Standard Operating Procedure: Storage of Cold Chain Medicines

Every effort has been made to ensure that the information provided in this procedure is accurate and up-to-date. However, the legal and regulatory framework governing Controlled Drugs is continuing to change significantly and readers should always check that they are referring to the most up-to-date version of this guide, as well as cross-checking with other recognised sources of information. The NPC website www.npc.co.uk, the Department of Health (DH) website www.dh.gov.uk/controlleddrugs, the Home Office websites www.homeoffice.gov.uk and www.drugs.gov.uk/drugs-laws/ and the Royal Pharmaceutical Society of Great Britain (RPSGB) website www.rpsgb.org.uk should be referred to regularly, amongst others.

NHS Swindon is the brand name for the organisation legally known as Swindon Primary Care Trust

Note: This document is electronically controlled. The master copy is maintained by the Clinical Governance Department. If this document is printed it becomes uncontrolled.

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DOCUMENT CONTROL Purpose To ensure that medicines requiring storage in a refrigerator are stored appropriately and that the cold chain is maintained. Medicine Governance Pharmacist Organisation wide all PCT staff March 2010 March 2012 March 2013

Author Application Implementation date Date of review Expiry date Link to Care Quality Commission Essential Standards of Quality & Outcome 9 Management of medicines Safety Link to Standards for Better Health Link to NHSLA Risk Standard(s) Responsibility for implementation Document Reference No: (Allocate from Policy Register) C4d Standard 1 Governance

Directors, Commissioning and Service Managers

Equality and Diversity

This document has been screen against race, disability, gender, age, sexual orientation and religion and belief equality and diversity criteria in line with current legislation and the requirements of the Single Equality Scheme 25 February 2010 Corporate Medicine Management Policy and Medicine Management Standard Operating Procedures. It is the responsibility of staff at all levels to ensure that they are working to the most up to date and relevant policies and procedures. By so doing, the quality of services offered will be maintained and the chances of staff making erroneous decisions, which may affect patient, staff or visitor safety, will be reduced.

Date of Equality Impact Assessment Links with other Documents

Policy Statement

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Review and Approval History

Version Reviewer/Approver R/A Outcome Date

1 1a

Medicine Committee Medicine Pharmacist

Management Management

A R

Approved Draft Version 2

August 2008 25 Feb. 10

Consultation and Revision History

Status Version Outcome Date Title

Draft

Review to keep in line with SOP on 25 Vaccine Storage 10

Feb.

Medicine Management Pharmacist

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CONTENTS Document Control ............................................................................................. 1 Review and Approval History ....................................................................... 3 Consultation and Revision History ............................................................... 3 Contents............................................................................................................ 4 Purpose............................................................................................................. 5 Scope ................................................................................................................ 5 Responsibilities ................................................................................................. 5 Review Procedure............................................................................................. 5 Introduction ....................................................................................................... 5 Stages of the Process....................................................................................... 5 Medication for Stock ..................................................................................... 5 Refrigerator................................................................................................... 6 Monitoring of the Refrigerator Temperature ................................................. 7 Organisation of Stock within Refrigerator..................................................... 7 Security of Medication .................................................................................. 8 Breach of cold chain ..................................................................................... 8 Medicines that have been Stored at temperatures at or below 00C............. 9 Vaccines that have been Stored at temperatures between 0-20C or above 80C ................................................................................................................ 9 Transport .................................................................................................... 10 Training for this Standard Operating Procedure ........................................ 10 Monitoring and Auditing for this Standard Operating Procedure. .............. 10 Summary of Changes from Version 1a .......................................................... 11 Appendix 1 Equality Impact Assessment Confirmation.................................. 12 Appendix 2 Fridge Temperature Recording Form.......................................... 13 Appendix 3 Fridge Incident Form.................................................................... 14

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Standard Operating Procedure: Storage of Cold Chain Medicines

PURPOSE To ensure that medicines requiring refrigeration, with the exception of vaccines are stored and transported appropriately. SCOPE This procedure covers the storage of medicines which require storage between 20C and 80C within the service. Storage of vaccines is dealt with in Standard Operating Procedure for Storage of Vaccines. RESPONSIBILITIES Any member of staff may be trained to carry out this procedure; however there must be a named person(s) responsible for storage of medicines. The named person is responsible at all times for the safekeeping of medicines in the service. REVIEW PROCEDURE This procedure will be reviewed every two years or when there is a major change in the procedure. If a document requires a very minor change the author does not need to send it through the whole consultation/ratification system. They must ensure that one expert peer has agreed the change prior to sending the revised version to the policy co-ordinator. If major changes are required a full consultation/ratification will be required. INTRODUCTION It is a requirement for all Services to have a Standard Operating Procedures (SOPs) for all medicine related activities within their service. There are a number of medical products requiring storage between 20C and 80C. These cold-chain products include high-risk items such as insulins, and blood products. These products must be protected from freezing as this can denature the product leading to a loss of efficacy.

STAGES OF THE PROCESS

Medication for Stock

1.

All medication that is received into the service will be checked according to the Standard Operating Procedure on acquiring medicines.

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2.

All staff involved in the receipt of medication requiring refrigeration must be aware of the importance of ensuring that they are handed over to the person responsible for storage of medication, or deputy immediately. If the person receiving the medicinal product is unhappy about maintenance of the cold chain and the length of time in transit, they should refuse to accept the order and return it to the supplier. If the product is accepted into the service it should be transferred to the refrigerator as soon as possible.

3.

4.

Refrigerator
5. The refrigerator for storage of medicinal products should be 6. 7. Specially designed for this purpose i.e. a pharmacy or vaccine refrigerator. Large enough to hold the stock carried by the service taking into consideration year-round needs (influenza programmes etc). Filled to around 50% capacity, so that there is sufficient room around the products for air to circulate. Have a lock. Located in an area with restricted public access.

The cooling plate of the refrigerator will be examined regularly and no medicinal products be placed directly next to the cooling plate. The refrigerator should be defrosted and cleaned regularly; a record of defrosting and cleaning will be kept. Measures should be taken during defrosting of the refrigerator to maintain the cold-chain of any stock by transferring the medicines into another refrigerator or an approved cool box with appropriate maximum/minimum thermometer for temperature monitoring. A domestic cool box should not be used to store, distribute or transport medications. Vaccines should not be allowed to freeze. Domestic refrigerators are not suitable for storage of medicinal products and should not be used to store stock products. The use of a domestic refrigerator to store patients own medications is acceptable in a service where care is being provided in a homely environment i.e. respite care. In this circumstance the medications must be clearly separated from any other contents and the temperature records must fulfil the requirements for medicines which differ to those for food storage. The electricity supply to the refrigerator is safeguarded against inadvertent breaks by use of a switchless electrical socket or a taped plug clearly marked vaccine/medicine fridge do not switch off.

8.

9.

10. The refrigerator must have annual electrical and calibration tests, the service records should kept for a minimum of three years.
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Monitoring of the Refrigerator Temperature

11. If there is an integral maximum/minimum thermometer system on the refrigerator, this should be used following the manufactures instructions. 12. The temperature readings should be verified annually or if there is cause for concern by use of an independent calibrated thermometer. 13. If the refrigerator does not have an integral thermometer then an independent calibrated digital maximum/minimum thermometer should be used. 14. If necessary the maximum/minimum thermometer will be calibrated annually according to the manufacturers instructions. 15. The following monitoring records must be recorded daily (unless the service is closed), preferably at the same time each day using an appropriate recording chart. (Appendix 2 is an example). current temperature maximum temperature minimum temperature time of reset signature of individual taking reading comments to include actions taken if reading outside 20C and 80C range

16. The member of staff who is taking and recording these reading must be trained and understand when and how to read and reset the thermometer. They must also understand when and how to take action if readings are out the outside 20C and 80C range. 17. At the end of the month the completed charts will be filed for a minimum of three years.

Organisation of Stock within Refrigerator

18. Opening the door to examine stock or to load new stock for long periods of time should be avoided. If this occurs record date, and duration the door was open and final temperature, in the notes section on the temperature control chart. 19. To avoid the need to open the refrigerator to see what stock is held, each refrigerator should have a stock control book / database listing the contents of the refrigerator, including running totals, batch numbers expiry dates of all stocks. 20. The responsible person for medicines should monitor medicine stocks to avoid over-ordering or stockpiling. 21. Stock should be rotated to ensure that use by dates are not exceeded i.e. the shortest dated stock should be stored at the front.
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Security of Medication
22. The named person for the local responsibility of storage of medicines should put in place a written procedure to ensure that the keys to the medicine refrigerator are secure at all times. 23. The use of several sets of keys for the medicine refrigerator should be avoided. However, if there is more than one set available (except for the emergency spare set), strict controls on who is in possession of these keys should be implemented by the named person responsible for storage of medicines. 24. Access to key cupboards should be restricted and removal of keys for the medicine refrigerator should be logged, so that it is known at all times who is in possession of the keys to the medicine storage area. 25. An emergency spare set of keys to the medicine refrigerator should be available. These should not be stored with the normal set of keys. Access to these should also be restricted and removal from the area should also be logged. 26. If there is an incident involving missing keys to the medicine refrigerator, the Service Manager and the named person responsible for storage of medicines should be informed and a Risk Management Incident Form (RM1) completed. 27. Missing medication should be reported immediately to the Service Manager and the named person responsible for storage of medicines should be informed and a Risk Management Incident Form completed.

Breach of cold chain

28. Arrangements should be in place for back-up facilities to be available in the event of a refrigerator failure or break down. These should be documented and kept near the refrigerator. 29. This emergency plan should include all contact number required, details of engineers and all documentation required in the event of a refrigerator failure. 30. Medications should only leave the fridge as it is required for use. 31. On removal of any item from the drug refrigerator there will be a visual inspection of the product to ensure that it meets with the described physical appearance. If there is any doubt about the product it should be disposed of according to the Standard Operating Procedure on the disposal of unwanted medicines. 32. Should the maximum/minimum thermometer readings be outside the ideal 80C and 20C and there is concern that there has been a breach in the cold chain then this should be brought to the attention of the Service Manager and the named person responsible for storage of medicines.
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33. How to proceed following a breach of the cold chain depends on whether the recorded temperatures were below or above the ideal of 20C and 80C.

Medicines that have been Stored at temperatures at or below 0 C

0

34. Should the minimum recording of the temperature be less than 00C then the stock in the refrigerator should be quarantined by placing it into an appropriate container or bag and labelling the container or bag DO NOT USE. 35. The stock will be then disposed of according to the Standard Operating Procedure on the disposal of unwanted medicines. 36. Appropriate action to correct fridge temperature should be taken, by adjustment of thermostat or calling engineer. 37. New stocks should be ordered once the refrigerator is functioning at the ideal temperature. 38. A Risk Management Incident Form completed. 39. If the breach of the cold chain is discovered after the vaccine has been given to the patient then the Incident Reporting Policy and Being Open Policy should be followed. The patient must be referred to a doctor for review.

Vaccines that have been Stored at temperatures between 0-2 C or above 8 C

0 0

40. Should there be a single one off measurement of temperature which just exceeds 80C, and relates to a know deviation such as a delivery of stock, then no further action is needed. 41. If the maximum recorded temperature regularly exceeds 80C or the minimum temperature is between 0 - 20C, or there has been a full breakdown of the refrigerator then all stocks should be clearly marked as quarantined stock and moved to another refrigerator as soon as possible. 42. Refrigerator incident form will need to be completed. (Appendix 3). 43. A list of all products affected by the malfunctioning fridge should be prepared minimising the time that the stock is kept outside the cold chain. (Using the stock control book / database, See Appendix 3) 44. The Medicine Information Centre at Great Western Hospital (01793 605029) will be contacted to establish whether the stock can be used. They will have access to the UKMi fridge database (www.ukmi.nhs.uk/applications/fridge). 45. Alternatively, the manufacturers of all stocks should be contacted. 46. If the stock can be used it can be removed from quarantine, a note that this particular stock has been subject to a breach in the cold chain will need to be recorded. 47. Appropriate action to correct fridge temperature should be taken, by adjustment of thermostat or calling engineer.
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48. New stocks should be ordered once the refrigerator is functioning at the ideal temperature. 49. A Risk Management Incident Form should be completed. 50. If the breach of the cold chain is discovered after the medicine has been given to the patient then Incident Reporting Policy and Being Open Policy should be followed. The patient must be referred to a doctor for review.

Transport 51. A cool pack/box must be used for transporting medicines requiring cold storage. . 52. Medicines must be kept in their original packaging, wrapped in bubble wrap (or similar insulation material) and placed in the cool box with cool packs as recommended by the manufacturer. This prevents direct contact between medicines and the cool packs and protects them from damage. 53. The time between removing medicines from cool storage and use must be kept to a minimum. 54. Advice should be obtained from the Medicine Information Centre at Great Western Hospital or the medicine manufacture when considering transport of medicines. 55. For medicines which are particularly temperature dependant, a maximum/minimum temperature probe should be placed in the middle of the cool pack/box to record maximum and minimum temperature. If a breach in the cold chain is experienced appropriate action should be taken.

Training for this Standard Operating Procedure

56. Training for this SOP will be the responsibility of the Service Manager and the named person responsible for storage of medicines. 57. Training may be formal or informal. 58. Training will be recorded in the member of staffs training records.

Monitoring and Auditing for this Standard Operating Procedure.

59. Monitoring the adherence to this SOP will be the responsibility of the Service Manager.

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60. If there has been a deviation from the procedure the Service Manager will need to document the deviation and the reasons for the deviation and a written report will be need to be forwarded to the Medicine Management Team. 61. Compliance with the SOP will be checked as part of the regular Medicine Management Audit. SUMMARY OF CHANGES FROM VERSION 1A 1. Changes made to ensure the same procedures are followed for storage of vaccines and cold chain medicines. To allow a service to store both in the same pharmaceutical fridge if necessary.

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APPENDIX 1 EQUALITY IMPACT ASSESSMENT CONFIRMATION

Equality Impact Assessment Report

Summary of Equality Impact Assessment for: Medicine Management SOP on Storage of Medicines in a refrigerator. Version 2 Date of Assessment: 25th February 2010

Main aim of the document / policy / strategy / service: To ensure that medicines requiring storage in a refrigerator are stored appropriately and that the cold chain is maintained.

Outcome of the Equality Impact Assessment Process: This Standard Operation Procedure has been screened and is not relevant to the general duties of the equality and diversity impact assessment.

Actions taken and planned as a result of the equality impact assessment, with details of action plan with timescales / review dates as applicable: None Groups / individuals consulted with as part of the impact assessment Not applicable

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APPENDIX 2 FRIDGE TEMPERATURE RECORDING FORM Service Name: Time Day 1st 2nd 3rd 4th 5th 6th 7th 8th 9th 10th 11th 12th 13th 14th 15th 16th 17th 18th 19th 20th 21st 22nd 23rd 24th 25th 26th 27th 28th 29th 30th 31st Refrigerator defrosted and cleaned by: * Date:
(Use 24hr clock)

Refrigerator Location: Time of reset

(Use 24hr clock)

Month: Recorded by (signature) Comments and Notes *

Current

(0C)

Min (0C)

Max (0C)

Comments: include actions taken if recorded reading is outside 20C and 80C how long the fridge is left open and final temperature reading when the fridge is opened for restocking, and any other relevant information. If the temperatures are out the recommended range take appropriate action as indicated in the Standard Operating Procedure.

THIS RECORD SHOULD BE KEPT FOR A MINIMUM OF THREE YEARS

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APPENDIX 3 FRIDGE INCIDENT FORM Location of Fridge Person Reporting incident Person filling in form Contact telephone number Date Position of reporter of incident: Time Details of incident What are the current minimum / Minimum current / maximum temperatures Which fridge was affected: How long has fridge been malfunctioning When were the correct Date temperatures last recorded Has stock in this fridge been affected by a previous breach in the cold chain, when how long. Are Vaccines stored in this fridge? When is the next vaccination session? Which vaccines are urgently required.? Where will these vaccines come from? A list of all products affected by the malfunctioning fridge should be prepared minimising the time that the stock is kept outside the cold chain. (Use the stock control book / database). The manufacturers (directly or via Medical Information Service) of all stocks should be contacted to establish whether the stock can be used. Current Maximum

Time

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What Stock is in the affected Fridge Previous Breach Manufacturers advice in Cold chain Returned to stock/ destroyed.

Product

Expiry Date

Batch Number

Manufacturer

Quantity

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