NHS England (West Midlands) POLICY FOR ORDERING, STORING AND HANDLING VACCINES

Transcription

1 NHS England (West Midlands) POLICY FOR ORDERING, STORING AND HANDLING VACCINES Coventry, Warwickshire, Herefordshire, Worcestershire Birmingham, Dudley Sandwell, Solihull, Walsall & Wolverhampton (Version 1.2 June 2016)

2 Version V2.0 June 2016 Policy Author Designation Target Audience Approved By: Designation Karen Marley Screening & Immunisation Coordinator Immunisation Providers Dr Ashis Banerjee Screening & Immunisation Lead Approval Date: 9/11/15 Review Date 9/11/17 Acknowledgements Name Dr Ash Banerjee Sue Bosworth Bronwen Spraggett Matthew Olley Screening & Immunisation Lead Screening & Immunisation Coordinator Screening & Immunisation Coordinator Public Health England Change History Version Number Change details Date V 1.1 New Cold Chain Policy 9/11/15 V 1.2 Change of Screening and Immunisation contact details. Review of PGD/PSD paragraph P a g e

3 Table of Contents 1 Background Ordering and Delivery Vaccine fridge Temperature Monitoring Cold chain maintenance off site (e.g.: schools, patients home) Routine maintenance of equipment Stock control Audit Cold Chain Incidents reporting and initial management Additional sources of information References Appendix 1: Monitoring Refridgerator Performance & Recording Temperatures (Specimen Standard Operating Procedure). 25 Appendix 2: A sample fridge temperature record chart Appendix 3: Incident check list.. 27 Appendix 4: Cold Chain Incident Investigation Form Appendix 5: Off label vaccine information for patients Appendix 6: Sample Vaccine Storage and Handling Self Audit Tool P a g e

4 1 Background 1.1 Introduction Vaccines are biological products affected by changes in the environmental temperature. The cold chain is the system of transporting and storing vaccines within the recommended temperature range of +2 C to +8 C from the place of manufacture to the point of administration to a patient (Nayda, et al, 2001). Heat speeds up the decline in potency of most vaccines. Vaccines must never be frozen. This causes deterioration of vaccines and may give rise to a loss of potency and an increased reactogenicity by: irreversibly denaturing the proteins in the vaccine and causing the emulsions in the vaccines to become unstable producing hairline cracks in the ampoule/vial/pre-filled syringe, potentially contaminating the contents. The glass spicules (small sharp pointed fragments) produced may also cause serious local adverse reactions (DH 2013) 1.2 Implications of poor vaccine storage For the patient poorly stored vaccines can lead to: individuals being left unnecessarily unprotected against potentially serious diseases increased adverse effects For the immunisation provider and the wider programme, it can lead to: loss in public confidence in immunisation programmes vaccine wastage leading to financial loss and pressure on limited vaccine supplies reputational loss to immunisation providers Increased workload to immunisation providers e.g. extra workload from reimmunisation and resources required for a look-back exercises. This is where an immunisation provider has to individually inform and manage all patients who have inadvertently received vaccines involved in a cold chain breach. 4 P a g e

5 1.3 Aims and Objectives The aims of this policy are to: reduce the number of preventable cold chain incidents minimise clinical adverse effects from the use of poorly stored vaccines e.g. loss in potency, increased risk of side effects minimise vaccine wastage and financial loss maintain the reputation of immunisation services The objectives of this policy are to provide best practice guidance on the ordering, storage and handling of vaccines set out procedures and protocols for reporting and initial management of cold chain incidents provide templates and protocols that can be used by immunisation providers 1.4 Scope This policy is relevant to all those with a role in the delivery of NHS England commissioned immunisation services in Coventry, Warwickshire, Herefordshire, Worcestershire, Birmingham, Dudley, Sandwell, Solihull, Walsall and Wolverhampton. This includes GP Practices, Community Immunisation Teams working in schools and Community Pharmacies. 5 P a g e

6 2 Ordering and Delivery 2.1 Responsibilities There should be at least two named individuals, one should be a qualified immuniser, and one should be from the administration/management team, with overall responsibility for handling and storage of vaccines. They should: ensure vaccines are stored in a fridge promptly after delivery and that there is maintenance of the cold chain at all stages understand the need for stock control and careful stock rotation using those vaccines with the shortest expiry dates first be responsible for ensuring there is regular recording of temperatures throughout the cold chain process ensure that damaged or out of date vaccines and vaccine related healthcare waste are disposed of appropriately (DH, 2013) The immuniser is responsible for checking vaccines meet with the manufacturer s recommendations for storage before administering the vaccine. 2.2 Receipt of Vaccine Stock Vaccines should be refrigerated immediately on receipt and should not be left at room temperature. Reception staff must be aware of the importance of ensuring that vaccines are handed over to the responsible individual or their deputy when they are delivered and know what action to take if those persons are unavailable. On receipt of vaccines, staff should check them against the order for discrepancies and leakage or damage before signing for them. Pharmaceutical distributors and manufacturers will not accept any vaccine for return once it has left their control. Vaccines must be unpacked from the outer cardboard box or paper/plastic delivery bag, to enable air circulation in the refrigerator. However vaccines must be kept in the original single or multi vaccine packaging and placed in the designated fridge immediately. The vaccines should be recorded on a stock inventory. It is the responsibility of the named individuals to ensure there is adequate recording of stock ordering and receipt of vaccines. 6 P a g e

7 2.3 Requirements of Storage Storage requirements are described in the manufacturers Summaries of Product Characteristics (SPCs) it usually states storage at +2 C to +8 C and protected from light. The SPC can be accessed on line at as well as within the vaccine packaging. Any vaccine not stored in line with SPC requirements is an unlicensed product which cannot be given under a PGD. All clinical liability for its use transfers to the prescriber. Before vaccine administration, the SPC should be reviewed to check if the vaccine can be used directly from the fridge or needs to be at room temperature before administration. The vaccine s original packaging has details of expiry dates and batch numbers printed on them and protects the vaccine from light and damage. Expired vaccine should not be used. All vaccines have a predetermined shelf life. The expiry date is dependent upon the vaccine being stored in the correct manner and maintenance of the cold chain throughout the shelf life of the product. Care should be taken to ensure that vaccines are checked for leakage or other damage before use. 7 P a g e

8 3 Vaccine fridge 3.1 Use of a validated vaccine fridges All Immunisation Providers should use a validated vaccine fridge domestic fridges are not suitable for storing vaccines. Domestic fridges are designed to run at temperatures between 0 C & 10 C and the temperature takes much longer to recover once the door has been opened. Domestic fridges not have the same powerful internal fans as used in vaccine fridges. A validated vaccine fridge is one that is: Suitable for the storage of vaccines between +2 and +8 C, a mid-range of +5 C is good practice. Locked or kept in a locked room - all vaccines are Prescription Only Medicines (POMs) and must be stored under locked conditions. Used only to store vaccines and medicines, i.e. food or specimens must not be stored alongside vaccines. Large enough to hold the stock and allow sufficient space around the vaccine packages for air to circulate; o The fridge is the right size to meet the vaccination storage needs, and there is sufficient capacity for vaccines for seasonal/ additional programmes such as the annual influenza vaccination campaign. o Within the refrigerator there should be sufficient space around the packages to enable air to circulate. Check with your vaccine fridge manufacturer who will advise requirements for your particular fridge. o Vaccine packages should not touch the fridge walls/floor. o Do not store vaccines in the fridge door, or on solid base / sided baskets or on the bottom of the fridge floor. Only wire mesh baskets should be used to store vaccine. Contact your vaccine fridge manufacturer for further information. o Ensure vaccines do not have direct contact with frozen ice packs when using validated cool boxes / bags for transporting vaccines. Steps must been taken to reduce the probability of accidental interruption of electricity supply, such as installing a switchless socket or clearly labelling the vaccine refrigerator plug. This is a very common cause of cold chain incidents. Warning stickers are available free of charge from the DH. Safe for example, by carrying out visual inspections and PAT testing. 8 P a g e

9 In addition each vaccine fridge should meet the following requirements: All fridges must have a unique identifier, such as a serial number. The temperature gauge should be clearly visible to read without needing to open the fridge door. The fridge is placed in a suitable position - ventilated and away from heat sources or direct sunlight. To help maintain optimum temperature, the fridge should only be opened when absolutely necessary, and the door should be opened for as short a period as possible. Regular checks should be undertaken to ensure ice is not building up in the fridge. A regular defrost procedure is required. During defrosting maintenance vaccines should be stored temporarily in a suitable alternative fridge or in a validated medical-grade cool box, but for the minimum possible time and with temperature monitoring during de-frosting procedure. The fridge is maintained in a clean condition. Consider back-up facilities to be available in the event of the fridge failing or breaking down. 3.2 Thermometers All fridges should ideally have two thermometers, one of which must be a max/min thermometer independent of mains power, (so that the temperature can be recorded in the event of a power failure), and the service is alerted quickly if one thermometer is malfunctioning. Alarmed digital minimum / maximum thermometers are the most reliable. If only one thermometer is used, then a monthly check should be considered to confirm that the calibration is accurate. The internal and independent maximum-minimum thermometers of the fridge should be professionally calibrated at least annually to confirm that it is giving accurate readings. The Green Book pg. 28 states there is a maintenance contract that allows for at least yearly servicing and calibration of the temperature gauge. Care should be taken that the thermometer probe cable does not interfere with the door seal, causing the temperature to fall outside the permitted range. A data logger can be used as a secondary thermometer but only if it is independent of the mains power. Some vaccine fridges have data loggers as the primary integral fridge thermometer but these may not be independent of the power supply and therefore not function if the power is disrupted. 9 P a g e

10 3.3 Data loggers More sophisticated temperature-recording devices are now available such as data loggers. These can be set to record the fridge temperature every 1 to 15 minutes and can be valuable at assessing temperature ranges when for example the fridge has been open and closed regularly during a busy vaccination clinic. The information may be useful in assessing if vaccines involved in a cold chain breach are still safe and effective to use, even though they are unlicensed products. However they should not replace the daily recording chart. 10 P a g e

11 4 Temperature Monitoring One of the two nominated individuals is required to read and record the maximum, minimum and current temperature on each working day (see appendix 2 for example of temperature monitoring sheet). The thermometer must be reset after each reading. If you are unsure how to do this refer to the fridge manufacturers instruction booklet are contact the manufacturer. If both the named person and their deputy are unavailable it is their responsibility to ensure a suitably trained individual continues the process in their absence. It is good practice for practitioners to check the temperature record sheet when removing vaccine from the fridge, as they are also responsible for ensuring the vaccine they are about to administer, has been stored within the cold chain. For Nurses the Nursing and Midwifery Council (NMC) guidance - standards for medicine management: standard 6: storage pg. 22 states Registrants must ensure all medicinal products are stored in accordance with the patient information leaflet, summary of product characteristics document found in dispensed UK-licensed medication and in accordance with any instruction on the label Use of vaccines stored outside the SPC temperature requirements is not supported by PGD s. Practitioners do not need to record anything on the temperature record sheet each time stock is removed Vaccines should not be administered if they have been stored outside the cold chain requirements and further advice must be sought from NHS England (West Midlands) via your local immunisation line address. It is good practice to record the temperature at a similar time each day e.g. first thing in the morning before the fridge door is opened for the first time. It is also necessary to record any activity which may affect the temperatures recorded e.g. tidying, restocking, cleaning, defrosting at the time it takes place. During these processes the door should be regularly closed to allow the temperature to be maintained within the cold chain parameters. The following information MUST be recorded every working day: o Date and Time temp recordings taken o Current, Minimum and Maximum Temperature o Record that the thermometer has been reset o Identify the person who has taken the recording 11 P a g e

12 o Additional comments e.g. if the temperature has breached what action was taken, how long was the breach etc. If the recorded temperature (maximum, minimum or current) is outside 2 C to 8 C range then the recorder must ACT immediately. The temperature monitoring sheets / book for each fridge should be readily accessible, and clearly labelled so that it is easy to determine which record relates to which fridge (when a practice has more than one vaccine fridge). The temperature record will be inspected by the nominated person, or deputy, weekly and action will be taken as necessary if there have been any undue variations in temperature. The records should be readily accessible, be retained for at least one year, and cover the full storage history of any products contained in the fridge. As vaccine shelf lives specified by vaccine manufacturers can be up to four years or longer, retaining records for five years will generally enable the full storage history of the vaccines be accounted for. ( Table 1: Summary of temperature monitoring requirements Read: Daily reading of the thermometer s maximum, minimum and current temperatures at the same time every day during the working week. Record: recording temperatures in a standard fashion and on a standard form, including signing each entry on the recording sheet. Reset: resetting the thermometer after each reading. The thermometers should also be reset when temperatures have stabilized after periods of high activity. React: the person making the recording should take action if the temperature falls outside +2 C to +8 C and document this action. 12 P a g e

13 5 Cold chain maintenance off site (e.g.: schools, patients home) 5.1 Cool boxes and portable fridges The cold chain should continue to be maintained when vaccinations are administered or stored off site for example in school immunisation sessions, nursing homes and patients homes. A validated cool box or a validated portable vaccine fridge should be used for off site immunisation sessions. If using a portable vaccine fridge, it needs to be plugged into the cars auxiliary 12V socket (formally cigarette lighter) during transport and plugged back into the mains as soon as they reach the vaccination site. Care should be taken to ensure the fridge remains set at the correct temperature throughout transport, and the immunisation session, as some of the older models can be easily be accidentally knocked, which can alter the temperature considerably. If using validated cool boxes: Use a validated medical grade cool box and cool packs. Monitor max/min temperature while the box is in use: o Portable digital thermometer recording min max temperatures for use with thermal bags/boxes and portable fridges (N.B. Portable devices do not necessarily have digital thermometers. Portable fridges have digital temperature settings but this is not the same as a digital thermometer). Keep vaccines in their original packaging. Take only enough vaccine for a particular session and minimise exposure of the vaccines to room temperatures. Mark vaccines removed for an external session before returning to the fridge and then use at the earliest opportunity. Choose appropriate sizes of cool box for the amount of vaccine needed. Most cool gel packs are now cooled by refrigeration rather than by pre-freezing, check with you manufacturer to ensure the packs are cooled as recommended. If using frozen gel packs, thermal dividers must be used to prevent the vaccine packaging coming into contact with the frozen gel pack. Excess space should be filled with insulating material / dividers such as polystyrene to minimise pockets of warm air around the vaccines. Vaccine packaging should not come into contact with any frozen ice or gel pack. 13 P a g e

14 5.2 Community protocol For community immunisation sessions, the vaccine should be logged out by the person removing them from the main storage fridge and the running total completed in the vaccine stock log. Steps should be taken to keep the vaccines within this temperature range for the duration of the vaccination session and transportation i.e. keep the lid in place as much as possible, keep away from sun or heat sources. The temperature of the portable fridge / thermal bag should be recorded prior to vaccines being placed in them to ensure the correct temperature. Further recording should be monitored on arrival and completion at the site and if applicable, at least 2 hourly during the vaccination session, to ensure the cold chain has been maintained. It is best practice that following the immunisation session, any unused vaccines should be returned to the fridge and the packaging should be clearly marked with the date and time of its return and place it at the front of the fridge so it is used first at the next session this should only be done with vaccines that have remained in the cold chain. /Protocol_for_ordering storing_and_handling_vaccines_march_2014.pdf 5.3 Collection of vaccines from pharmacies by patients. If the SPC of a specific vaccine says it must be stored between 2-8 C, patients or carers should not normally be asked to store vaccines at home in domestic fridges (as discussed earlier the cold chain cannot be guaranteed without monitoring and a dedicated vaccine fridge). It is best practice for the surgery to order the vaccine direct from the manufacturer/supplier and have it delivered to ensure the cold chain has been maintained. If the patient has collected and or stored the vaccine you have no evidence the vaccine has been stored correctly the vaccine could potentially be off licence Exceptionally patients or carers may be asked to transport and/or to store them for short periods of time. Should the need arise; advise appropriate storage and monitoring must be given to the patient/carer. Practitioners are responsible for ensuring the SPC guidelines on storage have been followed before administering, as discussed earlier : for nurses see NMC guidance- standards for medicine management: standard 6: storage; pg P a g e

15 6 Routine maintenance of equipment Records should be kept of regular visual checks, servicing, defrosting, cleaning, calibration and electrical (PAT) testing. All maintenance actions should be recorded on a log sheet, which should be kept with the vaccine fridge. It is good practice to keep the fridge s model instruction manual close to the fridge so that all staff can easily access the instructions. The fridge should be maintained in a clean condition. There should be a maintenance contract that allows for at least yearly professional servicing and professional calibration of temperature gauge. o The Electricity at Work Regulations (1989) requires electrical systems to be maintained, o DH requires a maintenance contract that allows for at least yearly servicing and calibration of the temperature gauge and fridge. o Calibration, PAT and service certifications and reports must be kept for the duration of the life of the fridge and be available for inspection should this be required, e.g. in a cold chain incident assessment. A routine vaccine management review should be performed quarterly by the nominated individual. When a new fridge has been installed or where a fridge has been moved it should be placed into the area where it will be used, ensuring that it is level, and left for 24 hours before switching it on, as tilting fridges can affect the location and hence performance of the coolant within the compressor. Where a fridge is switched on for the first time or after a prolonged period of time where it has been switched off, the fridge should be left to run for a period of time before it is used to store vaccines. There is no exact requirement stated by fridge manufacturers but good practice suggests that the fridge is run for 48 hours with twice daily checks of current, maximum and minimum temperature to ensure the unit is functioning correctly before it is used to store vaccines. When a fridge has been switched off for a short period to undertake defrosting or as a result of a brief interruption in power supply, the fridge temperature should be allowed to stabilise within the recommended range (+2 C to +8 C) after it has been switched on before being used to store vaccines. Please note even self-defrosting fridges can accumulate ice build-up so visually inspect your fridge regularly and read you vaccine fridge manual to ensure you are complying with its recommendations. 15 P a g e

16 7 Stock control The nominated individual is responsible for ensuring there is good stock management and monitoring of stock. Any system should: keep track of orders keep track of expiry dates, and Keep a running total of vaccines, including wastage. As a minimum, a paper-based record or simple spreadsheets could be used for stock management and monitoring. Stock information systems are most effective when updated immediately upon ordering and receipt of vaccines and at the end of clinical sessions where vaccines have been administered. Vaccines can have short expiry dates, so do not over-order or stockpile. Two to four weeks supply of vaccine at any one time is sufficient. Rotate stock so that those with the shortest expiry date are used first. Make regular checks to remove expired vaccines which should then be disposed of as per organisation policy. If large quantities of vaccine are required e.g. flu season, it may be necessary to increase the frequency of ordering, rather than the quantity ordered, to avoid receiving more than can be stored safely. 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 fridge. It is good practice to post a list of products stored in the fridge with a shelf location (as appropriate) on the outside of the door. This will minimise the amount of time the fridge door is open. For example it is good practice to arrange vaccines so that primary vaccines are separate to booster vaccines etc. As shelf lives specified by vaccine manufacturers can be up to four years or longer, retaining full storage history of any products contained in each fridge for five years will generally enable the full storage history of the vaccines be accounted for (Records Management NHS Code of Practice Part 2 (2nd Edition) page 46 pharmacy records - (NHS East of England Senior Pharmacy Managers Network 2008; Department of Health 2014) also page 48 Quality Control Documentation). 16 P a g e

17 8 Audit Every time a member of staff who is about to immunise, takes a vaccine out of the fridge, they are responsible for ensuring that that vaccine has been maintained within its licence, and so should visually check the temperature monitoring chart. Regular audits are also necessary to ensure procedures are being carried out effectively. The Department of Health also suggest: Every week : Fridge contents should be checked at least once to ensure no stock is out of date and there is adequate stock for upcoming immunisations Every Month: Vaccine stock should be audited and recorded 9 Cold Chain Incidents reporting and initial management 9.1 Introduction A cold chain incident is when the vaccine product licences requirements related to storage temperature is breached. Most SPCs require vaccines to be stored between +2 C and + 8 C, however some product licences allow limited exposure to higher temperatures - please refer to the SPC. Vaccines that have gone outside of the specified storage requirements should not be used without a risk assessment, based on a thorough understanding of the likely impact of the temperature variation on the effectiveness of the vaccine. Any use of vaccines that have deviated from recommended storage or transportation conditions is the responsibility of the user/ administrator. The risk assessment and decision to use the vaccine after it has been stored at an incorrect temperature must be made on a case-by-case basis. Consideration must be given to the level of evidence available regarding the stability of the vaccine outside the correct temperature range over the relevant duration of time. Users must ensure that they have sufficient information to make an informed assessment and decision. Vaccine manufacturer will be able to advice on the latest temperature stability. NHS England, Immunisation Coordinators will give further advice and the incident must be reported via your area immunisation enquiry address immediately. 17 P a g e

18 9.2 Action following identification of cold chain incident In the event of a power cut / fridge failure it is necessary to: a) Power supply failure Keep the vaccine fridge door closed until a rapid assessment of the situation has been undertaken and an action plan formed. Keeping the door closed will help to maintain the temperature. b) Fridge malfunction - transfer vaccine to back-up facilities ensuring cold chain is continuously maintained. The following check list provides a framework for the essential steps that should be taken in the event of a cold chain incident: 1) Quarantine the vaccine Quarantined vaccines should continue to be stored in the cold chain and neither used nor destroyed until advice has been obtained from the Immunisation Lead. Quarantined vaccines must be clearly labelled Quarantined Vaccine Do Not Use to prevent accidental administration. 2) Inform / report The nominated individual or their deputy should be informed and the incident reported to the local NHS England screening & Immunisation Team who will advise further action. NHS England West Midlands england.wmid-imms@nhs.net A note of any action taken or comments on temperatures outside the +2 C to +8 C range should be clearly made on the temperature recording log. For non NHS vaccine stock i.e. travel vaccine, flu vaccine which has been purchased by the practice - inform the insurance company if appropriate. 3) Investigate cause The cause should be immediately investigated and where possible the problem should be rectified. Reasons for readings being out of recommended range may include: door being left open re-stocking defrosting unplugging of fridge from power socket or other loss of power malfunction or failure of the fridge or thermometer Ice build-up on the fridge or probe. 18 P a g e

19 4) Gather evidence for risk assessment (see appendix 3 for check list) Assess the period of time the products have been exposed to temperature out with recommended range. Record details of products that are affected; vaccine name, batch numbers, expiry dates, quantity. Order history is necessary to determine frequency of vaccine turn over. Check for physical evidence was there any ice build-up in the fridge; was the vaccine packaging damaged / soggy / waxy; was the fridge over loaded. Contact the vaccine manufacturers with all the temperature data (Including details of previous fluctuations in temperatures) and ask two separate questions: o Is the product licence still applicable for the particular vaccines affected? o Does the manufacturer have any evidence that the vaccines are still safe and effective to use? o For each vaccine the response may be: Vaccine still in license and safe/effective to use Vaccine now unlicensed and not safe/effective to use Vaccine now unlicensed and safe/effective to use Vaccine now unlicensed and no evidence available on safety/effectiveness following this incident o Forward responses to address: england.wmid-imms@nhs.net Send a copy of last fridge & thermometer calibration certificate and service engineers report to NHS England via your local Imms enquiry line address (above). If vaccines have been administered to patients, identify approximately how many patients have been affected. Patients may need to be contacted to either offer re-vaccination or to be informed that they have received off licence vaccine, however the Screening & immunisation Lead (SIL) will conduct a risk assessment. In order to prevent unnecessary worry to the patients and potentially risk damaging the reputation of the immunisation programme do not contact patients until this risk assessment has been completed and the SIM has discussed with the practice 5) Restock 19 P a g e

20 Assess implications for loss of stock and arrange for further supplies to meet immediate clinical need if reliable vaccine fridge available, this will prevent delay in the immunisation programme. If you require an out of schedule delivery of replacement vaccines Immform will also ask you to fax ( ) or with your Fridge temperature record chart. 6) Prevent Ensure action is taken to prevent/reduce risk of recurrence of problem. If applicable assess training needs of staff and re-evaluate practice procedures. 7) Document Document all action; complete incident form (See Appendix 4) and send copy to NHS England (West midlands) via your local imms enquiry line address. If patients have been immunised with out of licence vaccine, this must be documented on the patients medical records and if applicable (0-18 yrs.) on Child Health Information System (CHIS). IMMform will also require information of vaccine stock wasted (see section 7.3). 9.3 Off- licence & off label vaccine A marketing authorisation or product licence defines a medicine s terms of use: its SPC outlines, among other things, the indications, recommended doses, contraindications, and special warnings and precautions for use on which the licence is based, and it is in line with such use that the benefits of the medicine have been judged to outweigh the potential risks. Furthermore, a licensed medicine: has been assessed for efficacy, safety, and quality; has been manufactured to appropriate quality standards; and when placed on the market is accompanied by appropriate product information and labelling (MHRA 2009). Any vaccine that has not been stored at 2 0 C to 8 0 C is no longer a licensed product unless the SPC specifically allows time limited storage outside this range. The vaccine may still be safe and effective to use but liability rests with the immuniser rather than the manufacturer. General practices will not be able to administer Off Label or unlicensed vaccines via the national NHS England patient group directions (PGDs). Off label or unlicensed vaccines should be administered under a patient specific direct (PSD). The NMC advises nursing professionals that as a registrant, you should be satisfied that you have sufficient information to administer a medicine prescribed off-label safely and, wherever possible, that there is acceptable published evidence for the use of that product for the intended indication. With regards to accountability, all registered nurses and midwives are bound by The Code: Standards of conduct, performance and ethics for nurses and midwives which states that as a 20 P a g e

21 professional, you are personally accountable for actions and omissions in your practice and must always be able to justify your decisions. It is important therefore that vaccines involved in a cold chain incident are quarantined and are not administered until the results of the risk assessment by the Screening & Immunisation Team is available. A patient leaflet is available in Appendix Reporting wastages If, following a cold chain incident risk assessment it is decided that the vaccine is not safe/effective to use, the Department of Health (DH) must be informed of those vaccines that require disposing of. The DH records details of vaccine wastages and other stock incidents. In cases where there is a need to dispose of vaccines please fill in the Stock Incident Capture form on Immform (see the Green Book or Immform Help sheet 18 for details). A copy of this information is also required by NHS England (West Midlands) Screening & Immunisation team. 9.5 Expired vaccines Any out-of-date stock should be clearly labelled, removed from the fridge immediately and disposed of according with Health Technical Memorandum (HTM) Safe management of healthcare waste and where applicable to local policy. Vaccines must never be used past their expiry date. If this does occur, expert advice should be sought and it should be reported to england.wmids-imms@nhs.net immediately, using the immunisation enquiry procedure it is often necessary to re-administer the vaccine dose. The screening & immunisation lead will be able to provide or direct to the relevant expert advice please your local imms enquiry line address. 21 P a g e

22 10 Additional sources of information Immunisation and vaccine information and schedules are getting more complicated and change regularly, it is therefore important that staff who immunise not only have the necessary fundamental knowledge, but also keep up to date on a regular basis. Information is regularly changed due to new developments or changes in disease patterns, efficacy data and the main sources for ensuring practitioners are receiving the most recent advice are the following: The Green Book Immunisation against Infectious Disease accesses on line only as the individual chapters are updated regularly. The last hard copy of this book was published in 2006 and is outdated and should NOT be used : The UK immunisation schedule The most up to date version at the time of writing this report is: Vaccination of individuals with incomplete or unknown immunisation status Check you have the most recent issue. NHS England and Public Health England - Official Letters and information Vaccine Update A national monthly newsletter send free via to subscribers. To access past copies : To subscribe AHW AT web site For local information (e.g. PGD s) & signposts to national information. Appendix 6 shows an example of a cold chain audit tool that can prove helpful. Further advice can also be sought for your local screening & imms team enquiry line england.wmidsimms@nhs.net HPA Vaccine incident guidance Travel Guidance : National travel health and network centre NaTHNaC: 22 P a g e

23 DH protocol for immunisation: 10 Immform: For further information and helpsheets on how to use Immform, please see: The fridge database-guidance is available from UK Medicines Information (UKMi). NHS pharmacists at UKMi collate published and unpublished information from manufacturers Access for NHS staff and contractors can be obtained by contacting the regional medicines information centre telephone numbers are in the British National Formulary (BNF). The UKMi fridge database also summarises the relevant sections of the manufacturers summaries of product characteristics (SPC). SPCs are also available at www. medicines.org.uk/emc. Manufacturers medical information departments can also be contacted for information which is available at HPA - Core curriculum for immunisation training available at: HPA - National minimum standards and core curriculum for immunisation training of healthcare support workers : HPA - National Minimum Standards for Immunisation Training available at : HTM Safe management of healthcare waste 23 P a g e

24 11 References DH (2013), Immunisation against Infectious Disease: The Green Book; Chapter 3; PP 29; available at; HPA & NHS (2010), Vaccine Handling and Storage guidance; Health Protection Scotland & National Health Scotland, Sept 2010; MHRA (2009), Drug Safety Update; Off-label or unlicensed use of medicines: prescribers responsibilities: Medicines and Healthcare Products Regulatory Agency; (accessed 9/1/14) NMC guidelines NMC guidance- standards for medicine management (first published Updated April 2010 and 2015): standard 6: storage; pg Nayda C., Kempe A., Miller N. (2001) Keep it Cool: the Vaccine Cold Chain. Guidelines for Immunisation Providers on Maintaining the Cold Chain. Second edition. Commonwealth of Australia Records management NHS Code of Practice (Part 2) 24 P a g e

25 Appendix 1: Monitoring Refridgerator Performance & Recording Temperatures (Specimen Standard Operating Procedure) Practice / Clinic / Unit name Designated Vaccine Supervisor Deputy SOP Number SOP Title Page (s) Written by Approved by Date Approved Review date Temperature recording and checking procedure Signature Signature Appliance Details Appliance Identification Appliance Location Use and Limits Fitness for purpose review Vaccine storage at + 2 C to +8 C Daily on all working days Standard Limits Fridge temperature +2 C to +8 C Procedure 1) At the start of each month, a new record should be used for each appliance. 2) At least once each day, preferably at the start of the day, the maximum/minimum thermometer is read and the maximum temperature, minimum temperature and current temperature are recorded along with the date and time. 3) Each entry should be checked to ensure that all three are within the +2 C to + 8 C. 4) Note any cleaning, re-stocking activities which may have been undertaken and which may have a potential. 5) If all readings are within range, then the person recording signs the entry no further action needed. 6) If any part of the entry is out of range, then the person recording should try to identify any reason that could explain the discrepancy and they should bring it to the attention of the designated vaccine supervisor/ deputy and/or manager of the practice/clinic/department or GP. 7) If there is any doubt about whether the contents may have been compromised due to inappropriate storage conditions, quarantine the stock but continue to keep it under the correct refrigeration conditions. Check as soon as possible with an appropriate person, e.g. Screening & Imms Team. 8) Record any reason for the discrepancy, any advice given and the expert source consulted. 9) Record any action taken and sign the log sheet. 10) On each occasion, after the daily temperatures have been recorded, the maximum/minimum thermometer should be reset following the manufacturer s instructions. 11) When re-stocking or any activities that cause the temperature to increase above 8 C - monitor the temperature and record how long it takes to return to 8 C. Reset the temperature when it is back at 8 C, If longer than 5 minutes, contact the vaccine manufacturers and check the vaccine is still safe to use and within its licence. (Health Protection Scotland & NHS Scotland; Guidance on Vaccine Storage and Handling 2010) 25 P a g e

26 Appendix 2: A sample fridge temperature record chart Name of health facility:... Fridge identifier:... Month and Year:... The temperature should be between +2 C and +8 C. Check each working day. If the temperature is outside the recommended range, take appropriate action as indicated in the written procedure. Remember: Read, Record, Reset and React. Date Time Current Temp Min Temp Max Temp Reset (tick) Checked by Comments 1/1/ AM A. Smith New vaccine delivery at 11:15. Temp reached 10 for 5 min, thermomter reset Monthly review by Date 26 P a g e

27 Appendix 3: Incident check list Date & Time of breach INCIDENT CHECK LIST What were the temperature readings when the breach was noticed? i.e Current Minimum, Maximum How long was the temperature outside 2-8 C or when was the cold chain last guaranteed? What alerted you to the cold chain breach/storage event? (eg thermometer out of range, fridge alarming, temperature log) Has the cause of the breach been rectified and/or steps taken to prevent the problem recurring? Has anybody been vaccinated with potentially affected vaccines? If so how many? And with what vaccine? How often are fridge temperatures usually recorded? When was the thermometer last reset? When was the thermometer last calibrated? When was the firdge last serviced? How would you describe the current stock level of the fridge (eg less than 10% full, 25%,50%,75%, full, very full or over stocked ) Are vaccines stored in their original packaging? Are there any obvious signs of freezing (eg frosting on sides or back of the fridge, wet or damaged vaccine boxes? Have any vaccines been pushed up against the cooling plate or cold air inlet? What is the expiry date of the vaccines? Have any of the vaccines involved in this incident previously been exposed to temperatures outside 2-8 C? (ie involved in previous cold chain incident) 27 P a g e

28 Appendix 4: Cold Chain Incident Investigation Form 1.0 Practice Details Surgery Name, Code & CCG : Lead GP : Name of reporter Tel: address 2.0 Incident Details Please include date, what happened, why it happened, where any patients vaccinated, why did staff not report a breach in temperature (If applicable), why did the nurse not act / check the temperature (if applicable)? 3.0 Detailed questions Is this the first vaccine incident of the Practice? Yes No If the above question was answered no please give details of the earlier incident here: On discussion with the member of staff who made the error (if applicable) do they understand the reason why the incident occurred? 1) Staff who were monitoring temperature 2) Nurse who gave vaccine? Has the staff involved in the incident received cold chain training? (Refer to Heath Protection Agency standards for immunisation: Cold chain. For appropriate standards in training). N/B Nurses who immunised are required to have a yearly immunisation update which includes a refresher on cold chain. 1) Y/N 2) Y/N 1) Staff monitoring temp= Y/N 2) Nurse administering vaccine = Y/N If yes give details of dates: Staff 1) Nurse 2) Have the patient/s been advised of the incident (If applicable)? Has there been any reaction to the child / adult following the immunisation error (if applicable) Does the practice have a SOP in place for the delivery and storage of vaccine. Y/N Y/N Y/N 28 P a g e

29 4.0 Follow up action Example please include advice from NHSE, i.e. quarantine vaccine, contacting vaccine manufacturer, fridge engineer report etc. 5.0 Please record further actions required and lessons learnt in order to prevent a further incident: E.g. practice incident meeting, root cause analysis, changes to procedure / operating framework, staff training etc. 29 P a g e

30 6.0 ACTION PLAN TEMPLATE 1 Area of Concern/Issue Action Person responsible for implementation Implementation date How will completion of the action be evidenced? P a g e

31 Appendix 5: Off label vaccine information for patients 31 P a g e

32 32 P a g e

33 Appendix 6: Sample Vaccine Storage and Handling Self Audit Tool The purpose of this audit tool is to provide a checklist to allow the designated vaccine supervisor or their deputy to undertake a self-audit of the arrangements for the storage and handling of vaccines in any areas where vaccines are stored in order to identify areas where improvement is necessary. A separate form should be used for each fridge used to store vaccines. Any areas of concern should be discussed with the manager in charge of the practice/clinic or department. Where any issues are identified these should be discussed where required with the immunisation & screening coordinator and remedial action undertaken. Audit Undertaken by Date of Audit Location of fridge Fridge Identification Number Manufacturer/Model/Serial Number Approximate age (years) Section 1 People There is evidence that: Yes No Comment There is a designated person in charge of monitoring the storage and handling of vaccines There is a named deputy for the designated person All staff involved with the handling of vaccines have been trained appropriately in maintenance of the cold chain All staff involved with recording of daily temperatures are familiar with the operation of max/min thermometers Section 2 Equipment The Fridge Thermometer Yes No Comment There is evidence that: The thermometer is digital The thermometer can record current, maximum and minimum temperature and can be reset. The thermometer is integrated into the fridge with a digital display In case of independent Max/Min digital thermometer the probe is placed in middle of the fridge The calibration is checked on an annual basis & Date of last calibration 33 P a g e

34 General requirements of vaccine fridge Yes No Comment There is evidence that: A pharmaceutical fridge is used to store vaccines The fridge is locked when not in use or within a room that is locked when not occupied The fridge is only used for storage of vaccines and medicines There is sufficient space around the packages to enable air to circulate There are no vaccines stored in the door of the fridge There are no vaccines stored in enclosed plastic trays or at bottom of fridge Vaccines packaging are no touching the walls of the fridge Stock is arranged systematically within the fridge so that any member of staff looking for a product can determine quickly whether that product is available in the fridge The fridge is hard wired or all plugs are clearly marked fridge: do not switch off The fridge is situated away from heat sources The fridge is situated away from direct sunlight The fridges is in an area where the ambient room temperature is in accordance with the operating conditions recommended by the fridge manufacturer There is adequate ventilation space around the fridge The fridge has an auto defrost function or for fridges which do not have an auto defrost, that the fridge is defrosted in accordance with manufacturer s advice The fridge is cleaned regularly The fridge is serviced and PAT tested yearly Dates of last test / service Daily Temperature Recording Yes No Comments There is evidence that: A separate record is used for each fridge The current, maximum and minimum temperature has been recorded at least daily on working days The temperature record is kept close to the fridge There is evidence that the thermometer is reset after each reading The daily temperature records are signed by the person taking the reading The designated person has reviewed the temperature records on a monthly basis The designated person has reviewed the temperature records on a monthly basis Information about activity such as defrosting / restocking etc that may affect temperature is recorded Temperature records are retained for at least one year or the life of the vaccines stored. 34 P a g e