Using FMEA for New Medications

Author: Michael J. Gaunt, PharmD



Failure Mode and Effects Analysis provides a systematic method for evaluating potential points of error.

Failure mode and effects analysis (FMEA) is a process to systematically identify areas of potential failure within a process and gauge what the effects would be—before an error actually takes place. This proactive process can be used before new medications are prescribed, purchased, dispensed, and administered so that preemptive action can be taken to detect, eliminate, or mitigate any potential patient harm (FMEA can also be used to evaluate other new processes and systems within the pharmacy).

Both brand and generic medication names are vulnerable to confusion (eg, CeleXA and CeleBREX; traZODone and traMADol). Labeling and packaging, dosing considerations (eg, mg or mL), and route of administration can all lead to potential errors if risk is not identified prior to stocking or dispensing.



How the FMEA Process Would Work

Step 1. Start by creating a detailed diagram (a process flow diagram) of the process and tasks involved with storing and dispensing the new product. Explore how the intended product would be prescribed. How will the prescription be received? Who would prescribe it and for which patients? What clinical patient information will be needed before it is prescribed or dispensed? How would it be procured, stored, and used, from acquisition through dispensing and administration? Who would prepare and dispense it? What information will need to be given to the patient or caregiver?

Step 2. Identify how and where systems and processes may fail (failure modes) and what can go wrong while considering how the product would be used. See the Table for a few examples of drug characteristics and questions to consider.

Step 3. Determine for each failure mode the likelihood of making an error, as well as the potential consequences of the failures. How often could this failure mode occur? What would happen to the patient if the drug were given at the wrong dose or at the wrong time, or by the wrong route? What would happen if a patient received the wrong medication or if the wrong patient received the medication?

Step 4. Consider the severity of the outcome and identify any pre-existing processes that could help eliminate or detect the error before it reaches the patient. Evaluate each process for its effectiveness based upon what was learned in previous steps. For example, would obtaining additional patient information, using computer alerts, or bar-code scanning catch these errors every time? Numerical values can be assigned to determine the likelihood of the occurrence, its severity, and the chance that it would be detected before reaching the patient and causing patient harm.

Step 5. Develop actions to prevent the error, detect it before it reaches the patient, or minimize its consequences if failure modes reveal errors with significant consequences. High-leverage strategies (www.ismp.org/Newsletters/ambulatory/archives/200602_4.asp) should be implemented whenever possible.

Final Thought

A simplified FMEA process as described above can be an efficient, proactive risk management tool, especially when practice sites consider what is already known about error potential from past experiences or information available in this column and publications such as the ISMP Medication Safety Alert!


Dr. Gaunt is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/ Ambulatory Care Edition.