Proactive risk assessment of vincristine use process in a teaching and referral hospital in Kenya and the implications.

INTRODUCTION: The chemotherapy use process is potentially risky for cancer patients. Vincristine, a "High Alert" medicine, has been associated with fatal but preventable medication errors. Consequently, there is a need to improve the use of vincristine especially in lower- and middle-income countries where there are constraints with resources and often a lack of trained personnel to administer cancer medicines. However, where there is a rising prevalence of cancer cases. These concerns can be addressed by performing proactive risk assessments using Healthcare Failure Mode Effect Analysis (HFMEA) and implementing the findings. METHODS: A multidisciplinary health team driven by pharmacists identified and evaluated potential failure modes based on a vincristine use process flow diagram using a hazard scoring matrix in a leading referral hospital in Kenya. RESULTS: The processes evaluated were: prescribing, preparation and dispensing, transportation and storage, administration and monitoring of the use of vincristine. Seventy-seven failure modes were identified over the three-month study period, of which 25 were classified as high risk. Thirteen were adequately covered by existing control measures while 12 including one combined mode required new strategies. Two of the failure modes were single-point weaknesses. Recommendations were subsequently made for improving the administration of vincristine. CONCLUSIONS: HFMEA is a useful tool to identify improvements to medication safety and reduction of patient harm. The HFMEA process brings together the multidisciplinary team involved in patient care in actively identifying potential failure modes and owning the recommendations made, which are now being actively followed up in this hospital. Pharmacists are a key part of this process.