Background The Pharmacy Department is involved in providing information and recording adverse drug reactions (ADRs) in the national system. The Oncology/Day Hospital provides clinical data. This study increases the culture of safety and security of processing through the collection of data, helping to give statistical and epidemiological value to otherwise casual observations.
Purpose To detect adverse drugs events in oncohaematology in a systematic and timely manner: the FARMAREL project.
Materials and Methods Following the training sessions at the regional level, meetings were held every three months, to monitor progress and analyse any problems found. All haematological patients treated from April 2009 to July 2012 were monitored and if ADRs occurred, a team of physicians and pharmacists analysed the event according to the World Health Organization definition.
The ADRs observed were posted to the network using special software, set up specifically to allow computerization and real-time monitoring progress of the project, as well as statistical analysis of epidemiological data.
Results We reported a total of 74 cases, categorised by the severity of adverse events (38 not severe, 3 deaths, 3 life-threatening, 30 hospitalizations or extended hospitalisation). Among the ADRs reported the most significant clinical cases in terms of severity were: Gram-negative septic shock (suspect drug: thalidomide), intestinal infarction (bortezomib), acute renal failure (amphotericin B); hypokinetic cardiomyopathy (doxorubicin); atrioventricular conduction block (lenalidomide). The most significant case studies were presented and discussed with other participating hospitals during a meeting of Lombardy Region, and in a national conference.
Conclusions The study has increased the culture of pharmacovigilance and awareness of the clinical data constituting ADRs. The present evaluation has revealed opportunities for intervention especially for the preventable ADRs which will help in promoting safer drug use.
No conflict of interest.
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