Title

 

Authors

A. Pergola¹, C. Blandizzi^1,2, M. Rossi³, A. Capogrosso Sansone¹, M. Moschini⁴, F. Rimoli⁵, E. Cecchi⁶, A. Vannacci⁴, S. Montagnani¹, C. Scollo¹, E. Ruggiero², S. Mantarro¹, L. Picchianti¹, M.C. Leo⁴, G. Giustarini¹, A. Testi², M. Santini⁷, L. Spisni⁸, F. Mannelli⁹, M.S. Verzuri¹⁰, M. Tuccori^2,11

1. Interdipartimental Centre of Research in Clinical Pharmacology and Experimental Therapeutics, University of Pisa, Italy
2. Tuscan Regional Centre of Pharmacovigilance
3. Unit of Pharmacology, University Hospital of Siena
4. Department of Preclinical and Clinical Pharmacology, University of Florence, Florence, Italy
5. Pharmaceutical Unit, Hospital of Prato
6. Emergency Department Hospital of Prato
7. Emergency Department, University Hospital of Pisa
8. Emergency Department Hospital of Pontedera
9. Emergency Department, Pediatric University Hospital Meyer-Florence
10. Emergency Department, University Hospital of Siena
11. Unit of Pharmacology University Hospital of Pisa

 

Abstract

Adverse drug reactions (ADRs) represent a common cause of admission to Emergency Departments (EDs). In USA, ED visits due to drug-related problems have been estimated in about 700.000 patients/year (Budnitz, 2006). The prospective Italian study “PSADE” (Pronto Soccorso And Adverse Drug Events) showed that 4.3% of overall hospitalizations was caused by ADRs (Trifirò et al., 2005). The MEREAFaPS study was started in Lombardy in 2006 with the aim of describing frequency and characteristics of ADR-related ED admissions. In 2010, the MEREAFaPS study was started also in five Tuscan EDs at the hospitals of Pisa, Prato, Siena, Pontedera and the pediatric hospital Meyer of Florence. The MEREAFaPS study is a three-year prospective cohort, observational, multicentre, no profit study. In the present report, an interim analysis of data, recorded in Tuscany from July 2010 to January 2011, is presented. Patients accessing ED for a possible ADR were included in the study. Clinical and demographic data were collected. Adverse drug events were classified as serious when they caused hospitalization or prolonged hospitalization, were life-threatening, resulted in death, or produced permanent malformations or disability. Therapeutic failures were not considered as ADRs. Data collected have been retrieved from three databases: MEREAFaPS for 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. During the study period, 1,247 reports from Tuscany were recorded in the Italian database of spontaneous ADRs, 398 (32%) of which were issued from the Tuscan MEREAFaPS network. Patients screened for possible ADR-related ED admission were 126,303 (frequency of ED admission due to ADR: 0.32%). Among these, 106 (27% of overall patients with ADR) had a serious event (98 required hospitalization). ADR involved 235 females (59%) and 163 males (41%), with a mean age of 44.5±33.9 years (the mean age with exclusion of data collected from the Meyer Pediatric Hospital was 51.2 ±6.4 years). ADR outcomes were distributed as follows: 54 complete recovery; 3 recovery with sequelae; 223 improvements; 117 outcome not available; 1 death. The drugs most frequently involved in ADRs were: amoxicillin + clavulanic acid (43 reports), acetylsalicylic acid (27), ketoprofen (20), paracetamol (19), lansoprazole (18). The system organ class most commonly involved in ADR was skin (n=118), followed by gastrointestinal tract (n=107) and nervous system (n=52). At present, the Tuscan network of MERAEFaPS has estimated a lower incidence of ED visits due to ADRs as compared with data recorded in USA by Budnitz et al. (2006). This difference might be explained by inclusion of drug therapeutic failures and other drug related problems in the USA study. However, the frequency of ADR-related ED visits, as yielded by the MEREAFaPS study in Tuscany, is comparable with that obtained in the initials months of the study in Lombardy (0.32% vs 0.35%, respectively). The main limitation of the present analysis is the high number of reports with ADRs of unknown outcomes. These information refers mainly to patients hospitalized in different departments after ED discharge, for which outcomes are recorded in databases other than those used in the present study. 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.  
References
Trifirò et al. (2005) Pharmacoepidemiol Drug Saf. 14:333-40
Budnitz et al. (2006) JAMA. 296:1858-66