1. Storage and Management of Vaccines
Neelam Ali
Senior Community Services Pharmacist
Introduction - Me
Nurses
Background/experience
Before next slide
Discuss in groups 3 minutes
What is the ‘Cold chain’?

2. The Cold Chain The Cold Chain
Maintaining vaccines within the manufacturer’s recommended storage temperature during transport and storage until the point of administration
Covers the process of:
Manufacturer – wholesaler – pharmacy – GP/HC - patient

3. Emphasises the previous slide in a visual form

4. Why is the “Cold chain” so important?
Efficacy depends on correct storage conditions +2oC to + 8oC
Compliance with Specific Product Characteristics and marketing authorisation
Assurance and confidence in a potent product
Ensuring maximum benefit from immunisation
Vaccines deteriorate when stored outside these temperatures
Storage conditions are specified in the SPC and form part of the conditions of the product licence. Pharmaceutical companies state that if the vaccines are used outside these temperatures then the optimum potency can not be assured. Use is then outside the product licence
As registered nurses when administering medicines you should be satisfied the product is of satisfactory quality
Maintaining the cold chain ensures maximum immunity is produced by the vaccines

5. Storage
Storage
Storage of vaccines outside recommended storage temperatures can lead to:
Deterioration in the vaccine and failure to produce a satisfactory level of immunity
Heat speeds up decline in potency - ↓shelf life
Freezing causes
Increased reactogenicity & loss of potency
can lead to hair line cracks in ampoules, vials or pre-filled syringes causing contamination of contents
Increases the number of reactions
World Health Organisation in their work in developing countries have shown a reduction in vaccine efficacy with Polio when there has been disruption in the cold chain
Also when exposed to repeated freeze/thaw cycle hair line cracks appeared in ampoules or pre-filled syringes of diphtheria, tetanus and pertussis vaccines

6. Vaccine Stability Vaccine Stability Temperature Sensitivity
Sensitive to Cold and Heat
Light Sensitivity
Sensitive to strong light, sunlight, ultraviolet and fluorescent light (neon)
All vaccines should be stored in their original packaging until they are administered
Vaccines are also very sensitive to strong light which again causes loss of potency
All vaccines should be stored in their original packaging

7. Storage and Management of Vaccines
Receipt and Transport
Storage
Temperature monitoring
Use in vaccination sessions
Disposal and spillage
Disruption of the cold chain
During the session I will cover………………
Group work: Divide into 3 groups
1) Receipt and transport
2) Storage
3) Temperature monitoring
Spend 5 minutes discussing one of the topics and how to maintain the cold chain
Discuss feedback and give out handouts

8. Receipt of Vaccines Receipt of Vaccines
Checked against order for discrepancies
Have vaccines been stored between 2oC – 8oC ?
Inspect for leakage and damage
Signed for and refrigerated immediately
Record vaccine type, brand, quantity and batch numbers (date and time)
Group 1
Report discrepancies ASAP
Leakage or damaged – return or destroy as agreed by supplier
If not transported at 2 - 8°C contact supplier and arrange return
Record – Information needs to be readily available for batch recalls or monitoring of expiry dates
Vaccines must be stored at manufacturers recommended temperatures to maintain potency
Vaccines should not be left unattended at delivery points

9. Transport of Vaccines Insulated validated cool boxes Cool boxes
Fridge packs
Frozen packs
Spaces in cool box filled with insulating material
Vaccines should not be in direct contact with cool packs
Group 1

10. Transport of Vaccines
Vaccines taken to schools or outside clinics must be transported so that the cold chain is maintained using validated insulated cool boxes
Then transferred to a fridge if available or left in a validated cool box
Unused vaccine transported in a validated cool box for a morning or afternoon session may be returned to the fridge with a note attached to use first
Vaccines stored for 8 hours or more in a validated cool box should be disposed of and not returned to the fridge
Group 1

11. Storage of Vaccines
Within recommended storage temperatures between 2oC – 8oC
Refrigerator Specifications:
Designed for storing medicines- Lockable
Minimal opening to maintain constant temperature
Ice build up reduces effectiveness
No items other than medicines stored in fridge (e.g. food, drink, clinical specimens)
Should not be over full
Ensure can not be accidentally switched off
Group 2
Must use medicine fridges and not domestic
Do not situate near radiators or heat sources
No blood/urine/stool samples etc and NO FOOD
Lockable fridges or in a room that is lockable when not occupied

12. Storage of Vaccines Vaccines
must not be removed from packaging during storage
Stocks stored tidily
Not stored on shelves in fridge doors or bottom drawers
Not stored next to freezing compartments
Group 2
Packaging protects from light, insulates the vial, provides information and the product information leaflet
Avoid over stocking, only keep 2 – 4 weeks supply

13. Storage of Vaccines
Patients/Parents should not be requested to store vaccines in a domestic fridge.
Fridges should be cleaned on a regular basis
Emergency storage available if fridge fails
Group 2
Do not let ice build up in the fridge

14. Temperature Monitoring
Fridges must have a reliable maximum/minimum thermometer (in addition to any integral thermometer)
Calibrate annually to ensure correct functioning
Designated person responsible for vaccine storage and fridge monitoring
Trained to read and record current temperature, maximum and minimum temperatures correctly
Group 3
Use a digital thermometer
Must record on the temperature chart – there have been problems with incorrect recording
Hand out sheet – what has happened?
Must have a designated person and a deputy to monitor fridge temperatures
Nurses administering vaccines should ensure there is a local policy for the receipt, storage, transport and temperature monitoring of vaccines. Staff must be trained and understand their responsibilities – this must be audited

15. Temperature Monitoring
Readings should be taken daily
Keep record chart on or near the fridge
Retain records until next audit
If the recorded temperature goes outside the range, contact community services pharmacy and or the manufacturer’s for advice
Group 3
Daily readings must be taken Monday to Friday
Everyone must be aware of where the temperature log is kept
End of group feedback

16. Guide to what a temperature record sheet should look like

17. Fridge Temperature Recording
NMC Standards - Registered professional has overall responsibility.
The designated person, (who shall be a professional), shall have responsibility for ensuring that the system is followed and that the security of medicines in the clinic site is maintained.
The designated person may decide to delegate some of the duties but the responsibility always remains with that designated person.
Duthie Report Community Services Pharmacy.

18. Vaccination Sessions Use vaccines with shortest expiry first
Vaccines should only be removed at the beginning of session for the shortest possible time
Only remove the required number of doses for the session
Prior to administration check the identity of the vaccine, its appearance and expiry date
Record date, brand name, manufacturer, batch number and details of any diluent used in patients’ notes
Keep stock rotated, shortest expiry at the front – use stocks due to expire first
Record details of vaccine used

19. Vaccination Sessions
Freeze dried vaccines should be reconstituted immediately prior to use and used within the recommended period
Any remaining vaccine in vials should be drawn into a syringe and disposed of
Part vials, prepared unused vaccines and out of date vaccines should be placed in a sharps box labelled “Vaccine waste”. The box should be sealed when two thirds full
Multidose vials are not used now but could be used in an emergency campaign. If so once they are opened they must be disposed of at the end of the session or at the end of the manufacturers recommended period, whichever is the soonest.

20. Disposal of Vaccines
In Health Centres the box will then be either collected by pharmacy technicians or returned to community services pharmacy on secure transport
GP Practices should make arrangements for disposal of vaccine waste through their waste contractor
We now have hazardous waste regulations
This separates hazardous from non-hazardous
Medicines including vaccines must be separated from clinical waste

21. Spillage of Vaccines Wear gloves and mop up with paper towels
Clean area using Sodium Hyperchlorite 1% (Milton) solution for blood and body fluid “Spill Paks” as per local policy
Dispose of contaminated waste in “Vaccine Waste” sharps box
Spillage on skin should be washed with soap and water
Affected eyes should be washed with sterile sodium chloride 0.9% and medical advice sought
Copies of the (Control of Substances Hazardous to Health) COSHH data sheets should be obtained from the manufacturer
COSHH data sheets are available for all medicines/vaccines from the manufacturer on request

22. Disruption to the Cold Chain
Arrange for vaccines to be returned to the correct storage conditions as soon as possible
Do not use vaccines stored outside of the recommended temperature range until advice has been sought
Telephone the manufacturer for advice
Any vaccines that do not have to be discarded should be used a soon as possible
Quarantine vaccines – put in a bag and label do not use
Contact the manufacturer for advice – you will need to give information on the temperature they have been stored at and for how long – by looking at the temperature records
Ask for a written copy of the advice given
Label with the new expiry date and store separately and use first
If not used within the new expiry ensure they are disposed of appropriately
If in any doubt ring Community Services Pharmacy and ask for the pharmacist for advice.
If I am in any doubt I will tell you to dispose of them
*Patient safety must always come first*
Any questions?

23. References
Department of Health: Immunisation against infectious disease 2006.
The Green Book. Publication date: 30th October 2007.
Check website
If in any doubt always refer to the Green Book!
Make sure you are looking at the most up to date version of the Green Book.