DISPENSARY REFRIGERATOR TEMPERATURE MONITORING …

DISPENSARY REFRIGERATOR TEMPERATURE MONITORING RECORD

1

Some medicines and all vaccines require storage between +2˚C and +8˚C i.e. in a refrigerator. All pharmacies are required to comply with the

Health & Disability Pharmacy Service Standards 2010 Criteria 5.13.4. This criteria states that the “refrigerator maximum/minimum temperatures

shall be appropriately monitored and recorded to ensure maintenance of correct temperature” and that “corrective measures shall be taken

when specified conditions have not been maintained.” All refrigerators used to store medicines, including dispensed medicines waiting for

collection, must be monitored.

Vaccinating pharmacies must have a pharmaceutical grade refrigerator for vaccine storage and follow the Ministry of Health National Standards

for Vaccine Storage and Transportation for Immunisation Providers 2017.

This monitoring record is designed for pharmacies to document dispensary refrigerator minimum and maximum (min/max) temperature

recordings, actions taken when temperature readings are out of range, and related equipment checks in one place. It has been adapted from

the Ministry of Health Annual Cold Chain Management Record for Immunisation Providers and may be used by vaccinating pharmacies. It

contains best practice recommendations agreed upon by the Pharmaceutical Society, Pharmacy Guild and Green Cross Health.

DISPENSARY REFRIGERATOR TEMPERATURE MONITORING RECORD APRIL 2019

https://www.health.govt.nz/publication/national-standards-vaccine-storage-and-transportation-immunisation-providers-2017

https://www.health.govt.nz/publication/national-standards-vaccine-storage-and-transportation-immunisation-providers-2017

https://www.health.govt.nz/publication/annual-cold-chain-management-record


2

DAILY CHECKS

Daily monitoring of all dispensary refrigerator min/max temperatures is expected. For non-vaccinating pharmacies, this may be undertaken either

manually using a digital min/max or in-built thermometer each day or using a data logger. Some non-vaccinating pharmacies choose to use both

methods. This dual approach is considered best practice as it allows issues to be identified quickly and provides details to inform decision-making.

It is important to note that although a data logger is downloaded weekly (see ‘weekly checks’ on the next page), a daily check to verify the logger is

functioning correctly and there have been no temperature breaches is best practice (refer to individual data logger manual for details of how to do

this - alarms can be set on some devices). This check should be recorded and there is space to do so in the monthly recording chart.

Vaccinating pharmacies must undertake BOTH daily manual min/max recordings and weekly download and review of data logger information.

For manual min/max monitoring, record each dispensary refrigerator’s minimum and maximum temperatures (ideally at the same time) EVERY DAY

that the pharmacy is open. The person recording the temperatures should initial in the space provided on the monthly recording chart, see example

below. Reset the device after the temperatures have been recorded.

Any temperature outside the +2˚C to +8˚C range must be followed up and the outcome documented according to the pharmacy’s incident

reporting procedure – a ‘DISPENSARY REFRIGERATOR TEMPERATURE INCIDENT REPORT’ template is provided in this document on page 19. The only

exception is temperatures between +8˚C and +12˚C for less than 30 minutes for known reasons, e.g. stocktake. This type of breach should be

documented in the comments section of the monthly recording chart but does not require further action - see example above.


3

WEEKLY CHECKS

For data loggers, data should be downloaded on an agreed day EVERY WEEK, reviewed and action taken if temperatures are outside the required

+2˚C to +8˚C range (see flow chart on page 18). Any action taken must be documented – a ‘DISPENSARY REFRIGERATOR TEMPERATURE INCIDENT

REPORT’ template is provided on page 19.

For vaccinating pharmacies, weekly data from the data logger must be reviewed to check for any unexplained temperature variations compared to

the manually recorded daily min/max temperatures for the same week.

For non-vaccinating pharmacies choosing to undertake both manual daily monitoring and weekly data logger download, this check is also

encouraged.

MONTHLY CHECKS At the end of every month, a review of the refrigerator’s performance is undertaken by answering the questions in the ‘comments and checklist’

section of the monthly recording chart.

It is good practice to review your temperature records for unusual temperature trends that may warrant further investigation.

VALIDATION OF TEMPERATURE MONITORING EQUIPMENT

Regular validation of digital thermometers, data loggers and in-built thermometers is required to assure that the equipment is providing accurate

readings. The exact method and frequency of validation may be specific to device. Refer to your pharmacy’s SOP for the validation process used in

your pharmacy. Guidance on suitable validation method or frequency may be provided a reputable source such as a refrigeration expert or

manufacturer’s equipment manual. It is important to retain evidence of any guidance being used and its source.

A commonly used process for validation is to place two temperature measurement devices as close as possible to each other. Give them a chance

to stabilise, then reset both devices. Leave for 24 hours, then read the minimum and maximum on both. Medicines Control advice is that 0.5°C is the

accepted difference when using digital devices which read down to 0.1°C. The results of the validation process must be documented and signed by

a pharmacist as verification that the equipment is suitable to use. If using this ‘side-by-side’ method, validation outcome can be documented on the

‘TEMPERATURE MONITORING DEVICE VALIDATION RECORD’ on page 17 of this document.


4

ANNUAL CHECKS Yes No

The refrigerator is positioned to have at least 4cm, but preferably 10cm, clearance from surrounding surfaces to allow adequate

circulation, and has nothing stored on the top.

The refrigerator is positioned in such a way that the door closes automatically.

The batteries for the digital min/max thermometer and/or data logger have been replaced as per the manufacturer’s

recommendations. Devices should be re-validated after a battery change.

Temperature monitoring equipment (e.g. data logger, digital thermometer) has been validated at least quarterly (every 3 months) or at

an interval determined by device specifications or verifiable specialist advice. Check your pharmacy’s SOP.

Plans are in place and current for alternative storage of medicines/vaccines in the case of issue with the dispensary refrigerator (e.g.

power outage or equipment failure).

The pharmacy SOP on refrigerator temperature monitoring has been reviewed and updated if necessary and staff aware of any

changes.

All documentation associated with the monitoring of refrigerator temperatures is stored for 10 years.

Refrigerator used for storing vaccines is less than 10 years old (this is good practice but optional if the refrigerator is not storing vaccines).

Refrigerator used for storing vaccines has been serviced annually by an appropriately qualified independent technician and according

to manufacturer’s recommendations – retain report for audit purposes.

Refrigerator used for storing vaccines has been externally monitored for at least 24 hours by either the local immunisation/cold chain

coordinator or alternative calibration service - retain all records.

Name Signature Date

Month/Year:


5

CHECKLIST & COMMENTS:

Yes No

Have there been any temperatures outside +2°C to +8°C? If yes, see flow chart (pg. 18) and document actions taken.

Validation of digital thermometers, in-built thermometer and/or data loggers has been undertaken as per the pharmacy’s SOP.

Only medicines and vaccines are stored in the dispensary refrigerator.

There is enough space for air circulation around products (2-3 cm gap between product and walls of refrigerator or shelf above).

Is there any visible ice on or behind the back plate inside the refrigerator? If yes, document action taken:

The door seal is checked and in good condition. If no, document action taken:

The refrigerator interior is clean. If no, undertake cleaning and document here:

Vaccinating pharmacies (and others using dual monitoring), data logger downloaded weekly and compared with daily min/max temperatures.

DAILY MINIMUM / MAXIMUM TEMPERATURE RECORDING CHART

Month/Year:


6


Yes No










Month/Year:


7


Yes No










Month/Year:


8


Yes No










Month/Year:


9


Yes No










Month/Year:


10


Yes No










Month/Year:


11


Yes No










Month/Year:


12


Yes No










Month/Year:


13


Yes No










Month/Year:


14


Yes No










Month/Year:


15


Yes No










Month/Year:


16


Yes No











17

TEMPERATURE MONITORING DEVICE

Date Reading thermometer 1 Reading thermometer 2

Variation Within 0.5°C

(Y/N) Pharmacist Signature

Min Max Min Max

22/11/2018 Device name e.g. digital Device name e.g. data logger Min

0.3°C

Max

0.2°C Y SAMPLE ENTRY 2.5°C 5.5°C 2.8°C 5.3°C

Min

Max

Min

Max

Min

Max

Min

Max

Min

Max

Min

Max

Min

Max

Min

Max

Min

Max

Min

Max

VALIDATION RECORD


18

DISPENSARY REFRIGERATOR

ACTION

N

STEP 2

Has the Dispensary Manager/Charge Pharmacist (and for

vaccinating pharmacies, the Immunisation Coordinator)

been alerted?

If YES, go to Step 3 If NO, follow ‘ACTION’

Alert the Dispensary Manager/Charge Pharmacist

immediately. Vaccinating pharmacies must also notify local

Immunisation Coordinator immediately.

STEP 1

Was the temperature between +8 and +12oC and for less

than 30 minutes? *

ALL other breaches, go to Step 2 If YES, follow ‘ACTION’

If there is a known reason for the breach, make note on

monthly record, no further action required. If the breach is

unexplained but has only occurred once, make a note on the

monthly record. If the breach is unexplained and has

happened more than once, further investigation is required –

go to Step 2.

STEP 3

Have actions been taken to quarantine stock in suitable

storage conditions?

If YES, go to Step 4 If NO, follow ‘ACTION’

Put sign on refrigerator “OUT OF ORDER – DO NOT USE”.

Quarantine stock - keep refrigerated between +2 and +8oC

(i.e. move to another monitored refrigerator or chilly bin). ACTION

ACTION

STEP 4

Undertake investigation using the ‘DISPENSARY

REFRIGERATOR TEMPERATURE INCIDENT REPORT FORM’ and

make notes in the ‘DISPENSARY REFRIGERATOR

TEMPERATURE MONITORING RECORDS.’

* If you have a data logger, download to ascertain how long the temperature has been out of range. If no data logger, look at the last previously recorded

min/max temperatures and when they were taken to ascertain the maximum possible duration of the breach.

TEMPERATURE BREACH FLOW CHART


19

DISPENSARY REFRIGERATOR TEMPERATURE

Date temperature breach identified

Name and position of staff member(s) involved in the monitoring the

dispensary refrigerator(s)

Name and position of staff member completing this report

Insurance company details and $ excess

Details of the dispensary refrigerator affected

(include brand, age, last service)

Have all medicines/vaccines been quarantined?

(all stock should be quarantined & labelled “NOT TO BE USED” until

investigation complete)

Have all quarantined medicines/vaccines been placed in an

alternative monitored refrigerator or chilly bin?

Has the data logger been downloaded?

If yes, what were the minimum and maximum temperatures and for how long

were the medicines/vaccines stored outside the +2°C to +8°C range?

(attach data logger printout to this report)

If no data logger, document the current min/max temperatures and

the last previously recorded min/max temperatures and when they

were taken to ascertain possible duration of the breach

If vaccines are affected, has the immunisation/cold chain coordinator

been contacted?

(document the name and contact details of the Immunisation/Cold Chain

Coordinator and any instructions they have provided)

TEMPERATURE INCIDENT REPORT FORM


20

Medicines/vaccines affected by the temperature breach

(collate list of all affected medicines/vaccines including quantities, batch

numbers, expiry dates & attach to this report)

Has the impact of the temperature breach on the medicines/vaccines

been established?

(check the Medsafe data sheets and attach to this report)

(call manufacturers/distributors where further clarification is needed and ask

for their answers to be provided in writing and attach to this report)

Have any patients been affected by this temperature breach?

If yes, document actions taken to ensure patient safety and include

medicines/vaccines affected and quantity retrieved &/or replaced in the

accurate list of affected medicines/vaccines

Establish cause(s) of the temperature breach

What other actions have been taken?

(include repairs/replacement of equipment, other people contacted)


21

Outcome of the temperature breach

(include decision to keep or discard medicines/vaccines and whether

insurance claim lodged – attach separate report if more space required)

(see ‘National Standards for Vaccine Storage and Transportation for

Immunisation Providers’ page 18 for information on vaccine disposal)

(Medicines/vaccines exposed to out of range temperatures that are able to

be kept should be identified in some way so this may be taken into account in

the case of further breaches – refer to your pharmacy SOP).

Has a staff meeting been held to discuss this incident?

(attach copy of the minutes of the meeting to the report)

Have any procedures been updated as a result of this incident?

If yes, detail which SOPs have been updated & attach a copy of the training

record confirming staff have read & understood the updated SOPs


22

DISPENSARY REFRIGERATOR

Use this area to record relevant events for the year, for example:

• change in individual(s) responsible for refrigerator temperature monitoring

• annual refrigerator maintenance and for vaccinating pharmacies, annual

refrigerator logging (retain report for audit purposes)

• battery replaced in a temperature monitoring device

• purchase of a new refrigerator or other equipment (retain invoice for

audit purposes)

• review of and resulting amendments to the pharmacy’s SOP on

refrigerator temperature monitoring

• staff training e.g. document when staff have read the pharmacy SOP

DATE COMMENTS – ACTION TAKEN NAME SIGN

TEMPERATURE MONITORING RECORDS


23



24


Documents

DISPENSARY REFRIGERATOR TEMPERATURE MONITORING …