Instituto do Câncer do Estado de São Paulo (ICESP-HCFMUSP) is a public universitaryoncological hospital, with currently 43 thousand active patients. As an exception in Brazil, it deliversanticoagulants to outpatients to assure the continuation of treatment after hospital discharge.Anticoagulants are considered high vigilance medicines due to their potential to significantly jeopardizepatients health if misused. They are specially identified and stored to differentiate them from otherproducts, exhibit a special alert when prescribed and are delivered to patients with a folder containinginformation on them. In October 2018, a recommendation on the treatment of venous thromboembolism incancer patients was launched at ICESP-HCFMUSP aiming to optimize local resources, improve theanticoagulation management, overcome the irregular supply of enoxaparin and reduce the burden ofparenteral anticoagulation whenever possible. It's available at the intranet. Concomitantly, rivaroxabanbecame available and a 6-month period of dedicated pharmaceutical vigilance was started.

This report aims to show the relevance of pharmaceutical vigilance, how it can be carried out and itscontribution to refine the management of a new anticoagulant.

48 pharmacists and 2 hematologists (Thrombosis and Hemostasis team)handled the pharmaceutical vigilance process from October 2018 to April 2019. All professionals weretrained on the recommendation regarding the eligibility and exclusion criteria for prescribing rivaroxaban,its dosage, interactions and management details. The process comprised: evaluation of inpatients andoutpatients rivaroxaban prescriptions, investigation of adverse events, longitudinal evaluation of clinicalrecords of patients on rivaroxaban and medical support to anticoagulation management as requested. Anydiscrepancy between the recommendation and a prescription was considered a non conformity. Specialmaterials to identify the new anticoagulant and educate professionals and patients were developed. Allclinical documents were electronic (TASY) accessible only by authorized professionals by password.Results are described as frequencies.

762 evaluations were performed by the pharmacists in the 6-month period: 490 inpatients (100%)and 199 outpatients (44.6%) prescriptions, 69 recordings and 4 notified (100%) adverse events, resultingin 126, 13, 9 and 8 non conformities, respectively. Besides supporting the pharmacists, the hematologistsreplied to additional 22 requests, finding out 15 non conformities. Seven bleeding episodes and 7thrombosis recurrences were detected, none resulting in death. All except 1 recurrence were associated tosome non conformity. Clarification and/or educational actions were carried out whenever a non conformitywas found. Around 500 outpatients received the folder on rivaroxaban.

The comprehensive analysis of prescriptions and records with prompt interaction withprescribers facing non conformities could contribute to improve the management of a new anticoagulant ata cancer institution.