Goldstein, H. Medication Safety Monday – Part 2, Don't Forget the Bubbles, 2014. Available at:
Nearly ten years ago, I undertook an project for my Pharmacy degree, with the title “Minimising Medication Errors for Paediatric Inpatients”. The TGA’s recent alert about Paracetamol dosing in addition to events in the Australian national news have lead me to consider some of the newer literature in and around the of inpatient medication safety in children. This post is the second in a series of five brief reviews.
Since the Kaushal paper, a 2009 New Zealand study by Kunac et al prospectively looked specifically at Adverse Drug Events (ADEs) in paediatric inpatients. ADEs are “actual injuries resulting from medical interventions related to a medicine”. This is a more eloquent patient-oriented outcome – it focuses on those events which have real-world consequences.
More Bottom Lines:
Adverse Drug Events (ADEs) are a patient-oriented outcome.
ADEs occurred about 1 in every 50 prescriptions.
For every hundred admissions, there are about 22 preventable ADEs or potential ADEs.
More than half of the ADEs are preventable.
ADEs are a significant drain on hospital resources.
Kunac DL, Kennedy J, Austin N, Reith D. Incidence, preventability, andimpact of Adverse Drug Events (ADEs) and potential ADEs in hospitalized children in New Zealand: a prospective observational cohort study. PaediatrDrugs. 2009;11(2):153-60. doi: 10.2165/00148581-200911020-00005. PMID19301935 (it’s paywalled, sorry!)
What was found?
67 ADEs were identified, at a rate of 2.1 per 100 prescription episodes. Of these, more than half were classified as preventable. An additional 77 potential ADEs were noted.
The numbers have also been analysed on a per admission basis; for every 100 admissions there were ~22 preventable occurrences that were potential or actual ADEs.
Quite correctly, the authors looked at the seriousness of the events. They classified ADEs and Potential ADEs as fatal, persistent disability, life threatening, hospitalisation, intervention to prevent permanent impairment or not serious.
Thankfully, there were no fatal ADEs during the study period, however three events, all in neonates resulted in ‘preventable persistent disability’. Two of the events were related to ‘inadequate management’ of hyponatremia, and a third related to concomitant administration of vancomycin & indomethacin and increasing levels of creatinine.
A further seven further ADEs were life threatening, and seven more as requiring intervention to prevent permanent impairment, all of which were preventable ADEs.
A few specific examples of potential ADEs given include:
- No maximum dose on a PRN morphine prescription (potentially fatal).
- Gentamicin dosing & frequency in neonates (persistent disability).
- A high number of ADE reports centred around opiate medications.
I think it’s good that the authors have been specific about these events; they’re illustrative of how ADEs increase in seriousness quite insidiously, as though sliding through the Swiss Cheese. It’s a nice mix of the data, but with those practical stories that help this kind of research stick.
Finally, there are several paragraphs discussing the costs of ADEs, incorporating causality and costs. They are a quantified as a significant expenditure. I think that as there’s all kinds of volatility in repeating a dollar amount that’s more than a decade old in a small country I’ll refrain from re-posting it. It is worth noting that there’s comprehensive universal healthcare and significant Tort Law reform in New Zealand, so this cost would be about as under inflated as it gets in the developed world.[Dr Desireé Kunac PharmD. was my supervisor for the aforementioned elective.]