Root cause analysis of safety incidents in antineoplastic use in children

to identify and analyze the factors that contribute to safety incident occurrence in the processes of prescribing, preparing and dispensing antineoplastic medications in pediatric oncology patients.

Methods:

a quality improvement study focused on oncopediatric pharmaceutical care processes that identified and analyzed incidents between 2019-2020. A multidisciplinary group performed root cause analysis (RCA), identifying main contributing factors.

Results:

in 2019, seven incidents were recorded, 57% of which were prescription-related. In 2020, through active search, 34 incidents were identified, 65% relating to prescription, 29% to preparation and 6% to dispensing. The main contributing factors were interruptions, lack of electronic alert, work overload, training and staff shortages.

Conclusions:

the results showed that adequate recording and application of RCA to identified incidents can provide improvements in the quality of pediatric oncology care, mapping contributing factors and enabling managers to develop an effective action plan to mitigate risks associated with the process.

Descriptors:
Root Cause Analysis; Antineoplastic Agents; Patient Safety; Medication Errors; Child

Type	Description	N	Contributing Factors	Medications Involved
Prescription	Medication prescribed on a different day or dose than the therapeutic protocol	7	Manual prescription Interruptions Lack of electronic prescription for some protocols	Asparaginase, carboplatin Cyclophosphamide, vincristine
	Adjusting the formula by weight for patients weighing less than 10 or 12 kg	5	Absence of electronic alert (barrier)	Actinomycin#, carboplatin, etoposide, ifosfamide
	Supportive medication omission	5	Lack of policy for including supportive medications Lack of permanent education for professionals	Diphenhydramine, electrolytes, hydrocortisone, ondansetron
	Mistake in dose calculation	4	Absence of electronic prescription Lack of attention	Cyclophosphamide, electrolytes
	Need for dose reduction	3	Absence of electronic alert (barrier) Team overload	Carboplatin, irinotecan, mesna
	Dose omission	1	Absence of electronic prescription Lack of attention	Cytarabine
	Presence of doubtful information	1	Lack of knowledge of registered protocols	Cyclophosphamide
Preparation	Request to prepare the medication with a different dose	5	Mistake in transcription Lots of interruptions Failure to check the compounded medication with the prescription	Carboplatin, etoposide, ifosfamide, mesna, vincristine
	Wrong request to prepare unprescribed medication	4	Error in transcription High number of prescriptions to analyze Many interruptions Failure to check the compounded medication with the prescription Multiple tasks Delay in moving medical records	Carboplatin, Doxorubicin, vincristine
	Wrong identification on the vial of products handled in the biological safety cabinet	2	Failure to check the label with the handled bag Prescription delivery times at the pharmacy Number of patients Limited physical space Employee deficit Work overload Tiredness of employees who spend a long time in the handling area	Cyclophosphamide/ifosfamide Cyclophosphamide/cytarabine
	Wrong labeling by the technician	1	Failure to check the label with the handled bag Employee deficit Work overload Tiredness of employees who spend a long time in the handling area	Doxorubicin
Dispensation	Omission of prescribed medication	2	Error in transcription Failure to check compounded medication with prescription Multiple tasks	Vincristine, mesna
Dispensation	Medication dispensed to the wrong patient	1	Limited physical space Lack of adequate packaging material Hand label with illegible handwriting	Ondansetron

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[1] Corresponding author: Elizangela Barreto. E-mail: elizangela.barreto@inca.gov.br