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

6. 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) MOST SENSITIVE LEAST SENSITIVE

7. 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

8. 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 Excess stock • Excess stock may: • Increase the risk of using out-of-date vaccines • Increase wastage and cost of disposal by incineration • Increase dangers of over-packed fridges, leading to poor air flow, potential freezing and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 • Any out-of-date stock should be labelled clearly, removed from the fridge and destroyed as soon as possible according to local policy.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.

12. 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.

14. 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

16. 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.

17. 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

18. 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 5˚C as this gives a safety margin of + or – 3˚c

20. A sample refrigerator temperature record chartName 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 Defrosted and cleaned by………… Date …………….

21. Ordering and Delivery • Named trained designated person and deputy who haveoverall 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)

28. 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

30. 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

31. 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

32. 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

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