Before undertaking this learning resource all staff should consult their NHS Board s local policy on the storage and handling of vaccines.

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2 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 2 Acknowledgements NHS Education for Scotland gratefully acknowledges the hard work and effort made by all who contributed to the development of this learning resource which was adapted, with kind permission from an existing resource written by Liz McGovern, Specialist Pharmaceutical Public Health, NHS Greater Glasgow and Clyde. Special thanks are due to: Dr Diane Kelly, Assistant Director CPD, NHS Education for Scotland Susan Kennedy, National Co-ordinator GPN, NHS Education for Scotland Marion MacLeod, National Co-ordinator, Scottish Practice Management Development Network, NHS Education for Scotland William Malcolm, Pharmaceutical Adviser, HAI and Infection Control Group, Health Protection Scotland Liz McGovern, Specialist Pharmaceutical Specialist, NHS Greater Glasgow and Clyde Aileen Muir, Consultant in Pharmaceutical Public Health at NHS Lothian and NHS Fife Ruth Robertson, Health Protection Education Programme Manager, NHS Education for Scotland Disclaimer While every precaution has been taken in the preparation of these materials, neither NHS Education for Scotland nor external contributors shall have any liability to any person or entity with respect to liability, loss or damage caused or alleged to be caused directly or indirectly by the information therein. Before undertaking this learning resource all staff should consult their NHS Board s local policy on the storage and handling of vaccines. NHS Greater Glasgow & Clyde staff should access their local learning resource via LearnPro

3 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 3 About this learning resource Who is this learning resource for? All staff working in the primary care setting. However, the general principles are also applicable to staff working in the acute setting. How long should it take? This learning resource will take you approximately 30 minutes to complete excluding the activities, depending on your own learning style and experience. It is best to work your way through the sections from the beginning to the end in a logical order, completing the activities for each section as you go. Why should I complete this learning resource? It provides practical tips and examples of best practice It will help ensure correct storage of medicines It identifies ways in which to avoid waste and patients being recalled for repeat immunisation after vaccine incidents It contributes to your Continuing Professional Development. Multiple choice questionnaire assessment Once you have completed this learning resource you should undertake the multiple choice questionnaire assessment. This will allow you to formally check your knowledge and understanding of the resource.

4 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 4 Contents

5 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 5 Section 1 Introduction The cold chain is the name given to the system of transportation and storage of vaccines whilst maintaining the recommended temperature range between 2 C to 8 C. Heat speeds up the decline in potency of most vaccines. Freezing of vaccines can cause loss of vaccine effectiveness, increased reaction at the injection site and hairline cracks in the container, the latter leading to contamination of the contents. Effectiveness cannot be guaranteed for vaccines unless they have been transported and stored at the correct temperature. Cold chain maintenance has three main components: Equipment used for transport and storage Appropriately trained personnel Procedures. All three elements must combine to guarantee vaccine effectiveness is maintained by ensuring the vaccine is transported and stored at the recommended temperature up to the point that the vaccine is administered. The maintenance of the cold chain is therefore important to: Give assurance/confidence in potency of vaccine Ensure maximum effectiveness/clinical benefit from immunisation Ensure compliance with manufacturer s marketing authorisation Minimise financial loss from vaccine wastage.

6 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 6 Section 2 Guidance and policies There is a range of guidance and policies relating to the storage and handling of vaccines. A key reference is the Guidance on Vaccine Storage and Handling produced by Health Protection Scotland (click on the picture). This guidance sets out a framework outlining the minimum standards required for storage and handling of vaccines. Another national reference is The Department of Health Publication Immunisation against Infectious Diseases also known as the `Green Book`. Regular updates are posted on the website so it is advisable to always refer to the online version (click on the picture). Each NHS Board will have developed local guidelines and policies related to vaccine handling and storage. There are likely to be some differences between NHS Boards and you should become familiar with the guidance for your specific area by accessing the relevant documents and discussing the content with your colleagues.

7 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 7 Activity Access the local guidance on vaccine storage and handling for your NHS Board and discuss the local procedures with colleagues from your place of work. Make a note of your discussions below.

8 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 8 Section 3 Ordering Vaccine stocks must be monitored, by a designated person, to avoid over-ordering or stockpiling. Incorrect ordering can result in wastage and unnecessary costs to GP practices and the NHS. There are two main ways of ordering vaccines: 1. Childhood vaccines and Hepatitis B for at risk babies should be ordered from the vaccine holding centre using the appropriate order forms. GP practices should normally have no more than two to four weeks supply of vaccines at any time. Remember some vaccines come in multiple packs. It is recommended best practice to order small quantities on a regular, scheduled basis using Scottish Immunisation Recall System (SIRS) data to estimate the number of vaccines required. Arrangements for large clinics (or unscheduled / ad hoc catch-up) should be discussed with the vaccine holding centre in advance to ensure sufficient vaccine is available for the required date. 2. Winter, travel and adult booster vaccines should be ordered from a community pharmacy using individual prescriptions (GP10) or exceptionally a Stock Order Form (GP10a). Close liaison between the practice and the community pharmacy is important to discuss delivery arrangements and ensure the practice has sufficient capacity to receive deliveries.

9 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 9 Activity Note here who is responsible for ordering vaccines in your place of work, the delivery day and ordering schedule. Confirm the contact details for the vaccine holding centre.

10 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 10 Section 4 Receipt of vaccines Refrigerate vaccine deliveries immediately. (This is the responsibility of the member of staff accepting delivery). Activity Note here the location of the keys for vaccine refrigerators in your place of work and how to access to them to prevent delay in vaccines being stored at an inappropriate temperature. Practice point Your place of work should have a policy and procedure which clearly states the steps to be followed and who should be advised of the receipt of vaccines.

11 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 11 Check the received vaccines against the order for discrepancies and for leakage or damage as soon as possible as vaccines cannot be returned to the vaccine holding centre later. On receipt, all deliveries and existing stock should be routinely date checked and rotated within the refrigerator to ensure that those vaccines with the earliest expiry date are at the front and used first. Remember - the vaccine with the shortest expiry date may not always be the most recently delivered. Companies differ in the format they use for expiry dates. Please be careful when checking expiry dates e.g. Batch: 2585H EXP: 10/2014 Batch: 68689Y EXP BY: 10/2014 Batch: 2299J USE BEFORE: 10/2014 Expiry would be 31/10/2014 Expiry would be 30/09/2014 Expiry would be 30/09/2014 Record that a delivery has been received, expiry dates checked and stock rotated on the temperature monitoring chart. It is good practice to record the temperature and reset the thermometer when this has been completed. A check should be made to ensure that the running temperature is satisfactory (i.e. between 2 C to 8 C) 30 minutes later. Any out of date stock should be labelled clearly, removed from the refrigerator and returned for destruction as soon as possible. Local arrangements will vary between NHS Boards.

12 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 12 Activity Contact your vaccine holding centre to obtain details of the local arrangements for dealing with out of date stock. Make a note of your findings here. Recall of vaccines In the event of vaccines being recalled, all ordering sites will be notified by the vaccine holding centre. The person in the practice responsible for vaccine storage and handling must check all stock in the practice as soon as possible. Any affected vaccines should be placed in refrigerated quarantine clearly marked NOT TO BE USED.

13 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 13 Section 5 The vaccine refrigerator Vaccines should be stored in their original packaging at 2 C to 8 C protected from light. Exposure to ultraviolet light may cause loss of potency. Repeated warming and cooling of vaccines may reduce potency. Storage Storage in the original packaging allows easy product identification, easy checking of expiry dates and the packing offers some protection against temperature fluctuation. Vaccines must never be exposed to below 0 C as freezing may cause hairline cracks in the container, invisible to the naked eye, which could lead to contamination of the contents. It is generally recommended that vaccine refrigerators should be maintained as close as possible to 5 C, as this gives a safety margin of +/- 3 C. The vaccine refrigerator Vaccines should always be stored within a pharmaceutical refrigerator that is specifically designed for the purpose of storing vaccines or medicines, to provide a stable, uniform and controlled temperature throughout the unit. Only pharmaceutical refrigerators must be used for vaccine storage as domestic refrigerators are unsuitable. A pharmaceutical refrigerator must have: A lock An integral thermometer capable of reading minimum, maximum and actual temperature An alarm for when the temperature is out of range. Pharmaceutical refrigerators do not usually have storage space in the door. Where a refrigerator with door space is being utilised, do not store vaccines in this area, to avoid the risk of a temperature rise when the door is opened.

14 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 14 Practice point Where the purchase of a pharmaceutical refrigerator is being considered advice should be sought from the appropriate person in your NHS Board. Check your local guidance for details of who to contact. For maximum efficiency, the refrigerator should be positioned away from a radiator or any other heat source (including direct sunlight), be well ventilated and at a comfortable working temperature. Further information is available from the manufacturer s user guide. Vaccines should be spaced evenly throughout the refrigerator, to allow cool air to circulate around the vaccine packages. They should be stored in the middle of the refrigerator away from any freezing component such as the back wall in a self-defrosting refrigerator. Vaccine stock should be arranged systematically so that any member of staff looking for a product can determine quickly whether that product is available in the refrigerator. Practice point It is good practice to post a list of products stored in the refrigerator with a shelf location (as appropriate) on the outside of the door. This will minimise the amount of time the refrigerator door is open. There should be sufficient refrigerator capacity to store the maximum vaccine storage needs (including influenza vaccine). Do not overfill the refrigerator, even at maximum stock level no more than two thirds (66%) should be filled to allow circulation of air. Vaccines should not be stored in enclosed plastic drawers with a lid or directly on the floor of the refrigerator since this restricts airflow circulation. Do not store foodstuffs in the vaccine refrigerator at any time. Ensure the power supply is protected ideally with a switchless socket and a fixed unit over the plug and socket to ensure it cannot be turned off by accident.

15 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 15 Practice point Where this is not possible any plugs/switches used to connect refrigerators to the power supply should be clearly marked Refrigerator Do Not Switch Off Practice point Vaccines are prescription only medicines (POMs) and should be stored under locked conditions. Refrigerators should either be lockable or within a room that is locked when not occupied by a member of staff. When the refrigerator is not in use the key should be removed and held by the appropriate person as detailed in local procedures. Activity Check the storage arrangements in the refrigerator in your place of work and ensure capacity is sufficient even during busy periods. Can you estimate the percentage capacity filled in the refrigerator at this point in time? Note down what action you need to take, if any.

16 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 16 Activity Study the image below and see if you can spot the problems. Click on to the next page to see the answers.

17 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 17 Activity Deliberate mistakes The product is packed too close to the wall. Some refrigerators will have a curve on the shelf to prevent this. You can t use the plastic enclosed salad drawers that you get with domestic refrigerators. There should be a little more space for air to circulate around the product. The refrigerator is just over 50% full. This is okay but it can be seen how quickly a refrigerator can get filled. You can use the wire basket designed for a pharmaceutical refrigerator. It has feet on to keep it off the floor of the refrigerator. Items are crammed together in an open box in the wire drawer at the bottom of the refrigerator. Ideally no box at all would be better.

18 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 18 Refrigerator maintenance Routine maintenance should be carried out by appropriate staff (for full instructions consult the manufacturer s user guide). Generally, this should include cleaning and/or defrosting the vaccines refrigerator on a regular basis. Unless the refrigerator has an auto defrost facility, it should be defrosted at least quarterly. Before routine maintenance: Ensure vaccine stock levels are at a minimum Remove/transfer the vaccines to another monitored refrigerator. Record vaccine removal/transfer on both sets of temperature recording sheets (in the comments section) Replace the vaccines in the refrigerator only once it has returned to the correct temperature after cleaning/ defrosting. If an alternative refrigerator is not available a validated and approved cool box may be used. Cleaning and defrosting Clean/defrost the refrigerator ensuring: An appropriate/compatible cleaning agent is used (check manufacturer s instructions but generally a domestic detergent and warm water can be used for routine cleaning) The drainage hole for self-defrosting models is wiped well and not blocked The door seal is washed to remove all dust/debris and is checked to ensure it is intact and free from any punctures The door hinges are checked and are dust free The element at the back of the refrigerator is regularly dusted and remains dust free Temperatures are recorded and the thermometer reset before and after cleaning and defrosting.

19 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 19 Build up of ice Some models of refrigerators are self-defrosting and there should be no ice build up in the cabinet. If ice build up does occur, it may be an indication that there is moisture in the cabinet, which may be due to: The room being too warm -- or even damp The refrigerator thermostat/temperature is set too low Cardboard packaging may have come in contact with the back wall at some point and is wet Open plastic airtight containers are being used and are attracting moisture. You must investigate why ice is building up, as the self-defrosting refrigerator will not be working at full efficiency when there is any ice build up. Additional / annual maintenance All vaccine refrigerators should have an electrical check undertaken regularly (usually annually) as part of the workplace routine approach/contract for portable appliance testing (PAT testing).

20 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 20 Section 6 Temperature recording and monitoring Roles and responsibilities It is everybody s responsibility to ensure the cold chain is monitored. There should be a named person for monitoring the temperature. Deputising arrangements are required to be in place to cover any staff absences, e.g. holidays and sickness. Activity Note down who is the deputy in your workplace to ensure the cold chain is monitored in the event of the named person being unavailable.

21 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 21 All staff should be trained to use the equipment and respond to any abnormal readings. Any staff involved with immunisation should ensure that the vaccines they administer have been stored within the correct range of 2ºC to 8ºC. Thermometers Thermometers must be able to continually monitor the minimum, maximum and actual temperatures of the refrigerator. If the refrigerator does not have an integral thermometer, a stand-alone digital thermometer is required. When a new vaccine refrigerator or a calibrated maximum/minimum digital thermometer is being procured the thermometer should be independent of mains power, so temperatures can be measured in the event of electricity loss, advice should be sought from the appropriate person in your NHS Board. Check your local guidance for details of who to contact. Some thermometers/temperature monitoring devices measure air temperature but simulated vial temperature is preferred. Recalibrate the thermometer regularly according to manufacturer s recommendations. Recalibration can be expensive and replacement of the thermometer may be cheaper. Calibration of the thermometer needs to be checked regularly. This is part of the annual audit that should be undertaken in practices. Temperature monitoring and recording Refrigerator temperature readings (maximum, minimum and current) must be read and legibly recorded, as a minimum, at least once every working day. In each NHS Board there will be standard charts to record these temperatures. Temperature records relating to a particular refrigerator should be kept close to that refrigerator (but not inside) for ease of reference and should be clearly identified as relating to that appliance. A separate temperature record should be kept for each refrigerator.

22 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 22 Activity Do you have a Board policy for temperature recording? Note down the key points from the policy below. Locate the standardised recording sheet.

23 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 23 The thermometer should be reset after each reading. Different thermometers may have slightly different ways of resetting. To check the reset has been carried out correctly, the maximum, minimum and current temperatures should be checked again and if the thermometer has been correctly reset these should all show the same (current) temperature. It is good practice to record the temperature at a similar time each day e.g. first thing in the morning before the refrigerator door is opened for the first time. This will allow review of trends in results recorded; help highlight any changes in temperatures recorded and deviation in refrigerator performance. If there has been a vaccination clinic the temperature should be recorded and the thermometer reset after this has finished and a note made on the comments section. Review temperature records at the end of the month for temperature drift. Any trend of increasing or decreasing temperatures within the recommended range should be investigated before temperatures exceed the recommended range. Retention of records under the NHS Code of Practice (Scotland) is governed by CEL 31 (2010) issued by the Scottish Government. Under pharmacy records: quality assurance it is recommended that refrigerator temperature records should be retained for the life of any vaccine stored therein with a minimum of a one year retention period. Activity Note here who has responsibility for reviewing temperature charts in your place of work.

24 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 24 Setting temperature alarm parameters Where a refrigerator has an integral alarm to alert high and low temperatures it is important to ensure that the appropriate parameters for the alarm are set. It is recommended that the alarm should be set to sound after the temperature has been below 2ºC or higher than 8ºC for more than 15 minutes. Activity Note down here your refrigerator s alarm parameters

25 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 25 Section 7 Action in the event of abnormal temperatures Action should be taken immediately if a temperature out with the range of 2ºC to 8ºC is observed. There should be a procedure in the workplace to describe the actions that should be taken in the event of the temperature going outside the recommended range. Consider whether the temperature could be explained by the door being left open or a new delivery of stock etc. Action must be taken in the event of unexplained temperatures above 8 C or any recording below 2 C. In such cases the individual with overall responsibility for vaccine storage must be informed and action taken.

26 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 26 Activity Check the temperature records for your workplace for the last month and note down any unexplained temperature readings and what action was taken e.g. how they were reported and reviewed to prevent further occurrence.

27 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 27 Responding to abnormal temperatures After quarantining stock involved, advice may be needed on the vaccine and its viability. Activity Note down here who should be contacted in your NHS Board if there is an incident where vaccines may have been exposed to temperatures outwith the recommended range. You may also need to consider while the stock is under quarantine if further supplies are needed to meet immediate clinical need. All incidents occurring in the managed service require to be recorded on the web-based incident reporting system e.g. Datix. Where incidents occur within a general practice setting, independent contractors and their staff should be encouraged to use local NHS Board procedures for incident reporting. This will provide details of the incident and action taken to reduce the risk of recurrence.

28 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 28 Contingency arrangements In the event of a refrigerator failure it is important to have arrangements in place for suitable storage of vaccines whilst advice is sought on whether the vaccines are suitable for future use. Pharmaceutical refrigerators can normally be expected to maintain their temperature for up to four hours in the event of a power failure. Therefore if the power supply has been interrupted for a period of four hours or less, the refrigerator door should be kept closed and close monitoring of temperatures undertaken to ensure it is operating within normal temperature limits. If the failure lasts longer than four hours a suitable back-up or alternative refrigerator is required. Transfer the vaccines and record vaccine removal/transfer on both sets of temperature recording sheets. In emergencies, where there is no alternative appropriate storage available, contact the supplying vaccine holding centre in the first instance for advice. Keep a record of these discussions to enable you to create a standard operating procedure for future occasions.

29 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 29 Section 8 Handling of vaccines in clinics Use in clinics When running a clinic in a room that does not have a refrigerator, it is not necessary to store the vaccines in a validated and approved cool box during the clinic session. Only remove the minimum vaccine required from the refrigerator. Reconstituted vaccines and opened multi-dose vials should be disposed of at the end of an immunisation session in a sharps box. Practice point Any surplus vaccine not used during a short clinic session should be returned and marked `use first` for the next clinic session. Any vaccine not used during second session should be discarded. All relevant details should be recorded as per local/national guidance ensuring that the batch number and expiry date are recorded accurately. This is necessary to provide and audit trail in the incidence of product withdrawal or adverse reaction, which may be attributable to the vaccine. Local NHS Board hand washing guidelines should always be adhered to before and after vaccine administration to a patient.

30 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 30 Activity Note down the arrangements in place for transport outside your place of work.

31 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 31 Transportation from practice to another location When vaccines are required outside the practice validated and approved cool boxes should always be used. Return surplus marked use first to prioritise its use. Larger cool boxes are not normally practical for GP practices since they take up a lot of space and require several shelves of refrigerator space to store the cool packs prior to their use. Practice point Smaller validated and approved cool boxes are available for transport of up to 10 vials of vaccine. They require the insertion of a frozen cool pack for accredited use and are validated for up to 18 hours. Disposal Disposal of vaccines should take place in accordance with local clinical/pharmaceutical waste arrangements. Vaccines which are unfit for use through being out of date or because of storage irregularities should be returned by prior arrangement (telephone) to the vaccine holding centre for destruction. Any opened or prepared vaccines that have not been used during a clinic session should be destroyed in the following manner: Opened vials should be placed in a sharps container for incineration Any vaccine in an ampoule should be drawn up into a syringe and placed in a sharps container for incineration. Vaccines must not be flushed down the toilet or sink. Spillages Contaminated waste and spillages should be dealt with according to the local NHS Board Clinical Waste Policy and Decontamination Guidelines and the Prevention and Control of Infection Manual respectively. In the event of eyes being splashed with vaccine, they should be rinsed with copious amounts of Sodium Chloride 0.9% and immediate medical advice sought.

32 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 32 Audit A self audit is recommended to be undertaken annually in line with HPS guidance, click on the link below and view Appendix 1:Vaccine Storage and Handling Specimen Self Audit Tool Activity Review the summary report from the previous self audit for your place of work. Have all the recommendations been undertaken? When is the next self audit due? Note your answers here.

33 NHS Education for Scotland A learning resource on the Storage and Handling of Vaccines Page 33 Section 9 Multiple choice questionnaire assessment Now that you have completed this learning resource you are ready to undertake the multiple choice questionnaire assessment. This will allow you to formally check your knowledge and understanding of the module. Please note: Pharmacists and pharmacy technicians should complete the multiple choice questionnaire via Portal All other healthcare professionals should complete the multiple choice questionnaire using the following link l5wb8whzrp The learning resource can be accessed repeatedly and can be used to