Learning Objectives Describe the cold chain and the importance of its maintenance Specify minimum/maximum temperatures for vaccine storage Describe the effects of temperature on potency and efficacy of vaccine Describe the requirements for the correct ordering, delivery and storage of vaccines in the workplace Identify vaccines sensitive to light heat and freezing Know how to manage breakdowns in the cold chain, where to dispose of damaged vaccine, who to inform and what action to take Explain how to audit current management of cold chain within their practice area.

Cold Chain The ‘cold chain’ is the system of transporting and storing vaccines within the safe temperature range of 2˚C to 8˚C

Why is the cold chain important? Vaccines  Biological products lose potency with time, if lost the process is irreversible and accelerated if proper storage conditions are not adhered to.  Professional responsibility  Public Health responsibility  Responsibility not to waste scarce NHS resources

Vaccine Stability Sensitivity to HEAT BCG Varicella MMR MenC Hepatitis B DT and/or aP/IPV/HIB Sensitivity to COLD HepB and combination DTand/or aP/IPV/HIB Influenza MenC *MMR *Varicella *BCG (*Freeze dried) LEAST SENSITIVE MOST SENSITIVE

Storage temperature Never exceed 8ºC or fall below 2ºC Aim for 5ºC Aim to maintain vaccine fridge as close as possible to 5˚C as this gives a safety margin of + or – 3˚c

Why is the cold chain important? 4.Compliance with SPC/Manufacturer  Any vaccine that has not been stored at a temperature of 2-8ºC as per its licensing conditions is no longer a licensed product  Responsibility/ liability rests with immunisation provider and the Health Organisation

Temperature Monitoring Use max/min thermometer Probe should be placed in the centre of fridge Temperature should be recorded at least once a day Reset daily Calibrate as recommended Take immediate action if temperature is outside recommended range

Cool Boxes and Transporting vaccines Use a validated cool box and ice packs from recognised medical supply company Monitor maximum/minimum temperature, recording at regular intervals Vaccines should be wrapped in bubble wrap or similar insulation material to prevent direct contact with ice packs Use insulating material to fill any spaces within the cool box Only take enough vaccine for particular session and minimise exposure of the vaccines to room temperatures

What to do if there has been a Cold Chain failure Prior to administration  Any vaccine that has not been stored at a temperature of 2-8ºC as per its licensing conditions is no longer a licensed product Where there is any doubt that cold chain has not been maintained, vaccines should not be used until further advice has been sought from the vaccine manufacturer  Written procedure for the disposal of vaccines by incineration should be available locally

Post administration Treat as Serious Untoward Incident Inform Practice Manager/Line manager/Health Organisation of the incident Suspend all immunisation clinics until resolved

Best practice in Cold Chain compliance Define local policies should be in place and written in accordance with PGDs, SPCs, DH and Green Book Regular audit of current practice Training Local multidisciplinary support

Sample refrigerator temperature record chart Available at:

Why is handling important ???

Light Sensitive Sensitive to strong light, sunlight, ultraviolet, fluorescents (neon) BCG MMR Varicella Meningococcal C Conjugate Most DTaP containing vaccines Vaccines should always be stored in their original packaging until point of use to protect them from light

To follow correct procedures for storage and handling of vaccines Why is storage important ??

Risks of excess stock Over-Packed Fridge Poor Air Flow Poor Storage Rotation Increased Risk of using out of date Stock Freezing Increased Waste Increased Cost To Clinic Sub-Optimal Vaccines Unprotected patient

Vaccine Storage Use a dedicated vaccine fridge Safeguard electricity supply No more than 50% full Place vaccines in clearly labelled plastic mesh baskets Group vaccines by type (Paediatric, Adult, Adolescent) Defrost/calibrate fridge regularly Ensure back up facilities are available in the event of fridge failing X No food or medical specimens X Do not place fridge in direct sunlight or near heat source X Do not remove vaccines from original boxes until ready to use X Do not store vaccines in fridge doors or in solid plastic trays/containers within the fridge X Keep vaccines away from fridge walls and cold air vents Picture taken from

Ordering and Delivering

Ordering and Delivery Named trained designated person and deputy who have overall responsibility for ordering, receipt and care of vaccines. Responsibilities include:  Ensuring cold chain has been maintained during transport and managing receipt of vaccines directly into refrigeration  Checking delivery for leakage, damage and discrepancies  Rotation of stock  Maintaining stock information system to keep track of orders, expiry dates and running total of vaccines  Ensuring adequate supply/ Minimising over ordering or stockpiling

Wastage The Department of Health spends over £150 million a year on vaccines for the routine childhood programme, This dose not include a 3 dose course of HPV (Human Papillomavirus) vaccine!

Useful resources

Further Information Chapter 3&4 Green Book: “Storage, distribution and disposal of vaccines” and “Immunisation Procedures” Poster and plug stickers available to order from DH publications order line ( CDC Vaccine Storage and Handling Toolkit WHO. Temperature sensitivity of vaccines. August