Publications

OBJECTIVE: To evaluate Medicare Part D's impact on use of antihypertensive medications among seniors with hypertension.

DATA SOURCES: Medicare-Advantage plan pharmacy data from January 1, 2004 to December 12, 2007 from three groups who before enrolling in Part D had no or limited drug benefits, and a comparison group with stable employer-based coverage.

STUDY DESIGN: Pre-post intervention with a comparison group design was used to study likelihood of use, daily counts, and substitutions between angiotensin-converting enzyme inhibitors and angiotensin-II receptor blockers (ARBs).

PRINCIPAL FINDINGS: Antihypertensive use increased most among those without prior drug coverage: likelihood of use increased (odds ratio = 1.40, 95 percent confidence interval [CI] 1.25-1.56), and daily counts increased 0.29 (95 percent CI 0.24-0.33). Proportion using ARBs increased from 40 to 46 percent.

CONCLUSIONS: Part D was associated with increased antihypertensive use and use of ARBs over less expensive alternatives.

BACKGROUND: Medication nonadherence is a common problem among the elderly.

OBJECTIVE: To conduct a systematic review of the published literature describing potential nonfinancial barriers to medication adherence among the elderly.

METHODS: The PubMed and PsychINFO databases were searched for articles published in English between January 1998 and January 2010 that (1) described "predictors," "facilitators," or "determinants" of medication adherence or that (2) examined the "relationship" between a specific barrier and adherence for elderly patients (ie, ≥65 years of age) in the United States. A manual search of the reference lists of identified articles and the authors' files and recent review articles was conducted. The search included articles that (1) reviewed specific barriers to medication adherence and did not solely describe nonmodifiable predictors of adherence (eg, demographics, marital status), (2) were not interventions designed to address adherence, (3) defined adherence or compliance and specified its method of measurement, and (4) involved US participants only. Nonsystematic reviews were excluded, as were studies that focused specifically on people who were homeless or substance abusers, or patients with psychotic disorders, tuberculosis, or HIV infection, because of the unique circumstances that surround medication adherence for each of these populations.

RESULTS: Nine studies met inclusion criteria for this review. Four studies used pharmacy records or claims data to assess adherence, 2 studies used pill count or electronic monitoring, and 3 studies used other methods to assess adherence. Substantial heterogeneity existed among the populations studied as well as among the measures of adherence, barriers addressed, and significant findings. Some potential barriers (ie, factors associated with nonadherence) were identified from the studies, including patient-related factors such as disease-related knowledge, health literacy, and cognitive function; drug-related factors such as adverse effects and polypharmacy; and other factors including the patient-provider relationship and various logistical barriers to obtaining medications. None of the reviewed studies examined primary nonadherence or nonpersistence.

CONCLUSION: Medication nonadherence in the elderly is not well described in the literature, despite being a major cause of morbidity, and thus it is difficult to draw a systematic conclusion on potential barriers based on the current literature. Future research should focus on standardizing medication adherence measurements among the elderly to gain a better understanding of this important issue.

BACKGROUND: Certain medications increase the risk of birth defects whether used during pregnancy or immediately preconception.

OBJECTIVES: To describe dispensing of potentially teratogenic medications (Food and Drug Administration classes D or X) to female Veterans treated by the Veterans Affairs (VA) Healthcare System, and assess whether documented provision of family planning services is more common when potentially teratogenic medications are prescribed.

RESEARCH DESIGN: We examined all 2,634,441 prescriptions filled in fiscal year 2007 or 2008 by 78,232 female Veterans, aged 18 to 45, who made >or=2 visits to VA clinics within the year prior to medication dispensing from VA pharmacies.

MEASURES: : Medications dispensed, contraceptive counseling, and pregnancy testing.

RESULTS: Prescriptions for potentially teratogenic medications were filled by 48.8% of female Veterans who received medications from a VA pharmacy. Women who filled prescriptions for potentially teratogenic medications were only slightly more likely to have documented family planning services (eg, contraception, contraceptive counseling, or pregnancy testing) than women who filled class C, but not class D or X, prescriptions (55.7% vs. 51.8%). Women filling only class A or B prescriptions were least likely to have documented family planning services (35.9%). Among women dispensed potentially teratogenic medications, family planning services were significantly more likely to be documented for women who were >or=25 years (odds ratio [OR], 2.82; 95% confidence interval [CI], 2.57-3.11), unmarried (OR, 1.30; 95% CI, 1.23-1.35), non-White (OR, 1.17; 95% CI, 1.09-1.26), seen at a women's clinic (OR, 1.96; 95% CI, 1.88-2.05), received a retinoid medication (OR, 7.72; 95% CI, 3.02-19.7), or had serious mental illness (OR, 1.26; 95% CI, 1.18-1.34).

CONCLUSIONS: Medications that may cause birth defects if used during pregnancy are dispensed frequently to female Veterans by VA pharmacies without documented receipt of contraceptive counseling or pregnancy testing.

OBJECTIVES: To examine variation in outpatient prescription use and spending for hyperlipidemia and diabetes mellitus in the Veterans Affairs Healthcare System (VA) and its association with quality measures for these conditions.

STUDY DESIGN: Cross-sectional.

METHODS: We compared outpatient prescription use, spending, and quality of care across 135 VA medical centers (VAMCs) in fiscal year 2008, including 2.3 million patients dispensed lipid-lowering medications and 981,031 patients dispensed diabetes medications. At each facility, we calculated VAMC-level cost per patient for these medications, the proportion of patients taking brand-name drugs, and Healthcare Effectiveness Data and Information Set (HEDIS) scores for hyperlipidemia (low-density lipoprotein cholesterol level <100 mg/dL) and for diabetes (glycosylated hemoglobin level >9% or not measured).

RESULTS: The median cost per patient for lipid-lowering agents in fiscal year 2008 was $49.60 and varied from $39.68 in the least expensive quartile of VAMCs to $69.57 in the most expensive quartile (P < .001). For diabetes agents, the median cost per patient was $158.34 and varied from $123.34 in the least expensive quartile to $198.31 in the most expensive quartile (P < .001). The proportion of patients dispensed brand-name oral drugs among these classes in the most expensive quartile of VAMCs was twice that in the least expensive quartile (P < .001). There was no correlation between VAMC-level prescription spending and performance on HEDIS measures for lipid-lowering drugs (r = 0.12 and r = 0.07) or for diabetes agents (r = -0.10).

CONCLUSIONS: Despite the existence of a closely managed formulary, significant variation in prescription spending and use of brand-name drugs exists in the VA. Although we could not explicitly risk-adjust, there appears to be no relationship between prescription spending and quality of care.

There is no question that 2009 was a year of change within the pharmacy industry. Several new requirements were implemented, including the need for an Inventory Information Approval System for accepting flexible spending or health reimbursement account cords. Some pharmacies relied on the 90% exemption rule, which is discussed within this article, or an alternative method to avoid the expense of a point of sale. However, with flexible spending or health reimbursement account card participation expected to reach 85% in 2010, now bay be the time for compounding pharmacists to weigh the pros and cons of Inventory Information Approval System certification.

This article addresses the content of the workshop, including a panel discussion relevant to delineation of a path forward in relation to risk assessment of essential metals. The state of the art of risk assessment and associated issues for essential metals are outlined initially, followed by brief illustration by the case studies considered at the workshop (i.e., copper, zinc, and manganese). Approaches for the future testing strategies of essential metals are discussed in terms of options to increase efficiency and accuracy of assessments. Subsequently, recommendations for pragmatic next steps to advance progress and facilitate uptake by the regulatory risk assessment community are presented.

BACKGROUND: Several studies have shown that use of medications to treat chronic conditions is highly sensitive to out-of-pocket price and influenced by changes in insurance coverage. Because antibiotics target infections and are used for a short period, one may expect antibiotic use to be less responsive to price. However, no studies have evaluated how antibiotic use changes with drug coverage. We evaluate changes in ambulatory oral antibiotic use after implementation of the Medicare drug benefit (Part D).

METHODS: We conducted a comparison group analysis 2 years before and after implementation of Part D using insurance claims data from a large Medicare Advantage plan (January 1, 2004, through December 31, 2007). Outcomes included the likelihood of using any oral antibiotics and major antibiotic subclasses among 35 102 older adults and rates of antibiotic use among those with pneumonia and other acute respiratory tract infections.

RESULTS: Overall antibiotic use increased most among those who did not previously have drug coverage (relative odds ratio [OR], 1.58; 95% confidence interval [CI], 1.36-1.85). Use of the broad spectrum antibiotic subclasses of quinolones (OR, 1.70; 95% CI, 1.35-2.15) and macrolides (1.59; 1.26-2.01) increased more than the use of other subclasses, especially for those with prior drug coverage. Rates of ambulatory antibiotic use associated with pneumonia increased (OR, 3.60; 95% CI, 2.35-5.53) more than those associated with other acute respiratory tract infections (2.29; 1.85-2.83).

CONCLUSIONS: Antibiotic use increased among older adults whose drug coverage improved after Part D implementation, with the largest increases for broad spectrum, newer, and more expensive antibiotics. Our study suggests reimbursement may play a role in addressing inappropriate antibiotic use.

BACKGROUND: Adherence to pharmacotherapy for heart failure is poor among older adults in part because of high prescription drug costs. We examined the impact of improvements in drug coverage under Medicare Part D on utilization of, and adherence to, medications for heart failure in older adults.

METHODS: We used a quasi-experimental approach to analyze pharmacy claims for 6,950 individuals aged >or=65 years with heart failure enrolled in a Medicare managed care organization 2 years before and after Part D's implementation. We compared prescription fill patterns among individuals who moved from limited (quarterly benefits caps of USD 150 or USD 350) or no drug coverage to Part D in 2006 with those who had generous employer-sponsored coverage throughout the study period.

RESULTS: Individuals who previously lacked drug coverage filled approximately 6 more heart failure prescriptions annually after Part D (adjusted ratio of prescription counts = 1.36, 95% CI 1.29-1.44, P < .0001 relative to the comparison group). Those previously lacking drug coverage were more likely to fill prescriptions for an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker plus a beta-blocker after Part D (adjusted ratio of odds ratios = 1.73, 95% CI 1.42-2.10, P < .0001) and more likely to be adherent to such pharmacotherapy (adjusted ratio of odds ratios = 2.95, 95% CI 1.85-4.69, P < .0001) relative to the comparison group.

CONCLUSIONS: Medicare Part D was associated with improved access to medications and adherence to pharmacotherapy in older adults with heart failure.

OBJECTIVE: To examine the impact of the Medicare drug benefit (Part D) on the distribution of out-of-pocket pharmacy spending among older adults.

METHODS: We used a pre-post-with-comparison-group design to compare four groups of beneficiaries continuously enrolled in a Medicare Advantage plan between 2004 and 2007: three intervention groups with no or limited (quarterly caps of $150 or $350) prior coverage that obtained Part D benefits in 2006 and a comparison group with stable drug coverage from 2004 to 2007.

RESULTS: The comparison group's out-of-pocket drug spending was stable throughout 2004-2007, whereas Part D reduced out-of-pocket spending 13.4% among those without prior coverage (95% confidence interval [CI] -17.1% to -9.1%) and 15.9% among those with $150 quarterly caps (95% CI -19.1% to -12.8%) relative to the comparison group. Individuals in the top decile of drug spending paid a greater share of their costs out-of-pocket than others in the top 5 deciles.

DISCUSSION: Although Part D reduced out-of-pocket expenditures for older adults, those with the highest drug spending still pay a substantial share of their drug costs out-of-pocket. Thus, the Part D benefit does not achieve a primary purpose of insurance-to offer the greatest financial protection to those at the highest risk.

BACKGROUND: Little is known about how Medicare Part D affects the medication refill adherence for cardiovascular and diabetes medications, particularly among beneficiaries without prior drug coverage.

OBJECTIVES: To evaluate Medicare Part D's effect on medication adherence among beneficiaries with hyperlipidemia, hypertension, and/or diabetes enrolled in Medicare Advantage products.

RESEARCH DESIGN: We used a quasi-experimental pre-post design, with 3 treatment groups and a comparison group, to assess the effect of Part D on several measures of adherence to prescription medications.

SUBJECTS: Adults aged 65 or older with hyperlipidemia, hypertension, and/or diabetes in 2003 continuously enrolled between 2004 and 2007 in a large Pennsylvania insurer's Medicare Advantage products.

MEASURES: Medication possession ratios (MPR), good adherence with MPR >0.8, and intensity of treatment measured by average daily counts of pills per day of treatment.

RESULTS: Part D improved MPRs in the group without prior drug coverage by 13.4 percentage points (95% CI, 10.1-16.8), 17.9 (95% CI, 13.7-22.1), and 13.5 (95% CI, 11.5-15.5) for those with hyperlipidemia, diabetes, and hypertension, respectively. Adherence improved less in the other 2 groups with limited prior drug benefits. Although the proportion of beneficiaries in the intervention groups who attained good adherence levels increased after Part D, less than 50%, 68%, and 78% of beneficiaries with hyperlipidemia, diabetes, and hypertension, respectively, attained good adherence.

CONCLUSION: Part D increased adherence to medications that reduce the risk of cardiovascular events for patients with hypertension, diabetes, and hyperlipidemia. This should improve the health of the elderly people in the long run.