Implementation of an ICU bundle along with staff education and case conferences is effective for improving delirium screening, detection, and treatment and is associated with decreased delirium prevalence.

The probability of achieving an AUC/MIC > 400 using only a trough serum concentration and an MIC with patients receiving 15 mg/kg every 6 hours is variable based on the method used to calculate the AUC. An AUC/MIC of 400 in children correlated to a trough concentration of 11 mg/L using a trapezoidal Method to calculate AUC.

OBJECTIVE: To compare withdrawal symptoms among pediatric intensive care patients receiving clonidine to those not receiving clonidine while being weaned from long-term dexmedetomidine. METHODS: This retrospective analysis evaluated Withdrawal Assessment Tool-1 (WAT-1) scores and hemodynamic parameters in pediatric patients on dexmedetomidine for 5 days or longer between January 1, 2009, and December 31, 2012. The primary objective was to compare withdrawal symptoms based on the number of elevated WAT-1 scores among patients on clonidine to those not on clonidine, while being weaned from long-term dexmedetomidine. The secondary objective was to describe withdrawal symptoms associated with long-term dexmedetomidine use. RESULTS: Nineteen patients (median age, 1.5 years; interquartile range [IQR], 0.67–3.3) received 20 treatment courses of dexmedetomidine for at least 5 days. Clonidine was received by patients during 12 of the treatment courses. The patients in the clonidine group had an average of 0.8 (range, 0–6) elevated WAT-1 scores 24 hours post wean compared to an average of 3.2 (0–8) elevated WAT-1 scores in the no clonidine group (p = 0.49). There were no significant difierences between prewean and postwean systolic or diastolic blood pressures among the 2 groups. The average heart rate during the postwean period was 112 beats per minute (bpm) (range, 88.5–151.5) in the clonidine group compared to 138.4 bpm (range, 117.8–168.3) in the no clonidine group (p = 0.003). In the clonidine group, the mean change in heart rate postwean compared to prewean was an increase of 3.6 bpm (range, −39.6 to 47.5), compared to a mean increase of 29.9 bpm (range, 5.5–74.7) in the no clonidine group (p = 0.042). CONCLUSIONS: There was no difierence in WAT-1 scores between groups, with the clonidine group displaying a trend towards fewer elevated WAT-1 scores during the 24 hours post dexmedetomidine wean. Patients who received clonidine had significantly lower heart rates than the no clonidine group.

OBJECTIVE To describe the use of pharmacologic treatment in critically ill children treated according to a delirium protocol and compare those treated with antipsychotics to those treated non-pharmacologically. METHODS The study included a retrospective matched cohort describing patients who were pharmacologically treated for delirium compared to those with delirium but not treated in a PICU from December 2013 to September 2015, using a delirium management protocol. Patients were matched by age, sex, diagnosis, mechanical ventilation (MV), and presence of delirium. RESULTS Of 1875 patients screened, 188 (10.03%) were positive for delirium. Of those, 15 patients (8%) were treated with an antipsychotic for delirium. Patients with delirium treated with antipsychotics were younger, had more delirium days (6 vs. 3, p=0.022), longer MV days (14 vs. 7, p=0.017), and longer PICU length of stay (34 vs. 16 days, p=0.029) than in the untreated group. Haloperidol, risperidone, and quetiapine were used in 9, 6, and 2 patients, respectively. Two patients were treated with multiple antipsychotics. Antipsychotic treatment was initiated on day 2 of delirium for 8 of 15 patients (53.3%). Ten patients in the treatment group had improved delirium scores by day 2 of treatment. No significant differences in sedation exposure between groups. No significant adverse effects were reported. CONCLUSIONS No significant adverse events seen in this small cohort of critically ill pediatric patients with delirium treated with antipsychotic therapy. Patients with early-onset delirium refractory to non-pharmacologic treatment may have a more effective response to antipsychotic therapy than patients with late-onset refractory delirium.

Aortitis is a rare disorder involving inflammation of one or more layers of the aortic wall and is a risk factor for acute aortic syndromes, including aortic dissection and rupture. 1 It presents with nonspecific symptoms such as abdominal pain, back pain, fever, malaise, and elevated inflammatory markers, which make diagnosis challenging. Aortitis can be classified as either infectious or noninfectious. Infectious causes are rarer than noninfectious, which include rheumatologic disorders such as giant cell arteritis and Takayasu arteritis. 1 We report a case series of fulminant aortitis associated with the use of granulocyte colony-stimulating factor (G-CSF), a myeloid growth factor indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae.We searched the FDA adverse event reporting system (FAERS) and the medical literature through April 5, 2018 for post-marketing cases of aortitis in patients treated with G-CSFs. In addition to filgrastim and pegfilgrastim, the biologic tbo-filgrastim and the biosimilar filgrastim-sndz were included in this search, as well as lipegfilgrastim and lenograstim, two chemically distinct G-CSFs that are only available outside of the US. Cases were included if there was a temporal exposure to a G-CSF and a diagnosis of aortitis was reported by a health care professional. Cases were excluded if the adverse event was not aortitis, aortitis was attributed to an alternate etiology, or insufficient information was provided.We identified 15 FAERS cases of G-CSF associated aortitis that met our case definition, four of which were also published in the literature. Nine cases were associated with the long acting pegfilgrastim, four with filgrastim, and one with lenograstim. Twelve cases occurred in women and the mean patient age was 62 years old. Table 1 In all cases, aortitis was unlikely attributed to underlying disease or other drugs. Two cases received G-CSF as a stem cell donor, one of which was an otherwise healthy 55-year old female who developed aortitis 6 days after her initial dose of filgrastim. 4 All patients with an underlying cancer diagnosis (n = 13) received chemotherapy concomitantly with the G-CSF product. Cases received a variety of chemotherapeutic agents, (bevacizumab, carboplatin, cisplatin, cyclophosphamide, docetaxel, doxorubicin, epirubicin, fluorouracil, paclitaxel, pertuzumab, rituximab, trastuzumab, and vincristine) none of which have been associated with aortitis. None of the cases had a history of aortic disease.

No abstract

This commentary from the 2010 Task Force on Acute Care Practice Model of the American College of Clinical Pharmacy was developed to compare and contrast the "unit-based" and "service-based" orientation of the clinical pharmacist within an acute care pharmacy practice model and to offer an informed opinion concerning which should be preferred. The clinical pharmacy practice model must facilitate patient-centered care and therefore must position the pharmacist to be an active member of the interprofessional team focused on providing high-quality pharmaceutical care to the patient. Although both models may have advantages and disadvantages, the most important distinction pertains to the patient care role of the clinical pharmacist. The unit-based pharmacist is often in a position of reacting to an established order or decision and frequently is focused on task-oriented clinical services. By definition, the service-based clinical pharmacist functions as a member of the interprofessional team. As a team member, the pharmacist proactively contributes to the decision-making process and the development of patient-centered care plans. The service-based orientation of the pharmacist is consistent with both the practice vision embraced by ACCP and its definition of clinical pharmacy. The task force strongly recommends that institutions pursue a service-based pharmacy practice model to optimally deploy their clinical pharmacists. Those who elect to adopt this recommendation will face challenges in overcoming several resource, technologic, regulatory, and accreditation barriers. However, such challenges must be confronted if clinical pharmacists are to contribute fully to achieving optimal patient outcomes. Key Words: clinical pharmacist, clinical pharmacy, practice model, pharmacotherapy. (Pharmacotherapy 2012;32(2):e35-e44)The 2010 Task Force on Acute Care Practice Model of the American College of Clinical Pharmacy was charged with preparing this commentary to critically compare and contrast the "unit-based" and "service-based" acute care practice models for the delivery of clinical pharmacy services and relate these practice models to the definition of clinical pharmacy and other relevant ACCP documents. The task force's charge reflected concern that the unitbased model, which has evolved in many acute care settings, places the clinical pharmacist in an intrinsically reactive position in the therapeutic decision-making process. Thus, rather than having the opportunity to participate proactively in the evaluation and selection A C C P C O M M E N T A R Y

Objectives Half of prescription drugs commonly given to children lack product labeling on pediatric safety, efficacy, and dosing. Two drugs most widely used off-label in pediatrics are azithromycin and fentanyl. We sought to determine the risk of serious adverse events (SAEs) when oral azithromycin or intravenous/intramuscular fentanyl are used off-label compared to on-label in pediatric intensive care units (ICUs). Study Design Six pediatric hospitals participated in a retrospective chart review of patients administered oral azithromycin (n = 241) or intravenous/intramuscular fentanyl (n = 367) between January 5, 2013 and December 26, 2014. Outcomes were SAEs by drug and labeling status: off-label compared to on-label by Food and Drug Administration (FDA)-approved age and/or indication. Statistical analysis was performed using logistic regression to estimate odds ratios (ORs) and Cox regression to estimate hazard ratios (HRs). Results Twenty-one (9%) children receiving azithromycin experienced SAEs. Off-label use of azithromycin was not associated with a higher risk of SAE (OR 0.87, 95% CI 0.27–2.71, p = 0.81). Ninety-five (26%) children receiving fentanyl experienced SAEs. Fentanyl off-label use by both age and indication was not associated with a higher risk of overall SAEs compared to on-label use (OR 1.99, 95% CI 0.94–4.19, p = 0.07). However, the risk of the SAE respiratory depression was significantly greater when fentanyl was used off-label by both age and indication (OR 5.05, 95% CI 1.08–23.56, p = 0.044). Results based on HRs were similar. Conclusions Azithromycin off-label use in pediatric ICUs does not appear to be associated with an increased risk of SAEs. Off-label use of fentanyl appears to be more frequently associated with respiratory depression when used off-label by both age and indication in pediatric ICUs. Prospective studies should be undertaken to assess the safety and efficacy of fentanyl in the pediatric population so that data can be added to the FDA labeling.