[Failure Mode and Effects Analysis (FMEA) method applied to anticoagulation of patients with non-valvular atrial fibrillation]

Abstract

Objectives: To contribute to the improvement of the process of anticoagulation in patients with nonvalvular atrial fibrillation (NVAF) through awareness and training activities for Primary Care Physicians.

Materials and methods: A total of 38 focus groups, sequenced according to an adaptation of the Failure Mode and Effects Analysis (FMEA) method. Each meeting was driven by «brainstorming» methodology. The geographical representation was homogeneous, with a total of 482 national. physicians (444 Primary Care Physicians, and 38 cardiologists). The meetings were held between March 28 and June 20, 2017.

Results: The main unsafe actions that can lead to a haemorrhagic or thrombotic event are incorrect anticoagulation or lack of patient follow-up. These events are mainly caused by training deficiencies in the management of NVAF, or by not taking into account possible interactions with vitamin K antagonist drugs. The main recommendations to alleviate these failures were focused on a good follow-up of patients with NVAF, on creating or updating the protocols or clinical practice guidelines, and on promoting the continuous training of physicians who usually manage patients with non-valvular AF treated with oral anticoagulants.

Conclusions: A significant percentage of patients with NVAF are not correctly anticoagulated. Specific actions are required to alleviate this problem. Among them, the importance of a general anticoagulation training was emphasised, and particularly, the use of direct oral anticoagulants.

Keywords: Anticoagulantes; Anticoagulants; Atrial fibrillation; Fibrilación auricular; Patient safety; Seguridad del paciente; Thrombosis; Trombosis.