Background Pharmacovigilance is a key medicine safety aspect, which is an important principle of patient care and a critical component of quality management. Improving it requires a comprehensive approach, a task that affects the operation of the whole system; therefore it is essential to implement educational strategies targeted to health personnel and patients themselves, in order to timely intervene in the presence of adverse events (AE) to medicines.
Objectives The aim of this study was to describe and compare the record of adverse events between the periods (2011, 2012, 2013 years) and after implementation (2014) of educational strategies focused on prevention of adverse events and the implementation of a prevention scheme of infections in patients with rheumatoid arthritis (RA) who were receiving biological therapy
Methods In 2011 a low level of reporting of adverse events compared with literature was observed, so in early 2012 at our rheumatology center we began to conduct educational seminars for groups of patients and health personnel involved in the processing of reports of adverse events in order to improve reports. In late 2013 a scheme to prevent risk of infection in RA patients with recommendations on vaccination and care of immunosuppressed patients according to the type of therapy was implemented. A review and analysis of reports of adverse events at committee of pharmacovigilance in 2011, 2012, 2013 and 2014 in a specialized center in AR was conducted.
Results 374 adverse events were reported in patients with RA using biologic drugs between 2011 and 2014. In 2011 13 adverse events were reported; in 2012 95 adverse events were reported; in 2013 199 adverse events were reported biologics. As above mentioned, between 2011 and 2013 was observed an increase in reporting of adverse events attributed to education for better reporting. But in 2014 after the implementation of educational strategies and a scheme of infection prevention was observed a decrease in reporting of adverse events (n=67), which compared with 199 adverse events observed in 2013, implies a decrease more than 60% of cases statistically significant. Between biological more than 50% of cases of adverse events were with infliximab.
Conclusions It is concluded that during the first year there was an underreporting of patients with adverse events, which increased in next two years because educational programs; subsequently with the implementation of educational strategies and infection prevention scheme is achieved lower percentage of adverse events with biologicals in patients with RA.
Disclosure of Interest None declared
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