Handling and Storage of Vaccines David Morgan Regional Immunisation Co-ordinator National Public Health Service david.morgan@nphs.wales.nhs.uk Ref: vaccine cold chain April 2009/dam09

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

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

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”

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

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

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)

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

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

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

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

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?

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

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

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

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)

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?

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

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

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

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

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

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

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