M. A. Brookhart

Uric acid lowering therapy: prescribing patterns in a large cohort of older adults.

Background: Uric acid lowering therapy (UALT) is considered a chronic treatment for gout. Relatively little is known about adherence to UALT. Methods: We assessed adherence with UALT over a 1-year study period among 9823 older adults enrolled in a pharmacy benefit program. Two adherence measures were calculated, the percentage of days covered (PDC) and the time until an extended break (at least 60 days) in treatment. A PDC <80% was considered poor adherence and its predictors were examined in multivariable logistic models. Results: The mean (SD) PDC was 54% (36%) with 64% of patients considered poorly compliant over the study period. A total of 56% had experienced an extended break in UALT. Predictors of poor adherence included younger age (odds ratio (OR) 1.50, 95% CI 1.33–1.69 for ages 65–74 compared with 85 and above) and African–American race (OR 1.86, 95% CI 1.52–2.27 compared with Caucasian race). Most patients (93%) received their initial UALT prescription from a non-specialist and this also predicted poor adherence (OR 1.15, 95% CI 0.96–1.38 compared with rheumatologists or nephrologists). Conclusion Adherence with UALT is poor. While uric acid levels were not measured in this study, poor adherence with UALT is likely to reduce attainment of goal uric acid levels.

Identifying specific chemotherapeutic agents in Medicare data: a validation study.

Background:Large health care databases are increasingly used to examine the dissemination and benefits and harms of chemotherapy treatment in routine practice, particularly among patients excluded from trials (eg, the elderly). Misclassification of chemotherapy could bias estimates of frequency and association, warranting an updated assessment. Methods:We evaluated the validity of Medicare claims to identify receipt of chemotherapy and specific agents delivered to elderly stage II/III colorectal (CRC), in situ/early-stage breast, non-small–cell lung, and ovarian cancer patients using the National Cancer Institute’s Patterns of Care studies (POC) as the gold standard. The POC collected data on chemotherapy treatment by reabstracting hospital records, contacting physicians, and reviewing medical records. Patients’ POC data were linked and compared with their Medicare claims for 2 to 12 months postdiagnosis. &kgr;, sensitivity, specificity, positive and negative predictive values and 95% confidence intervals were calculated for the receipt of any chemotherapy and specific agents. Results:Sensitivity and specificity of Medicare claims to identify any chemotherapy were high across all cancer sites. We found substantial variation in validity across agents, by site and administration modality. Capecitabine, an oral CRC treatment, was identified in claims with high specificity (98%) but low sensitivity (47%), whereas oxaliplatin, an intravenously administered CRC agent had higher sensitivity (75%) and similar specificity (97%). Conclusions:Receipt of chemotherapy and specific intravenous agents can be identified using Medicare claims, showing improvement from prior reports; yet, variation exists. Future studies should assess newly approved agents and the impact of coverage decisions for these agents under the Medicare Part D program.

Placebo adherence, clinical outcomes, and mortality in the women's health initiative randomized hormone therapy trials.

BackgroundMedication adherence may be a proxy for healthy behaviors and other factors that affect outcomes. Prior studies of the association between placebo adherence and health outcomes have been limited primarily to men enrolled in clinical trials and cardiovascular disease outcomes. We examined associations between adherence to placebo and the risk of fracture, coronary heart disease, cancer, and all-cause mortality in the 2 Womens Health Initiative hormone therapy randomized trials. MethodsPostmenopausal women randomized to placebo with adherence measured at least once were eligible for analysis. Time-varying adherence was assessed by dispensing history and pill counts. Outcome adjudication was based on physician review of medical records. Cox proportional hazards models evaluated the relation between high adherence (≥80%) to placebo and various outcomes, referent to low adherence (<80%). ResultsA total of 13,444 postmenopausal women were under observation for 106,066 person-years. High placebo adherence was inversely associated with most outcomes including hip fracture [hazard ratio (HR), 0.50; 95% confidence interval (CI), 0.33-0.78], myocardial infarction (HR, 0.69; 95% CI, 0.50-0.95), cancer death (HR, 0.60; 95% CI, 0.43-0.82), and all-cause mortality (HR, 0.64; 95% CI, 0.51-0.80) after adjustment for potential confounders. Women with low adherence to placebo were 20% more likely to have low adherence to statins and osteoporosis medications. ConclusionsIn the Womens Health Initiative clinical trials, high adherence to placebo was associated with favorable clinical outcomes and mortality. Until the healthy behaviors and/or other factors for which high adherence is a proxy can be better elucidated, caution is warranted when interpreting the magnitude of benefit of medication adherence.

Prevalent but moderate variation across small geographic regions in patient nonadherence to evidence-based preventive therapies in older adults after acute myocardial infarction

Background:Patient long-term adherence to &bgr;-blockers, HMG-CoA reductase inhibitors (statins), and angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs) after acute myocardial infarction (AMI) is alarmingly low. It is unclear how prevalent patient adherence may be across small geographic areas and whether this geographic prevalence may vary. Methods:This is a retrospective cohort study using Medicare service claims files from 2007 to 2009 with Medicare beneficiaries 65 years and above who were alive 30 days after the index AMI hospitalization between January 1, 2008 and December 31, 2008 (N=85,017). The adjusted proportions of patients adherent to &bgr;-blockers, statins, and ACEIs/ARBs, respectively, in the 12 months after discharge across the 306 Hospital Referral Regions (HRRs) were measured and compared by control chart. The intracluster correlation coefficient (ICC) and the additional prediction power from this small-area variation on individual patient adherence were assessed. Results:The adjusted proportion of patients adherent across HRRs ranged from 58% to 74% (median, 66%) for &bgr;-blockers, from 57% to 67% (median, 63%) for ACEIs/ARBs, and from 58% to 73% (median, 66%) for statins. The ICC was 0.053 (95% CI, 0.043–0.064) for &bgr;-blockers, 0.050 (95% CI, 0.039–0.061) for ACEIs/ARBs, and 0.041 (95% CI, 0.031–0.052) for statins. The adjusted proportion of patients adherent across HRRs increased the c-statistic by 0.01–0.02 (P < 0.0001). Conclusions:Nonadherence to evidence-based preventive therapies post-AMI among older adults was prevalent across small geographic regions. Moderate small-area variation in patient adherence exists.

Rationale and design of the Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples (SAMPLES) trial

BACKGROUND Highly effective generic cardiovascular medications are frequently underused, leading to greater overall drug costs and cost-related nonadherence. OBJECTIVE We sought to assess an intervention to stimulate appropriate generic cardiovascular drug use without creating administrative or financial barriers that may impede essential medication use. TRIAL DESIGN The SAMPLES (Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples) trial is a clustered, randomized controlled trial of the effect of providing physicians with free generic samples of hydrochlorothiazide for hypertensive patients and simvastatin for patients with hyperlipidemia. We will randomize 660 primary care physicians in Pennsylvania, clustered by physician practice, to receive free samples for both conditions or to receive no samples. We will use data on filled prescriptions obtained from a state-sponsored prescription drug assistance program to perform an intention-to-treat evaluation of the impact of the intervention on physician prescribing behavior (proportion of prescriptions that are generic) and patient adherence. Secondary outcomes will include physician adherence to established guidelines and overall prescription drug costs. CONCLUSION This trial will define the potential role of an innovative approach to stimulate clinically appropriate cost-effective prescribing. We will determine whether free generic samples can reduce overall drug costs as well as out-of-pocket costs to the patient without sacrificing efficacy and whether this approach results in improved adherence to essential cardiovascular medications. This intervention may also improve adherence to practice guidelines and improve the quality of care received. If effective, this strategy could be used broadly by private insurers or government payers aiming to stimulate more cost-effective and higher-quality care.