ColdChain Incident

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SBAR Date: 2021/04/2
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Title: Pharmacy Services Cold Chain Incident

Author: Amanda Burke, Pharmacy Manager Formulary & Quality Improvement
Executive Sponsor / Division: Kilby Rinco, Director Pharmacy Services
Date: April 28, 2021
1. SITUATION
Concise statement of the issue/problem to be addressed; define what it is and identify gaps.
A cold chain breach involving a pharmaceutical fridge (hereafter referred to as fridge #2) containing a
large quantity of chemotherapy medications was discovered in the QEH pharmacy on November 7, 2020
(PSMS incident #100938).
2. BACKGROUND
Outline pertinent background information related to the issue (refer to relevant literature, national standards, policy,
regulations, standards, requirements).
Cold chain refers to an uninterrupted series of storage and distribution activities while maintaining the
product within a specific temperature range.
• standard cold chain temperature range is 2°C to 8°C
• a cold chain breach occurs when the temperature falls outside of this range
• pharmacy fridges at the QEH and PCH are configured for central temperature monitoring in
collaboration with facility maintenance
The QEH on-call pharmacist was paged at 0211 on November 7, 2020 by maintenance staff due to a high
temperature alarm for a fridge in the main dispensary.
• pharmacist arrived at QEH before 0300 to investigate
• medications in the alarming fridge were immediately removed and segregated in another
pharmacy refrigerator
The following workflow is relevant to the investigation:
• due to space limitations in the oncology pharmacy of the Cancer Treatment Centre (CTC),
chemotherapy drugs are received in the main pharmacy of QEH and stored in fridge#2
• CTC pharmacy staff retrieve chemotherapy medications daily from the main dispensary and
transfer them to a second smaller cytotoxic fridge in the oncology pharmacy
3. ASSESSMENT
Outline the analysis and considerations of options to address the issue.
Nov 7, 2020
• identified pharmacy fridge #2 alarm thresholds were set for less than 0 °C or greater than 12°C
with a time lapse of 30 minutes before contacting pharmacy
• alarm settings for all other QEH pharmacy fridges were requested
• inventory of all segregated medications from fridge# 2 was compiled
• inspection of fridge #2 by repair company
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Nov 2020 – March 2021
• alarm thresholds were reset to the standard range (less than 2°C or greater than 8°C) with a time
lapse of 15 minutes before contacting pharmacy for all QEH pharmacy fridges
• historical temperature logs for fridge#2 were requested
• initial calls were made to manufacturers of the affected products to request information
regarding cold chain excursions
• fridge#2 was repaired and is back in service
• Nov 9, 2020: discovered that the temperatures for fridge #2 had been above the recommended
range for several months; this information prompted segregation and documentation of
medications in the CTC oncology pharmacy fridge that had previously been stored in fridge #2
• audit of all patient dispenses involving cytotoxic medications from June 1, 2020 – Nov 7, 2020 was
completed; one additional product was identified that would have been stored in fridge #2 while
it was out of range; this medication was added to the log for investigation
• summary of monthly and weekly average temperatures for fridge #2 was added to the
investigation log; further inquiries were made to the drug manufacturers given the cold chain
breach involved a longer period of time than originally communicated; a review of patient specific
oncology drug transactions was completed to approximate the temperatures that drugs were
exposed to and duration
• temperature of fridge#2 gradually increased over several months; average/min/max temps in
°C are recorded below; of note, one company indicated they would not consider temps between
8°C and 8.5°C to be out of range; the temperatures were consistently in the cool range (8°C to
15°C) and never reached room temperature
Month
(2020) Average Min Max
June 6.72 4.43 11.9
July 8.7 6.23 11.9
August 8.82 6.5 15.15
September 9.25 7.59 13.46
October 9.15 7.06 12.81
November 9.91 8.47 13.99
• meeting with the pharmacy and CTC Quality Risk Consultants (QRC) and management for initial
discussion around focus of investigation and general considerations re disclosure and insurance
claim
• meeting with facility maintenance supervisor to review historical settings and maintenance
• meeting with leadership from QEH microbiology lab to learn more about their quality assurance
framework for fridges
• December 2020: accident- loss report form filed with Provincial Risk Management (SIMRF) on loss
of medications. Insurance claim interviews/statements completed by pharmacy staff and
management
• replacement value of drugs involved with the claim ~$465,000.00; fiscal analyst has been
informed; please note this is the max value – a minimal number of drugs may be returned to
inventory and safely used (under review)
• March 2021: notification from QRC re denial of insurance claim
• communication with ELT representative occurred in the week following the incident (Jamie
MacDonald); Corinne Rowswell and Kellie Hawes have also been briefed
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4. RECOMMENDATION
Provide recommendations/actions required about the proposed solution.
1. Ensure all pharmacy fridge alarm thresholds are set to the recommended range (completed at
QEH/HH and all other HPEI Hospitals).
2. Maintenance inspection of all pharmacy fridges (complete at QEH/HH & PCH; to be arranged for
community hospitals).
3. Schedule bi-annual preventative maintenance for all pharmacy fridges (complete at QEH; PCH &
community hospitals to be arranged).
4. Install auxiliary thermometers and temperature displays on pharmacy fridges (complete at
QEH/HH; to be arranged for PCH and community hospitals).
5. In addition to central monitoring, implement an independent pharmacy fridge temperature log, to
record temperatures daily (complete at QEH/HH; to be arranged for PCH and community
hospitals).
6. Implement pharmacy fridge alarm log to document any calls from boiler room regarding fridges
and notification of pharmacy management (complete at QEH/HH; to be arranged for PCH; not
applicable to community hospitals).
7. Develop and implement a Provincial Pharmacy Services Cold Chain Standard Operating Procedure
(in progress).
8. Establish a Provincial inventory of hospital pharmacy fridges, including model numbers and date
of purchase (in progress).
9. Pharmacy management assessment of temperature excursion information obtained from drug
manufacturers and collaboration with QRC and Risk Advisor to evaluate potential need for patient
disclosure (in progress).
10. Consultation with Drug Information Service for stability information of specific drugs if
information from the drug manufacturers is not helpful in the evaluation for disclosure (in
progress).
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Title: Pharmacy Services Cold Chain Incident

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