Medical error incident reporting in a Italian Academic Hospital: does it work in a long-term period?

Background: Recent critiques of incident reporting system (IRS) suggest that its role in managing safety has been over emphasized and call for less stress on counting incidents and more importance on the effective analysis of incidents and organizational learning. Few researches have examined the effectiveness of IR in improving safety. Aim of this study is to evaluate a long-term medication error (ME) IRS in an Italian Academic Hospital (AH). Methods: From 2010 a hospital wide IRS, voluntary and anonymous, is in operation. Safety managers in the central risk office receive and discuss all incident reports, decide further investigations, take ameliorative action, assess any measures undertaken and provide feedback. This retrospective study analysed all MEs [adverse drug events (ADEs) and near misses] database of 2010–2014 period during which none information technology (IT) system on drug management was introduced in AH. Results: ADEs were 40,5% (83/205) in 2010 and 24,9% (68/273) in 2014 of ME near misses [p < 0,001]. Hospital IRS showed 0,197 ADEs per 100 admissions in 2010 and 0,175 per 100 admissions in 2014 [OR = 1,127 (95% CI = 0,808–1,573); p = 0,465]. In 2010 none ADEs resulted in sentinel event, while in 2014 1 ADE determined the patient's re-operation. There is not significant statistical difference in ADEs percentages distribution, between the two years, by prescribing [27,7% (23/83) vs 25% (17/68)], dispensing [16,9% (14/83) vs 19,1% (13/68)] and administering [55,4% (46/83) vs 55,9% (38/68)]. Conclusions: This study shows that IRS underrated ADEs number per 100 admissions [<1 vs 2.43 reported by Classen et al (1997) in a best evidence in this field of research]. Prescribing and dispensing steps remained a problem in the years probably to a lack of resources investment in IT. On the other side, reported ME near misses increased. In conclusion IRS had spread a safety culture among health personnel but it was not effectiveness in monitoring the real dimension of ADEs phenomenon.