The cold chain and vaccine handling

Topics covered
Cold chain Ordering Storage Distribution Disposal Administration under Patient Group Direction

Introduction

Currently about 200m spent on vaccines each year nationally. 1% wastage can add on 2m Vaccines are biological substances that may loose 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.

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

A typical cold chain

Vaccine manufacturer Transportation in Refrigerated vans and/or cool boxes

Specialist pharmaceutical Distribution company

Pharmacy/GP surgery/Clinic

Patient

Vaccine Stability

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

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

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

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.

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Excess stock may: Increase the risk of using out-of-date vaccines Increase wastage and cost of disposal by incineration Increase dangers of over-packed fridges, leading to poor air flow, potential freezing and poor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

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 Any out-of-date stock should be labelled clearly, removed from the fridge and destroyed as soon as possible according to local policy.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

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.

The fridge

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.

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

Storage

Original packaging +2C to +8C 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

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.

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

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

Storage temperature
Never exceed 8C or fall below 2C

Aim for 5C
Aim to maintain vaccine fridge as close as possible to 5C as this gives a safety margin of + or 3c

. Temperature should be between +2c & +8c. If the temperatures are outside the recommended range take appropriate action as indicated in written procedure

Name of immunisation provider (GP practice, pharmacy)

MONTH

CURRENT TEMPERATU RE

MINIMUM TEMPERATU RE

MAXIMUM TEMPERATU RE

CHECKED BY (signature)

THERMOMET ER RESET (tick)

Day (1st)

Defrosted and cleaned by Date .

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

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 2-8C 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

Post administration

Treat as Serious Untoward Incident

Inform Practice Manager/Line Manager/PCT of the incident Suspend all immunisation clinics until resolved

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

Disposal

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

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.

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)

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.

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

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) 1:1000 (1mg/ml) solution 0.5 mL

Cold storage items

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

Temperature recording devices

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

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)

Vaccine Information

Immunisation against infectious disease

Green book Chapter 3

BNF Vaccine Update (monthly from DH)

Further info.

Immunisation against infectious disease

Green book, chapter 3

BNF

For general info vaccine update (monthly from DoH)

Acknowledgements

Paula Wilkinson Mid Essex PCT

Jane Allen South East Essex PCT