Primary Care Physicians', Psychiatrists', and Oncologists' Coordination While Prescribing Medications for Patients With Multiple Chronic Conditions.

OBJECTIVES: Coordination of medication prescribing is important in the care of patients with multiple chronic conditions (MCC) given the involvement of multiple providers and multiple medications used to manage MCC. The objective of this study was to identify physician and practice factors associated with physicians' coordination of prescribing for complex patients with MCC. METHODS: Our cross-sectional study used a 33-item anonymous, online survey to assess physicians' coordination practices while prescribing for patients with MCC. We sampled primary care physicians (PCPs), psychiatrists, and oncologists across the United States. Coordination of medication prescribing was measured on a 7-point Likert-type scale. χ2, Fisher exact test, and binomial logistic regression, adjusted for factors and covariates, were used to determine differences in coordination of prescribing. Average marginal effects were calculated for factors. RESULTS: A total of 50 PCPs, 50 psychiatrists, and 50 oncologists participated. Most psychiatrists (56%) and oncologists (52%) reported frequently coordinating prescribing with other physicians, whereas less than half of the PCPs (42%) reported frequently coordinating prescribing. Female physicians were 25% points more likely to report coordinating prescribing than male physicians (P = 0.0186), and physicians not using electronic medical records were 30% points more likely to report coordinating prescribing than physicians using electronic medical records (P = 0.0230). Four additional factors were associated with lower likelihood of coordinating prescribing. CONCLUSIONS: Physician and practice factors may influence differences in coordination of medication prescribing, despite physician specialty. These factors can provide a foundation for developing interventions to improve coordination of prescribing practices for MCC.

The impact of cognitive impairment on survival and medication adherence among older women with breast cancer.

INTRODUCTION: The purpose of this study was to examine the impact of preexisting cognitive impairments on survival and medication adherence, and whether chronic medication adherence mediates or moderates the association between cognitive impairments and mortality in patients with breast cancer. METHODS: This retrospective cohort study of older female patients diagnosed with breast cancer was conducted using the Surveillance, Epidemiology, and End Results Medicare Linked Database. We examined the risk of mortality from cancer and non-cancer causes in patients with and without a history of cognitive impairment. In addition, we examined if chronic medication adherence rates differ between these groups of patients and if medication adherence mediates or moderates the association between cognitive impairments and non-cancer mortality. RESULTS: Mortality from cancer-specific (HR 1.13, 95% CI 1.04-1.23) and non-cancer causes (HR 1.16, 95% CI 1.11-1.21) as well as all-cause mortality (HR 1.30, 95% CI 1.23-1.38) was significantly higher in patients with cognitive impairments compared to those without cognitive impairment. Both groups showed low adherence levels to chronic medication before and after the breast cancer diagnosis. Further analysis did not show that medication adherence mediates or moderates the relationship between cognitive impairment and non-cancer mortality (p value > 0.05). CONCLUSION: The results of this study indicate that older female patients with cognitive impairments and a breast cancer diagnosis have a heightened risk of cancer-specific and non-cancer mortality. Our findings do not indicate that chronic medication adherence plays a role in the association between a history of cognitive impairment and mortality, it is still necessary to further investigate this issue.

Patient and caregiver opinions about an FDA-developed generic drug educational handout: A pilot cross-sectional survey.

OBJECTIVE: To examine patient and caregiver opinions and "receptivity" regarding generic drug educational material in terms of content, format and design, delivery channel, and level of satisfaction. METHODS: Interviewer-administered surveys were conducted with patients and caregivers who were clients of a regional medication management program or pharmacy services clinic to gather perceptions about generic drugs and input on a generic drug educational handout developed by the U.S. Food and Drug Administration (FDA). Survey questions were developed by the investigators and pretested before use. Data were analyzed using descriptive statistics, and responses to open-ended questions were assessed using qualitative content analysis. Survey psychometrics were examined using exploratory factor analysis (EFA). RESULTS: Of the 100 survey participants, most (93%) had positive perceptions about generic drug safety and effectiveness after reading the handout. Most participants were satisfied or very satisfied with the handout's content (87%) as well as format and design (92%). However, more than 20% of participants were still unsure about the benefits and risks of generic drugs compared with those of brand drugs, and more than 15% were still unsure about which benefits and risks mattered most to them. The participants' preferred source for the handout was a pharmacy (49%) or doctor's office (27%). In an EFA of the survey instrument, 2 factors emerged related to the educational handout's content: (1) generic drug information, a 7-item factor (Cronbach alpha = 0.882); and (2) personal relevance, a 3-item factor (Cronbach alpha = 0.692). CONCLUSION: The findings indicate an overall positive "receptiveness" toward generic drug informational materials from patients and caregivers, which highlights the feasibility and importance of educational outreach programs about generic drugs targeted toward this population. Future studies may focus on more diverse populations and tailor materials to the needs of specific patient and caregiver subgroups and health literacy levels.

The association between antidepressants use and development of cognitive impairment among older women diagnosed with breast cancer.

PURPOSE: This study aimed to evaluate the association between the development of cognitive impairment and the use of antidepressants among older women with breast cancer. METHODS: This retrospective cohort study used the United States National Cancer Institute's Surveillance, Epidemiology, and End Results-Medicare database to identify women who were 67 years old and older and had breast cancer between 2008 and 2013. Propensity scoring was used to account for confounding pre-treatment factors, and Cox proportional hazards modeling was used to examine the risk of developing cognitive impairment among patients based on whether they used antidepressants. RESULTS: A total of 3174 women taking antidepressants (mean age 75.2 ± 6.4) were matched with 3174 women not taking antidepressants (mean age 75.4 ± 6.7). Antidepressant use was associated with a significantly increased risk of cognitive impairment (hazard ratio [HR]: 1.33, 95%; confidence interval [CI]: 1.18-1.48). Additionally, we found that older women without a history of depression or anxiety who use antidepressants have a higher risk of developing cognitive impairment than those who did not use antidepressants (HR: 1.53, 95%; CI: 1.34-1.75 and HR: 1.39, 95%; CI: 1.23-1.56, respectively). Subgroup analysis showed that the use of non-tricyclic antidepressants (TCAs) was associated with a higher risk of cognitive impairment. CONCLUSION: We found that non-TCA antidepressant use in older women with breast cancer was associated with a higher risk of cognitive impairment. This association was also observed among older women without depression or anxiety who used antidepressants.

Comparison of 3 risk factor-based screening tools for the identification of prediabetes.

OBJECTIVE: To compare risk factor-based screening tools for identifying prediabetes. METHODS: Participants in an employer-based wellness program were tested for glycosylated hemoglobin (A1C) at a regularly scheduled appointment, and prediabetes risk factor information was collected. The likelihood of having prediabetes and the need for laboratory testing were determined based on 3 risk factor-based screening tools: the Prediabetes Screening Test (PST), Prediabetes Risk Test (PRT), and 2016 American Diabetes Association guidelines (ADA2016). The results from the screening tools were compared with those of the A1C test. The predictive ability of the PST, PRT, and ADA2016 were compared using logistic regression. Results were validated with data from a secondary population. RESULTS: Of the 3 risk factor-based tools examined, the PRT demonstrated the best combination of sensitivity and specificity for identifying prediabetes. From July 2016 to March 2017, 740 beneficiaries of an employer-sponsored wellness program had their A1C tested and provided risk factor information. The population prevalence of prediabetes was 9.3%. Analysis of a second independent population with a prediabetes prevalence of more than 50% of confirmed PRT's superiority despite differences in the calculated sensitivity and specificity for each population. CONCLUSION: Because PRT predicts prediabetes better than PST or ADA2016, it should be used preferentially.

Healthcare provider opinions about a generic drug educational newsletter.

BACKGROUND: Increasing the prescribing and dispensing of generic drugs, compared to branded drugs, may increase patient access to affordable drug treatments. Healthcare providers have information needs regarding generic drugs, but available, tailored education materials designed for provider use are lacking. OBJECTIVES: To examine healthcare provider opinions and receptivity regarding generic drug educational materials in content, format and design, delivery channel, and level of satisfaction. METHODS: A national online survey was conducted in summer 2018 to gather practicing healthcare prescribers' (i.e., physicians, nurse practitioners, physician assistants) and pharmacists' opinions on an educational newsletter developed through a collaboration between the investigators and the U.S. Food and Drug Administration (FDA). Survey data were analyzed using descriptive statistics. Quantitative analyses were performed using SPSS version 24 (IBM, Armonk, NY), while responses to open-ended questions were assessed using qualitative content analysis in Excel. RESULTS: A total of 208 surveys were completed. Overall, participants expressed positive opinions about the newsletter's content and format/design. About 69% of prescribers and 60% of pharmacists stated the newsletter gave information that will help them better serve patients. While 15% of surveyed pharmacists stated that they did not have resources to help them get information on generic drug availability and cost, more prescribers (37%) responded similarly. Both prescribers and pharmacists preferred to receive this newsletter via email from the FDA or a professional association. CONCLUSIONS: Findings indicate the feasibility of educational outreach programs about generic drugs targeted towards healthcare providers. There is room for improvement in making prescribers and pharmacists aware of resources for learning about generic drug availability and cost. Future studies may test alternate versions of the newsletter that have been tailored to the needs of specific provider specialties or provider practices serving specific patient sub-groups, as well as preferred dissemination frequency.

How comfortable are primary care physicians and oncologists prescribing medications for comorbidities in patients with cancer?

BACKGROUND: Treating cancer and existing chronic comorbidities requires a dynamic mix of primary care and specialist providers. However, little is known regarding primary care physicians' (PCPs) and oncologists' comfort level prescribing for comorbid conditions. OBJECTIVES: The objectives of this study were to describe oncologists' and PCPs': 1) comfort-level prescribing, 2) perceptions of providers' role in prescribing cardiometabolic and psychiatric medications in persons with cancer and comorbidity, and 3) provider factors associated with comfort-levels. METHODS: This cross-sectional online survey examined responses from practicing U.S. PCPs and oncologists. A 33-question survey was used to assess PCPs' and oncologists' comfort-levels for prescribing 6 classes of medications used to treat common comorbid cardiometabolic or psychiatric conditions. Using t-tests, chi-square tests, or Fisher's Exact tests, physicians' own comfort and comfort with other physicians prescribing medications for shared patients were compared between PCPs and oncologists. Linear regression models were used to analyze predictors of comfort-level scale score for prescribing medications. RESULTS: Oncologists were more comfortable with PCPs initiating or refilling antidiabetics, antihyperlipidemics, antidepressants, and antipsychotics, and PCPs were more comfortable initiating antihypertensives, antidiabetics, antihyperlipidemics, antidepressants, and antipsychotics themselves as opposed to having an oncologist initiate or refill these medications. Compared to oncologists, PCPs reported a 32.3% higher comfort-level for initiating cardiometabolic medications (Adjusted Coefficient (standard error) = 0.323 (0.033), p < 0.001), and a 25.0% higher comfort-level for initiating psychiatric medications in cancer patients (Adjusted Coefficient (standard error) = 0.250 (0.030), p < 0.001), after controlling for prescriber demographics and practice site characteristics. CONCLUSIONS: Findings suggest that when a cancer diagnosis is made for patients with pre-existing cardiometabolic or psychiatric conditions, oncologists prefer PCPs to manage these medications. This enhanced understanding of PCPs' and oncologists' comfort managing these medications may help develop a standard for defining physician roles in medication therapy as part of a shared care plan for patients with cancer and comorbidities.

Communicating benefits and risks of generic drugs to consumers: Patient and caregiver opinions of two FDA-developed educational materials.

BACKGROUND: Increasing prescribing and dispensing of generic drugs, compared to brand drugs, may increase patient access to affordable medications. However, little is known about patients' and caregivers' needs and receptiveness regarding the design of educational materials about generic drugs. METHODS: The research used focus groups of patients and caregivers who were students or employees of one university in the Southeastern U.S. to gather input on the optimal content, format and design, delivery channel, and level of satisfaction for two existing, FDA-developed educational materials about generic drugs (infographic and brochure). RESULTS: Participants stated a need for the materials to modernize their graphics, emphasize generic drug cost-savings for consumers, reduce scare tactics when discussing adverse events, and be disseminated directly from physician's offices and pharmacies. Despite an overall positive impression of the materials, participants wanted more consumer-oriented materials that were tailored to fit the needs of different types of patients/caregivers, including older adults. CONCLUSIONS: This paper discusses how these findings relate to theories of multimedia learning and guidelines for designing health educational materials, as well as implications for the development of tailored generic drug educational materials for use in public health campaigns to improve access to medication therapy.

Serious Adverse Drug Events Reported to the FDA: Analysis of the FDA Adverse Event Reporting System 2006-2014 Database.

BACKGROUND: Data on adverse drug events (ADEs) observed at the population level provide important evidence regarding the safety of a pharmaceutical product in real-world settings. Recent patterns in serious and fatal ADE reporting have not been documented. OBJECTIVE: To assess recent patterns in serious and fatal ADE reports in the United States. METHODS: We conducted a retrospective analysis of the publicly available 2006-2014 FDA Adverse Event Reporting System database. Non-U.S. reports, reports from clinical trials, and reports with missing outcome data were excluded. The annual numbers of ADEs with reported outcome of death, disability, and other serious outcomes were determined. Types (direct, manufacturer expedited, or manufacturer periodic) and sources (consumer, health professional, or other) of these serious ADE reports were also identified. The distribution of serious ADE reports by patient age groups (< 18, 18-44, 45-64, and ≥ 65 years) was determined. Drugs listed as primary suspects in serious ADEs (death, disability, and other serious outcomes) were identified and ranked. Descriptive statistics were used to characterize the patterns in serious or fatal ADE reporting. RESULTS: From 2006 to 2014, the number of serious ADEs reported to the FDA increased 2-fold. A total of 902,323 serious outcomes were reported over the 9-year study period: 244,408 deaths, 72,141 disabilities, and 585,774 other serious outcomes. The relative percentage of reports of deaths was highest during 2012 (32.4%). The percentage of reports of disability was highest during 2006 (12.1%). Overall, the "other serious outcomes" category accounted for almost 65% of serious ADEs reports. Expedited reports from drug manufacturers were most common (about 72%) of the serious ADEs with available data on report type. Health professionals (47.3%) were the most common source of report followed by consumers (36.1%) and other sources (16.6%). A disproportionately high number of reported ADEs was among patients aged 45-64 years (40%) and ≥ 65 years (32.6%). Antineoplastic drugs were more frequently reported with deaths. Three antidepressant drugs were among the top 10 drugs reported with disability. During 2006-2014, there were 38 drugs with more than 1,000 reports of serious ADEs in a given year: 2 drugs currently withdrawn from the market (rofecoxib and parecoxib), 10 drugs with an FDA risk evaluation and mitigation strategies (REMS) program, 13 biologic or specialty drugs, and 14 others. CONCLUSIONS: An overall increase in the trend of the number of serious ADE reports was observed from 2006 to 2014. Drugs with a REMS program and biologic and specialty drugs were involved in a significant number of reported serious ADEs. Data on reporting patterns can guide surveillance and pharmacoepidemiological studies to understand the public health burden of serious ADEs. DISCLOSURES: No outside funding supported this study. Hansen has received consulting fees from and has provided expert testimony for Daichii Sankyo and Takeda. The other authors have nothing to disclose.

Trends in botanical dietary supplement use among US adults by cancer status: The National Health and Nutrition Examination Survey, 1999 to 2014.

BACKGROUND: Patients with cancer may use botanical dietary supplements (BDS) in an attempt to manage the side effects of chemotherapy, yet evidence about BDS use among patients with cancer is limited. The authors examined trends in BDS use among US adults according to cancer status and patient characteristics. METHODS: A serial, cross-sectional study was conducted using data from the National Health and Nutrition Examination Survey from 1999 through 2014 (n = 43,644). Self-reported cancer diagnosis history and any BDS use in the preceding 30 days were determined. The prevalence of BDS use was calculated in each cycle for respondents with and without cancer, both overall and by patient characteristics. Simple linear regression models were applied to test for trends in BDS use at a 2-sided P value < .05. Multiple logistic regression models were performed to identify the patient factors associated with BDS use. The results were weighted to represent national estimates. RESULTS: The prevalence of BDS use was greater among participants who had cancer compared with participants who did not have cancer, but trends remained stable during 1999 through 2014 for both groups. Trends in BDS use declined in patients with cancer who were older (Ptrend = .047), had a low annual family income (Ptrend = .028), and had a lower education level (Ptrend = .004). Among the respondents without cancer, trends in BDS use declined in those who were middle-aged (Ptrend = .025), non-Hispanic whites (Ptrend = .025), those with a lower education level (Ptrend = .011), and those who were not receiving prescription medication (Ptrend = .036). Patient age, sex, race/ethnicity, income, education, and health conditions were associated with BDS use. CONCLUSIONS: The overall use of BDS remained stable during 1999 through 2014 for US adults with and without cancer, but it varied by individual characteristics. Cancer 2018;124:1207-15. © 2017 American Cancer Society.

Prevention of Trastuzumab and Anthracycline-induced Cardiotoxicity Using Angiotensin-converting Enzyme Inhibitors or ß-blockers in Older Adults With Breast Cancer.

PURPOSE: Although clinical trials have provided some data on the benefit of angiotensin-converting enzyme inhibitors (ACEIs) or ß-blockers (BBs) in patients with chemotherapy-induced cardiotoxicity, evidence of ACEIs/BBs on prevention of trastuzumab and/or anthracycline-induced cardiotoxicity outside trials is limited. MATERIALS AND METHODS: A cohort study of 142,990 women (66 y and above) newly diagnosed with breast cancer from 2001 to 2009 was conducted using the Surveillance, Epidemiology, and End Results-Medicare-linked database. The ACEI/BB exposure was defined as filled prescription(s) before or after the initiation of trastuzumab/anthracyclines. The nonexposed group was defined as those who had never been prescribed ACEIs/BBs. Cumulative rates of cardiotoxicity and all-cause mortality were estimated and marginal structural Cox models were used to determine factors associated with cardiotoxicity and all-cause mortality adjusting for baseline covariates and use of chemotherapy. All statistical tests were 2 sided. RESULTS: The final sample included 6542 women. Adjusted hazard ratio for cardiotoxicity and all-cause mortality for the ACEI/BB exposed group were 0.77 (95% confidence interval, 0.62-0.95) and 0.79 (95% confidence interval, 0.70-0.90) compared with the nonexposed group, respectively. Starting ACEIs/BBs≤6 months after the initiation of trastuzumab/anthracyclines and having exposed duration≥6 months were also associated with decreased risk of cardiotoxicity and all-cause mortality. Baseline characteristics, including age, non-Hispanic black, advanced cancer, region, comorbidity, preexisting cardiovascular conditions, lower socioeconomic status, and concomitant treatment were significantly associated with an elevated risk of all-cause mortality and/or cardiotoxicity (all P<0.05). CONCLUSIONS: ACEIs/BBs show favorable effects on preventing cardiotoxicity and improving survival in female breast cancer patients undergoing trastuzumab/anthracycline treatment.

Cardiotoxicity in targeted therapy for breast cancer: A study of the FDA adverse event reporting system (FAERS).

Purpose Cancer chemotherapy-induced cardiotoxicity is concerning. Certain anthracyclines and targeted therapies are known to have potential for cardiotoxicity, but existing trial evidence is inadequate to understand real-world patterns of cardiotoxicity with newer targeted therapies and their common combinations with older agents. This study evaluated chemotherapy-related cardiotoxicity reports for targeted therapies and their combinations in breast cancer patients. Methods The US Food and Drug Administration Adverse Event Reporting System (FAERS) database from January 2004 through September 2012 was used to summarize characteristics of reported cardiotoxicity events and their health outcomes. Disproportionality analyses with reporting odds ratios (ROR) and 95% confidence intervals (95% CI) were conducted to detect event signals using a case/non-case method for each targeted therapy and combination. Results A total of 59,739 cases of cardiotoxicity reports were identified; 937 cases identified targeted therapy as the suspect drug. Trastuzumab had the highest number of reports followed by bevacizumab and lapatinib. Proportions of reports of death and disability outcomes for each targeted therapy were approximately 20-25% of the total reports of serious events. Trastuzumab had the highest ROR as a single agent (ROR = 5.74; 95% CI = 5.29-6.23) or combination use of cyclophosphamide (ROR = 16.83; 95% CI = 13.32-21.26) or doxorubicin (ROR = 17.84; 95% CI = 13.77-23.11). Relatively low cardiotoxicity reporting rates were found with lapatinib, regardless of use with combination therapy. Conclusions Analysis of FAERS data identified signals for adverse cardiotoxicity events with targeted therapies and their combinations. Practitioners should consider factors that may increase the likelihood of cardiotoxicity when assessing treatment. Findings support continued surveillance, risk factor identification, and comparative studies.

The association between regular use of aspirin and the prevalence of prostate cancer: Results from the National Health Interview Survey.

Prostate cancer is prevalent with significant morbidity in the United States. Aspirin previously has been found to be associated with reduced carcinogenesis of prostate cells. However, it remains unclear whether regularly taking aspirin could lower the risk of prostate cancer. Therefore, our aim was to examine the association between self-reported regular use of aspirin and the prevalence of prostate cancer in a national sample of the US adult population.The National Health Interview Survey is an annual survey conducted by the National Center for Health Statistics to investigate health and healthcare use of the US population. The current study is a population-based cross-sectional study using the 2010 National Health Interview Survey data. Adult male respondents who self-reported regularly taking aspirin at least 3 times per week were grouped as regular users. The prostate cancer prevalence was measured by respondents' self-report of prostate cancer. Multivariable logistic regression models were used to evaluate the association between these 2 factors by adjusting for covariates selected based on Andersen Behavioral Model of Health Services Use.An estimated 23 million (23.7%) males in the United States reported that they took aspirin regularly. Of them, 5.0% had prostate cancer. Regular aspirin use was significantly associated with a lower self-reported prevalence of prostate cancer after adjusting for predisposing, enabling, and need factors (odds ratio 0.60, 95% confidence interval 0.38-0.94).Regular aspirin use was found to be significantly associated with a lower self-reported prevalence of prostate cancer in the United States in 2010. Further clinical trials and longitudinal studies are needed to confirm the causality between regular aspirin use and prostate cancer.

Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review.

OBJECTIVE: To systematically compare the risk of adverse events (AEs) for 13 targeted immunomodulators (TIMs) indicated for ankylosing spondylitis (AS), inflammatory bowel diseases, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis (PsA), or rheumatoid arthritis (RA). METHODS: We searched electronic databases through July 2015 to retrieve randomized controlled trials (RCTs) and observational studies comparing AEs between 2 or more TIMs head-to-head. We reported on the following outcomes: number of AEs, discontinuation due to AEs, serious AEs, mortality, serious infections, tuberculosis, herpes zoster, and malignancies. We qualitatively synthesized the literature and conducted random-effects meta-analyses if 3 or more studies provided data for an outcome. RESULTS: Ten head-to-head RCTs and 51 observational studies were included in this systematic review. A majority of the studies (70%) were conducted in RA patients. Risk of treatment discontinuation due to AEs was higher with infliximab than with adalimumab or etanercept in RA, PsA, and AS. A higher risk for serious infections was noted with infliximab than with abatacept, adalimumab, or etanercept in RA. Risk for treatment discontinuation due to AEs, serious infections, and tuberculosis was lower with etanercept than with adalimumab in RA. Limited evidence suggested no comparative differences in risk for mortality, malignancies, and herpes zoster for adalimumab, etanercept, and infliximab in RA. CONCLUSION: Important differences were noted in the safety profile of TIMs in RA, generally favoring abatacept, adalimumab, and etanercept over infliximab. Head-to-head comparative evidence for other TIMs and non-RA populations was insufficient to draw conclusions for most of the safety outcomes.

Prescriber continuity and medication adherence for complex patients.

BACKGROUND: Medication adherence is a critical aspect of managing cardiometabolic conditions, including diabetes, hypertension, dyslipidemia, and heart failure. Patients who have multiple cardiometabolic conditions and multiple prescribers may be at increased risk for nonadherence. OBJECTIVE: The purpose of this study was to examine the relationship between number of prescribers, number of conditions, and refill adherence to oral medications to treat cardiometabolic conditions. METHODS: In this retrospective cohort study, 7933 veterans were identified with 1 to 4 cardiometabolic conditions. Refill adherence to oral medications for diabetes, hypertension, and dyslipidemia was measured using an administrative claims-based continuous multiple-interval gap (CMG) that estimates the percentage of days a patient did not possess medication. We dichotomized refill adherence for each condition as a CMG ≤20% for each year of analysis. Condition-specific logistic regression models estimated the relationship between refill adherence and number of cardiometabolic conditions and number of prescribers, controlling for demographic characteristics, other comorbidities, and a count of cardiometabolic drug classes used. RESULTS: Compared with patients with 1 prescriber, antihypertensive refill adherence was lower in patients seeing ≥4 prescribers (odds ratio [OR] = 0.69; 95% CI = 0.59-0.80), but the number of cardiometabolic conditions was not a significant predictor. Antidyslipidemia refill adherence was lower in patients seeing 3 prescribers (OR = 0.80; 95% CI = 0.70-0.92) or ≥4 prescribers (OR = 0.77; 95% CI = 0.64-0.91). Conversely, antidyslipidemia refill adherence improved with the number of cardiometabolic conditions, but differences were only statistically significant for ≥3 conditions (OR = 1.31; 95% CI = 1.09-1.57). In multivariate regression models, the number of conditions and number of prescribers were not significant predictors of refill adherence in the group of patients with diabetes. CONCLUSIONS: Effective management of care and medication regimens for complex patients remains an unresolved challenge, but these results suggest that medication refill adherence might be improved by minimizing the number of prescribers involved in a patient's care, at least for hypertension and dyslipidemia.

Treatment patterns among breast cancer patients in the United States using two national surveys on visits to physicians' offices and hospital outpatient departments.

BACKGROUND: Despite the availability of previous studies, little research has examined how types of anti-neoplastic agents prescribed differ among various populations and health care characteristics in ambulatory settings, which is a primary method of providing care in the U.S. Understanding treatment patterns can help identify possible disparities and guide practice or policy change. OBJECTIVES: To characterize patterns of anti-neoplastic agents prescribed to breast cancer patients in ambulatory settings and identify factors associated with receipt of treatment. METHODS: A cross-sectional analysis using the National Ambulatory Medical Care Survey data in 2006-2010 was conducted. Breast cancer treatments were categorized by class and further grouped as chemotherapy, hormone, and targeted therapy. A visit-level descriptive analysis using visit sampling weights estimated national prescribing trends (n = 2746 breast cancer visits, weighted n = 28,920,657). Multiple logistic regression analyses identified factors associated with anti-neoplastic agent used. RESULTS: The proportion of visits in which anti-neoplastic agent(s) was/were documented remained stable from 2006 to 2010 (20.47% vs. 24.56%; P > 0.05). Hormones were commonly prescribed (29.69%) followed by mitotic inhibitors (9.86%) and human epidermal growth factor receptor2 inhibitors (5.34%). Patients with distant stage were more likely than patients with in-situ stage to receive treatment (Adjusted Odds Ratio [OR] = 2.79; 95% CI, 1.04-7.77), particularly chemotherapy and targeted therapy. Patients with older age, being ethnic minorities, having comorbid depression, and having U.S. Medicaid insurance were less likely to receive targeted therapy (P < 0.05). Patients with older age, having comorbid obesity and osteoporosis were less likely to receive chemotherapy, while patients seen in hospital-based settings and settings located in metropolitan areas were more likely to receive chemotherapy (P < 0.05). CONCLUSIONS: Anti-neoplastic treatment patterns differ among breast cancer patients treated in ambulatory settings. Factors predicting treatment include certain socio-demographics, cancer stages, comorbidities, metropolitan areas, and setting.

Predictors of treatment initiation with tumor necrosis factor-α inhibitors in patients with rheumatoid arthritis.

BACKGROUND: Introduction of biologic disease-modifying antirheumatic drugs (DMARDs) has revolutionized treatment in patients with rheumatoid arthritis (RA). However, due to substantially higher costs of biologics compared with nonbiologics, patients with less insurance generosity may have difficulty affording these agents, which may lead to potential access disparities. OBJECTIVE: To identify factors affecting treatment initiation with tumor necrosis factor (TNF)-α inhibitor biologics in patients with RA. METHODS: Health insurance claims data derived from Truven's MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits (2007-2010) were used to conduct a retrospective cohort study. Two separate cohorts of RA patients were identified: (1) monotherapy nonbiologic DMARD users and (2) combination therapy nonbiologic DMARD users. The primary outcome was TNF-α inhibitor initiation 12 months following an index inpatient or outpatient RA visit during 2008-2009. Predictors were measured 12 months pre-index and grouped into predisposing, enabling, or need factors based on Andersen's Behavior Model. Predisposing variables included age, sex, and geographic location; enabling variables included insurance-related factors such as capitation, payer type, and insurance generosity, which was defined using cost-sharing information from prescriptions filled by the patients in the previous year; and need variables included disease-related factors such as severity of RA, use of pain control medications, and presence of other comorbidities. Hierarchical logistic regression models were used to derive estimates of the impact of individual predictors. RESULTS: Initiation of TNF-α inhibitors was observed in 10.31% of the monotherapy nonbiologic DMARD users (1,922 of 18,641) and 13.09% of combination nonbiologic DMARD users (983 of 7,508). Among monotherapy nonbiologic DMARD users, initiation with TNF-α inhibitors was associated with the predisposing factors of age (OR = 0.98, 95% CI = 0.97-0.98 for each year increase) and geographic region (Midwest vs. South OR = 0.83, 95% CI = 0.73-0.93; Northeast vs. South OR = 0.77, 95% CI = 0.64-0.92; and West vs. South OR = 0.86, 95% CI = 0.74-0.99); enabling factors of visit to rheumatologists (1 visit vs. no visit OR = 1.22, 95% CI = 1.01-1.46), health insurance type (commercial vs. Medicare supplemental OR = 0.79, 95% CI = 0.66-0.95), and drug benefit generosity (above average vs. poor OR = 1.16, 95% CI = 1.01-1.34 and most generous vs. poor OR = 1.21, 95% CI = 1.05-1.40); and need factors of RA severity (OR = 1.19, 95% CI = 1.14-1.23 for each unit increase in a claims-based RA severity index [CIRAS]), pre-index pain reliever use (steroids OR = 1.81, 95% CI = 1.62-2.02; nonselective nonsteroidal anti-inflammatory drugs [NSAID] OR = 1.17, 95% CI = 1.05-1.31; COX-2 inhibitors OR = 1.22, 95% CI = 1.05-1.41), and comorbidities (OR = 0.94, 95% CI = 0.90-0.99 for each unit increase in a comorbidity index). Treatment initiation with TNF-α inhibitors among patients with combination therapy nonbiologic DMARDs use at baseline was associated with age (OR = 0.98, 95% CI = 0.97-0.99 for each year increase) and region (Midwest vs. South OR = 0.81, 95% CI = 0.68-0.96). Stronger associations with some of the need factors were observed (CIRAS OR = 1.28, 95% CI = 1.21-1.35 for each unit increase, steroids use OR = 2.05, 95% CI = 1.73-2.42, and nonselective NSAID use OR = 1.36, 95% CI = 1.17-1.58) in these patients compared with the monotherapy nonbiologic DMARD users. However, unlike the monotherapy DMARD user group, the enabling factors of health insurance type and drug benefit generosity were not found to be associated with TNF-α inhibitor initiation among nonbiologic DMARD combination therapy users. CONCLUSIONS: Potential disparities in the initiation of TNF-α inhibitors among RA patients on monotherapy DMARDs at baseline were noted among older patients, patients in certain geographic region of the United States, and patients with less generous prescription drug benefits. Although future research should examine the impact of these disparities on health outcomes, payers should be aware of the potential for undertreatment among these groups of RA patients when making formulary decisions.

Tumor necrosis factor-α inhibitor treatment and the risk of incident cardiovascular events in patients with early rheumatoid arthritis: a nested case-control study.

OBJECTIVE: To compare the risk of cardiovascular (CV) events between use of tumor necrosis factor-α inhibitors (TNFi) and nonbiologic disease-modifying antirheumatic drugs (DMARD) in patients with early rheumatoid arthritis (RA). METHODS: A nested case-control study was conducted using data from Truven's MarketScan commercial and Medicare claims database for patients with early RA who started treatment with either a TNFi or a nonbiologic DMARD between January 1, 2008, and December 31, 2010. Date of CV event diagnosis for cases was defined as the event date, and 12 age-matched and sex-matched controls were sampled using incidence density sampling. Drug exposure was defined into the following mutually exclusive categories hierarchically: (1) current use of TNFi (with or without nonbiologics), (2) past use of TNFi (with or without nonbiologics), (3) current use of nonbiologics only, and (4) past use of nonbiologics only. Current use was defined as any use in the period 90 days prior to the event date. Conditional logistic regression models were used to derive incidence rate ratios (IRR). RESULTS: From the cohort of patients with early RA, 279 cases of incident CV events and 3348 matched controls were identified. The adjusted risk of CV events was not significantly different between current TNFi users and current nonbiologic users (IRR 0.92, 95% CI 0.59-1.44). However, past users of nonbiologics showed significantly higher risk compared to current nonbiologic users (IRR 1.47, 95% CI 1.04-2.08). CONCLUSION: No differences in the CV risk were found between current TNFi and current nonbiologic DMARD treatment in patients with early RA.

Statins are associated with reduced use of steroids in inflammatory bowel disease: a retrospective cohort study.

BACKGROUND: Statin medications have antiinflammatory effects. We sought to determine whether statin use in persons with inflammatory bowel disease (IBD) was associated with reduced rates of steroid use or other markers of disease activity. METHODS: We performed a retrospective cohort study using administrative data. Statin users with IBD were compared to statin-unexposed IBD subjects. The primary outcome was an oral steroid prescription; secondary outcomes included anti-tumor necrosis factor (TNF) initiation, hospitalization, or abdominal surgery. Cox proportional hazard models were used to estimate hazard ratios (HRs) adjusted for potential confounders. RESULTS: The study cohort included 1986 statin-exposed and 9871 unexposed subjects. Statin use was associated with an 18% reduction in the rate of steroid initiation (HR 0.82, 95% confidence interval [CI] 0.71, 0.94). A statistically significant result was seen with atorvastatin only (HR 0.76, 95% CI 0.60, 0.96). Statins were associated with a reduced rate of steroids in ulcerative colitis (HR 0.75, 95% CI 0.62, 0.91), but not in Crohn's disease (HR 0.91, 95% CI 0.74, 1.12). Statin use was associated with reduced hazard of anti-TNF use (HR 0.72, 95% CI 0.46, 1.11), abdominal surgery (HR 0.80, 95% CI 0.63, 1.02), and hospitalization (HR 0.88, 95% CI 0.74, 1.05), but these results did not reach statistical significance. CONCLUSIONS: In this large retrospective cohort study, statin use among persons with IBD was associated with reduced use of oral steroids, particularly for ulcerative colitis. Prospective clinical trials are needed to confirm whether adjuvant treatment of IBD with statin drugs may spare immunosuppressant therapy or ameliorate flares.

Treating depression after initial treatment failure: directly comparing switch and augmenting strategies in STAR*D.

OBJECTIVE: Augmenting and switching antidepressant medications are the 2 most common next-step strategies for depressed patients failing initial medication treatment. These approaches have not been directly compared; thus, our objectives are to compare outcomes for medication augmentation versus switching for patients with major depressive disorder in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) clinical trial. METHODS: We conducted a retrospective analysis of participants aged 18 to 75 years with DSM-IV nonpsychotic depression who failed to remit with initial treatment in the STAR*D clinical trial (N = 1292). We compared depressive symptom remission, response, and quality of life among participants in each study arm using propensity score matching to minimize selection bias. RESULTS: The propensity-score-matched augment (N = 269) and switch (N = 269) groups were well balanced on measured characteristics. Neither the likelihood of remission (risk ratio, 1.14; 95% confidence level, 0.82-1.58) or response (risk ratio, 1.14; 95% confidence level, 0.82-1.58), nor the time to remission (log-rank test, P = 0.946) or response (log-rank test, P = 0.243) differed by treatment strategy. Similarly, quality of life did not differ. Post hoc analyses suggested that augmentation improved outcomes for patients tolerating 12 or more weeks of initial treatment and those with partial initial treatment response. CONCLUSIONS: For patients receiving and tolerating aggressive initial antidepressant trials, there is no clear preference for next-step augmentation versus switching. Findings tentatively suggest that those who complete an initial treatment of 12 weeks or more and have a partial response with residual mild depressive severity may benefit more from augmentation relative to switching.