Title

 

Authors

F. Musicco (1),  M. G. Celeste (4), E.M. Proli (3), A. Tufo (1), R. Fraschetti (2), C. Peschi (4), N. Mores (2) 

 

Abstract

Patient safety is a key issue in the care of patient with cancer. The use of oral anticancer agents represents a challenge in patient safety particularly when oral agents are taken at home where neither a nurse or a clinician can monitor the patient and the treatment.. All the steps in the prescription process are vulnerable and challenging for patient safety. Even the prescriber usually cannot count on automatic alerts for dose limits or potential drug interactions since it is usually still filling prescription by handwriting. Even handling the drugs could be also harmful. Moreover most of the oral agents carry complex dosing schedules and are at high risks  for causing adverse reactions. The purpose of this multicentric study was to firstly analyze all the safety challenges specifically associated with oral chemotherapy by a questionnaire survey for the patients and in a second phase, jet to be started,  to propose a further survey following a specific  information and active vigilance action to the patient by a pharmacovigilance expert/ clinical pharmacist. All the patient treated with  Glivec, Navelbine, Nexavar, Revlimid, Sprycel, Sutent, Tarceva, Tasigna, Temodal, Tyverb, Xagrid, Xeloda, UFT, Fludara for at least two months have been enrolled whitout any further exclusion criteria. 348 patient have been interviewed after one year at the end of the first phase, observational of the study. Treatment with Xeloda and Glivec accounted for the mayority 28% of patients  and  26% respectively. 305 patients ( 87%) reported at least one adverse reaction causing additional pharmacological treatment (42%), changes in schedule or dosing of the chemotherapy (12%), dose was reduced in 4% of the patients and treatment suspended in 9%. Only 1 patient needed hospitalization  due to a serious ADR. Only 14% of the ADRs experienced by the patients  were present in the RNF due to medical reporting. Patient compliance has been evaluated by knowledge of schedule and dosing and precise question about missing doses. 23% of the patient reported at least one skipped dose. 15% of patient experienced difficulties in  drug refilling. 40% of the patients liked to be informed or communicate via web or keep track of the therapy by a notebook. These observations indicate the need of an active vigilance to improve and support patient safety during oral anticancer therapy. Effects of this activity would be further investigated in the second phase of this research.

This work is supported by a grant of Regione Lazio/AIFA for Pharmacovigilance