Medication use in the neonatal intensive care unit: current patterns and off-label use of parenteral medications.

OBJECTIVES: To study the current patterns of medication use, assess the extent of off-label parenteral medication use, and evaluate evidence for efficacy and safety of parenteral medications used off-label in neonates. STUDY DESIGN: We collected information on all medications dispensed for infants admitted to an urban tertiary care neonatal intensive care unit over a 3-year period. Parenteral drugs were reviewed for off-label use, and medications not approved for use in neonates were evaluated for evidence of efficacy and safety in neonates. RESULTS: The ranges of gestational age, length of stay, and number of medications per infant were 23 to 42 weeks, 1 to 190 days, and 1 to 62, respectively, for 2304 admissions during the study period. Infants with lower birth weight and shorter gestational age received more medications compared with more mature infants. Of 61 parenteral medications evaluated, 27 (45%) were used off-label in neonates. Food and Drug Administration (FDA) approval for use in neonatal period was highest for antibiotics (14/16); the parenteral medications most frequently used off-label were analgesics, vasopressors, and hematologic agents. CONCLUSIONS: Critically ill neonates are exposed to numerous medications, a significant proportion of which are not yet FDA-approved for use in this vulnerable group of patients.

Developing a model to determine the effects of adverse drug events in hospital inpatients.

PURPOSE: A study was conducted to develop a model to identify adverse drug events (ADEs) and quantify their effect on quality and cost in a large tertiary care hospital. METHODS: The drug-ADE relationship between unfractionated heparin and heparin-induced bleeding was studied for all inpatients receiving heparin infusions at the hospital between January 1 and December 31, 2004. Activated partial thromboplastin time (aPTT) values were used to help determine if the patients received blood products in response to excessive anticoagulation with heparin. The number of aPTT values of > or =150 seconds and the last aPTT value before discharge were evaluated. The key outcome measures were length of stay, cost per admission, and mortality. Of the 1455 admissions to the hospital, 122 patients received blood products before receiving heparin infusion only, 264 received blood products after receiving the drug only, 221 received blood products both before and after, and 848 who received the drug never received blood products. RESULTS: Differences in full cost and length of stay between the group receiving heparin infusion only and the groups receiving both blood products were significant. Differences in mortality between the group only receiving heparin infusion and the groups receiving both heparin infusion and blood products were also significant. CONCLUSION: Using the model developed to study the effect of heparin-induced bleeding, we found that the cost per patient day was highest for patients receiving blood products after heparin infusion treatment. There was a positive correlation between one or more aPTT values of > or =150 seconds and undesirable patient outcomes.

Lack of effect of fluoroquinolone resistance on mortality in subjects with Pseudomonas aeruginosa bacteraemia.

OBJECTIVES: Despite the well-documented increase in fluoroquinolone resistance to Pseudomonas aeruginosa, the effect on pathogenicity is unknown. This paper will explore the clinical effect. METHODS: A retrospective, observational, cohort study of 215 hospital inpatients was performed. Subjects with fluoroquinolone-resistant P. aeruginosa (FQRPA) bacteraemia were compared to subjects with fluoroquinolone-sensitive P. aeruginosa (FQSPA) bacteraemia from January 2000 to December 2003. Mortality prior to discharge, time to discharge, and time to negative culture were assessed. Additionally, baseline morbidity/mortality risk factors including Charlson morbidity score (CMS) were assessed. RESULTS: Mortality prior to discharge (32 vs. 29%, P=0.73), mean days to discharge (17.5 vs. 14.6, P=0.24), and mean days to negative culture (3.6 vs. 3.2, P=0.1) did not differ between FQRPA and FQSPA, respectively. Active antibiotic treatment within 24h of drawn blood culture (FQRPA 63% vs. FQSPA 93%, P<0.0001) and median CMS (FQRPA 3 vs. FQSPA 5, P=0.004) differed significantly between the groups. CONCLUSIONS: Subjects with FQRPA received active antibiotics less often within 24h of obtained culture. A large difference in mortality does not likely exist based on fluoroquinolone susceptibility. A study with greater enrollment must be conducted to determine if fluoroquinolone resistance imparts a smaller yet clinically significant impact on clinical outcomes.

Hospitalwide adverse drug events before and after limiting weekly work hours of medical residents to 80.

PURPOSE: Adverse drug events (ADEs) at a hospital before and after the weekly work hours of medical residents were limited to 80 were studied. METHODS: The study population included all adults admitted to a 750-bed academic tertiary care hospital where resident physicians provide direct care under the supervision of faculty attending physicians. The six-month period after implementation of the 80-hour work limit (July 1 to December 31, 2003) was compared with the same six-month period one year before implementation (July 1 to December 31, 2002). RESULTS: There were no significant differences between study periods in any measured variables, including number of confirmed ADEs (194 before, 172 after), number of ADEs per 1000 patient days (1.3 before, 1.1 after), and number of preventable ADEs (21 before, 22 after). CONCLUSION: Hospitalwide ADEs remained constant despite limiting of resident physician weekly work hours to 80.

Comparison of treatment of patients with congestive heart failure by cardiologists versus noncardiologists.

PURPOSE: The frequency of treatment with Heart Failure Society of America (HFSA)-recommended medications for the management of congestive heart failure (CHF) by cardiologists versus noncardiologists was studied. METHODS: The medical records of 227 patients admitted to our institution between January and June 2000 with a discharge diagnosis of CHF were retrospectively reviewed. Data collected included demographic information and medical history, severity of illness, prescribed level of hospital care at the time of admission, diagnostic evaluations conducted during admission, medications prescribed at admission and discharge, and any noted contraindications to these medications. Data for patients treated by cardiologists versus noncardiologists were compared. RESULTS: Patients treated by cardiologists were significantly more likely to be admitted to an intensive care unit; receive chest x-rays, electrocardiograms, nuclear medicine tests, cardiac catheterizations, and stress tests; and have their weight monitored daily than were patients treated by noncardiologists. The majority of patients with CHF who were eligible for an angiotensin-converting-enzyme (ACE) inhibitor, a beta-blocker, or an aldosterone antagonist did not receive these medications, regardless of the treating physician. Cardiologists prescribed significantly more beta-blockers and aldosterone antagonists for eligible patients at hospital admission. Greater differences were seen in discharge medications, as cardiologists were significantly more likely to prescribe ACE inhibitors, digoxin, beta-blockers, and aldosterone antagonists. CONCLUSION: Hospitalized patients with CHF were more likely to receive HFSA-recommended medications on admission and discharge when treated by cardiologists versus noncardiologists. Neither cardiologists nor noncardiologists prescribed ACE inhibitors to all eligible patients as frequently as recommended by HFSA guidelines.