xinhua Zhao, Joy S Boresi, Ivy Q Tonnu-Mihara, Kenneth J Smith, Roslyn A Stone, Chester B Good, and ESA Clinic Study Group. (2012) 2012. “Impact of Pharmacist-Managed Erythropoiesis-Stimulating Agents Clinics for Patients With Non-Dialysis-Dependent CKD.”. American Journal of Kidney Diseases : The Official Journal of the National Kidney Foundation 60 (3): 371-9. https://doi.org/10.1053/j.ajkd.2012.04.013.

BACKGROUND: Erythropoiesis-stimulating agents (ESAs) are associated with serious adverse events, and maintaining hemoglobin levels within a narrow range can be difficult. We examined the quality of ESA prescribing and monitoring in pharmacist-managed ESA clinics versus usual care in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD).

STUDY DESIGN: Historical cohort.

SETTING & PARTICIPANTS: Outpatients receiving ESAs for NDD-CKD at 10 Veterans Affairs Medical Centers with both pharmacist-managed ESA clinics (n = 314) and physician-based care (ie, usual care; n = 91) and 6 sites with usual care only (n = 167) on January 1, 2009, were followed up for 6 months.

PREDICTOR: Type/site of care (ie, pharmacist-managed ESA clinic, usual care at ESA clinic site, usual-care site).

OUTCOMES: Primary outcomes were proportion of hemoglobin values in the target range of 10-12 g/dL, ESA dose, and frequency of hemoglobin monitoring. Factors associated with hemoglobin values out of target range were identified using multinomial logistic regression.

RESULTS: More hemoglobin values were in the target range in pharmacist-managed ESA clinics (71.1% vs 56.9% for usual-care sites; P < 0.001). The average 30-day dose of darbepoetin was 163 μg in pharmacist-managed ESA clinic patients versus 240 μg in usual-care site patients and 258 μg in usual-care patients at ESA clinic sites. For epoetin, corresponding average 30-day doses were 44,890 versus 47,141 and 57,436 IU. Veterans in pharmacist-managed ESA clinics had more hemoglobin measurements on average (5.8 vs 3.6 in usual-care sites and 3.8 in usual care at ESA clinic sites; P = 0.007). In the multinomial model, usual care was associated with hemoglobin levels out of target range, whereas heart failure and diabetes were associated with values in range.

LIMITATIONS: We could not assess whether different hemoglobin targets were used by usual-care providers.

CONCLUSIONS: Relative to usual care, pharmacist-managed clinics provided improved quality of ESA dosing and monitoring for patients with NDD-CKD.

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.

Emmendorfer, Thomas, Peter A Glassman, Von Moore, Thomas C Leadholm, Chester B Good, and Francesca Cunningham. (2012) 2012. “Monitoring Adverse Drug Reactions across a Nationwide Health Care System Using Information Technology.”. American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists 69 (4): 321-8. https://doi.org/10.2146/ajhp110026.

PURPOSE: The improvement and linkage of two Department of Veterans Affairs (VA) databases for monitoring adverse drug reactions (ADRs) are described, with a discussion of the potential implications for improved medication safety within the VA health care system.

SUMMARY: Before 2007, VA had limited capability to track and evaluate ADRs across its nationwide network of health care facilities. Since then, VA has established a standardized monitoring system that has improved the reporting, analysis, and trending of ADRs reported by providers and pharmacists at individual VA facilities. The enhanced system has two components with distinct but complementary functions: the Adverse Reaction Tracking database, which is derived by extracting text-based, patient-specific information entered into the VA electronic medical record system by clinicians at the point of care; and the VA Adverse Drug Event Reporting System (VA ADERS), an external web-based portal that contains aggregated data from 146 VA facilities, with standardized coding of reported events. Both databases allow for ADR reporting at the local, regional, and national levels. The VA ADERS database permits rapid electronic reporting of certain ADRs to the federal MedWatch program. The two databases can be used in tandem for more comprehensive assessments of ADR patterns and reporting rates and to generate a wide range of benchmarking data.

CONCLUSION: In recent years, the refinement of two databases for ADR reporting has increased VA's capability to systematically monitor, track, and report ADRs across its national network of health care facilities. Linking the two databases has further strengthened those capabilities, enhancing medication safety practices and aiding in pharmacovigilance.

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.

Primack, Brian A, Maggie Hopkins, Cynthia Hallett, Mary Carroll V, Mitchell Zeller, Kathleen Dachille, Kevin H Kim, Michael J Fine, and Julie M Donohue. (2012) 2012. “US Health Policy Related to Hookah Tobacco Smoking.”. American Journal of Public Health 102 (9): e47-51.

OBJECTIVES: Although US cigarette smoking is decreasing, hookah tobacco smoking (HTS) is an emerging trend associated with substantial toxicant exposure. We assessed how a representative sample of US tobacco control policies may apply to HTS.

METHODS: We examined municipal, county, and state legal texts applying to the 100 largest US cities. We developed a summary policy variable that distinguished among cities on the basis of how current tobacco control policies may apply to HTS and used multinomial logistic regression to determine associations between community-level sociodemographic variables and the policy outcome variable.

RESULTS: Although 73 of the 100 largest US cities have laws that disallow cigarette smoking in bars, 69 of these cities have exemptions that allow HTS; 4 of the 69 have passed legislation specifically exempting HTS, and 65 may permit HTS via generic tobacco retail establishment exemptions. Cities in which HTS may be exempted had denser populations than cities without clean air legislation.

CONCLUSIONS: Although three fourths of the largest US cities disallow cigarette smoking in bars, nearly 90% of these cities may permit HTS via exemptions. Closing this gap in clean air regulation may significantly reduce exposure to HTS.

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, 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.

Dusetzina, Stacie B, Alisa B Busch, Rena M Conti, Julie M Donohue, Caleb Alexander, and Haiden A Huskamp. (2012) 2012. “Changes in Antipsychotic Use Among Patients With Severe Mental Illness After a Food and Drug Administration Advisory.”. Pharmacoepidemiology and Drug Safety 21 (12): 1251-60. https://doi.org/10.1002/pds.3272.

PURPOSE: A 2003 Food and Drug Administration advisory warned of increased hyperlipidemia and diabetes risk for patients taking second-generation antipsychotics (SGAs). After the advisory, a professional society consensus statement provided treatment recommendations and stratified SGAs into high, intermediate, and low metabolic risk. We examine subsequent changes in incident and prevalent SGA use among individuals with severe mental illness.

METHODS: We created a retrospective cohort using Florida Medicaid's claims from 2001 to 2006. We included non-Medicare eligible adults with bipolar disorder or schizophrenia who filled an SGA prescription. We assessed changes in overall and agent-specific use, discontinuations, interruptions, and therapeutic alternative use among prevalent users and agent-specific use among incident users. Pre-advisory utilization was compared with utilization initially after the advisory and two subsequent periods.

RESULTS: Among prevalent users, overall SGA use decreased slightly, and no increases in treatment interruptions or discontinuations were observed after the advisory and consensus statement publication. Compared with the pre-advisory period, in the months immediately after the advisory, the use of the highest metabolic-risk agent, olanzapine, decreased by 34% among prevalent users with bipolar disorder (adjusted risk ratio [aRR] = 0.66, 95%CI = 0.59-0.74) and 26% among prevalent users with schizophrenia (aRR = 0.74, 95%CI = 0.72-0.76). A greater decrease was estimated among incident users with bipolar disorder (aRR = 0.37, 95%CI = 0.29-0.47) and schizophrenia (aRR = 0.42, 95%CI = 0.35-0.51) during this period. During each subsequent post-advisory period, olanzapine use continued to decrease whereas quetiapine, ziprasidone, and aripiprazole use increased.

CONCLUSIONS: The metabolic risk advisory and the published consensus statement were associated with a selective reduction in olanzapine use without evidence of treatment disruptions among this population.