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Aim: This study explores parental understanding and attitudes around pharmacogenomic results in their child(ren). Patients and methods: In-depth interviews with parents whose child(ren) had received a pharmacogenomic testing panel for management of neuropsychiatric medications were completed. Interviews were analyzed for themes and accuracy of understanding of results. Results: In 18 parents interviewed, 49/63 (78%) of statements made regarding results were accurate. Differences in understanding were seen by clinic, number of medications and result type. Parents expected results to guide prescribing and perceived the greatest utility in results that could impact current care. Results predicting normal drug metabolism may create mixed feelings. Conclusion: Parents perceive utility in pharmacogenomic testing for their children. Challenges exist in understanding probabilistic and multifactorial information about pharmacogenomic results.

There is limited evidence to support pharmacogenetic (PGx) testing in children. We conducted a retrospective review of PGx testing among 452 patients at an academic children's hospital to determine the potential utility of PGx in diseases of childhood and to identify targets for future pediatric pharmacogenetic research. An actionable gene-drug pair associated with the 28 genes tested (Clinical Pharmacogenetics Implementation Consortium (CPIC) level A or B, Pharmacogenomics Knowledge Base (PharmGKB) level 1A or B, or US Food and Drug Administration (FDA) recommendation and a PharmGKB level) was present in 98.7% of patients. We identified 203 actionable gene-drug-diagnosis groups based on the indications for each actionable drug listed in Lexicomp. Among patients with an actionable gene-drug-diagnosis group, 49.3% had a diagnosis where the drug was a therapeutic option and PGx could be used to guide treatment selection. Among patients with an associated diagnosis, 30.9% had a prescription for the actionable drug allowing PGx guided dosing. Three genes (CYP2C19, CYP2D6, and CYP3A5) accounted for all the gene-drug-diagnosis groups with matching diagnoses and prescriptions. The most common gene-drug-diagnosis groups with matching diagnoses and prescriptions were CYP2C19-citalopram-escitalopram-depression 3.3% of patients tested; CYP2C19-dexlansoprazole-gastritis-esophagitis 3.1%; CYP2C19-omeprazole-gastritis-esophagitis 2.4%; CYP2D6-atomoxetine-attention deficit hyperactivity disorder 2.2%; and CYP2C19-citalopram-escitalopram-obsessive-compulsive disorder 1.5%. PGx could be used to guide selection of current treatment options or medication dosing in almost half (48.7%) of pediatric patients tested. Mood disorders and gastritis/esophagitis are promising targets for future study of PGx testing because of the high prevalence of these diagnoses and associated actionable gene-drug pairs in the pediatric population.

We retrospectively evaluated the effect of penicillin adverse drug reaction (ADR) labeling on surgical antibiotic prophylaxis. Cefazolin was administered in 86% of penicillin ADR-negative (−) and 28% penicillin ADR-positive (+) cases. Broad-spectrum antibiotic use was more common in ADR(+) cases and was more commonly associated with perioperative adverse drug events.

OBJECTIVE: Conventionally, intravenous N-acetylcysteine (IV-NAC) administration is a 3-bag regimen administered over the course of 21 hours, which increases the risk of reconstitution and administration errors. To minimize errors, an alternative IV-NAC regimen consists of a loading dose (150 mg/kg) followed by a maintenance infusion (15 mg/kg/hr) until termination criteria are met. The aim was to determine the clinical outcomes of an alternative IV-NAC regimen in pediatric patients.METHODS: A retrospective review of pharmacy dispensing records and diagnostic codes at a pediatric hospital identified patients who received alternative IV-NAC dosing from March 1, 2008, to September 10, 2012, for acetaminophen overdoses. Exclusion criteria included chronic liver disease, initiation of oral or other IV-NAC regimens, and initiation of standard IV-NAC infusion prior to facility transfer. Clinical and laboratory data were abstracted from the electronic medical record. Descriptive statistics were utilized. Clinical outcomes and adverse drug reaction incidences were compared between the alternative and Food and Drug Administration (FDA)–approved IV-NAC regimens.RESULTS: Fifty-nine patients (mean age 13.4 ± 4.3 years; range: 2 months-18 years) with acetaminophen overdoses were identified. Upon IV-NAC discontinuation, 45 patients had normal alanine transaminase (ALT) concentrations, while 14 patients' ALT concentrations remained elevated (median 140 units/L) but were trending downward. Two patients (3.4%) developed hepatotoxicity (aspartate transaminase/ALT > 1000 units/L). No patients developed hepatic failure, were listed for a liver transplant, were intubated, underwent hemodialysis, or died. Two patients (3.4%) developed anaphylactoid reactions. No known medication or administration errors occurred. Clinical outcome incidences of the studied endpoints with the alternative IV-NAC regimen are at the lower end of published incidence ranges compared to the FDA IV-NAC regimen for acetaminophen overdoses.CONCLUSIONS: This alternative IV-NAC regimen appears to be effective and well tolerated among pediatric patients when compared to the FDA-approved regimen. It may also result in fewer reconstitution and administration errors, leading to improved patient safety.

Pain assessment documentation was inadequate because of the use of a subjective pain assessment strategy in a tertiary level IV neonatal intensive care unit (NICU). The aim of this study was to improve consistency of pain assessment documentation through implementation of a multidimensional neonatal pain and sedation assessment tool. The study was set in a 60-bed level IV NICU within an urban children's hospital. Participants included NICU staff, including registered nurses, neonatal nurse practitioners, clinical nurse specialists, pharmacists, neonatal fellows, and neonatologists. The Plan Do Study Act method of quality improvement was used for this project. Baseline assessment included review of patient medical records 6 months before the intervention. Documentation of pain assessment on admission, routine pain assessment, reassessment of pain after an elevated pain score, discussion of pain in multidisciplinary rounds, and documentation of pain assessment were reviewed. Literature review and listserv query were conducted to identify neonatal pain tools. Survey of staff was conducted to evaluate knowledge of neonatal pain and also to determine current healthcare providers' practice as related to identification and treatment of neonatal pain. A multidimensional neonatal pain tool, the Neonatal Pain, Agitation, and Sedation Scale (N-PASS), was chosen by the staff for implementation. Six months and 2 years following education on the use of the N-PASS and implementation in the NICU, a chart review of all hospitalized patients was conducted to evaluate documentation of pain assessment on admission, routine pain assessment, reassessment of pain after an elevated pain score, discussion of pain in multidisciplinary rounds, and documentation of pain assessment in the medical progress note. Documentation of pain scores improved from 60% to 100% at 6 months and remained at 99% 2 years following implementation of the N-PASS. Pain score documentation with ongoing nursing assessment improved from 55% to greater than 90% at 6 months and 2 years following the intervention. Pain assessment documentation following intervention of an elevated pain score was 0% before implementation of the N-PASS and improved slightly to 30% 6 months and 47% 2 years following implementation. Identification and implementation of a multidimensional neonatal pain assessment tool, the N-PASS, improved documentation of pain in our unit. Although improvement in all quality improvement monitors was noted, additional work is needed in several key areas, specifically documentation of reassessment of pain following an intervention for an elevated pain score.

Purpose The results of a study to identify factors associated with serum gentamicin levels outside the therapeutic range in a neonatal population are reported. Methods A single-center retrospective chart review was conducted to identify cases involving gentamicin use in the neonatal intensive care unit; a sample of cases sufficient for risk-factor analysis ( n = 225) was selected for evaluation. In all evaluated cases, gentamicin was administered according to a standardized dosing protocol based on gestational age and weight. Selected clinical factors and laboratory values potentially associated with undesirably high or low serum drug levels were analyzed. Results Of the 225 patient cases included in the analysis, 184 (82%) involved appropriate (i.e., per protocol) gentamicin dosing. Of the 41 doses classified as inappropriate, 33 were higher and 8 were lower than those recommended by the protocol. Six (18%) of the newborns who received doses classified as inappropriately high had supratherapeutic serum trough concentrations, and 3 (9%) had subtherapeutic trough values. Among the neonates with supratherapeutic peak values, none had an elevated trough value and only 1 received a gentamicin dose deemed to be inappropriately high. Factors associated with an increased relative risk (RR) of a supratherapeutic trough included inappropriate dosing (RR, 2.9; 95% confidence interval [CI], 1.18–6.9), an elevated serum creatinine (SCr) concentration (>0.8 mg/dL) on the day of blood sampling for drug level assessment (RR, 25.6; 95% CI, 9.1–71.4), low urine output (

Use of magnetic resonance imaging (MRI) in the neonatal intensive care unit has been increasing over the past several years because of improved MRI technology and increased clinical awareness of the prognostic and diagnostic information available. Historically, the use of sedation has been the standard for achieving quality imaging without motion artifact, but it exposed the patient to risks associated with sedation medications. In an effort to obtain MRI studies with elimination of risks associated with sedation, a quality improvement project was initiated. Implementing a standardized approach utilizing a vacuum immobilizer has led to successful neonatal MRI completion without the need for sedation in 94% of study attempts. Acceptable or excellent image quality was achieved in more than 97% of attempts. Time away from the neonatal intensive care unit significantly decreased with this approach, with the mean duration of time away decreasing from 60 to 48 minutes (P < .0001). Obtaining MRI studies without sedation can be successfully implemented in a neonatal intensive care unit, nearly eliminating patient risks associated with sedation while improving utilization of hospital resources and maintaining adequate quality imaging.

Palivizumab, a humanized monoclonal antibody, has been approved by the FDA to prevent severe lower respiratory tract infections caused by RSV in high-risk patients. Prophylaxis of RSV infections with palivizumab requires monthly injections (15 mg/kg) during the RSV season. In the IMpact-RSV study, hospitalizations resulting from RSV decreased by 55% in the palivizumab treatment group. Palivizumab has also been shown to decrease the number of days with moderate or severe RSV infection, with an increased oxygen requirement, and ICU admissions. Palivizumab has been shown to be well tolerated with minimal adverse effects. The most frequently reported adverse effects were fever and minor injection site reactions. Determination of which patients should receive RSV prophylaxis should take into consideration all risk factors. Recommendations for RSV prophylaxis with RSV-IGIV and palivizumab have been published by the American Academy of Pediatrics. To date, no studies directly comparing RSV-IGIV and palivuzumab have been conducted. Neither product is recommended in children with congenital heart disease.