Iatrogenic events (IEs) -- that is, unintended harm or suffering arising from any aspect of health-care management -- occur frequently in newborn babies, are sometimes serious, and often preventable. These are the conclusions of authors of an Article published in this week's edition of The Lancet.
In the published report To Err is Human*, medical errors were estimated to have caused 44000 deaths in the USA every year. However, available reports on IEs have focussed mainly on adults and (older) paediatric patients, and thus more information is needed to excess the risk to newborn babies, who are a high-risk group.
Professor Umberto Simeoni, Division of Neonatology, La Conception Hospital, Marseille, France, and colleagues did an observational, prospective study of IEs in all newborn babies** admitted to the Division of Neonatology of an academic, tertiary neonatal centre in southern France between January and September 2005. For the study, iatrogenic events were defined as any event that compromised the safety margin for the patient, in the presence or absence of harm. The report of an IE was voluntary, anonymous, and non-punitive. The primary outcome was the rate of IEs per 1000 patient days.
The researchers studied a total of 388 patients during 10346 patient-days, and recorded 267 IEs in 116 of these patients. The rate of IEs was 25.6 per 1000 patients days. Of these, 92 (34%) were preventable, and 78 (29%) were severe. Two IEs were fatal, but neither of these were preventable. The categories of IE of which the highest proportion were severe were nosocomial infections (49/62 = 79%) and respiratory events (9/26 = 35%). There were 34 adverse drug IEs, and 19 of these were medication errors. Of these 19, 12 were in the administration phase, and nine of the 19 were 10-fold dosing errors -- an error which many investigators have shown to be "potentially dangerous".
The main risk factors for experiencing an IE were low birthweight and gestational age; length of hospital stay; a central venous line; mechanical ventilation; and support with continuous positive airway pressure.
The authors say: "This study allows the cause, severity, and preventability of iatrogenic events in neonatology to be defined. A third of all iatrogenic events and more than a quarter of severe iatrogenic events were preventable. Iatrogenic events seem to be less preventable in neonates that in adults and children, in whom 40-60% of adverse events are preventable."
They conclude: "The high risk of iatrogenic events draws attention to the importance of developing, testing, and implementing effective error-prevention strategies in paediatric medicine. Prospective, anonymous incident reporting offers both a means to monitor and prevent iatrogenic events, and an educational advantage to staff. Reduction of the rate of iatrogenic events in vulnerable, neonatal patients should be one of the main aims in providing best possible quality of health care for children."
In an accompanying Comment, Dr Gitte Larsen and Dr Howard Parker, Primary Children's Medical Center, University of Utah, Salt Lake City, say: "These approaches have similarly illuminated local problems and enabled focussed corrective actions."
They conclude: "The universal safe practice approach continues to have value as a strategy to improve patients' safety, but with important limitations -- it should be seen as a place to start, not to end. The local epidemiological approach exemplified by Simeoni and colleagues is an essential complement to the global strategy, and promises to be a highly effective method of reducing harm to patients. Let us hope that more institutions recognise the value of this approach."
Notes to editors: *see ref 2, full paper **the newborn babies (neonates) studied had been hospitalised either at birth or within a few days of birth.
Professor Umberto Simeoni, Division of Neonatology, La Conception Hospital, Marseille, France T) +33 6 08376459 E) umberto.simeoni@mail.ap-hm.fr
Dr Gitte Larsen, Primary Children's Medical Center, University of Utah, Salt Lake City T) +1-801-587-7561 E) gitte.larsen@hsc.utah.edu
PDF OF ARTICLE: http://multimedia.thelancet.com/pdf/press/Unintendedharms.pdf
Journal
The Lancet