79Dispensary Procedures: Standard Operating Procedure SI SOP 111 Date of preparation: August 2014

11 Fridge Temperature Monitoring

Scope

This SOP will detail the procedure to be followed when recording and maintaining the dispensary refrigerator temperature in order to store cold chain products appropriately.

Risks

❚ Incorrect storage of medicines which require cold storage

❚ Refrigerator temperature outside of recommended guidelines resulting in medication not being suitable to supply to the patient

❚ Refrigerator temperature not being monitored and recorded daily resulting in failure to identify any faults with the fridge or breach of cold chain

Responsibility

Only those members of the pharmacy team who have been considered competent and listed in the declaration of competence can carry out this procedure.

Objectives

The SOP is designed to ensure maintenance of the cold supply chain of pharmaceuticals.

This SOP will ensure: ❚ Maintenance of the cold supply chain and protection of patients and the public ❚ Evidence that pharmaceuticals are continuously stored within the licensed criteria for the product ❚ Dispensary refrigerators are maintained and operated correctly to ensure that the temperature is within the recommended guidelines (2ºC and 8ºC)

❚ Accurate refrigerator temperature monitoring is carried out and recorded daily (when the pharmacy is open) ❚ Correct procedures are followed if there is a breach in the cold chain

80 Dispensary Procedures: Standard Operating Procedure SI SOP 111Date of preparation: August 2014

11 Fridge Temperature Monitoring

Review

The SOP will be reviewed every two years by the Pharmacy Superintendents Office (PSO) to reflect any changes to legislation affecting the process.

A review of the SOP is required in the event of any change of staff, or any increase or decrease in the competence level of the staff. The SOP should also be reviewed following a critical incident.

The responsibility for reviewing the SOP rests with the Pharmacy Manager (Pharmacist), or in their absence, the Pharmacist or Pharmacy Manager (non-Pharmacist). In the absence of these members of staff, the appropriate Field Manager will be responsible for review.

If as a result of the review any changes to the SOP are deemed necessary, these must be approved by the PSO. For any changes to the SOP a written application must be submitted, using the SOP Local Variation Template. The application should be sent either by fax (0870 928 9766) or post to the PSO at Support Centre.

81Dispensary Procedures: Standard Operating Procedure SI SOP 111 Date of preparation: August 2014

11 Fridge Temperature Monitoring

These tasks must be undertaken on a daily basis: ❚ Read and record fridge temperature ❚ If appropriate, test the fridge alarm to ensure it

is operating

Once the temperature values have been recorded, reset the max-min thermometer

Inform RP; RP to use professional judgement as to suitability of the cold chain

products affected

Quarantine all cold chain products affected, continue to read and record the fridge temperature every hour

Further fridge temperature to be read and recorded one

hour later

Record the fridge temperature again the following day

Are all of the temperatures recorded within +2°C to + 8˚C?

Has thetemperature also

been out of range within the last 24-48

hours

Yes

No

No

No

Yes

Yes

Inform the RP

Contact manufacturers for guidance on the stability of the cold chain products affected

RP to use professional judgement as to whether cold chain products affected are suitable to dispense

or require disposal

Inform RP; RP to use professional judgement as to suitability of the cold chain

products affected (quarantine if appropriate)

Contact the PSO at any stage for further advice and/or guidance

Are all of the temperatures recorded within +2°C to + 8˚C?

82 Dispensary Procedures: Standard Operating Procedure SI SOP 111Date of preparation: August 2014

11

Practice Guidance

Operating standards for dispensary refrigerator The correct operating temperature of pharmacy refrigerators is between +2°C and +8°C. The temperature should be checked a minimum of once daily using a maximum/minimum thermometer in accordance with the manufacturer’s instructions. Any deviations in temperature must be reported to the RP and a further reading must be recorded one hour later to check whether any deviation has been corrected.

Avoid the fridge being near a heat source and keep its surroundings clear.

If the Pharmacist believes the fridge is not working correctly they should contact the Area Manager.

Storage of MedicinesAll pharmaceuticals should be refrigerated immediately on delivery and it is important stock is rotated to ensure the shortest dated stock is used first.

Products should be stored in an orderly fashion and not on the floor of the fridge. High risk cold chain products such as vaccines and insulin should be stored in the body of the fridge. They should not be stored in the fridge door or in the bottom drawer, and should be away from any freezer compartment.

Ensure the fridge is not overloaded and the contents are not packed too tightly to allow even distribution and circulation of cold air.

Foodstuffs or drinks must not be stored in the pharmacy fridge. This is to minimise the risk of contamination.

Fridge Temperature MonitoringA written daily record of minimum/maximum temperatures for refrigerators must be in place. If two dispensary fridges are in place separate records must be maintained for both fridges. The records must be retained for two years and be available for audit.

Fridge temperature record charts are available on OnePortal.

The fridge should be cleaned and defrosted on a regular basis (monthly) and a record should be made of this.

ThermometersEnsure you know how to use and read your thermometer – refer to manufacturer’s guidance. Reset the thermometer after recording the temperature each day in order to obtain a new baseline. If using a digital thermometer, ensure the probe is in an appropriate position – refer to manufacturer’s guidance. If the thermometer is not part of the fridge, keep spare batteries and a replacement in the dispensary.

Fridge Temperature Monitoring

83Dispensary Procedures: Standard Operating Procedure SI SOP 111 Date of preparation: August 2014

11 Fridge Temperature Monitoring

Practice Guidance - Continued

Cold Chain breaches

It is down to the professional judgement of the Responsible Pharmacist on duty to determine if the safety of the cold chain stock has been compromised due to adverse temperatures. i.e. has the temperature fallen below 2°C or exceeded 8°C.

Consider the possible length of time that the fridge temperature has been affected for and if there has been a breach in the cold chain.

Contact the manufacturers of each medicine for guidance on the stability of the medicine, as they may not be suitable for supply to patients. Supply of a medicine which has not been stored in accordance with the manufacturer’s storage requirements will be outside of the product licence for the medicine. The Responsible Pharmacist must use their professional judgement to determine if such a supply is appropriate.

For further information on individual products please refer to http://www.ukmi.nhs.uk/applications/fridge/ Username: articPassword: f7idge

If a power cut has occurred, and the stock cannot be moved to another working fridge, ensure the door is kept shut to avoid any cold air from escaping. It is good practice to keep an hourly record of the fridge temperature.

In the event of a power cut, you can contact the distribution network providers on the following numbers to receive an update on the problem, alternatively contact the PSO.

North Scotland SSE Power Distribution 0800 300 999South Scotland SP Power Systems 0845 272 7999North East England CE Electric (NEDL) 0800 668 877North West Electricity North West Ltd 0800 195 4141Yorkshire CE Electric (YEDL) 0800 375 675East Midlands Central Networks 0800 056 8090West Midlands Central Networks 0800 328 1111Eastern England UK Power Networks 0800 783 8838South Wales Western Power Distribution 0800 052 0400Southern England SSE Power Distribution 0800 072 7282London UK Power Networks 0800 028 0247South East England UK Power Networks 0800 783 8866South West England Western Power Distribution 0800 365 900North Wales, Merseyside and Cheshire SP Manweb 0845 272 2424

84 Dispensary Procedures: Standard Operating Procedure SI SOP 111Date of preparation: August 2014

11 Fridge Temperature Monitoring

Practice Guidance

Ensure that the member of staff responsible for taking the temperature has received appropriate training and ensure the Responsible Pharmacist reviews readings on a daily basis.

Fridge temperature record charts are available on OnePortal.