The Drug Shortage Crisis in the United States: Impact on Cancer Pharmaceutical Safety.

Drug shortages pose a significant public health concern in the United States, and cancer drugs are among those most affected. Shortages present serious safety risks for patients and substantial burden on providers and the healthcare system. Multifaceted drivers of this complex problem include manufacturing disruptions, raw material shortages, regulatory issues, market dynamics, and limited financial incentives that reward quality and production of off-patent drugs. Oncology drugs in short supply have resulted in substitution of less effective or more toxic alternatives, medication errors, and treatment delays, and are especially concerning for medications with no adequate substitute. Consequently, patient outcomes such as disease progression and survival have been adversely affected. Furthermore, emerging gray markets have contributed to cost-prohibitive markups and introduction of counterfeit products that compromise patient safety. The Food and Drug Administration plays a key role in preventing and managing pharmaceutical shortages, largely through regulations requiring early notification of manufacturing interruptions. Other proposed strategies similarly target upstream causes and center on reducing regulatory hurdles for manufacturers and increasing incentives for market entry and quality improvement. Despite progress in preventing supply disruptions, continued exploration of underlying systemic drivers remains critical to informing long-term solutions and alleviating the clinical and economic impact of drug shortages.

Behavioral and mental health risk factor profiles among diverse primary care patients.

Behavioral and mental health risk factors are prevalent among primary care patients and contribute substantially to premature morbidity and mortality and increased health care utilization and costs. Although prior studies have found most adults screen positive for multiple risk factors, limited research has attempted to identify factors that most commonly co-occur, which may guide future interventions. The purpose of this study was to identify subgroups of primary care patients with co-occurring risk factors and to examine sociodemographic characteristics associated with these subgroups. We assessed 12 behavioral health risk factors in a sample of adults (n=1628) receiving care from nine primary care practices across six U.S. states in 2013. Using latent class analysis, we identified four distinct patient subgroups: a 'Mental Health Risk' class (prevalence=14%; low physical activity, high stress, depressive symptoms, anxiety, and sleepiness), a 'Substance Use Risk' class (29%; highest tobacco, drug, alcohol use), a 'Dietary Risk' class (29%; high BMI, poor diet), and a 'Lower Risk' class (27%). Compared to the Lower Risk class, patients in the Mental Health Risk class were younger and less likely to be Latino/Hispanic, married, college educated, or employed. Patients in the Substance Use class tended to be younger, male, African American, unmarried, and less educated. African Americans were over 7 times more likely to be in the Dietary Risk versus Lower Risk class (OR 7.7, 95% CI 4.0-14.8). Given the heavy burden of behavioral health issues in primary care, efficiently addressing co-occurring risk factors in this setting is critical.

The Affordable Care Act's Impacts on Access to Insurance and Health Care for Low-Income Populations.

The Patient Protection and Affordable Care Act (ACA) expands access to health insurance in the United States, and, to date, an estimated 20 million previously uninsured individuals have gained coverage. Understanding the law's impact on coverage, access, utilization, and health outcomes, especially among low-income populations, is critical to informing ongoing debates about its effectiveness and implementation. Early findings indicate that there have been significant reductions in the rate of uninsurance among the poor and among those who live in Medicaid expansion states. In addition, the law has been associated with increased health care access, affordability, and use of preventive and outpatient services among low-income populations, though impacts on inpatient utilization and health outcomes have been less conclusive. Although these early findings are generally consistent with past coverage expansions, continued monitoring of these domains is essential to understand the long-term impact of the law for underserved populations.

Public Funds Account for Over 70 Percent of Health Care Spending in California.

In California, personal health care expenditures are estimated to total more than $367 billion in 2016. Approximately 71 percent of these expenditures will be paid for with public funds (i.e., taxpayer dollars). This estimated contribution of public funds to health care expenditures is much higher than estimates that include only major health insurance programs such as Medicare and Medicaid. Several additional public funding sources also contribute to health care expenditures in the state, including government spending for public employee health benefits, tax subsidies for employer-sponsored insurance and the Affordable Care Act (ACA) insurance exchange, and county health care expenditures. As health care reform continues to take effect, it will be important to monitor the public versus private contributions to state health care expenditures to ensure that funds are being distributed both efficiently and equitably.

Delays in Cancer Care Among Low-Income Minorities Despite Access.

INTRODUCTION: Narrowing the racial/ethnic and socioeconomic disparities in breast and cervical cancer requires an in-depth understanding of motivation for adherence to cancer screening and follow-up care. To inform patient-centered interventions, this study aimed to identify reasons why low-income women adhered to or delayed breast or cervical cancer screening, follow-up and treatment despite access to cancer care-related services. METHODS: Semistructured qualitative interviews were conducted among women with access to cancer care-related services receiving care at an academic cancer center, federally qualified health centers, or free clinics in the Chicago metropolitan area. Transcripts were coded and analyzed for themes related to rationales for adherence. RESULTS: Among 138 participants, most were African American (46%) or Hispanic (36%), English speaking (70%), and between ages 41 and 65 years (64%). Primary drivers of nonadherence included lack of knowledge of resources, denial or fear, competing obligations, and embarrassment. Facilitators included abnormality identification, patient activation, provider-initiated actions, and motivation from family or friends. CONCLUSIONS: Interventions targeting increased adherence to care among low-income and ethnic minority women should direct efforts to proactive, culturally and patient-informed education that enables patients to access resources and use the health care system, address misconceptions about cancer, ensure health care providers' communication of screening guidelines, and leverage the patient's social support network.

What women want: patient recommendations for improving access to breast and cervical cancer screening and follow-up.

BACKGROUND: The patient voice remains underrepresented in clinical and public health interventions. To inform interventions that strive to improve access to breast and cervical cancer screening and follow-up among low-income populations, we explored recommendations from low-income women pursuing health care in the safety net. METHODS: Semi-structured interviews were conducted among women receiving follow-up care for an abnormal breast or cervical cancer screening result or a positive cancer diagnosis in federally qualified health centers, free clinics, or an academic cancer center in the Chicago metropolitan area. FINDINGS: Of the 138 women interviewed in the parent study, 52 women provided recommendations for improving access to screening and follow-up care. Most were between 41 and 65 years old (62%) and African American (60%) or White (25%). Recommendations included strengthening community-based health education with more urgent messaging, strategic partnerships, and active learning experiences to increase patient engagement, which women regarded as a key driver of access. Women also suggested increasing access by way of changes to health care delivery systems and policy, including more direct patient-provider and patient-clinic communications, addressing delays caused by high patient volume, combining preventive services, expanding insurance coverage, and adjusting screening guidelines. CONCLUSIONS: This exploratory study demonstrates important insights from the patient lens that may help to increase the acceptability and efficacy of community and clinical interventions aimed at improving access to breast and cervical cancer screening and follow-up. Further research is needed to identify appropriate integration of patient input into interventions, practice, and policy change.

Community-campus partnership in action: lessons learned from the DuPage County Patient Navigation Collaborative.

BACKGROUND: Using community-based participatory research (CBPR), the DuPage County Patient Navigation Collaborative (DPNC) developed an academic campus-community research partnership aimed at increasing access to care for underserved breast and cervical cancer patients within DuPage County, a collar county of Chicago. Given rapidly shifting demographics, targeting CBPR initiatives among underserved suburban communities is essential. OBJECTIVES: To discuss the facilitating factors and lessons learned in forging the DPNC. METHODS: A patient navigation collaborative was formed to guide medically underserved women through diagnostic resolution and if necessary, treatment, after an abnormal breast or cervical cancer screening. LESSONS LEARNED: Facilitating factors included (1) fostering and maintaining collaborations within a suburban context, (2) a systems-based participatory research approach, (3) a truly equitable community-academic partnership, (4) funding adaptability, (5) culturally relevant navigation, and (6) emphasis on co-learning and capacity building. CONCLUSIONS: By highlighting the strategies that contributed to DPNC success, we envision the DPNC to serve as a feasible model for future health interventions.

Access to care outcomes: a telephone interview study of a suburban safety net program for the uninsured.

Access DuPage (AD) currently provides primary care for about 14,000 low income, uninsured residents of suburban DuPage County, IL, an area with a very limited healthcare safety net infrastructure. A telephone interview survey evaluated health care utilization, satisfaction, and health status outcomes and compared recent enrollees to individuals in the program for at least 1 year. Sequential new AD enrollees (n = 158) were asked about the previous year when uninsured, while randomly selected established AD enrollees (n = 135) were asked the same questions about the previous year when actively enrolled in AD. Established enrollees reported being more likely to get 'any kind of tests or treatment' (96.3 vs. 46.2 %, p < 0.0001), fewer cost (78.5 vs. 21.3 %, p < 0.0001) and transportation barriers to care, more preventive and mental health services, and better self-management care. However, established enrollees also reported 14 % greater use of hospital inpatient and 9 % greater use of emergency room care, as well as continued difficulty in accessing needed specialty and dental care services. Despite more (diagnosed) conditions, established enrollees were over 2.5 times more likely to report good to excellent health status and over three times more likely to rate their satisfaction with health care as good to excellent. Findings illustrate the substantial benefits of assuring access to care for the uninsured, but do not reflect immediate savings from reduced hospital utilization. Access to care programs will be an important tool to address the needs of the 30 million people who will continue to be uninsured in the United States.

Evaluating the supportive care costs of severe radiochemotherapy-induced mucositis and pharyngitis : results from a Northwestern University Costs of Cancer Program pilot study with head and neck and nonsmall cell lung cancer patients who received care at a county hospital, a Veterans Administration hospital, or a comprehensive cancer care center.

BACKGROUND: Few studies have examined the costs of supportive care for radiochemotherapy-induced mucosits/pharyngitis among patients with head and neck cancer (HNC) or lung cancers despite the documented negative clinical impact of these complications. METHODS: The authors identified a retrospective cohort of patients with HNC or nonsmall lung cancer (NSCLC) who had received radiochemotherapy at 1 of 3 Chicago hospitals (a Veterans Administration hospital, a county hospital, or a tertiary care hospital). Charts were reviewed for the presence/absence of severe mucositis/pharyngitis and the medical resources that were used. Resource estimates were converted into cost units obtained from standard sources (hospital bills, Medicare physician fee schedule, Red Book). Estimates of resources used and direct medical costs were compared for patients who did and patients who did not develop severe mucositis/pharyngitis. RESULTS: Severe mucositis/pharyngitis occurred in 70.1% of 99 patients with HNC and in 37.5% of 40 patients with NSCLC during radiochemotherapy. The total median medical costs per patient were USD 39,313 for patients with mucositis/pharyngitis and USD 20,798 for patients without mucositis/pharyngitis (P = .007). Extended inpatient hospitalization accounted for USD 12,600 of the increased medical costs (median 14 days [USD 19,600] with severe mucositis/pharyngitis vs 5 days [USD 7,000] without; P = .017). For patients who had HNC with mucositis/pharyngitis, incremental inpatient hospitalization costs were USD 14,000, and total medical costs were USD 17,244. For patients who had NSCLC with mucositis/pharyngitis, these costs were USD 11,200 and USD 25,000, respectively. CONCLUSIONS: In the current study, the medical costs among the patients with HNC and NSCLC who received radiochemotherapy were greater for those who developed severe mucositis/pharyngitis than for those who did not.

Cost considerations in the management of cancer in the older patient.

Patients aged 65 years and older represent 12% of the US population yet account for approximately 56% of cancer cases and 69% of all cancer mortalities. The overall cost of cancer in 2005 was $209.9 billion--$74 billion for direct medical costs and $118.4 billion for indirect mortality costs. This paper considers the direct, indirect, and out-of-pocket expenditures incurred by cancer patients > or = 50 years of age. Several major empirical studies on supportive care for older patients and cancer-related costs were reviewed. Insurance coverage, hematologic malignancies, squamous cell carcinoma of the head and neck, and cancers of the breast, prostate, colorectum, and lung were evaluated. Major sources of direct medical expenditures covered by third-party insurers for patients aged 65 years and older include extended length of hospital stay, home health assistance following hospital discharge, adjuvant prescription medications, lower-risk treatment (for prostate cancer), and advent of new pharmaceuticals (for colorectal cancer). The mean total direct medical cost for breast cancer is $35,164, and the cumulative cost for prostate cancer is $42,570. Emerging targeted cancer drug costs range from $20,000 to $50,000 annually per patient. Additional clinical trials and cost-effective treatments are needed for older patients to ameliorate the disproportionate economic burden among older individuals with cancer. Additional research about cancer costs may also lead to reforms in cancer care reimbursement, and therefore provide access to affordable health care for older patients.