CPC-071 Incidence and Causes of Capecitabine Dose Adjustment in Colon Cancer Patients

Abstract

Background Good Clinical Practice specifies the role of the pharmacist in clinical trials. For each prescription dispensed for a named patient, the pharmacist is responsible for educating the patient on the treatment, counting any residual Investigational Medicinal Product (IMP), and thus for evaluating the compliance. Purpose To assess the importance of pharmaceutical vigilance about IMPs. Materials and Methods This prospective study took three months. For each named-patient prescription dispensed, a count of returned treatment (RT) by the patient from the previously dispensed medicines was performed to assess compliance. Results 117 RTs were analysed. 43 additional RTs from 1 clinical trial were not included in this study due to the impossibility of evaluating compliance (posology changes not notified to the pharmacy and unsuitable secondary packaging). The non-conformity rate was 20% (23 RT). 39% (n = 9) of the non conformities (NC) were due to allowing empty boxes not to be returned. In 61% (n = 14) of NC there was a discrepancy between the expected count of returned IMPs and the one actually made, showing poor compliance.Average counting time was 12 minutes (5-30 min). An exact count of returned IMP was operated during dispensing for 34% of returns and after dispensing for 66%. In all cases, a global analysis was performed before the prescription was dispensed. Conclusions This study points out the major role of the pharmacist in the education of the patient enrolled in clinical trials, about the return of all experimental medicines and the therapeutic schedule. It appeared very important to evaluate compliance while the pharmacist was dispensing the next prescription, independently of the time consumed, in order to correct possible errors in taking the medicines at that time.No conflict of interest. Background Capecitabine is indicated in colon cancer alone or in combination. Recommended posology is calculated with reference to the body surface area (BSA) and pharmacotherapeutic regimen, although adjustments can be made if drug-related toxicity occurs. Purpose To describe the incidence of capecitabine dose adjustment in colon cancer patients (CCPs). To analyse the reasons for this adjustment. unit. For each patient, we detected potentially inappropriate medication (overuse, misuse and underuse) depending on the chronic conditions and suggested drug modifications to the general practitioner (GP). Three months after discharge, we phoned the GPs to find out if the pharmaceutical interventions had been accepted or not, and if patients had fallen again. Results 96 patients (65% of women; median age 85 years) were admitted for falls due to medicines. 86% of the patients were living at home. Medicines involved with the risk of falling were essentially diuretics, benzodiazepines, calcium inhibitors, antiarrhythmics, sartans, anticholinesterases. The modifications usually suggested related to diuretics, benzodiazepines, anticholinergics, vitamin-calcium supplements, osteoporosis treatment and the use of stockings. ...