The needle and the damage done: Deaths of despair, economic precarity, and the white working-class.

Economic insecurity has grown in the United States since the 1970s impacting all segments of the working-class, including previously insulated sub-groups such as non-Hispanic whites. Moreover, the white working-class has experienced a surge in socio-cultural isolation, and disengagement with societal institutions. This analysis focuses on the health consequences of these developments, with a particular emphasis on the rising "deaths of despair" (suicide, drug poisoning, alcohol related). These deaths have been increasing since the mid-1990s and, at least until recently, tended to be clustered amongst whites without a four-year college degree. Various competing explanations have been put forth, emphasizing distinct factors such as material conditions, socio-cultural dynamics, and accessibility to opioids. Using a series of linear models this analysis examines the county-level association between economic precarity, white working-class population size, opioid accessibility, and deaths of despair. Results affirm the net effect of each predictor and illuminate an interactive relationship between opioid accessibility and precarity, as well as an interactive relationship between all three predictors. By undertaking an interdisciplinary synthesis of existing research, this study contributes to the understanding of the social determinants of mortality while providing crucial insights into an ongoing crisis in contemporary America.

Healthcare costs and mortality associated with serious fluoroquinolone-related adverse reactions.

The aim of this study was to estimate healthcare costs and mortality associated with serious fluoroquinolone-related adverse reactions in Finland from 2008 to 2019. Serious adverse reaction types were identified from the Finnish Pharmaceutical Insurance Pool's pharmaceutical injury claims and the Finnish Medicines Agency's Adverse Reaction Register. A decision tree model was built to predict costs and mortality associated with serious adverse drug reactions (ADR). Severe clostridioides difficile infections, severe cutaneous adverse reactions, tendon ruptures, aortic ruptures, and liver injuries were included as serious adverse drug reactions in the model. Direct healthcare costs of a serious ADR were based on the number of reimbursed fluoroquinolone prescriptions from the Social Insurance Institution of Finland's database. Sensitivity analyses were conducted to address parameter uncertainty. A total of 1 831 537 fluoroquinolone prescriptions were filled between 2008 and 2019 in Finland, with prescription numbers declining 40% in recent years. Serious ADRs associated with fluoroquinolones lead to estimated direct healthcare costs of 501 938 402 €, including 11 405 ADRs and 3,884 deaths between 2008 and 2019. The average mortality risk associated with the use of fluoroquinolones was 0.21%. Severe clostridioides difficile infections were the most frequent, fatal, and costly serious ADRs associated with the use of fluoroquinolones. Although fluoroquinolones continue to be generally well-tolerated antimicrobials, serious adverse reactions cause long-term impairment to patients and high healthcare costs. Therefore, the risks and benefits should be weighed carefully in antibiotic prescription policies, as well as with individual patients.

Relative risks of adverse events among older adults receiving opioids versus NSAIDs after hospital discharge: A nationwide cohort study.

BACKGROUND: Although analgesics are initiated on hospital discharge in millions of adults each year, studies quantifying the risks of opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) among older adults during this transition are limited. We sought to determine the incidence and risk of post-discharge adverse events among older adults with an opioid claim in the week after hospital discharge, compared to those with NSAID claims only. METHODS AND FINDINGS: We performed a retrospective cohort study using a national sample of Medicare beneficiaries age 65 and older, hospitalized in United States hospitals in 2016. We excluded beneficiaries admitted from or discharged to a facility. We derived a propensity score that included over 100 factors potentially related to the choice of analgesic, including demographics, diagnoses, surgeries, and medication coadministrations. Using 3:1 propensity matching, beneficiaries with an opioid claim in the week after hospital discharge (with or without NSAID claims) were matched to beneficiaries with an NSAID claim only. Primary outcomes included death, healthcare utilization (emergency department [ED] visits and rehospitalization), and a composite of known adverse effects of opioids or NSAIDs (fall/fracture, delirium, nausea/vomiting, complications of slowed colonic motility, acute renal failure, and gastritis/duodenitis) within 30 days of discharge. After propensity matching, there were 13,385 beneficiaries in the opioid cohort and 4,677 in the NSAID cohort (mean age: 74 years, 57% female). Beneficiaries receiving opioids had a higher incidence of death (1.8% versus 1.1%; relative risk [RR] 1.7 [1.3 to 2.3], p < 0.001, number needed to harm [NNH] 125), healthcare utilization (19.0% versus 17.4%; RR 1.1 [1.02 to 1.2], p = 0.02, NNH 59), and any potential adverse effect (25.2% versus 21.3%; RR 1.2 [1.1 to 1.3], p < 0.001, NNH 26), compared to those with an NSAID claim only. Specifically, they had higher relative risk of fall/fracture (4.5% versus 3.4%; RR 1.3 [1.1 to 1.6], p = 0.002), nausea/vomiting (9.2% versus 7.3%; RR 1.3 [1.1 to 1.4], p < 0.001), and slowed colonic motility (8.0% versus 6.2%; RR 1.3 [1.1 to 1.4], p < 0.001). Risks of delirium, acute renal failure, and gastritis/duodenitis did not differ between groups. The main limitation of our study is the observational nature of the data and possibility of residual confounding. CONCLUSIONS: Older adults filling an opioid prescription in the week after hospital discharge were at higher risk for mortality and other post-discharge adverse outcomes compared to those filling an NSAID prescription only.

Risk of Immune-related Adverse Events in Melanoma Patients With Preexisting Autoimmune Disease Treated With Immune Checkpoint Inhibitors: A Population-based Study Using SEER-Medicare Data.

OBJECTIVE: The objective of this study was to examine the risk of immune-related adverse events (irAEs) in patients with a preexisting autoimmune disease (pAID) presenting with a cutaneous melanoma receiving an immune checkpoint inhibitor (ICI) therapy. METHODS: Data from the Surveillance, Epidemiology, and End Results cancer registries and linked Medicare claims between January 2010 and December 2015 was used to identify patients diagnosed with cutaneous melanoma who had pAID or received ICI or both. Patients were then stratified into 3 groups: ICI+pAID, non-ICI+pAID, and ICI+non-pAID. Inverse probability of treatment weighted Cox proportional hazards regression models were fitted to assess the risk of cardiac, pulmonary, endocrine, and neurological irAE. RESULTS: In total, 3704 individuals were included in the analysis. The majority of patients consisted of non-ICI+pAID patients (N=2706/73.1%), while 106 (2.9%) patients and 892 (24.1%) were classified as ICI+pAID and ICI+non-pAID, respectively. The risk of irAE was higher in the ICI+pAID group compared with the non-ICI+pAID and ICI+non-pAID, respectively (non-ICI: cardiac: hazard ratio [HR]=3.59, 95% confidence interval [CI]: 2.83-4.55; pulmonary: HR=3.94, 95% CI: 3.23-4.81; endocrine: HR=1.72, 95% CI: 1.53-1.93; neurological: HR=3.88, 95% CI: 2.30-6.57/non-pAID: cardiac: HR=3.83, 95% CI: 3.39-4.32; pulmonary: HR=2.08, 95% CI: 1.87-2.32; endocrine: HR=1.23, 95% CI: 1.14-1.32; neurological: HR=3.77, 95% CI: 2.75-5.18). CONCLUSIONS: Patients with a pAID face a significantly higher risk of irAEs. Further research examining the clinical impact of these events on the patients' oncological outcome and quality of life is urgently needed given our findings of significantly worse rates of adverse events.

Causality assessment between reported fatal cerebral haemorrhage and suspected drugs: developing a new algorithm based on the analysis of the Japanese Adverse Event Report (JADER) database and literature review.

PURPOSE: Cerebral haemorrhage is a life-threatening event with various causes including adverse drug reactions (ADRs). Several methods have been proposed for the causality assessment of ADRs, but none specific for cerebral haemorrhage. The purpose of this study was to develop an algorithm for causality assessment between drugs and fatal cerebral haemorrhage, based on the analysis of data from the Japanese Adverse Drug Event Report (JADER) database and literature review. METHODS: All fatal ADRs reported in the JADER database between April 2004 and March 2020 were searched, and literature on drug-related cerebral haemorrhage or general causality assessment was reviewed to summarise the information on causality between cerebral haemorrhage and ADRs. RESULTS: Of the 50,095 cases identified in the JADER database, cerebral haemorrhage was the fifth most reported cause of fatal ADRs, but the causality of >80% of the events was published as 'Unassessable'. The literature review identified articles on drug-related cerebral haemorrhage and causality assessment methods in general. Based on these articles, information on five categories (temporal relationship, previous knowledge about the relationship between drug action and ADRs, alternative aetiological candidate, appropriateness of drug use, and the relationship between death and ADRs) was determined for causality assessment between a suspected drug and fatal cerebral haemorrhage; a new algorithm was created using this information. CONCLUSION: In this study, the information considered necessary for causality assessment between drugs and fatal cerebral haemorrhage was reviewed and an assessment algorithm was developed. Future studies are needed to validate the usefulness of this method.

Adverse Drug Reactions in Canada (2009-2018): Insights from the Canada Vigilance Database.

Annually, thousands of individuals die and tens of thousands are hospitalized in association with suspected adverse drug reactions (ADRs) in Canada. We analyzed the reports from the Canada Vigilance Adverse Reaction online database and present a synopsis of the state of ADRs in Canada between 2009 and 2018. Our synopsis includes both cross-sectional and longitudinal insights into ADR demographics, outcomes, associated drugs and disease indications. In closing, we highlight five overarching issues uncovered in our analysis, which have potential implications for future policy formulation. Further in-depth exploration is required to shine some additional light on these issues.

5-Fluorouracil and Capecitabine: Assessment and Treatment of Uncommon Early-Onset Severe Toxicities Associated With Administration.

BACKGROUND: Uncommon early-onset severe toxicities from 5-fluorouracil (5-FU) and capecitabine can be fatal if early warning signs are not recognized and treated promptly. OBJECTIVES: This article delineates the differences between expected side effects and uncommon early-onset severe toxicities from 5-FU and capecitabine. It also provides background for understanding the reasons patients may develop these toxicities and reviews the efficacy of standard supportive care against a novel therapy (uridine triacetate). METHODS: A panel of nurses convened to review the literature about toxicities associated with 5-FU and capecitabine administration and determined methods to educate nurses about toxicities and treatment. FINDINGS: Standard supportive care for 5-FU and capecitabine toxicities is associated with high fatality rates. Uridine triacetate treatment within 96 hours of administration is associated with survival.

Severe adverse events impact overall survival and costs in elderly patients with advanced non-small cell lung cancer on second-line therapy.

OBJECTIVES: Elderly patients with advanced non-small lung cancer (aNSCLC) represent a high-risk patient population due to disease burden, comorbidities, and performance status, particularly after progressing on first-line therapy. Among elderly patients who receive second-line therapy, treatment related toxicities can have substantial impact on both clinical and economic outcomes. This study assessed the impact of severe adverse events (AEs) during second-line therapy on overall survival (OS) and all-cause heathcare costs in elderly with aNSCLC. MATERIALS AND METHODS: Patients with aNSCLC aged ≥65 years who initiated second-line chemotherapy/targeted therapy were identified in the SEER-Medicare database (2007-2011). Fifty-seven AEs were identified by literature review and consultation with two oncologists. Severe AEs were defined as AEs that required a hospitalization and were operationalized based on AE diagnosis(es) recorded during hospitalizations. OS post-second-line initiation and healthcare costs during second-line were compared between patients with and without severe AEs. RESULTS: Among 3967 patients initiating second-line therapy, 1624 (41%) had ≥1 severe AE, where hypertension (26%), anemia (24%), and pneumonia (23%) were most commonly reported. Patients with and without severe AEs had similar demographic and cancer characteristics at diagnosis and similar second-line treatment regimens, but patients with severe AEs had more comorbidities at second-line initiation. Median OS was lower in patients with versus without severe AEs (6 vs. 11 months). After multivariate adjustment, hazard of death was more than twice higher in patients with versus without severe AEs (adjusted hazard ratio [HR] 2.31, 95% CI 2.16-2.47). Healthcare costs were more than twice higher in patients with versus without severe AEs ($16,135 vs. $7559 per-patient-per-month). CONCLUSION: Severe AEs among elderly patients with aNSCLC treated with second-line chemotherapy/targeted therapy were found to be associated with decreased OS and increased healthcare costs. Results suggest a potential link between severe AEs in second-line treated aNSCLC elderly and patient survival and economic burden to the healthcare system.

Evaluation of Amphetamine-Related Hospitalizations and Associated Clinical Outcomes and Costs in the United States.

Importance: Despite indications of increasing amphetamine availability and psychostimulant deaths in the United States, evidence across data sources is mixed, and data on amphetamine-related hospitalizations are lacking. Objective: To clarify trends in amphetamine-related hospitalizations and their clinical outcomes and costs in the United States. Design, Setting, and Participants: This repeated, cross-sectional study used hospital discharge data from the Healthcare Cost and Utilization Project National Inpatient Sample. The nationally representative sample included US adults (n = 1 292 300) who had amphetamine-related hospitalizations between January 1, 2003, and December 31, 2015. Multivariable logistic and Poisson regression models were used to examine in-hospital mortality and length of stay. Analysis of these data was conducted from November 2017 to August 2018. Exposure: Amphetamine dependence or abuse or amphetamine poisoning. Main Outcomes and Measures: Annual hospitalizations, in-hospital mortality, length of stay, transfer to another facility, and costs. Results: Over the 2003 to 2015 study period, there were 1 292 300 weighted amphetamine-related hospitalizations. Of this population, 541 199 (41.9%) were female and 749 392 (58.1%) were male, with a mean age of 37.5 years (95% CI, 37.4-37.7 years). Amphetamine-related hospitalizations, compared with other hospitalizations, were associated with age younger than 65 years (98.0% vs 58.0%; P < .001), male sex (60.3% [95% CI, 59.7%-60.8%] vs 41.1% [95% CI, 40.9%-41.3%]), Medicaid coverage (51.2% [95% CI, 49.8%-52.7%] vs 17.8% [95% CI, 17.5%-18.1%]), and residence in the western United States (58.5% [95% CI, 55.9%-61.0%] vs 18.9% [95% CI, 18.0%-19.8%]). Amphetamine-related hospitalizations declined between 2005 and 2008, and then increased from 55 447 hospitalizations (95% CI, 44 936-65 959) in 2008 to 206 180 hospitalizations (95% CI, 95% CI, 189 188-223 172) in 2015. Amphetamine-related hospitalizations increased to a greater degree than hospitalizations associated with other substances. Adjusted mean length of stay (5.9 [95% CI, 5.8-6.0] vs 4.7 [95% CI, 4.7-4.8] days; P < .001), transfer to another facility (26.0% [95% CI, 25.3%-26.8%] vs 18.5% [95% CI, 18.3%-18.6%]; P < .001), and mean in-hospital mortality (28.3 [95% CI, 26.2-30.4] vs 21.9 [95% CI, 21.6-22.1] deaths per 1000 hospitalizations; P < .001) were higher for amphetamine-related than other hospitalizations. Annual hospital costs related to amphetamines increased from $436 million (95% CI, $312 million-$559 million) in 2003 to $2.17 billion (95% CI, $1.95 billion-$2.39 billion) by 2015. Conclusions and Relevance: Given that amphetamine-related hospitalizations and costs substantially increased between 2003 and 2015, pharmacologic and nonpharmacologic therapies for amphetamine use disorders and a coordinated public health response are needed to curb these rising rates.

Improving Assessment of Drug Safety Through Proteomics: Early Detection and Mechanistic Characterization of the Unforeseen Harmful Effects of Torcetrapib.

BACKGROUND: Early detection of adverse effects of novel therapies and understanding of their mechanisms could improve the safety and efficiency of drug development. We have retrospectively applied large-scale proteomics to blood samples from ILLUMINATE (Investigation of Lipid Level Management to Understand its Impact in Atherosclerotic Events), a trial of torcetrapib (a cholesterol ester transfer protein inhibitor), that involved 15 067 participants at high cardiovascular risk. ILLUMINATE was terminated at a median of 550 days because of significant absolute increases of 1.2% in cardiovascular events and 0.4% in mortality with torcetrapib. The aims of our analysis were to determine whether a proteomic analysis might reveal biological mechanisms responsible for these harmful effects and whether harmful effects of torcetrapib could have been detected early in the ILLUMINATE trial with proteomics. METHODS: A nested case-control analysis of paired plasma samples at baseline and at 3 months was performed in 249 participants assigned to torcetrapib plus atorvastatin and 223 participants assigned to atorvastatin only. Within each treatment arm, cases with events were matched to controls 1:1. Main outcomes were a survey of 1129 proteins for discovery of biological pathways altered by torcetrapib and a 9-protein risk score validated to predict myocardial infarction, stroke, heart failure, or death. RESULTS: Plasma concentrations of 200 proteins changed significantly with torcetrapib. Their pathway analysis revealed unexpected and widespread changes in immune and inflammatory functions, as well as changes in endocrine systems, including in aldosterone function and glycemic control. At baseline, 9-protein risk scores were similar in the 2 treatment arms and higher in participants with subsequent events. At 3 months, the absolute 9-protein derived risk increased in the torcetrapib plus atorvastatin arm compared with the atorvastatin-only arm by 1.08% (P=0.0004). Thirty-seven proteins changed in the direction of increased risk of 49 proteins previously associated with cardiovascular and mortality risk. CONCLUSIONS: Heretofore unknown effects of torcetrapib were revealed in immune and inflammatory functions. A protein-based risk score predicted harm from torcetrapib within just 3 months. A protein-based risk assessment embedded within a large proteomic survey may prove to be useful in the evaluation of therapies to prevent harm to patients. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00134264.

The Yusuf-Peto method was not a robust method for meta-analyses of rare events data from antidepressant trials.

OBJECTIVES: The aim of the study was to identify the validity of effect estimates for serious rare adverse events in clinical study reports of antidepressants trials, across different meta-analysis methods. STUDY DESIGN AND SETTING: Four serious rare adverse events (all-cause mortality, suicidality, aggressive behavior, and akathisia) were meta-analyzed using different methods. The Yusuf-Peto odds ratio ignores studies with no events and was compared with the alternative approaches of generalized linear mixed models (GLMMs), conditional logistic regression, a Bayesian approach using Markov Chain Monte Carlo (MCMC), and a beta-binomial regression model. RESULTS: The estimates for the four outcomes did not change substantially across the different methods; the Yusuf-Peto method underestimated the treatment harm and overestimated its precision, especially when the estimated odds ratio deviated greatly from 1. For example, the odds ratio for suicidality for children and adolescents was 2.39 (95% confidence interval = 1.32-4.33), using the Yusuf-Peto method but increased to 2.64 (1.33-5.26) using conditional logistic regression, to 2.69 (1.19-6.09) using beta-binomial, to 2.73 (1.37-5.42) using the GLMM, and finally to 2.87 (1.42-5.98) using the MCMC approach. CONCLUSION: The method used for meta-analysis of rare events data influences the estimates obtained, and the exclusion of double-zero event studies can give misleading results. To ensure reduction of bias and erroneous inferences, sensitivity analyses should be performed using different methods instead of the Yusuf-Peto approach, in particular the beta-binomial method, which was shown to be superior through a simulation study.

Biometrical issues in the analysis of adverse events within the benefit assessment of drugs.

The analysis of adverse events plays an important role in the benefit assessment of drugs. Consequently, results on adverse events are an integral part of reimbursement dossiers submitted by pharmaceutical companies to health policy decision-makers. Methods applied in the analysis of adverse events commonly include simple standard methods for contingency tables. However, the results produced may be misleading if observations are censored at the time of discontinuation due to treatment switching or noncompliance, resulting in unequal follow-up periods. In this paper, we present examples to show that the application of inadequate methods for the analysis of adverse events in the reimbursement dossier can lead to a downgrading of the evidence on a drug's benefit in the subsequent assessment, as greater harm from the drug cannot be excluded with sufficient certainty. Legal regulations on the benefit assessment of drugs in Germany are presented, in particular, with regard to the analysis of adverse events. Differences in safety considerations between the drug approval process and the benefit assessment are discussed. We show that the naive application of simple proportions in reimbursement dossiers frequently leads to uninterpretable results if observations are censored and the average follow-up periods differ between treatment groups. Likewise, the application of incidence rates may be misleading in the case of recurrent events and unequal follow-up periods. To allow for an appropriate benefit assessment of drugs, adequate survival time methods accounting for time dependencies and duration of follow-up are required, not only for time-to-event efficacy endpoints but also for adverse events. © 2016 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd.

Classification of treatment-related mortality in children with cancer: a systematic assessment.

Treatment-related mortality is an important outcome in paediatric cancer clinical trials. An international group of experts in supportive care in paediatric cancer developed a consensus-based definition of treatment-related mortality and a cause-of-death attribution system. The reliability and validity of the system was tested in 30 deaths, which were independently assessed by two clinical research associates and two paediatric oncologists. We defined treatment-related mortality as death occurring in the absence of progressive cancer. Of the 30 reviewed deaths, the reliability of classification for treatment-related mortality was noted as excellent by clinical research associates (κ=0·83, 95% CI 0·60-1·00) and paediatric oncologists (0·84, 0·63-1·00). Criterion validity was established because agreement between the consensus classifications by clinical research associates and paediatric oncologists was almost perfect (0·92, 0·78-1·00). Our approach should allow comparison of treatment-related mortality across trials and across time.

Epidemiology of adverse drug reactions in Europe: a review of recent observational studies.

Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3 September 2014. Included studies assessed the number of patients who were admitted to hospital due to an ADR, studies that assessed the number of patients who developed an ADR during hospitalization, and studies that measured ADRs in the outpatient setting. In total, 47 articles were included in the final review. The median percentage of hospital admissions due to an ADR was 3.5 %, based on 22 studies, and the median percentage of patients who experienced an ADR during hospitalization was 10.1 %, based on 13 studies. Only five studies were found that assessed ADRs occurring in the outpatient setting. These results indicate that the occurrence of ADRs in the European hospital setting-both ADRs that result in hospitalization and ADRs that occur during the hospital stay-is significant. Furthermore, the limited number of studies that were performed in the outpatient setting identify a lack of information regarding the epidemiology of ADRs in this setting.

Quality-of-life-adjusted hazard of death: a formulation of the quality-adjusted life-years model of use in benefit-risk assessment.

BACKGROUND: Although the quality-adjusted life-years (QALY) model is standard in health technology assessment, quantitative methods are less frequent but increasingly used for benefit-risk assessment (BRA) at earlier stages of drug development. A frequent challenge when implementing metrics for BRA is to weigh the importance of effects on a chronic condition against the risk of severe events during the trial. The lifetime component of the QALY model has a counterpart in the BRA context, namely, the risk of dying during the study. METHODS: A new concept is presented, the hazard of death function that a subject is willing to accept instead of the baseline hazard to improve his or her chronic health status, which we have called the quality-of-life-adjusted hazard of death. RESULTS: It has been proven that if assumptions of the linear QALY model hold, the excess mortality rate tolerated by a subject for a chronic health improvement is inversely proportional to the mean residual life. CONCLUSIONS: This result leads to a new representation of the linear QALY model in terms of hazard rate functions and allows utilities obtained by using standard methods involving trade-offs of life duration to be translated into thresholds of tolerated mortality risk during a short period of time, thereby avoiding direct trade-offs using small probabilities of events during the study, which is known to lead to bias and variability.

Drug-induced deaths - United States, 1999-2010.

Drug-induced deaths include all deaths for which drugs are the underlying cause, including those attributable to acute poisoning by drugs (drug overdoses) and deaths from medical conditions resulting from chronic drug use (e.g., drug-induced Cushing's syndrome). A drug includes illicit or street drugs (e.g., heroin and cocaine), as well as legal prescription and over-the-counter drugs; alcohol is not included. Deaths from drug overdose have increased sharply in the past decade. This increase has been associated with overdoses of prescription opioid pain relievers, which have more than tripled in the past 20 years, escalating to 16,651 deaths in the United States in 2010. Most drug-induced deaths are unintentional drug poisoning deaths, with suicidal drug poisoning and drug poisoning of undetermined intent comprising the majority of the remainder.

Adverse drug events resulting in admission to the intensive care unit in oncology patients: Incidence, characteristics and associated cost.

PURPOSE: Describe the incidence, characteristics and cost of adverse drug events that necessitate admission to the intensive care unit in oncology patients. METHODS: This was a prospective observational 5-months study at a medical/surgical intensive care unit of a comprehensive teaching cancer center. Patients admitted to the intensive care unit were screened to determine whether the admission was due to an adverse drug event. The adverse drug events were characterized based on the suspected medication, system involved and preventability. Patient demographics, length of stay, mortality and the total patient charges during their intensive care unit stay were recorded. RESULTS: During the study period, 249 patients were screened and an adverse drug event was the primary cause of 57 (22.9%) admissions. The most common medications associated with an adverse drug event requiring intensive care unit admission were antineoplastics (n = 37), analgesics (n = 9) and anticoagulants (n = 4). Ten adverse drug events were considered preventable. The average length of stay for patients with adverse drug events resulting in intensive care unit admission was 6.2 days ±9.8 (SD) and the mortality rate was 28.1%. Hematological malignancy was independently associated with adverse drug events resulting in intensive care unit admission. The average patient charges for the intensive care unit stay was US$11,692 ± 17,529 (SD), which corresponded to about US$1.5 million in annual patient charges for a 12-bed intensive care unit at a cancer institution. CONCLUSIONS: Adverse drug events resulting in intensive care unit admission in oncology patients are common and often associated with significant morbidity, mortality, and cost.