RESUMEN
Due to an evidence gap, the emetogenicity of intravenous (IV) pegaspargase was unable to be included in the clinical practice guideline classifying chemotherapy emetogenicity in pediatric patients. This single-center, retrospective chart review describes the proportion of pediatric patients who did not vomit during the acute phase (complete response; CR) after receiving IV pegaspargase and provides an emetogenicity classification using a preexisting framework. Of 44 patients who received IV pegaspargase between 2011 and 2020, 13 received a serotonin receptor antagonist plus dexamethasone or palonosetron alone and all experienced a CR. We, therefore, recommend classifying IV pegaspargase as moderately emetogenic.
Asunto(s)
Asparaginasa , Polietilenglicoles , Vómitos , Humanos , Estudios Retrospectivos , Niño , Adolescente , Polietilenglicoles/administración & dosificación , Polietilenglicoles/efectos adversos , Polietilenglicoles/uso terapéutico , Masculino , Femenino , Asparaginasa/administración & dosificación , Asparaginasa/efectos adversos , Vómitos/inducido químicamente , Preescolar , Dexametasona/administración & dosificación , Dexametasona/efectos adversos , Dexametasona/uso terapéutico , Administración Intravenosa , Antieméticos/administración & dosificación , Antieméticos/uso terapéutico , LactanteRESUMEN
Children's Oncology Group (COG) pharmacists and pharmacy technicians from more than 200 COG-member institutions comprise the COG Pharmacy Discipline. Discipline members serve an essential role in the design and execution of COG clinical trials. Core activities include study drug management, study drug access, clinical trial operations, protocol harmonization, and direct patient care. Discipline members are also actively involved in continuing education, membership engagement, and research across other COG committees/domains. Future areas of committed growth for the discipline include pharmacogenomics, pharmacokinetics, pharmacoeconomics, pharmaceutics, and implementation science.
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Farmacias , Farmacia , Humanos , Niño , Oncología Médica , Evaluación de Medicamentos , FarmacéuticosRESUMEN
This clinical practice guideline update provides recommendations for treating breakthrough chemotherapy-induced nausea and vomiting (CINV) and preventing refractory CINV in pediatric patients. Two systematic reviews of randomized controlled trials in adult and pediatric patients informed the recommendations. In patients with breakthrough CINV, escalation of antiemetic agents to those recommended for chemotherapy of the next higher level of emetogenic risk is strongly recommended. A similar recommendation to escalate therapy is made to prevent refractory CINV in patients who did not experience complete breakthrough CINV control and are receiving minimally or low emetogenic chemotherapy. A strong recommendation to use antiemetic agents that controlled breakthrough CINV for the prevention of refractory CINV is also made.
Asunto(s)
Antieméticos , Antineoplásicos , Neoplasias , Adulto , Niño , Humanos , Antieméticos/efectos adversos , Antineoplásicos/efectos adversos , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Náusea/prevención & control , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológico , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Vómitos/prevención & controlRESUMEN
This clinical practice guideline provides recommendations for preventing acute and delayed phase chemotherapy-induced nausea and vomiting (CINV) in pediatric patients. The recommendations are based on two systematic reviews of randomized controlled trials evaluating interventions to prevent (1) acute phase CINV and (2) delayed phase CINV. Recommendations for acute phase and delayed phase CINV prophylaxis are made for patients receiving chemotherapy of varying emetogenicity, as well as for patients not able to receive dexamethasone or a neurokinin-1 receptor antagonist. Evidence gaps, including antiemetic safety and optimal dosing, were identified.
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Antieméticos , Antineoplásicos , Neoplasias , Niño , Humanos , Antieméticos/uso terapéutico , Antineoplásicos/efectos adversos , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Náusea/prevención & control , Neoplasias/tratamiento farmacológico , Vómitos/inducido químicamente , Vómitos/prevención & control , Vómitos/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Revisiones Sistemáticas como AsuntoRESUMEN
PURPOSE: To identify effective and safe interventions to prevent acute phase chemotherapy-induced nausea and vomiting (CINV) in adult and pediatric patients. METHODS: We conducted a systematic review of randomized trials evaluating interventions to prevent acute CINV. Outcomes assessed were complete chemotherapy-induced vomiting (CIV) control, complete chemotherapy-induced nausea (CIN) control, complete CINV control, and discontinuation of antiemetics due to adverse effects. RESULTS: The search identified 65,172 citations; 744 were evaluated at full-text, and 295 (25 pediatric) met eligibility criteria. In patients receiving highly emetogenic chemotherapy (HEC), complete CIV (risk ratio (RR) 1.23, 95% confidence interval (CI) 1.05-1.44) and CIN (RR 1.34, 95% CI 1.10-1.62) control improved when olanzapine was added. The addition of a neurokinin-1 receptor antagonist (NK1RA) to a corticosteroid plus a serotonin-3 receptor antagonist (5HT3RA) also improved complete CIV (RR 1.11, 95% CI 1.08-1.14) and CIN (RR 1.05, 95% CI 1.01-1.08) control. Compared to granisetron/ondansetron, palonosetron provided improved complete CIV control when the 5HT3RA was given alone or when combined with dexamethasone. In patients receiving moderately emetogenic chemotherapy (MEC), dexamethasone plus a 5HT3RA improved complete CIV control compared to a 5HT3RA alone (RR 1.29, 95% CI 1.21-1.39). Only a single meta-analysis evaluating the safety outcome was possible. CONCLUSIONS: For patients receiving HEC, various antiemetic regimens improved CIV and CIN control. For patients receiving MEC, administration of a 5HT3RA plus dexamethasone improved CIV control. Analysis of antiemetic safety was constrained by lack of data.
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Antieméticos , Antineoplásicos , Neoplasias , Adulto , Humanos , Niño , Antieméticos/uso terapéutico , Neoplasias/tratamiento farmacológico , Náusea/inducido químicamente , Náusea/prevención & control , Náusea/tratamiento farmacológico , Vómitos/inducido químicamente , Vómitos/prevención & control , Vómitos/tratamiento farmacológico , Dexametasona/uso terapéutico , Antineoplásicos/efectos adversosRESUMEN
This 2021 clinical practice guideline update provides recommendations for preventing anticipatory chemotherapy-induced nausea and vomiting (CINV) in pediatric patients. Recommendations are based on systematic reviews that identified (1) if a history of acute or delayed CINV is a risk factor for anticipatory CINV, and (2) interventions for anticipatory CINV prevention and treatment. A strong recommendation to optimize acute and delayed CINV control in order to prevent anticipatory CINV is made. Conditional recommendations are made for hypnosis, systematic desensitization, relaxation techniques, and lorazepam for the secondary prevention of anticipatory CINV. No recommendation for the treatment of anticipatory CINV can be made.
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Antineoplásicos/efectos adversos , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Náusea/prevención & control , Neoplasias/tratamiento farmacológico , Vómito Precoz/prevención & control , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Náusea/inducido químicamente , Vómito Precoz/psicologíaRESUMEN
PURPOSE: With the rapid spread of COVID-19 in New York City since early March 2020, innovative measures were needed for clinical pharmacy specialists to provide direct clinical care safely to cancer patients. Allocating the workforce was necessary to meet the surging needs of the inpatient services due to the COVID-19 outbreak, which had the potential to compromise outpatient services. We present here our approach of restructuring clinical pharmacy services and providing direct patient care in outpatient clinics during the pandemic. DATA SOURCES: We conducted a retrospective review of electronic clinical documentation involving clinical pharmacy specialist patient encounters in 9 outpatient clinics from March 1, 2020 to May 31, 2020. The analysis of the clinical pharmacy specialist interventions and the impact of the interventions was descriptive. DATA SUMMARY: As hospital services were modified to handle the surge due to COVID-19, select clinical pharmacy specialists were redeployed from the outpatient clinics or research blocks to COVID-19 inpatient teams. During these 3 months, clinical pharmacy specialists were involved in 2535 patient visits from 9 outpatient clinics and contributed a total of 4022 interventions, the majority of which utilized telemedicine. The interventions provided critical clinical pharmacy care during the pandemic and omitted 199 in-person visits for medical care. CONCLUSION: The swift transition to telemedicine allowed the provision of direct clinical pharmacy services to patients with cancer during the COVID-19 pandemic.
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Instituciones de Atención Ambulatoria/organización & administración , COVID-19 , Instituciones Oncológicas/organización & administración , Neoplasias/terapia , Pandemias , Servicio de Farmacia en Hospital/organización & administración , COVID-19/terapia , Humanos , Ciudad de Nueva York , Atención al Paciente , Farmacéuticos , Rol Profesional , Estudios Retrospectivos , TelemedicinaRESUMEN
OBJECTIVES: The safe use of medications in pediatric patients requires practitioners to consider the unique pharmacokinetics and pharmacodynamics of drugs prescribed in this age group. In an effort to create a standard of care for the safe use of medications in this population, a list of drugs that are potentially inappropriate for use in pediatric patients has been developed and titled the "KIDs List." METHODS: A panel of 7 pediatric pharmacists from the Pediatric Pharmacy Association were recruited to evaluate primary, secondary, and tertiary literature; FDA Pediatric Safety Communications; the Lexicomp electronic database; and product information for drugs that should be considered potentially inappropriate for use in pediatric patients. Information was rated using predefined criteria. A PubMed search was conducted using the following terms: adverse drug events OR adverse drug reactions. The search was limited to humans; age <18 years; case reports, observational studies, or clinical trials; and English language. No date range was used. Results were used to create an evidence-based list of candidate drugs that was then peer-reviewed and subjected to a 30-day public comment period prior to being finalized. RESULTS: A PubMed search yielded 4049 unique titles, of which 210 were deemed relevant for full review. Practitioner recommendations highlighted an additional 77 drugs. FDA Pediatric Safety Communications and the Lexicomp database yielded 22 and 619 drugs, respectively. After critical analysis, peer review, and public review the final KIDs List contains 67 drugs and/or drug classes and 10 excipients. CONCLUSIONS: This extensive effort led to compilation of the first list of drugs that are potentially inappropriate for prescribing in all or in a select subgroup of pediatric patients. If avoidance is not clinically possible, the drug should be used with caution and accompanied by appropriate monitoring.
RESUMEN
This clinical practice guideline (CPG) provides clinicians with recommendations regarding chemotherapy emetogenicity classification in pediatric oncology patients. This information is critically important for the appropriate selection of antiemetic prophylaxis. Recommendations are based on a systematic review limited to pediatric patients and a framework for classification when antiemetic prophylaxis is provided. Findings of 87 publications informed the emetogenicity classification of 49 single-agent and 13 combination-agent regimens. Information required for the classification of many chemotherapies commonly administered to pediatric patients is lacking. In the absence of pediatric data, consultation of methodologically sound CPGs aimed at adult oncology patients may be appropriate.
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Antineoplásicos/efectos adversos , Antineoplásicos/clasificación , Náusea/inducido químicamente , Neoplasias/tratamiento farmacológico , Guías de Práctica Clínica como Asunto/normas , Vómitos/inducido químicamente , Niño , Ensayos Clínicos como Asunto , Humanos , PronósticoRESUMEN
Providing evidence-based supportive care for children with cancer has the potential to optimize treatment outcomes and improve quality of life. The Children's Oncology Group (COG) Supportive Care Guidelines Subcommittee conducted a systematic review to identify current supportive care clinical practice guidelines (CPGs) relevant to childhood cancer or pediatric hematopoietic stem cell transplant. Only 22 papers met the 2011 Institute of Medicine criteria to be considered a CPG. The results highlight the paucity of CPGs available to pediatric oncology healthcare professionals and the pressing need to create CPGs using current methodological standards.
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Neoplasias/terapia , Cuidados Paliativos/normas , Guías de Práctica Clínica como Asunto/normas , Pautas de la Práctica en Medicina/normas , Niño , Necesidades y Demandas de Servicios de Salud , HumanosRESUMEN
Limited data on optimal posaconazole dosing strategies for pediatric patients exist. In this study, we found that the median initial dose in patients who achieved a posaconazole plasma concentration of 0.7 µg/mL was 22.8 mg/kg per day whereas the median initial dose in those who did not reach the target concentration was 15.8 mg/kg per day; this result suggests that higher initial doses might be warranted.
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Antifúngicos/administración & dosificación , Neoplasias/complicaciones , Triazoles/administración & dosificación , Adolescente , Antifúngicos/sangre , Antifúngicos/uso terapéutico , Niño , Preescolar , Esquema de Medicación , Femenino , Humanos , Masculino , Estudios Retrospectivos , Suspensiones , Triazoles/sangre , Triazoles/uso terapéuticoRESUMEN
This update of the 2013 clinical practice guideline provides clinicians with guidance regarding the use of aprepitant and palonosetron for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) in children. The recommendations were based on three systematic reviews. Substantive changes were made to the guideline recommendations including the inclusion of palonosetron to the 5-HT3 antagonists recommended for children receiving highly emetogenic chemotherapy (HEC) and the recommendation of aprepitant for children 6 months of age or older receiving HEC. To optimize CINV control in children, future work must focus on closing critical research gaps.
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Isoquinolinas/uso terapéutico , Náusea , Neoplasias/tratamiento farmacológico , Quinuclidinas/uso terapéutico , Antagonistas de la Serotonina/uso terapéutico , Vómitos , Adolescente , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Náusea/inducido químicamente , Náusea/prevención & control , Palonosetrón , Guías de Práctica Clínica como Asunto , Vómitos/inducido químicamente , Vómitos/prevención & controlRESUMEN
BACKGROUND: This retrospective review provides preliminary data regarding the safety and efficacy of olanzapine for chemotherapy-induced vomiting (CIV) control in children. PROCEDURE: Children <18 years old who received olanzapine for acute chemotherapy-induced nausea and vomiting (CINV) control from December 2010 to August 2013 at four institutions were identified. Patient characteristics, chemotherapy, antiemetic prophylaxis, olanzapine dosing, CIV control, liver function test results and adverse events were abstracted from the health record. Toxicity was graded using CTCAEv4.03. RESULTS: Sixty children (median age 13.2 years; range: 3.10-17.96) received olanzapine during 158 chemotherapy blocks. Olanzapine was most often (59%) initiated due to a history of poorly controlled CINV. The mean initial olanzapine dose was 0.1 mg/kg/dose (range: 0.026-0.256). Most children who received olanzapine beginning on the first day of the chemotherapy block experienced complete CIV control throughout the acute phase (83/128; 65%). There was no association between the olanzapine dose/kg and complete CIV control (OR 1.01; 95% CI: 0.999-1.020; P = 0.091). Sedation was reported in 7% of chemotherapy blocks and was significantly associated with increasing olanzapine dose (OR: 1.17; 95% CI: 1.08-1.27; P = 0.0001). Of the 25 chemotherapy blocks where ALT and/or AST were reported more than once, grade 1-3 elevations were observed in five. The mean weight change in 31 children who received olanzapine during more than one chemotherapy block was 0% (range: -22 to +18). CONCLUSION: Olanzapine may be an important option to improve CIV control in children. Prospective controlled evaluation of olanzapine for CINV prophylaxis in children is warranted.
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Antieméticos/administración & dosificación , Antineoplásicos , Benzodiazepinas/administración & dosificación , Neoplasias/tratamiento farmacológico , Vómitos , Enfermedad Aguda , Adolescente , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Niño , Preescolar , Femenino , Humanos , Masculino , Olanzapina , Estudios Retrospectivos , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológicoAsunto(s)
Antiprotozoarios/provisión & distribución , Instituciones Oncológicas/organización & administración , Industria Farmacéutica/organización & administración , Pentamidina/provisión & distribución , Servicio de Farmacia en Hospital/organización & administración , Antiinfecciosos/provisión & distribución , Comunicación , Humanos , Inyecciones , Estudios de Casos OrganizacionalesRESUMEN
Vitamin D is essential for calcium absorption and for maintaining bone health in the pediatric population. Vitamin D deficiency may develop from nutritional deficiencies, malabsorption, enzyme-inducing medications, and many other etiologies. It may present as hypocalcemia before bone demineralization at periods of increased growth velocity (infancy and adolescence) because the increased calcium demand of the body cannot be met. In children, inadequate concentrations of vitamin D may cause rickets and/or symptomatic hypocalcemia, such as seizures or tetany. In this review, we will discuss the pharmacology behind vitamin D supplementation, laboratory assessments of vitamin D status, current literature concerning vitamin D supplementation, and various supplementation options for the treatment of vitamin D deficiency in the pediatric population.