Proactive risk assessment of intrathecal chemotherapy in paediatric oncology at Kenyatta National Hospital

Abstract

Background: Chemotherapeutic agents are listed as high alert medications due to their high toxicity, narrow therapeutic range and high potential for medication related problems arising from the complexities associated with their use. The goal of intrathecal chemotherapy is to maximize central nervous system drug exposure in the cerebrospinal fluid while reducing or eliminating systemic drug toxicity. Intrathecal chemotherapy use is associated with potentially fatal but preventable medication errors. Objectives: This study aimed to determine the extent of use of intrathecal chemotherapy and identify potential risks to patient safety and the appropriate mitigation strategies in paediatric oncology in Kenyatta National Hospital, Nairobi, Kenya. Methodology: The first phase of the study was a cross-sectional study whereby a universal sampling of medical records for paediatric oncology patients admitted in Kenyatta National Hospital between January and December 2015 was done. Patient demographics such as age, sex, admission diagnosis, rationale for intrathecal chemotherapy the medication administered and number of doses received was collected via a structured data collection tool. Descriptive statistics were used to summarize data using mean, median, range, frequency and percentages. Logistic regression was used to present within-variable difference using odds ratio, p-values and confidence intervals. The second phase applied Healthcare Failure Mode and Effect Analysis, a proactive risk assessment method to identify the potential hazards associated with the prescribing, dispensing, preparation and administration of intrathecal chemotherapy in paediatric oncology. A multi-disciplinary team elaborately described the processes and sub processes of intrathecal chemotherapy. The risk assessment identified the potential failure modes, their cause and the appropriate mitigation strategies through development of recommendations that upon implementation, would improve the quality of care in paediatric oncology. Results: A total of 281 patient records were retrieved, 198 patients were on chemotherapy. There were 33 patients on intrathecal chemotherapy, representing a prevalence of 16.7% (CI 13.0- xviii 21.3). A total of 151 Intrathecal doses were administered to 63.6% of Acute Lymphoid Leukaemia (ALL) and 63.3% of Non Hodgkins Lymphoma (NHL) patients. Methotrexate was used as prophylaxis for central nervous system infiltration or in combination with cytarabine as treatment for confirmed disease. Among ALL patients, males were 11.0 times likely to receive intrathecal chemotherapy when compared to females (p = 0.022). The study identified 54 failure modes which were subjected to hazard and decision tree analyses. Ten failure modes were deemed to have a sufficient likelihood of occurrence and severity to warrant control measures. A further 7 failure modes were identified as single point weaknesses whose occurrence would lead to process failure. Recommendations for these 17 failure modes were made on the basis of criticality, absence of effective control measures and lack of detectability. Conclusion: In paediatric oncology, intrathecal chemotherapy is used as treatment of confirmed CNS disease or as prophylaxis for infiltration. Out of the 198 paediatric patients who received chemotherapy in 2015, 16.7% received intrathecal chemotherapy that involved the use of intrathecal methotrexate alone or in combination with cytarabine. Intrathecal chemotherapy was used as a component of combined therapy for management of ALL and NHL. All intrathecal doses were administered via lumbar puncture. This prospective risk assessment identified key gaps in the current practice of intrathecal chemotherapy in paediatric oncology in KNH and consultatively developed the appropriate mitigation strategies to improve efficiency and the safety of patients and providers.