Intensive monitoring programme of adverse drug reactions in emergency department (MEREAFaPS Study): The tuscan experience

Objectives: The MEREAFaPS study was aimed at investigating drugrelated admission to the emergency department (ED). A preliminary analysis of data, recorded in 5 Tuscan EDs from 1st July 2010 to 31st May 2011, is presented. Methods: The MEREAFaPS study is a three-year prospective cohort, observational, multicentre, multiregional, no profit study, coordinated by the Lombardy Pharmacovigilance Centre. Patients accessing ED for a possible adverse drug reaction(ADR) were included in the study. Clinical and demographic data were collected. Data presented in this analysis have been retrieved from three databases: MEREAFaPS for ED-ADR data, ED database for the number of ED admissions and the Italian database of spontaneous ADR reporting, held by the Italian Drug Agency (AIFA), for the overall number of ADR reports. Results: During the study period, patients screened for possible ADRrelated ED admission were 243 383. Overall, 2505 ADR reports from Tuscany were recorded in the Italian database of ADRs report, 837 (33.4%) of which were issued from the Tuscan MEREAFaPS network (frequency of ED admission due to ADR: 0.34%). Among these, 245 (28.7% of overall patients with ADR) described a serious event (227 required hospitalization). ADR involved 508 females (59.6%) and 344 males (40.4%), and the age range was 17-65 years. ADR outcomes were distributed as follows: 101 complete recovery; 3 recovery with sequelae; 498 improvements; 246 outcome not available; 1 death. The drugs most frequently involved in ADRs were: amoxicillin + clavulanic acid (94 reports), acetylsalicylic acid (39), furosemide (33), ketoprofen (32), warfarin (32), paracetamol (27), lansoprazole (25), amoxicillin (22), ibuprofen (22) and allopurinol (21). The system organ class most commonly involved in ADR was skin (n = 382), followed by gastrointestinal tract (n = 255), general disorders and administration site conditions (n = 153) and nervous system (n = 146). Conclusions: Overall, our preliminary data indicate that ADRs are a common cause of ED admission. These events are often serious and require hospitalization. Conclusive data from this study will be helpful to achieve a better clinical definition of these adverse events, thus helping ED caregivers to better recognize and manage them.