Food and Drug Administration approval for medications used in the pediatric intensive care unit: a continuing conundrum.

OBJECTIVES: Many drugs used in the pediatric intensive care unit are administered "off label," i.e., they have been neither thoroughly tested for efficacy and safety nor approved for use in children. The U.S. Congress has enacted legislation to promote standards and requirements for Food and Drug Administration labeling for drugs used in pediatrics. Nevertheless, we hypothesized that most medications used in our pediatric intensive care unit were not Food and Drug Administration approved for use in pediatric patients. DESIGN: A list of medications dispensed in the pediatric intensive care unit from January through February 2008 was obtained from our pharmacy database. We then determined whether each medication had been granted Food and Drug Administration approval for use in children. Medications were divided into the following categories: not approved for use in any pediatric age group, approved for use in limited age groups only, and approved for use in all pediatric age groups. SETTING: A pediatric intensive care unit at a tertiary care hospital with 26 beds and 1,500 admissions per year. MEASUREMENTS AND MAIN RESULTS: In the 2-month period, 248 different medications were dispensed with a total of 49,707 medication orders. Sixty (24.2%) of the medications dispensed were not Food and Drug Administration approved for use in any pediatric age group, 106 (42.7%) were approved for use in limited age groups, and 82 (33%) were approved for use in all pediatric age groups. Eleven of the 25 most frequently dispensed medications were approved for use in limited age groups, but none of them was used for the indication or age group for which they were approved. CONCLUSIONS: Despite the efforts of Congress, 67% of medications prescribed and administered in the pediatric intensive care unit did not have Food and Drug Administration approval or had only limited approval, underscoring the need for the medical community to demand oversight and research to improve drug labeling for our patient population.

Membrane Oxygenator Use With Biventricular Assist Device: Facilitation of Support and Lung Recovery.

We present the use of a low-resistance membrane oxygenator (Quadrox D, Maquet) in series with a pulsatile right ventricular assist device (Berlin Heart EXCOR, Berlin Heart) in a patient with biventricular support who required high-frequency oscillatory ventilation (HFOV), due to refractory acute respiratory distress syndrome associated with Cytomegalovirus pneumonia. The high mean airway pressure associated with the use of HFOV resulted in a significant negative impact on left ventricular assist device (LVAD) filling that led to a combined respiratory and metabolic acidosis and the need for vasopressor support. Oxygenator placement enabled transition to conventional ventilation and the discontinuation of vasopressor support. This case demonstrates the feasibility and safety of the use of this lung support system in patients requiring ventricular assist device (VAD) support.

Fatal complication from a balloon-expandable tracheal stent in a child: a case report.

OBJECTIVE: The use of airway stents in the pediatric population is uncommon, reflected in the few patient series reported in the literature. We describe a fatal complication of tracheal stent placement in an 18-month-old child with spondylothoracic dysplasia. DESIGN: Case report. SETTING: Intensive care unit of a tertiary academic pediatric center. PATIENT: An 18-month-old child with spondylothoracic dysplasia who underwent tracheal stent placement for tracheomalacia. INTERVENTIONS: Management of an acute upper-airway hemorrhage. MAIN RESULTS: The patient died, despite aggressive interventions. CONCLUSION: Use of tracheal stents in pediatric patients with tracheomalacia is not without risks; tracheal erosion with severe hemoptysis is an infrequent but devastating complication of this intervention.

Lung isolation in a child with unilateral necrotizing Clostridium perfringens pneumonia.

OBJECTIVE: To describe lung isolation and the selective application of continuous positive airway pressure using an endobronchial blocker in a patient with sickle cell disease and unilateral necrotizing Clostridium perfringens pneumonia. DESIGN: Case report. SETTING: Pediatric intensive care unit. PATIENT: A 12-yr-old male with sickle cell disease developed persistent necrotizing pneumonia of the left lung following exchange transfusion for acute chest syndrome and hyper-hemolytic syndrome. INTERVENTIONS: An endobronchial blocker was placed into the left main stem bronchus for lung isolation and application of continuous positive airway pressure to the left lung for 48 hrs. MEASUREMENTS AND MAIN RESULTS: After 14 days of persistent atelectasis of the left lung despite thorascopic decortication and multiple bronchoscopies, our patient had substantial lung aeration within 48 hrs of continuous positive airway pressure applied via the endobronchial blocker. Lung resection was avoided and the patient was successfully extubated 2 days after removal of the blocker. CONCLUSIONS: This case report demonstrates a therapeutic application of prolonged lung isolation and differential ventilation in a patient with an airway too small for commercially available double-lumen endotracheal tubes. The apparent success of this intervention suggests the feasibility of selective ventilation in pediatric patients and highlights a novel application of the bronchial blocker.

The physician's role in discussing organ donation with families.

Federal Conditions of Participation from the Health Care Financing Administration (now the Centers for Medicare and Medicaid Services) introduced in 1998 require that all families be presented the option of organ and tissue donation when death is imminent. The perception that physicians were being excluded from participating in this process led to a resolution at the American Medical Association House of Delegates meeting in December 1999, calling on the American Medical Association Council on Scientific Affairs to review the Conditions of Participation "to ensure that there is no prohibition of physician involvement in the organ donation process..." The number of organs procured for transplantation in the United States is insufficient to meet needs. Families' hospital experiences significantly affect their decisions to donate organs. Discussing severe brain injury, brain death, and organ donation after brain death with families is a specialized form of end-of-life decision-making and care in the intensive care unit; however, the knowledge, skills, and attitudes necessary for physicians and nurses to promote good end-of-life decision-making are widely variable. The federal Conditions of Participation require that those making requests of families for organ donation receive specific training. They do not prohibit physician involvement in initiating organ donation requests, provided these individuals are properly trained. Physicians have an important role in caring for patients and families in these circumstances, and the care they provide is enhanced through training, attention to the special issues involved, and collaboration with organ procurement organization personnel.