BACKGROUND: Self-administration of oral chemotherapy regimens in the home setting leading to new challenges in the health system. OBJECTIVE: To develop and evaluate a comprehensive pharmaceutical care program for cancer outpatients treated with oral antineoplastic agents. SETTING: A Spanish tertiary hospital. METHODS: During 2012, a comprehensive pharmaceutical care program was elaborated following the standards recommended by ASCO. It comprised a standard procedure focusing on: drug indication, dosing regimen, required laboratory tests, route of administration, interactions with other current medications and adverse events; a checklist and informational brochures. A pharmaceutical follow up was defined and structured into three clinical interviews over 6 months which focused on safety and efficiency outcomes. Patients starting treatment with oral antineoplastic agents during 2011 (control group) without pharmacist monitoring were compared to patients beginning treatment at some point in 2013 who were prospectively monitored by a pharmacist (intervention group). Statistical analysis was performed by the statistical program SPSS, 21.0 and p < 0.05 was considered significant. MAIN OUTCOME MEASURES: Patient demographics and clinical data were recorded. The primary endpoint was safety outcomes: detection of drug related problems, drug interactions, and adverse events. Adherence, permanence and patient satisfaction were also collected. RESULTS: A total of 249 patients were enrolled in the study. Two hundred and seventy-five medication errors were recorded [106 in the control group and 169 in the intervention group (p = 0.008)]. The pharmacist intervened in 362 occasions being accepted 88.8 % of the time, mainly to reinforce patient education and literacy and giving information on co-administration with other drugs and herbal medicines. Adherent patients increased at the 6th month of treatment in the intervention group by 20 % (p < 0.001). High satisfaction was reported. CONCLUSION: The program has been implemented and evaluated successfully. It ensures a high quality and standard of pharmaceutical care with high patient satisfaction rate and the key points to prioritize for improvement in terms of safety (interactions and administration errors) and efficiency (adherence and permanence) of oral antineoplastic agents.
