The cold chain and vaccine handling

1
The cold chain and vaccine handling
2
Topics covered

• Cold chain
• Ordering
• Storage
• Distribution
• Disposal
• Administration under Patient Group Direction

3
Introduction

• Currently about 200m spent on vaccines each year
  nationally.
• 1 wastage can add on 2m
• Vaccines are biological substances that may lose
  their effectiveness quickly if they become too
  hot or too cold, especially during transport and
  storage. May result in failure of the vaccine to
  protect, as well as resulting in vaccine wastage.

4
Importance of cold chain

• The cold chain is standard practice for vaccines
  throughout the pharmaceutical industry
• Maintaining the cold chain ensures that vaccines
  are transported and stored according to the
  manufacturer's recommended temp range 2C to 8C
  until point of administration

5
A typical cold chain
Vaccine manufacturer
Specialist pharmaceutical Distribution company
Transportation in Refrigerated vans and/or cool
boxes
Pharmacy/GP surgery/Clinic
Patient
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Vaccine Stability
MOST SENSITIVE

• Sensitivity to COLD
• HepB and combination
• DTand/or aP/IPV/HIB
• Influenza
• MenC
• MMR
• Varicella
• BCG
• (Freeze dried)

• Sensitivity to HEAT
• BCG
• Varicella
• MMR
• MenC
• Hepatitis B
• DT and/or aP/IPV/HIB

LEAST SENSITIVE
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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
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Ordering and monitoring

• May be packaged in multiple quantities
• Stocks should be monitored by a designated
  person(s) to avoid over-ordering or stockpiling.
• Surgeries/clinics should have no more than 2 to 4
  weeks supply of vaccines at any time. This will
  be sufficient for routine provision. Best
  practice order small quantities on a regular,
  schedules basis.

9
Excess stock

• Excess stock may
• Increase the risk of using out-of-date vaccines
• Increase wastage and cost of disposal by
  incineration
• Increase dangers of over-packed fridges, leading
  to poor air flow, potential freezing and poor
  stock rotation
• Delay in introduction of new vaccines until local
  supplies used
• Increase costs if fridge fails
• Increased pressure on fridge in times of high
  demand, e.g during flu session

10
Excess stock cont.

• Vaccine stock should be placed within the fridge
  so that those with shorter expiry dates are used
  first.
• Any out-of-date stock should be labelled clearly,
  removed from the fridge and destroyed as soon as
  possible according to local policy.
• Vaccines must never be used past their expiry date

11
Receipt of vaccines

• Check vaccines against order for discrepancies,
  leakage or damage before signing for them.
• Distributors will not accept any vaccine for
  return once it has left their control
• Vaccines must be refrigerated immediately on
  receipt and must not be left at room temperature.
• Record type, brand, quantities, batch numbers and
  expiry dates. Also date and time at which
  vaccines were received.

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The fridge
13
The fridge

• Specialised fridges are available and must be
  used for vaccines and diluents- not domestic
  fridges.
• Food, drink and clinical specimens must never be
  stored in the same fridge as vaccines.
• Opening of the door should be kept to a minimum
  in order to maintain constant temperature.
• Vaccines are PoM and must be stored under secure
  conditions
• Lockable fridge or within a room that is locked
  when not occupied.

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Fridge cont.

• Vaccines should not be left unattended at
  outlying clinics.
• Accidental interruption of electricity can be
  prevented by using a switchless socket. Fridge
  should not be situated near a radiator or
  anything else that could affect their working
• Appropriately ventilated.
• Don't let ice build up

15
Storage

• Original packaging
• 2ºC to 8ºC
• Protect from light exposure to ultraviolet
  light will cause loss of potency
• All vaccines are sensitive to heat and cold
• Heat speeds up the decline in potency, thus
  reducing shelf life
• Freezing may increase reactogenicity and loss
  of potency for some vaccines. Also, hairline
  cracks in the container, leading to contamination
  of the contents

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Storage cont.

• Don't store in the door, bottom drawers or
  adjacent to freezer plate
• If there are temp variations outside of 2C to
  8C, they usually occur in these parts of the
  fridge
• Allow sufficient space for air to circulate
  freely.

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Fridge cont.

• Keep records of servicing and cleaning.
• Thermometers
• Use a max-min thermometer
• Monitor fridge temp at least once a day, using a
  chart
• Check calibration annually
• Have back-up facilities in the event of fridge
  breakdown

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Temperature Monitoring

• Min/max thermometer or in-built thermometer
• Daily record keeping
• Record temperature accurately-use ºCentigrade
• Check in the correct range
• Take action if outside 4-6ºC
• Adjust thermostat if possible
• Report
• Re-check
• Find alternative fridge storage if outside 2-8ºC

19
Storage temperature

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

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




Defrosted and cleaned by Date .
21
Ordering and Delivery

• Named trained designated person and deputy who
  have overall responsibility for ordering, receipt
  and care of vaccines.
• 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

22
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
• Written procedure for the disposal of vaccines by
  incineration should be available locally

23
Post administration

• Treat as Serious Untoward Incident
• Inform Practice Manager/Line Manager/PCT of the
  incident
• Suspend all immunisation clinics until resolved

24
Transportation to outlying clinics

• Use validated cool boxes (with max-min
  thermometers) and cool packs from a medical
  supply company.
• Vaccines must be kept in original packaging,
  wrapped in bubble wrap (or similar) and placed
  into a cool box with cool packs
• This will prevent direct contact between vaccine
  and cool packs prevents damage, i.e. being
  frozen

25
Disposal

• Follow PCT policy on disposal of medicines policy
• Use yellow lidded sharps bin

26
Spillage

• Use COSHH data sheets
• Clear up quickly, wear gloves
• Soaked up with paper towels, taking care to avoid
  skin puncture from glass or needles.
• Clean area according to local chemical
  disinfection policy or COSHH safety data sheets.
• Spillages on skin should be washed with soap and
  water. If a vaccine is splashed in eyes, they
  should be washed with sterile 0.9 NaCl solution
  and seek medical advice.

27
Ordering

• Childhood vaccines are centrally purchased by DH
  supplied through Movianto
• On allocation based on local populations
• Ordered from DH by designated person- ( name of
  local contact)
• Delivered to ( local arrangement)
• Distributed to ( local arrangement) by courier
  (or other arrangement)

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Ordering contd

• One designated person in each clinic needs to
  order vaccine from ( local contact)
• Email
• Name of designated person
• Contact details including
• Email address,
• Clinic details and
• Times to contact of the person at your clinic who
  will be responsible for requesting the HPV
  vaccine.

29
Adverse Drug Reactions

• All suspected adverse events must be reported
• to the MHRA using the yellow card system
• on the website www.yellowcard.gov.uk
• (paper copies are available from Medicines
• Information, Broomfield Pharmacy or they can
• be found in the back of the BNF.)
• A copy should be sent to
• the Community Services Pharmacy Team, Broomfield
  Hospital,
• the Clinical Governance Lead Mid-Essex PCT
• The adverse event should be recorded in the girls
  health records and on their medical records and
  their GP informed

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Anaphylaxis

• Must have adrenaline available
• Age of child-12-18 years
• Dose of intramuscular injection of adrenaline
  (epinephrine) for anaphylactic shock-500
  micrograms
• Volume of epinephrine (adrenaline) 11000
  (1mg/ml) solution 0.5 mL

31
Cold storage items

• Clinimed at www.clinimed.co.uk (Vaccine Porters)
• 01628 850100/ 0800 0360100 (CS)
• HH system www.wicker.co.uk (Fridges)
• 0114 275 6642
• LEC medical www.lec.co.uk (Fridges)
• 08712225118
• MAILBOX www.mailboxmouldings.co.uk

32
Temperature recording devices

• HH systems
• Feedback data ltd 01892 601400
• f-log
• www.feedback-data.com
• COMARK 01438 367367
• Data loggers (N2011)
• www.comarkltd.com

33
Vaccine Information

• www.dh.gov.uk (greenbook)
• www.immunisation.org.uk (fact sheets)
• www.nathnac.org (National Travel Health Network)
• www.apmsd.co.uk (VIS)
• www.hpa.org.uk
• www.rpsgb.org.uk (fridge temperature monitoring,
  how to use a thermometer)
• www.cdc.gov/node (USA)
• www.medicines.org.uk (emc)

34
Vaccine Information

• Immunisation against infectious disease
• Green book Chapter 3
• BNF
• Vaccine Update (monthly from DH)

35
Further info.

• Immunisation against infectious disease
• Green book, chapter 3
• BNF
• For general info vaccine update (monthly from
  DoH)

36
Acknowledgements

• Paula Wilkinson Mid Essex PCT
• Jane Allen South East Essex PCT