Survey nonresponders to a medication-beliefs survey have worse adherence and persistence to chronic medications compared with survey responders.

OBJECTIVE: The primary objective of this study was to investigate whether nonresponders to a medication-beliefs survey exhibited different adherence and persistence patterns than survey responders. METHODS: A medication-beliefs survey was mailed to 7795 adults aged from 40 to 88 years, who filled a qualifying index prescription (cardiovascular, dyslipidemia, oral-antihyperglycemic, oral-bisphosphonate, and asthma-controller medications) in June 2008 at 1 national and 2 regional retail pharmacies. Adherence and persistence to the index drug class was measured using pharmacy-claims data over 12 months. A multivariate generalized linear model with a negative binomial distribution and log-link function was used to determine whether response status was a significant predictor of adherence. Kaplan-Meier estimates of survival curves were used to assess the time to discontinuation (persistence). Differences between nonresponders and responders were assessed using the log-rank test. RESULTS: The survey response rate was 24.25%. The final analytic sample size after exclusions was 6740 patients (5044 nonresponders and 1696 responders). On the basis of multivariate generalized linear model analysis, survey nonresponders had 11% lower medication adherence compared with responders (P < 0.01; goodness-of-fit=1.09 as defined by deviance/df statistics). The proportion of nonresponders deemed nonpersistent at day 305 was 66.3% compared with 58.1% of responders (P < 0.001). The Kaplan-Meier persistence curves were significantly different for nonresponders and responders as assessed by the log-rank test (χ statistic=49.38; P < 0.001). CONCLUSIONS: Our study found that the responders and nonresponders to a medication-beliefs survey differed significantly in their subsequent adherence and persistence, suggesting that biased survey results are likely to accompany low response rates in surveys of medication use. The use of modest monetary incentives had a small effect on survey response; multiple survey levers are recommended to reduce nonresponse and the potential for biased results.

Asymmetric responsiveness of physician prescription behavior to drug promotion of competitive brands within an established therapeutic drug class.

This article examines the impact of direct-to-physician, direct-to-consumer, and other marketing activities by pharmaceutical companies on a mature drug category which is in the later stage of its life cycle and in which generics have accrued a significant market share. The main objective of this article is to quantitatively estimate the impact of pharmaceutical promotions on physician prescribing behavior for three different statin brands, after controlling for factors such as patient, physician and physician practice characteristics, generic pressure, et cetera. Using unique panel data of physicians, combined with patient pharmacy prescription records, the authors developed a physician level generalized linear regression model. The generalized estimating equations method was used to account for within physician serial correlations and estimate physician population averaged effects. The findings reveal that even though on average the marketing efforts affect the brand share positively, the magnitude of the effects is very brand specific. Generally, each statin brand has its own trend and because of this, the best choice of predictors for one brand could be suboptimal for another.

Evaluation of a monthly coverage maximum (drug-specific quantity limit) on the 5-HT1 agonists (triptans) and dihydroergotamine nasal spray.

BACKGROUND: Ensuring the appropriate use of migraine therapies is an important consideration for care providers, patients, employers, and managed care organizations (MCOs) because of the high cost of treatment for this fairly prevalent disabling disease. A review of utilization of serotonin 5-HT1 receptor agonists (triptans) in an MCO determined that about 24% of the patients who received triptan therapy exceeded the manufacturers. recommendations regarding the maximum daily dose and safe treatment guidelines in a 30-day period. An initiative was designed to manage the coverage of migraine abortive therapies with the anticipated outcome of decreasing potential misuse or overuse of the medications. OBJECTIVE: The objective of this retrospective, observational study was to determine the impact of a monthly drug-specific milligram coverage maximum (quantity limit) on serotonin 5-HT1 receptor agonists (triptans) and dihydroergotamine (DHE) nasal spray on the utilization and costs of migraine care in an MCO with approximately 600000 covered members. METHODS: A longitudinal, retrospective cohort analysis was conducted. All migraine-related services were analyzed, including outpatient medical visits, emergency department utilization, inpatient hospitalizations, and outpatient prescription drug use. The analysis was conducted using medical and pharmacy administrative claims. Analysis of data was performed for the period 12 months prior (October 1999 to September 2000) and 18 months postimplementation of the monthly drug-specific milligram coverage maximum (October 2000 through March 2002). RESULTS: Imposition of a monthly coverage maximum for migraine-abortive therapies was associated with a 26.1% reduction in overall per- patient-per-month (PPPM) medical costs for migraine care, from US dollars 55.52 PPPM to US dollars 41.02 PPPM (P<0.01). Utilization of serotonin 5-HT1 receptor agonists and DHE nasal spray declined by 16.7%, from 0.18 prescriptions PPPM to 0.15 prescriptions PPPM (P=0.039), and direct drug costs declined by 28.8%, from US dollars 29.18 PPPM to US dollars 20.78 PPPM (P<0.001). Utilization and costs of outpatient and inpatient migraine-related medical services declined by 40% from US dollars 16.58 PPPM in the preperiod to US dollars 9.94 PPPM in the postperiod (P<0.001). CONCLUSION: A monthly drug-specific milligram coverage maximum was associated with significant reduction in drug costs and utilization of serotonin 5-HT1 receptor agonists (triptans) and DHE nasal spray. Utilization and costs of migraine-related medical services also declined after implementation of the coverage maximum for triptans and DHE nasal spray. The monthly drug-specific milligram coverage maximum appeared to have been successful in managing utilization of triptans and DHE nasal spray, including reduction of overall costs of migraine-related medical services and direct drug costs.

The LifeSite hemodialysis access system: implications for the nephrology nurse.

A new subcutaneous device--the LifeSite Hemodialysis Access System (Vasca, Inc., Tewksbury, MA)--was designed to overcome limitations of transcutaneous dialysis catheters and is now available for use in the United States. A fully implantable device, the LifeSite System provides immediate, reliable, high-flow vascular access. The durable stainless steel and titanium LifeSite valve is implanted in a subcutaneous tissue pocket, typically below the clavicle. It is connected to a biocompatible silicone cannula that is tunneled to a central vein. The device is cannulated using a virtually pain-free, buttonhole technique. The valve is designed to allow cleansing of the valve, valve pocket, and buttonhole site with 70% isopropyl alcohol before and after each use to minimize the risk of infection. One hundred fifty-day results from an ongoing multicenter trial designed to compare the LifeSite System to a Tesio Cath dialysis catheter are reviewed. These results demonstrate that the LifeSite System is associated with statistically significant higher blood flow rates (p < 0.001) and lower rates of adverse events (p < 0.0004), infection (p < 0.032), and thrombolytic infusions (p < 0.044) than a standard dialysis catheter. The positive clinical experience with the LifeSite System carries significant implications for the dialysis team, indicating that this subcutaneous, pain-free route to vascular access may offer a safer, more effective bridge to a permanent arteriovenous (AV) access than a tunneled dialysis catheter. Potential implications of these benefits include improved outcomes, greater convenience for patients, improved efficiency and time management for the nursing staff, along with reduced direct and indirect costs related to vascular access management.

Assessment of drug consumption patterns for Medicare Part D patients.

OBJECTIVES: To assess the time needed to reach the "doughnut hole" (DH) and catastrophic coverage (CC) periods and to identify prescription drug use patterns among patients eligible for the standard Medicare Part D drug benefit. STUDY DESIGN: Retrospective cohort study. METHODS: Data for all prescription drugs dispensed to subjects over age 65 years from November 1, 2006, through February 29, 2008, were obtained from 2 large retail pharmacy chains. Kaplan-Meier estimates of survival curves were used to assess the time to reach the DH and CC thresholds. RESULTS: Of all 2007 Medicare Part D standard benefit patients in our sample, 18.5% reached the DH, but only 11.6% of those patients reached the CC threshold by the end of 2007. Patients who did not reach the DH in 2007 filled an average of 2.13 prescriptions per month. Patients who reached the DH but did not reach the CC threshold filled an average of 4.86 and 4.40 (9.47% decrease; P <.001) prescriptions per month during the initial coverage and DH periods, respectively. Patients who reached the CC threshold filled an average of 7.59, 8.38, and 7.86 prescriptions per month during the initial coverage, DH, and CC periods, respectively. Similar quantitative patterns were observed for patients with various chronic conditions. CONCLUSION: A sizable proportion of standard Medicare Part D drug program beneficiaries reached the DH. Prescription data can help predict the problems beneficiaries enrolled in the standard Medicare Part D drug program might face over time.

The role of patient inexperience in medication discontinuation: a retrospective analysis of medication nonpersistence in seven chronic illnesses.

BACKGROUND: Previous studies have reported that patients who are medication naive in some medication classes have a higher risk of medication discontinuation during the first 30 days of treatment and shorter median times to discontinuation than do medication-experienced patients. OBJECTIVES: This study compared the risk of discontinuation during the first 30 days after the index fill and the median time to discontinuation for medication-naive and medication-experienced patients who were prescribed drugs for asthma, diabetes mellitus, high cholesterol, cardiovascular disease, breast cancer, glaucoma, or osteoporosis. METHODS: Deidentified outpatient pharmacy records from 4 large US retail chains were searched for patients who had obtained a prescription for one of the index medications between January 1, 2007, and January 31, 2007. Included medication classes were asthma inhalers, asthma pills, oral breast-cancer agents, cardiovascular medications, oral antidiabetic medications, insulin, glaucoma drops, osteoporosis medications, and statins. Patients were divided into 2 groups: those for whom an in-class medication was not dispensed in the previous 180 days were identified as medication naive, and those for whom an in-class medication was dispensed during this period were identified as medication experienced. Discontinuation was defined as being >30 days late for a scheduled refill. Time to discontinuation was measured using Kaplan-Meier analysis during a 360-day follow-up period. RESULTS: Data for 2.17 million patients who received prescriptions from 3821 pharmacies were analyzed. During the first 30 days of therapy, rates of discontinuation for medication-naive patients were 17.4% to 42.6% higher than for medication-experienced patients, and their median times to discontinuation were 14.2% to 28.9% as long. The difference in persistence between medication-naive and medication-experienced patients emerged during the first 30 days of medication use, after which rates of discontinuation were relatively consistent. Patients prescribed nonoral medications for diabetes mellitus (insulin), asthma (inhalers), and glaucoma (drops) had an especially high risk of discontinuation during the first month of treatment. CONCLUSION: This study found that medicationnaive patients had a higher risk of discontinuation during the first 30 days of therapy than did medicationexperienced patients, regardless of the medication class prescribed, leading to shorter median times to discontinuation.

The effect of Medicare Part D coverage on drug use and cost sharing among seniors without prior drug benefits.

This study evaluates the effect of Medicare Part D among seniors who previously lacked drug coverage, using time-trend analyses of patient-level dispensing data from three pharmacy chains. Of 114,766 seniors without drug benefits, 55 percent initiated drug insurance under Part D. After the penalty-free Part D enrollment period, use of statins, clopidogrel, and proton pump inhibitors stabilized at levels ranging from 11 percent to 37 percent above the trend that would have been expected if Part D had not been implemented. Patients reaching the Part D coverage gap (12 percent) experienced a decrease in essential medication use ranging from 5.7 percentage points per month for warfarin to 6.3 percentage points for statins.

The effect of transitioning to medicare part d drug coverage in seniors dually eligible for medicare and medicaid.

OBJECTIVES: To evaluate medication use, out-of-pocket spending, and medication switching during the transition period for patients dually eligible for Medicaid and Medicare (dual eligibles). DESIGN: Time-trend analysis, using segmented linear regression. SETTING: Patient-level pharmacy dispensing data from January 2005 to December 2006 from a large pharmacy chain with stores in 34 states. PARTICIPANTS: Dual eligibles aged 65 and older. MEASUREMENTS: Changes in utilization, patient copayments, and medication switching were analyzed using interrupted time trend analyses. Utilization and spending were evaluated for five study drugs: clopidogrel, proton pump inhibitors (PPIs), warfarin, and statins (essential drugs covered by Part D plans) and benzodiazepines (not covered through Part D but potentially covered through Medicaid). RESULTS: Drug use for 13,032 dual eligibles was evaluated. There was no significant effect of the transition to Medicare Part D on use of all study drugs, including the uncovered benzodiazepines. Cumulative reductions were seen in copayments for all covered drugs after implementation of Part D, ranging from 25% annually for PPIs to 53% for warfarin, but there was a larger increase in copayments, 91% annually, for benzodiazepines after the transition. The rate of switching medications was 3.0 times as great for the PPIs after implementation of Part D than before implementation, but there was no significant change in the other study drug classes. CONCLUSION: These findings in a single, large pharmacy chain indicate that the transition plan for dual eligibles led to less medication discontinuation and switching than many had expected. The substantially greater cost sharing for benzodiazepines highlights the importance of implementing a thoughtful transition plan when executing such a national policy.

Adherence and persistence with fluticasone propionate/salmeterol combination therapy.

BACKGROUND: Pharmacy database medication refill studies provide a panoramic view of medication-taking behavior in patients nationally. OBJECTIVE: To investigate fluticasone propionate/salmeterol combination (FSC) adherence, including the factors associated with refill adherence in a large national pharmacy database. METHODS: Adherence and persistence were documented for 12 months from date of initial FSC prescription in 5504 patients who filled their medication at a nationwide pharmacy chain. RESULTS: On average, patients filled enough medication to cover 22.2% of days. More than half the patients filled a 30-day prescription only once over the 1-year interval. Higher adherence levels were associated with being male, being older than 35 years, having a comorbid disorder, a having a copay of 1.01 dollar to 10 dollars, previous beta2-agonist use, and a prescription for higher-dose FSC. CONCLUSION: This pharmacy database study portrays medication adherence levels to be considerably lower than those reported in most clinical trials, suggests that most adults taking FSC obtain a single fill before abandoning their controller medication, and indicates a need for a reappraisal of current treatment guidelines and educational strategies for both providers and patients. CLINICAL IMPLICATIONS: For many patients, filling of a controller medication is markedly discrepant with practice guidelines. Reappraisal of both the guidelines and strategies to implement them is in order.

Association of the ADAM33 gene with asthma and bronchial hyperresponsiveness.

Asthma is a common respiratory disorder characterized by recurrent episodes of coughing, wheezing and breathlessness. Although environmental factors such as allergen exposure are risk factors in the development of asthma, both twin and family studies point to a strong genetic component. To date, linkage studies have identified more than a dozen genomic regions linked to asthma. In this study, we performed a genome-wide scan on 460 Caucasian families and identified a locus on chromosome 20p13 that was linked to asthma (log(10) of the likelihood ratio (LOD), 2.94) and bronchial hyperresponsiveness (LOD, 3.93). A survey of 135 polymorphisms in 23 genes identified the ADAM33 gene as being significantly associated with asthma using case-control, transmission disequilibrium and haplotype analyses (P = 0.04 0.000003). ADAM proteins are membrane-anchored metalloproteases with diverse functions, which include the shedding of cell-surface proteins such as cytokines and cytokine receptors. The identification and characterization of ADAM33, a putative asthma susceptibility gene identified by positional cloning in an outbred population, should provide insights into the pathogenesis and natural history of this common disease.