Electronic letters to:

Research:
Christopher S. Parshuram, MB ChB DPh, Teresa To, PhD, Winnie Seto, BScPhm Pha, Angela Trope, MSc RPh, Gideon Koren, MBBS, and Andreas Laupacis, MD MSc
Systematic evaluation of errors occurring during the preparation of intravenous medication
CMAJ 2008; 178: 42-48 [Abstract] [Full text] [PDF]
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[Read eLetter] Clinical evidence in favour of the implementation of a pediatric vial to improve dose accuracy
Karel Allegaert   (24 January 2008)

Clinical evidence in favour of the implementation of a pediatric vial to improve dose accuracy 24 January 2008
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Karel Allegaert,
NICU, University Hospitals Leuven, Herestraat 49 3000 Leuven, Belgium
Neonatal Intensive Care Unit, Division of Woman and Child

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Re: Clinical evidence in favour of the implementation of a pediatric vial to improve dose accuracy

Email Karel Allegaert

Dear editor,

We read with great interest the paper of Parshuram et al. on the systematic evaluation of errors occurring during the preparation of intravenous medication. In an out-of-clinic experimental design, the authors documented errors in 34.7 % of the prepared infusions and suggested that the reduction of provider fatigue and the production of pediatric-strength solutions or industry-prepared solutions may reduce medication errors.1 Taking the author’s conclusions into account, we would like to report on the impact of a pediatric vial on the magnitude of interindividual variability in amikacin clearance in extreme preterm neonates at birth to underscore the relevance of pediatric-strength solutions to improve drug administration based on a (unintended) clinical observation.

In a cohort of 205 preterm neonates (24-30 weeks gestational age, 1/1/1999 – 1/9/2004) at birth in whom amikacin peak and trough samples were collected just before and one hour after the second intravenous administration for therapeutic drug monitoring. A population pharmacokinetic study was performed and documented that amikacin clearance (CL) increased from 0.486 at 24 to 0.940 l h-1 70 kg-1 at 30 weeks gestational age (GA). Covariate effects of CL were observed for size (48 %), gestational age (15 %) and the co-administration of a non-selective cyclo-oxygenase inhibitor (2 %) still leaving 35 % of the observed interindividual CL variability unexplained.2 During this time interval, an adult vial (250 mg/mL, Amukin ready-to-use, Bristol Myers Squibb, Belgium) was used to prepare the individual amikacin doses. Doses were prepared bedside by a registered nurse.

The GA-dependent dose of amikacin administered is 15.5 to 20 mg/kg.2 Taking the mean birth weight (1,1 kg) of this cohort into account, this often necessitates the drawing of a drug volume below 0.1 mL when based on an adult vial resulting in sequential dilution. In contrast, when drawn from a pediatric vial (50 mg/mL, Amukin ready-to-use, Bristol Myers Squibb, Belgium), a volume of 0.4 to 0.6 mL is needed. Based on the still clinical relevant unexplained variability observed in the initial population, we decided to introduce a pediatric vial and subsequently evaluated its impact on the interindividual variability of amikacin CL in 56 preterm neonates with the same clinical characteristics as the initial cohort. Amikacin CL estimates were the same in neonates given either the adult or the pediatric vial, but CL variability was reduced by 53 %, very likely reflecting improved dose precision.3

Guidelines to improve patient safety by reducing errors occurring during the preparation of intravenous medication should be based on available evidence since a pediatric vial will result in additional costs and potential confusion when an ‘adult’ vial already exist. The current clinical observation further supports the conclusions of Parshuram et al that preparation of medicine at doses appropriated for use in children has the potential to reduce preventable (systematic) errors and to improve clinical care.

K Allegaert, Brian J Anderson

References

1.Parshuram CS, To T, Seto W, Trope A, Koren G, Laupacis A. Systematic evaluation of errors occurring during the preparation of intravenous medication. CMAJ 2008;178:42-8. 2.Allegaert K, Anderson BJ, Cossey V, Holford NH. Limited predictability of amikacin clearance in extremely preterm neonates at birth. Br J Clin Pharmacol 2006;61:39-48. 3.Allegaert K, Anderson BJ, Vrancken M, et al. Impact of a paediatric vial on the magnitude of systematic medication errors in neonates. Paed Perinat Drug Ther 2006;7:59-63

Conflict of Interest:

None declared