This document discusses a root cause analysis (RCA) and failure modes and effects analysis (FMEA) conducted after a medication error involving amphotericin. The error occurred when a physician prescribed 340mg of amphotericin daily for a patient, rather than the recommended 340mg total dose. This led to the patient receiving an overdose of the drug. The RCA identified factors that contributed to the error, including a lack of physician knowledge, communication issues during rounds, and distractions in the pharmacy. The analysis also found issues with look-alike drug names, a lack of standardized ordering processes, and that the computer system and compounding pharmacist failed to catch the overdose. Recommendations include improving

1. Root Cause Analysis (RCA)
&
Failure Modes and Effects Analysis
(FMEA)
Tom Johns, PharmD, BCPS
Shands at the University of Florida

2. “Healthy” Root Cause Analysis
 A Structured (Reactive) Response to Medication
Errors
 Multidisciplinary team including individuals
involved in the error
 Importance of medical staff involvement
 Structured (semi) process - what happened, why
did it happen (causes/contributing factors); what
can be done to prevent it from happening again
 Everyone needs to play well in sandbox together:
no finger pointing, no accusations, no passing
judgment

3. Medication
Error
Analysis
www.ismp.org

5. A Framework for a Root Cause Analysis and
Action Plan In Response to a Sentinel Event
www.jointcommission.org

8. Amphotericin RCA
 What happened?
 24 y/o male in MICU s/p peripheral stem cell transplant.
Wt = 68kg
 Problem list: respiratory failure being mechanically
ventilated, fungal pneumonia (mucormycosis v aspergillus),
acute renal failure, CMV colitis, diabetes
 BMT clinical pharmacist recommends ABLC 340 mg IV daily
– recommended to BMT team. Pharmacist is not sure how it
was communicated to MICU team.

9. Amphotericin RCA
 What happened?
 Medical team discusses on rounds and decides to initiate
amphotericin therapy
 Another physician on rounds shows the prescribing intern
information sheet for prescribing amphotericin
 Physician completes handwriting order
 Other team members provided “second” check of new intern
work

10. Amphotericin RCA
 What happened?
 Order faxed to Pharmacy satellite for processing
 “Pharmacist in training” discussed with
experienced pharmacist because orders needed
approval from ID; Pharmacist has conversation
with ID physician to discuss antifungal drug as the
patient was on posaconazole – no discussion of
doses.

11. Amphotericin RCA
 What happened?
 Pharmacist enters order into Pharmacy Computer System –
Pharmacist unaware of BMT pharmacist recommendation.
States she was preoccupied with working with ID and taking
care of other patients at the same time. She did not double
check the dose.
 IV label is printed in sterile products area for compounding
by pharmacy technician. Nine vials of amphotericin (50
mg/vial) used to compound infusion.
 Compounded product is checked by sterile products
pharmacist and delivered to the satellite pharmacy for
delivery to nursing unit
 Amphotericin is administered by the nurse

12. Amphotericin RCA
 What happened?
 Error discovered by BMT pharmacist the following
day (only one dose given)
 HD initiated (attending felt that amphotericin was a
contributing factor to worsening renal failure)
 Family and risk management notified of the error
 Patient expired – unrelated to amphotericin error

13. Why did it happen?

14. Amphotericin RCA
 Why did it happen? (causes and contributing factors)
 Knowledge
 Physician was not familiar with amphotericin
dosing
• “I’ve only been a doctor for 6 weeks”
 MICU team was not familiar with amphotericin
formulations and dosing

15. Amphotericin RCA
 Why did it happen? (causes and contributing factors)
 Communication
 Rounds in MICU are busy and contain
distractions with multiple individuals
communicating at the same time
 Prescribing physician was transcribing another
physician’s verbal order
 Complicated culture of physician training versus
allowing consultants to prescribe directly

16. Amphotericin RCA
 Why did it happen? (causes and contributing factors)
 No standardized, required method for writing
amphotericin

17. Amphotericin RCA
 Why did it happen? (causes and contributing factors)
 Look-alike/sound-alike medication
 Amphotericin, amphotericin B, amphotericin B
deoxycholate, ABLC, Abelcet, amphotericin B lipid
complex, Ambisome
 Different dosing (lipid formulations commonly prescribed at
5mg/kg; traditional amphotericin 0.5-1mg/kg)
 Very common LA/SA error reported in literature
 TJC requirement to develop LA/SA like
 Dispense message in pharmacy computer system
contains label “Caution – Look-alike/Sound-alike
Medication”. Also appear on MAR and storage containers
in pharmacy.
 Use of medication name abbreviations (ABLC) – not
recommended (ISMP)

18. Amphotericin RCA
 Why did it happen? (causes and contributing factors)
 Distractions in Pharmacy by pharmacist
training and need for ID pre-approval of
medication
 Pharmacy computer system did not produce
clinical alert for the overdose

23. Amphotericin RCA
 Why did it happen? (causes and contributing
factors)
 Compounding pharmacist did not
recognized the overdose or the excessive
number of vials needed to prepare the
infusion
 Nurse did not perform dose check prior to
administration

24. RANK ORDER OF ERROR REDUCTION STRATEGIES
Forcing functions and constraints
Automation, computerization, bar code scanning
Standardization and protocols
Time out, checklists and double check systems
Rules and policies
Visual warnings (auxiliary labels)
Education/information
Be more careful, be vigilant

25. Amphotericin RCA
 What can be done to prevent futures errors?
 Removal of conventional amphotericin B from
Formulary
 Is there a clinical need to use this product?
 Fix “bug” in Pharmacy computer system
 Develop standardized pre-printed amphotericin B
order set
 Seek P&T Committee approval to require use of
standardized form when prescribing amphotericin
 Implement CPOE with functional clinical alerts
 Education

27. Failure
Modes
and
Effects
Analysis
(FMEA)

28. Failure
Mode
and
Effects
Analysis
(FMEA)