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Immunisation Resource Pack Section 4: Pharmacy
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Section 4: Ordering, Storage and Handling of Vaccines Index 4.1 Background 2 4.1.1 Guidance and Policies 4.1.2 Purpose of Guidelines and Ordering Support Material 4.2 Main Recommendations 3 4.2.2 Summary of Recommendations 4.3 Ordering 5 4.3.1 Who Supplies Vaccine 4.3.2 How to Order 4.4 Receipt 8 4.5 Storage and Equipment 8 4.5.1. Storage 4.5.2. Stock Management and Rotation of stock 4.5.3. Fridge Use and Specifications 4.5.4. Thermometer Specifications 4.6 Temperature Monitoring 17 4.6.1. Roles and Responsibilities 4.6.2. Monitoring and Recording Temperatures 4.6.3. Setting Temperature Alarm Parameters 4.6.4. Action in the Event of Abnormal Temperatures 4.6.5. Contingency Arrangements 4.7 Transportation 20 4.7.1 From Holding Centres to Practices 4.7.2 From Practice to another Location 4.7.3 During Clinic within Practice 4.8 Disposal 22 4.9 Spillage 22 4.10 Recall 22 4.11 Support materials 23 4.11.1. Summary of GG&C Guidelines on Storage of Vaccines 4.11.2. GG&C Equipment Guidance 4.11.3. GG&C Temperature Monitoring Log and Guidance 4.11.4. Vaccine Refrigerator Incident Checklist 4.12 References 35 Appendices Appendix 1 Refrigerator Information Guide Appendix 2 Vaccine Order form Appendix 3 Vaccine Refrigerator Incident Form Appendix 4 Vaccine returns form
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4.1 Background Vaccines naturally biodegrade over time and storage outside of the recommended temperature range at any time will speed up loss of potency which cannot be reversed. It may result in the failure of the vaccine to protect as well as resulting in vaccine wastage. It is essential that all those handling vaccines follow policies to ensure cold chain compliance.
The terms of marketing authorisations (product licences) cover storage requirements. Vaccines that have not been properly distributed or stored are therefore no longer within the terms of the marketing authorisation and require confirmation using manufacturer’s stability data on whether they can still be used.
4.1.1. Guidance and Policies There is a range of guidance and policies relating to vaccine handling and storage.
The Department of Health Publication “Immunisation against Infectious Diseases” also known as ‘The Green Book’ is well recognised and provides general guidelines and information on vaccination. The updated book was published in August 2006; however, regular updates are posted on the website. It is recommended that this is the version referred to http://www.dh.gov.uk/en/Publichealth/Healthprotection/Immunisation/Greenbook/index.htm )
The NHS (General Medical Services Contracts) (Scotland) Regulations 2004 sets out detailed requirements for GP practices regarding the proper storage of vaccines. Specifically, these regulations, at paragraph 8 of Schedule 5, require the contractor to ensure that:
a) all vaccines are stored in accordance with the manufacturer’s instructions, and
b) all refrigerators in which vaccines are stored have a maximum/minimum thermometer, and
c) that readings are taken on all working days
The GG&C Board have produced these guidelines and National Guidelines are currently being developed, it is anticipated that they will be available in 2010.
A magnetic fridge sticker with a summary of best cold chain practice designed to be displayed prominently on each vaccine fridge in the practice, providing a quick and practical reference, is available and should be followed by all primary care staff involved in the storage and handling of vaccines.
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4.1.2 Purpose of Guidelines and Ordering Support Material
These guidelines aim to provide detailed information to support primary care staff in the storage and handling of vaccines.
It is also hoped that practices will find the information a valuable tool in supporting the training of all relevant staff at a local level.
An electronic version of this pack can be accessed on-line on the Public Health Protection Unit website at: http://www.nhsggc.org.uk/content/default.asp?page=s843
Further hard copies of materials in this section may be obtained from:
For Greater Glasgow Practices: Primary Care Distribution Centre, Clutha House, 120 Cornwall Street South, Glasgow, G41 1AD,
Tel: 0141 427 8246, Fax: 0141 427 8270
For Clyde Practices: Argyle and Clyde Primary Care Supplies, NHS GG&C Central Store (South), 1 Carnegie Road, Hillington, Glasgow, G52 4NY,
Tel: 0141 278 2531, Fax: 0141 892 0758.
4.2 Main Recommendations
Specific member(s) of staff should be identified to monitor the pharmaceutical supplies refrigerator. Any temperature readings outside 2-8°C should be investigated and discussed with the Pharmacy Distribution Centre or Pharmaceutical Public Health. Refer to Section 4.6
The correct maintenance temperature of the vaccine refrigerator is 2-8°C. Refer to section 4.5
Check and record the fridge temperature (maximum, minimum and current) twice daily. Suitable sheets are available from Primary Care Distribution Centres. The thermometer should be re-set after each reading. Refer to Section 4.6
Store vaccines in the middle of the fridge away from elements and freezer compartments. Do not fill fridge more than two thirds full. Do not store in the fridge door, to avoid the risk of a temperature rise when door is opened. Refer to Section 4.5
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Always check “Expiry Date” of vaccine following removal from the refrigerator and before dispensing. Check expiry dates and rotate stock to ensure shortest shelf life is used first. Do not keep excess stocks. Refer to Section 4.5
Refrigerate vaccine deliveries immediately. (This is the responsibility of the member of staff accepting delivery). Refer to Section 4.4
Clean and defrost vaccine fridges on a regular basis (3 monthly). Place vaccines in another fridge or in a validated cool box* while this takes place and until the refrigerator temperature is restored to 2-8°C. Refer to Section 4.5
Recalibrate the thermometer regularly according to manufacturer’s recommendations. Refer to Section 4.5
Protect power supply to the fridge ideally with a switchless socket and a fixed unit over the plug and socket to ensure the plug cannot be pulled out. Mark the electrical socket with a cautionary notice advising staff not to switch off power. Refer to Section 4.5
Do not store foodstuffs in the vaccine fridge at any time. Refer to Section 4.5
Any vaccine unsuitable for use (e.g. expired stock or heat/cold damaged vaccines) should be clearly identified and returned for disposal. Telephone the Pharmacy Distribution Centre to arrange. Refer to Section 4.6
Vaccines should only be transported to peripheral clinics using validated cool boxes*. Refer to Section 4.7
Only remove from fridge at any one time the minimum quantity required. Reconstituted vaccines and opened multidose vials should be disposed of at the end of an immunisation session in a 'sharps' box. Any surplus vaccine not used during a clinic session should be returned and used first for subsequent session. Discard any vaccine not used during second session. Refer to Section 4.7
4.2.2 Summary of Recommendations
A summary of the GG&C Guidelines are available in a fridge magnet form and should be displayed prominently (preferably on the refrigerator door) within every immunisation area (see Section 4.11)
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4.3. Ordering
4.3.1 Who Supplies Vaccine
Childhood vaccines for use in the Scottish Immunisation Recall System (SIRS), selective immunisation for Hepatitis B for at risk babies and any additional childhood vaccines for ad hoc vaccination clinics should be ordered from the Pharmacy Distribution Centre (PDC) which took over from the Vaccine Holding Centres in February 2010, using the appropriate order forms provided. An example of an order form is available in the appendices of this section.
Winter, Travel and Adult Booster vaccines should be ordered from the Local Community Pharmacy using individual prescriptions (GP10) or exceptionally a Stock Order Form (GP10a). The table below highlights this information,
Vaccine Type Order From
Contact Order Method
Childhood Vaccines
(Baby, Pre-School and missed School Programme)
Pharmacy Distribution Centre
Pharmacy Distribution Centre, Dava Street, Moorpark Central, Govan, Glasgow, G51 2JA
Tel 0141 347 8981
Fax 0141 445 1513
Vaccine Order Form (copy available as Appendix 2.)
Winter Vaccines
(Flu, Pneumococcal)
Local Community Pharmacy
n/a Individual Prescriptions (GP10) or Stock Order (GP10a)*
Travel Vaccines
Local Community Pharmacy
n/a Individual Prescriptions (GP10) or Stock Order (GP10a)*
Adult Booster Vaccines
(e.g. Revaxis)
Local Community Pharmacy
n/a Individual Prescriptions (GP10) or Stock Order (GP10a)*
* Stock Order forms (GP10a) should only be used in exceptional circumstances
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4.3.2 How to Order
The Pharmacy Distribution Centre (PDC) receives twice weekly SIRS summaries of each GP practice’s call list. This information, in conjunction with details of the amount of vaccines that a practice already has in stock at the time of ordering, is used to allocate stock according to need. This approach is used to help prevent overstocking in practices, which can be wasteful and reduces the efficiency of fridge storage.
Care must be taken in counting and ordering vaccines, especially as certain vaccines are packaged in multiple quantities. Incorrect ordering can result in wastage and unnecessary costs to GP practices and the NHS.
Vaccine stocks must be monitored to avoid over-ordering or stockpiling, ideally by a designated person. GP practices should have no more than two to four weeks’ supply of vaccines at any time which should be sufficient for routine provision.
When placing ad hoc orders for vaccines from the Pharmacy Distribution Centre (PDC), please ensure that:
• The pre-printed order forms provided by the PDC are used and that all details are completed.
• The order is signed by the agreed authorised signatories.
• The order is faxed or posted to the PDC. Any faxed orders subsequently posted should be clearly marked ‘confirmation of fax’.
• Arrangements for large clinics (or unscheduled/ ad hoc catch-up) should be discussed with the Pharmacy Distribution Centre prior to making appointments to ensure sufficient vaccine can be made available for the required date.
The Pharmacy Distribution Centre has different delivery times for vaccines depending upon a surgeries’ geographical position Please ensure that vaccine orders are placed with this in mind. The table overleaf illustrates the schedule.
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Pharmacy Distribution Centre Delivery Schedule
Glasgow Practices
(Formerly supplied by Leverndale Hospital)
Routine Delivery Day
South West Monday
East Tuesday
West Wednesday
South East Thursday
North Friday
Renfrewshire and Inverclyde Practices
(Formerly supplied by Royal Alexandria Hospital (RAH) and Inverclyde Royal Hospital (IRH))
All areas Thursday
The West (Formerly supplied by Vale of Leven Hospital
Dumbarton, Alexandria, Helensburgh
Monday- Friday every week, mainly in the mornings or lunchtime. If necessary deliveries can be made Tues-Fri afternoons (not Mondays),
To guarantee delivery, a vaccine order must be with the PDC 48 hours before the expected delivery day. If a practice is not going to make this deadline but needs the vaccine before the following scheduled delivery day, contact The PDC to arrange an alternative. This may for example involve someone from the practice uplifting the vaccine.
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4.4 Receipt
Refrigerate vaccine deliveries immediately. (This is the responsibility of the member of staff accepting delivery).
Vaccines must be placed in the vaccines refrigerator(s) IMMEDIATELY they are delivered to the practice or clinic. It is good practice to record the fridge temperature after a vaccine delivery has been placed in the refrigerator and again 30 minutes later (See Section 4.5.2 for appropriate stock rotation and temperature monitoring advice)
Ensure all staff know where the keys for vaccine refrigerators are kept and have access to them to prevent delay in vaccines being stored at the appropriate temperature.
It is good practice for staff to check the received vaccines against the order for discrepancies and for leakage or damage before signing for them.
4.5 Storage and Equipment
4.5.1. Storage
Check and record the fridge temperature (maximum, minimum and current) twice daily. Suitable sheets are available from Primary Care Distribution Centres. The thermometer should be re-set after each reading.
The correct maintenance temperature of the vaccine refrigerator is 2-8°C.
Store vaccines in the middle of the fridge away from elements and freezer compartments. Do not fill fridge more than two thirds full. Do not store in the fridge door, to avoid the risk of a temperature rise when door is opened.
Do not store foodstuffs in the vaccine fridge at any time
Correct Temperatures
Vaccines should be stored in the original packaging at +2°C to +8°C and protected from light, as exposure to ultraviolet light may cause loss of potency. Repeated warming and cooling of vaccines may also result in reduced potency.
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.
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Too warm
Heat speeds up the decline in potency of most vaccines and reduces their shelf life. Therefore, the effectiveness of the vaccine cannot be guaranteed unless it has been stored at the correct temperature.
It is important that the fridge is not overfilled, since this can restrict the circulation of air within the fridge, resulting potentially in some parts of the fridge becoming warmer than others. It is recommended that the internal volume of the fridge cabinet area (main body of the fridge) is only partially filled (around 50%) and even at maximum stock level is not more than two thirds (66%) filled to allow circulation of air and hence the achievement of correct temperature gradients.
‘Salad drawers’ with a lid are unsuitable as these are subject to temperature fluctuations and vaccines should not be stored directly on the floor of the refrigerator. Both of these practices have the potential to restrict airflow circulation and hence may cause temperature variations. Additionally vaccines should not be stored in the refrigerator door as they will warm up every time the door is opened.
Too cold
Vaccines must not be kept at temperatures below 0°C as freezing may cause increased reactogenicity and loss of potency for some vaccines. It can also cause hairline cracks in the container, invisible to the naked eye, which could lead to contamination of the contents.
It is therefore important that the vaccines are not stored in or close to any freezing component in the refrigerator such as the back wall in a self defrosting fridge.
Non-pharmaceutical items
Food, drink and clinical specimens must never be stored in the same refrigerator as vaccines. This would cause the door to be opened frequently for access, resulting in a raised temperature.
Use of temperature recording charts
Review temperature records at the end of the month. Sense check them, for example are the temperatures showing no variation, which may indicate that the thermometer is not being reset or are there any unexplained wide variations in temperature? Temperature recording charts are available to order from Primary Care Distribution centres. Further advice about their use is in the section 4.11.
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4.5.2 Stock Management and Rotation of Stock
Always check “Expiry Date” of vaccine following removal from the refrigerator and before dispensing. Check expiry dates and rotate stock to ensure shortest shelf life is used first. Do not keep excess stock.
On receipt, all deliveries and existing stock should be routinely date checked and rotated within the fridge to ensure that those vaccines with the earliest expiry date are at the front and used first. Ideally, any vaccines with a short shelf life should be marked “use first”. It is good practice to have this process as part of your written procedures. All pharmacy products carry a batch/lot number and expiry date. Companies differ in the format they use for expiry dates. Please be careful when checking expiry dates and be aware of the following very different examples.
Batch: 2585H
EXP:
10/2007
Batch: 68689Y
EXP BY:
10/2007
Batch: 2299J
EXP BEFORE:
10/2007
Expiry would be 31/10/2007 Expiry would be 30/9/2007 Expiry would be 30/9/2007
Make a note on your temperature recording chart that a delivery has been received, expiry dates checked and stock rotated alongside recording the temperature of the fridge after the stock has been received and rotated.
Check the temperature again 30 minutes later to ensure that the running temperature is satisfactory and record on the temperature recording chart. Any out of date stock should be labelled clearly, removed from the refrigerator and returned for destruction as soon as possible according to local procedure (See Section 4.8 Disposal)
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4.5.3 Fridge Use and Specifications
Fridge Specifications
Specialised refrigerators are available for the storage of pharmaceutical products and must be used for vaccines and diluents. Ordinary domestic refrigerators must not be used since they are not designed to maintain the rigorous temperatures and temperature gradients required for storage of vaccines.
The following features are considered essential to best practice and should be sought when purchasing a pharmaceutical fridge for storage of vaccines:
• Operational temperature +2°C to +8°C
• Forced air cooling – interior fan for temperature stability and rapid temperature recovery after door openings.
• Door lock
• CFC, HCFC and Ammonia free
• Auto-defrost function
• Wire shelves/baskets or shelves capable of allowing air ventilation.
• Integral thermometer which has a digital display recording actual and maximum/minimum temperatures
• Thermometer has an integral high/low temperature alarm (audio/visual)
Where a practice already has a fridge which does not have the essential features listed above, a replacement should be considered, unless the missing specifications can be addressed by an alteration to the equipment or environment e.g. if fridge is not lockable it should be kept in a lockable room, which is locked when not in use, or if a fridge does not have an integral thermometer, a recommended stand alone digital thermometer could be purchased.
Age of Fridge
Where a practice fridge is over 5 years old, it should be considered for replacement. Fridges are likely to remain operating satisfactorily for at least 5 years. Beyond this age the fridge functioning may deteriorate and its ability to maintain correct temperatures cannot be guaranteed. Daily temperature monitoring and routine maintenance should be used to ensure ongoing satisfactory performance.
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Manufacturers and Fridge Purchase Guidance
There are a number of manufacturers of refrigerators such as Lec, Labcold, Swan and Sanyo, or thermometers such as Fisher Price (Healthcare Logistics US). We have given a list of manufacturers and suppliers with contact details and an approximate dimension and price list in Section 4.11.
Installing a new fridge or moving a fridge
When a new refrigerator is installed the manufacturer’s guidelines should be referred to before switching the appliance on because if the oil in the compressor has been displaced and has not settled back, the fridge may break!
After relocating a fridge, if it hasn’t been tilted or placed on its side it may be turned on immediately. If it has been significantly disturbed or there is any dubiety it should be allowed to settle for 24 hours.
In either instance the refrigerator temperature should allowed to stabilise before it is used to store vaccines. The time for this may vary according to the make of the refrigerator and ambient temperatures. Best practice would suggest a period of 48 hours for installation of a new fridge but an existing fridge may be used after a minor relocation as soon the temperature is in the 2-8C range.
A note should be made in the temperature log book of the date a new fridge is used for the first time or the date an existing fridge is relocated or recommissioned.
Fridge Location/ Environment
Protect power supply to the fridge ideally with a switchless socket and a fixed unit over the plug and socket to ensure the plug cannot be pulled out. Mark electrical socket with a cautionary notice advising staff not to switch off power.
Sockets for fridges should be marked with a cautionary notice advising staff not to switch off power or ideally, there should be a switchless electrical supply installed. This is important in order to avoid the possibility that the fridge is accidentally switched off.
Generally, a refrigerator should not be situated near a radiator or any other heat source (including direct sunlight). The fridge should also be positioned to ensure that it is appropriately ventilated (i.e. has adequate space for air circulation between the compressor and the wall) and is in a well ventilated room where the temperature is comfortable (i.e. no extremes of <16°c or > 32°c and ideally at 20-24°c maximum) to ensure performance at maximum efficiency. The manufacturer’s user guide will provide specific information relating to this and should be consulted.
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Fridge Maintenance
Clean and defrost vaccine fridges on a regular basis (three monthly). Place vaccines in another monitored fridge or in a validated cool box while this takes place and until the refrigerator temperature is restored to 2-8°C.
In addition to purchasing the correct type of fridge and locating it appropriately within the surgery, it is also essential that the fridge is properly and regularly maintained to ensure adequate performance.
Routine Maintenance
Routine maintenance should be carried out by practice staff. The manufacturer’s user guide for your product will provide specific information on this and should be consulted. Generally, this should include cleaning and/or defrosting the vaccines fridges on a regular basis. Unless the fridge has an auto defrost facility, it should be defrosted at least quarterly. When a refrigerator is to be cleaned /defrosted the following should be ensured:
• Ensure that vaccine stock levels are at a minimum.
• Remove/transfer the vaccine to another monitored refrigerator (which is also maintained in accordance with GG&C Guidelines)
• 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 an appropriately prepared approved vaccine porter may be used.
• Clean/defrost the refrigerator ensuring that: o An appropriate/compatible cleaning agent is used (check
manufacturer’s instructions but generally a dilute solution of sodium bicarbonate and water or detergent and water for routine cleaning)
o The drainage hole for self defrosting models is wiped well and not blocked.
o The door seal is washed to remove all dust/debris and is checked that it is intact and free from any punctures.
o The door hinges are checked and are dust free. o The element at the back of the refrigerator is regularly dusted and
remains dust free.
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Note:
Some models of fridges 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 is too warm -- or even damp
• The fridge thermostat/temperature is set too low
• Cardboard packaging may have come in contact with the back wall at some point and is wet
• Open Tupperware® containers are being used and are attracting moisture.
The practice should investigate why ice is building up, as the self- defrosting fridge will not be working at full efficiency when there is any ice buildup.
Additional/ Annual Maintenance
All vaccine fridges should have an electrical check undertaken regularly (usually annually) as part of the practices routine approach/contract for checking of all electrical equipment (PAT testing). There are a range of providers who can be contracted to undertake this work, including the Clinical Physics Department at the Southern General Hospital (Contact Mark Prentice on Tel: 0141 201 1895).
Regular (e.g. annual) servicing of fridges can be arranged via contractors such as McMillan Refrigeration, www.mcmillanrefrigeration.co.uk. Tel: 0845 293 0823 or E-mail [email protected]. Practices may wish to have this in place, to provide independent reassurance on their fridges’ performance.
If regular temperature monitoring, in-house maintenance and annual audit are being carried out in accordance with GG&C guidelines specialist annual servicing by a contractor may not be necessary. However, it is essential that
• Temperature monitoring is carried out in accordance with GG&C Guidelines.
• Temperature charts are reviewed on a monthly basis to determine that temperature ‘drift’ (a widening range of maximum minimum temperatures and steadily increasing or decreasing mean temperatures) is not occurring.
If it appears that ‘drift’ is occurring then a temperature mapping exercise may be carried out to determine whether the fridge is working within desired parameters.
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Temperature mapping
When a practice has any concerns about temperature drift or the age of a fridge it may be possible to arrange a temperature mapping exercise of the fridge by the Clinical Physics Department at the Southern General Hospital. Contact Mark Prentice on Tel: 0141 201 1895. A small charge is made for this service. Alternatively contact the Public Health Pharmacist 0141 201 4502 for further advice.
Where the fridge temperatures appear to be fluctuating or the fridge is operating outside of the 2-8°C range with no clear and fixable explanation, then servicing should be considered. Refrigerators with excessive temperature fluctuations or temperature gradients should be replaced.
When a new fridge is purchased, the old fridge must be disposed of appropriately. When supplying a new fridge, manufacturers must (by law) provide the opportunity for the old fridge to be picked up and disposed of. This may be free of charge if the old fridge is one of their models or for a small cost if the product is from another manufacturer.
4.5.4 Thermometer Specifications
Thermometers/ temperature monitoring devices must be able to record the minimum, maximum and actual temperatures of the refrigerator.
Digital thermometers are recommended to record the minimum, maximum and actual temperatures, since these are more reliable. These are often fitted by the manufacturer as integral to the refrigerator.
Where a digital thermometer is not fitted as integral to the refrigerator, or if a practice is using a manual thermometer a stand-alone digital thermometer should be purchased and situated centrally within the cabinet, next to the stored vaccines.
Stand alone digital thermometer
We recommend a digital thermometer (Traceable Memory Monitoring Thermometer 10368) with a min/max reading that has an inbuilt alarm. Attached to the thermometer is a probe that is sealed in a small bottle of non-toxic glycol solution. This allows the thermometer to record the product temp, not the fridge air temp. This provides a more accurate reading reflecting the temperature of stored vaccine rather than the air temperature of the fridge. See Section 4.11 for details of thermometer manufacturers and suppliers.
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Thermometer Use and Resetting
Only use one thermometer for each fridge.
It is essential that the thermometer/temperature monitoring device is reset after every reading.
Some thermometers/temperature monitoring devices measure air temperature. The temperature reading of this type of thermometer will respond immediately to any rise in actual air temperature. Therefore, even if it’s >8ºC for a few seconds e.g. via the air temperature increasing because the door was opened, this maximum temperature is recorded and will remain until the next time the thermometer is re-set. This may not reflect the actual temperature of the stored vaccines.
The recommended type of thermometers or temperature monitoring devices are designed to simulate the actual temperature of the vaccines rather than measuring the air temperature (this is often the case for integral thermometers in modern pharmaceutical fridges). The actual temperature of a vial of vaccine will not change as quickly as air temperature. These devices provide a more accurate reading of the actual vaccine temperature and hence the actual maximum and minimum temperature of the vaccine. As with the thermometers measuring air temperature, the maximum and minimum temperatures recorded will remain until the next time the thermometer is reset and again must be reset after every reading.
Guidance on the use and resetting of the digital thermometer suggested above is included in the Toolkit Section 4.11. For guidance on the use and resetting of all other thermometers, please refer to the manufacturer’s instructions.
Thermometer Calibration
Recalibrate the thermometer regularly according to manufacturer’s recommendations.
Recalibration of temperature monitoring equipment by an appropriate contractor in accordance with manufacturer’s recommendations can be expensive. In many instances it’s probably cheaper to replace a stand alone thermometer or logging device with a new model.
It is acceptable to verify the calibration of the thermometer. This may be done simply by comparing the temperatures registered by the thermometer with a logging device or ideally as part of a ‘temperature mapping’ exercise (see Section 4.5.3.) Verification of the calibration of the thermometer should be undertaken annually. Contact the Public Health Pharmacist for further advice Tel. 0141 201 4502
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4.6 Temperature Monitoring
Specific member(s) of staff should be identified to monitor the pharmaceutical supplies refrigerator. Any temperature readings outside 2-8°C should be investigated and discussed with the Pharmacy Distribution Centre or Pharmaceutical Public Health.
Check and record the fridge temperature (maximum, minimum and current) twice daily. Suitable recording sheets are available. The thermometer should be re-set after each reading.
4.6.1 Roles and Responsibilities
It is important that designated members of staff are identified as responsible for monitoring the fridge temperatures every day. It is also important that arrangements are clear with regard to who should deputise in the event of holidays, sickness, absences etc. Designated staff should all be trained to use the equipment and respond to any abnormal readings.
It should also be made clear to all staff involved with immunisation that designating a member of staff to monitor temperatures does not devolve them from responsibility in ensuring that the vaccines they administer have been stored within the correct range of +2 ºC to +8ºC.
4.6.2 Monitoring and Recording Temperatures To ensure compliance with the GG&C guidelines, refrigerator temperature readings (maximum, minimum and current) must be read and recorded twice every working day. Readings must be taken (and recorded) usually at the start and near the close of the working day. If a vaccination clinic has been run the temperature should be recorded after this has finished and a note made on the recording sheet that a clinic has taken place. The PDC must be contacted if there is doubt about any temperature variations outwith acceptable levels.
Care must be taken to ensure that the thermometer is reset after each reading.
Each practice or vaccinating centre should nominate staff to undertake the monitoring procedure and a permanent programme should be in place to cover absences.
Temperature records should be retained for at least twelve years in line with HDL 2006-28 requirements for Quality Assurance Documents.
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Monthly review of fridge temperature charts should be undertaken. This can highlight temperature ‘drift’ which may indicate that a fridges temperature control is beginning to become less reliable. This is important for all fridges but particularly for ageing models. The temperature chart should be signed after monthly review has been completed to audit compliance.
To support GP practices in ensuring that they adopt best practice in monitoring and recording fridge temperatures, Temperature Recording Sheets (pads) and a cover sheet with Best Practice Recommendations were prepared on behalf of the NHS Greater Glasgow and Clyde Immunisation Liaison Group. These were previously issued to all GP practices.
A copy of the Best Practice Recommendations and the Temperature Recording sheets is included in the Section 4.11. Further copies of the Temperature Recording Sheets can be ordered from Primary Care Distribution Centres.
4.6.3 Setting Temperature Alarm Parameters
Where a fridge 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.
4.6.4 Action in the Event of Abnormal Temperatures
Any vaccine unsuitable for use (e.g. expired stock or heat/cold damaged vaccines) should be clearly identified and returned for disposal. Telephone Pharmacy Distribution Centre to arrange.
Abnormal temperatures are those which are out with the recommended vaccine storage range of 2-8°C. If vaccines have been stored out with the recommended temperature range, the cold chain may have been broken and the vaccine may be unsuitable for use.
Action taken in the event of abnormal temperatures, or reasons for abnormal temperatures should be clearly recorded on the temperature monitoring sheets e.g. “Delivery Received”.
Any temperature out with the recommended range which cannot be attributed to the putting away of an order or vaccine being removed for a clinic, should be dealt with according to the GG&C guidance.
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When to contact the Pharmacy Distribution Centre for further advice
• A current temperature reading above 8ºC which has not corrected within 1 hour.
• A maximum temperature reading above 8ºC when the refrigerator has not been opened.
• Any temperature reading below 2ºC.
• Any identical Min/Max/Actual reading (exceptionally readings may be identical if the fridge has not been opened).
• A temp greater than 8ºC at routine monitoring at start or end of day.
Action for potentially hot/cold damaged stock
• Quarantine stock. Place the vaccine within a sealed bag labeled “DO NOT USE QUARANTINED” with date/ time and transfer to a back-up fridge which has been monitored for temperature efficiency.
• Record Min/Max/Actual readings immediately on identification of incident
• Seek further advice as soon as possible the Pharmacy Distribution Centre (PDC) will require details of recent temperature readings.
• Ensure sufficient non-quarantined vaccine remains available. Order if necessary.
To provide the best possible advice the PDC will require details of the incident. A “Vaccine Incident Checklist” and a copy of the “Vaccine Refrigerator Incident Form” are included in Section 4.11 to give you a guide to the types of information that the PDC may ask you for. Once a response is received from the PDC:
• If the quarantined vaccines are deemed unsuitable for further use, they will require to be disposed of by return to the PDC . See Section 4.8 Disposal
• If the quarantined vaccines are deemed suitable to be used, they will require to be clearly marked with “Subject to Cold Chain Breach. Use First” and if a second exposure occurs, then the vaccine will have to be destroyed.
• Please note that the use of any vaccine stored out with the manufacturers recommended temperature range is unlicensed, therefore the existing PGD will no longer be valid. The list of patients requiring vaccination would have to be signed by the prescriber.
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4.6.5 Contingency Arrangements
In the event of a fridge 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 fridges can normally be expected to maintain the fridge temperature for up to 4 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 fridge door should be kept closed and close monitoring of temperatures undertaken to ensure the fridge is operating within normal temperature limits until either the supply is reinstated or alternative arrangements for storage can be made.
If the failure lasts longer than four hours a suitable back-up or alternative fridge should be available, which is also maintained in accordance with GG&C Guidelines. Transfer the vaccines and record “vaccine removal/transfer” on both sets of fridge temperature recording sheets (in the comments section).
Practices need to consider the practicality of alternative pharmaceutical fridge storage arrangements and ensure that they have suitable contingency plans in place which are clearly outlined to all staff.
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 this discussion and advice to enable you to create a standard operating procedure for future occasions.
4.7 Transportation
4.7.1. From Holding Centres to Practices
The World Health Organisation (WHO) has undertaken studies on vaccine storage and transportation and recommends that an efficient ‘cold chain’ is established for vaccine distribution to ensure that the correct temperatures are maintained throughout, as any breaks in the cold chain, may reduce the potency of vaccines and contribute to primary vaccine failure.
Within GG&C vaccines are distributed from the Pharmacy Distribution Centre to health centres, clinics and surgeries using “Vaccine Porters”. The Vaccine Porters are special containers (validated cool boxes) which are validated to maintain the cold chain for eight hours, including allowance for multiple openings. Once received by the surgery/clinic, immediate transfer of vaccines to the vaccine fridge will ensure that the cold chain is fully maintained.
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4.7.2. From Practice to another Location
Vaccines should only be transported to peripheral clinics using validated cool boxes.
Occasionally vaccines may have to be transferred from the practices vaccine refrigerator to another clinic or for domiciliary visits. Where this occurs, validated cool boxes e.g. Vaccine Porters or Mini Vaccine Porters – must be used. Large Vaccine Porters are not normally practical for GP practices since they take up a lot of space and require several shelves of fridge space to store the cool packs prior to their use.
Smaller cool boxes (Mini Vaccine Porters) are available for transport of up to 10 vials of vaccine and are normally suitable for GP Practices. They require the insertion of a cool pack, which must be frozen in advance, for accredited use and are validated for up to 18 hours. See Section 4.11 for further information.
4.7.3. During Clinic within Practice
Only remove from fridge at any one time the minimum quantity required. Reconstituted vaccines and opened multidose vials should be disposed of at the end of an immunisation session in a 'sharps' box. Any surplus vaccine not used during a clinic session should be returned and used first for subsequent session. Discard any vaccine not used during second session.
When running a clinic in a room that does not have a refrigerator, it is not necessary to store the vaccines in a cool box during the clinic session. Only remove the minimum vaccine required for a session from the fridge and don’t remove it from the fridge any earlier than necessary.
Unused vaccines removed from the refrigerator for one clinic session in unopened packs, should be returned to the refrigerator clearly labelled “Use First“ and should be selected immediately for the subsequent session requirement. They should not be returned for refrigeration more than once.
Vaccines which are presented as solutions in multi-dose vials must be discarded after four hours, or at the end of the session, whichever is sooner. The individual Summary of Product Characteristics (SPCs) should be consulted for exceptions e.g. Pandemrix® (24 hours after reconstitution) and Celvepan® (3 hours after removal from fridge). SPCs are available at http://emc.medicines.org.uk/.
Expiry dates and batch numbers of each vaccine must be recorded in patient records. This is necessary to provide an audit trail in the incidence of product withdrawal or adverse reaction, which may be attributable to the vaccine.
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4.8 Disposal
Vaccine which is unfit for use through being out of date or because of storage irregularities should be returned by prior arrangement (telephone) to the PDC for destruction. A duplicate returns form will be provided by the PDC and should be completed ensuring that the date, batch number, expiry, quantity returned and reason for return is provided. An example of a returns form document is included in Section 4.11. 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 into a syringe and the whole syringe placed in a sharps container for incineration.
Vaccines must not be flushed down the sink or toilet
4.9 Spillage Where live vaccines are used staff should exercise due care and attention, which eliminates any risk of the hands being contaminated. Contaminated waste and spillage should be dealt with according to the GG&C Clinical Waste Policy and Decontamination Guidelines and the GG&C Division Prevention and Control of Infection Manual respectively.
Hand washing, as outlined in Part 2, Section 1 of the GG&C Division Prevention and Infection Control Manual must be undertaken before and after the vaccine administration procedure for each patient.
In the event of eyes being splashed with vaccine, the eyes should be rinsed with copious amounts of Sodium Chloride 0.9% and immediate medical advice sought. (Refer to GGNHSB Management of Occupational and non Occupational exposure to blood borne viruses at http://www.nhsggc.org.uk ).
4.10 Recall
In the event of vaccines being recalled, all ordering sites will be notified by the Pharmacy Distribution 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’.
The responsible person should notify the Pharmacy Distribution Centre that stock requires to be returned as outlined in Section 4.8 Disposal, or as directed by the initial recall notification. The practice must keep records of all stocks returned, (as per returns sheet).
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4.11 Support materials
4.11.1 Summary of GG&C Guidelines on Storage of Vaccines Specific member(s) of staff should be identified to monitor the pharmaceutical supplies refrigerator. Temperature readings outside 2-8°C must be investigated and discussed with the Pharmacy Distribution Centre* or Pharmaceutical Public Health**.
1. Record the fridge temperature (maximum, minimum and current) twice daily. Suitable sheets are available from Primary Care Distribution Centres. Re-set the thermometer after each reading.
2. Do not overfill the fridge or pack too closely. Do not store vaccines
in the fridge door or near the walls particularly the back wall and freezer compartment.
3. Review temperature records monthly to identify temperature drift
which may highlight failing equipment. 4. Refrigerate vaccine deliveries immediately. (This is the responsibility
of the member of staff accepting delivery.) 5. Return any vaccine unsuitable for use (e.g. expired stock or heat/cold
damaged vaccines) clearly identified for disposal. Telephone the Pharmacy Distribution Centre to arrange*.
6. Only remove from the fridge the minimum quantity required for a
session. Reconstituted vaccines and opened multidose vials should be disposed of at the end of an immunisation session in a ‘sharps’ box. Any surplus vaccine not used during a session should be returned to the fridge and used first the next time. Discard any vaccine not used during the second session.
These guidelines were approved by the Immunisation Liaison Group, NHS GG&C September 2009
* Pharmacy Distribution Centre, Dava Street, Moorpark Central, Govan, Glasgow, G51 2JA Telephone 0141 347 8981, Fax 0141 445 1513
** Pharmaceutical Public Health Telephone 0141 201 4502
Further fridge magnets can be ordered from Primary Care Distribution Centres.
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4.11.2 GG&C Equipment Guidance
Refrigerators
When purchasing a pharmaceutical refrigerator or a temperature recording device, we strongly recommend that you seek the advice of Public Health Pharmacy on 0141 201 4502 or the Pharmacy Distribution Centre. Often medical supplies wholesalers are unable to offer technical advice on such equipment and apparatus.
The dimensions, prices and specifications of equipment offered by suppliers can vary quite widely. As a rough guide, however, GG&C and PPSU have studied the evidence and believe that LEC, Labcold, Sanyo and Swan manufactured pharmacy refrigerators generally fulfil the guidelines for storage of vaccines. Details of equipment may be accessed on line or telephone the manufacturer or supplier for a catalogue. Early models of Electrolux pharmacy refrigerators MR60 and RA122H are not recommended for vaccine storage due to their slow adjustment to temperature variations although upgraded models DS300H and DS600H have an improved mechanism
We have compiled a Refrigerator Information Chart listing suitable models for guidance. This is by no means an exhaustive list and it should be noted that manufacturers are continually developing product ranges. This list is shown as Appendix1
The chart below gives a rough guide to the size and price of fridges and where they may be sited in a practice.
Typical Pharmacy fridge sizes and prices n.b. these are for guidance only
Typical Location-
size Dimensions
W/D/H (mm)
Capacity
litres
Number of
shelves
Price range
*Approximation only
Table top - small 380/500/660 35-60 2 £350
Under bench - medium
560/600/865 135-150 2-3 £450
Tall - large 595/ 910/1850
300-500 5-7 £850-£1800
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There are a variety of suppliers, it is not possible to supply an exhaustive list of these. However, the table below suggests a few examples. Check when ordering equipment if discounts may be applied.
Manufacturer/Supplier contact information
Manufacturer Supplier address details
Telephone Website
Sanyo Electric Co. Ltd. Scanfrost
Shoreline
Swan
Lec
Labcold
Vicarey Davidson & Co Surgical Instrument Makers, 30 Cumberland Street, Glasgow G5
0141 420 1778
n/a
Also
Lec Glen Dimplex Professional Appliances (for Lec Medical)
Stoney Lane, Prescot, Merseyside, L35 2XW
0871 222 5119
Fax 0871 222 9636
www.lec-medical.co.uk
Labcold
Wade Road Basingstoke
RG24 8FL
0870 300 1001
Email : [email protected]
Swan Robson Medical
01228 510044 www.robson-medical.com
Contractors may obtain NHSNSS contract prices quote Contract number A517560F when ordering equipment. N.B. prices quoted using this code are confidential NHSNSS contract prices and ex vat. Prices must not be discussed with any third party. Please check with supplier as not all suppliers may be able to apply a discount.
26
Thermometers
Recording pharmacy fridge temperature readings TWICE daily may not seem to be of much importance at the time, but, when a fridge incident occurs, this information is the deciding factor as to whether a vaccine can safely be used. Spending a couple of minutes each day to record minimum, maximum and current temperatures could save thousands of pounds when you cost the value of stock stored in your fridges. A designated person should be responsible for taking these readings. This person should also be trained and confident in using the thermometer and be aware of the actions to be taken if the temperature falls outwith the recommended 2°C to 8°C range. Records of daily temperature readings should then be reviewed on a monthly basis to check for ‘drift’ in temperatures. This may highlight failing equipment or the need to reset thermostats.
The fridges we recommend will have an integral thermometer, however, we realise that for various reasons a thermometer to monitor a fridge’s temperature may need to be purchased separately. We recommend a digital thermometer with a min/max reading that has an inbuilt alarm. Attached to the thermometer is a probe that is sealed in a small bottle of non-toxic glycol solution. This allows the thermometer to record the product temp, not the fridge air temp. This provides a more accurate reading reflecting the temperature of stored vaccine rather than the air temperature of the fridge. Suppliers of the: Traceable Memory Monitoring Refrigerator/Freezer Thermometer are shown below. Please note these thermometers include a 2 year calibration certificate which indicates an expiry date at which point the accuracy will no longer be guaranteed.
Instructions for the Traceable Memory Monitoring Thermometer (Model 10368) recommended by NHS Greater Glasgow and Clyde
There are two ways to reset the Max/Min memories:
1. Reset both memories – Press (MEMORY CLEAR) button once.
2. Reset individual Max or Min memories – Press either (MAX) button or (MIN) button once to reset the respective memory. The other memory will be unaffected
NOTE: - Resetting a memory will result in current temperature being displayed in the max or min memory display
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Suppliers of the recommended thermometer
Manufacturer Supplier contact details Order number
Approximate Price
Fisher Price (Healthcare Logistics US)
Vicarey Davidson & Co Surgical Instrument Makers,
30 Cumberland Street, Glasgow G5
Tel 0141 420 1778
Item code 10368
£49.99 + vat
Carriage £3.95
Fisher Price (Healthcare Logistics US)
Distinctive Medical Products
3 Seymour Court
Runcorn, Cheshire, WA7 1PT
Tel 0800 525076 or 01928 571 801
Fax 0800 590014 or 01928 571430
Item code
10368
£56.50 +vat
Carriage £8.00
Contractors may obtain NHSNSS contract prices quote Contract number A517560F when ordering equipment.
N.B. prices quoted using this code are confidential NHSNSS contract prices and ex vat. Prices must not be discussed with any third party. Please check with supplier as not all suppliers may be able to apply a discount.
Temperature monitoring apparatus (loggers)
Temperature “loggers” are available to monitor fridges continuously. Temperature information is downloaded into tailored software to allow preparation of a temperature history graph.
They should not be used to monitor the fridge temperature alone as they will usually only measure air temperature rather than the simulated vaccine temperature. However, they can be useful as they give an indication of how long a fridge has run outwith the approved temperature range and provide a better guide to decisions about whether vaccines may be used or destroyed.
Prices for these vary widely and may require the purchase of software to download and analyse data onto a laptop or PC. In particular those which monitor simulated vaccine temperature may be very expensive. The table below gives examples of some devices available, these measure ambient air temperature only.
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There are more available such as Comark®, Testo® and ETI®. Contact the Public Health pharmacist for further guidance on 0141 2014502. Manufacturer Supplier contact details Order
number Approximate
Price Thermadata®
Vicarey Davidson & Co Surgical Instrument Makers, 30 Cumberland Street, Glasgow G5 Tel 0141 420 1778
Item code 296-501 Software 299-801
£100 + vat (Additional probe model£110) Carriage £3.95 £40 + vat Carriage £3.95
Lec USB Data logger (same as EL USB-1)
Glen Dimplex Professional Appliances (for Lec Medical)
Stoney Lane, Prescot, Merseyside,
L35 2XW
www.lec-medical.co.uk
Tel 0844 815 3755 Fax 0844 815 3748
n/a
£39 NHS price (Includes software and carriage)
EL USB-1 (same as LEC)
Omni Instruments
www.omniinstruments.co.uk
Tel 08700 434040
n/a
£35 +VAT Carriage £10 (software included)
Ice Spy® (MR model)
www.icespy.com
e-mail [email protected]
Tel 01872 266329
n/a £83 Software pack £55
Contractors may obtain NHSNSS contract prices quote Contract number A517560F when ordering equipment.
N.B. prices quoted using this code are confidential NHSNSS contract prices and ex vat. Prices must not be discussed with any third party. Please check with supplier as not all suppliers may be able to apply a discount.
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Vaccine transport
Cool boxes must be of the required certificated standard to maintain the cold chain and manufacturers can advise on the validation and appropriate use of these. Vicarey Davidson & Co Surgical Instrument Makers, 30 Cumberland Street, Glasgow G5, Tel 0141 420 1778 can advise on models currently available The Clinimed website is http://www.clinimed.co.uk/cl/products/UK/Porters/vaccine-porter.htm.
Large cool boxes (e.g. Vaccine Porters) are not normally practical for GP practices since they take up a lot of space and require several shelves of fridge space to store the cool packs prior to their use. Health and Safety require 2 persons to carry the Vaccine Porter 24.
Smaller cool boxes (e.g. Mini Vaccine Porters) are available for transport of up to 10 vials of vaccine and are normally suitable for GP Practices e.g. domiciliary visits. It should be noted that the cool pack used in this box must be frozen prior to use rather than chilled. Recent developments include a coolbox which may be plugged into a car power point. The LABCOLD Pharmacy Transporter costs about £280 and is currently being assessed by GG&C Quality Assurance teams. Contact Pharmacy Public Health 0141201 4502 for further advice.
Comparison Chart Vaccine Porters Vaccine Porter Order
code Available product
space (mm) Price Number and
type of Packs
Required each
Validated with multiple openings for
Mini Vaccine Porter including one MC11pack
UMP911
210x115x30 £29.36 1XMC11
(frozen)
18 hours
Vaccine Porter 6 UVP-310 108 x 108 x 130 £60.00 6xMC28 8 hours
Vaccine Porter 9 UVP-330 144 x 144 x 105 £75.00 6XMC28
8 hours
Vaccine Porter 16 UVP-350 254 x 199 x 120 £98.00 14xMC28 8 hours
Vaccine Porter 24 UVP-370 250 x 250 x 135 £89 8XMC3 8 hours
Medicool 28 (MC28)
UMC-530 Spare MC28 packs £36.00 18 n/a
Prices quoted are for example and discounts for multiple purchases may be applied.
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Guidance and Procedures for Use of Mini Vaccine Porters
Mini Vaccine Porters, correctly prepared, are validated to maintain the interior temperature at 2° to 8°C for 18 hours with multiple openings and may be used to transport up to 10 vials.
The vaccine ‘cold chain’ can thus be maintained from surgery to patient in domiciliary visits. In such situations use of the vaccine porter enables any unused vaccine to be returned to the surgery refrigerator. This removes concerns about ‘time out of fridge’ and the requirement to ‘Use First’.
Therefore Mini Vaccine Porters should be used for all transport of vaccines from a surgery to a domiciliary situation. The only requirement for the accredited operation of a Mini Vaccine Porter is access to a refrigerator with a full freezer compartment as the MC11 MEDICOOL COOLPACK pack used to ensure temperature maintenance must be frozen and not simply chilled
As the normal cycle of use would be encompassed within the eight hour working day the performance of the Mini Vaccine Porter is more than adequate for most applications. However, it is good practice to return all vaccines, thus transported, back to the main holding refrigerator on the same day as they were issued. Leaving vaccines overnight in the Mini Vaccine Porter should be avoided.
Procedure for using the Mini Vaccine Porter:-
The Mini Vaccine Porter is comprised of
1. an outer carrying case
2. an inner polystyrene insulated box and lid
3. a MEDICOOL MC11 coolpack (to be frozen ) and
4. a spacer/protection mat (to be chilled)
As it takes 24 hours to prepare the coolpack and the mat, each Mini Vaccine Porter can only be used on alternate days. If transporting ability is needed daily then each user will need two porters.
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1. Freeze the MC11 Medicool Coolpack for at least 24 hours at -18° C. This temperature can be achieved in the freezer or ‘ice cube’ compartment of a refrigerator and may be confirmed by placing a maximum/minimum thermometer in the freezer compartment for a few hours.
2. Chill the spacer/protection mat at +5° for at least 24 hours. This can be achieved in the main storage area of a refrigerator.
3. Remove the Medicool unit from the freezer 20 minutes before needed. It is important that this unit is not taken directly from the freezer and placed in the insulated box.
4. Firstly, place the vaccine to be transported in the bottom of the insulated box.
5. Secondly, place the spacer/protection mat directly on top of the vaccine.
6. Thirdly, place the Medicool Coolpack on top of the spacer/protection mat.
7. Finally, replace the insulated lid and close the flap of the outer carrying case.
The porter is now ready for use and is validated for 18 hours with multiple openings. Upon return to base at the end of the day the cooling units should be returned to their respective areas of the refrigerator to be recharged for subsequent use.
If more than one Mini Porter is being operated from one refrigerator it is good practice to mark the time that each cooling unit is returned to the refrigerator thus ensuring that properly prepared mats and Medicools are being used.
N.B The MC11 MEDICOOL COOLPACK for the Mini Vaccine Porter requires to be frozen prior to use. Larger vaccine porters use different cool packs which require refrigeration prior to use. Please ascertain carefully which system you are using prior to use and read the manufacturers instructions.
For further information about preparing vaccine porters and the vaccine mini porter please go to http://www.clinimed.co.uk/blood-vaccine-porters/vaccine-porters/how-to-use.aspx
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4.11.3 GG&C Temperature Monitoring Log and Guidance NHS Greater Glasgow & Clyde Fridge Temperature Monitoring Log Best practice recommendations
• Record temperatures first thing in the morning and towards end of day. • Record an entry in each column. • Ensure others are trained to perform the task and cover staff absences. • Reset thermometer after every reading. The maximum temperature setting
within the thermometer responds immediately to any rise in actual temperature. Therefore, even if >8ºC for a few seconds the maximum temperature is recorded until the next time the thermometer is re-set.
• Following removal of vaccine from the fridge or receipt of fresh stock, read the current temperature. If it reads above 8ºC record temperature, time and reason in comments column. Repeat procedure 30mins later and record results. If current temperature has not returned to normal (2-8ºC) seek further advice*.
• Monthly review of fridge temperature charts should be undertaken. This can highlight temperature ‘drift’ which may indicate that a fridges temperature control is beginning to become less reliable. This is important for all fridges but particularly for aging models. The temperature chart should be signed after monthly review has been completed to audit compliance.
When to contact Vaccine Holding Centres for further advice* • A current temperature reading above 8ºC which has not corrected within 1
hour. • A maximum temperature reading above 8ºC when the refrigerator has not been
opened. • Any temperature reading below 2ºC. • Any identical Min/Max/Actual reading (readings are sometimes. identical if the
fridge has not been opened but should be in the range 2-4ºC). Any higher indicates that the thermostat should be lowered slightly –refer to manual.
• A temp greater than 8ºC at routine monitoring at start or end of day. Action for potentially hot/cold damaged stock • Quarantine stock. Place the vaccine within a sealed bag labeled “DO NOT USE
QUARANTINED” with date/ time and transfer to a back-up fridge which has been monitored for temperature efficiency.
• Record Min/Max/Actual readings immediately on identification of incident • Seek further advice as soon as possible*. The holding centre will require details of
recent temperature readings. • Ensure sufficient non-quarantined vaccine remains available. Order if necessary. *Further advice available from: Pharmacy Distribution Centre, Dava Street, Moorpark Central, Govan, Glasgow, G51 2JA Tel: 0141 347 8981 Fax: 0141 445 1513 Pharmaceutical Public Health PH Pharmacist (Immunisation) Tel: 0141 201 4502 Further copies of these charts available from Primary Care Distribution Centres, Glasgow Tel: 0141 427 8246, Fax: 0141 427 8270 or Clyde Tel: 0141 314 4179, Fax: 0141 884 5296.
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Date fridge first installed…………………………………….
Location of fridge………………………………………………… Month........... Year........... Any temperature reading outwith 2-8ºC must be investigated and discussed with holding centre (contact numbers as shown below).
• Record Minimum, Maximum and Actual temperatures TWICE DAILY each working day. Reset thermometer after reading.
• Give full details of action taken in comments section.
Date Time Max Min Actual
(present)
when thermometer reset ( after each reading )
Initials Comments when temp range exceeded
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
Monthly review of record conducted by (Name)……………………………………………………
Signature………………………………………………… Date………………………...
*Further advice available from: Pharmaceutical Public Health PH Pharmacist (Health Protection) Tel: 01412014502 Pharmacy Distribution Centre, Dava Street, Moorpark Central, Govan, Glasgow, G51 2JA Tel: 01413478981
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4.11.4 Vaccine Refrigerator Incident Checklist
Please ensure affected vaccines are kept in quarantine, in a monitored refrigerator, until a decision is reached regarding suitability for use and fill out the Vaccine Refrigerator Incident Form (Appendix 2) for reporting to the PDC.
Important details required include:
• Clinic/Practice Name and Address
• Contact Name and Phone Number
• Refrigerator affected (ID and Location)
• Background to the incident
• Maximum (or Minimum) Temperature Vaccine Reached
• Length of time vaccines exposed
• When were the correct temperatures last recorded
• Copy of Temperature Recording sheets for preceding month
• Details of any affected vaccines used for immunisation during period of malfunctioning:
• Details of affected vaccines (type, manufacturer, batch number, quantity, expiry dates
If an incident has occurred this may provide an opportunity to review your current procedures and undertake a self audit. Further information and support in these is available from the Public Health Pharmacist telephone 0141 201 4502
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4.12 References
Department of Health (2006) Immunisation against Infectious Diseases (The Green Book) http://www.dh.gov.uk/en/Publichealth/Healthprotection/Immunisation/Greenbook/dh4097254
NHS HDL 2007-18 accessed February 2010 at http://www.sehd.scot.nhs.uk/mels/HDL2007_18.pdf
Summary of Product Characteristics for Pandemrix® and Celevac® accessed November 2009. http://emc.medicines.org.uk
Grampian Health Board July 2007. ‘Vaccine handling policy for clinics, hospitals, community pharmacies and GP practices’. accessed in November 2009 at. http://www.nhsgrampian.org/grampianfoi/files/Vaccine_Handling_July_07.pdf
World Health Organisation. ‘Temperature Sensitivity of Vaccines’ August 2006 accessed November 2009 at http://www.who.int/vaccines-documents/DocsPDF06/847.pdf
NHS HDL 2006-28 accessed February 2010 at http://www.sehd.scot.nhs.uk/details.asp?PublicationID=1892
Appendix 1. Refrigerator Information Guide The following manufacturers are recommended as the refrigerators meet all the specification criteria listed below:-
• Operational temperature +2°C to +8°C • Forced air cooling – interior fan for temperature stability and rapid temperature recovery after door openings. • Door lock • CFC, HCFC and Ammonia free • Auto-defrost function • Efficient operation at high ambient temperatures • Integral thermometer which has a digital display recording actual and maximum/minimum temperatures *(apart from Sanyo models which only record actual
temperature an additional stand alone thermometer is required). • Thermometer has an integral high/low temperature alarm audio/visual **
Mains failure alarm, adjustable feet, castors and glass doors are options available – check with the supplier for individual refrigerators Make Model Dimensions
(H)x(W)x(D) Capacity Shelf Description Glass/Solid Door Thermometer/
Alarm Details Door Ajar Alarm
*Sanyo MPR 161D(H) 1090x800x450 158 litres Rigid wire with zinc plate finish
2 sliding doors – double pane glass As Above Yes
*Sanyo MPR 311D(H) 1800x800x450 340 litres Rigid wire with zinc plate finish
2 sliding doors – double pane glass As Above Yes
*Sanyo MPR 311DR(H 1800x800x450 340 litres Rigid wire with zinc plate finish
2 sliding doors – double pane glass As Above Yes
Labcold RLDG0505 820x600x600 150 litres 3 plastic coated wire mesh Glass, hinged As Above No Labcold RLDF1804 1775x760x720 490 litres 6 plastic coated wire mesh Solid, hinged As Above No Labcold RLDF02041 572x485x535 60 litres 2 plastic coated wire mesh Solid, hinged As Above No LEC PG207 660x502x540 67 litres 2 wire mesh plus 1 wire
drawer Glass, hinged As Above No
LEC PE507 863x558x600 137 litres 2 wire mesh plus 1 wire drawer
Solid, hinged As Above No
LEC PE907 1550x595x600 275 litres 5 wire mesh plus 1 wire drawer
Solid, hinged As Above No
LEC PE207 660x502x540 67 litres 2 wire mesh plus 1 wire drawer
Solid, hinged As Above No
Swan AWR-SW135 850x500x600 135 litres 3 wire Solid, hinged As Above No Swan AWR-SW160 850x600x600 160 litres 3 wire Solid, hinged As Above No **Swan AWR-SW165E 850x600x650 160 litres 2 wire Solid, hinged. Optional glass
available Optional display of high & low temperatures achieved
No
Swan AWRSW175HD 850x600x600 175 litres 3 wire Solid, hinged As Above No Shoreline SM150 855x550x600 150 litres 3 wire mesh Solid, hinged As Above No Scanfrost CPH207 520x470x490 80 litres 1 wire mesh Solid, hinged As Above *audio only No
Appendix 2
NHS GREATER GLASGOW AND CLYDE
GENERAL PRACTITIONER VACCINE REQUISITION FORM
COMMUNITY SERVICE ORDER NO………….............. PHARMACY DISTRIBUTION CENTRE DAVA STREET EXPECTED DATE OF DELIVERY…………………… GOVAN GLASGOW G51 DATE OF CLINIC………………………………………. TEL (0141) 347 8981 FAX (0141) 445 1513
COMPLETE AND RETURN TWO COPIES, RETAINING BOTTOM COPY IN DEPARTMENT
CALL No’s
CODE
VACCINE ISSUE UNIT
REQ’D
SENT
STOCK IN PRACTICE*
GGS456A Hepatitis B 10mcg/0.5ml Vaccine (Paed ) 1x0.5ML
GGT010C Meningococcal C Vaccine (Menjugatekit) 1x0.5ML
GGS682B Meningococcal C Vaccine (Menjingitec) 10x0.5ML
GGS656A Measles Mumps Rubella Priv (Priorix) Single
GGT059E Measles Mumps Rubella MMR (Vaxpro) Single
GGT575E Vaccine dTaP IPV (Repevax) Single
GGT576E Vaccine DTaP HIB IPV (pediacel) Single
GGS665A Vaccine DTaP + IPV (Infanrix IPV) Single
GGT511B Haemophilus B/Menc (Menitorix) Single
GGS951A Pneumococcal Vaccine (Prevenar) 10x0.5ML
ALL VACCINES MUST BE REFRIGERATED
PRACTICE NAME and ADDRESS.………………………………………………………………………………..
TELEPHONE No …………………………………………………………………………………………………….
CLINIC/HEALTH CENTRE for DELIVRY …………………………………………………………………………
ORDER AUTHORISED BY …………………………………………………………………………………………
DISPENSED BY ……………………………………………..DATE ………………………………………………
CHECKED BY ………………………………………………..DATE ………………………………………………
TICK FOR NEW ORDER FROMS □
PDC Fax No: 0141-445-1513 Incident Ref No:
Vaccine Refrigerator Incident Form Please ensure affected vaccines are kept in quarantine, within a monitored fridge, until a decision is reached regarding suitability for use. Ensure you have sufficient alternative stock for your immediate needs.
PRACTICE DETAILS
GP Name & Practice No:……………………………………………………………………………………………………..
Practice Name:…………………………………………………………………………………………………………………
Address:………………………………………………………………………………………………………………………..
Contact Name: …………………………………………………………………………………………………………………
Phone Number:………………………………………………………………………………………………………………..
Date and Time:…………………………………………………………………………………………………………………
INCIDENT DETAILS
Refrigerator affected (ID and Location): ..………………………………………………………………………..………
Background details of incident:…………………………………………………….………………………….…………..
…………………………………………………………………………………………….………………………………….…..
……………………………………………………………………………………………………………………………..……..
…………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………….
Maximum or Minimum temperature vaccine reached:……………………..…..…………………………..………...
Length of time vaccines exposed:………………..….….………………………………………...……………..………..
Correct temperatures last recorded: Date:……………..…..….…………………………..………..
Time:…………..…….….…………………..………………..
Affected vaccines quarantined in monitored fridge: Date:................................................................................
Time:……………………….………………………………...
Copy of preceding 1 month temperature record faxed □ (attach faxed copy)
Details of any affected vaccines used for immunisation during period of malfunctioning:
…………………………………………………………………………………………………………..………………………..
…………………………………………………………………………………………………..………………………………..
……………………………………………………………………………………………….……….…………………………..
FOR PHARMACY DISTRIBUTION CENTRE USE ONLY
Enquiry Origin: Answer Method Actual Time Taken Category
GP/PN Telephone advice < 1 hour Fridge Power failure in hours
HV E-mail 1 – 3 hours Fridge Power failure out of hours
Practice Manager Fax >3 hours Thermometer failure
Child/School Health Not Answered Not Answered Poor monitoring practice
Other (specify) Other (specify) Other (specify)
PDC Fax No: 0141-445-1513 Incident Ref No:
Practice to complete columns 1, 2, 3 and 4 of the table below in block capitals, providing details of all vaccines affected.
When completed please fax this form back to the Pharmacy Distribution Centre along with last month’s practice temperature records.
AFFECTED VACCINE DETAILS
1 2 3 4 5 6
Vaccine Name Manufacturer and Batch Number ………………………………………….. Quantity Expiry Date Stability Check Outcome
NAME…………………………………………………………………………. DESIGNATION………………………………………………………………… DATE……………………………………..
PDC Fax No: 0141-445-1513 Incident Ref No:
Appendix 4 Vaccine Return Form
Returned by: Date: GP Name: Ascribe/Practice No: GP Address: Reason for Return: Comments:
Vaccine Name Batch Number Quantity
PLEASE ATTACH TO VACCINES RETURNING FOR DESTRUCTION
