Coping with critical drug shortages: an ethical approach for allocating scarce resources in hospitals.

The number of critical medication shortages in the United States has reached an unprecedented level, requiring decisions about allocating limited drug supplies. Ad hoc decisions are susceptible to arbitrary judgments, revealing preformed biases for or against groups of people. Health care institutions lack standardized protocols for rationing scarce drugs. We describe the principles on which an ethically justifiable policy of medication allocation during critical shortages was created at our hospital. Based on supportable scientific evidence and with all clinically similar patients treated as similarly deserving of consideration, drugs were distributed according to a hierarchy of clinical need and predicted efficacy. We explain the ethical rationale for the procedures we adopted, how the policy was implemented at a large academic medical center, and more than 1 year of experience with a number of different medications. Our experience has demonstrated the feasibility and utility of formulating a rational and ethically sound policy for scarce resource allocation in an academic teaching hospital that could be used in a variety of health care settings. The method has proven to be reliable, workable, and acceptable to clinicians, staff, and patients.

One-year trajectories of care and resource utilization for recipients of prolonged mechanical ventilation: a cohort study.

BACKGROUND: Growing numbers of critically ill patients receive prolonged mechanical ventilation. Little is known about the patterns of care as patients transition from acute care hospitals to postacute care facilities or about the associated resource utilization. OBJECTIVE: To describe 1-year trajectories of care and resource utilization for patients receiving prolonged mechanical ventilation. DESIGN: 1-year prospective cohort study. SETTING: 5 intensive care units at Duke University Medical Center, Durham, North Carolina. PARTICIPANTS: 126 patients receiving prolonged mechanical ventilation (defined as ventilation for >or=4 days with tracheostomy placement or ventilation for >or=21 days without tracheostomy), as well as their 126 surrogates and 54 intensive care unit physicians, enrolled consecutively over 1 year. MEASUREMENTS: Patients and surrogates were interviewed in the hospital, as well as 3 and 12 months after discharge, to determine patient survival, functional status, and facility type and duration of postdischarge care. Physicians were interviewed in the hospital to elicit prognoses. Institutional billing records were used to assign costs for acute care, outpatient care, and interfacility transportation. Medicare claims data were used to assign costs for postacute care. RESULTS: 103 (82%) hospital survivors had 457 separate transitions in postdischarge care location (median, 4 transitions [interquartile range, 3 to 5 transitions]), including 68 patients (67%) who were readmitted at least once. Patients spent an average of 74% (95% CI, 68% to 80%) of all days alive in a hospital or postacute care facility or receiving home health care. At 1 year, 11 patients (9%) had a good outcome (alive with no functional dependency), 33 (26%) had a fair outcome (alive with moderate dependency), and 82 (65%) had a poor outcome (either alive with complete functional dependency [4 patients; 21%] or dead [56 patients; 44%]). Patients with poor outcomes were older, had more comorbid conditions, and were more frequently discharged to a postacute care facility than patients with either fair or good outcomes (P < 0.05 for all). The mean cost per patient was $306,135 (SD, $285,467), and total cohort cost was $38.1 million, for an estimated $3.5 million per independently functioning survivor at 1 year. LIMITATION: The results of this single-center study may not be applicable to other centers. CONCLUSION: Patients receiving prolonged mechanical ventilation have multiple transitions of care, resulting in substantial health care costs and persistent, profound disability. The optimism of surrogate decision makers should be balanced by discussions of these outcomes when considering a course of prolonged life support. PRIMARY FUNDING SOURCE: None.

Economic evaluation of propofol and lorazepam for critically ill patients undergoing mechanical ventilation.

OBJECTIVE: The economic implications of sedative choice in the management of patients receiving mechanical ventilation are unclear because of differences in costs and clinical outcomes associated with specific sedatives. Therefore, we aimed to determine the cost-effectiveness of the most commonly used sedatives prescribed for mechanically ventilated critically ill patients. DESIGN, SETTING, AND PATIENTS: Adopting the perspective of a hospital, we developed a probabilistic decision model to determine whether continuous propofol or intermittent lorazepam was associated with greater value when combined with daily awakenings. We also evaluated the comparative value of continuous midazolam in secondary analyses. We assumed that patients were managed in a medical intensive care unit and expected to require ventilation for > or = 48 hrs. Model inputs were derived from primary analysis of randomized controlled trial data, medical literature, Medicare reimbursement rates, pharmacy databases, and institutional data. MAIN RESULTS: We measured cost-effectiveness as costs per mechanical ventilator-free day within the first 28 days after intubation. Our base-case probabilistic analysis demonstrated that propofol dominated lorazepam in 91% of simulations and, on average, was both $6,378 less costly per patient and associated with more than three additional mechanical ventilator-free days. The model did not reveal clinically meaningful differences between propofol and midazolam on costs or measures of effectiveness. CONCLUSION: Propofol has superior value compared with lorazepam when used for sedation among the critically ill who require mechanical ventilation when used in the setting of daily sedative interruption.

An economic evaluation of prolonged mechanical ventilation.

OBJECTIVE: Patients who receive prolonged mechanical ventilation have high resource utilization and relatively poor outcomes, especially the elderly, and are increasing in number. The economic implications of prolonged mechanical ventilation provision, however, are uncertain and would be helpful to providers and policymakers. Therefore, we aimed to determine the lifetime societal value of prolonged mechanical ventilation. DESIGN AND PATIENTS: Adopting the perspective of a healthcare payor, we developed a Markov model to determine the cost effectiveness of providing mechanical ventilation for at least 21 days to a 65-yr-old critically ill base-case patient compared with the provision of comfort care resulting in withdrawal of ventilation. Input data were derived from the medical literature, Medicare, and a recent large cohort study of ventilated patients. MEASUREMENTS AND MAIN RESULTS: We determined lifetime costs and survival, quality-adjusted life expectancy, and cost effectiveness as reflected by costs per quality-adjusted life-year gained. Providing prolonged mechanical ventilation to the base-case patient cost "dollars"55,460 per life-year gained and "dollars"82,411 per quality-adjusted life-year gained compared with withdrawal of ventilation. Cost-effectiveness ratios were most sensitive to variation in age, hospital costs, and probability of readmission, although less sensitive to postacute care-facility costs. Specifically, incremental costs per quality-adjusted life-year gained by prolonged mechanical ventilation provision exceeded "dollars"100,000 with age >or=68 and when predicted 1-yr mortality was >50%. CONCLUSIONS: The cost effectiveness of prolonged mechanical ventilation provision varies dramatically based on age and likelihood of poor short- and long-term outcomes. Identifying patients likely to have unfavorable outcomes, lowering intensity of care for appropriate patients, and reducing costly readmissions should be future priorities in improving the value of prolonged mechanical ventilation.

Differences in one-year health outcomes and resource utilization by definition of prolonged mechanical ventilation: a prospective cohort study.

INTRODUCTION: The outcomes of patients ventilated for longer than average are unclear, in part because of the lack of an accepted definition of prolonged mechanical ventilation (PMV). To better understand the implications of PMV provision, we compared one-year health outcomes between two common definitions of PMV as well as between PMV patients and those ventilated for shorter periods of time. METHODS: We conducted a secondary analysis of prospectively collected data from medical and surgical intensive care units at an academic tertiary care medical center. The study included 817 critically ill patients ventilated for > or = 48 hours, 267 (33%) of whom received PMV based on receipt of a tracheostomy and ventilation for > or = 96 hours. A total of 114 (14%) patients met the alternate definition of PMV by being ventilated for > or = 21 days. Survival, functional status, and costs were measured at baseline and at 2, 6, and 12 months after discharge. Of one-year survivors, 71 (17%) were lost to follow up. RESULTS: PMV patients ventilated for > or = 21 days had greater costs ($140,409 versus $143,389) and higher one-year mortality (58% versus 48%) than did PMV patients with tracheostomies who were ventilated for > or = 96 hours. The majority of PMV deaths (58%) occurred after hospital discharge whereas 67% of PMV patients aged 65 years or older had died by one year. At one year PMV patients on average had limitations in two basic and five instrumental elements of functional status that exceeded both their pre-admission status and the one-year disability of those ventilated for < 96 hours. Costs per one-year survivor were $423,596, $266,105, and $165,075 for patients ventilated > or = 21 days, > or = 96 hours with a tracheostomy, and < 96 hours, respectively. CONCLUSION: Contrasting definitions of PMV capture significantly different patient populations, with > or = 21 days of ventilation specifying the most resource-intensive recipients of critical care. PMV patients, particularly the elderly, suffer from a significant burden of costly, chronic critical illness and are at high risk for death throughout the first year after intensive care.