RESUMEN
The objective of this study was to describe the variation in preparation and administration of cyclophosphamide, mesna, and hydration for the treatment of childhood malignancies within clinical trial protocol documents. All cyclophosphamide-containing cooperative group (Pediatric Oncology Group) protocols that were open at Dana-Farber Cancer Institute in April 1998 were evaluated. Among the 14 active protocols, there were 23 unique cyclophosphamide regimens. Marked variation existed in infusion rate, fluid type, and volume used for admixing cyclophosphamide and mesna, as defined in the "Treatment" section of the protocols that we evaluated. Further variation was found in the type, amount, and rate of infusion of prehydration and posthydration fluid. Internal inconsistency existed within the protocols pertaining to the administration methods described in the "Agent Information," "Treatment," and "Consent" sections of the written documents. Clinical trial protocol documents serve as reference material for health care providers who prescribe, dispense, and administer protocol chemotherapy. Misinterpretation of protocol documents and clinician orders are contributing factors in serious and deadly medication errors. Internal inconsistency within protocol documents and variation in drug administration across protocols is a potential source of error. We recommend improved accuracy, clarity, and internal consistency of protocol documents to improve patient safety and compliance with protocol specifications. In addition, the use of standard concentrations, volumes, and methods of administration of chemotherapeutic agents and accompanying fluids is recommended.
Asunto(s)
Antineoplásicos Alquilantes/administración & dosificación , Ciclofosfamida/administración & dosificación , Mesna/administración & dosificación , Sustancias Protectoras/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , California , Niño , Fluidoterapia/métodos , Humanos , Infusiones IntravenosasRESUMEN
The serotonin 5-HT3 receptor antagonists or 'setrons' have become the standard of care for the prevention of chemotherapy-induced emesis (CIE) and are first-line therapy for acute CIE in healthcare organisations worldwide. However, their superior efficacy versus standard antiemetics comes at a significant cost. Currently, 3 agents are available in the US: ondansetron, granisetron and dolasetron. The most important treatment-related factor contributing to CIE is the emetogenicity of chemotherapy. The ability to customise, or stratify, the setron dose to match the emetogenic challenge of the chemotherapy administered has potential benefits, both clinically and economically. In adults, there is an appreciable amount of clinical literature addressing stratified administration; however, the amount of 'hard' economic data is rather limited. Intuitively, if clinical outcomes are equivalent, then stratified administration should be associated with economic benefits, as it generally promotes the use of doses lower than those recommended by the manufacturer. The literature strongly substantiates this for ondansetron, but is not as favourable for granisetron or dolasetron. As the rationale and justification for dose stratification is contained in the clinical literature, the authors have reviewed the pertinent literature supporting the clinical and economic benefits of dose stratification in both adult and paediatric patients. The authors also provide a discussion of various additional strategies that can be employed to ensure the appropriate and cost-effective use of setrons in real-world practice settings. These strategies include the use of lower doses than recommended by manufacturers, use for acute versus delayed phase emesis, enhancing the antiemetic efficacy by the addition of a corticosteroid, use of oral versus injectable formulations (when appropriate) and the implementation and use of local, national and international drug use guidelines.