Retrospective comparison of two enoxaparin dosing and monitoring protocols at a pediatric hospital.

PURPOSE: The study analyzes the effectiveness and safety of a higher than standard enoxaparin dosing protocol implemented for pediatric patients requiring initiation of therapeutic anticoagulation. METHODS: A retrospective review of 2 enoxaparin dosing and monitoring protocols was performed. The standard protocol used 1.5 mg/kg/dose (in patients <3 months of age) and 1 mg/kg/dose (in patients ≥3 months of age) with anti-Xa monitoring following the first dose. The high-dose protocol was implemented at 1.7 mg/kg/dose (in patients <3 months of age), 1.5 mg/kg/dose (in patients 3 through 11 months of age), 1.2 mg/kg/dose (in patients 1 through 4 years of age), and 1.1 mg/kg/dose (in patients 5 through 17 years of age), with anti-Xa monitoring after the second dose. Primary outcomes were number of dosing changes prior to and time to first target anti-Xa level. Secondary outcomes included percentage of patients with anti-Xa levels above target level. RESULTS: The median number of dose changes required to achieve a target anti-Xa level was 1 (interquartile range [IQR], 0-1.5) and 0 (IQR, 0-1) for the standard-dose (n = 87) and high-dose groups (n = 132) (p = 0.17), respectively. The median number of dose adjustments to achieve target anti-Xa levels in the 3 through 11 months of age subgroup declined from 2 (IQR, 1-3.25) to 0 (IQR, 0-1) in the standard- versus high-dose groups, respectively (p < 0.01). No difference was seen in other age subgroups. Patients with above-target levels did not differ statistically between groups. CONCLUSION: Initiating enoxaparin at higher doses in pediatric patients may result in fewer dosing changes than standard dosing. Benefit was demonstrated for the 3-11 months of age high-dose subgroup. Across all groups, the high-dose strategy was safe and did not result in a statistically significant increase in above-target levels.

Avoidance of Overt Precipitation and Patient Harm Following Errant Y-Site Administration of Calcium Chloride and Parenteral Nutrition Compounded With Sodium Glycerophosphate.

Calcium phosphate precipitates present 1 of many challenges associated with parenteral nutrition (PN) compounding. Extensive research has led to the establishment of solubility curves to guide practitioners in the prescription and preparation of stable PN. Concurrent dosing of intravenous products via y-site administration with PN can alter the chemical balance of the solution and modify solubility. Medications containing calcium or phosphate should not be administered in the same line as PN, due to the high potential for precipitation. Herein a case is reported from a pediatric cardiac intensive care unit where a physician ordered the administration of calcium chloride. The bedside nurse added the calcium chloride intermittent infusion as a y-site administration with the patient's PN. The patient's PN had been compounded with sodium glycerophosphate, temporarily available in the United States during a sodium phosphate shortage. The patient did not experience any observable adverse effects from the y-site administration with PN. Following this event, the scenario was replicated to investigate any precipitation risk associated with the y-site administration. Additionally, a separate PN solution containing sodium phosphate rather than glycerophosphate was compounded and used in a laboratory setting to demonstrate the potential for harm had the patient's PN been compounded with an inorganic phosphate source. This replication of the error demonstrates the additional safety gained in relation to precipitation risk when PN solutions are compounded with sodium glycerophosphate in place of sodium phosphate.

Frequency and Severity of Parenteral Nutrition Medication Errors at a Large Children's Hospital After Implementation of Electronic Ordering and Compounding.

INTRODUCTION: The Institute for Safe Medication Practices has stated that parenteral nutrition (PN) is considered a high-risk medication and has the potential of causing harm. Three organizations--American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), American Society of Health-System Pharmacists, and National Advisory Group--have published guidelines for ordering, transcribing, compounding and administering PN. These national organizations have published data on compliance to the guidelines and the risk of errors. The purpose of this article is to compare total compliance with ordering, transcription, compounding, administration, and error rate with a large pediatric institution. METHOD: A computerized prescriber order entry (CPOE) program was developed that incorporates dosing with soft and hard stop recommendations and simultaneously eliminating the need for paper transcription. A CPOE team prioritized and identified issues, then developed solutions and integrated innovative CPOE and automated compounding device (ACD) technologies and practice changes to minimize opportunities for medication errors in PN prescription, transcription, preparation, and administration. Thirty developmental processes were identified and integrated in the CPOE program, resulting in practices that were compliant with A.S.P.E.N. safety consensus recommendations. Data from 7 years of development and implementation were analyzed and compared with published literature comparing error, harm rates, and cost reductions to determine if our process showed lower error rates compared with national outcomes. RESULTS: The CPOE program developed was in total compliance with the A.S.P.E.N. guidelines for PN. The frequency of PN medication errors at our hospital over the 7 years was 230 errors/84,503 PN prescriptions, or 0.27% compared with national data that determined that 74 of 4730 (1.6%) of prescriptions over 1.5 years were associated with a medication error. Errors were categorized by steps in the PN process: prescribing, transcription, preparation, and administration. There were no transcription errors, and most (95%) errors occurred during administration. CONCLUSION: We conclude that PN practices that conferred a meaningful cost reduction and a lower error rate (2.7/1000 PN) than reported in the literature (15.6/1000 PN) were ascribed to the development and implementation of practices that conform to national PN guidelines and recommendations. Electronic ordering and compounding programs eliminated all transcription and related opportunities for errors.

Physical and chemical compatibility of injectable acetaminophen during simulated y-site administration.

PURPOSE: The physical and chemical compatibility of intravenous acetaminophen with commonly administered injectable medications was evaluated. METHODS: Simulated Y-site evaluation was accomplished by mixing 2 mL of acetaminophen (10 mg/mL) with 2 mL of an alternative intravenous medication and subsequently storing the mixture in a polypropylene syringe for 4 hours. The aliquot solutions were visually inspected and evaluated for crystal content at 4 hours by infusing 4 mL of the medication mixture through a 0.45-µm nitrocellulose filter disc. Medication mixtures that were selected for chemical stability testing were analyzed by high-performance liquid chromatography at 0, 1, and 4 hours using a Zorbax Eclipse Plus C18, 4.6 x 100 mm, 3.5-µm column for separation of analytes with subsequent diode-array detection. Medications were considered chemically compatible if the concentrations of all components were >90% of the original concentrations during the 4 hour simulated Y-site compatibility test. RESULTS: U.S. Pharmacopeial Convention (USP) standards for physical particle counts were met for acetaminophen injection (10 mg/mL) when combined with cefoxitin, ceftriaxone, clindamycin, dexamethasone, diphenhydramine, dolasetron, fentanyl, granisetron, hydrocortisone, hydromorphone, ketorolac, meperidine, methylprednisolone, midazolam, morphine, nalbuphine, ondansetron, piperacillin/tazobactam, ranitidine, and vancomycin. Injectable acetaminophen is incompatible with acyclovir and diazepam and therefore should not be administered concomitantly with either of these products. Further testing confirmed the chemical compatibility of acetaminophen with ceftriaxone, diphenhydramine, granisetron, ketorolac, nalbuphine, ondansetron, piperacillin/tazobactam, and vancomycin. CONCLUSION: All medications tested with acetaminophen were physically compatible except for acyclovir and diazepam. All 8 medications tested for chemical compatibility with acetaminophen were stable over the 4 hour simulated Y-site administration study.

Hospital admission medication reconciliation in medically complex children: an observational study.

OBJECTIVE: To evaluate admission medication reconciliation in children with medically complex conditions (MCC) by determining the availability and accuracy of five information sources and characterising admitting order errors. DESIGN: Prospective quality improvement cohort study. SETTING: Tertiary care free-standing children's hospital in the Intermountain west, USA. PARTICIPANTS: 23 children with MCC identified from 219 admissions between 16 December 2004 and 7 January 2005. INTERVENTION: Medication reconciliation at hospital admission using information from five sources. MAIN OUTCOMES: The accuracy of information sources was determined by sensitivity and specificity compared with verified outpatient medication lists. Errors were determined by comparing admitting orders with reconciled inpatient medication lists and categorised by frequency, type and clinical risk. RESULTS: Children with MCC averaged 5.3 chronic medications. The reconciliation process took an average of 90 min. Availability/sensitivity/specificity respectively were parents 52%/0.75/0.96, pharmacy 61%/0.64/0.74, primary provider 43%/0.25/0.86, last admission electronic health record 87%/0.74/0.33 and admitting history 65%/0.31/0.94. Thirty-nine errors were identified in 182 admission medications (21%) including 17 omissions, affecting 13 patients (57%). The estimated clinical risk, if an adverse drug event had occurred, was serious or life-threatening in five instances. CONCLUSIONS: In children with MCC admitted at our institution during the study period, no medication information source was optimally available, sensitive and specific. Admitting order medication errors affected more than half of patients, the most common being omissions. Efforts to improve medication reconciliation at hospital admission in this population must account for availability and accuracy of information sources and medication omissions at the time of hospital admission.

Improving Pediatric Outcomes through Intravenous and Oral Medication Standardization.

BACKGROUND: Standardization is an invaluable tool to promote safety, improve care, and decrease costs, which ultimately improves outcomes. However, a pediatric setting presents unique challenges with its wide variety of weights, medications, and needs that are distinctly different. Our goal was to develop and implement standards in complex high risk areas that show improved outcomes and safety. PROGRAM DESCRIPTION: A computerized prescriber order entry program with decision support for pediatrics was developed for parenteral nutrition prescribing. The program included dosing, calculations, calcium phosphate compatibility checks, automated IV compounder interface, osmolarity route calculation, end product testing verification, aluminum exposure and many other quality improvements. This same electronic order program, interface to sterile compounders, and end product testing was used to standardize and make common non-manufactured intravenous solutions. The drip compounding process was reengineered to include standard concentrations, label changes, and beta-testing of a smart syringe pump with dosing ranges for pediatrics. Common standard oral doses were developed along with standard oral formulations. CONCLUSIONS: Total parenteral nutrition (TPN) error rates decreased from 7% to less than 1% and compatibility issues decreased from 36 to 1 per year. Neonatal osteopenia rates decreased from 15% to 2%. Results from end product testing of TPN solutions were within USP standards showing statistical correlation (p<0.001). Intravenous standardization decreased error rates by 15% and compounding time decreased by 12 minutes (64%). Drip standardization allowed for drug concentration and smart pump standardization and decreased drip errors by 73% from 3.1 to 0.8 per 1000 doses. Compounding errors decreased from 0.66 to 0.16 per 1000 doses and ten-fold errors decreased from 0.41 to 0.08 per 1000 doses. Eleven oral liquids, including 329 different doses, were standardized, decreasing the number of doses to 59 (83% change). This decreased workload 15%, wastage 90%, improved turnaround time 32%, and saved $15,000/year. One hundred evidence-based standard oral formulations were developed and used in 22 different hospitals.

Amifostine-induced fever: case report and review of the literature.

Amifostine, also known as WR-2721 (S-2-(3-aminopropylamino)-ethylphosphorothioic acid), is an organic thiophosphate cytoprotective agent used to reduce the frequency of severe xerostomia in patients with cancer undergoing postoperative radiation of the head and neck. A 56-year-old Caucasian man who received concomitant chemotherapy and radiation for head and neck cancer developed fever concurrent with the administration of amifostine. To our knowledge, this is the first case report that demonstrates the occurrence of fever with low-dose amifostine therapy without the manifestation of accompanying rash or hypotension. Patients receiving amifostine who develop only fever should be evaluated for an adverse drug reaction, as well as for sepsis and fevers of neutropenia, and it may be necessary to discontinue the drug. Recognition of amifostine as the cause of this adverse event may prevent the cost and inconvenience of a hospital admission.