1. Handling and Storage of Vaccines David Morgan Regional Immunisation Co-ordinator National Public Health Service Ref: vaccine cold chain April 2009/dam09

2. Handling and storage of vaccines
Aims:
handling
storage and packing
ordering
maintaining the cold chain.
disposal
audit
Learning Outcomes:
understand the ordering process
develop an awareness of the guidance
be aware of the importance of maintaining the cold chain
be aware of the safe disposal of vaccines
be able to audit activity

5. Essential resources: NPHS website: Order form - green
nww.nphs.wales.uk/immunisation
Order form - green
Returns procedure
Green Book (Chapter 3)
Vaccine Update - monthly
BNF (includes Yellow Cards)
Immunisation data e.g. COVER, Practice, HVs?
Prescription/PGDs/PSDs
Posters and plug stickers

8. NPSA vaccine incident April 2005
use of Tuberculin PPD for heaf testing
resulted from a combination of:
systems failures;
human error;
led to considerable distress and anxiety
PCT review
adopt “philosophy of an enquiring mind”

9. Northfield Practice Incident, Grampian, Sept 2006
Fridge failure in treatment room
Incomplete records
Vaccines destroyed
Vaccination programme was suspended
800 children affected
Re vaccination required

10. Local breaches – cold chain
FLHB (2007) - children recalled for re-vaccination
GLHB (March 08) – 14 hours break because of a plug problem
ALHB (March 08) – stock destroyed because of a faulty fridge
FLHB and WLHB (April 2009) – annual calibration shows low temperatures of
0-1ºC

11. Cold chain The ‘cold chain’ is the system of transporting
and storing vaccines
within the safe temperature
range of 2°C to 8°C
(includes the equipment and the staff)

12. Typical cold chain Vaccine manufacturers refrigerated lorry
Pharmaceutical distribution company
refrigerated lorry
Pharmacy/clinic/practice
cool box
Recipient

13. Vaccine stability MOST SENSITIVE Sensitivity to COLD
HepB and combination
DT and/or a aP/IPV/HIB
Influenza
MenC
*MMR
*Varicella
*BCG
(*Freeze dried)
Sensitivity to HEAT
BCG
Varicella
MMR
Men C
Hepatitis B
DT and/or aP/IPV/HIB
LEAST SENSITIVE

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

15. Handling and Storage of Vaccines
Vaccines are POMs
Designate a responsible person and a trained deputy to:
Order vaccines
Receive and supply vaccines
Monitor storage and delivery
Destroy vaccines
Audit annually

16. Ordering and receipt of vaccines
Order once monthly only
Use North Wales order form
Deliveries should be clearly labelled ‘vaccines’
Sign for vaccines on receipt
Check delivery against invoice
Inspect for damage or leakage
Return excess stock of vaccines to supplier
Check discrepancies against the order and report to supplier
Refrigerate a.s.a.p.
Patient involvement?

17. Risk of excess stock Over-packed fridge Poor air Poor storage flow
rotation
Freezing
Increasing risk of
using out of
date stock
Sub-optimal
vaccines
Increased
waste
Increased cost
to clinic

18. Storage of vaccines Refrigerator should be lockable
Or room is lockable
Do not use domestic refrigerators. Why?
Refrigerators should not be sited near a heat source

19. Storage of vaccines Emergency storage procedure (for fridge failure)
Refrigerator plug
Switchless sockets
Cautionary notices
Disruption of power?
Store at 2-8 degrees centigrade
Avoid freezing and hairline cracks
Monitor at a regular time each day and record
Maximum/minimum thermometer
Alarmed and digital
Calibration – at least annually
Place at the back of the middle shelf
Report any variances
Report and record all cold chain incidents

20. A sample refrigerator temperature record chart
Name of immunisation provider (GP practice, pharmacy)
……………………………………………………………………..
Temperature should be between + 2°c & + 8°c. If the temperatures are outside the recommended range take appropriate action as indicated in written procedure.
MONTH
…………..
CURRENT
TEMPERATURE
MINIMUM
MAXIMUM
CHECKED BY
(signature)
THERMOMETER
RESET (tick)
Day (1st)

21. Storage of vaccines
Vaccines should not be frozen or repeatedly warmed/cooled
Refrigerators should be:
- serviced
- defrosted monthly
- cleaned quarterly.
No food and drink in the vaccine fridge – why?

24. Storage of vaccines Vaccines - avoid tight packing
Do not remove ampoules from original packaging (retain product information, protect from light)
Do not store in the fridge door, bottom drawer or near freezer plate
Establish stock rotation system
- check expiry dates

25. Vaccine storage Use a dedicated vaccine fridge
√ No food/medical specimens
√ Safeguard electricity supply
√ Do not place in direct sunlight or near heat source
√ No more than 50% full
√ Defrost/calibrate regularly
√ Ensure back up facilities are available in the event of fridge failing
√ Use maximum/minimum thermometers inside fridge
√ Monitor and record maximum/minimum and current temperature daily

26. Packing of vaccines
Assemble orders in a designated area close to the refrigerator
Use secure, approved, calibrated, insulated “cool” boxes
Record temperature within boxes during transit.
Use water, ice packs
Avoid contact between ice pack and vaccine

27. Packing of vaccines Fill spaces with insulating material
Pack orders immediately prior to dispatch
Label ‘VACCINES-URGENT’

28. Vaccination session Disinfection & spillage: Policy?
COSHH safety data sheets
eyes – 0.9% saline
Remove vaccines just before the session
Return vaccines immediately after the session has finished
Avoid opening and closing the fridge door too often

29. Vaccination session
Vaccines should not be out of the fridge longer than 3 HOURS
Mark unused vaccines, replace in fridge and use first at the next session
Destroy vaccines which have been removed twice and not used
Vaccine vial monitors (heat sensitive indicators)
changes colour from light to dark when exposed to heat

30. Vaccination session - Expired vaccines
Dispose of all vaccines by incineration e.g.
- Expired vaccines
- Partly use ampoules/vials
- XX marked vaccines
- All contaminated waste
- BCG vaccine – pharmaceutical hazardous waste
Anaphylactic shock packs
Record:
- date
- name of vaccine & manufacturer
- batch numbers and expiry
- strength, dosage
- diluent details
- adverse drug reactions