A Pharmacovigilance Program from Laboratory Signals In Hospitalizaed Patients: Results Of 2014

August 2015 e137 Functional Unit Risk Management, Hospital La Paz-Carlos III, IdiPAZ, Madrid, Spain; and Computing Service, Hospital La PazCarlos III, IdiPAZ, Madrid, Spain Background: Incidents, errors or adverse events affect 10 to 17% of hospitalized patients; more than half are related to drugs. The Functional Unit of Risk Management (FURM) has developed a Computerized System for Reporting Incidents, errors or adverse events (SINOIRES for its acronym in Spanish) which is voluntary, anonymous and confidential, allowing the analysis through online collaboration with Responsible of Clinical Safety (RCS) of the units involved. We described the results of the first year of work. Methods: SINOIRES has been developed as a project of JAVA programming Struts frame work as a database using Microsoft SQL Server with functionalities:(i) reporting form, and subsequent consult by the notifier by an identification code,(ii) information of method, characteristics and conditions of the system,(iii) management of incidents with 3 profiles: administrator, manager and RCS,(iv) communication between users of the system. Procedure: managers (4 FURM s members) access to the notifications assign state (open, in process, implementing improvements, closed), priority (high, medium, low), and assigned 2 or 3 RCS that analyse the notification. Once the analysis (not visible to the notifier) has been completed, managers decided the actions (visible to the notifier) and together with RSC monitoring the recommendations. Results: SINOIRES received 203 notifications in 2014: medication/ vaccine (63 notifications), continuity of care (18), infrastructure (17), diagnostic test (17), patient monitoring and care (16), patient identification (13), therapeutic procedure (10), clinical/diagnosis assessment (10), rest of phases (39). Were decided 104 systemic actions, of them one generalizable action to improve “the prescription and administration of intravenous paracetamol”. Conclusions: SINOIRES facilitates the notification and the study of incidents, allowing standardization of the procedure in the hospital, keeping the main features of confidentiality and feedback from the notifier. The system allows knowing the circumstances that favour the occurrence of human errors and system failures, to improve the defences of the organization.