IMMUNISATION AND BEST PRACTICE GUIDELINE January 2013

IMMUNISATION AND BEST PRACTICE GUIDELINE

January 2013 Responsable Director Dr Syed Ahmed Approved by Immunisation Liaison Group Date of approval August 2012 Date for review January 2015 Replaces previous version (if applicable) Immunisation Resource Pack 2008 Version Final

Produced by the Public Health Protection Unit NHS Greater Glasgow and Clyde

West House Gartnavel Royal Hospital 1055 Great Western Road

Glasgow G12 0XH

Tel: 0141 201 4917

This document can be downloaded from www.nhsggc.org.uk

Contents

Pg Introduction 4 Abbreviation Glossary 5 Section 1 Immunisations – Routine and Otherwise 1.1 Timetable of Routine Childhood Immunisations 6/7 1.2 Routine Tetanus, Diphtheria and Polio Immunisation

Schedules 8

1.3 Tetanus‐containing Vaccines and Human Tetanus Immunoglobulin

9

1.4 Individuals with Uncertain or Incomplete Immunisation Status

11

1.5 Hepatitis B Immunisation of ‘At‐risk’ Infants 14 1.6 BCG 15 1.7 Travel Health and Travel Clinics 16 Section 2 Immunisation Management 2.1 Consent 17 2.2 Scottish Immunisation Recall System (SIRS) 19 2.3 Patient Group Directions (PGDs) 21 2.4 Correct Administration of Vaccines and Documentation 23 2.5 Operational Standards for Immunisation Clinics 27 2.6 Vaccine Error and Reporting 28 2.7 Immunisation Audit 29 2.8 Accountability and Responsibility 32 Section 3 Immunisation – Further Help 3.1 Frequently Asked Questions 34 3.2 Immunisation e‐learning 40 3.3 Internet and Reading Resources 41 Section 4 Ordering, Storage and Handling Vaccines 4.1 Background 43 4.1.1 Guidance and Policies 43 4.1.2 Purpose of Guidelines and Ordering Support Material 44 4.2 Main Recommendations 45 4.2.1 Summary of Recommendations 45 4.3 Ordering 46 4.3.1 Who Supplies Vaccines 46 4.3.2 How to Order 47 4.4 Receipt 49 4.5 Storage and Equipment 50 4.5.1 Storage 50 4.5.2 Stock Management and Rotation of Stock 51

4.5.3 Fridge Use and Specifications 52 4.5.4 Thermometer Specifications 55 4.6 Temperature Monitoring 56 4.6.1 Roles and Responsibilities 56 4.6.2 Monitoring and Recording Temperatures 56 4.6.3 Setting Temperature Alarm Parameters 57 4.6.4 Action in the Event of Abnormal Temperatures 57 4.6.5 Assessment and Response to Incidents 59 4.6.6 Contingency Arrangements 61 4.7 Transportation 62 4.7.1 From Holding Centres to Practices 62 4.7.2 From Practice to another Location 62 4.7.3 During Clinic within Practice 62 4.8 Disposal 63 4.9 Spillage 63 4.10 Recall 63 4.11 Support Materials 64 4.11.1 Fridge Magnets and Temperature Charts 64 4.11.2 NHSGGC Equipment Guidance 65 4.11.3 Vaccine Refrigerator Incident Checklist 72 4.11.4 Training 72 4.12 References 73 Appendix 1: Refrigerator Information Guide 74

Introduction

This Immunisation and Best Practice Guideline has been recently updated to assist staff within Greater Glasgow and Clyde involved in immunisation within the community. This guideline is designed to provide information and support to staff in the management of these clinics. This is not an exhaustive guideline but designed to be added to by individuals and used by staff to support their continuing professional development. Information changes frequently and so some internet resources are listed to provide links for further information. In addition, guidance and information will be circulated via CMO letters and Public Health Protection Unit (PHPU) newsletters. http://www.nhsggc.org.uk/content/default.asp?page=s1843_7 More detailed general information about vaccination and individual vaccines are given in the Immunisation Against Infectious Disease http://www.dh.gov.uk/en/Publichealth/Immunisation/Greenbook/index.htm

and it is strongly recommended that all staff involved in immunisation are familiar with the on‐line version of the Green Book before undertaking immunisation clinics.

Dr Syed Ahmed Immunisation Co‐ordinator

NHS Greater Glasgow and Clyde

http://www.dh.gov.uk/en/Publichealth/Immunisation/Greenbook/index.htm

Abbreviation glossary

A A&E ‐ Accident and Emergency

B BCG (Tuberculosis) ‐ Bacille Calmette–Guérin

C CMO ‐ Chief Medical Officer CPC ‐Community and Preventive Care CHI ‐ Community Health Index CHP ‐ Community Health Partnership CHCP ‐ Community Health Care Partnership CHSP/PS ‐ Child Health Surveillance Programme Pre‐School CHSP/S ‐ Child Health Surveillance Programme‐School

D

E

F

G GP ‐ General Practitioner GPASS ‐ General Practice Administration System for Scotland,

H HV ‐ Health Visitor HVFVR ‐ Health Visitor First Visit Report HPS ‐ Health Protection Scotland

I IDU ‐ Injecting Drug User IPV ‐ Inactivated Polio Vaccine

J

K KSF ‐ Knowledge & Skills Framework

L

M MMR ‐ Measles, Mumps and Rubella

N NMC ‐ Nursing and Midwifery Council NES ‐ NHS Education Scotland NSS ‐ NHS National Services Scotland

O OPV ‐ Oral Polio Vaccine

P PHPU ‐ Public Health Protection Unit PGD ‐ Patient Group Directions PCHR ‐ Personal Child Health Record PDC ‐ Pharmacy Distribution Centre PAT ‐ Portable Appliance Testing PPH ‐ Pharmacy Public Health PPSU ‐ Pharmacy Prescribing Support Unit

Q

R

S SIRS ‐ Scottish Immunisation Recall System SPC ‐ Summary of Product Characteristics SOP ‐ Standing Operational Procedure

T TB ‐ Tuberculosis

U

V

W WHO ‐ World Health Organisation

X

Y

Z

Section 1: Immunisations – Routine and Otherwise 1.1. Timetable of Routine Childhood Immunisations

1.2. Routine Tetanus, Diphtheria and Polio Immunisation Schedules

1. Children aged 10 years and over and adults requiring tetanus immunisation should now receive combined adsorbed tetanus/low dose diphtheria and inactivated polio vaccine (Td/IPV).

2. A full course of tetanus immunisation consists of a minimum of 5 doses of tetanus‐containing vaccine at intervals as follows:

Schedule Children < 10 years Adults and children > 10 years

Primary Course

3 doses of vaccine (usually as DTaP/IPV/Hib) at 2, 3 and 4 months of age

3 doses of vaccine (as Td/IPV) each one month apart

1st booster dose = 4th dose

Ideally 3 years after the primary course, usually pre‐school entry (as DTaP/IPV OR dTaP/IPV) (can be given 1 after year primary course)

1 ‐ 5 years after last dose should receive further dose of Td/IPV (4th dose)

2nd booster dose = 5th dose

Aged 13 ‐ 18 years ideally 10 years after 1st booster (as Td/IPV) (can be given 5 years after 4th dose)

Ideally 5 ‐ 10 years give 2nd booster (5th dose) (as Td/IPV)

3. Older adults may be unimmunised and at particular risk. Opportunities should be taken to

check their immunisation status when attending surgery, for example for their influenza immunisation, and complete the recommended 5 dose schedule. Td/IPV can be given at the same time as influenza vaccine in a different arm.

4. For travellers to areas where medical attention may not be accessible should a tetanus prone

injury occur and whose last dose of a tetanus containing vaccine was more than 10 years previously, a booster dose should be given prior to travelling, even if the individual has received 5 doses of vaccine previously. This is a precautionary measure in case immunoglobulin is not available to the individual should a tetanus prone injury occur. Where tetanus, diphtheria or polio protection is required and the last dose was more than 10 years before, Td/IPV should be given.

1.3. Tetanus‐containing Vaccines and Human Tetanus Immunoglobulin Tetanus as a single vaccine is no longer in use and is only available as part of a combined product. Following injury (e.g. wounds, burns, compound fractures) selection of the most appropriate tetanus‐containing vaccine will depend on the age and immunisation status of the patient. This chart provides guidance on when to use tetanus‐containing vaccines and human tetanus immunoglobulin, and on the selection of the most appropriate vaccine.

1. Assess immunisation status

Immunisation status should be assessed following thorough cleaning of the wound.

The UK tetanus immunisation schedule consists of the following:

Primary immunisation with three doses of tetanus‐containing vaccine, at least 1

month apart, usually given at 2,3 and 4 months of age

1st booster dose of tetanus‐containing vaccine ideally 3 years after primary course

2nd booster dose of tetanus‐containing vaccine ideally 10 years after 1st booster

Patients should be considered fully immunised if they have received a total of 5 doses of tetanus‐containing vaccine at appropriate intervals.

2. Give tetanus‐containing vaccine and/or human tetanus immunoglobulin if required

Immunisation Status Vaccine

Human tetanus immunoglobullin2

Fully immunised (see definition above) or primary immunisation complete, boosters up to date

None required

Give human tetanus immunoglobulin1 only if high risk tetanus‐prone injury (see Box A)

Primary immunisation complete, boosters NOT up to date

Required for all injuries:

Child under 10 years ‐

give dTaP/IPV3 (Repevax) or DTaP/IPV2 (Infanrix‐IPV)

Adults and children aged 10 years and over ‐

give Td/IPV (Revaxis)

Give human tetanus immunoglobulin1 if tetanus‐prone injury (see Box A) Note: should be given in a different site from vaccine

Primary immunisation incomplete or unimmunised or immunisation status unknown / uncertain

Required for all injuries:

Child under 10 years ‐

give DTaP/IPV/Hib2 (Pediacel)

Adults and children aged 10 years and over ‐

give Td/IPV2 (Revaxis)3

Give human tetanus immunoglobulin1 if tetanus‐prone injury (see Box A) Note: should be given in a different site from vaccine

3. Refer (if appropriate) to GP or Pubic Health for completion of tetanus immunisation

Primary immunisation now complete and boosters up to date:

No further action required

Primary immunisation incomplete or vaccination status unknown:

Refer to GP for follow‐up and completion of immunisation

If GP details not available refer to Public Health (details opposite)

Public health referrals should be made by fax or telephone to:

Public Health Protection Unit

GGCNHS Board

Telephone: 0141 201 4917

Fax: 0141 201 4950

Please supply patient’s name, date of birth, address, and details of vaccination given in A&E

1 Dosage of human tetanus immunoglobulin: 250 units by IM injection. Increase to 500 units if more than 24 hours have elapsed or there is risk of heavy contamination of following burns. 2 D=diphtheria toxoid; d=diphtheria toxoid (low‐dose); T=tetanus toxoid; aP=acellular pertussis vaccine; IPV=inactivated poliomyelitis vaccine; Hib=Haemophilus influenza type b vaccine

Box A: Tetanus‐prone and high risk injuries/groups

a) Tetanus‐prone injuries include:

wounds or burns requiring surgical intervention, if surgery is delayed > 6 hours

wounds or burns that have a significant degree of devitalised tissue or are puncture‐type (particularly when in contact with soil or manure)

wounds containing foreign bodies

compound fractures

wounds or burns in patients who have systemic sepsis

b) A wound or burn is considered high risk if:

there is heavy contamination with material likely to contain tetanus spores (e.g. soil or manure) and/or there is extensive devitalised tissue

Injecting drug users

Injecting drug users (IDUs) may be at risk from tetanus‐contaminated illicit drugs, particularly when they have sites of focal infection, such as skin abscesses, that may promote growth of anaerobic organisms. Every opportunity should be taken to assess the immunisation status of IDUs, and to give tetanus‐containing vaccine (Revaxis) if immunisation is incomplete or status uncertain.

1.4. Individuals with Uncertain or Incomplete Immunisation Status

General Principles of Vaccination of Individuals with Uncertain or Incomplete Immunisation Status

Unless there is a reliable vaccine history, individuals should be assumed to be unimmunised and a full course of immunisations planned

Individuals coming to the UK part way through their immunisation schedule should be transferred onto the UK schedule and immunised as appropriate for age

If primary course has been started but not completed, continue where left off – NO NEED TO REPEAT DOSES OR RESTART COURSE

IPV should be used to complete a vaccination course which may have been started with OPV (Oral Polio Vaccine)

aP should be used to complete a primary course which may have been started with whole cell pertussis vaccine

MenC/Hib combined vaccine can be used when Hib alone or Hib/MenC is required

A minimum of 1 year should be left between DTP/IPV primary course and 1st booster and a minimum of 5 years should be left between the 1st and 2nd boosters

Note: BCG and Hep B vaccine are not included in the above algorithm

1.5. Hepatitis B Immunisation of ‘At‐risk’ Infants

There are two groups of babies who are at increased risk of contracting hepatitis B infection:

Babies of mothers who are chronically infected with hepatitis B virus

Babies of mothers not known to be infected but who participate in high risk behaviour, e.g. injecting drug users, sex workers

Mothers are identified during pregnancy and the baby will begin a course of hepatitis B vaccine at birth in the hospital. The paediatrician will notify Child Health when the first dose of hep B vaccine (together with hepatitis B immunoglobulin if required) has been given to the baby. This means that the baby can be called and recalled for subsequent doses of hepatitis B vaccine to complete the course via SIRS. Child Health via SIRS will issue letters to both the GP/health visitor and the parent when the subsequent doses are due (1 month of age, 2 months and 12 months). After the GP/health visitor gives a dose of vaccine and informs Child Health, an automatic letter will be generated when the next dose is due. The system will also generate reminder letters for the GP/health visitor if Child Health is not been informed that the baby has received the 2nd, 3rd or 4th doses of vaccine. Babies born to mothers who are chronically infected with hepatitis B virus should have a blood sample taken at 12 months to check that they have not become infected with the virus. A paediatrician/GP can take this blood test. Babies born to mothers who are chronically infected with hepatitis B virus also require a pre‐school booster of hepatitis B vaccine. Child Health will send a letter to the GP/health visitor and parent about this booster. For further information please contact PHPU, 0141 201 4917.

1.6. BCG The programme of BCG vaccination formerly offered to all young people at school was discontinued in 2005. This is because the way TB (tuberculosis) affects the population has changed. When the school BCG programme was put in place in 1953, most cases of TB were in young people. Since that time the number of cases has fallen dramatically, and the disease now mainly affects people with specific risk factors for TB. Groups recommended for BCG vaccination include: Infants and young people under 16 years whose parents or grandparents were born in a

country where the annual incidence of TB is 40/100,000 or greater.

Previously unvaccinated new immigrants under 16 years of age from countries where the annual incidence of TB is 40/100,000 or greater.

Contacts of cases known to be suffering from active pulmonary TB.

See also Green Book chapter 32 for occupational recommendations. http://immunisation.dh.gov.uk/gb‐complete‐current‐edition/ The school catch‐up campaign organised by NHS Greater Glasgow and Clyde during 2007/08 identified unvaccinated children under 16 who required the BCG. This campaign will not be repeated. Any other children identified as requiring the BCG vaccination should be referred to one of the community clinics. For further information please contact PHPU, 0141 201 4917.

http://immunisation.dh.gov.uk/gb-complete-current-edition/

1.7. Travel Health and Travel Clinics

Health professionals can access the TRAVAX website at www.travax.scot.nhs.uk for advice on travel health. TRAVAX has been provided as a resource by the National Health Service since 1984 to help health care professionals who are advising patients on how to avoid illness when travelling abroad. The site provides detailed information on the illnesses specific to each destination. It is accessed through a log‐in address, the registration system is straightforward and the database easy to use. The public can use the Fit for Travel section at www.fitfortravel.scot.nhs.uk which provides good and updated information and links to a number of other websites including the Foreign and Commonwealth website which gives safety recommendations for travellers. Yellow Fever For information and a list of clinics providing yellow fever vaccination go to www.hps.scot.nhs.uk/yellowfever Travel Clinics

The Travel Clinic, Brownlee Centre, Gartnavel Hospital 0141 211 1074

Glasgow Occupational Health 0141 211 0422

Glasgow Airport 0141 848 4800

Parkside Clinic 0141 636 0054

Kinning Park 0141 429 0913

http://www.travax.scot.nhs.uk/

http://www.fitfortravel.scot.nhs.uk/

http://www.hps.scot.nhs.uk/yellowfever

Section 2: Immunisation Management 2.1. Consent Clinicians’ responsibilities To seek authorisation to proceed with immunisation from parent/guardian/patient at

each episode.

To provide the relevant verbal and written information to the parent/guardian/patient at an appropriate time to allow them to make an informed decision. This should include benefits and risks.

To obtain consent voluntarily: this means without pressure, deceit or under influence from family, health professionals or others.

To answer any questions the parent/patient may have about the immunisation. The Green Book provides comprehensive information on all vaccines.

To know that there is no legal requirement for consent to be in writing. Consent may be given in writing, verbally or by co‐operation.

To communicate effectively with other members of the healthcare team any knowledge and information you may have regarding parents/patients desires relating to immunisation.

Parental responsibility Mothers automatically have parental responsibility. Fathers also have parental

responsibility if they were married to the mother when the child was conceived or born or married to her later. An unmarried father who is the natural father can also acquire parental responsibility if named on the birth certificate (births registered on or after 4th May 2006).

The person with parental responsibility need not to be present for immunisation and

may be brought by for example by a childminder or grandparent. The clinician must be satisfied that the circumstances indicate that the person has the necessary authority i.e. the person with parental responsibility has previously indicated that they wish their child to be included in the programme and there is no indication that the parent has negative views of immunisation.

Patients’ rights Parents or those with parental rights have the right to decide whether their child is

immunised.

Children aged 16 or over are presumed to have decision making capacity.

Children under the age of 16 have the legal capacity to consent to immunisation where, in the opinion of the clinician, they have the capability of understanding its nature and consequences.

Children under 16 who do not have the capability to understand, a parent or adult with parental responsibility can make the decision on their behalf.

Children over 16 who lack the capacity to make decision regarding immunisation must be treated under Part 5 of the Adults with Incapacity (Scotland) Act 2000.

Parents/patients have the right to receive verbal and written information on immunisation.

Parents/patients have the right to change their mind.

For further information see ‘NHS Greater Glasgow and Clyde: Consent Policy on Healthcare Assessment, Care and Treatment; March 2011’ provides a comprehensive guide to consent.

http://staffnet/Corporate+Services/Clinical+Governance/Key+Information/CG_StrategiesPolicies_CM_050107.ht

m

http://staffnet/Corporate+Services/Clinical+Governance/Key+Information/CG_StrategiesPolicies_CM_050107.htm

http://staffnet/Corporate+Services/Clinical+Governance/Key+Information/CG_StrategiesPolicies_CM_050107.htm

2.2. Scottish Immunisation Recall System (SIRS) Why SIRS? The Scottish Immunisation Recall System (SIRS) was introduced to ensure that all pre‐school children are invited to receive full courses of all routine primary and booster immunisations. The main benefits are: a) The automated call and recall of children for immunisation. b) The availability of standard reporting. c) Linkage with other Community and Preventive Care Systems (CPC) – including the

Community Health Index (CHI) and the Child Health Surveillance Programme Pre‐School (CHSP‐PS) and School (CHSP‐S).

d) The availability of information for statistical analysis. e) The generation of GP payment prints. Who uses SIRS? The two principal groups of users are the practice staff who administer immunisations and the screening department who facilitate the call/recall process which includes the recording of the immunisation results. The SIRS child event cycle This is a standard sequence of events applying to all children who are registered on SIRS from notification of birth. After a child is registered on SIRS, the ‘Health Visitor First Visit Report’ (HVFVR) is produced with labels for the ‘Family Health Record’ and the ‘Personal Child Held Record’, which are sent to the health visitor attached to the GP practice as notified by the maternity hospital. On return of the completed HVFVR form the information is recorded onto the CHSP‐PS which automatically updates the mandatory SIRS data fields which includes the SIRS treatment centre number and any exceptions/refusals to immunisation. Children are then scheduled for immunisation in accordance with a predefined timetable and available practice sessions. The timing and frequency of these sessions is determined by the health care team who are involved in immunisation and can be changed by writing to Child Health. Children are given an appointment via a confidential invitation produced by SIRS, which is either sent to the child’s home, or sent to the practice for distribution. This informs the parent/carer where, when and what the child is due to attend for. The child’s treatment centre receives an immunisation schedule which lists the children appointed and immunisations due.

After the immunisation clinic, the completed schedule should be returned as soon as possible to Child Health where the page will be processed and the child’s record updated accordingly on the SIRS. The child would then be re‐scheduled where appropriate to the next available session. If you have any queries regarding this or any questions about SIRS, please do not hesitate to contact someone in the Child Health Team – Screening Department. Please see Section 3, Frequently Asked Questions for further information about SIRS

2.3. Patient Group Directions (PGDs)

Definition A PGD is defined as a written instruction for the sale, supply and/or administration of named medicines in an identified clinical situation. It applies to group of patients who may not be individually identified before presenting for treatment. Relevance to vaccines It could be argued that patients requiring vaccines may be identified before presentation for treatment and, therefore, PGDs are not appropriate for them. NHS Greater Glasgow and Clyde has considered this position carefully and concluded that as the prescribing channels for vaccine are sometimes unclear, PGDs should be established and used to provide clarity to the authorisation process and thus protect patients and staff. This decision is in line with most other Health Boards in this regard. The legal position Legislation changes in the form of amendments to the Medicines Act 1968 were required to allow PGDs to be used legally. These changes came into effect in 2000. PGDs unlike guidelines, protocols, procedures and polices are LEGAL documents and need to be considered in this way. They need to be very robust and safe documents and, therefore the process of development from first consideration to final approval can be quite lengthy. The Board has a PGD Subgroup of the Area Drug and Therapeutics Committee which considers all proposed PGDs across Greater Glasgow and Clyde and ratifies them if the correct criteria are met. Standards and requirements for PGDs 1. A PGD is drawn up and signed by a multi‐disciplinary group that must include a doctor, a

pharmacist and a member of the professional group, which will be empowered by the PGD (nurses in the case of vaccine administration).

2. All professionals involved in the preparation, supply or administration of medicines under a PGD must act within their appropriate code of professional practice and conduct, having signed and agreed to work within the PGD.

3. A senior person within each local area is designated with the responsibility of ensuring that only fully competent, qualified and trained persons are authorised to operate within the PGD.

4. The use of any medicine within a PGD should be consistent with the product licence. Relevant guidance in this regard can be found in the Summary of Product Characteristics (SPC) for the product concerned.

5. Black triangle drugs and medicines used outside the terms of the SPC may be included in a PGD provided such use is exceptional, is justified by current best practice and that the direction clearly describes the status of the product.

6. The PGD must be written using the standard Greater Glasgow and Clyde template and

must contain the following information: ‐ The patient group, clinical condition or situation to which the direction applies. A description of patients, clinical conditions or situations excluded from treatment

under the PGD. The vaccine which is to be administered, and specific details of:‐ the dose the route/method of administration the maximum number of doses that may be administered warnings, cautions, and contra‐indications to treatment with the vaccine legal status of the vaccine

Instructions on the documentation required to record supply and other records to be kept for audit purposes.

The skills, knowledge and qualifications required by staff approved to authorise administration of vaccines under the terms of the PGD.

The action to be taken if an adverse drug reaction is suspected or occurs to a patient being treated under the PGD.

Details of any necessary follow‐up action that will be taken after administration. Evidence of approval by each party involved in the authorisation process. The date that the PGD comes into force, and the date that it expires.

7. The Designated Nurse Lead must maintain an up‐to‐date record of persons approved to authorise administration of vaccines under the PGD in their area of responsibility. The record must be signed by the approved person as confirmation that he/she has read and understood the direction. The record must be held by the local area.

8. The Designated Nurse Lead must also be responsible for ensuring that within each area there is a defined system of document control to ensure that all staff involved in the operation of the PGD have access to the current version, and are aware of any changes or amendments. The system must include a record of location of all copies of the PGD, a record of review of the PGD, and a method of communication of changes and new versions to all copy holders and persons involved in the operation of the direction.

9. Details of administration of a vaccine under a PGD must be recorded on standard locally approved documentation. The record must include: ‐ The patient name and date of birth The vaccine name, dose, route, time of dose(s), start date, number of doses The batch number – this must be recorded on SIRS The injection site The date of administration ‐ this must be recorded on SIRS The signature/initials of the person who administered the vaccine Informed consent

Administration should be recorded on the GP record and if possible on the parent held record. More information For more information on PGDs please contact Susan Donnelly (201 5157) or Jane Camp (201 5312) or http://www.nhsggc.org.uk/content/default.asp?page=s1843_5_3

http://www.nhsggc.org.uk/content/default.asp?page=s1843_5_3

2.4 CORRECT ADMINISTRATION OF VACCINES AND DOCUMENTATION

Vaccine Administration Preparation Injection technique Choice of needle length Injection site Disposal Recording These are all important considerations as each factor can affect both the immunogenicity and the risk of local reactions at the injection site. Reconstitution of Vaccine Each vaccine should only be reconstituted and drawn up when required in order to: avoid errors maintain efficacy and stability

Reconstitution of freeze‐dried vaccines: only use diluent supplied and use within specified time period only mix vaccines that are licensed and recommended to be mixed with other

vaccines diluent should be drawn up using a green (21G) needle and slowly added to vaccine to

avoid frothing

Before administration: check colour and composition of vaccine is as specified in description in vaccine’s SPC check vaccine to ensure is right product and correct dose for patient check expiry date

Route of Injection Vaccines should not be given intravenously. Most vaccines should be given intramuscularly as this reduces the chance of local

reactions and leads to a better immune response to the vaccine. Exceptions are BCG (intradermal injection), Japanese Encephalitis and Varicella vaccines (subcutaneous injection) and Cholera vaccine (oral).

It is important the vaccine is injected into muscle and not into fat. This is why the deep subcutaneous route is no longer recommended for most vaccines.

However, individuals with a bleeding disorder should receive their vaccines by deep subcutaneous injection to reduce risk of bleeding.

Needle Size

Orange 25 gauge 16 mm long 25 mm long

Blue 23 gauge 25 mm long

Green 21 gauge 38 mm long

For IM injection, needle needs to be long enough to ensure vaccine is injected into muscle. A 25 mm needle length is preferable and suitable for all ages. 16 mm needle length is only recommended for pre‐term or very small infants. A larger adults, a longer length (38 mm) may be required – individually assess patients. Injection Site For infants under 1 year: Anterolateral aspect of the thigh is preferred site as it provides a large muscle mass. For infants over 1 year and adults: Deltoid area of upper arm generally preferred but anterolateral aspect of thigh can also be used. When 2 or more injections need to be given at the same time, they should preferably be

given at separate sites in different limbs. If more than one injection needs to be given into the same limb, they should be given at

least 2.5 cm apart. The site at which each vaccine was given should be recorded. The injection site needs to avoid major nerves and blood vessels. Immunisations should not be given into the buttock due to risk of: sciatic nerve damage injecting the vaccine into fat rather than muscle

Injection of vaccine into fatty tissue of the buttock has been shown to reduce the

immunogenicity of Hep B and rabies vaccines. Skin Cleansing Clean skin does NOT require cleansing. Visibly dirty skin need only be washed with soap and water. If alcohol and other disinfecting agents are used, skin must be allowed to dry as these

could inactivate live vaccines.

Injection Technique IM injections should be given with needle at a 90º angle to the skin. The skin should be stretched flat (NOT bunched). It is not necessary to aspirate the syringe after the needle is put into the muscle. Prior to Administration Vaccinators should ensure that: There are no contraindications to the vaccines being given. Consent has been obtained. The vaccinee or carer is fully informed about the vaccines that are being given and

understands the vaccination procedure. The vaccinee or carer is aware of possible adverse reactions and how to treat them. Positioning of Patient All ages: ensure vaccination area is completely exposed. Babies and young children: Sit child sideways on parent’s lap Ensure child is held securely If anterolateral aspect of thigh being used: parent to ‘cuddle’ child closely and place

child’s nearest arm around parent’s back. Parent to place one of their arms over child’s other arm and hold both legs firmly by placing their hand just above the child’s knees.

If deltoid being used: parent to hold arm to be injected close to child’s body and tuck

other arm behind parent’s back. Tuck child’s legs between parent’s legs or ask parent to hold legs firmly.

Disposal of Vaccination Equipment All: Reconstituted vaccines Opened single and multidose vials Empty vials and ampoules Used needles and syringes should be disposed of in yellow sharps bin (except for BCG) BCG vaccine and equipment should be disposed of in the purple lidded waste container

for cytotoxic waste. Sharps bins should be replaced once 2/3rds full.

Recording The following information should be recorded accurately: Vaccine name, batch number and expiry date Dose administered Site(s) used – including clear description of which injection was administered in each site,

especially where two injections were administered in the same limb Date immunisation(s) were given Names and signature of vaccinator This information should be recorded in: Patient held record or Personal Child Health Record (PHCR) for children Patient’s GP record or other patient record depending on location Child Health Information System

2.5. Operational Standards for Immunisation Clinics

Facilities and equipment 1. The facilities have adequate space to accommodate staff, patient and parent/carer.

2. The waiting area is adequate to accommodate the patients and parents waiting to be seen.

3. There is staff to manage the registering and calling of patients and parents within the clinic (as well as the nurse administering the vaccines).

4. Patient records are available and accessible for review and recording in the clinic.

5. The hand washing facilities meet infection control standards and are audited to ensure they are maintained.

6. There are relevant immunisation supplies that are stored in accessible, safe and secure environment.

7. Vaccines are stored and maintained to preserve the cold chain and regular audit takes place to ensure this is maintained according to guidelines.

8. Stock is rotated to ensure vaccines are current and expiry dates are noted and managed and there is an audit process to evidence this.

9. The facilities for drawing up and checking vaccines meet infection control standards and are audited to ensure they are maintained. (Audit tool available in chapter 2.6)

10. There is a system in place in the event of an adverse reaction and emergency drugs are available according to Anaphylaxis and CPR Guidelines.

11. Sharps disposal containers are accessible and operated according to safety standards and Prevention and Control of Infection Manual.1

Clinic processes

1. All medication administration is recorded in the GP record, Child health SIRS form, and if available the parent held record (Schools, in School Health Record and copy sent to GP for GP record).

2. Patient Group Directions are signed by an appropriate medical professional, and signed and implemented by nurses providing routine immunisation.

3. A Patient Specific Direction is utilised when there is no Patient Group Direction for a specific vaccine.

4. Access to records and review of records is conducted in the clinic setting at the time of the immunisation clinic and prior to administration of vaccine.

5. Recording of vaccine administration is accurate, timely and according to NMC Standard for Medicine Management. This should include vaccine, date, site of administration, expiry date and batch number.

6. The clinic appointments are spaced appropriately to allow enough time for the nurse to focus on the individual needs of the patient and the vaccine to be administered.

7. When nurses are working in partnership each nurse demonstrates accountability for their own practice.

1 NHS Greater Glasgow and Clyde, Prevention and Control of Infection Manual

2.6. Vaccine Errors and Reporting

Flow chart to be followed in the event of a single vaccine error identified in the primary care setting

If an error is identified by Child Health they will contact the relevant practice to investigate and advice can be sought from PHPU (0141 201 4917)

2.7. Immunisation Audit Part A: Clinic Facilities and equipment

Clinic Facilities Yes No Comment

Room has adequate space

Waiting area has adequate space

There are staff to support the clinic

Patient records are available and accessible to review and record in the clinic

Hand washing facilities are available in the room and meet infection control standards

Facilities for drawing up and checking vaccines meet infection control standards

There is a system in place in the event of an adverse reaction

Immunisation supplies are stored in safe and secure environment

Vaccines are stored and maintained to preserve the cold chain

Vaccine storage is monitored and records are audited

Emergency medicines are available in accordance with Anaphylaxis/CPR guidelines – See page 12 Section 2.5

Sharps Disposal Containers are accessible

Part B: Preparation, administration and recording

1. Please indicate which systems are in place to ensure that parents are aware of screening and consenting: (please tick) a) List of questions signed by the child’s parent

b) Verbal screening

c) Screening by another team member

d) Other If other, please expand: __________________________________

2. What sites do you normally use when administering the vaccine?

a) Arm

b) Leg

c) Buttock d) A combination (please specify ___________________)

3. When are vaccines drawn up?

a) At the beginning of the clinic session

b) Periodically throughout the clinic session

c) Immediately prior to administration 4. Which staff are involved at immunisation sessions and how many?

a) Health visitor ____

b) Staff nurse ____

c) Practice nurse ____

d) Admin staff ____

e) Other ____ please state other: ______________________________

5. Does the person who draws up the vaccine personally administer it?

a) Yes, always

b) Most of the time

c) Only sometimes

d) Never 6. Is there a system in place for recording the temperature of the fridge?

Yes

No If yes, please indicate who is responsible: ________________________

7. Is the fridge used solely for the storage of child health vaccines?

Yes

No

If you answered no, please indicate what other vaccines are stored in the fridge

a) Flu vaccine

b) Travel vaccine

c) Other d) Please state other: ___________________________

8. Does the person who personally administers the vaccine record that it has been given?

a) Yes, always

b) Most of the time

c) Only sometimes

d) Never 9. Are vaccines and batch numbers checked before administration?

Vaccines Batch Numbers

a) Yes, always a) Yes, always

b) Most of the time b) Most of the time

c) Only sometimes c) Only sometimes

d) Never d) Never 10. Where do you normally record the child’s immunisation? (tick all that apply)

GP record under:

Nursing section Immunisation section GP section

HV record Parent held record GPASS

SIRS call sheet Other (please specify) ___________________

2.8. Accountability and Responsibility

The NMC Standards for Medicines Management (NMC Website) and Code of Professional Conduct indicate the nurse is personally accountable for his/her practice. And when administering medications the nurse must exercise his/her professional judgement and apply his/her knowledge and skill to the given situation.

Competency criteria

All staff directly employed by the NHS and subject to Agenda for Change now need to meet the requirements of the Knowledge Skills Framework (KSF) described for their post. Outlined below are how evidencing competence in different elements of immunisation may be utilised against KSF dimensions.

Criteria • Aware of and can describe current vaccine schedule. (KSF HWB1.2)

• Reflect on your clinical decision making in relation to immunisation practice. (KSF Core 4.2/5.2)

• Work with members of the multi‐disciplinary team in relation to immunisation programmes. (KSF core 1.2)

• Advise patients with uncertain immunisation history. (KSF core 1.2/HWB2.2)

• Evaluate your consultation style with patients/clients in immunisation clinics. (KSF Core 4.2/5.2)

• Reflect on own practice and identify when support from other is required. (KSF core 3.2)

• Demonstrate up to date knowledge of ordering, handling and storage of vaccines. (KSF EF1.2)

• Access literature and data about immunisations. (KSF IK3.1)

• Provide support and guidance to other professional. (KSF G1.2)

Criteria

• Demonstrate an understanding of the immune system and how vaccines work. (KSF HWB3.2)

• Review and monitor your standard of vaccine administration and record keeping. (KSF Core 4.2/5.2)

• Access and use current patient group directions ensuring they signed by the appropriate people. (KSF core IK3.2)

• Demonstrate and understanding of the public health aspects of immunisation. (KSF core 3.2/HWB 1.2)

• Discuss immunisation issues with other professionals. (KSF core 5.2)

• Demonstrate ability to identify and manage adverse events including anaphylaxis. (KSF HWB7.3)

• Demonstrate up to date knowledge about professional accountability in relation to administration and recording of immunisations. (C2 L2)

• Demonstrate knowledge of patient confidentiality in light of current legislation regarding the handling of personal data. (KSF Core 6.2/3.2)

• Review and monitor your own practice in connection with professional and policy guidelines and immunisation standards. (KSF Core 4.2/5.2)

• Demonstrate up to date knowledge of the principles of consent and recording in the records. (KSF IK3.2)

Section 3: Immunisation ‐ Further Help 3.1. Frequently Asked Questions

1. Q: A child has arrived from abroad with a history of receiving single measles vaccine. Do they require MMR vaccination? A: Even if the child has received single measles vaccine, they should still be given MMR (depending on their age, either one now and one at pre‐school age, or two doses three months apart) to maximise their protection against measles, mumps and rubella. If the child is 18 months or over, two doses can be given one month apart. 2. Q: A child has arrived from a country that routinely gives an extra dose of DTP (usually around the age of 18 months). Does the child require its pre‐school DTaP/IPV booster in the UK? A: Many countries have a six dose DTP strategy (e.g. Australia 2m, 4m, 6m, 18m, 4y plus Td at school leaving age), rather than the UK five dose strategy which has been shown to provide adequate immunity in the context of our vaccination schedule and disease burden. A pre‐school booster should be given as this would keep the child in line with the vaccination schedule in their own country and provide additional immunity. 3. Q: What time interval should be left between the administration of different vaccines?

A: If it is necessary to administer more than one live vaccine at the same time, they should be given either at the same appointment time in different sites (unless a combined preparation is used) or be separated by a minimum period of 4 weeks. No interval is required between the administration of live and non‐live vaccines. 4. Q: A child is a household contact of someone who is immunocompromised. Can they be immunised? A: There are no concerns now that inactivated polio vaccine (IPV) is routinely used instead of oral polio vaccine (OPV) which was a live vaccine. Live virus may be shed in the stool following OPV which could potentially infect an immunocompromised person. There is no risk of transmission of measles, mumps or rubella following MMR vaccination; therefore this vaccine should be given as usual. All other vaccines in the current UK immunisation schedule can be given. All other vaccines in the current UK immunisation schedule can be given. 5. Q: A mother is worried about Thiomersal in vaccines and requests Thiomersal‐free vaccines. A: Thiomersal was present in DTwP‐Hib, DT and Td. However, the vaccines now in use are all Thiomersal free – the DTaP/IPV/Hib, dTaP/IPV and Td/IPV. Thiomersal is not added to DTaP‐Hib, MMR, polio, Men C, BCG or PCV. 6. Q: A child is going abroad shortly. Can their immunisations be brought forward slightly? A: Reducing the interval between doses by a few days is acceptable, especially if a child is going to a country where vaccine‐preventable illness is a real threat. Shortening the interval

by more than a few days may reduce the effectiveness of vaccines. To ensure full protection, the child may require an extra dose. Seek further advice from the PHPU (Tel: 0141 201 4917) 7. Q: What are the contraindications to immunisation? A: General contraindications Minor illness without fever or systemic upset are not valid reasons to postpone immunisation. If an individual is acutely unwell, immunisation may be postponed until they have fully recovered.

A confirmed anaphylactic reaction to a previous dose of a vaccine containing the same antigens or a confirmed anaphylactic reaction to another component contained in the relevant vaccine, e.g. neomycin, streptomycin or Polymyxin B (which may be present in trace amounts in some vaccines). (Green Book chapter 6) https://www.wp.dh.gov.uk/immunisation/files/2012/09/Green‐Book‐updated‐2811121.pdf

The following conditions are NOT contraindications to routine immunisation (in some of these situations, additional precautions may be required, refer to Green Book chapter 6 for further information): Family history of any adverse reactions following immunisation Previous history of the disease (with the exception of BCG for people with evidence of

past exposure to TB) Prematurity: immunisation should not be postponed Stable neurological conditions such as cerebral palsy and Down’s syndrome. Contact with an infectious disease Asthma, eczema, hay fever or “snuffles” Treatment with antibiotics or locally‐acting (e.g. topical or inhaled) steroids Child’s mother, or someone in the household is pregnant Currently breast‐feeding or being breast‐fed History of jaundice after birth Under a certain weight Over the age recommended in the immunisation schedule Personal history of febrile convulsions or epilepsy Close family history (parent or sibling) of febrile convulsions or epilepsy Mild self‐limiting illness without fever, e.g. runny nose Being a sibling or close contact of an immunosuppressed individual Recent or imminent elective surgery Unknown or inadequately documented immunisation history 8. Q: A mother/carer is asking about single antigen vaccines instead of MMR. A: Single vaccines are not given in the UK due to: Increased risk of disease Increased risk of missing a dose completely Increased risk of local reactions at injection site Increased trauma to child

https://www.wp.dh.gov.uk/immunisation/files/2012/09/Green-Book-updated-2811121.pdf

Giving the vaccines separately would mean a child needing a total of six injections to complete the course, instead of two. These children would remain unprotected and at risk of disease for longer. Six injections could also mean an increased risk of local reactions at the injection site. Control programmes would be less effective and this would lead to more cases of measles, mumps and rubella. Drug companies do not manufacture single antigen measles or mumps vaccines that match UK licence specifications. Some of the unlicensed single antigen vaccines imported into the UK and offered in private clinics are known to be less effective, or to have a higher risk of side‐effects than the MMR vaccine. 9. Q: Is a history of egg allergy a contraindication to receiving the MMR vaccine? A: No. Children with egg allergy should have MMR vaccine. Recent data suggest that anaphylactic reactions to MMR vaccine are not associated with hypersensitivity to egg antigens but to other components of the vaccine (such as gelatin) (Fox and Lack, 2003). In three large studies with a combined total of over 1,000 patients with egg allergy, no severe cardiorespiratory reactions were reported after MMR vaccination (Fasano et al., 1992; Freigang et al., 1994; Aickin et al., 1994; Khakoo and Lack, 2000). If there is a history of confirmed anaphylactic reaction to egg‐containing food, paediatric advice should be sought with a view to immunisation under controlled conditions, such as admission to hospital as a day case.. (Page 353, Chapter 21, Green Book) https://www.wp.dh.gov.uk/immunisation/files/2012/09/Green‐Book‐updated‐2811121.pdf 10. Q: Does a child who has already had measles infection still need MMR? A: Yes. Clinically, measles is very difficult to diagnose and other mild viral infections could be mistaken for measles. The only reliable means of diagnosis these days is by taking a saliva or blood sample. Even if the child has had measles, (confirmed by laboratory tests) then the vaccine is quite safe and acts as a booster to the immune system. In summary, MMR should be given irrespective of a history of measles, mumps or rubella. 11. Q: A mother wants her child tested for MMR antibodies before agreeing to the second dose. Can this be done? A: A single dose of MMR vaccine confers protection in around 90% of children for measles and rubella. After two doses of MMR, the level of protection increases to 99%. Blood tests to check immunity before giving a second dose is not recommended as the results can be very difficult to interpret. 12. Q: I have a very difficult client group who do not always bring their children for vaccination on the scheduled day. How important is it to keep to the exact scheduled time? A: Increasing the interval between doses of a multi‐dose vaccine does not diminish the effectiveness of the vaccine. It is therefore NOT necessary to restart the series of any vaccine (except oral typhoid in some circumstances) due to extended intervals between doses. However, decreasing the recommended interval between doses of a multi‐dose vaccine may interfere with antibody response and protection. Please seek further guidance from the PHPU on 0141 201 4917.

https://www.wp.dh.gov.uk/immunisation/files/2012/09/Green-Book-updated-2811121.pdf

13. Q: Why does the Batch Number appearing on the outer pack of the vaccine often differ from that on the actual vial(s)/ampoules(s) and how should this be recorded? A: Only the batch number on the original outer pack need be recorded. Manufacturers of vaccines composed of more than one component must ensure that each component is recognised by a specific batch recording. However, for the users it is the one batch number on the outer pack which should be recorded in patient records. 14. Q: What should I do if I have discarded the outer pack? A: Note the batch numbers of all components of the vaccine and advise pharmacy who may be able to provide the details of the number to record. However, the component numbers are sufficient data for any future 'searches'. 15.Q: What is the actual expiry date of a vaccine when only a month/year system appears on the label? A: When a manufacturer prints; 'Use before' 03/12 ‐ the vaccine expires at the end of the previous month, i.e. Expiry is 28/2/12. 'Use by' 03/12 ‐ the vaccine expires at the end of that month, i.e. Expiry is 31/03/12. The preferred labelling system is to use the full date ‐ 'expires 13/03/12' and this indicates that the vaccine expires on the end of that day and can be used on that day. 16. Q: Why do vaccines have such short shelf‐lives? A: Vaccine manufacturing involves lengthy testing at many of the processing stages which reduces the shelf‐life. Global manufacturing involves more testing for UK Licensing and the shelf‐life of the vaccine is determined prior to licensing. Therefore, much of a vaccines shelf‐life can pass by during the 'quarantined' phases.

17. Q: A child is receiving a course of hepatitis B vaccine. Can these be given at the same time as other vaccines, e.g. primary immunisations. A: Yes. There is no need to leave an interval between administering hepatitis B vaccine and other vaccines. For example a child may have a Pediacel, MenC and can receive hepatitis B vaccine at the same time. 18. Q: When can a baby safely have BCG administered if mum is HIV positive? A: The baby can only have BCG once two negatives test results for HIV have been received.

Frequently Asked Questions Scottish Immunisation And Recall System (SIRS) 1. Q: The child has failed to attend the appointment and a reason is known, how should I

complete the scheduled appointment page? A: Circle ‘2’ on the page, this will ensure the child is scheduled to the next available session once the page has been received and processed by Child Health.

2. Q: The child has failed to attend and a reason is not known?

A: Circle ‘3’ on the page, however if a ‘3’ has been completed previously this will suspend scheduling, a defaulters report will be produced from SIRS and sent to the Public Health Nurse for investigation, the child will only be re‐scheduled by SIRS when advised.

3. Q: The child appears on the appointment page but was immunised on a different day

from the scheduled clinic? A: If you have not already completed an unscheduled attendance form, circle ‘1’ and enter the date given and batch numbers used.

4. Q: The child has been scheduled for an immunisation which they have already

received. A: If a child receives an immunisation outwith the scheduled clinic date and an unscheduled form has not been received by this Department an appointment may be produced by SIRS. Please advise of this on the schedule page and return as soon as possible.

5. Q: I returned my schedule page on time and the children were not scheduled for the

next session? A: We would strongly advise practices to send immunisation returns by post, using other internal mailing systems may result in the forms not reaching Child Health in time for the next scheduling run.

6. Q: I have received my schedule page but the children from the last session were not

re‐called? A: Until a schedule page is received and processed by Child Health all children on that specific page will not be re‐appointed by SIRS, please ensure that the Child Health copy has been sent.

7. Q: I have received a report ‘Treatment Centre Queue Print’ with my schedule, what

should I do with it? A: You have previously arranged with us a specific day, time and maximum number to be appointed; if you have more children due than this predefined maximum then they will appear on the ‘queue’ print. You can either invite these children to attend yourself and complete an unscheduled attendance form or contact us to increase your numbers and have them invited by SIRS.

8. Q: I have received a report of ‘SIRS appointment schedules outstanding for more than

5 weeks’ what should I do? A: If an scheduled appointment page has not been received and processed by Child Health after 5 weeks from the clinic date, an overdue report will be produced, you should check that the child health copy has been returned, if so it may be necessary for you to send a copy of the original.

9. Q: Do I need to complete the batch number?

A: Yes, it is mandatory to complete the batch number for all immunisations notified on the SIRS returns.

3.2. Immunisation e‐learning

To meet the training needs following the changes in 2006 to the national immunisation schedule and help staff to address parental concerns more effectively, NHS Greater Glasgow and Clyde is encouraging all health professionals who are involved in immunisation in any context, whether administering or advising, to use a new educational resource in immunisation. This includes practice nurses, health visitors, school nurses, community nurses, specialist nurses such as TB nurses, paediatric and A&E nurses, GPs, paediatricians, pharmacists and occupational health professionals. ‘Promoting Effective Immunisation Practice’ is a self‐directed e‐learning training package for all healthcare workers who have a remit for immunisation. The programme has been developed as a result of collaboration between Health Protection Scotland (HPS) and NHS Education for Scotland (NES) and was launched in September 2006. The programme is delivered in 12 modules which enable healthcare professionals to confidently, competently, and effectively promote and administer vaccinations. It covers topics such as national immunisation policy and schedules, the immune system and how vaccines work, legal aspects of vaccination and current issues and controversies regarding immunisation. More information can be found at: www.immunisation‐elearning.nhs.uk If you would like to register to do the course, email Dr Gillian Penrice, consultant in public health medicine, PHPU, NHS Greater Glasgow and Clyde [email protected] for an application form.

http://knhswww1.the-knowledge-business.com/KNHSIMM/index.asp

mailto:[email protected]

3.3. Internet and Reading Resources

Internet

Foreign language terms – An aid to translating immunisation terms www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/foreign‐products‐tables.pdf

Foreign country vaccination schedules and coverage information www.who.int/vaccines/globalsummary/immunization/countryprofileselect.cfm

Vaccination of individuals with uncertain /incomplete immunisation status

http://www.hpa.org.uk/infections/topics_az/vaccination/vac_guidelines.htm http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1194947406156 www.hps.scot.nhs.uk ‐ Health Protection Scotland website, current news available

Department of Health website, Green Book available here www.dh.gov.uk

www.healthscotland.com/immunisation ‐ provides up‐to‐date information for parents, healthcare professionals and the wider public ‐ anyone who needs to know the facts about immunisation

www.show.scot.nhs.uk ‐ good up‐to‐date site with information for health professionals

www.dh.gov.uk/en/Publichealth/Immunisation/index.htm ‐ comprehensive site, up‐to‐date and accurate sources of information on vaccines, disease and immunisation in the UK dated regularly with relevant immunisation news

www.who.int/en ‐ global health information available in different languages including Arabic and Chinese

www.mrc.ac.uk ‐ Medical Research Council, reliable information on a searchable site

www.amicus‐cphva.org ‐ Community Practitioners and Health Visitor Association site, useful for school nurses and health visitors

www.spmsd.co.uk ‐ sanofi‐pasteur MSD website with info on a drug company that produces vaccines, information service and news

www.rcn.org.uk ‐ health care professional information, Child Vaccine Factfile available as a PDF file here

www.uvig.org ‐ UK Vaccine Industry Group, news updates and simple factsheets

www.inmed.co.uk ‐ useful site on meningitis

www.nes.scot.nhs.uk/pgds/ ‐ reliable information on Patient Group Directions and a searchable archive of PGDs

www.fitfortravel.scot.nhs.uk ‐ information on travel vaccinations for the public

www.travax.scot.nhs.uk ‐ information for healthcare professionals, requires registration

www.mmrthefacts.nhs.uk ‐ news, resources and scientific evidence specifically concerning MMR vaccination

www.ich.ucl.ac.uk/immunisation/ ‐ Institute for Child Health, includes a facility for asking questions and some useful links

www.iom.edu/ ‐ Institute of Medicine of the National Academies website (USA) with extensive unbiased vaccine study reviews and evidence‐based scientific information

www.prevenar.co.uk ‐ Information about pneumococcal vaccine and useful immunisation training resources including best practice demonstration of how to administer 3 jabs in 1 visit.

http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/foreign-products-tables.pdf

http://www.who.int/vaccines/globalsummary/immunization/countryprofileselect.cfm

http://www.hpa.org.uk/infections/topics_az/vaccination/vac_guidelines.htm%0Bhttp://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1194947406156

http://www.hpa.org.uk/infections/topics_az/vaccination/vac_guidelines.htm%0Bhttp://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1194947406156

http://www.hps.scot.nhs.uk/

http://www.dh.gov.uk/

http://www.healthscotland.com/immunisation

http://www.show.scot.nhs.uk/

http://www.dh.gov.uk/en/Publichealth/Immunisation/index.htm

http://www.who.int/en

http://www.mrc.ac.uk/

http://www.amicus-cphva.org/

http://www.spmsd.co.uk/

http://www.rcn.org.uk/

http://www.uvig.org/

http://www.inmed.co.uk/

http://www.nes.scot.nhs.uk/pgds/

http://www.fitfortravel.scot.nhs.uk/

http://www.travax.scot.nhs.uk/

http://www.mmrthefacts.nhs.uk/

http://www.ich.ucl.ac.uk/immunisation/

http://www.iom.edu/

http://www.prevenar.co.uk/

General books

Immunisation Against Infectious Disease. (The Green Book) Department of Health (2006) Also available online at: www.dh.gov.uk/greenbook

Vaccines Plotkin S, Orenstein W (Eds) WB Saunders and Company, Philadephia. (4th Edition, 2004)

Immunization: childhood and travel health Kassianos G Oxford: Blackwell Science Ltd. (4th Edition, 2001)

Manual of Childhood Infections Davies E, Elliman D, Hart C, Nicoll A and Rudd P Royal College of Paediatrics and Child Health. WB Saunders (2nd Edition, 2001)

Vaccination Ada G, Isaacs D. Allen and Unwin, St Leonards, NSW (2000)

UK Guidance on Best Practice in Vaccine Administration Published by Shire Hall Communications (2001)

Specialist publications

Immunisation of the immunocompromised child. Best Practice Statement Royal College of Paediatrics and Child Health London: RCPCH, 2002 http://www.rcpch.ac.uk/doc.aspx?id_Resource=1768

Position Statement on Injection Technique March 2002 Royal College of Paediatrics and Child Health (RCPCH) http://www.rcpch.ac.uk/sites/default/files/asset_library/Publications/P/Injections1.pdf

Centres for Disease Control and Prevention. General Recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices, January 28, 2011/60 (RR02); 1‐60 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm?s_cid=rr6002a1_e

http://www.dh.gov.uk/greenbook

http://www.rcpch.ac.uk/doc.aspx?id_Resource=1768

http://www.rcpch.ac.uk/sites/default/files/asset_library/Publications/P/Injections1.pdf

http://www.rcpch.ac.uk/sites/default/files/asset_library/Publications/P/Injections1.pdf

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm?s_cid=rr6002a1_e

Section 4: Ordering, Storage and Handling of Vaccines

4.1 Background Vaccines naturally biodegrade over time and storage outside of the recommended temperature range at any time will speed up loss of potency which cannot be reversed. It may result in the failure of the vaccine to protect as well as resulting in vaccine wastage. It is essential that all those handling vaccines follow policies to ensure cold chain compliance. The terms of marketing authorisations (product licences) cover storage requirements. Vaccines that have not been properly distributed or stored are therefore no longer within the terms of the marketing authorisation and require confirmation using manufacturer’s stability data on whether they can still be used. 4.1.1. Guidance and Policies

There is a range of guidance and policies relating to vaccine handling and storage. The Department of Health Publication “Immunisation against Infectious Diseases” also known as ‘The Green Book’ is well recognised and provides general guidelines and information on vaccination. The updated book was published in August 2006; however, regular updates are posted on the website. It is recommended that this is the version referred to http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_079917

The NHS (General Medical Services Contracts) (Scotland) Regulations 2004 sets out detailed requirements for GP practices regarding the proper storage of vaccines. Specifically, these regulations, at paragraph 8 of Schedule 5, require the contractor to ensure that: a) all vaccines are stored in accordance with the manufacturer’s instructions, and b) all refrigerators in which vaccines are stored have a maximum/minimum thermometer,

and c) that readings are taken on all working days The NHSGGC Board have produced these guidelines and National Guidelines are currently being developed, it is anticipated that they will be available in 2010. A magnetic fridge sticker with a summary of best cold chain practice designed to be displayed prominently on each vaccine fridge in the practice, providing a quick and practical reference, is available and should be followed by all primary care staff involved in the storage and handling of vaccines.

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_079917


4.1.2 Purpose of Guidelines and Ordering Support Material

These guidelines aim to provide detailed information to support primary care staff in the storage and handling of vaccines.

It is also hoped that practices will find the information a valuable tool in supporting the training of all relevant staff at a local level.

An electronic version of this pack can be accessed on‐line on the Public Health Protection Unit website at: http://www.nhsggc.org.uk/content/default.asp?page=s843

Further hard copies of materials in this section may be obtained from:

For Greater Glasgow Practices: Primary Care Distribution Centre, Clutha House, 120 Cornwall Street South, Glasgow, G41 1AD,

Tel: 0141 427 8246, Fax: 0141 427 8270

For Clyde Practices: Argyle and Clyde Primary Care Supplies, NHS NHSGGC Central Store (South), 1 Carnegie Road, Hillington, Glasgow, G52 4NY, Tel: 0141 278 2531, Fax: 0141 892 0758.

http://www.nhsggc.org.uk/content/default.asp?page=s843

4.2 Main Recommendations

Specific member(s) of staff should be identified to monitor the pharmaceutical supplies

refrigerator. Any temperature readings outside 2‐8C should be investigated immediately and discussed with a CH(C)P Pharmacist or Pharmaceutical Public Health if necessary Refer to Section 4.6

The correct maintenance temperature of the vaccine refrigerator is 2‐8C. Refer to section 4.5

Check and record the fridge temperature (maximum, minimum and current) twice daily. Suitable sheets are available from Primary Care Distribution Centres. The thermometer should be re‐set after each reading. Refer to Section 4.6

Store vaccines in the middle of the fridge away from elements and freezer compartments. Do not fill fridge more than two thirds full. Do not store in the fridge door, to avoid the risk of a temperature rise when door is opened. Refer to Section 4.5

Always check “Expiry Date” of vaccine following removal from the refrigerator and before dispensing. Check expiry dates and rotate stock to ensure shortest shelf life is used first. Do not keep excess stocks. Refer to Section 4.5

Refrigerate vaccine deliveries immediately. (This is the responsibility of the member of staff accepting delivery). Refer to Section 4.4

Clean and defrost vaccine fridges on a regular basis (3 monthly). Place vaccines in another fridge or in a validated cool box* while this takes place and until the refrigerator temperature

is restored to 2‐8C. Refer to Section 4.5

Recalibrate the thermometer regularly according to manufacturer’s recommendations. Refer to Section 4.5

Protect power supply to the fridge ideally with a switchless socket and a fixed unit over the plug and socket to ensure the plug cannot be pulled out. Mark the electrical socket with a cautionary notice advising staff not to switch off power. Refer to Section 4.5

Do not store foodstuffs in the vaccine fridge at any time. Refer to Section 4.5

Any vaccine unsuitable for use (e.g. expired stock or heat/cold damaged vaccines) should be clearly identified and returned for disposal. Telephone the Pharmacy Distribution Centre to arrange. Refer to Section 4.6

Vaccines should only be transported to peripheral clinics using validated cool boxes*. Refer to Section 4.7

Only remove from fridge at any one time the minimum quantity required. Reconstituted vaccines and opened multidose vials should be disposed of at the end of an immunisation session in a 'sharps' box. Any surplus vaccine not used during a clinic session should be returned and used first for subsequent session. Discard any vaccine not used during second session. Refer to Section 4.7

4.2.2 Summary of Recommendations

A summary of the NHSGGC Guidelines are available in a fridge magnet form and should be displayed prominently (preferably on the refrigerator door) within every immunisation area (see Section 4.11)

4.3. Ordering

4.3.1 Who Supplies Vaccine

Childhood vaccines for use in the Scottish Immunisation Recall System (SIRS), selective immunisation for Hepatitis B for at risk babies and any additional childhood vaccines for ad hoc vaccination clinics should be ordered from the Pharmacy Distribution Centre (PDC) which took over from the Vaccine Holding Centres in February 2010, using the appropriate order forms provided.

Winter, Travel and Adult Booster vaccines should be ordered from the Local Community Pharmacy using individual prescriptions (GP10) or exceptionally a Stock Order Form (GP10a). The table below highlights this information,

Vaccine Type Order From Contact Order Method

Childhood Vaccines

(Baby, Pre‐School and missed School Programme)

Pharmacy Distribution Centre

Pharmacy Distribution Centre, Dava Street, Moorpark Central, Govan, Glasgow, G51 2JA

Tel 0141 347 8981

Fax 0141 445 1513

Vaccine Order Form. Each practice has an electronic copy with SIRS list and practice details

Winter Vaccines

(Flu, Pneumococcal)

Local Community Pharmacy

n/a Individual Prescriptions (GP10) or Stock Order (GP10a)*

Travel Vaccines



Adult Booster Vaccines

(e.g. Revaxis)



* Stock Order forms (GP10a) should only be used in exceptional circumstances

4.3.2 How to Order

The Pharmacy Distribution Centre (PDC) receives twice weekly SIRS summaries of each GP practice’s call list. This information, in conjunction with details of the amount of vaccines that a practice already has in stock at the time of ordering, is used to allocate stock according to need. This approach is used to help prevent overstocking in practices, which can be wasteful and reduces the efficiency of fridge storage.

Care must be taken in counting and ordering vaccines, especially as certain vaccines are packaged in multiple quantities. Incorrect ordering can result in wastage and unnecessary costs to GP practices and the NHS.

Vaccine stocks must be monitored to avoid over‐ordering or stockpiling, ideally by a designated person. GP practices should have no more than two to four weeks’ supply of vaccines at any time which should be sufficient for routine provision.

When placing ad hoc orders for vaccines from the Pharmacy Distribution Centre (PDC), please ensure that:

The pre‐prepared order forms with practice details are used and that all details are completed.

The order is signed by the agreed authorised signatories. The order is faxed to the PDC. (Please do not post any confirmation of fax) Arrangements for large clinics (or unscheduled/ ad hoc catch‐up) should be discussed

with the Pharmacy Distribution Centre prior to making appointments to ensure sufficient vaccine can be made available for the required date.

The Pharmacy Distribution Centre has different delivery times for vaccines depending upon a surgeries’ geographical position Please ensure that vaccine orders are placed with this in mind. The table overleaf illustrates the schedule.

Pharmacy Distribution Centre Delivery Schedule

Glasgow Practices

Routine Delivery Day

South West Monday

East Tuesday

West Wednesday

South East Thursday

North Friday

Renfrewshire

Despatched from PDC on Tuesday to RAH for onward delivery

Wednesday

Inverclyde Practices

Despatched from PDC on Wednesday to IRH for onward delivery

Thursday

Dunbartonshire

Despatched from PDC on Monday to VOL for onward delivery.

Tuesday

To guarantee delivery, a vaccine order must be with the PDC 48 hours before the expected delivery day. If a practice is not going to make this deadline but needs the vaccine before the following scheduled delivery day, contact The PDC to arrange an alternative. This may for example involve someone from the practice uplifting the vaccine.

4.4 Receipt

Refrigerate vaccine deliveries immediately. (This is the responsibility of the member of staff accepting delivery).

Vaccines must be placed in the vaccines refrigerator(s) IMMEDIATELY they are delivered to the practice or clinic. It is good practice to record the fridge temperature after a vaccine delivery has been placed in the refrigerator and again 30 minutes later (See Section 4.5.2 for appropriate stock rotation and temperature monitoring advice)

Ensure all staff know where the keys for vaccine refrigerators are kept and have access to them to prevent delay in vaccines being stored at the appropriate temperature.

It is good practice for staff to check the received vaccines against the order for discrepancies and for leakage or damage before signing for them.

4.5 Storage and Equipment 4.5.1. Storage Check and record the fridge temperature (maximum, minimum and current) twice daily. Suitable sheets are available from Primary Care Distribution Centres. The thermometer should be re‐set after each reading.

The correct maintenance temperature of the vaccine refrigerator is 2‐8C. Store vaccines in the middle of the fridge away from elements and freezer compartments. Do not fill fridge more than two thirds full. Do not store in the fridge door, to avoid the risk of a temperature rise when door is opened. Do not store foodstuffs in the vaccine fridge at any time Correct Temperatures Vaccines should be stored in the original packaging at +2°C to +8°C and protected from light, as exposure to ultraviolet light may cause loss of potency. Repeated warming and cooling of vaccines may also result in reduced potency. It is generally recommended that vaccine refrigerators should be maintained as close as possible to 5°C, as this gives a safety margin of +/‐ 3°C. Too warm Heat speeds up the decline in potency of most vaccines and reduces their shelf life. Therefore, the effectiveness of the vaccine cannot be guaranteed unless it has been stored at the correct temperature. It is important that the fridge is not overfilled, since this can restrict the circulation of air within the fridge, resulting potentially in some parts of the fridge becoming warmer than others. It is recommended that the internal volume of the fridge cabinet area (main body of the fridge) is only partially filled (around 50%) and even at maximum stock level is not more than two thirds (66%) filled to allow circulation of air and hence the achievement of correct temperature gradients. ‘Salad drawers’ with a lid are unsuitable as these are subject to temperature fluctuations and vaccines should not be stored directly on the floor of the refrigerator. Both of these practices have the potential to restrict airflow circulation and hence may cause temperature variations. Additionally vaccines should not be stored in the refrigerator door as they will warm up every time the door is opened. Too cold Vaccines must not be kept at temperatures below 0°C as freezing may cause increased reactogenicity and loss of potency for some vaccines. It can also cause hairline cracks in the container, invisible to the naked eye, which could lead to contamination of the contents. It is therefore important that the vaccines are not stored in or close to any freezing component in the refrigerator such as the back wall in a self defrosting fridge. Non‐pharmaceutical items Food, drink and clinical specimens must never be stored in the same refrigerator as vaccines. This would cause the door to be opened frequently for access, resulting in a raised temperature.

Use of temperature recording charts Review temperature records at the end of the month. Sense check them, for example are the temperatures showing no variation, which may indicate that the thermometer is not being reset or are there any unexplained wide variations in temperature? Temperature recording charts are available to order from Primary Care Distribution centres. Further advice about their use is in the section 4.11.

4.5.2 Stock Management and Rotation of Stock

Always check “Expiry Date” of vaccine following removal from the refrigerator and before dispensing. Check expiry dates and rotate stock to ensure shortest shelf life is used first. Do not keep excess stock.

On receipt, all deliveries and existing stock should be routinely date checked and rotated within the fridge to ensure that those vaccines with the earliest expiry date are at the front and used first. Ideally, any vaccines with a short shelf life should be marked “use first”. It is good practice to have this process as part of your written procedures. All pharmacy products carry a batch/lot number and expiry date. Companies differ in the format they use for expiry dates. Please be careful when checking expiry dates and be aware of the following very different examples.

Expiry would be 31/10/2007 Expiry would be 30/9/2007 Expiry would be 30/9/2007

Batch: 2585H EXP: 10/2007

Batch: 68689Y

EXP BY: 10/2007

Batch: 2299J EXP BEFORE: 10/2007

Make a note on your temperature recording chart that a delivery has been received, expiry dates checked and stock rotated alongside recording the temperature of the fridge after the stock has been received and rotated.

Check the temperature again 30 minutes later to ensure that the running temperature is satisfactory and record on the temperature recording chart. Any out of date stock should be labelled clearly, removed from the refrigerator and returned for destruction as soon as possible according to local procedure (See Section 4.8 Disposal)

4.5.3 Fridge Use and Specifications Fridge Specifications Specialised refrigerators are available for the storage of pharmaceutical products and must be used for vaccines and diluents. Ordinary domestic refrigerators must not be used since they are not designed to maintain the rigorous temperatures and temperature gradients required for storage of vaccines. The following features are considered essential to best practice and should be sought when purchasing a pharmaceutical fridge for storage of vaccines: Operational temperature +2°C to +8°C Forced air cooling – interior fan for temperature stability and rapid temperature recovery

after door openings. Door lock CFC, HCFC and Ammonia free Auto‐defrost function Wire shelves/baskets or shelves capable of allowing air ventilation. Integral thermometer which has a digital display recording actual and

maximum/minimum temperatures Thermometer has an integral high/low temperature alarm (audio/visual)

Where a practice already has a fridge which does not have the essential features listed above, a replacement should be considered, unless the missing specifications can be addressed by an alteration to the equipment or environment e.g. if fridge is not lockable it should be kept in a lockable room, which is locked when not in use, or if a fridge does not have an integral thermometer, a recommended stand alone digital thermometer could be purchased. Age of Fridge Where a practice fridge is over 5 years old, it should be considered for replacement. Fridges are likely to remain operating satisfactorily for at least 5 years. Beyond this age the fridge functioning may deteriorate and its ability to maintain correct temperatures cannot be guaranteed. Daily temperature monitoring and routine maintenance should be used to ensure ongoing satisfactory performance. Manufacturers and Fridge Purchase Guidance There are a number of manufacturers of refrigerators such as Lec®, Labcold®, Swan® and Sanyo®, or thermometers such as Fisher Price (Healthcare Logistics US). We have given a list of manufacturers and suppliers with contact details and an approximate dimension and price list in Section 4.11. Installing a new fridge or moving a fridge When a new refrigerator is installed the manufacturer’s guidelines should be referred to before switching the appliance on because if the oil in the compressor has been displaced and has not settled back, the fridge may break! After relocating a fridge, if it hasn’t been tilted or placed on its side it may be turned on immediately. If it has been significantly disturbed or there is any dubiety it should be allowed to settle for 24 hours.

In either instance the refrigerator temperature should allowed to stabilise before it is used to store vaccines. The time for this may vary according to the make of the refrigerator and ambient temperatures. Best practice would suggest a period of 48 hours for installation of a new fridge but an existing fridge may be used after a minor relocation as soon the temperature is in the 2‐8C range. A note should be made in the temperature log book of the date a new fridge is used for the first time or the date an existing fridge is relocated or recommissioned. Fridge Location/ Environment Protect power supply to the fridge ideally with a switchless socket and a fixed unit over the plug and socket to ensure the plug cannot be pulled out. Mark electrical socket with a cautionary notice advising staff not to switch off power. Sockets for fridges should be marked with a cautionary notice advising staff not to switch off power or ideally, there should be a switchless electrical supply installed. This is important in order to avoid the possibility that the fridge is accidentally switched off. Generally, a refrigerator should not be situated near a radiator or any other heat source (including direct sunlight). The fridge should also be positioned to ensure that it is appropriately ventilated (i.e. has adequate space for air circulation between the compressor and the wall) and is in a well ventilated room where the temperature is comfortable (i.e. no extremes of <16°c or > 32°c and ideally at 20‐24°c maximum) to ensure performance at maximum efficiency. The manufacturer’s user guide will provide specific information relating to this and should be consulted. Fridge Maintenance Clean and defrost vaccine fridges on a regular basis (three monthly). Place vaccines in another monitored fridge or in a validated cool box while this takes place and until the refrigerator

temperature is restored to 2‐8C. In addition to purchasing the correct type of fridge and locating it appropriately within the surgery, it is also essential that the fridge is properly and regularly maintained to ensure adequate performance. Routine Maintenance Routine maintenance should be carried out by practice staff. The manufacturer’s user guide for your product will provide specific information on this and should be consulted. Generally, this should include cleaning and/or defrosting the vaccines fridges on a regular basis. Unless the fridge has an auto defrost facility, it should be defrosted at least quarterly. When a refrigerator is to be cleaned /defrosted the following should be ensured: Ensure that vaccine stock levels are at a minimum. Remove/transfer the vaccine to another monitored refrigerator (which is also maintained in

accordance with NHSGGC Guidelines) Record “vaccine removal/transfer” on both sets of temperature recording sheets (in the

comments section) Replace the vaccines in the refrigerator only once it has returned to the correct temperature

after cleaning/defrosting. If an alternative refrigerator is not available an appropriately prepared validated cool box e.g.

Vaccine Porter® may be used. Clean/defrost the refrigerator ensuring that:

An appropriate/compatible cleaning agent is used (check manufacturer’s instructions

but generally a dilute solution of sodium bicarbonate and water or detergent and water for routine cleaning)

The drainage hole for self defrosting models is wiped well and not blocked. The door seal is washed to remove all dust/debris and is checked that it is intact and free

from any punctures. The door hinges are checked and are dust free. The element at the back of the refrigerator is regularly dusted and remains dust free.

Note: Some models of fridges are self‐defrosting and there should be no ice build up in the cabinet. If ice build up does occur, it may be an indication that there is moisture in the cabinet, which may be due to: The room is too warm ‐‐ or even damp The fridge thermostat/temperature is set too low Cardboard packaging may have come in contact with the back wall at some point and is wet Open Tupperware® style containers are being used and are attracting moisture.

The practice should investigate why ice is building up, as the self‐ defrosting fridge will not be working at full efficiency when there is any ice buildup.

Additional/ Annual Maintenance All vaccine fridges should have an electrical check undertaken regularly (usually annually) as part of the practices routine approach/contract for checking of all electrical equipment (PAT testing), n.b. PAT testing does not need to be conducted when a new fridge is installed as this is covered by the manufacturer’s warranty. There are a range of providers who can be contracted to undertake this work, including the Clinical Physics Department at the Southern General Hospital (Contact 0141 201 1895). Regular (e.g. annual) servicing of fridges can be arranged via contractors such as McMillan Refrigeration, www.mcmillanrefrigeration.co.uk. Tel: 0845 293 0823 or E‐mail [email protected]. Practices may wish to have this in place, to provide independent reassurance on their fridges’ performance. If regular temperature monitoring, in‐house maintenance and annual audit are being carried out in accordance with NHSGGC guidelines specialist annual servicing by a contractor may not be necessary i.e. Temperature monitoring is carried out in accordance with NHSGGC Guidelines. Temperature charts are reviewed on a monthly basis to determine that temperature ‘drift’ (a

widening range of maximum minimum temperatures and steadily increasing or decreasing mean temperatures) is not occurring.

However have a service carried out If it appears that ‘drift’ is occurring to determine whether the fridge is working within desired

parameters. The fridge is more than ten years old Where the fridge temperatures appear to be fluctuating or the fridge is operating outside of

the 2‐8°C range with no clear and fixable explanation When a new fridge is purchased, the old fridge must be disposed of appropriately. When supplying a new fridge, manufacturers must (by law) provide the opportunity for the old fridge to be picked up and disposed of. This may be free of charge if the old fridge is one of their models or for a small cost if the product is from another manufacturer.

http://www.mcmillanrefrigeration.co.uk/


4.5.4 Thermometer Specifications Thermometers/ temperature monitoring devices must be able to record the minimum, maximum and actual temperatures of the refrigerator. Digital thermometers are recommended to record the minimum, maximum and actual temperatures, since these are more reliable. These are often fitted by the manufacturer as integral to the refrigerator. Where a digital thermometer is not fitted as integral to the refrigerator, or if a practice is using a manual thermometer a stand‐alone digital thermometer should be purchased and situated centrally within the cabinet, next to the stored vaccines.

Stand alone digital thermometer We recommend a digital thermometer (Traceable Memory Monitoring Thermometer 17988) with a min/max reading that has an inbuilt alarm. The device will record the time that the alarm is triggered, providing a useful audit trail for breaks in the cold chain. Attached to the thermometer is a probe that is sealed in a small bottle of non‐toxic glycol solution. This allows the thermometer to record the product temp, not the fridge air temp. This provides a more accurate reading reflecting the temperature of stored vaccine rather than the air temperature of the fridge. See Section 4.11 for details of thermometer manufacturers and suppliers.

Thermometer Use and Resetting Only use one thermometer for each fridge. It is essential that the thermometer/temperature monitoring device is reset after every reading. Some thermometers/temperature monitoring devices measure air temperature. The temperature reading of this type of thermometer will respond immediately to any rise in actual air temperature. Therefore, even if it’s >8ºC for a few seconds e.g. via the air temperature increasing because the door was opened, this maximum temperature is recorded and will remain until the next time the thermometer is re‐set. This may not reflect the actual temperature of the stored vaccines.

The recommended type of thermometers or temperature monitoring devices are designed to simulate the actual temperature of the vaccines rather than measuring the air temperature (this is often the case for integral thermometers in modern pharmaceutical fridges). The actual temperature of a vial of vaccine will not change as quickly as air temperature. These devices provide a more accurate reading of the actual vaccine temperature and hence the actual maximum and minimum temperature of the vaccine. As with the thermometers measuring air temperature, the maximum and minimum temperatures recorded will remain until the next time the thermometer is reset and again must be reset after every reading. Guidance on the use of the digital thermometer suggested above is included in the Toolkit Section 4.11. For guidance on the use and resetting of all other thermometers, please refer to the manufacturer’s instructions.

Thermometer Calibration Recalibrate the thermometer regularly according to manufacturer’s recommendations. Recalibration of temperature monitoring equipment by an appropriate contractor in accordance with manufacturer’s recommendations can be expensive. In many instances it’s probably cheaper to replace a stand alone thermometer or logging device with a new model. It is acceptable to verify the calibration of the thermometer. This may be done simply by comparing the temperatures registered by the thermometer with a logging device or ideally as part of a ‘temperature mapping’ exercise (see Section 4.5.3.) Verification of the calibration of the thermometer should be undertaken annually. Contact the Public Health Pharmacist for further advice Tel. 0141 201 4502

4.6 Temperature Monitoring Specific member(s) of staff should be identified to monitor the pharmaceutical supplies

refrigerator. Any temperature readings outside 2‐8C should be investigated immediately and discussed with Pharmacy Public Health if necessary. Check and record the fridge temperature (maximum, minimum and current) twice daily. Suitable recording sheets are available. The thermometer should be re‐set after each reading. 4.6.1 Roles and Responsibilities It is important that designated members of staff are identified as responsible for monitoring the fridge temperatures every day. It is also important that arrangements are clear with regard to who should deputise in the event of holidays, sickness, absences etc. Designated staff should all be trained to use the equipment and respond to any abnormal readings. It should also be made clear to all staff involved with immunisation that designating a member of staff to monitor temperatures does not devolve them from responsibility in ensuring that the vaccines they administer have been stored within the correct range of +2 ºC to +8ºC. 4.6.2 Monitoring and Recording Temperatures To ensure compliance with the NHSGGC guidelines, refrigerator temperature readings (maximum, minimum and current) must be read and recorded twice every working day. Readings must be taken (and recorded) usually at the start and near the close of the working day. If a vaccination clinic has been run the temperature should be recorded after this has finished and a note made on the recording sheet that a clinic has taken place. Pharmacy Public Health must be contacted if there is doubt about any temperature variations outwith acceptable levels. Care must be taken to ensure that the thermometer is reset after each reading. Each practice or vaccinating centre should nominate staff to undertake the monitoring procedure and a permanent programme should be in place to cover absences. National guidelines state that temperature records should be retained for at least twelve years in line with HDL 2006‐28 requirements for Quality Assurance Documents. However, in practice it is sufficient to have a minimum of 2 years charts readily available to enable review. Monthly review of fridge temperature charts should be undertaken. This can highlight temperature ‘drift’ which may indicate that a fridges temperature control is beginning to become less reliable. This is important for all fridges but particularly for ageing models. The temperature chart should be signed after monthly review has been completed to audit compliance. To support GP practices in ensuring that they adopt best practice in monitoring and recording fridge temperatures, Temperature Recording Sheets (pads) and a cover sheet with Best Practice Recommendations were prepared on behalf of the NHS Greater Glasgow and Clyde Immunisation Liaison Group. These were previously issued to all GP practices. A copy of the Best Practice Recommendations and the Temperature Recording sheets is included in the Section 4.11. Further copies of the Temperature Recording Sheets can be ordered from Primary Care Distribution Centres.

4.6.3 Setting Temperature Alarm Parameters Where a fridge has an integral alarm to alert high and low temperatures it is important to ensure that the appropriate parameters for the alarm are set. It is recommended that the alarm should be set to sound after the temperature has been below +2ºC or higher than +8ºC for more than 15 minutes. 4.6.4 Action in the Event of Abnormal Temperatures Any vaccine unsuitable for use (e.g. expired stock or heat/cold damaged vaccines) should be clearly identified and returned for disposal. Telephone Pharmacy Distribution Centre to arrange. Abnormal temperatures are those which are out with the recommended vaccine storage range of 2‐8°C. If vaccines have been stored out with the recommended temperature range, the cold chain may have been broken and the vaccine may be unsuitable for use. Action taken in the event of abnormal temperatures, or reasons for abnormal temperatures should be clearly recorded on the temperature monitoring sheets e.g. “Delivery Received”. Any temperature out with the recommended range which cannot be attributed to the putting away of an order or vaccine being removed for a clinic, should be dealt with according to the NHSGGC guidance. See Figure 1. ‘Management of Fridge Temperature Problems for Practice Staff’ below.

Figure 1

Is the fridge temperature above 8°C? Is the fridge temperatureor has it been at some point since below 2°C or has it beenthe thermometer last reset? since last reset?

Yes No

No ActionCan anybody explain the temperatureproblem e.g. door left open; newdelivery of stock?

YesYes No

If the rise can be explained & the No explanation or temperaturetemperature falls to below 8°C remains above 8°C for moreafter 30 minutes then no further than 30 minutes.action needs to be taken.This must be clearly explainedin the comments section oftemperature pad.

Contact the responsible clinician or their deputy. Ifthey are not available then follow the instructionsbelow.

Quarantine all vaccines held in the fridge. Clearlymark vaccines not to be used. Remove them to a properly functioning fridge. Notice to be placed onfridge door:-PLEASE DO NOT USE UNTIL FURTHER NOTICE

Report problem to Pharmacy Public Health as soonas possible to determine if vaccine requires to beordered.

Management of Fridge Temperature Problems for Practice Staff

N.B. Regular review at end of each month should identify any temperature drift, temperature records maintained satisfactorily and explanations provided for any temperatures outside 2°C - 8°C

To provide the best possible advice Pharmacy Public Health (PPH) will require details of the incident. They will fax or e‐mail a Vaccine Incident Form to the practice to collect information. A “Vaccine Incident Checklist” is included in Section 4.11 to give you a guide to the types of information that you will be asked for. Once a response is received; PPH will follow the NHSGGC Pharmacy Public Health Standard Operating Procedure. If the quarantined vaccines are deemed unsuitable for further use, they will require to be disposed of by return to the PDC. See Section 4.8 Disposal If the quarantined vaccines are deemed suitable to be used, they will require to be clearly marked with “Subject to Cold Chain Breach. Use First” and if a second exposure occurs, then the vaccine will have to be destroyed. 4.6.5 Assessment and Response to Incidents An incident may be identified in 2 ways: When a GP practice reports an incident after failure of storage After analysis of audit data undertaken routinely or at the request of PPH.

Analysis of practice temperature record charts for adequacy of recordings, temperature drift and explanation for any >8°C temperatures recorded e.g. constant minimum and maximum readings may indicate that thermometer is not being re‐set, temperature may have increased temporarily as a result of stock check but this has not been recorded.

Analysis of temperature logger results in comparison to fridge thermometer recordings and temperature ‘swing’ which might indicate failing fridge performance.

Responses to reported self audit data. The process to be followed for all incidents is; GP practice responsible clinician or their deputy contacts PPH to report the incident and arrange new vaccine supply if required see Figure 1. PPH will provide advice depending on the scale of the incident see Figure 2. ‘Pharmacy Public Health Risk Assessment of Vaccines Process’ below.

Figure 2

Please note any vaccine >72 hrs above 12°C as stored below 0°C will single or cumulative be recommended to be figure. High temperatures unexplained:- Transient minor breach/ destroyed and a risk More than 6 minor Undertake risk assessment. high temperatures assessment required breaches of cold chain. Contact vaccine manufacturers. explained e.g. clinic for potential

Record advice on vaccine Ensure these are well reimmunisation.risk assesment form. documented on practice Contact PDC to return any records.

e-mail response report vaccine requiring destruction. Label vaccine 'subject to cold chain breach, date, use first' Incident Form not

required.Audit may be required if >1 year since lastaudit.

Telephone NumbersPDC 0141-347-8981PPH 0141-201-4824

Audit and training may be required. Vaccines risk assesment report returned to practice

Pharmacy Public Health Risk Assessment of Vaccines Process

<2°C

incident or regular review of temperature monitoring records

> 8°C

Fridge temperature problem identified by an

Prepare Steering Group

Does incident require referal to the Steering Group?

Refer to Steering Group for approval via e-mail response report if vaccine considered potentially viable

YES NO

Review potential contributing factors

All incidents will require completion of a Vaccine Incident Form to be returned promptly to Pharmacy Public Health (PPH). The response to incidents will be made following the NHS GG& C Pharmacy Public Health Standard Operating Procedure (SOP) and will include: PPH provides a ‘vaccine risk assessment report’ detailing how vaccines may be used. This

advice will state that vaccines may be used as normal, used ‘off license’ or need to be destroyed. The vaccine risk assessment report should be retained for practice records.

In response to the incident forms received, PPH prepares an individualised report for the practice detailing any recent previous incidents, potential reasons for incident, recommendations to prevent future similar incidents and an invitation to undertake a self audit of their vaccine storage arrangements. Copies of this report are also sent to the CHCP or Sector Clinical Director and CHCP Lead Clinical Pharmacist. This incident letter is prepared and issued as soon as possible after the incident.

Although the immediate needs of a practice regarding the continued use of the vaccine may have been managed, professional review undertaken by PPH enables an assessment of contributory factors and provides recommendations to improve practice and prevent future repeat occurrences.

4.6.6 Contingency Arrangements In the event of a fridge failure it is important to have arrangements in place for suitable storage of vaccines whilst advice is sought on whether the vaccines are suitable for future use. Pharmaceutical fridges can normally be expected to maintain the fridge temperature for up to 4 hours in the event of a power failure. Therefore if the power supply has been interrupted for a period of four hours or less, the fridge door should be kept closed and close monitoring of temperatures undertaken to ensure the fridge is operating within normal temperature limits until either the supply is reinstated or alternative arrangements for storage can be made. If the failure lasts longer than four hours a suitable back‐up or alternative fridge should be available, which is also maintained in accordance with NHSGGC Guidelines. Transfer the vaccines and record “vaccine removal/transfer” on both sets of fridge temperature recording sheets (in the comments section). Practices need to consider the practicality of alternative pharmaceutical fridge storage arrangements and ensure that they have suitable contingency plans in place which are clearly outlined to all staff. In emergencies, where there is no alternative appropriate storage available, contact the supplying vaccine holding centre in the first instance for advice. Keep a record of this discussion and advice to enable you to create a standard operating procedure for future occasions.

4.7 Transportation 4.7.1. From Holding Centres to Practices The World Health Organisation (WHO) has undertaken studies on vaccine storage and transportation and recommends that an efficient ‘cold chain’ is established for vaccine distribution to ensure that the correct temperatures are maintained throughout, as any breaks in the cold chain, may reduce the potency of vaccines and contribute to primary vaccine failure. Within NHSGGC vaccines are distributed from the Pharmacy Distribution Centre to health centres, clinics and surgeries using cool boxes. These are special containers which are validated to maintain the cold chain for eight hours, including allowance for multiple openings. Once received by the surgery/clinic, immediate transfer of vaccines to the vaccine fridge will ensure that the cold chain is fully maintained. 4.7.2. From Practice to another Location Vaccines should only be transported to peripheral clinics using validated cool boxes. Occasionally vaccines may have to be transferred from the practices vaccine refrigerator to another clinic or for domiciliary visits. Where this occurs, validated cool boxes e.g. Vaccine Porters® or Mini Vaccine Porters® – must be used. Large Vaccine Porters® are not normally practical for GP practices since they take up a lot of space and require several shelves of fridge space to store the cool packs prior to their use. Smaller cool boxes (Mini Vaccine Porters®) are available for transport of up to 10 vials of vaccine and are normally suitable for GP Practices. They require the insertion of a cool pack, which must be frozen in advance, for accredited use and are validated for up to 18 hours. See Section 4.11 for further information. 4.7.3. During Clinic within Practice Only remove from fridge at any one time the minimum quantity required. Reconstituted vaccines and opened multidose vials should be disposed of at the end of an immunisation session in a 'sharps' box. Any surplus vaccine not used during a clinic session should be returned and used first for subsequent session. Discard any vaccine not used during second session. When running a clinic in a room that does not have a refrigerator, it is not necessary to store the vaccines in a cool box during the clinic session. Only remove the minimum vaccine required for a session from the fridge and don’t remove it from the fridge any earlier than necessary. Unused vaccines removed from the refrigerator for one clinic session in unopened packs, should be returned to the refrigerator clearly labelled “Use First“ and should be selected immediately for the subsequent session requirement. They should not be returned for refrigeration more than once. Vaccines which are presented as solutions in multi‐dose vials must be discarded after four hours, or at the end of the session, whichever is sooner. The individual Summary of Product Characteristics (SPCs) should be consulted for exceptions e.g. Pandemrix® (24 hours after reconstitution) and Celvepan® (3 hours after removal from fridge). SPCs are available at http://emc.medicines.org.uk/. Expiry dates and batch numbers of each vaccine must be recorded in patient records. This is necessary to provide an audit trail in the incidence of product withdrawal or adverse reaction, which may be attributable to the vaccine.

http://emc.medicines.org.uk/

4.8 Disposal Vaccine which is unfit for use through being out of date or because of storage irregularities should be returned by prior arrangement (telephone) to the PDC for destruction. A duplicate returns form will be provided by the PDC and should be completed ensuring that the date, batch number, expiry, quantity returned and reason for return is provided. Any opened or prepared vaccines that have not been used during a clinic session should be destroyed in the following manner:‐ Opened Vials should be placed in a sharps container for incineration. Any vaccine in an ampoule should be drawn into a syringe and the whole syringe placed in a

sharps container for incineration. Vaccines must not be flushed down the sink or toilet

4.9 Spillage Where live vaccines are used staff should exercise due care and attention, which eliminates any risk of the hands being contaminated. Contaminated waste and spillage should be dealt with according to the NHSGGC Clinical Waste Policy and Decontamination Guidelines and the NHSGGC Division Prevention and Control of Infection Manual respectively. Hand washing, as outlined in Part 2, Section 1 of the NHSGGC Division Prevention and Infection Control Manual must be undertaken before and after the vaccine administration procedure for each patient. In the event of eyes being splashed with vaccine, the eyes should be rinsed with copious amounts of Sodium Chloride 0.9% and immediate medical advice sought. (Refer to GGNHSB Management of Occupational and non Occupational exposure to blood borne viruses at http://www.nhsggc.org.uk ). 4.10 Recall In the event of vaccines being recalled, all ordering sites will be notified by the Pharmacy Distribution Centre. The person in the practice responsible for vaccine storage and handling must check all stock in the practice as soon as possible. Any affected vaccines should be placed in refrigerated quarantine clearly marked ‘NOT TO BE USED’. The responsible person should notify the Pharmacy Distribution Centre that stock requires to be returned as outlined in Section 4.8 Disposal, or as directed by the initial recall notification. The practice must keep records of all stocks returned, (as per returns sheet).

http://www.nhsggc.org.uk/

4.11 Support materials 4.11.1 Fridge magnets and temperature charts Fridge magnets with a summary of the NHS NHSGGC Guidelines and contact numbers for advice and temperature charts have been prepared. The magnets should be placed on all vaccine refrigerators. (Appendix 2 and 3) Recommended temperature charts for use in NHS NHSGGC premises are available. In addition to a full list of the guidelines the charts have a copy of the incident checklist. An initial distribution of the magnets and temperature chart pads has been made to all GP practices. Extra magnets for second or back up refrigerators or replacements for lost or damaged magnets and replacement temperature chart pads may be obtained from the Primary Care Distribution Centres. For Greater Glasgow Practices: Primary Care Distribution Centre, Clutha House, 120 Cornwall Street South, Glasgow, G41 1AD Tel: 0141 427 8246, Fax: 0141 427 8270 For Clyde Practices: Argyle and Clyde Primary Care Supplies, NHS NHSGGC Central Store (South), 1 Carnegie Road, Hillington, Glasgow, G52 4NY Tel: 0141 278 2531, Fax: 0141 892 0758

4.11.2 NHSGGC Equipment Guidance Refrigerators When purchasing a pharmaceutical refrigerator or a temperature recording device, we strongly recommend that you seek the advice of Public Health Pharmacy on 0141 201 4502 or the Pharmacy Distribution Centre. Often medical supplies wholesalers are unable to offer technical advice on such equipment and apparatus. The dimensions, prices and specifications of equipment offered by suppliers can vary quite widely. As a rough guide, however, NHSGGC and PPSU have studied the evidence and believe that LEC®, Labcold®, Sanyo® and Swan® manufactured pharmacy refrigerators generally fulfil the guidelines for storage of vaccines. Labcold now offer a range of fridges incorporating a logging device which may be used to determine when and for how long a cold chain breach has occurred see Appendix 1. Details of equipment may be accessed on line or telephone the manufacturer or supplier for a catalogue. We have compiled a Refrigerator Information Chart listing suitable models for guidance. This is by no means an exhaustive list and it should be noted that manufacturers are continually developing product ranges. This list is shown as Appendix1 The chart below gives a rough guide to the size and price of fridges and where they may be sited in a practice. Typical Pharmacy fridge sizes and prices n.b. these are for guidance only

Typical Location‐size Dimensions W/D/H (mm)

Capacity litres

Number of shelves

Price range *Approximation only

Table top ‐ small 380/500/660 35‐60 2 £400‐£500

Under bench ‐ medium 560/600/865 135‐150 2‐3 £650‐£800

Tall ‐ large 595/ 910/1850 300‐500 5‐7 £1000‐£3000

There are a variety of suppliers; it is not possible to supply an exhaustive list of these. However, the table below suggests a few examples. Check when ordering equipment if discounts may be applied.

Manufacturer/Supplier contact information

Contractors may obtain NHSNSS contract prices quote Contract number A517560F when ordering equipment. N.B. prices quoted using this code are confidential NHSNSS contract prices and ex vat. Prices must not be discussed with any third party. Please check with supplier as not all suppliers may be able to apply a discount.

Manufacturer Supplier address details

Telephone Website

Sanyo Electric Co. Ltd. Scanfrost® Shoreline® Swan® Lec® Labcold®

Vicarey Davidson & Co Surgical Instrument Makers, 30 Cumberland Street, Glasgow G5

0141 420 1778

n/a

Also

Lec® Glen Dimplex Professional Appliances (for Lec Medical) Stoney Lane, Prescot, Merseyside, L35 2XW

0871 222 5119 Fax 0871 222 9636

www.lec‐medical.co.uk

Labcold®

Wade Road BasingstokeRG24 8FL

0870 300 1001

Email : [email protected]

Swan® Robson Medical

01228 510044 www.robson‐medical.com

Thermometers Recording pharmacy fridge temperature readings TWICE daily may not seem to be of much importance at the time, but, when a fridge incident occurs, this information is the deciding factor as to whether a vaccine can safely be used. Spending a couple of minutes each day to record minimum, maximum and current temperatures could save thousands of pounds when you cost the value of stock stored in your fridges. A designated person should be responsible for taking these readings. This person should also be trained and confident in using the thermometer and be aware of the actions to be taken if the temperature falls outwith the recommended 2°C to 8°C range. Records of daily temperature readings should then be reviewed on a monthly basis to check for ‘drift’ in temperatures. This may highlight failing equipment or the need to reset thermostats. The fridges we recommend will have an integral thermometer, however, we realise that for various reasons a thermometer to monitor a fridge’s temperature may need to be purchased separately. We recommend a digital thermometer with a min/max reading that has an inbuilt alarm. . The device will record the time that the alarm is triggered, providing a useful audit trail for breaks in the cold chain. Attached to the thermometer is a probe that is sealed in a small bottle of non‐toxic glycol solution. This allows the thermometer to record the product temp, not the fridge air temp. This provides a more accurate reading reflecting the temperature of stored vaccine rather than the air temperature of the fridge. Suppliers of the: Traceable Memory Monitoring Refrigerator/Freezer Thermometer are shown below.

http://www.lec-medical.co.uk/

Please note these thermometers include a 2 year calibration certificate which indicates an expiry date at which point the accuracy will no longer be guaranteed. Recalibration of the thermometer is expensive and in practical terms it is usually cheaper to replace the thermometer. In the event of a second thermometer being purchased for a refrigerator we recommend that only one thermometer is used to monitor the cold chain.

Suppliers of the recommended thermometer

Manufacturer Supplier contact details Order number

Approximate Price

Fisher Price (Healthcare Logistics US)

Vicarey Davidson & Co Surgical Instrument Makers,

30 Cumberland Street, Glasgow G5

Tel 0141 420 1778

Item code 17988

£80 + vat

Carriage £3.95

Fisher Price (Healthcare Logistics US)

Distinctive Medical Products

3 Seymour Court

Runcorn, Cheshire, WA7 1PT

Tel 0800 525076 or 01928 571 801

Fax 0800 590014 or 01928 571430

Item code

17988

£84.27 +vat

Carriage £8.00

Contractors may obtain NHSNSS contract prices quote Contract number A517560F when ordering equipment. N.B. prices quoted using this code are confidential NHSNSS contract prices and ex vat. Prices must not be discussed with any third party. Please check with supplier as not all suppliers may be able to apply a discount. Temperature monitoring apparatus (loggers) Temperature “loggers” are available to monitor fridges continuously. Temperature information is downloaded into tailored software to allow preparation of a temperature history graph. They should not be used to monitor the fridge temperature alone as they will usually only measure air temperature rather than the simulated vaccine temperature. They can be useful as they give an indication of how long a fridge has run outwith the approved temperature range but variations between logger and thermometer readings can raise uncertainties around the temperature audit trail Prices for these vary widely and may require the purchase of software to download and analyse data onto a laptop or PC. In particular those which monitor simulated vaccine temperature may be very expensive. Contact the Public Health pharmacist for further guidance on 0141 2014502. Vaccine transport Cool boxes must be of the required certificated standard to maintain the cold chain and manufacturers can advise on the validation and appropriate use of these. Vicarey Davidson & Co Surgical Instrument Makers, 30 Cumberland Street, Glasgow G5, Tel 0141 420 1778 can advise on models currently available. The manufacturer of the Vaccine Porter’s® website is at www.helapet.co.uk/catalog/index.php?CG_ID=4 Large cool boxes (e.g. Vaccine Porters®) are not normally practical for GP practices since they take up a lot of space and require several shelves of fridge space to store the cool packs prior to their use. Health and Safety require 2 persons to carry the Vaccine Porter 24.

http://www.helapet.co.uk/catalog/index.php?CG_ID=4

Smaller cool boxes (e.g. Mini Vaccine Porters) are available for transport of up to 10 vials of vaccine and are normally suitable for GP Practices e.g. domiciliary visits. It should be noted that the cool pack used in this box must be frozen prior to use rather than chilled. Recent developments include a coolbox which may be plugged into a car power point. The LABCOLD® Pharmacy Transporter costs about £280 and is currently being assessed by NHSGGC Quality Assurance teams. Contact Pharmacy Public Health 0141201 4502 for further advice.

Comparison Chart Vaccine Porters

Vaccine Porter® Order code

Available product space (mm)

Price Number and type of Packs

Required each

Validated with multiple openings for

Mini Vaccine Porter® including one MC11pack

UMP911

210x115x30 £29.36 1XMC11

(frozen)

18 hours

Vaccine Porter® 6

UVP‐310 108 x 108 x 130 £60.00 6xMC28 8 hours

Vaccine Porter® 9

UVP‐330 144 x 144 x 105 £75.00 6XMC28

8 hours

Vaccine Porter® 16

UVP‐350 254 x 199 x 120 £98.00 14xMC28 8 hours

Vaccine Porter® 24

UVP‐370 250 x 250 x 135 £89 8XMC3 8 hours

Medicool® 28 (MC28)

UMC‐530 Spare MC28 packs

£36.00 18 n/a

Prices quoted are for example and discounts for multiple purchases may be applied. Guidance and Procedures for Use of Mini Vaccine Porters® Mini Vaccine Porters®, correctly prepared, are validated to maintain the interior temperature at 2° to 8°C for 18 hours with multiple openings and may be used to transport up to 10 vials.

The vaccine ‘cold chain’ can thus be maintained from surgery to patient in domiciliary visits. In such situations use of the Vaccine Porter® enables any unused vaccine to be returned to the surgery refrigerator. This removes concerns about ‘time out of fridge’ and the requirement to ‘Use First’.

Therefore Mini Vaccine Porters® should be used for all transport of vaccines from a surgery to a domiciliary situation. The only requirement for the accredited operation of a Mini Vaccine Porter is access to a refrigerator with a full freezer compartment as the MC11 MEDICOOL® COOLPACK pack used to ensure temperature maintenance must be frozen and not simply chilled

As the normal cycle of use would be encompassed within the eight hour working day the performance of the Mini Vaccine Porter is more than adequate for most applications. However, it is good practice to return all vaccines, thus transported, back to the main holding refrigerator on the same day as they were issued. Leaving vaccines overnight in the Mini Vaccine Porter® should be avoided.

Procedure for using the Mini Vaccine Porter®:‐

The Mini Vaccine Porter® is comprised of

1. an outer carrying case

2. an inner polystyrene insulated box and lid

3. a MEDICOOL® MC11 coolpack (to be frozen ) and

4. a spacer/protection mat (to be chilled)

As it takes 24 hours to prepare the coolpack and the mat, each Mini Vaccine Porter® can only be used on alternate days. If transporting ability is needed daily then each user will need two porters.

1. Freeze the MC11 Medicool® Coolpack for at least 24 hours at ‐18° C. This temperature can

be achieved in the freezer or ‘ice cube’ compartment of a refrigerator and may be confirmed by placing a maximum/minimum thermometer in the freezer compartment for a few hours.

2. Chill the spacer/protection mat at +5° for at least 24 hours. This can be achieved in the main storage area of a refrigerator.

3. Remove the Medicool® unit from the freezer 20 minutes before needed. It is important that this unit is not taken directly from the freezer and placed in the insulated box.

4. Firstly, place the vaccine to be transported in the bottom of the insulated box. 5. Secondly, place the spacer/protection mat directly on top of the vaccine. 6. Thirdly, place the Medicool® Coolpack on top of the spacer/protection mat. 7. Finally, replace the insulated lid and close the flap of the outer carrying case.

The porter is now ready for use and is validated for 18 hours with multiple openings. Upon return to base at the end of the day the cooling units should be returned to their respective areas of the refrigerator to be recharged for subsequent use.

If more than one Mini Porter® is being operated from one refrigerator it is good practice to mark the time that each cooling unit is returned to the refrigerator thus ensuring that properly prepared mats and cool packs are being used.

N.B The MC11 MEDICOOL® COOLPACK for the Mini Vaccine Porter® requires to be frozen prior to use. Larger vaccine porters use different cool packs which require refrigeration prior to use. Please ascertain carefully which system you are using prior to use and read the manufacturers instructions.

For further information about preparing Vaccine Porters® and the Vaccine Mini Porter® please go to www.helapet.co.uk/catalog/index.php?CG_ID=4

http://www.helapet.co.uk/catalog/index.php?CG_ID=4

4.11.3 Vaccine Refrigerator Incident Checklist

Please ensure affected vaccines are kept in quarantine, in a monitored refrigerator, until a decision is reached regarding suitability for use and fill out the Vaccine Refrigerator Incident Form (Appendix 3).

Important details required include:

Clinic/Practice Name and Address Contact Name and Phone Number Refrigerator affected (ID and Location) Background to the incident Maximum (or Minimum) Temperature Vaccine Reached Length of time vaccines exposed When were the correct temperatures last recorded Copy of Temperature Recording sheets for preceding month Details of any affected vaccines used for immunisation during period of malfunctioning: Details of affected vaccines (type, manufacturer, batch number, quantity, expiry dates

If an incident has occurred this may provide an opportunity to review your current procedures and undertake a self audit. Further information and support in these is available from the Public Health Pharmacist telephone 0141 201 4502.

4.11.4 Training

A learn pro course Cold Chain Management has been developed by pharmaceutical public health which is suitable for all staff involved in the delivery of immunisation and vaccination services. Like all learn pro programmes, the online course can be accessed anywhere, any time and takes less than 30 minutes to complete

To access the course visit http://nhs.learnprouk.com/ and register.

Click on more learning and the module is listed under Pharmacy tab. Please forward any comments you have on this module to [email protected]

http://nhs.learnprouk.com/


4.12 References Department of Health (2006) Immunisation against Infectious Diseases (The Green Book) http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_079917 NHS HDL 2007‐18 accessed February 2010 at http://www.sehd.scot.nhs.uk/mels/HDL2007_18.pdf Summary of Product Characteristics for Pandemrix® and Celevac® accessed November 2009. http://emc.medicines.org.uk Grampian Health Board July 2007. ‘Vaccine handling policy for clinics, hospitals, community pharmacies and GP practices’. accessed in November 2009 at. http://www.nhsgrampian.org/grampianfoi/files/Vaccine_Handling_July_07.pdf World Health Organisation. ‘Temperature Sensitivity of Vaccines’ August 2006 accessed November 2009 at http://www.who.int/vaccines‐documents/DocsPDF06/847.pdf NHS HDL 2006‐28 accessed February 2010 at http://www.sehd.scot.nhs.uk/details.asp?PublicationID=1892



http://www.sehd.scot.nhs.uk/mels/HDL2007_18.pdf

http://emc.medicines.org.uk/

http://www.nhsgrampian.org/grampianfoi/files/Vaccine_Handling_July_07.pdf

http://www.who.int/vaccines-documents/DocsPDF06/847.pdf

http://www.sehd.scot.nhs.uk/details.asp?PublicationID=1892

Appendix 1. : Refrigerator Information Guide These refrigerators meet all the specification criteria listed below:‐ Operational temperature +2°C to +8°C Forced air cooling – interior fan for temperature stability and rapid temperature recovery after door openings. Door lock CFC, HCFC and Ammonia free Auto‐defrost function Efficient operation at high ambient temperatures Integral thermometer which has a digital display recording actual and maximum/minimum temperatures Thermometer has an integral high/low temperature alarm audio/visual

Make Model Dimensions (H)x(W)x(D)

Capacity Shelf Description Glass/Solid Door Thermometer/ Alarm Details

Door AjarAlarm

Labcold® RLDF0110 535x450x485cm 36 litre 2 plastic coated wire mesh Solid, hinged As above plus logger Yes





Labcold® RLDG0510 820x660x610cm 150 litre 3 plastic coated wire mesh Glass, hinged As above plus logger Yes



LEC® PG207 660x502x540cm 67 litres 2 wire mesh plus 1 wire drawer Glass, hinged As Above No

LEC® PE507 863x558x600cm 137 litres 2 wire mesh plus 1 wire drawer Solid, hinged As Above No

LEC® PE907 1550x595x600 275 litres 5 wire mesh plus 1 wire drawer Solid, hinged As Above No

LEC® PE207 660x502x540cm 67 litres 2 wire mesh plus 1 wire drawer Solid, hinged As Above No

Swan® AWR‐SW135 850x500x600cm 135 litres 3 wire Solid, hinged As Above No

Swan® AWR‐SW160 850x600x600cm 160 litres 3 wire Solid, hinged As Above No

Swan® AWRSW175HD 850x600x600cm 175 litres 3 wire Solid, hinged As Above No

Shoreline® SM150 855x550x600cm 150 litres 3 wire mesh Solid, hinged As Above No

IMMUNISATION AND BEST PRACTICE GUIDELINE January 2013

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