Safety and efficacy of fosaprepitant in pediatric patients for prevention of chemotherapy induced nausea and vomiting.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e22023-e22023 ◽  
Author(s):  
Karissa N Kusick ◽  
Madeline Waldron ◽  
Anthony Zembillas ◽  
Maya Wai ◽  
Rabi Hanna ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Safety Evaluation ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Cost Effective ◽  
Marrow Transplant ◽  
Primary Objective ◽  
Nausea And Vomiting ◽  
Patients Âgés ◽  
Cycle Basis

e22023 Background: Aprepitant is an antiemetic that antagonizes the substance P neurokinin-1 receptor. Fosaprepitant is an intravenous prodrug of aprepitant and is FDA-approved for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults. Although the FDA extended approval of oral aprepitant to children and adolescents for CINV, pediatric patients have challenges obtaining aprepitant due to insurance or have difficulty taking oral medications during chemotherapy. Fosaprepitant is a logical alternative but data are lacking for safe and effective dosing in children. In 2015, fosaprepitant was added to our hospital formulary for pediatric patients receiving moderate to highly emetogenic chemotherapy. The fosaprepitant dose established was 150mg for weight ≥30kg or 3mg/kg/dose for < 30kg. There is also potential for overall cost savings to our institution. Fosaprepitant is about half the cost of aprepitant using equivalent adult doses. Methods: This retrospective chart review was considered exempt from IRB.All pediatric patients who received fosaprepitant between April 2015 and October 2016 while inpatient were included.Patients undergoing bone marrow transplant were excluded from the study.The primary objective was to determine safety of fosaprepitant. To evaluate safety, incidence of infusion related reactions related to fosaprepitant administration were assessed. Secondary objectives include efficacy of fosaprepitant in pediatric patients and evaluation of cost savings. To evaluate efficacy, the use of breakthrough antiemetics, documented emesis, and Adapted Rhodes Index for Nausea and Vomiting score were collected. Descriptive statistics were used for all data analyses on a per cycle basis. Results: A preliminary safety evaluation of 20 patients ages 9 months through 16 years received 87 doses of fosaprepitant for CINV prophylaxis.Six patients < 30kg received weight-based dosing; the other 14 patients received a dose of 150mg.One patient experienced an infusion related reaction from fosaprepitant but symptoms resolved after the infusion was stopped. Conclusions: Fosaprepitant appears to be safe and cost-effective to prevent CINV in children.

scholarly journals Aprepitant and Fosaprepitant Use in Children and Adolescents at an Academic Medical Center

2014 ◽  
Vol 19 (2) ◽  
pp. 127-131 ◽  
Author(s):  
Alexandra Shillingburg ◽  
Lisa Biondo
Keyword(s):  
Children And Adolescents ◽  
Pediatric Patients ◽  
Medical Center ◽  
Academic Medical Center ◽  
Retrospective Chart Review ◽  
Primary Prophylaxis ◽  
Emetogenic Chemotherapy ◽  
Record System ◽  
Patients Âgés ◽  
Academic Medical

OBJECTIVE: To describe the use of aprepitant and fosaprepitant, a neurokinin 1 (NK-1) receptor inhibitor, in children and adolescents at a large academic medical center, for the prevention and management of chemotherapy-induced nausea and vomiting (CINV). METHODS: A retrospective chart review was conducted using an electronic medical record system to evaluate the use of aprepitant and fosaprepitant in all pediatric patients that were discharged from a single academic medical center between February 25, 2009 and May 25, 2012. RESULTS: Twenty-six patients were included in this review and received a total of 287 doses over the span of 114 cycles. Mean age was 10.1 years, with a range of 11 months to 17 years old. In 16 of 26 patients, aprepitant was used as the primary prophylaxis. Of those patients who received primary prophylaxis, 6 of 16 received it for highly emetogenic chemotherapy, and 10 of 16 received it for moderately emetogenic chemotherapy. Intravenous fosaprepitant was used in 7 of 26 patients, ages 13 to 17 (median 14) years old. No adverse effects attributable to aprepitant were reported. CONCLUSIONS: Use of aprepitant and fosaprepitant in pediatric patients appeared to be well tolerated. No currently published reports data using aprepitant in a patient younger than 32 months old, whereas we reported its use in patients as young as 11 months old.

scholarly journals Pharmacist-Driven Management of Chemotherapy Induced Nausea and Vomiting in Hospitalized Adult Oncology Patients. A Retrospective Comparative Study

2011 ◽  
Vol 2 (3) ◽  
Author(s):  
Ramy Elshaboury ◽  
Kathleen Green
Keyword(s):  
Practice Guidelines ◽  
Primary Outcome ◽  
Medical Center ◽  
Academic Medical Center ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Standard Of Care ◽  
Nausea And Vomiting ◽  
P Value ◽  
Potential Cost

Chemotherapy-induced nausea and vomiting (CINV) is a major adverse event associated with cancer treatments. There are clinical practice guidelines that assist practitioners in managing CINV. Many cancer centers develop protocols for physicians and pharmacists to guide prophylaxis and breakthrough treatments of CINV based on published guidelines. The purpose of this study was to evaluate the outcome differences between pharmacist and physician -driven management of CINV in adult hospitalized cancer patients in a large academic medical center. This is a single center retrospective chart review study. The primary outcome of the study was the number of breakthrough antiemetic doses needed throughout the hospitalization. A total of 106 adult patients receiving inpatient chemotherapy were reviewed for CINV management. Fifty-five patients (52%) were managed according to the pharmacist-driven protocol, and fifty-one patients (48%) were managed by the physician. There was no difference between the two groups in the primary outcome. Patients in the pharmacist-managed group needed 6.4 breakthrough antiemetic doses; whereas, patients in the physician managed group needed 5.9 doses throughout the hospital stay (P-value = 0.7). No difference was seen when results were adjusted for length of hospitalization. There was a difference in adherence to the institution CINV guidelines favoring the pharmacist-driven approach (85% versus 33%, P < 0.0001). In conclusion, pharmacist-run protocol for CINV management was as effective as the standard of care. Protocols that are based on practice guidelines may offer the advantage of care standardization and potential cost savings.   Type: Student Project

Assessment of rasburicase utilization for tumor lysis syndrome management in pediatric and adult patients in the inpatient and outpatient settings

2020 ◽  
pp. 107815522094536
Author(s):  
Marin I Abousaud ◽  
Marie C Rush ◽  
Michelle Rockey
Keyword(s):  
Tumor Lysis Syndrome ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Outpatient Setting ◽  
Primary Objective ◽  
Adult Patients ◽  
Potential Cost ◽  
Tumor Lysis ◽  
Laboratory Values ◽  
Outpatient Settings

Introduction At Wake Forest Baptist Health, an adult tumor lysis syndrome pocket card was created in order to optimize management of tumor lysis syndrome and outline specific recommendations for the use of rasburicase. Due to the increased use of rasburicase at our institution and its cost, the purpose of this study was to evaluate the utilization of rasburicase for the management of tumor lysis syndrome in pediatric and adult patients in the inpatient and outpatient settings. Methods This was an observational, single-center, non-randomized, retrospective chart review conducted between September 2018 and August 2019. The primary objective was to evaluate the utilization of rasburicase and appropriateness for the management of tumor lysis syndrome in pediatric and adult patients based on the Wake Forest Baptist Health tumor lysis syndrome pocket card. The secondary objectives were to assess response to prophylactic and treatment doses of rasburicase and to quantify drug cost versus expense of rasburicase utilization. Results Overall, 64 patients (57 adults and 7 pediatric patients) were included in the study. Rasburicase use for tumor lysis syndrome indication adhered to the pocket card 64% of the time. Appropriate fluids and/or allopurinol were initiated in only 34% of patients. For monitoring, 80% of patients had all necessary tumor lysis syndrome laboratory values collected after rasburicase administration. All 11 patients (17%) who received rasburicase in the outpatient setting did not have follow-up labs collected. Of the patients who had tumor lysis syndrome laboratory values collected post rasburicase, 39% were appropriately timed to accurately assess efficacy of rasburicase with the median time of laboratory monitoring after rasburicase being 6.5 h. Response was observed with rasburicase 3 mg (92%), 6 mg (100%), and weight-based dosing (100%). The wholesale acquisition cost per patient was $5203 (1101–10,406). The potential cost savings of using the 3 mg dose versus the 6 mg dose for the patients who did not meet tumor lysis syndrome treatment recommendations based on the Wake Forest Baptist Health pocket card was estimated to be $36,419.46. Conclusion There are several opportunities for improvement in tumor lysis syndrome management and rasburicase utilization at our institution. This study will lead to the implementation of formal restrictions for rasburicase use and selection of rasburicase dose. Updating the rasburicase order panel to include appropriate prophylaxis and require input of uric acid level, populating pertinent tumor lysis syndrome laboratory values on the order verification screen for pharmacists to appropriately assess if rasburicase meets the institution restriction criteria, and providing education to providers on the appropriate ordering and timing of labs.

scholarly journals Impact of a reduced palonosetron maximum dose on the incidence of chemotherapy-induced nausea and vomiting in pediatric patients

2021 ◽  
Author(s):  
Liza Kramer ◽  
Heidi Trinkman ◽  
Robert Arrowood ◽  
Anish Ray
Keyword(s):  
Chart Review ◽  
Pediatric Patients ◽  
Maximum Dose ◽  
Medical Center ◽  
Pediatric Population ◽  
Retrospective Chart Review ◽  
Nausea And Vomiting ◽  
Cell Transplant ◽  
The Impact ◽  
Antiemetic Agents

Background Palonosetron is a serotonin-3 (5-HT3) receptor antagonist indicated in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric and adult patients. Traditional dosing for palonosetron in the pediatric population has been 20 mcg/kg with a maximum dose of 1500 mcg. This study aimed to evaluate the impact of an institutional dose cap of 750 mcg on pediatric CINV. Procedure This is a retrospective chart review of admitted patients given palonosetron intended for prevention of CINV at a pediatric medical center between July 1, 2018 and June 30, 2020. Patients 1 month up to 17 years of age who received at least one dose of palonosetron prior to chemotherapy (not preceding stem cell transplant) were included. Information regarding chemotherapy, antiemetic premedication, emesis, and breakthrough antiemetic agents were recorded to quantify the instances of CINV. Results Seven hundred and seventy-one patient encounters met inclusion criteria (n=485 traditional dose, n=286 dose capped). There was no statistical difference in the instances of emesis (p=0.98) or breakthrough agents administered (p=0.65) between the two groups. Dose capping patients at 750 mcg reduced cost by approximately 34.9% compared to traditional dosing. Conclusions The use of a dose cap of palonosetron at 750 mcg maintains efficacy for prevention of CINV while reducing cost in pediatric patients receiving chemotherapy.

Syndesmotic Screw Removal in a Clinic Setting Is Safe and Cost-effective

2019 ◽  
Vol 13 (2) ◽  
pp. 144-151 ◽  
Author(s):  
Michelle T. Sugi ◽  
Brandon Ortega ◽  
Lane Shepherd ◽  
Charalampos Zalavras
Keyword(s):  
Operating Room ◽  
Chart Review ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Cost Effective ◽  
Level Of Evidence ◽  
Superficial Infection ◽  
Syndesmotic Screw ◽  
Level 1 ◽  
Level 1 Trauma Center

Background. There is no consensus in the literature regarding the necessity of syndesmotic screw removal, but the majority of surgeons prefer screw removal in the operating room. Purpose. The aim of this study is to analyze the safety and cost-effectiveness of syndesmotic screw removal in the clinic. Methods. A retrospective chart review was performed on all acute, traumatic ankle fractures that required syndesmotic stabilization over 5 years at a level 1 trauma center. Radiographs were evaluated for maintenance of syndesmotic reduction. Orthopaedic clinic visits and operating room costs were calculated. Results. Of 269 patients, syndesmotic screws were successfully removed in the clinic in 170 patients and retained in 99 patients. Two superficial infections (1.2%) developed following screw removal. The superficial infection rate was 3.3% (2 of 60) in patients who did not receive antibiotics compared with 0% (0 of 110) in patients who received antibiotics (P = .12). No patient lost syndesmotic reduction after screw removal. Cost savings of $13 829 per patient were achieved by syndesmotic screw removal in the clinic. Conclusion. Our study demonstrates that syndesmotic screw removal in the clinic is safe, does not result in tibiofibular diastasis, is cost-effective, and results in substantial financial savings. Level of Evidence: Level IV

scholarly journals 0975 Iron Infusion Protocol For Restless Leg Syndrome In Pediatric Patients

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A370-A371
Author(s):  
S Taravath ◽  
M Peedin
Keyword(s):  
Pediatric Patients ◽  
Medical Center ◽  
Retrospective Chart Review ◽  
Intravenous Iron ◽  
Leg Pain ◽  
Published Data ◽  
Poor Sleep ◽  
Iron Dextran ◽  
Restless Leg Syndrome ◽  
Patients Âgés

Abstract Introduction Iron dextran protocols have been studied for adults with restless leg syndrome; this study aims to determine the benefit of iron infusions (iron dextran or sucrose) in the improvement or resolution of restless sleep in pediatric patients. Methods IRB approval was granted by New Hanover Regional Medical Center. A retrospective chart review was performed using the hospital’s electronic medical record (EMR). A data report was requested for all pediatric patients who received the iron dextran protocol. Patients who received at least one dose of iron dextran or iron sucrose per the protocol were included. Manual data collection included patient demographics, CBCs, iron panels, the dose of iron they received, polysomnogram results, symptom resolution (as described by the physician), and adverse events. Results Between January 1, 2017 and January 3, 2018, 55 patients received iron dextran per the weight-based protocol. Patients’ ages ranged from 23 months to 17 years and 5 months old. Of the 55 patients, 27 patients (49%) had documented restless leg syndrome and/or symptoms of leg pain or movement during sleep. All patients experienced restlessness or difficulty sleeping prior to the infusion. Of the 27 patients who experienced leg pain, 10 patients (37%) experienced an improvement in their leg pain or restlessness. Fifty-five percent (55%) of patients in this group reported an improvement in sleep symptoms. Conclusion Iron dextran protocols have been studied for adults with restless leg syndrome, but this is the first published data for a weight-based protocol in pediatric patients. While only 27 patients included in this study had a diagnosis of restless leg syndrome or leg pain symptoms, all patients experienced restlessness or other negative sleep symptoms. Overall, most patients with restless leg syndrome experienced an improvement in their leg and sleep symptoms. No patients reported worsening of symptoms. Intravenous iron dextran infusion may greatly improve the quality of life for children with restless leg syndrome or poor sleep quality. With the overall safety of the iron infusions, this protocol’s benefits outweigh their risks and should be considered in this patient population. Support  

scholarly journals Safety evaluation of intravenous immunoglobulin in pediatric patients: a retrospective, 1-year observational study

2019 ◽  
Vol 10 ◽  
pp. 204209861987673
Author(s):  
Reem Elajez ◽  
Asmaa Ezzeldin ◽  
Hossamaldein Gaber
Keyword(s):  
Intravenous Immunoglobulin ◽  
Safety Profile ◽  
Chart Review ◽  
Pediatric Patients ◽  
Safety Evaluation ◽  
Retrospective Chart Review ◽  
Risk Category ◽  
Good Safety Profile ◽  
Review Study ◽  
Infusion Protocol

Background: Intravenous immunoglobulin (IVIG) is a pooled human plasma protein that has shown efficacy in treating a variety of disorders. IVIG is generally well tolerated and has a good safety profile. There are various IVIG products available on the market, which results in differences in efficacy and safety profile. The aim of this study was to assess the safety profile of IVIG use in pediatric patients and its association with other predicted factors. Methods: Retrospective chart review study of all pediatric patients who received IVIG as an inpatient at Hamad General Hospital in Qatar during 2014. The occurrence of adverse drug reactions (ADR) was tested for any association with other predicted factors, such as patient age, IVIG dose, brand, and adherence to infusion protocol. Results: A total of 345 IVIG prescriptions were received by pediatric patients during the study period. Most common documented side effects were: fever (5.8%), chills (2.6%), and headache (2%). Renal insufficiency was observed only in six cases, with five of those in ‘Risk’ category according to RIFLE criteria. A hypersensitivity reaction was documented in seven patients, despite being premedicated with paracetamol and/or diphenhydramine and following the infusion protocol. None of the predicted factors were found to be significantly associated with ADR incidence except IVIG brand. Conclusions: IVIG generally has a good safety profile in pediatric patients, with low risk of severe ADR. More studies are needed to evaluate the correlation between ADR and IVIG formulation, taking into account other factors that may affect results.

Safety of transdermal scopolamine in pediatric patients for chemotherapy-induced nausea and vomiting (CINV)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19568-19568
Author(s):  
L. M. Weber ◽  
D. Alexander ◽  
M. Finkelstein ◽  
S. Chen
Keyword(s):  
Adverse Events ◽  
Pediatric Patients ◽  
Hospital Admissions ◽  
Average Length ◽  
Retrospective Chart Review ◽  
Nausea And Vomiting ◽  
Older Children ◽  
Patch Use ◽  
Antiemetic Guidelines ◽  
To Receive

19568 Background: Transdermal scopolamine has been used for over 25 years in the treatment of nausea and vomiting, but little information is available on its safety in pediatric patients. The antiemetic guidelines established at our hospital allow children between 8 and 15kg to receive a ½ patch every 3 days and children greater than 15 kg to receive 1 patch every 3 days as an adjunct agent for CINV. The goal of this study was to assess the safety of transdermal scopolamine in hospitalized pediatric patients during chemotherapy treatment. Methods: A retrospective chart review was conducted at Children’s Hospital and Clinics of Minnesota from April to September 2005. A total of 82 hospital admissions (41 patients) were reviewed for adverse effects specific to scopolamine using the National Cancer Institute’s Common Terminology Criteria for Adverse Events. Results: Mean patient age was 8 years (1–20 years) and the average length of patch use was 6 days (2–31 days). Of the 82 admissions reviewed, a total of 20 adverse events occurred (24%) in 14 patients. Median weight was significantly greater for patients experiencing the following adverse events compared to patients that did not: headaches (p=0.009), mental status changes (p=0.01) and hallucinations (p=0.003). Age > 12 years (p<0.001) and use of the patch > 4 days (p<0.01) were significantly correlated with the incidence of an adverse event. 75% of patients did not experience an adverse effect from transdermal scopolamine therapy when used 4 days or less. Conclusions: Transdermal scopolamine is a safe adjuvant for treatment of CINV in pediatric patients; however, as many as 1 in 5 may suffer adverse events. When used for more than 4 days the risk of adverse events increases. Older children and adolescents are more prone to adverse events. No significant financial relationships to disclose.

scholarly journals Characteristics, management and outcome of prehospital pediatric emergencies by a Dutch HEMS

2021 ◽  
Author(s):  
Michelle Berdien Oude Alink ◽  
Xavier Roland Johnny Moors ◽  
Senned Karrar ◽  
Robert Jan Houmes ◽  
Dennis Den Hartog ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Prehospital Care ◽  
Survival Rates ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Helicopter Emergency Medical Service ◽  
Primary Objective ◽  
Trauma Patients ◽  
Trauma Group ◽  
Overall Mortality

Abstract Background In prehospital care, the Helicopter Emergency Medical Service (HEMS) can be dispatched for critically injured or ill children. However, little detail is known about dispatches for children, in terms of the incidence of prehospital interventions and overall mortality. The primary objective of this study is to provide an overview of pediatric patient characteristics and incidence of interventions. Methods A retrospective chart review of all patients ≤ 17 years who received medical care by Rotterdam HEMS from 2012 until 2017 was carried out. Results During the study period, 1905 pediatric patients were included. 59.1% of patients were male and mean age was 6.1 years with 53.2% of patients aged ≤ 3 years. 53.6% were traumatic patients and 49.7% were non-traumatic patients. 18.8% of patients were intubated. Surgical procedures were performed in 0.9%. Medication was administered in 58.1% of patients. Cardiopulmonary resuscitation (CPR) was necessary in 12.9% of patients, 19.9% were admitted to the intensive care unit and 14.0% needed mechanical ventilation. Overall mortality was 9.5%. Mortality in trauma patients was 5.5% and in non-trauma group 15.3%. 3.9% of patients died at the scene. Conclusions Patients attended by HEMS are at high risk of prehospital interventions like CPR or intubation. EMS has little exposure to critically ill or injured children. Hence, HEMS expertise is required to perform critical procedures. Trauma patients had higher survival rates than non-traumatic patients. This may be explained by underlying illnesses in non-traumatic patients and CPR as reason for dispatch. Further research is needed to identify options for improving prehospital care in the non trauma pediatric patients.

Impact of embedded medication assistance program specialists on medication access in outpatient oncology clinics

2020 ◽  
pp. 107815522097026
Author(s):  
Seyram S Fudzie ◽  
Brandon Luong ◽  
Stephanie J Jean ◽  
Suzanne J Francart
Keyword(s):  
Medical Center ◽  
Academic Medical Center ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Turnaround Time ◽  
Primary Objective ◽  
Financial Assistance ◽  
Assistance Program ◽  
Assistance Programs ◽  
The Impact

Introduction Medication prior authorizations (PA) required by insurance payers can be time-consuming to complete and may lead to delays in treatment for cancer patients. The primary objective of this study is to assess the impact of Medication Assistance Program (MAP) specialists embedded in adult hematology and oncology clinics on the PA and financial assistance process. Methods This was a retrospective chart review study performed at a large academic medical center that examined medication referrals completed by MAP specialists in four hematology and oncology clinics. The primary outcome was the median PA turnaround time, defined as time from initial referral creation to final referral completion. Secondary outcomes assessed median turnaround time for financial assistance programs and total patient savings. Results A total of 176 prior authorization, 92 manufacturer patient assistance program (PAP), and 37 copay assistance referrals were completed. The median turnaround times were 24, 154, and 19 hours for PA, manufacturer PAP, and copay assistance program referrals, respectively. Total cost savings amounted to over $1.8 million for patients approved to receive medications through manufacturer PAPs. Conclusions Embedding MAP specialists in adult hematology/oncology clinics supports an efficient and timely process for PA approvals while also providing patient cost-savings.

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