Intravenous Chemotherapy Compounding Errors in a Follow-Up Pan-Canadian Observational Study

Abstract

Purpose:Intravenous (IV) compounding safety has garnered recent attention as a result of high-profile incidents, awareness efforts from the safety community, and increasingly stringent practice standards. New research with more-sensitive error detection techniques continues to reinforce that error rates with manual IV compounding are unacceptably high. In 2014, our team published an observational study that described three types of previously unrecognized and potentially catastrophic latent chemotherapy preparation errors in Canadian oncology pharmacies that would otherwise be undetectable. We expand on this research and explore whether additional potential human failures are yet to be addressed by practice standards.Methods:Field observations were conducted in four cancer center pharmacies in four Canadian provinces from January 2013 to February 2015. Human factors specialists observed and interviewed pharmacy managers, oncology pharmacists, pharmacy technicians, and pharmacy assistants as they carried out their work. Emphasis was on latent errors (potential human failures) that could lead to outcomes such as wrong drug, dose, or diluent.Results:Given the relatively short observational period, no active failures or actual errors were observed. However, 11 latent errors in chemotherapy compounding were identified. In terms of severity, all 11 errors create the potential for a patient to receive the wrong drug or dose, which in the context of cancer care, could lead to death or permanent loss of function. Three of the 11 practices were observed in our previous study, but eight were new. Applicable Canadian and international standards and guidelines do not explicitly address many of the potentially error-prone practices observed.Conclusion:We observed a significant degree of risk for error in manual mixing practice. These latent errors may exist in other regions where manual compounding of IV chemotherapy takes place. Continued efforts to advance standards, guidelines, technological innovation, and chemical quality testing are needed.

Automated compounding technology and workflow solutions for the preparation of chemotherapy: a systematic review

“…Chemotherapy compounding is a high-risk medical practice due to the toxicity of antineoplastics and the risk of contamination during the manufacturing process. The primary risk for patients includes errors in product identification, dose calculation, dose measurement, and drug preparation labelling 2 3. Medical staff are also exposed to the risk of accidental exposure to antineoplastics during drug preparation or administration due to accidental inhalation, ingestion, injection and percutaneous absorption 4 5.…”

The effect of nigellasativaoil on the prevention of phlebitis induced by chemotherapy: a clinical trial

“…Intravenous chemotherapy is the most effective treatment for cancer in clinical settings [1, 2]. Intravenous catheters are used in cancer patients for hydration, administration of medications, administration of nutritional solutions, blood transfusion and blood products.…”

How human activity impacted manufacturing non-compliances: A multivariate analysis in a centralized cytotoxic preparation unit

“…[25][26][27] Gilbert et al also shown the importance to act on underlying potential human failure or latent error. 28 Additionally, qualitative or/and quantitative control are more and more used to overpass human error. 29,30 Utility of human assistive technology, or workflow management technology, has also been demonstrated in recent years.…”