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Volume 19 - Issue 5, September-October 2017
ORIGINAL
INACCURACIES IN PEDIATRIC CHEMOTHERAPIES WITH LOW DRUG VOLUME: A PRELIMINARY STUDY PRIOR TO THE IMPLEMENTATION OF A GRAVIMETRIC-BASED CONTROL SYSTEM
OLIVERAS ARENAS MARIA, MOLAS FERRER GLÒRIA, RENEDO MIRÓ BERTA, FARRIOLS DANÉS ANNA, CARRERAS SOLER MARIA JOSEP, MARTÍNEZ CUTILLAS JULIO


The preparation of chemotherapies including volumes of cytostatic ≤5 ml is more susceptible to volume inaccuracies. The aims of this study were to assess volume deviations in pediatric chemotherapeutic preparations and establish appropriate deviation cut-off points to ensure that most preparations automatically
pass quality controls. Study was conducted at the Pediatric Cytostatic-compounding Unit from a third level Hospital between April and May 2015. All parenteral pediatric chemotherapies with a volume of ≤5 ml of drug were eligible for the study. The inclusion criteria required the physical presence of a pharmacist in the clean room who supervised the preparation process, and recorded the weight of the container inside the BSC before
and after the cytostatic was added to the preparation. The difference between the actual weight and the expected weight was calculated. Deviations were expressed in percentages. The volume required to rectify preparations with insuficient drug was calculated.

Results: In total, 66 intravenous chemotherapies were compounded and weighed under pharmacist’s supervision. Cytarabine 100 mg/ml was used in six preparations, cytarabine 50 mg/ml in twenty-eight, etoposide 20 mg/ml in six, irinotecan 20 mg/ml in nine, vincristine 1 mg/ml in twelve, fludarabine 25 mg/ml in three,
and busulfan 6 mg/ml in two. The six cytarabine 100 mg/ml preparations were excluded from analysis due to unacceptable inaccuracy. In total, 60 chemotherapeutic preparations with cytostatic volumes ranging from 0.35 to 4.75 ml (median: 0.8 ml) were included for analysis. Deviations from the theoretical volume were –2.47
+/-9.39% (SD), with a median of –1.1% (–27.56-14.85). Inaccuracies were ≤5% in 34 (56.67%), 5.1-10% in 11 (18.33%) and >10% in 15 (25%) of preparations. The greatest inaccuracies were observed in volumes <1 ml. Inaccuracies of the seven chemotherapeutic preparations with volumes 3.1-5 ml did not exceed 7.5%. The
median volume of cytostatic to be added to the preparations with insuficient drug was 0.09 ml (0.04 to 0.34 ml).

Conclusions: 1) To ensure accuracy, use the cytostatic drug at the lowest concentration available. 2) The automatic deviation cut-off points for ≤5 ml cytostatic volumes must be established at ±10%. 3) The volume to be added to preparations with an insuficient drug is dificult to measure accurately. 4) Larger studies are
needed to determine if different cut-off points should be set for volumes above and below 3 ml.

ACCURACY – CHEMOTHERAPY – PEDIATRIC – QUALITY CONTROL



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