Health insurance among survivors of childhood cancer following affordable care act implementation.

BACKGROUND: The Affordable Care Act (ACA) increased private non-employer health insurance options, expanded Medicaid eligibility, and provided pre-existing health conditions protections. We evaluated insurance coverage among long-term adult survivors of childhood cancer pre/post-ACA implementation. METHODS: Using the multicenter Childhood Cancer Survivor Study, we included participants from two cross-sectional surveys: pre-ACA (2007-2009; survivors: N = 7,505; siblings: N = 2,175) and post-ACA (2017-2019; survivors: N = 4,030; siblings: N = 987). A subset completed both surveys (1,840 survivors; 646 siblings). Multivariable regression models compared post-ACA insurance coverage and type (private/public/uninsured) between survivors and siblings and identified associated demographic and clinical factors. Multinomial models compared gaining and losing insurance vs staying the same among survivors and siblings who participated in both surveys. RESULTS: The proportion with insurance was higher post-ACA (survivors pre-ACA 89.1% to post-ACA 92.0% [+2.9%]; siblings pre-ACA 90.9% to post-ACA 95.3% [+4.4%]). Post-ACA insurance coverage was greater among those age 18-25 (survivors: 15.8% vs < 2.3% ages 26+; siblings +17.8% vs < 4.2% ages 26+). Survivors were more likely to have public insurance than siblings post-ACA (18.4% vs 6.9%; odds ratios [OR]=1.7, 95%CI 1.1-2.6). Survivors with severe chronic conditions (OR = 4.7, 95%CI 3.0-7.3) and those living in Medicaid expansion states (OR = 2.4, 95%CI 1.7-3.4) had increased odds of public insurance coverage post-ACA. Among the subset completing both surveys, low/mid income survivors (<$60,000) experienced both insurance losses and gains in reference to highest household income survivors (≥$100,000), relative to odds of keeping the same insurance status. CONCLUSIONS: Post-ACA, more childhood cancer survivors and siblings had health insurance, although disparities remain in coverage.

Disparities in clinical trial enrollment at a Canadian comprehensive cancer center: A 15-year retrospective study.

INTRODUCTION: Disparities in clinical trials (CTs) enrollment perpetuate inequities in treatment access and outcomes, but there is a paucity of Canadian data. The objective of this study was to examine disparities in cancer CT enrollment at a large Canadian comprehensive cancer center. METHODS: Retrospective study of CT enrollment among new patient consultations from 2006 to 2019, with follow-up to 2021 (N = 154,880), with the primary outcome of enrollment as a binary variable. Factors associated with CT enrollment were evaluated using multivariable Bayesian hierarchical logistic regression with random effects for most responsible physician (MRP) and geography, adjusted for patient characteristics (sex, age, language, geography, and primary care provider [PCP]), area-level marginalization (residential instability, material deprivation, dependency, and ethnic concentration), disease (cancer site and stage), and MRP (department, sex, language, and training). A sensitivity analysis of the cumulative incidence of enrollment was conducted to account for differences in disease type and follow-up length. RESULTS: CT enrollment was 11.2% overall, with a 15-year cumulative incidence of 18%. Lower odds of enrollment were observed in patients who were female (adjusted odds ratio [AOR], 0.82; 95% confidence interval [CI], 0.78-0.86), ≥65 years (AOR vs. <40, 0.61; 95% CI, 0.56-0.66), non-English speakers (0.72; 95% CI, 0.67-0.77), living ≥250 km away (AOR vs. <15 km, 0.71; 95% CI, 0.62-0.80), and without a PCP. Disease characteristics accounted for the largest proportion of observed variation (20.8%), with significantly greater odds of enrollment in patients with genitourinary cancers and late-stage disease. CONCLUSION: Significant sociodemographic disparities were observed, suggesting the need for targeted strategies to increase diversity in access to cancer CTs in Canada.

Job lock among survivors of childhood cancer and their spouses post Affordable Care Act implementation: A Childhood Cancer Survivor Study brief report.

It is unknown how common job lock (i.e., staying at job to maintain health insurance) remains among childhood cancer survivors after Affordable Care Act (ACA) implementation in 2010. We examined prevalence of and factors associated with job lock using a cross-sectional survey from the Childhood Cancer Survivor Study (3503 survivors; 942 siblings). Survivor, spousal, and any survivor/spouse job lock were more frequently reported by survivors than siblings. Survivor job lock/any job lock was associated with older age, low income, severe chronic conditions, and debt/inability to pay debt. Job lock remains more common among survivors than siblings after ACA implementation.

Financial hardship among siblings of long-term survivors of childhood cancer: A Childhood Cancer Survivor Study report.

BACKGROUND: Siblings of children with cancer may experience adverse household economic consequences, but their financial outcomes in adulthood are unknown. METHODS: A total of 880 siblings (aged 18-64 years) of adult-aged childhood cancer survivors were surveyed to estimate the prevalence of financial hardship by three established domains (behavioral, material, and psychological). For individual financial hardship items matching the contemporaneous National Health Interview Survey or Behavioral Risk Factor Surveillance System, siblings were compared with the general population by calculating adjusted prevalence odds ratios (ORs) to sample-weighted responses. Multivariable logistic regression models examined associations between sibling characteristics and each hardship domain and between sibling hardship and survivors' cancer/treatment characteristics. RESULTS: Behavioral, material, and psychological hardship was reported by 24%, 35%, and 28%, respectively. Compared with national survey respondents, siblings were more likely to report worries about medical bills (OR, 1.14; 95% confidence interval [CI], 1.06-1.22), difficulty affording nutritious foods (OR, 1.79; 95% CI, 1.54-2.07), and forgoing needed medical care (OR, 1.38; 95% CI, 1.10-1.73), prescription medications (OR, 2.52; 95% CI, 1.99-3.20), and dental care (OR, 1.34; 95% CI, 1.15-1.57) because of cost. Sibling characteristics associated with reporting financial hardship in one or more domains included female sex, older age, chronic health conditions, lower income, not having health insurance, high out-of-pocket medical expenditures, and nonmedical/nonhome debt. No survivor cancer/treatment characteristics were associated with sibling financial hardship. CONCLUSIONS: Adult siblings of childhood cancer survivors were more likely to experience financial hardship compared with the general population. Childhood cancer may adversely affect entire households, with potentially lasting implications.

Out-of-Pocket Costs of Treatment Among Employer-Insured Women With Invasive Breast Cancer.

This cross-sectional study examines out-of-pocket costs for the treatment of invasive breast cancer in employer-insured women younger than 65 years.

Financial Hardship in Adult Survivors of Childhood Cancer in the Era After Implementation of the Affordable Care Act: A Report From the Childhood Cancer Survivor Study.

PURPOSE: To estimate the prevalence of financial hardship among adult survivors of childhood cancer compared with siblings and identify sociodemographic, cancer diagnosis, and treatment correlates of hardship among survivors in the era after implementation of the Affordable Care Act. METHODS: A total of 3,555 long-term (≥ 5 years) survivors of childhood cancer and 956 siblings who completed a survey administered in 2017-2019 were identified from the Childhood Cancer Survivor Study. Financial hardship was measured by 21 survey items derived from US national surveys that had been previously cognitively tested and fielded. Principal component analysis (PCA) identified domains of hardship. Multiple linear regression examined the association of standardized domain scores (ie, scores divided by standard deviation) with cancer and treatment history and sociodemographic characteristics among survivors. RESULTS: Survivors were more likely than siblings to report hardship in ≥ 1 item (63.4% v 53.7%, P < .001). They were more likely to report being sent to debt collection (29.9% v 22.3%), problems paying medical bills (20.7% v 12.8%), foregoing needed medical care (14.1% v 7.8%), and worry/stress about paying their rent/mortgage (33.6% v 23.2%) or having enough money to buy nutritious meals (26.8% v 15.5%); all P < .001. Survivors reported greater hardship than siblings in all three domains identified by principal component analysis: behavioral hardship (mean standardized domain score 0.51 v 0.35), material hardship/financial sacrifices (0.64 v 0.46), and psychological hardship (0.69 v 0.44), all P < .001. Sociodemographic (eg,

COVID-19 Vaccine-Related Beliefs and Behaviors Among Patients With and Survivors of Hematologic Malignancies.

PURPOSE: Patients with and survivors of hematologic malignancies are particularly vulnerable to COVID-19 disease and complications. This study examined patients' vaccination attitudes and behaviors and their correlates. METHODS: A two-wave survey was fielded in December 2020 and June 2021 among hematologic malignancy patients and survivors (N = 2,272). Demographic characteristics, intent to get vaccinated, vaccination status, attitudes toward vaccination, and level of trust in specific sources of information about COVID-19 vaccines were assessed. Descriptive statistics were calculated, and linear probability models were estimated to examine binary outcomes and their correlates. RESULTS: In December 2020, before COVID-19 vaccines were available, 73% stated they were likely or very likely to get vaccinated if an FDA-approved vaccine became available; however, in June 2021 over 90% reported being vaccinated. Being younger, unmarried, trusting local faith leaders, and not having a bachelor's degree or more were negatively associated with getting vaccinated. Among those hesitant in December 2020, those who expressed a distrust of vaccines in general were least likely to get vaccinated. Being vaccinated in June 2021 was positively associated with the degree to which respondents trust their oncologist, federal agencies, and pharmaceutical companies. Oncologists and primary care physicians were reported as the most trusted sources for information about vaccines. DISCUSSION: COVID-19 vaccine hesitancy remains a public policy concern even now, as additional boosters are recommended among vulnerable populations. Our findings suggest that patient trust in their treating physicians can play a critical role in promoting individual patient and public health goals.

Navigating financial toxicity in patients with cancer: A multidisciplinary management approach.

Approximately one-half of individuals with cancer face personal economic burdens associated with the disease and its treatment, a problem known as financial toxicity (FT). FT more frequently affects socioeconomically vulnerable individuals and leads to subsequent adverse economic and health outcomes. Whereas multilevel systemic factors at the policy, payer, and provider levels drive FT, there are also accompanying intervenable patient-level factors that exacerbate FT in the setting of clinical care delivery. The primary strategy to intervene on FT at the patient level is financial navigation. Financial navigation uses comprehensive assessment of patients' risk factors for FT, guidance toward support resources, and referrals to assist patient financial needs during cancer care. Social workers or nurse navigators most frequently lead financial navigation. Oncologists and clinical provider teams are multidisciplinary partners who can support optimal FT management in the context of their clinical roles. Oncologists and clinical provider teams can proactively assess patient concerns about the financial hardship and employment effects of disease and treatment. They can respond by streamlining clinical treatment and care delivery planning and incorporating FT concerns into comprehensive goals of care discussions and coordinated symptom and psychosocial care. By understanding how age and life stage, socioeconomic, and cultural factors modify FT trajectory, oncologists and multidisciplinary health care teams can be engaged and informative in patient-centered, tailored FT management. The case presentations in this report provide a practical context to summarize authors' recommendations for patient-level FT management, supported by a review of key supporting evidence and a discussion of challenges to mitigating FT in oncology care. CA Cancer J Clin. 2022;72:437-453.

Financial toxicity impact on younger versus older adults with cancer in the setting of care delivery.

BACKGROUND: Young adults and other working-age adults with cancer are at risk for cancer-related financial toxicity (FT), including material hardships, depletion of coping resources, and psychological burden. This study compares FT domains in young adults (18-39 years old) (YAs), other working-age adults (40-64 years old), and older adults (≥65 years old) receiving cancer care. METHODS: A total of 311 adults were surveyed using the multi-domain Economic Strain and Resilience in Cancer instrument measuring FT (0-10 score indicating least to greatest FT; score ≥5 severe FT). Participants were receiving ambulatory care from March-September 2019. Associations of age with overall FT and material hardship, coping resource depletion, and psychological burden FT domains were tested using Kruskal-Wallis and χ2 tests and multivariable generalized linear models with gamma distribution. RESULTS: YAs (median age, 31.5 years) comprised 9.6% of the sample; other working-age adults comprised 56.9%. Overall, material, coping, and psychological FT scores were worse in younger age adults versus older adults (P < .001 in all multivariable models). Compared with older adults, younger age adults demonstrated worse material hardship (median scores, 3.70 vs 4.80 vs 1.30 for YAs, other working-age, and older adults, respectively; P < .001), coping resource depletion (4.50 vs 3.40 vs 0.80; P < .001), and psychological burden (6.50 vs 7.00 vs 1.00; P < .001). Fifty percent of YAs had severe overall FT versus 40.7% of other working-age adults and 9.6% of older adults (P < .001). CONCLUSIONS: Younger age adults with cancer bore disproportionate FT. Interventions to address unmet needs are critical components for addressing FT in this population.

The cost-effectiveness of therapeutic drug monitoring for the prescription drug-based treatment of chronic myeloid leukemia.

BACKGROUND: A recent study demonstrating the use of Therapeutic Drug Monitoring (TDM) in patients with chronic myeloid leukemia (CML) resulted in a higher response rate with imatinib (IM) than demonstrated in second-generation tyrosine kinase inhibitor studies. The cost-effectiveness of TDM combined with IM (IM TDM) in first-line CML treatment has not yet been studied. OBJECTIVES: To determine the cost-effectiveness of IM TDM for the first-line treatment of CML compared to tyrosine kinase inhibitor only treatment. METHODS: A recently published cost-effectiveness model of tyrosine kinase inhibitor-treatment in CML was modified to include IM TDM as a first-line tyrosine kinase inhibitor-based CML treatment option. Efficacy inputs for major molecular response (MMR) rates were taken from previously published studies: IM TDM 65%, dasatinib 52%, nilotinib 53%. Annual tyrosine kinase inhibitor drug prices were derived from the Federal Supply Schedule (FSS) and the average and lowest wholesale acquisition costs (WAC) reported in the Red Book; the annual cost of TDM was $228. Other input costs modeled in the original CML CEA model were updated to 2016 US dollars using the medical service component of the Consumer Price Index. A US payer perspective was used with a 5-year time horizon and a 3.0% discount rate. The model compared first-line IM TDM versus IM alone, nilotinib (NIL) or dasatinib (DAS) in terms of the following outcomes: costs, quality-adjusted life-years (QALYs), and cost-effectiveness (total cost/QALY). Deterministic and probabilistic sensitivity analyses were performed using all key clinical and economic parameters. RESULTS: This study found that IM TDM dominates IM alone with $15,452 to $36,940 in savings and 0.25 higher QALYs. Using FSS, per patient total costs for IM and IM TDM were $270,905 and $233,965, respectively.; Using average WAC, these costs were $461,657 and $446,205, and using lowest WAC, these costs were $366,966 and $350,090. The results comparing first line using of IM TDM to NIL/DAS found that TDM IM had higher QALYs and lower costs (0.08 QALYs lower, and $117,006 to $172,420 savings per patient [varying by price basis]). Thus, in terms of cost-effectiveness, IM TDM dominates NIL/DAS with both lower costs and higher QALYs. CONCLUSIONS: IM TDM is a clinically and economically viable first-line treatment option for CML. DISCLOSURES: This study was funded by Saladax Biomedical. Salamone is an employee of Saladax Biomedical. This study was presented at the IATDMCT Congress, September 2018, Brisbane, Australia.

Sensitivity of Psychosocial Distress Screening to Identify Cancer Patients at Risk for Financial Hardship During Care Delivery.

PURPOSE: Patients with cancer frequently encounter financial hardship, yet systematic strategies to identify at-risk patients are not established in care delivery. We assessed sensitivity of distress-based screening to identify patients with cancer-related financial hardship and associated care delivery outcomes. METHODS: A survey of 225 patients at a large cancer center assessed cancer-related financial hardship (0-10 Likert scale; highest quintile scores ≥ 5 defined severe hardship). Responses were linked to electronic medical records identifying patients' distress screening scores 6 months presurvey (0-10 scale) and outcomes of missed cancer care visits and bad debt charges (unrecovered patient charges) within 6 months postsurvey. A positive screen for distress was defined as score ≥ 4. We analyzed screening test characteristics for identifying severe financial hardship within 6 months and associations between financial hardship and outcomes using logistic models. RESULTS: Although patients with positive distress screens were more likely to report financial hardship (odds ratio [OR], 1.21; 1.08-1.37; P < .001), a positive distress screen was only 48% sensitive and 70% specific for identifying severe financial hardship. Patients with worse financial hardship scores were more likely to miss oncology care visits within 6 months (for every additional point in financial hardship score from 0 to 10, OR, 1.28; 1.12-1.47; P < .001). Of patients with severe hardship, 72% missed oncology visits versus 35% without severe hardship (P = .006). Patients with worse hardship were more likely to incur any bad debt charges within 6 months (OR, 1.32; 1.13-1.54; P < .001). CONCLUSION: Systematic financial hardship screening is needed to help mitigate adverse care delivery outcomes. Existing distress-based screening lacks sensitivity.

Association of Opioid Prescribing Patterns With Prescription Opioid Overdose in Adolescents and Young Adults.

Importance: Safe opioid prescribing practices are critical to mitigate the risk of prescription opioid overdose in adolescents and young adults. However, studies that examine opioid prescribing patterns associated with prescription opioid overdose have mostly focused on older adults. The generalizability of these studies to adolescents and young adults is unclear. Objective: To identify opioid prescribing patterns associated with prescription opioid overdose in adolescents and young adults. Design, Setting, and Participants: This retrospective cohort study assessed privately insured patients aged 12 to 21 years with opioid prescription claims in the IBM MarketScan Commercial Claims and Encounters database between July 1, 2009, and October 1, 2017, and no cancer diagnosis. Data analysis was performed from January 1 to April 30, 2019. Main Outcomes and Measures: The outcome was a treated opioid overdose as indicated by diagnosis codes. On the basis of days supplied, opioid prescription claims were converted to person-days (the unit of analysis) on which opioid exposure would occur if patients took medications as prescribed. Logistic regression with clustered SEs at the patient level was used to model the occurrence of overdose on a person-day as a function of daily opioid dosage category (<30, 30-59, 60-89, 90-119, or ≥120 morphine milligram equivalents), concurrent benzodiazepine use, and extended-release or long-acting opioid use. Regressions controlled for demographic characteristics, year, opioid use within 180 days, and comorbidities (mental health disorder, substance use disorder, and other chronic condition). Results: A total of 2 752 612 patients (mean [SD] age at cohort entry, 17.2 [2.5] years; 1 451 918 [52.8%] female) participated in the study. Patients had 4 686 355 opioid prescription claims, corresponding to 21 605 444 person-days. Overdose occurred on 255 person-days among 249 patients (0.01% of the sample). Each increase in daily opioid dosage category was associated with higher overdose risk (adjusted odds ratio [AOR], 1.18; 95% CI, 1.05-1.31). Compared with no use, both concurrent benzodiazepine use (AOR, 1.83; 95% CI, 1.24-2.71) and extended-release or long-acting opioid use (AOR, 2.01; 95% CI, 1.16-3.46) were associated with increased overdose risk. Conclusions and Relevance: The findings suggest that when prescribing opioids to adolescents and young adults, practitioners could potentially mitigate overdose risk by using the lowest effective daily dosage, avoiding concurrent opioid and benzodiazepine prescribing, and relying on short-acting opioids. Findings are broadly consistent with prior opioid safety studies focused on older adults.

Trends in the Price per Median and Mean Life-Year Gained Among Newly Approved Cancer Therapies 1995 to 2017.

BACKGROUND: The prices of newly approved cancer drugs have risen over the past decades. A key policy question is whether the clinical gains offered by these drugs in treating specific cancer indications justify the price increases. OBJECTIVES: To evaluate the price per median and mean life year gained among newly approved cancer therapies from 1995 to 2017. METHODS: We collected data on the price (in 2017 USD) per life-year gained among cancer drug-indication pairs approved by the US Food and Drug Administration (FDA) between 1995 and 2017. We modeled trends using fractional polynomial and linear spline regression models that controlled for route of administration and cancer type fixed effects. RESULTS: We found that between 1995 and 2012, price increases outstripped median survival gains, a finding consistent with previous literature. Nevertheless, price per mean life-year gained increased at a considerably slower rate, suggesting that new drugs have been more effective in achieving longer-term survival. Between 2013 and 2017, price increases reflected equally large gains in median and mean survival, resulting in a flat profile for benefit-adjusted launch prices in recent years. CONCLUSIONS: Although drug costs have been rising more rapidly than median survival gains, they have been rising at about the same rate as mean survival gains. This suggests that when accounting for longer-term survival gains, the benefits of new drugs are roughly keeping pace with their costs, despite rapid cost growth.

Assessment of Prescriber and Pharmacy Shopping Among the Family Members of Patients Prescribed Opioids.

Importance: Most prescription opioid misuse involves opioids prescribed to others-a form of opioid diversion. However, few indicators of diversion risk exist. Because family members can often access patients' opioids, one such indicator may be the frequency with which opioid prescriptions are filled by patients when their family members are engaged in opioid prescriber and pharmacy shopping ("doctor and pharmacy shopping"). To date, this frequency has not been estimated. Objective: To estimate the proportion of opioid prescription fills for which family members meet prescriber and pharmacy shopping criteria. Design, Setting, and Participants: A cross-sectional analysis of 2015-2016 claims from a national commercial insurer was conducted from August to October, 2018. The sample included patients without cancer who were covered by family insurance plans and had 1 or more opioid prescription fill in 2016, as measured by prescription drug claims. Fills were the unit of analysis. Main Outcomes and Measures: For each fill in 2016 by the patient and each family member enrolled in the same plan (eg, spouse or child), the number of prescribers and number of pharmacies in the prior 12 months were counted. Prescriber and pharmacy shopping was defined as 4 or more prescribers and 4 or more pharmacies, following a National Quality Forum-endorsed measure. The proportion of fills for which 1 or more family member met criteria and the proportion for which the patient met criteria were calculated. Results: Among 554 417 patients in the sample, 301 297 (54.3%) were female and 48 047 (8.7%) were children. Mean (SD) age was 41.4 (16.4) years. Patients were enrolled in 469 913 plans and, after exclusions, filled 1 471 971 opioid prescriptions in 2016. For 8485 fills (0.6%), 1 or more family member met prescriber and pharmacy shopping criteria. For 44 547 fills (3.0%), the patient met criteria. For 6947 of the 8485 fills (81.9%) for which 1 or more family member met criteria, patients did not meet criteria. When criteria were 3 or more prescribers at 3 or more pharmacies, the proportion of fills for which 1 or more family member met criteria increased to 1.9%. Conclusions and Relevance: In this national study of US patients with private family insurance plans, 0.6% of opioid prescription fills occurred when at least 1 of the patient's family members met prescriber and pharmacy shopping criteria. For most of these fills, patients did not meet criteria. Findings suggest the potential for opioid diversion within families.

Effect of FDA Investigation on Opioid Prescribing to Children After Tonsillectomy/Adenoidectomy.

BACKGROUND: In August 2012, the Food and Drug Administration investigated the safety of codeine use by children after tonsillectomy and/or adenoidectomy, culminating in a black box warning in February 2013. The objective of this study was to evaluate the association between the investigation and opioid prescribing to children undergoing these surgeries. METHODS: We identified 362 992 privately insured children in the 2010-2015 Truven MarketScan Commercial Claims and Encounters database who underwent tonsillectomy and/or adenoidectomy. Using an interrupted time series design, we estimated level and slope changes in the proportion of children with ≥1 prescription fills for codeine and ≥1 fills for an alternative opioid, such as hydrocodone, within 7 days of surgery. RESULTS: The investigation was associated with a significant -13.3 (95% confidence interval: -14.5 to -12.1) percentage point level change in the proportion of children with ≥1 prescription fills for codeine after tonsillectomy and/or adenoidectomy. Despite this drop, 5.1% of children had ≥1 prescription fills for codeine in December 2015. The investigation was not associated with significant level changes in alternative opioid prescribing, although the proportion of children receiving alternative opioids increased during the study period because of other factors. CONCLUSIONS: The Food and Drug Administration investigation substantially decreased codeine prescribing to children after tonsillectomy and/or adenoidectomy. However, 1 in 20 children undergoing these surgeries were still prescribed codeine in December 2015 despite its well-documented safety and efficacy issues.

21st century pharmacovigilance: efforts, roles, and responsibilities.

In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice. Pharmacovigilance identifies previously unrecognised adverse events or changes in the patterns of these effects, the quality and adequacy of drug supply, and should ensure effective communication with the public, health-care professionals, and patients about the optimum safety and effective use of medicines. In this paper, the first in a Series of three about drug safety in oncology, we discuss evolving challenges in the purview, roles, and responsibilities of the US Food and Drug Administration and the European Medicines Agency with respect to pharmacovigilance efforts, with a special emphasis on oncology treatment.