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Updated: Aug 13, 2025
Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
Published on: February 6, 2015
Using Failure Mode, Effect and Criticality Analysis to improve safety in the cancer treatment prescription and
Alessandra Buja1, Giuseppe De Luca2, Ketti Ottolitri3
1Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, 35131, Padua, Italy. alessandra.buja@unipd.it.
Background:
Administering cancer drugs is a high-risk process, and mistakes can have fatal consequences. Failure Mode, Effect and Criticality Analysis (FMECA) is a widely recognized method for identifying and preventing potential risks, applied in various settings, including healthcare. The aim of this study was to recognize potential failures in cancer treatment prescription and administration, with a view to enabling the adoption of measures to prevent them.
Methods:
This study consists of a FMECA. A team of resident doctors in public health at the University of Padua examined the cancer chemotherapy process with the support of a multidisciplinary team from the Veneto Institute of Oncology (an acknowledged comprehensive cancer center), and two other provincial hospitals. A diagram was drafted to illustrate 9 different phases of chemotherapy, from the adoption of a treatment plan to its administration, and to identify all possible failure modes. Criticality was ascertained by rating severity, frequency and likelihood of a failure being detected, using adapted versions of already published scales. Safety strategies were identified and summarized.
Results:
Twenty-two failure modes came to light, distributed over the various phases of the cancer treatment process, and seven of them were classified as high risk. All phases of the cancer chemotherapy process were defined as potentially critical and at least one action was identified for a single high-risk failure mode. To reduce the likelihood of the cause, or to improve the chances of a failure mode being detected, a total of 10 recommendations have been identified.
Conclusions:
FMECA can be useful for identifying potential failures in a process considered to be at high risk. Safety strategies were devised for each high-risk failure mode identified.
Insights
Failure Mode, Effect and Criticality Analysis (FMECA) identified high-risk failures in cancer drug administration. This analysis enabled the development of safety strategies to prevent potentially fatal errors in chemotherapy processes.
Area of Science:
- Oncology
- Healthcare Safety
- Risk Management
Background:
- Cancer drug administration is inherently high-risk, with potential for fatal errors.
- Failure Mode, Effect and Criticality Analysis (FMECA) is a recognized risk assessment tool applicable to healthcare.
- Previous studies highlight the need for systematic risk identification in cancer treatment.
Purpose of the Study:
- To identify potential failure modes in cancer treatment prescription and administration.
- To proactively implement preventive measures against identified risks.
- To enhance patient safety during chemotherapy.
Main Methods:
- A Failure Mode, Effect and Criticality Analysis (FMECA) was conducted.
- A multidisciplinary team analyzed the 9 phases of chemotherapy from planning to administration.
- Severity, frequency, and detection likelihood were rated to determine criticality.
Main Results:
- Twenty-two failure modes were identified across all chemotherapy phases.
- Seven failure modes were classified as high-risk.
- Ten recommendations and specific safety strategies were developed for high-risk failures.
Conclusions:
- FMECA is effective in identifying critical failures in high-risk processes like cancer treatment.
- The study successfully devised safety strategies for identified high-risk failure modes.
- This approach can improve the safety and reliability of cancer drug administration.
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