Safe Handling & Storage of Vaccines

Safe Handling & Storage of Vaccines Who Should Read This Policy Target Audience All staff handling vaccines

Safe Handling & Storage of Vaccines CONTENTS PAGE NUMBER 1. Introduction 3 2. Aim 3 3. Objectives 3 4. Responsibilities 4 5. Definitions 5 6. Ordering, Storage, Distribution and Disposal of Vaccine 5 6.1 Importance of Cold Chain 5 6.2 Named responsible person 6 6.3 Ordering vaccines 6 6.4 Receipt of Vaccine 6 6.5 The vaccine/drug fridge 6 6.6 Fridge thermometers 7 6.7 Storage of Vaccine 8 6.8 Packing and transport to other clinic/venue 8 6.9 Cool boxes 8 6.10 Expiry dates 8 6.11 Spillage of Vaccine 9 6.12 Disposal of Vaccine 9 7. Safe Use of Vaccine 9 7.1 Skin Preparation 9 7.2 Record Keeping 9 7.3 Adverse Reactions 10 7.4 Managing Side Effects 10 7.5 Patient Group Directions 11 7.6 Patient Specific Prescriptions 11 7.7 Anaphylaxis Management 11 7.7.1 Nurses doing immunisation should ensure; 11 7.7.2 Equipment for anaphylaxis 11 7.7.3 Immediate action if anaphylaxis suspected 11 7.7.4 Adrenaline 12 7.8 Consent 13 8. Training 13 9. Audit 13 10. References 13 Appendix 1 Vaccine order & delivery record chart 14 Appendix 2 Vaccine cold chain audit tool 20 Version 1.0 January 2015 2

1.0 Introduction Vaccine efficacy depends on maintaining the vaccine cold chain at every stage from the manufacturer to the recipient. Vaccines are biological substances, that may lose their effectiveness quickly if they become too hot or too cold at any time, especially during transport and storage. Vaccines naturally biodegrade over time and storage outside of recommended temperature range including during transport and storage may speed up this loss of potency, which cannot be reversed. This may result in the vaccine failing to protect, as well as resulting in vaccine wastage. Inactivation of vaccines may only come to light when immunised individuals acquire the disease in question. It may then be difficult to demonstrate a clear link between this and previous inadequate storage, distribution and handling practices. Each stage in the cold chain should be subject of careful quality control, not least in the hospital/clinic setting. High standards are necessary and are encouraged within Black Country Partnership NHS Foundation Trust (BCPFT), by appropriate training of staff involved with immunisation, clear designation of responsibilities to named individuals, the development and implementation of written protocols, and continuing regular audit. This document applies to all staff employed by BCPFT involved in the receipt, storage, handling, administration & disposal of vaccines. The Trust needs to ensure that there are safe systems in place for the safe handling of vaccines whether in hospitals, community homes, or clinics. This policy will be implemented by all staff to ensure adherence to best practice. This policy relates to all vaccines including: Vaccines used as part of an NHS immunisation programme eg. Influenza and Pneumococcal immunisation and vaccines for other high-risk groups e.g. Hepatitis B and Hepatitis A immunisations. The policy should be read in conjunction with: Immunisation against Infectious Disease 2006 - "The Green Book. Draft copies of the new replacement Chapters are available on the internet. www.dh.gov.uk BNF (most recent edition) Chapter 14 Immunological products and vaccines Advice on vaccine storage from the Royal Pharmaceutical Society of Great Britain www.rpsgb.org.uk BCPFT Medicines Management Policy Health Protection Agency Core Curriculum for Immunisation Training June 2005 UK Guidance on Best Practice in Vaccine Administration, Royal College of Nursing Oct 2001 Temperature sensitivity of vaccines 2006, World Health Organisation Vaccine Cold Storage, Jan 2010, National Patient Safety Agency This policy covers safe handling of vaccines and safe management of vaccine administration. It does not include guidance related to actual injection of a vaccine 2.0 Aim To ensure safe handling of vaccines within BCPFT Version 1.0 January 2015 3

3.0 Objectives To ensure staff are aware of their responsibilities To provide a standardised system for handling of vaccines To ensure that audit and monitoring is in place to confirm adherence to this policy 4.0 Responsibilities 4.1 Ward/Department Managers Managers have a responsibility to ensure all their staff who may be involved in any type of immunisation of any patient, have completed an annual training course in Immunisation and in use of Adrenaline (for anaphylaxis). Managers of areas where immunisation is carried out are responsible to ensure that staff are aware of and are updated in procedures related to this policy. Managers must also ensure that any relevant Patient Group Directions have been completed and signed for each medication (renewable every two years) Managers must ensure that a member of who has undertaken the vaccine training takes responsibility for overseeing the ordering, storing and administration of vaccines (Vaccine Monitor) Managers responsible to ensure an audit of vaccine fridge temperatures are undertaken records should be retained for at least 6 months for inspection by the Pharmacy Technicians. 4.2 Vaccine Monitor The Vaccine Monitor has overall responsibility for vaccine stock control including: Ordering vaccines Receive & record vaccine deliveries Correct storage of the vaccines Checking expiry dates Recording daily the temperature of the vaccine refrigerator, and if applicable defrosting the refrigerator on a monthly basis. To notify Pharmacy if for any reason the temperatures recorded are outside of the required range 4.3 Pharmacy Team 4.4 All staff To advise staff on correct & safe storage of vaccines T audit compliance with this policy To review/update PGD s annually with the Drug & Therapeutics Committee (August Meeting) To review this policy as/when required To provide information on recommended vaccine fridges, fridge min/max thermometers and cool transport boxes. It is the responsibility of the Clinical Pharmacy Team to ensure that immunisations and adrenaline are delivered to Trust sites in compliance with Guidelines and to ensure that any necessary records are made of Batch Numbers It is an individual s professional responsibility to update themselves on this policy on an at least annual basis. It is the responsibility of all staff to ensure they adhere to best practice Version 1.0 January 2015 4

5.0 Definitions PRESCRIBER DOCTOR PHARMACIST NURSE VACCINE LIVE ATTENUATED VACCINE INACTIVATED VACCINE DETOXIFIED ENDOTOXINS (TOXOIDS) PGD A registered healthcare practitioner who is authorised to prescribe a medicinal product in accordance with legal and professional restrictions A fully or provisionally registered person within the meaning of the Medical Act, 1983. Any person registered in the Register of Pharmaceutical Chemists maintained under the Pharmacists & Pharmacy Technicians Order, 2007. Any qualified practitioner registered with the Nursing and Midwifery Council A special preparation of antigenic material that can be used to stimulate the development of antibodies and thus confer active immunity against a specific disease or a number of diseases A vaccine produced by culturing a virus or bacteria under conditions that lead to a loss of virulence but not antigenic properties. Use produces a durable immunity, but which is not always as long lasting as that of the natural infection. When 2 live vaccines are required (and are not available in a combined preparation) they should be given either simultaneously at different sites or separated by an interval of at least 3 weeks. Viral examples include rubella and measles, bacterial examples include BCG Inactivated preparations of a virus (e.g. influenza) or bacteria (e.g. typhoid). May require a primary series of injections of vaccine to produce adequate antibody response, and in most cases a booster injection is needed. The duration of immunity lasts from months to many years. Some are adsorbed onto an adjuvant (e.g. Aluminium hydroxide) to enhance antibody response. Specially treated toxins produced by microorganism e.g. tetanus Patient Group Directions. PGDs are written agreements for the supply and administration of medicines to groups of patients who may not be individually identified before presentation for treatment. 6.0 Ordering, Receipt, Storage, Distribution and Disposal of Vaccines 6.1 Importance of the Cold Chain Maintaining the cold chain ensures that vaccines are transported and stored until the point of administration according to the manufacturers recommended temperature range which is normally +2 C to +8 C. The cold chain is standard practice throughout the pharmaceutical industry for vaccines. Sensitivity to heat and cold Do NOT freeze vaccines: Freezing may cause increased reactogenicity and loss of potency rendering the vaccine useless. Can also cause hairline cracks in containers, leading to contamination of contents. Version 1.0 January 2015 5

Potency and effectiveness cannot be guaranteed unless vaccines have been stored between +2C and +8 C. If vaccine has been exposed to temperatures outside the recommended storage range: Do not administer Discard or salvage stock as advised by manufacturer or Trust pharmacy advisor Complete a vaccine refrigerator incident form & send to Pharmacy Dept Notify patients if re-vaccination is required 6.2 Named person responsible for receipt, storage and record keeping of vaccines (vaccine monitor see 4.2) Each ward, clinic or home (where relevant) must have a trained individual responsible for the ordering, receipt and storage of vaccines and for the recording of refrigerator temperatures (vaccine monitor). Any other staff who may be involved with vaccines must be trained appropriately. It is good practice to identify the vaccine monitor (and deputy) with a label fixed on, or close by, the fridge 6.3 Ordering vaccines The vaccine monitor is responsible for managing the vaccine and Adrenaline orders. Some vaccines are packed in multiple packs; take care that the correct quantity is ordered to avoid waste. Two to four weeks supply of vaccines at any one time is normally sufficient. Best practice is to order smaller quantities on a regular, scheduled basis. Records of orders & delivery to be maintained (appendix 1) Excess stock may: increase the risk of vaccination with out-of-date vaccines increase wastage and cost of disposal by incineration increase the dangers of over-packed refrigerators leading to poor air flow, potential freezing and poor stock rotation delay the introduction of new vaccines until local supplies have been used increase the cost of replacement of stocks if the refrigerator fails increase the pressure on clinic refrigerators in periods of high demand, e.g. during the influenza vaccination season. 6.4 Receipt of vaccines When vaccines are delivered, staff (ideally the vaccine monitor) must check the vaccines against the order for leakage, damage and discrepancies before signing for them. Vaccines must be refrigerated immediately on receipt and not be left at room temperature. Vaccine type, brand, quantity, batch numbers and expiry dates must be recorded with the date and time at which they were received. (See Appendix 1, this record sheet should be kept with the Drug Fridge records) The name of the person checking the delivery must also be recorded. The vine refrigerator 6.5 The vaccine fridge drug fridge Version 1.0 January 2015 6

Specialised fridges, for storage of pharmaceutical products, are recommended for vaccines and diluents. They should be: Capable of measuring maximum and minimum temperatures within the fridge cabinet Fitted with an external digital minimum and maximum memory display Capable of automatic defrosting Secured with an integral locking system (which complies with Control of Substances Hazardous to Health (COSHH) regulations. Ordinary domestic refrigerators must NOT be used except in an emergency. Food, drink and clinical specimens must NOT be stored in the same fridge as vaccines. Opening of the refrigerator door should be kept to a minimum. Back-up facilities should be available in case the fridge fails or breaks-down (staff must be aware of the procedure) Do not site the fridge near a radiator or any heat source that could affect it Make sure that it is appropriately ventilated. NB. When vaccines are to be stored very infrequently and for very short periods (i.e. Flu immunizations) it is acceptable that a standard drug fridge is used provided that temperature records are recorded daily and the temperature is within approved limits (see MP1 SOP ) 6.5.1 Security of vaccines in the fridge Vaccines are Prescription Only Medicines (POMs) and must be stored under locked conditions. Fridges must either be lockable or within a room that is locked when not occupied by a member of staff. A lockable fridge is essential if the public could have direct access to the fridge. 6.5.2 Defrosting Do not allow ice to build up within the fridge as this reduces effectiveness. If the fridge is not an auto-defrost fridge it should be defrosted regularly (monthly) during which vaccines should be stored temporarily in another fridge or in an pharmacy approved cool box After defrosting, vaccines should only be replaced once the refrigerator has returned to the correct temperature. Refrigerator thermometers N.B. If any problems occur, such as accidental switching off, power failure etc, please contact the Pharmacy Team for advice. In these circumstances, avoid opening the door of the fridge. 6.6 Fridge thermometers Drug fridge temperatures must be continually monitored and recorded at least once each working day, and before an immunization session. An independent maximum and minimum thermometer, located within the fridge cabinet should be used to independently monitor fridge temperatures. The probe sits in the back of the fridge and the maximum and minimum readings can be read off the display, which sits on the top. This procedure is good practice for care of any drug fridge. Version 1.0 January 2015 7

An example of a chart for recording the temperatures is at Appendix 3. The record should be readily accessible for easy reference and retained until the next audit. 6.7 Storage of vaccines Keep vaccines in their original packaging so batch numbers and expiry dates are available and the packaging can protect against light and temperature changes Vaccines are very sensitive to strong light, and exposure to UV light will cause loss of potency, so they must always be protected against light. Do not pack in the fridge too tightly. The space used by stock must be 75% or less. This allows the air to circulate inside the fridge Do not store in or against any freezer compartment. Do not store in any trays attached to the fridge door or the bottom drawer as these may be outside the +2C to +8 C range. Ensure that any information, which reduces the risk of an incorrect vaccine being administered, is clearly visible to all practitioners. 6.8 Packing and transporting vaccines to outlying clinics /departments Transport the minimum amount of vaccine needed. Use an approved vaccine cool box/bag for transit and storage for the session. N.B domestic cool bags are not suitable for this purpose. Remove/open the lid as little as possible Return un-constituted or untouched multi-dose vials vaccines to the fridge as soon as possible. Place at the front of the stock and use first at the next session. 6.9 Cool Boxes Do NOT use a domestic cool box to store, distribute or transport vaccines. Use validated and appropriate cool boxes and ice packs from a recognised medical supply company and strictly adhere to manufacturers instructions Keep vaccines in original packaging, wrapped in bubble wrap (or similar insulation material) and place into a cool box with cool packs as recommended by the manufacturers. This will prevent direct contact between the vaccine and the cool packs and protects it from any damage. ld chain 6.10 Expiry dates Check expiry dates on receipt of vaccines report abnormalities immediately. Check expiry date before taking vaccines to a session and check again before drawing up and administering. Use the following guidance when checking expiry dates (Reference MHRA): Batch: 12585H Batch: 68689Y Batch: 2299J EXP: 10/2007 EXP BY: 10/2007 USE BY: 10/2007 EXP BEFORE: 10/2007 Version 1.0 January 2015 8

Expiry would be 31/10/2007 Expiry would be 30/9/2007 Expiry would be 30/9/2007 Expires MM/YYYY: Use by MM/YYYY: vaccine can be used until the last day of MM/YYYY vaccine must be used by the last day of the month preceding MM/YYYY Vaccine stocks should be stored within the refrigerator so that those with shorter expiry dates are used first. Any out-of-date stock should be labelled clearly, removed from the refrigerator and destroyed as soon as possible according to the local procedure. Vaccines must NEVER be used when past their expiry date. Storage of vaccines 6.11 Spillage of vaccine Spillage Spillages must be cleared up quickly and gloves should be worn. The spillage should be soaked up with paper towels, taking care to avoid skin puncture from glass or needles. The area should be cleaned according to COSHH safety data sheets. Gloves, towels, etc. should be placed in an orange bag for incineration. If the spillage involves broken glass, use of a spill kit is recommended as good practice. Spillages on skin should be washed with soap and water. If vaccine is splashed in the eyes, they should be irrigated with sterile 0.9% sodium chloride solution and medical advice sought. sposal of vaccines 6.12 Disposal of vaccines Unused reconstituted vaccines or partly used multidose vials must be disposed of at the end of any session (Yellow Sharps Box). At the end of any session, any prepared vaccine or partly used multidose vials must be disposed of by sealing in a proper, puncture-resistant yellow sharps box (UN approved, BS 7320). The sharps container should be replaced once it is two-thirds full and should not be accessible to any unauthorised individual. 7.0 Safe use of vaccines 7.1 Skin preparation If the skin is clean, no further cleaning is necessary. Only visibly dirty skin need be washed with soap and water. It is not necessary to disinfect the skin. Studies have shown that cleaning the skin with isopropyl alcohol reduces the bacterial count but there is evidence that disinfecting makes no difference to the incidence of bacterial complications of injections (Sutton et al., 1999). If alcohol or other disinfecting agents are used, they must be allowed to dry before injection of vaccine because they could inactivate live vaccine preparations eg MMR, Rubella, BCG. 7.2 Record keeping Version 1.0 January 2015 9

Record of vaccination should be documented and include: Date of vaccination Vaccine name, brand name, batch number and expiry date of vaccine Site/s used including clear description of which injection was administered in each site, especially where two injections were administered in the same limb Name of person administering the vaccine Any special advice offered to the patient. Any side-effects noted (at time of vaccination or at a later time, provide details). Additional comments, which may include adverse reaction, report, incident report etc. This information should be recorded in one or more of the following as appropriate: Trust medical records. Prescription chart. (For ward patients, record batch number given against signature on prescription sheet.) Immunisation record ledger (for BBV nurse) Flu vaccine consent & record chart (see Seasonal Influenza policy) 7.3 Adverse reactions An adverse reaction is a reaction in an individual specifically caused by a particular vaccine. It may be an induced, direct effect of the vaccine or one of its components, and/or may be due to an underlying medical condition or an idiosyncratic response in the recipient. Records should be made of adverse incidents in the patients medical notes, on a Trust incident report and via the Yellow Card reporting system. Blank copies of the yellow card forms should be kept near to the drug fridge, they are also to be found at the back of the BNF books. Yellow Cards / Reports can be completed by any doctor or nurse involved with the immunization. Yellow cards should be posted to the Medicines Control Agency (address on bottom of yellow card) a photocopy of the form should be attached to the Trust incident report. A report can also be completed on-line on the MHRA website at www.yellowcard.gov.uk Adverse events and incident reporting A BCPFT incident report should be completed following an adverse incident such as: wrong dose of vaccine used vaccines used beyond expiry date vaccines administered at inappropriate intervals inappropriate route, site or technique of administration used vaccine reconstituted with incorrect diluent wrong amount of diluent used vaccine prepared incorrectly inappropriate combinations of vaccines mixed drugs substituted for vaccine or diluent vaccine or diluent contaminated vaccine stored incorrectly contraindications not elicited or ignored reconstituted vaccine kept beyond the recommended period. 7.4 Managing side-effects Where relevant patients should be given advice about the side-effects that they can expect and how such events should be managed. Version 1.0 January 2015 10

Leaflets on vaccinations are provided by the Department of Health; these give information about side-effects and include advice on their management. Local reactions are usually self-limiting and do not require treatment. If they appear to cause discomfort, then Paracetamol or Ibuprofen can be given. NB. Note that people may develop a cold with coryzal symptoms following flu vaccination. Flu vaccine does not prevent the common cold, and colds are common in the winter when people are receiving flu vaccine. 7.5 Patient Group Directions (PGD) Only nurses approved under the appropriate BCPFT Patient Group Direction (PGD) are authorised to administer a vaccine if it is not specifically prescribed for an individual patient. PGD s authorised for use in BCPFT have been approved by the BCPFT Drugs and Therapeutics Committee. Nurses accredited under a PGD must have their own individual copy of each PGD for which they are accredited. It is the nurse s individual responsibility to ensure he/she is accredited to administer under a valid PGD, which includes a copy of the signatures of the authorising doctor, pharmacist and Director of Nursing and Risk. The Director of Nursing and Risk and the BCPFT Chief Pharmacist manage the process for development of PGDs and accreditation of practitioners. A nurse may not administer any vaccine under a PGD if he/she is not also accredited to administer adrenaline for anaphylaxis under a PGD. 7.6 Patient Specific Prescriptions Vaccines may be administered using a patient specific prescription authorised by a doctor. This will be required for administration of flu vaccines to patients taking Warfarin or Theophyllines which may not be administered under a PGD. 7.7 Anaphylaxis management All medical and nursing staff involved in immunisation should be able to distinguish an anaphylactic reaction from fainting (syncope) and panic attacks. Fainting is relatively common when vaccinating adults and adolescents (but infants and children rarely faint). A strong central pulse persists during a faint or convulsion. 7.7.1 Nurses responsible for running a vaccine session should ensure: An anaphylaxis pack is available The pack should be checked regularly to ensure it is in-date A nurse authorised by PGD to use adrenaline injections if a doctor is not available. 7.7.2 Equipment for anaphylaxis: two ampoules of adrenaline (epinephrine) 1:1000 four green needles (for drawing up) four blue needles (for administration) and four graduated 1 ml syringes Laerdal or equivalent masks suitable for adults. Version 1.0 January 2015 11

7.7.3 Immediate action if anaphylaxis is suspected Send for additional health professional assistance Send a responsible adult to dial 999 & state there is a case of suspected anaphylaxis Never leave the patient unattended Lie the patient down, ideally with the legs raised (unless the patient has breathing difficulties) Administer oxygen if available (see oxygen policy) If breathing stops, mouth to mouth/mask resuscitation should be performed All patients with clinical signs of shock, airway swelling or definite breathing difficulties should be given adrenaline (epinephrine) 1:1000 administered by intramuscular injection (never subcutaneously). For information on dosage to be given see below. The preferred site is the mid-point of the anterolateral aspect of the thigh (Simons et al., 1998). If there is no clinical improvement, the dose may be repeated once after five minutes. Further doses of adrenaline can be given if needed. Because of the possibility of delayed reactions, individuals who have had an anaphylactic reaction should be sent to hospital, even though they may appear to have made a full recovery. An airway should only be used by properly trained and competent health professionals, and only in unconscious patients. 7.7.4 Adrenaline (Epinephrine) Adrenaline (epinephrine) is dispensed as 1:1000 (1mg/ ml) solution The appropriate dose of adrenaline should be administered immediately by intramuscular (IM) injection. If there is no clinical improvement, the dose given may be repeated after about five minutes. In some cases, several doses may be needed at 5-minute intervals according to BP, pulse and respiratory function, particularly if improvement is transient. Dose of adrenaline (epinephrine) by IM injection for anaphylactic shock should be administered as; Adults and adolescents 500 micrograms IM (0.50ml) Auto-injectors for self-administration of adrenaline should not be used as a substitute for a proper anaphylaxis pack. Cautions Patients taking beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors should receive 50% of the usual dose of adrenaline because of a potentially dangerous drug interaction. Although cocaine may interact with adrenaline, anaphylaxis is sufficiently rare to not recommend either withholding immunisation or undertaking routine questioning about recreational drug use in individuals attending for vaccination. In the unlikely event of collapse in someone who is suspected of having recently taken cocaine, adrenaline should be used only with extreme caution and using the reduced dose as above. Version 1.0 January 2015 12

Current UK resuscitation guidelines are provided by The UK Resuscitation Council www.resus.org.uk 7.8 Consent The giving and obtaining of consent is viewed as a process, not a one-off event. There is no legal requirement for consent to be in writing and a signature on a consent form is not conclusive proof that consent has been given, but serves to record the decision and the discussions that have taken place with the patient. 7.8.1 Recording consent Those who are capable of giving consent may do so in writing, orally or by cooperation. Completion of a consent form is not a legal requirement for immunisation. A signature on a consent form does not itself prove that the consent is valid but it does serve to record the decision that was reached, and the discussions that have taken place. The Bristol Royal Infirmary Inquiry Final Report (2001) (www.bristol- inquiry.org.uk ) reported that too great a regard is paid to the symbolic act of signing a piece of paper rather than to the real task which involves explaining what is to take place. Provided they have clearly not refused the treatment in advance, you may treat an adult who is unable to consent if the treatment would be in their best interests, e.g. in a nursing home situation where the risk of influenza could compromise the individual s health. This decision would be made by the patient s doctor in discussion with those close to the patient, in line with the Mental Capacity Bill (see www.publications.parliament.uk) Consent 8.0 Training Nurses who undertake vaccination and immunisation, assume professional accountability as outlined in the NMC Guidelines for Professional Practice and should ensure that they keep up to date with all aspects of immunisation. The Department of Health, Immunisation against Infectious Disease 1996 says that a doctor who delegates the task of Immunisation to a nurse also has responsibility to see that they are adequately trained and have opportunity for regular updates. BCPFT expects that nurses involved in immunisation will undertake modules in Immunisation and Vaccination and Anaphylaxis and Basic Life Support. These are available through University of Central England. 9.0 Audit The Pharmacy Team/ICNS will undertake regular audit of temperature monitoring & compliance with this policy using the tool seen in appendix 7. BCPFT will audit adherence to this policy as part of medicines risk management procedures. 10.0 References BNF Number 58 (September 2009) The Green Book, DOH 2006 (all updates available online http://www.dh.gov.uk/en/publichealth/healthprotection/immunisation/greenbook/dh_ 4097254 Sutton CD, White SA, Edwards R, Lewis MH. (1999). A prospective controlled trial of the efficacy of isopropyl alcohol wipes before venesection in surgical patients. Annals of the Royal College of Surgeons England 81(3): 183-6. Version 1.0 January 2015 13

Temperature sensitivity of vaccines 2006, World Health Organisation http://www.who.int/vaccines-documents/docspdf06/847.pdf Vaccine Cold Storage January 2010, National Patient Safety Agency For pharmaceutical queries, please contact the BCPFT pharmacist. Version 1.0 January 2015 14

Appendix 1 Safe Handling & Storage of Vaccines VACCINE ORDER & DELIVERY RECORD CHART This chart should be kept with the Temperature Record Chart wherever vaccines are ordered. A separate sheet for each type of vaccine should be maintained e.g. Seasonal Influenza, HBV,etc. Any abnormalities should be immediately reported to the Pharmacy Team. DRUG NAME: Quantity Date of ordered Order & Signature Date Received (delivery) Time Received Quantity received Record all Batch Numbers Condition & Expiry Date Date & Time refrigerated Signature Version 1.0 January 2015 15

Appendix 2 Safe Handling & Storage of Vaccines VACCINE COLD CHAIN AUDIT TOOL WARD/DEPT: DATE: TIME: Name & position of person-in-charge at time of visit VACCINES CURRENTLY HELD IN STOCK - NAME of AUDITOR: COMPLIANCE Yes / No / Partial Yes / No No Question 1 Is there a named individual who is responsible for: Ordering vaccines Receiving vaccines Monitoring the storage & administration of vaccines YES NO Comments/evidence 2 Is there a named deputy who is responsible for the above the named persons absence? 3 Are the following available? Safe handling & storage of vaccines policy Immunisation against infectious disease (Green Book) - access via the internet RECEIPT 4 Are the deliveries signed for on receipt 5 Are the vaccines stored immediately on receipt (in fridge) 6 A record is kept of the manufacturers name, batch number & expiry date? No Question YES NO Comments/evidence Version 1.0 January 2015 16

STORAGE 7 Are the vaccines stored in a medical/pharmaceutical refrigerator? 8 Is the refrigerator lockable or is in a room which is lockable? 9 Is the refrigerator located in an area with restricted public access? 10 Is the refrigerator not situated near a heat source? 11 Is there enough space for air to circulate freely around the back of the refrigerator? 12 Is the refrigerator plug secured to the wall and or labelled Do not switch off or similar? 13 The temperature of the refrigerator is recorded by a minimum/maximum thermometer? 14 Is the thermometer calibrated annually? 15 Are the following storage temperatures monitored & recorded at the beginning of each working day? Maximum temperature over the last 24 hours Minimum temperature over the last 24 hours Actual temperature at time of checking? 16 Is the thermometer reset after each reading is made? 17 Does the refrigerator (or thermometer) have an alarm which is activated when the temperature exceeds +8 C or falls below +2 C? 18 Is the refrigerator serviced on a regular basis in line with the manufacturers instructions & are records kept? 19 If NO state where manufacturer s instructions are stored 20 Is the refrigerator checked, defrosted & cleaned on a monthly basis and are records kept? 21 Are vaccines kept in an insulated box/bag (cool box) or alternative refrigerator when the refrigerator is defrosted? 22 Is the refrigerator dedicated to vaccine storage? 23 Are the contents evenly distributed within the refrigerator to allow air to circulate? 24 Is the stock rotated according to expiry date? No Question YES NO Comments/evidence Version 1.0 January 2015 17

25 Is there any out of date stock in the refrigerator? 26 Are vials or ampoules stored in original packaging? 27 Are vaccines stored correctly (i.e. not in the door or touching the sides of the fridge) ADMINISTRATION of VACCINES 28 Is Adrenaline / Epinephrine, together with advice on symptoms & management of anaphylactic shock available during every immunisation session? 29 Is the expiry date of the drugs checked before each vaccination session? 30 When vaccines are to be administered away from base are they removed from the base refrigerator immediately before leaving for the session? 31 At the end of the session away from base are the vaccines returned immediately to the base refrigerator? 32 Are all vaccines required for the session taken from the refrigerator at the same time? 33 Are vaccines left out of the refrigerator for longer than 3 hours? 34 When vaccines are taken to an outside clinic location are vaccines carried in a suitable cool box? 35 Are freeze-dried vaccines reconstituted immediately prior to use and used within the manufacturer s recommended period? 36 Are open multi-dose vials disposed of at the end of the session, or if the manufacturers recommended period has expired, whichever is soonest? 37 Is the identity of the vaccine and expiry date checked prior to administration? 38 Is the date of vaccination, name of vaccine, name of manufacturer, batch number of vaccine and dilutent recorded in the patient's notes? 39 Are unused vaccines from a clinic session clearly marked as having been out of the refrigerator? 40 Are all such vaccines used first next time? 41 When vaccines have been removed from the refrigerator twice and are still unused are they then destroyed? No Question YES NO Comments/evidence Version 1.0 January 2015 18

DISPOSAL 42 Are vaccines disposed of by incineration? 43 At the end of the vaccination session are any opened multi-dose vials or prepared unused vaccines sent for disposal? 44 Are any vaccines that have reached their expiry date disposed of according to local policy (incineration)? HAZARD / INCIDENT REPORTING 45 Are all disruptions to the cold chain reported in line with Trust policy? 46 Are all vaccine related incidents reported & investigated? 47 Are suspected Adverse Drug Reactions reported via the Yellow Card Scheme? COMMENTS Version 1.0 January 2015 19

Policy Details Title of Policy Safe Handling & Storage of Vaccines Unique Identifier for this policy State if policy is New or Revised New Previous Policy Title where applicable Policy Category Clinical, HR, H&S, Infection Control etc. Executive Director whose portfolio this policy comes under Policy Lead/Author Job titles only Committee/Group responsible for the approval of this policy Month/year consultation process completed * Clinical Executive Director of Nursing, AHPs and Governance Chief Pharmacist Month/year policy approved January 2015 Month/year policy ratified and issued January 2015 Next review date February 2016 Medicines Management Committee Implementation Plan completed * Equality Impact Assessment completed * Previous version(s) archived * Disclosure status Yes Yes Yes B can be disclosed to patients and the public Key Words for this policy * For more information on the consultation process, implementation plan, equality impact assessment, or archiving arrangements, please contact Corporate Governance Review and Amendment History Version Date 1.0 January 2015 Details of Change Reformatted to meet new Trust policy template Version 1.0 January 2015 20