BACKGROUND: Disclosure of conflicts of interest in biomedical research is receiving increased attention. The authors sought to define current disclosure policies and how they relate to disclosure statements provided by authors in major oncology journals. METHODS: The authors identified all oncology journals listed in the Thomson Institute for Scientific Information and sought their policies on conflict-of-interest disclosure. For a subset of journals with an Impact Factor >2.0, they catalogued the number and type of articles and the details of the published disclosures in all papers from the 2 most recent issues. RESULTS: Disclosure policies were provided by 112 of 131 journals (85%); 99 (88%) of these requested that authors disclose conflicts of interest (mean Impact Factor for these journals: 4.6), whereas the remaining 13 (12%) did not (mean Impact Factor: 2.9). Ninety-three journals (94%) required financial disclosure, and 42 (42%) also sought nonfinancial disclosures. For a subset of 52 higher-impact journals (Impact Factor >2.0), we reviewed 1734 articles and identified published disclosures in 51 journals (98%). Many of these journals (31 of 51, 61%) included some disclosure statement in >90% of their articles. Among 27 journals that published editorials/commentaries, only 14 (52%) included disclosures with such articles. There was no publication of any nonfinancial conflicts of interest in any article reviewed. CONCLUSIONS: Disclosure policies and the very definition of conflict of interest varied considerably among journals. Although most journals had some policy in this area, a substantial proportion did not publish disclosure statements consistently, with deficiencies particularly among editorials and commentaries.
A substantial threat to the overall health of the American public is nonadherence to medications used to treat diabetes, as well as physicians' failure to initiate patients' use of those medications. To address this problem, we evaluated an integrated, pharmacy-based program to improve patients' adherence and physicians' initiation rates. The study included 5,123 patients with diabetes in the intervention group and 24,124 matched patients with diabetes in the control group. The intervention consisted of outreach from both mail-order and retail pharmacists who had specific information from the pharmacy benefit management company on patients' adherence to medications and use of concomitant therapies. The interventions improved patients' medication adherence rates by 2.1 percent and increased physicians' initiation rates by 38 percent, compared to the control group. The benefits were greater in patients who received counseling in the retail setting than in those who received phone calls from pharmacists based in mail-order pharmacies. This suggests that the in-person interaction between the retail pharmacist and patient contributed to improved behavior. The interventions were cost-effective, with a return on investment of approximately $3 for every $1 spent. These findings highlight the central role that pharmacists can play in promoting the appropriate initiation of and adherence to therapy for chronic diseases.
BACKGROUND: The affordability of prescription medications continues to be a major public health issue in the United States. Estimates of cost-related medication underuse come largely from surveys of ambulatory patients. Hospitalized patients may be vulnerable to cost-related underuse and its consequences, but have been subject to little investigation. OBJECTIVE: To determine impact of medication costs in a cohort of hospitalized managed care beneficiaries. METHODS: We surveyed consecutive patients admitted to medical services at an academic medical center. Questions about cost-related underuse were based on validated measures; predictors were assessed with multivariable models. Participants were asked about strategies to improve medication affordability, and were contacted after discharge to determine if they had filled newly prescribed medications. RESULTS: One-hundred thirty (41%) of 316 potentially eligible patients participated; 93 (75%) of these completed postdischarge surveys. Thirty patients (23%) reported cost-related underuse in the year prior to admission. In adjusted analyses, patients of black race were 3.39 times (95% confidence interval [CI], 1.05 to 11.02) more likely to report cost-related underuse than non-Hispanic white patients. Virtually all respondents (n = 123; 95%) endorsed at least 1 strategy to make medications more affordable. Few (16%) patients, prescribed medications at discharge, knew how much they would pay at the pharmacy. Almost none had spoken to their inpatient (4%) or outpatient (2%) providers about the cost of newly prescribed drugs. CONCLUSIONS: Cost-related underuse is common among hospitalized patients. Individuals of black race appear to be particularly at risk. Strategies should be developed to address this issue around the time of hospital discharge. Journal of Hospital Medicine 2011. (c) 2011 Society of Hospital Medicine.
OBJECTIVES: We sought to evaluate the cost-effectiveness of applying the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial results into clinical practice. BACKGROUND: The JUPITER trial found that rosuvastatin reduces vascular events in apparently healthy subjects with elevated high-sensitivity C-reactive protein (hs-CRP) but normal low-density lipoprotein (LDL) cholesterol levels. The implications of expanding treatment recommendations based on these results have not been evaluated. METHODS: We constructed a cost-effectiveness model of men >/=50 years and women >/=60 years with LDL cholesterol levels of <130 mg/dl and no known cardiovascular disease. We compared: 1) hs-CRP testing followed by rosuvastatin treatment for patients with hs-CRP levels >/=2.0 mg/l; and 2) usual care (i.e., no testing and no treatment). Estimates of treatment effectiveness were based on the JUPITER trial and were varied in sensitivity analyses. RESULTS: Among patients with LDL <130 mg/dl and hs-CRP levels >/=2.0 mg/l, rosuvastatin had an incremental cost-effectiveness of $25,198 per quality-adjusted life year (QALY) gained compared to usual care. If the effectiveness of rosuvastatin were 50% of that observed in JUPITER, the incremental cost-effectiveness ratio would increase to $50,871 per QALY. Implementing this strategy only in patients with a Framingham risk score >/=10% yielded an incremental cost-effectiveness of $14,205 per QALY. Among such intermediate-risk patients, a JUPITER-based strategy becomes cost-saving at a rosuvastatin price of <$0.86 per day. CONCLUSIONS: Rosuvastatin treatment for JUPITER-eligible patients appears to be cost-effective, particularly among those with a Framingham risk score >/=10%.
BACKGROUND: Patients with chronic disease often take many medications multiple times per day. Such regimen complexity is associated with medication nonadherence. Other factors, including the number of pharmacy visits patients make to pick up their prescriptions, may also undermine adherence. Our objective was to estimate the extent of prescribing and filling complexity in patients prescribed a cardiovascular medication and to evaluate its association with adherence. METHODS: The study population comprised individuals prescribed a statin (n = 1 827 395) or an angiotensin- converting enzyme inhibitor or renin angiotensin receptor blocker (ACEI/ARB) (n = 1 480 304) between June 1, 2006, and May 30, 2007. We estimated complexity by measuring the number of medications, prescribers, pharmacies, pharmacy visits, and refill consolidation (a measure of the number of visits per fill) during the 3 months from the first prescription. The number of daily doses was also measured in ACEI/ARB users. After this period, adherence was evaluated over the subsequent year. The relationship between complexity and adherence was assessed with multivariable linear regression. RESULTS: The statin cohort had a mean age of 63 years and were 49% male. On average, during the 3-month complexity assessment period, statin users filled 11.4 prescriptions for 6.3 different medications, had prescriptions written by 2 prescribers, and made 5.0 visits to the pharmacy. Results for ACEI/ARB users were similar. Greater prescribing and filling complexity was associated with lower levels of adherence. In adjusted models, patients with the least refill consolidation had adherence rates that were 8% lower over the subsequent year than patients with the greatest refill consolidation. CONCLUSION: Medication use and prescription filling for patients with cardiovascular disease is complex, and strategies to reduce this complexity may help improve medication adherence.
Background Adherence to medications that are prescribed after myocardial infarction is poor. Eliminating out-of-pocket costs may increase adherence and improve outcomes. Methods We enrolled patients discharged after myocardial infarction and randomly assigned their insurance-plan sponsors to full prescription coverage (1494 plan sponsors with 2845 patients) or usual prescription coverage (1486 plan sponsors with 3010 patients) for all statins, beta-blockers, angiotensin-converting-enzyme inhibitors, or angiotensin-receptor blockers. The primary outcome was the first major vascular event or revascularization. Secondary outcomes were rates of medication adherence, total major vascular events or revascularization, the first major vascular event, and health expenditures. Results Rates of adherence ranged from 35.9 to 49.0% in the usual-coverage group and were 4 to 6 percentage points higher in the full-coverage group (P<0.001 for all comparisons). There was no significant between-group difference in the primary outcome (17.6 per 100 person-years in the full-coverage group vs. 18.8 in the usual-coverage group; hazard ratio, 0.93; 95% confidence interval [CI], 0.82 to 1.04; P=0.21). The rates of total major vascular events or revascularization were significantly reduced in the full-coverage group (21.5 vs. 23.3; hazard ratio, 0.89; 95% CI, 0.90 to 0.99; P=0.03), as was the rate of the first major vascular event (11.0 vs. 12.8; hazard ratio, 0.86; 95% CI, 0.74 to 0.99; P=0.03). The elimination of copayments did not increase total spending ($66,008 for the full-coverage group and $71,778 for the usual-coverage group; relative spending, 0.89; 95% CI, 0.50 to 1.56; P=0.68). Patient costs were reduced for drugs and other services (relative spending, 0.74; 95% CI, 0.68 to 0.80; P<0.001). Conclusions The elimination of copayments for drugs prescribed after myocardial infarction did not significantly reduce rates of the trial's primary outcome. Enhanced prescription coverage improved medication adherence and rates of first major vascular events and decreased patient spending without increasing overall health costs. (Funded by Aetna and the Commonwealth Fund; MI FREEE ClinicalTrials.gov number, NCT00566774 .).
BACKGROUND: Patient nonadherence to prescribed medication is common and limits the effectiveness of treatment for many conditions. Most adherence studies evaluate behavior only among patients who have filled a first prescription. The advent of electronic prescribing (e-prescribing) systems provides the opportunity to track initial prescriptions and identify nonadherence that may have previously been undetected. METHODS: We analyzed e-prescribing data and filled claims for all patients with CVS Caremark (Woonsocket, RI) drug coverage who received e-prescriptions from the iScribe e-prescribing system in calendar 2008. We matched e-prescriptions with filled claims by using data on the drug name, date of e-prescription, and date of filled claims, allowing up to 180 days for patients to fill e-prescriptions. We evaluated the rate of primary nonadherence to newly prescribed medications across multiple characteristics of patients, prescribers, and prescriptions and developed multivariable models to identify predictors of nonadherence. RESULTS: We identified 423,616 e-prescriptions for new medications, with 3634 prescribers and 280,081 patients. The primary nonadherence rate was 24.0%. Several factors were associated with nonadherence to e-prescriptions, including nonformulary status of medications (odds ratio [OR] 1.31 compared with preferred medications; 95% confidence interval [CI], 1.26-1.36; P<.001) and residence in a low-income ZIP code (OR 1.23 compared with high-income ZIP code; 95% CI, 1.17-1.30; P<.001) Nonadherence occurred less often when e-prescriptions were transmitted directly to the pharmacy rather than printed to give to patients (OR 0.54; 95% CI, 0.52-0.57; P<.001). CONCLUSION: 24% of e-prescriptions for new medications were not filled. Our results suggest that interventions to address economic barriers and increase electronic integration in the healthcare system may be promising approaches to improve medication adherence.
SummaryBackground and objectives Although generally recommended in atrial fibrillation (AF) patients, the effectiveness and safety of oral anticoagulation in dialysis patients with AF is unknown.Design, setting, participants, & measurements We assembled a cohort of older hemodialysis patients who initiated dialysis without prior record of AF and who had prescription drug benefits through three state-administered programs. The index event was a first hospitalization with diagnosed AF; patients with any recorded prior warfarin use were excluded. Eligible patients survived >/=30 days from discharge, and new warfarin use was recorded from prescription records during that 30-day window. Propensity-matched warfarin users and nonusers were compared using Cox regression. Outcomes included ischemic stroke, hemorrhagic stroke, and mortality.Results Among 2313 patients with new AF who survived 30 days from discharge, 249 (10.8%) filled a prescription for warfarin. Comparing 237 warfarin users and 948 propensity-matched nonusers over 2287 person-years of follow-up, the occurrence of ischemic stroke was similar (HR = 0.92; 95% CI, 0.61 to 1.37), whereas warfarin users experienced twice the risk of hemorrhagic stroke (HR = 2.38; 95% CI, 1.15 to 4.96). The risks of stroke, gastrointestinal hemorrhage, and mortality did not differ between groups. As-treated analyses yielded similar findings, as did analyses restricted to patients with CHADS(2) scores >/=2.Conclusions Although we confirmed association between warfarin use and hemorrhagic stroke in dialysis patients with AF, we found no association between warfarin use and ischemic stroke. Adequately powered randomized trials are required to conclusively determine the risks and benefits of the studied warfarin indication in hemodialysis patients.
BACKGROUND: Medications are a cornerstone of the prevention and management of cardiovascular disease. Long-term medication adherence has been the subject of increasing attention in the developed world but has received little attention in resource-limited settings, where the burden of disease is particularly high and growing rapidly. To evaluate prevalence and predictors of non-adherence to cardiovascular medications in this context, we systematically reviewed the peer-reviewed literature. METHODS: We performed an electronic search of Ovid Medline, Embase and International Pharmaceutical Abstracts from 1966 to August 2010 for studies that measured adherence to cardiovascular medications in the developing world. A DerSimonian-Laird random effects method was used to pool the adherence estimates across studies. Between-study heterogeneity was estimated with an I(2) statistic and studies were stratified by disease group and the method by which adherence was assessed. Predictors of non-adherence were also examined. FINDINGS: Our search identified 2,353 abstracts, of which 76 studies met our inclusion criteria. Overall adherence was 57.5% (95% confidence interval [CI] 52.3% to 62.7%; I(2) 0.98) and was consistent across study subgroups. Studies that assessed adherence with pill counts reported higher levels of adherence (62.1%, 95% CI 49.7% to 73.8%; I(2) 0.83) than those using self-report (54.6%, 95% CI 47.7% to 61.5%; I(2) 0.93). Adherence did not vary by geographic region, urban vs. rural settings, or the complexity of a patient's medication regimen. The most common predictors of poor adherence included poor knowledge, negative perceptions about medication, side effects and high medication costs. INTERPRETATION: Our study indicates that adherence to cardiovascular medication in resource-limited countries is sub-optimal and appears very similar to that observed in resource-rich countries. Efforts to improve adherence in resource-limited settings should be a priority given the burden of heart disease in this context, the central role of medications in their management, and the clinical and economic consequences of non-adherence.
In this article we highlight the important role that medication therapy can play in preventing disease and controlling costs. Focusing on coronary artery disease, we demonstrate that prevention, with the appropriate use of generic medications, appears far more cost-effective than previously documented, and it may even save on costs. For example, an earlier study estimated that reducing blood pressure to widely established clinical guidelines in nondiabetic patients cost an estimated $52,983 per quality-adjusted life-year if a brand-name drug was used. However, we estimate that the cost is just $7,753 per quality-adjusted life-year at generic medication prices. As the nation attempts to find strategies to improve population health without adding to the unsustainably high cost of care, policy makers should focus on ensuring that patients have access to essential generic medications.
Objective: To explore caregiver adherence to chronic medications and predictors of appropriate medication use.Design: Descriptive, nonexperimental, cross-sectional study.Setting: United States in May 2009.Participants: 2,000 adults randomly selected from a large national consumer panel.Intervention: Web-based survey of community pharmacy patients.Main outcome measure: Self-reported medication adherence.Results: 21% of those invited (3,775) responded to the survey invitation. Of the 2,000 individuals who were eligible to participate, 38% described themselves as caregivers. Among caregivers, 45% agreed that they were more likely to forget their own medications than medications for their caregivees. Caregivers were 10% more likely to forget to take their medications, 11% more likely to stop taking medications if they felt well, and 13% more likely to forget to refill their medications than noncaregivers (P < 0.001 for all). In fully adjusted models, caregivers had 36% greater odds (95% CI 0.52-0.79) of reporting that they were nonadherent compared with noncaregivers and increased medication use among caregivees was associated with worse adherence among caregivers (P < 0.05).Conclusion: Medication nonadherence was common in this population, and caregivers were more likely to report poor medication adherence than noncaregivers. Considering that caregivers often engage health professionals, physicians and pharmacists may choose to screen for caregiving status. Pharmacists are uniquely positioned to intervene to enhance appropriate medication adherence.
PURPOSE: Myocardial infarction (MI) survivors benefit from receiving secondary prevention, including beta-blockers, angiotensin-blocking agents, and statins, as recommended by guidelines. Compliance with these guidelines is suboptimal. We sought to describe the initiation of secondary prevention in MI survivors, and to describe the variation in initiation by discharging the hospital, the physician, and the physician "responsible" for secondary prevention prescribing decisions in British Columbia in 1997-2004. METHODS: We assembled a cohort of 28 613 patients discharged alive from the hospital after their first MI and were not readmitted within 30 days. Physicians responsible for prescribing post-MI secondary prevention medications were identified as the physicians prescribing the greatest number of cardiac medications (post-discharge cardiac prescribers). We used multilevel logistic regression to assess the variation in drug initiation at discharging hospital, discharging physician, and post-discharge cardiac prescriber levels, which were adjusted for patient and provider characteristics during the study period. RESULTS: Beta-blockers initiation increased from 56 to 71% over the 8-year study period; angiotensin-converting enzyme/angiotensin II receptor blocker initiation increased from 37 to 70%, and statin initiation increased from 22 to 66% (0-28% for high-potency statins). The probability for initiating an average patient with the study drugs varied widely in age-sex-adjusted models at the hospital and physician levels. Further adjustment did not meaningfully change findings. The variation was largest for statins. The maximum between-provider variance was found for high-potency statins in 2003-2004 at the post-discharge cardiac prescriber level. CONCLUSIONS: Study-drug initiation is increasing among MI survivors, but the variation in initiation is wide between discharging hospitals and physicians. Copyright (c) 2011 John Wiley & Sons, Ltd.
BACKGROUND:: Pulmonary vein isolation (PVI) is recognized as a potentially curative treatment for atrial fibrillation (AF). Ablation of complex fractionated atrial electrograms (CFAEs) in addition to PVI has been advocated as a means to improve procedural outcomes, but the benefit remains unclear. OBJECTIVE:: To synthesize the available data testing the incremental benefit of adding CFAE ablation to PVI. METHODS:: We performed a meta-analysis of controlled studies comparing the effect of PVI with CFAE ablation versus PVI alone in patients with paroxysmal and nonparoxysmal AF. RESULTS:: Of the 481 reports identified, 8 studies met our inclusion criteria. There was a statistically significant increase in freedom from atrial tachyarrhythmia (AT) with the addition of CFAE ablation (RR 1.15, p=0.03). In the 5 reports of nonparoxsymal AF (3 randomized controlled trials, one controlled clinical trial, and one trial using matched historical controls), addition of CFAE ablation resulted in a statistically significant increase in freedom from AT (n=112/181 [62%] for PVI+CFAE versus n=84/179 [47%] for PVI alone; RR 1.32, p=0.02). In trials of paroxysmal AF (3 randomized controlled trials and one trial using matched historical controls), addition of CFAE ablation did not result in a statistically significant increase in freedom from AT (n=131/166 [79%] for PVI+CFAE versus n=122/164 [74%] for PVI alone; RR 1.04, p=0.52). CONCLUSIONS:: In these studies of patients with nonparoxysmal AF, addition of CFAE ablation to PVI results in greater improvement in freedom from AF. No additional benefit of this combined approach was observed in patients with paroxysmal AF.
Low levels of statin adherence have been documented in patients with coronary artery disease (CAD), but whether coronary revascularization is associated with improved adherence rates has yet to be evaluated. We identified all Medicare beneficiaries enrolled in 2 statewide pharmacy assistance programs who were >/=65 years old, who had been hospitalized for CAD from 1995 through 2004, and who had been prescribed statin therapy within 90 days of discharge (n = 13,130). Statin adherence was measured based on the proportion of days covered with statin therapy after hospital discharge, and full adherence was defined as proportion of days covered >/=80%. Statin adherence was compared in patients with CAD treated with medical therapy (n = 3,714), percutaneous coronary intervention (n = 6,309), or coronary artery bypass graft surgery (n = 3,107). Statin adherence significantly increased over the period of the study from 70.5% to 75.4% (p <0.0001). After hospitalization for CAD, patients treated with percutaneous coronary intervention and coronary artery bypass graft surgery had full adherence rates of 70.6% and 70.2%, respectively. Full adherence rates were significantly lower for patients treated with coronary revascularization compared to patients treated with medical therapy (79.4%, p <0.0001). Independent predictors of higher statin adherence included treatment with medical therapy, later year of hospital admission, white race, previous statin use, and use of other cardiac medications after CAD hospitalization (p <0.01 for all comparisons). In conclusion, in patients receiving invasive coronary treatment, statin adherence remains suboptimal, despite strong evidence supporting their use. Given the health and economic consequences of nonadherence, these findings highlight the need for developing cost-effective strategies to improve medication adherence after coronary revascularization.
BACKGROUND: All US states have adopted generic substitution laws to reduce medication costs. However, physicians may override these regulations by prescribing branded drugs and requesting that they are dispensed as written. Patients also can make these requests. Little is known about the frequency and correlates of dispense as written requests or their association with medication filling. METHODS: We identified beneficiaries of a large pharmacy benefits manager who submitted a prescription claim from any pharmacy in January 2009. We categorized claims as a physician-assigned dispense as written, patient-assigned dispense as written, or no dispense as written. We described rates of these requests and used generalized estimating equations to evaluate physician, patient, treatment, and pharmacy characteristics associated with dispense as written requests. We also used generalized estimating equations to assess the relationship between dispense as written designation and rates prescriptions are not filled by patients. RESULTS: Our sample included 5.6 million prescriptions for more than 2 million patients. More than 2.7% were designated as dispense as written by physicians, and 2.0% were designated as dispense as written by patients. Substantial variation in dispense as written requests were seen by medication class, patient and physician age, and geographic region. The odds of requesting dispense as written was 78.5% greater for specialists than generalists (P<;.001). When chronic prescriptions were initiated, physician dispense as written (odds ratio 1.50, P<;.001) and patient dispense as written (odds ratio 1.60, P<;.001) were associated with greater odds that patients did not fill the prescription. CONCLUSION: Dispense as written requests were common and associated with decreased rates of prescription filling. Options to reduce rates of dispense as written requests may reduce costs and improve medication adherence.
BACKGROUND: Several disease-specific information exchanges now exist on Facebook and other online social networking sites. These new sources of knowledge, support, and engagement have become important for patients living with chronic disease, yet the quality and content of the information provided in these digital arenas are poorly understood. OBJECTIVE: To qualitatively evaluate the content of communication in Facebook communities dedicated to diabetes. DESIGN: We identified the 15 largest Facebook groups focused on diabetes management. For each group, we downloaded the 15 most recent "wall posts" and the 15 most recent discussion topics from the 10 largest groups. PATIENTS: Four hundred eighty unique users were identified in a series of 690 comments from wall posts and discussion topics. MAIN MEASURES: Posts were abstracted and aggregated into a database. Two investigators evaluated the posts, developed a thematic coding scheme, and applied codes to the data. KEY RESULTS: Patients with diabetes, family members, and their friends use Facebook to share personal clinical information, to request disease-specific guidance and feedback, and to receive emotional support. Approximately two-thirds of posts included unsolicited sharing of diabetes management strategies, over 13% of posts provided specific feedback to information requested by other users, and almost 29% of posts featured an effort by the poster to provide emotional support to others as members of a community. Approximately 27% of posts featured some type of promotional activity, generally presented as testimonials advertising non-FDA approved, "natural" products. Clinically inaccurate recommendations were infrequent, but were usually associated with promotion of a specific product or service. Thirteen percent of posts contained requests for personal information from Facebook participants. CONCLUSIONS: Facebook provides a forum for reporting personal experiences, asking questions, and receiving direct feedback for people living with diabetes. However, promotional activity and personal data collection are also common, with no accountability or checks for authenticity.